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Standardize opioid prescribing after endocrine neck surgery, researchers say
Twenty oral morphine equivalents is the best option for pain relief medication with which to discharge outpatients after thyroidectomy or parathyroidectomy surgery, according to researchers. The report was published online in Annals of Surgical Oncology.
Irene Lou, MD, of the department of surgery at the University of Wisconsin–Madison, and her coauthors conducted a prospective observational cohort study collecting data on pain scores and the oral morphine equivalents used by 313 adult patients undergoing thyroidectomy or parathyroidectomy at two large endocrine surgery centers.
While patients were prescribed a median of 30 oral morphine equivalents at discharge – with a range from 0 to 120 – the median number of equivalents taken was 3 (with a range of 0-60).
Overall, 68.4% of patients took at least one oral morphine equivalent. The majority of patients (83%) took 10 or fewer oral morphine equivalents, and only 7% of patients took more than 20 oral morphine equivalents (Ann Surg Oncol. 2017 Feb 3. doi: 10.1245/s10434-017-5781-y).
Among the patients who took more than 10 oral morphine equivalents, 85% said it was for incisional pain, 4% said it was for sore throat, and 11% said it was for some other pain.
While the overall mean pain score after surgery was 2, the study found that mean pain scores in the patients who took more than 10 oral morphine equivalents were significantly higher than in patients who took 10 or fewer. Among patients who used narcotic pain relief, 1% said they did so because they were instructed to despite having reported no pain.
Other factors predicting higher oral morphine equivalent use were age – patients tended to be younger than 45 years – total thyroidectomy, or a history of previous narcotic use.
“Based on our results, we have changed our practices to discharge all patients undergoing parathyroid or thyroid surgery and to request an oral narcotic prescription with no more than 20 equivalents, which translates to 20 tablets of hydrocodone/acetaminophen 5/325” the authors wrote.
Noting that the abuse and misuse of prescription opioids is the leading cause of overdose deaths in the United States, they argued that standardized prescribing practices are a way to not only reduce waste but also to improve patient safety.
“We also discovered that even between our two institutions, there was no standard prescribing pattern, with a wide range of prescriptions and number of equivalents dispensed.”
The authors also examined alternative and adjunctive methods of pain relief, pointing to previous studies suggesting benefits from preoperative gabapentin, postoperative music therapy, postoperative ice packs, and nonopioid analgesics.
They noted that because their study covered the breadth of endocrine neck operations, it did include patients who had minimally invasive surgery through to those who underwent total thyroidectomy with neck dissections. They also pointed out that the data pain scores and oral morphine equivalent use was based on patient recollection.
“Notwithstanding these limitations, our study is the first to examine outpatient narcotic pain medication use after thyroid and parathyroid surgery,” they said. “A standardized practice of prescribing stands to increase patient safety and minimize the risks of dependence and overdose.”
Two authors were supported by National Institutes of Health grants. No other conflicts of interest were declared.
Twenty oral morphine equivalents is the best option for pain relief medication with which to discharge outpatients after thyroidectomy or parathyroidectomy surgery, according to researchers. The report was published online in Annals of Surgical Oncology.
Irene Lou, MD, of the department of surgery at the University of Wisconsin–Madison, and her coauthors conducted a prospective observational cohort study collecting data on pain scores and the oral morphine equivalents used by 313 adult patients undergoing thyroidectomy or parathyroidectomy at two large endocrine surgery centers.
While patients were prescribed a median of 30 oral morphine equivalents at discharge – with a range from 0 to 120 – the median number of equivalents taken was 3 (with a range of 0-60).
Overall, 68.4% of patients took at least one oral morphine equivalent. The majority of patients (83%) took 10 or fewer oral morphine equivalents, and only 7% of patients took more than 20 oral morphine equivalents (Ann Surg Oncol. 2017 Feb 3. doi: 10.1245/s10434-017-5781-y).
Among the patients who took more than 10 oral morphine equivalents, 85% said it was for incisional pain, 4% said it was for sore throat, and 11% said it was for some other pain.
While the overall mean pain score after surgery was 2, the study found that mean pain scores in the patients who took more than 10 oral morphine equivalents were significantly higher than in patients who took 10 or fewer. Among patients who used narcotic pain relief, 1% said they did so because they were instructed to despite having reported no pain.
Other factors predicting higher oral morphine equivalent use were age – patients tended to be younger than 45 years – total thyroidectomy, or a history of previous narcotic use.
“Based on our results, we have changed our practices to discharge all patients undergoing parathyroid or thyroid surgery and to request an oral narcotic prescription with no more than 20 equivalents, which translates to 20 tablets of hydrocodone/acetaminophen 5/325” the authors wrote.
Noting that the abuse and misuse of prescription opioids is the leading cause of overdose deaths in the United States, they argued that standardized prescribing practices are a way to not only reduce waste but also to improve patient safety.
“We also discovered that even between our two institutions, there was no standard prescribing pattern, with a wide range of prescriptions and number of equivalents dispensed.”
The authors also examined alternative and adjunctive methods of pain relief, pointing to previous studies suggesting benefits from preoperative gabapentin, postoperative music therapy, postoperative ice packs, and nonopioid analgesics.
They noted that because their study covered the breadth of endocrine neck operations, it did include patients who had minimally invasive surgery through to those who underwent total thyroidectomy with neck dissections. They also pointed out that the data pain scores and oral morphine equivalent use was based on patient recollection.
“Notwithstanding these limitations, our study is the first to examine outpatient narcotic pain medication use after thyroid and parathyroid surgery,” they said. “A standardized practice of prescribing stands to increase patient safety and minimize the risks of dependence and overdose.”
Two authors were supported by National Institutes of Health grants. No other conflicts of interest were declared.
Twenty oral morphine equivalents is the best option for pain relief medication with which to discharge outpatients after thyroidectomy or parathyroidectomy surgery, according to researchers. The report was published online in Annals of Surgical Oncology.
Irene Lou, MD, of the department of surgery at the University of Wisconsin–Madison, and her coauthors conducted a prospective observational cohort study collecting data on pain scores and the oral morphine equivalents used by 313 adult patients undergoing thyroidectomy or parathyroidectomy at two large endocrine surgery centers.
While patients were prescribed a median of 30 oral morphine equivalents at discharge – with a range from 0 to 120 – the median number of equivalents taken was 3 (with a range of 0-60).
Overall, 68.4% of patients took at least one oral morphine equivalent. The majority of patients (83%) took 10 or fewer oral morphine equivalents, and only 7% of patients took more than 20 oral morphine equivalents (Ann Surg Oncol. 2017 Feb 3. doi: 10.1245/s10434-017-5781-y).
Among the patients who took more than 10 oral morphine equivalents, 85% said it was for incisional pain, 4% said it was for sore throat, and 11% said it was for some other pain.
While the overall mean pain score after surgery was 2, the study found that mean pain scores in the patients who took more than 10 oral morphine equivalents were significantly higher than in patients who took 10 or fewer. Among patients who used narcotic pain relief, 1% said they did so because they were instructed to despite having reported no pain.
Other factors predicting higher oral morphine equivalent use were age – patients tended to be younger than 45 years – total thyroidectomy, or a history of previous narcotic use.
“Based on our results, we have changed our practices to discharge all patients undergoing parathyroid or thyroid surgery and to request an oral narcotic prescription with no more than 20 equivalents, which translates to 20 tablets of hydrocodone/acetaminophen 5/325” the authors wrote.
Noting that the abuse and misuse of prescription opioids is the leading cause of overdose deaths in the United States, they argued that standardized prescribing practices are a way to not only reduce waste but also to improve patient safety.
“We also discovered that even between our two institutions, there was no standard prescribing pattern, with a wide range of prescriptions and number of equivalents dispensed.”
The authors also examined alternative and adjunctive methods of pain relief, pointing to previous studies suggesting benefits from preoperative gabapentin, postoperative music therapy, postoperative ice packs, and nonopioid analgesics.
They noted that because their study covered the breadth of endocrine neck operations, it did include patients who had minimally invasive surgery through to those who underwent total thyroidectomy with neck dissections. They also pointed out that the data pain scores and oral morphine equivalent use was based on patient recollection.
“Notwithstanding these limitations, our study is the first to examine outpatient narcotic pain medication use after thyroid and parathyroid surgery,” they said. “A standardized practice of prescribing stands to increase patient safety and minimize the risks of dependence and overdose.”
Two authors were supported by National Institutes of Health grants. No other conflicts of interest were declared.
FROM ANNALS OF SURGICAL ONCOLOGY
Key clinical point: Twenty oral morphine equivalents is the ideal amount of pain relief medication with which to discharge outpatients after thyroidectomy or parathyroidectomy surgery.
Major finding: Only 7% of patients who undergo thyroidectomy or parathyroidectomy use more than 20 oral morphine equivalents for postoperative pain relief.
Data source: Observational cohort study of 313 adult patients undergoing thyroidectomy or parathyroidectomy.
Disclosures: Two authors were supported by National Institutes of Health grants. No other conflicts of interest were declared.
Watch and wait often better than resecting in ground-glass opacities
Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.
The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.
Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.
The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.
Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.
After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.
A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.
There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.
Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.
Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”
By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.
Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”
Neither the investigators nor the editorial writer had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.
Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.
Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.
Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.
The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.
Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.
The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.
Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.
After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.
A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.
There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.
Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.
Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”
By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.
Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”
Neither the investigators nor the editorial writer had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.
The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.
Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.
The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.
Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.
After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.
A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.
There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.
Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.
Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”
By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.
Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”
Neither the investigators nor the editorial writer had any relevant disclosures.
[email protected]
On Twitter @whitneymcknight
FROM CHEST
Key clinical point:
Major finding: Of 226 patients with ground-glass opacity lesions 3 cm or less in size, 124 had resection, 57 required no further follow-up, and 45 continue to receive follow-up.
Data source: Long-term study of 226 patients with pure or mixed ground-glass opacities of 3 cm or less given regular CT imaging between 2000 and 2005.
Disclosures: Neither the investigators nor the editorial writer had any relevant disclosures.
One-third of micropapillary thyroid cancer found to be multifocal
LAS VEGAS – Micropapillary thyroid carcinoma may not be as indolent as generally thought, according to the findings of a retrospective study of thyroidectomy cases.
A review of 213 patients diagnosed with the cancer found that 34% of them had multifocal disease, and 14%, metastatic disease, Maggie Bosley reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
Ms. Bosley presented a review of 213 consecutive patients who underwent thyroidectomy from 2007 to 2015, and were found to have micropapillary thyroid cancer. She reviewed the pathology reports for tumor size, presence or absence of metastases in the central and lateral node basins, and multifocality.
Most of the patients (88%) were women, with an average age of 56 years, although the range was wide (18-89 years).
About a third of the patients (73; 34%) had multifocal disease. This was bilateral in 21 (29%). Metastasis to the central nodes was present in 31 patients (14%); 4 of these patients also had positive lateral neck node metastases (2%).
“Approximately 13% of patients with node metastasis also required selective lateral neck dissections,” Ms. Bosley said.
She noted that, in 2015, the American Thyroid Association published a set of guidelines for diagnosing and treating micropapillary cancer. The guidelines suggest that most of these cancers can be safely followed with ultrasound exams, if there is no extrathyroid extension or nodal metastasis.
“However, ultrasound surveillance [quality] is very operator dependent,” Ms. Bosley said. Technician skill “could potentially impact the quality of surveillance.”
She had no relevant financial declarations.
[email protected]
On Twitter @Alz_Gal
LAS VEGAS – Micropapillary thyroid carcinoma may not be as indolent as generally thought, according to the findings of a retrospective study of thyroidectomy cases.
A review of 213 patients diagnosed with the cancer found that 34% of them had multifocal disease, and 14%, metastatic disease, Maggie Bosley reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
Ms. Bosley presented a review of 213 consecutive patients who underwent thyroidectomy from 2007 to 2015, and were found to have micropapillary thyroid cancer. She reviewed the pathology reports for tumor size, presence or absence of metastases in the central and lateral node basins, and multifocality.
Most of the patients (88%) were women, with an average age of 56 years, although the range was wide (18-89 years).
About a third of the patients (73; 34%) had multifocal disease. This was bilateral in 21 (29%). Metastasis to the central nodes was present in 31 patients (14%); 4 of these patients also had positive lateral neck node metastases (2%).
“Approximately 13% of patients with node metastasis also required selective lateral neck dissections,” Ms. Bosley said.
She noted that, in 2015, the American Thyroid Association published a set of guidelines for diagnosing and treating micropapillary cancer. The guidelines suggest that most of these cancers can be safely followed with ultrasound exams, if there is no extrathyroid extension or nodal metastasis.
“However, ultrasound surveillance [quality] is very operator dependent,” Ms. Bosley said. Technician skill “could potentially impact the quality of surveillance.”
She had no relevant financial declarations.
[email protected]
On Twitter @Alz_Gal
LAS VEGAS – Micropapillary thyroid carcinoma may not be as indolent as generally thought, according to the findings of a retrospective study of thyroidectomy cases.
A review of 213 patients diagnosed with the cancer found that 34% of them had multifocal disease, and 14%, metastatic disease, Maggie Bosley reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
Ms. Bosley presented a review of 213 consecutive patients who underwent thyroidectomy from 2007 to 2015, and were found to have micropapillary thyroid cancer. She reviewed the pathology reports for tumor size, presence or absence of metastases in the central and lateral node basins, and multifocality.
Most of the patients (88%) were women, with an average age of 56 years, although the range was wide (18-89 years).
About a third of the patients (73; 34%) had multifocal disease. This was bilateral in 21 (29%). Metastasis to the central nodes was present in 31 patients (14%); 4 of these patients also had positive lateral neck node metastases (2%).
“Approximately 13% of patients with node metastasis also required selective lateral neck dissections,” Ms. Bosley said.
She noted that, in 2015, the American Thyroid Association published a set of guidelines for diagnosing and treating micropapillary cancer. The guidelines suggest that most of these cancers can be safely followed with ultrasound exams, if there is no extrathyroid extension or nodal metastasis.
“However, ultrasound surveillance [quality] is very operator dependent,” Ms. Bosley said. Technician skill “could potentially impact the quality of surveillance.”
She had no relevant financial declarations.
[email protected]
On Twitter @Alz_Gal
AT THE ACADEMIC SURGICAL CONGRESS
Key clinical point:
Major finding: Micropapillary thyroid cancer was metastatic in 14% of cases.
Data source: A review involving 213 patients.
Disclosures: Ms. Bosley had no relevant financial disclosures.
Can a nomogram foretell invasive pulmonary adenocarcinoma?
The diagnosis of solitary peripheral subsolid nodule carries with it an undefined risk of invasive pulmonary carcinoma, but clinicians have not had a tool that can help guide their planning for surgery. However, researchers in China have developed a nomogram that they said may aid clinicians to predict the risk of invasive pulmonary adenocarcinoma in these patients.
“Validation by the use of bootstrap resampling revealed optimal discrimination and calibration, indicating that the nomogram may have clinical utility,” said Chenghua Jin, MD, and Jinlin Cao, MD, of Zhejiang University, Hangzhou, China, and coauthors. They reported their findings in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:42-9).
The nomogram accounts for the following factors: computed tomography attenuation; nodule size; spiculation; signs of vascular convergence; pleural tags; and solid proportion. “The nomogram showed a robust discrimination with an area under the receiver operating characteristic curve of 0.894,” Dr. Jin and coauthors reported. An area under the curve of 1 is equivalent to 100%, so the area under the curve this study reported shows close to 90% accuracy.
The study involved a retrospective analysis of 273 consecutive patients who had resection of a solitary peripheral subsolid nodule at Zhejiang University School of Medicine from January 2013 to December 2014. Subsolid pulmonary nodules include pure ground-glass nodules and part-solid nodules that feature both solid and ground-glass components. “The optimal management of patients with a subsolid nodule is of growing clinical concern, because the most common diagnosis for resected subsolid nodules is lung adenocarcinoma,” Dr. Jin and colleagues indicated.
Of the study population, 58% were diagnosed with invasive pulmonary adenocarcinoma. Other diagnoses within the group were benign (13%), atypical adenomatous hyperplasia (1%), adenocarcinoma in situ (6.5%) and minimally invasive adenocarcinoma (21%).
Results of the multivariable analyses showed that invasive pulmonary adenocarcinoma correlated with the following characteristics: lesion size; spiculation; vascular convergence; and pleural tag. Factors that were not significant included age, family history of lung cancer, CT attenuation, and solid proportion. However, the researchers did include CT attenuation, along with solid proportion, in the final regression analysis based on their contributions to the statistical analysis.
For the model, CT attenuation of –500 to –200 Hounsfield units carried an odds ratio of 1.690 (P = .228) while CT attenuation greater than –200 HU had an OR of 1.791 (P = .645). Positive spiculation had an OR of 3.312 (no P value given) and negative vascular convergence an OR of 0.300 (no P value given).
While a number of prediction models have been devised and validated to evaluate the likelihood of malignancy in pulmonary nodules, they have not given subsolid nodules “specific or detailed consideration,” Dr. Jin and and coauthors said. “To our knowledge, this study was the first to construct a quantitative nomogram to predict the probability of invasive pulmonary adenocarcinoma in patients with subsolid nodules,” the researchers wrote.
One limitation of the study is its selection bias toward patients with a greater probability of having a malignancy. Also, validation of the nomogram requires external analysis with additional databases from other countries and with more diverse ethnic groups. Another shortcoming is the retrospective nature of the study and a small number of patients who had positron emission tomography. “Further data collection, wider geographic recruitment, and incorporation of positron emission tomography results and some molecular factors could improve this model for future use,” Dr. Jin and coauthors concluded.
Dr. Jin and Dr. Cao had no relevant financial disclosures. The study received funding from the Zhejiang Province Science and Technology Plan.
The nomogram Dr. Jin and coauthors present can be a valuable tool for determining the extent of resection of subsolid pulmonary nodules and to distinguish invasive from preinvasive disease where preoperative needle biopsy and intraopertiave frozen section typically cannot, Bryan Burt, MD, of Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:460-1).
“However,” Dr. Burt added, “as the accuracy of frozen section for this disease improves, as it has in select centers, the clinical utility of such a nomogram will diminish.”
Use of the nomogram relies on experienced chest radiologists to aid in scoring variables and a validation methodology that a retrospective trial cannot meet, Dr. Burt said. “Of note, this nomogram was constructed from a dataset composed of only surgically resected lesions, and it will be imperative to validate these methods among a larger cohort of individuals with subsolid pulmonary nodules treated both surgically and nonsurgically, ideally in a prospective trial,” Dr. Burt concluded.
Dr. Burt had no relevant financial disclosures.
The nomogram Dr. Jin and coauthors present can be a valuable tool for determining the extent of resection of subsolid pulmonary nodules and to distinguish invasive from preinvasive disease where preoperative needle biopsy and intraopertiave frozen section typically cannot, Bryan Burt, MD, of Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:460-1).
“However,” Dr. Burt added, “as the accuracy of frozen section for this disease improves, as it has in select centers, the clinical utility of such a nomogram will diminish.”
Use of the nomogram relies on experienced chest radiologists to aid in scoring variables and a validation methodology that a retrospective trial cannot meet, Dr. Burt said. “Of note, this nomogram was constructed from a dataset composed of only surgically resected lesions, and it will be imperative to validate these methods among a larger cohort of individuals with subsolid pulmonary nodules treated both surgically and nonsurgically, ideally in a prospective trial,” Dr. Burt concluded.
Dr. Burt had no relevant financial disclosures.
The nomogram Dr. Jin and coauthors present can be a valuable tool for determining the extent of resection of subsolid pulmonary nodules and to distinguish invasive from preinvasive disease where preoperative needle biopsy and intraopertiave frozen section typically cannot, Bryan Burt, MD, of Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:460-1).
“However,” Dr. Burt added, “as the accuracy of frozen section for this disease improves, as it has in select centers, the clinical utility of such a nomogram will diminish.”
Use of the nomogram relies on experienced chest radiologists to aid in scoring variables and a validation methodology that a retrospective trial cannot meet, Dr. Burt said. “Of note, this nomogram was constructed from a dataset composed of only surgically resected lesions, and it will be imperative to validate these methods among a larger cohort of individuals with subsolid pulmonary nodules treated both surgically and nonsurgically, ideally in a prospective trial,” Dr. Burt concluded.
Dr. Burt had no relevant financial disclosures.
The diagnosis of solitary peripheral subsolid nodule carries with it an undefined risk of invasive pulmonary carcinoma, but clinicians have not had a tool that can help guide their planning for surgery. However, researchers in China have developed a nomogram that they said may aid clinicians to predict the risk of invasive pulmonary adenocarcinoma in these patients.
“Validation by the use of bootstrap resampling revealed optimal discrimination and calibration, indicating that the nomogram may have clinical utility,” said Chenghua Jin, MD, and Jinlin Cao, MD, of Zhejiang University, Hangzhou, China, and coauthors. They reported their findings in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:42-9).
The nomogram accounts for the following factors: computed tomography attenuation; nodule size; spiculation; signs of vascular convergence; pleural tags; and solid proportion. “The nomogram showed a robust discrimination with an area under the receiver operating characteristic curve of 0.894,” Dr. Jin and coauthors reported. An area under the curve of 1 is equivalent to 100%, so the area under the curve this study reported shows close to 90% accuracy.
The study involved a retrospective analysis of 273 consecutive patients who had resection of a solitary peripheral subsolid nodule at Zhejiang University School of Medicine from January 2013 to December 2014. Subsolid pulmonary nodules include pure ground-glass nodules and part-solid nodules that feature both solid and ground-glass components. “The optimal management of patients with a subsolid nodule is of growing clinical concern, because the most common diagnosis for resected subsolid nodules is lung adenocarcinoma,” Dr. Jin and colleagues indicated.
Of the study population, 58% were diagnosed with invasive pulmonary adenocarcinoma. Other diagnoses within the group were benign (13%), atypical adenomatous hyperplasia (1%), adenocarcinoma in situ (6.5%) and minimally invasive adenocarcinoma (21%).
Results of the multivariable analyses showed that invasive pulmonary adenocarcinoma correlated with the following characteristics: lesion size; spiculation; vascular convergence; and pleural tag. Factors that were not significant included age, family history of lung cancer, CT attenuation, and solid proportion. However, the researchers did include CT attenuation, along with solid proportion, in the final regression analysis based on their contributions to the statistical analysis.
For the model, CT attenuation of –500 to –200 Hounsfield units carried an odds ratio of 1.690 (P = .228) while CT attenuation greater than –200 HU had an OR of 1.791 (P = .645). Positive spiculation had an OR of 3.312 (no P value given) and negative vascular convergence an OR of 0.300 (no P value given).
While a number of prediction models have been devised and validated to evaluate the likelihood of malignancy in pulmonary nodules, they have not given subsolid nodules “specific or detailed consideration,” Dr. Jin and and coauthors said. “To our knowledge, this study was the first to construct a quantitative nomogram to predict the probability of invasive pulmonary adenocarcinoma in patients with subsolid nodules,” the researchers wrote.
One limitation of the study is its selection bias toward patients with a greater probability of having a malignancy. Also, validation of the nomogram requires external analysis with additional databases from other countries and with more diverse ethnic groups. Another shortcoming is the retrospective nature of the study and a small number of patients who had positron emission tomography. “Further data collection, wider geographic recruitment, and incorporation of positron emission tomography results and some molecular factors could improve this model for future use,” Dr. Jin and coauthors concluded.
Dr. Jin and Dr. Cao had no relevant financial disclosures. The study received funding from the Zhejiang Province Science and Technology Plan.
The diagnosis of solitary peripheral subsolid nodule carries with it an undefined risk of invasive pulmonary carcinoma, but clinicians have not had a tool that can help guide their planning for surgery. However, researchers in China have developed a nomogram that they said may aid clinicians to predict the risk of invasive pulmonary adenocarcinoma in these patients.
“Validation by the use of bootstrap resampling revealed optimal discrimination and calibration, indicating that the nomogram may have clinical utility,” said Chenghua Jin, MD, and Jinlin Cao, MD, of Zhejiang University, Hangzhou, China, and coauthors. They reported their findings in the February issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:42-9).
The nomogram accounts for the following factors: computed tomography attenuation; nodule size; spiculation; signs of vascular convergence; pleural tags; and solid proportion. “The nomogram showed a robust discrimination with an area under the receiver operating characteristic curve of 0.894,” Dr. Jin and coauthors reported. An area under the curve of 1 is equivalent to 100%, so the area under the curve this study reported shows close to 90% accuracy.
The study involved a retrospective analysis of 273 consecutive patients who had resection of a solitary peripheral subsolid nodule at Zhejiang University School of Medicine from January 2013 to December 2014. Subsolid pulmonary nodules include pure ground-glass nodules and part-solid nodules that feature both solid and ground-glass components. “The optimal management of patients with a subsolid nodule is of growing clinical concern, because the most common diagnosis for resected subsolid nodules is lung adenocarcinoma,” Dr. Jin and colleagues indicated.
Of the study population, 58% were diagnosed with invasive pulmonary adenocarcinoma. Other diagnoses within the group were benign (13%), atypical adenomatous hyperplasia (1%), adenocarcinoma in situ (6.5%) and minimally invasive adenocarcinoma (21%).
Results of the multivariable analyses showed that invasive pulmonary adenocarcinoma correlated with the following characteristics: lesion size; spiculation; vascular convergence; and pleural tag. Factors that were not significant included age, family history of lung cancer, CT attenuation, and solid proportion. However, the researchers did include CT attenuation, along with solid proportion, in the final regression analysis based on their contributions to the statistical analysis.
For the model, CT attenuation of –500 to –200 Hounsfield units carried an odds ratio of 1.690 (P = .228) while CT attenuation greater than –200 HU had an OR of 1.791 (P = .645). Positive spiculation had an OR of 3.312 (no P value given) and negative vascular convergence an OR of 0.300 (no P value given).
While a number of prediction models have been devised and validated to evaluate the likelihood of malignancy in pulmonary nodules, they have not given subsolid nodules “specific or detailed consideration,” Dr. Jin and and coauthors said. “To our knowledge, this study was the first to construct a quantitative nomogram to predict the probability of invasive pulmonary adenocarcinoma in patients with subsolid nodules,” the researchers wrote.
One limitation of the study is its selection bias toward patients with a greater probability of having a malignancy. Also, validation of the nomogram requires external analysis with additional databases from other countries and with more diverse ethnic groups. Another shortcoming is the retrospective nature of the study and a small number of patients who had positron emission tomography. “Further data collection, wider geographic recruitment, and incorporation of positron emission tomography results and some molecular factors could improve this model for future use,” Dr. Jin and coauthors concluded.
Dr. Jin and Dr. Cao had no relevant financial disclosures. The study received funding from the Zhejiang Province Science and Technology Plan.
EXPERT ANALYSIS FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Investigators developed a nomogram that may help predict the risk of invasive pulmonary adenocarcinoma for patients with a solitary peripheral subsolid nodule.
Major finding: This nomogram may help clinicians individualize each patient’s prognosis for invasive pulmonary adenocarcinoma and develop treatment plans accordingly.
Data source: Retrospective analysis of 273 consecutive patients who had surgery to remove a solitary peripheral subsolid nodule at a single center.
Disclosure: The investigators received support from the Zhejiang Province Science and Technology Plan. Dr. Jin and Dr. Cao reported having no relevant financial disclosures.
RNA-based biopsy test bests NCCN risk stratification for PC prognosis
ORLANDO – A genetic assay for prostate cancer typically used after radical prostatectomy could be used earlier, at the time of diagnostic biopsy testing, to classify patients as low, intermediate, and high risk for metastasis and disease-specific mortality, new research reveals.
Based on an approximately 1-mm biopsy sample, the Decipher Prostate Cancer Classifier assesses the activity of 22 genes relevant to prostate cancer. In a multicenter study of 175 patients, investigators found the 5-year risk for metastatic disease was 5.0% among patients classified as low risk by Decipher, 9.3% in the intermediate-risk group, and 23.4% in the high-risk patients.
“It turns out NCCN [National Comprehensive Cancer Network] risk groups can also provide this kind of risk stratification … so why do we need the extra test?” lead author Paul L. Nguyen, MD, of Dana-Farber Cancer Institute in Boston said here at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. Because, he added, Decipher provides “significant prognostic information for distant metastases beyond clinical variables alone,” even after controlling for prostate-specific antigen level, Gleason score, and treatment type, Dr. Nguyen said.
The Decipher RNA–based test also improved the c-index for predicting likelihood of distant metastases, with a 0.75 correlation, compared with 0.66 with NCCN risk stratification and 0.66 based on Cancer of the Prostate Risk Assessment score. “So this adds to what we already know, and it helps us decide which patients are going to develop metastases.”
Decipher’s prognostic value emerged regardless of first line therapy. A total 100 patients received radiation and androgen therapy at Dana-Farber and another 75 underwent radical prostatectomy at the Cleveland Clinic or Johns Hopkins University, Baltimore. Decipher classified 13% of patients as low risk, 51% as intermediate risk, and 34% as high risk. Because prostate tumors can be heterogeneous, researchers chose the highest-grade biopsy sample for each patient.
Local Therapy for High-Risk Patients?
A meeting attendee asked if a patient is “known to be high risk on biopsy, and has a 23% chance of metastasis after treatment, why treat with local treatment in the first place?”
“For these patients, we’re meeting them up front and they have a high risk of disease, a 23% chance of metastasis, I think we’re going to throw everything we can at them,” Dr. Nguyen said. Multiple randomized controlled trials indicate intensifying therapy can improve outcomes and that local therapy contributes to overall survival in these patients, he added. “For these patients who have very high risk disease, we have enough randomized data to show local therapy is still important. The next thing we need to do is work on personalizing their systemic therapy, and figuring out how to integrate these novel systemic therapies based on their genomic scores.”
Disease-Specific Survival
Eleven participants in the study died from prostate cancer. The only variable associated with prostate-specific disease mortality was the Decipher classification, with a hazard ratio of 1.57 for every 10% increase in the score on a univariate model (P = .02).
Dr. Nguyen and his coinvestigators also assessed 5-year prostate cancer specific mortality. They found a 9.4% rate in the Decipher high-risk group, compared with 0% in both the intermediate- and low-risk groups.
“Okay, we have this data. How do we incorporate this test into our practices?” Dr. Nguyen asked. Because the low-risk patients only comprised 13% of the study population, he was unable to state that this group could be directed to active surveillance based on the findings.
What about NCCN intermediate risk? Should these people treated with dose-escalated radiation therapy also be given short-course hormone therapy? “So far we have not seen a survival improvement, and we’re awaiting a definitive trial,” Dr. Nguyen said.
Prognostic, Not Predictive
Could the high-risk classification help physicians decide among prostatectomy, radiation, and long-course hormone therapy versus enrolling patients in a clinical trial to test a novel agent? “Perhaps, and there is some rationale for thinking in that direction,” Dr. Nguyen said. “But it is important to understand the difference between a prognostic and predictive biomarker. We’ve shown Decipher has prognostic value for identifying patients at risk for distant metastases and death.” In contrast, randomized controlled trials would be required to identify a predictive marker that ultimately could guide choice of treatment in an individual, he said.
“Robust markers are needed to see who needs treatment, and which treatment is best for primary and metastatic prostate cancer,” said study discussant Angelo DeMarzo, MD, PhD, of Johns Hopkins University. He asked Dr. Nguyen about the next best step in his research.
“Our paper was mostly intermediate- and high-risk patients; I would personally love to learn more about which patients need long-course, short-course, or no hormone treatment,” Dr. Nguyen said. He would also like to conduct randomized trials to assess any role of Decipher classification for active surveillance, and for guiding treatment intensification versus de-escalation for those patients who receive therapy.
ORLANDO – A genetic assay for prostate cancer typically used after radical prostatectomy could be used earlier, at the time of diagnostic biopsy testing, to classify patients as low, intermediate, and high risk for metastasis and disease-specific mortality, new research reveals.
Based on an approximately 1-mm biopsy sample, the Decipher Prostate Cancer Classifier assesses the activity of 22 genes relevant to prostate cancer. In a multicenter study of 175 patients, investigators found the 5-year risk for metastatic disease was 5.0% among patients classified as low risk by Decipher, 9.3% in the intermediate-risk group, and 23.4% in the high-risk patients.
“It turns out NCCN [National Comprehensive Cancer Network] risk groups can also provide this kind of risk stratification … so why do we need the extra test?” lead author Paul L. Nguyen, MD, of Dana-Farber Cancer Institute in Boston said here at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. Because, he added, Decipher provides “significant prognostic information for distant metastases beyond clinical variables alone,” even after controlling for prostate-specific antigen level, Gleason score, and treatment type, Dr. Nguyen said.
The Decipher RNA–based test also improved the c-index for predicting likelihood of distant metastases, with a 0.75 correlation, compared with 0.66 with NCCN risk stratification and 0.66 based on Cancer of the Prostate Risk Assessment score. “So this adds to what we already know, and it helps us decide which patients are going to develop metastases.”
Decipher’s prognostic value emerged regardless of first line therapy. A total 100 patients received radiation and androgen therapy at Dana-Farber and another 75 underwent radical prostatectomy at the Cleveland Clinic or Johns Hopkins University, Baltimore. Decipher classified 13% of patients as low risk, 51% as intermediate risk, and 34% as high risk. Because prostate tumors can be heterogeneous, researchers chose the highest-grade biopsy sample for each patient.
Local Therapy for High-Risk Patients?
A meeting attendee asked if a patient is “known to be high risk on biopsy, and has a 23% chance of metastasis after treatment, why treat with local treatment in the first place?”
“For these patients, we’re meeting them up front and they have a high risk of disease, a 23% chance of metastasis, I think we’re going to throw everything we can at them,” Dr. Nguyen said. Multiple randomized controlled trials indicate intensifying therapy can improve outcomes and that local therapy contributes to overall survival in these patients, he added. “For these patients who have very high risk disease, we have enough randomized data to show local therapy is still important. The next thing we need to do is work on personalizing their systemic therapy, and figuring out how to integrate these novel systemic therapies based on their genomic scores.”
Disease-Specific Survival
Eleven participants in the study died from prostate cancer. The only variable associated with prostate-specific disease mortality was the Decipher classification, with a hazard ratio of 1.57 for every 10% increase in the score on a univariate model (P = .02).
Dr. Nguyen and his coinvestigators also assessed 5-year prostate cancer specific mortality. They found a 9.4% rate in the Decipher high-risk group, compared with 0% in both the intermediate- and low-risk groups.
“Okay, we have this data. How do we incorporate this test into our practices?” Dr. Nguyen asked. Because the low-risk patients only comprised 13% of the study population, he was unable to state that this group could be directed to active surveillance based on the findings.
What about NCCN intermediate risk? Should these people treated with dose-escalated radiation therapy also be given short-course hormone therapy? “So far we have not seen a survival improvement, and we’re awaiting a definitive trial,” Dr. Nguyen said.
Prognostic, Not Predictive
Could the high-risk classification help physicians decide among prostatectomy, radiation, and long-course hormone therapy versus enrolling patients in a clinical trial to test a novel agent? “Perhaps, and there is some rationale for thinking in that direction,” Dr. Nguyen said. “But it is important to understand the difference between a prognostic and predictive biomarker. We’ve shown Decipher has prognostic value for identifying patients at risk for distant metastases and death.” In contrast, randomized controlled trials would be required to identify a predictive marker that ultimately could guide choice of treatment in an individual, he said.
“Robust markers are needed to see who needs treatment, and which treatment is best for primary and metastatic prostate cancer,” said study discussant Angelo DeMarzo, MD, PhD, of Johns Hopkins University. He asked Dr. Nguyen about the next best step in his research.
“Our paper was mostly intermediate- and high-risk patients; I would personally love to learn more about which patients need long-course, short-course, or no hormone treatment,” Dr. Nguyen said. He would also like to conduct randomized trials to assess any role of Decipher classification for active surveillance, and for guiding treatment intensification versus de-escalation for those patients who receive therapy.
ORLANDO – A genetic assay for prostate cancer typically used after radical prostatectomy could be used earlier, at the time of diagnostic biopsy testing, to classify patients as low, intermediate, and high risk for metastasis and disease-specific mortality, new research reveals.
Based on an approximately 1-mm biopsy sample, the Decipher Prostate Cancer Classifier assesses the activity of 22 genes relevant to prostate cancer. In a multicenter study of 175 patients, investigators found the 5-year risk for metastatic disease was 5.0% among patients classified as low risk by Decipher, 9.3% in the intermediate-risk group, and 23.4% in the high-risk patients.
“It turns out NCCN [National Comprehensive Cancer Network] risk groups can also provide this kind of risk stratification … so why do we need the extra test?” lead author Paul L. Nguyen, MD, of Dana-Farber Cancer Institute in Boston said here at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. Because, he added, Decipher provides “significant prognostic information for distant metastases beyond clinical variables alone,” even after controlling for prostate-specific antigen level, Gleason score, and treatment type, Dr. Nguyen said.
The Decipher RNA–based test also improved the c-index for predicting likelihood of distant metastases, with a 0.75 correlation, compared with 0.66 with NCCN risk stratification and 0.66 based on Cancer of the Prostate Risk Assessment score. “So this adds to what we already know, and it helps us decide which patients are going to develop metastases.”
Decipher’s prognostic value emerged regardless of first line therapy. A total 100 patients received radiation and androgen therapy at Dana-Farber and another 75 underwent radical prostatectomy at the Cleveland Clinic or Johns Hopkins University, Baltimore. Decipher classified 13% of patients as low risk, 51% as intermediate risk, and 34% as high risk. Because prostate tumors can be heterogeneous, researchers chose the highest-grade biopsy sample for each patient.
Local Therapy for High-Risk Patients?
A meeting attendee asked if a patient is “known to be high risk on biopsy, and has a 23% chance of metastasis after treatment, why treat with local treatment in the first place?”
“For these patients, we’re meeting them up front and they have a high risk of disease, a 23% chance of metastasis, I think we’re going to throw everything we can at them,” Dr. Nguyen said. Multiple randomized controlled trials indicate intensifying therapy can improve outcomes and that local therapy contributes to overall survival in these patients, he added. “For these patients who have very high risk disease, we have enough randomized data to show local therapy is still important. The next thing we need to do is work on personalizing their systemic therapy, and figuring out how to integrate these novel systemic therapies based on their genomic scores.”
Disease-Specific Survival
Eleven participants in the study died from prostate cancer. The only variable associated with prostate-specific disease mortality was the Decipher classification, with a hazard ratio of 1.57 for every 10% increase in the score on a univariate model (P = .02).
Dr. Nguyen and his coinvestigators also assessed 5-year prostate cancer specific mortality. They found a 9.4% rate in the Decipher high-risk group, compared with 0% in both the intermediate- and low-risk groups.
“Okay, we have this data. How do we incorporate this test into our practices?” Dr. Nguyen asked. Because the low-risk patients only comprised 13% of the study population, he was unable to state that this group could be directed to active surveillance based on the findings.
What about NCCN intermediate risk? Should these people treated with dose-escalated radiation therapy also be given short-course hormone therapy? “So far we have not seen a survival improvement, and we’re awaiting a definitive trial,” Dr. Nguyen said.
Prognostic, Not Predictive
Could the high-risk classification help physicians decide among prostatectomy, radiation, and long-course hormone therapy versus enrolling patients in a clinical trial to test a novel agent? “Perhaps, and there is some rationale for thinking in that direction,” Dr. Nguyen said. “But it is important to understand the difference between a prognostic and predictive biomarker. We’ve shown Decipher has prognostic value for identifying patients at risk for distant metastases and death.” In contrast, randomized controlled trials would be required to identify a predictive marker that ultimately could guide choice of treatment in an individual, he said.
“Robust markers are needed to see who needs treatment, and which treatment is best for primary and metastatic prostate cancer,” said study discussant Angelo DeMarzo, MD, PhD, of Johns Hopkins University. He asked Dr. Nguyen about the next best step in his research.
“Our paper was mostly intermediate- and high-risk patients; I would personally love to learn more about which patients need long-course, short-course, or no hormone treatment,” Dr. Nguyen said. He would also like to conduct randomized trials to assess any role of Decipher classification for active surveillance, and for guiding treatment intensification versus de-escalation for those patients who receive therapy.
AT THE GENITOURINARY CANCERS SYMPOSIUM
Key clinical point: A genomic test accurately risk stratifies patients with prostate cancer in study.
Major finding: Five-year risk of metastasis was 5.0% in a low-risk group, 9.3% in an intermediate-risk group, and 23.4% in a high-risk group.
Data source: A multicenter trial of needle biopsy samples taken from 175 people with prostate cancer.
Disclosures: Dr, Nguyen is a consultant/advisor for Ferring, GenomeDx, and Medivation, and also receives research funding from Astellas.
New AJCC guidance brings melanoma staging changes
WAILEA, HAWAII – The Eighth Edition of the American Joint Committee on Cancer Staging Manual includes significant changes in how melanoma is classified.
The manual has already been published and is available for purchase. However, its implementation will be delayed until Jan. 1, 2018, to give physicians, software vendors, and all other interested parties time to get up to speed. All cancers newly diagnosed through Dec. 31, 2017 should be staged in accord with the seventh edition, released in 2010.
The eighth edition breaks new ground, moving beyond TNM (Tumor, Node, Metastasis) anatomic staging to incorporate new evidence-based prognostic factors.
“There are some subtle differences here to be aware of. It can be a little bit tricky at first glance. You should become familiar with this,” advised Dr. Marchetti, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.
In addition to highlighting the changes in melanoma staging included in the new AJCC manual, he outlined key recommendations – some of them controversial – on the use of sentinel lymph node biopsy (SLNB) in melanoma patients incorporated in the 2017 National Comprehensive Cancer Network (NCCN) guidelines.
The biggest change for the dermatology community contained in the new edition of the AJCC staging manual is that the T1 classification of melanoma has changed. In the seventh edition, a melanoma was categorized as T1 if less than or equal to 1.0 mm thickness. The cancer was T1a if nonulcerated and had a mitosis rate of less than 1/mm2 and T1b if ulcerated or had at least 1 mitosis/mm2.
The eighth edition makes an evidence-based subcategorization of T1 based upon thickness in light of the prognostic implications of this distinction. A melanoma is defined as T1a if nonulcerated and less than 0.8 mm in thickness, and T1b if it is 0.8-1.0 mm thick or less than 0.8 mm with ulceration.
Of note, tumor mitotic rate has been dropped as a staging criterion for T1 tumors.
What this means is, for example, in 2017, a patient with a 0.9-mm nonulcerated melanoma with 1 mitosis/mm2 and a negative sentinel lymph node biopsy with wide local excision is T1bN0M0, pathologic Stage IB. Under the eighth edition of AJCC, the same patient is T1bN0M0, pathologic Stage IA, because that mitosis rate isn’t a factor.
Today, a patient with a 0.5-mm melanoma with 1 mitosis/mm2 with wide local excision is T1bN0M0, Pathologic Stage IB. Under the new system, the same tumor is downstaged to Pathologic Stage IA, Dr. Marchetti explained.
In the eighth edition, tumor thickness measurements are recorded with rounding to the nearest 0.1 mm, not to the nearest 0.01 mm as before. This change was prompted by the inherent lack of precision in measuring melanomas, especially thicker ones.
The T category definitions of primary tumors have been clarified in the eighth edition. A tumor should be classified as T0 only if there is no evidence of a primary tumor. T is utilized for melanoma in situ. TX is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained through curettage.
The N categorization of regional lymph node status has become much more complicated in the eighth edition, the dermatologist cautioned. Plus, the terminology for nodal disease has changed. The term micrometastasis has been replaced by “clinically occult disease” as detected by SLNB. Macrometastasis has been supplanted by “clinically detected disease.” And while in-transit or satellite node metastasis or microsatellite metastasis with satellite nodes was formerly listed simply as N3, in the new system there are subcategories for N3 based upon the number of metastatic nodes involved. For example, in the eighth edition, a melanoma is pathologic Stage N3a if there are four or more clinically occult regional lymph nodes and no in-transit, satellite, or matted nodes. Pathologic Stage N3b is shorthand for four or more tumor-involved regional lymph nodes, at least one of which was clinically detected, or any number of matted lymph nodes, with no in-transit or satellite nodal involvement. Stage N3c is reserved for melanomas with two or more clinically occult or clinically detected regional lymph nodes and/or any number of matted nodes, plus the presence of in-transit or satellite nodal metastasis.
As a result of the changes in the N classification, there are now four pathologic Stage III groups rather than three. Stages IIIA-C have been joined by pathologic Stage IIID, reserved for patients who are T4b, N3a, b, or c, and M0.
The M categorization of distant metastatic disease status has also become more elaborate. In the AJCC seventh edition, if serum lactate dehydrogenase (LDH) is elevated and a patient has any distant metastatic disease, that’s automatically category M1c. Not any longer, though.
Under the eighth edition, if a patient has distant metastasis to skin, soft tissue including muscle, and/or nonregional lymph nodes and the LDH is unspecified, the categorization is M1a. If serum LDH is not elevated, it’s M1a(0). If elevated, then M1a(1).
Similarly, for distant metastasis to the lung, the range of possibilities based upon LDH is M1b, M1b(0), and M1b(1). For distant metastasis to non-CNS visceral sites, the possibilities are M1c, M1c(0), and M1c(1).
M1d is a new classification, a clear departure from the seventh edition. It applies to patients with distant metastasis to the CNS. The classification is M1d if LDH isn’t recorded, M1d(0) if LDH isn’t elevated, and M1d(1) if it is.
Turning to the updated 2017 NCCN guidelines Version 1.2017 on the role of SLNB in melanoma, Dr. Marchetti noted that the procedure is not recommended in patients with melanoma in situ or Stage IA or IB disease 0.75 mm or less in thickness, regardless of features. Neither are routine imaging or lab tests. That’s because the pretest probability of a positive SLNB is so low, at around 3%.
For Clinicopathologic Stage IA disease, 0.76-1.0 mm in thickness with no ulceration and a mitotic rate of less than 1 per mm2, the guidelines recommend that physicians “discuss and consider” SLNB, which the available evidence suggests has roughly a 7% pretest probability of a positive result.
For Stage IB disease, 0.76-1.0 mm in thickness with ulceration or a mitotic rate of at least 1 per mm2, as well as for Stage IB or Stage II disease greater than 1.0 mm in thickness, with any feature, the language of the recommendation shifts to “discuss and offer” rather than “discuss and consider” SLNB, since various studies have reported pretest probabilities of a positive result as high as 35%.
“The rationale here for performing sentinel lymph node biopsy is primarily to acquire more staging information. Is it a perfect test? Absolutely not. But it’s the current standard of care in terms of providing additional information for staging,” according to Dr. Marchetti.
If the SLNB generates a positive result, by definition the patient now has Stage III melanoma. The NCCN guidelines recommend consideration of imaging to establish a baseline, and state further that the primary treatment is to discuss and offer complete lymph node dissection in order to control the regional nodal basin and because of a possible favorable impact on overall survival. But the question of a survival benefit has been controversial for many years, and it’s unlikely to be resolved soon, Dr. Marchetti predicted.
The final report from the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–1 (MSLT-1) concluded that patients with primary cutaneous melanomas 1.2 mm or more in thickness who were randomized to undergo SLNB and, if positive, immediate complete lymphadenectomy, fared significantly better in terms of 10-year disease-free survival, compared with those assigned to observation and lymphadenectomy in the event of nodal relapse (N Engl J Med. 2014 Feb 13;370[7]:599-609).
This conclusion has generated numerous letters to the editor from melanoma experts who took issue with the analysis and conclusion. To try to put the MSLT-1 results in perspective, Dr. Marchetti applied the results to a hypothetical cohort of 100 patients with intermediate-thickness melanomas of 1.2-3.5 mm undergoing SLNB.
Eighty of these patients would be true SLNB-negative for regional nodal disease. Five others would have a false-negative SLNB and would later develop clinically detectable nodal disease. Fifteen patients with a positive SLNB would undergo prompt complete lymph node dissection, of whom 12 or 13 would derive no mortality benefit at 10 years, assuming the MSLT-1 investigators are correct in their analysis.
“Two or three patients with a positive SLNB will derive mortality benefit at 10 years, but we have no way to identify who those people are from the original 100,” he said.
Since the MSLT-1 report, a phase III German multicenter randomized trial of 241 melanoma patients with a positive screening SLNB has reported results. The participants assigned to complete lymph node dissection didn’t differ in terms of 3-year overall survival, distant metastasis-free survival, or recurrence-free survival, compared with those assigned to observation and lymphadenectomy if nodal disease occurred (Lancet Oncol. 2016 Jun;17[6]:757-67). However, as the investigators noted, the study, known as DeCOG-SLT, was underpowered, and Dr. Marchetti’s view is that it can’t be considered definitive.
“Ultimately I don’t think we’ll have a definitive answer to this question until the final results of the MSLT-II trial in the fall of 2022,” he said.
The MSLT-II trial has the same design as DeCOG-SLT.
Dr. Marchetti reported having no financial conflicts of interest regarding his presentation.
SDEF and this news organization are owned by the same parent company.
WAILEA, HAWAII – The Eighth Edition of the American Joint Committee on Cancer Staging Manual includes significant changes in how melanoma is classified.
The manual has already been published and is available for purchase. However, its implementation will be delayed until Jan. 1, 2018, to give physicians, software vendors, and all other interested parties time to get up to speed. All cancers newly diagnosed through Dec. 31, 2017 should be staged in accord with the seventh edition, released in 2010.
The eighth edition breaks new ground, moving beyond TNM (Tumor, Node, Metastasis) anatomic staging to incorporate new evidence-based prognostic factors.
“There are some subtle differences here to be aware of. It can be a little bit tricky at first glance. You should become familiar with this,” advised Dr. Marchetti, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.
In addition to highlighting the changes in melanoma staging included in the new AJCC manual, he outlined key recommendations – some of them controversial – on the use of sentinel lymph node biopsy (SLNB) in melanoma patients incorporated in the 2017 National Comprehensive Cancer Network (NCCN) guidelines.
The biggest change for the dermatology community contained in the new edition of the AJCC staging manual is that the T1 classification of melanoma has changed. In the seventh edition, a melanoma was categorized as T1 if less than or equal to 1.0 mm thickness. The cancer was T1a if nonulcerated and had a mitosis rate of less than 1/mm2 and T1b if ulcerated or had at least 1 mitosis/mm2.
The eighth edition makes an evidence-based subcategorization of T1 based upon thickness in light of the prognostic implications of this distinction. A melanoma is defined as T1a if nonulcerated and less than 0.8 mm in thickness, and T1b if it is 0.8-1.0 mm thick or less than 0.8 mm with ulceration.
Of note, tumor mitotic rate has been dropped as a staging criterion for T1 tumors.
What this means is, for example, in 2017, a patient with a 0.9-mm nonulcerated melanoma with 1 mitosis/mm2 and a negative sentinel lymph node biopsy with wide local excision is T1bN0M0, pathologic Stage IB. Under the eighth edition of AJCC, the same patient is T1bN0M0, pathologic Stage IA, because that mitosis rate isn’t a factor.
Today, a patient with a 0.5-mm melanoma with 1 mitosis/mm2 with wide local excision is T1bN0M0, Pathologic Stage IB. Under the new system, the same tumor is downstaged to Pathologic Stage IA, Dr. Marchetti explained.
In the eighth edition, tumor thickness measurements are recorded with rounding to the nearest 0.1 mm, not to the nearest 0.01 mm as before. This change was prompted by the inherent lack of precision in measuring melanomas, especially thicker ones.
The T category definitions of primary tumors have been clarified in the eighth edition. A tumor should be classified as T0 only if there is no evidence of a primary tumor. T is utilized for melanoma in situ. TX is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained through curettage.
The N categorization of regional lymph node status has become much more complicated in the eighth edition, the dermatologist cautioned. Plus, the terminology for nodal disease has changed. The term micrometastasis has been replaced by “clinically occult disease” as detected by SLNB. Macrometastasis has been supplanted by “clinically detected disease.” And while in-transit or satellite node metastasis or microsatellite metastasis with satellite nodes was formerly listed simply as N3, in the new system there are subcategories for N3 based upon the number of metastatic nodes involved. For example, in the eighth edition, a melanoma is pathologic Stage N3a if there are four or more clinically occult regional lymph nodes and no in-transit, satellite, or matted nodes. Pathologic Stage N3b is shorthand for four or more tumor-involved regional lymph nodes, at least one of which was clinically detected, or any number of matted lymph nodes, with no in-transit or satellite nodal involvement. Stage N3c is reserved for melanomas with two or more clinically occult or clinically detected regional lymph nodes and/or any number of matted nodes, plus the presence of in-transit or satellite nodal metastasis.
As a result of the changes in the N classification, there are now four pathologic Stage III groups rather than three. Stages IIIA-C have been joined by pathologic Stage IIID, reserved for patients who are T4b, N3a, b, or c, and M0.
The M categorization of distant metastatic disease status has also become more elaborate. In the AJCC seventh edition, if serum lactate dehydrogenase (LDH) is elevated and a patient has any distant metastatic disease, that’s automatically category M1c. Not any longer, though.
Under the eighth edition, if a patient has distant metastasis to skin, soft tissue including muscle, and/or nonregional lymph nodes and the LDH is unspecified, the categorization is M1a. If serum LDH is not elevated, it’s M1a(0). If elevated, then M1a(1).
Similarly, for distant metastasis to the lung, the range of possibilities based upon LDH is M1b, M1b(0), and M1b(1). For distant metastasis to non-CNS visceral sites, the possibilities are M1c, M1c(0), and M1c(1).
M1d is a new classification, a clear departure from the seventh edition. It applies to patients with distant metastasis to the CNS. The classification is M1d if LDH isn’t recorded, M1d(0) if LDH isn’t elevated, and M1d(1) if it is.
Turning to the updated 2017 NCCN guidelines Version 1.2017 on the role of SLNB in melanoma, Dr. Marchetti noted that the procedure is not recommended in patients with melanoma in situ or Stage IA or IB disease 0.75 mm or less in thickness, regardless of features. Neither are routine imaging or lab tests. That’s because the pretest probability of a positive SLNB is so low, at around 3%.
For Clinicopathologic Stage IA disease, 0.76-1.0 mm in thickness with no ulceration and a mitotic rate of less than 1 per mm2, the guidelines recommend that physicians “discuss and consider” SLNB, which the available evidence suggests has roughly a 7% pretest probability of a positive result.
For Stage IB disease, 0.76-1.0 mm in thickness with ulceration or a mitotic rate of at least 1 per mm2, as well as for Stage IB or Stage II disease greater than 1.0 mm in thickness, with any feature, the language of the recommendation shifts to “discuss and offer” rather than “discuss and consider” SLNB, since various studies have reported pretest probabilities of a positive result as high as 35%.
“The rationale here for performing sentinel lymph node biopsy is primarily to acquire more staging information. Is it a perfect test? Absolutely not. But it’s the current standard of care in terms of providing additional information for staging,” according to Dr. Marchetti.
If the SLNB generates a positive result, by definition the patient now has Stage III melanoma. The NCCN guidelines recommend consideration of imaging to establish a baseline, and state further that the primary treatment is to discuss and offer complete lymph node dissection in order to control the regional nodal basin and because of a possible favorable impact on overall survival. But the question of a survival benefit has been controversial for many years, and it’s unlikely to be resolved soon, Dr. Marchetti predicted.
The final report from the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–1 (MSLT-1) concluded that patients with primary cutaneous melanomas 1.2 mm or more in thickness who were randomized to undergo SLNB and, if positive, immediate complete lymphadenectomy, fared significantly better in terms of 10-year disease-free survival, compared with those assigned to observation and lymphadenectomy in the event of nodal relapse (N Engl J Med. 2014 Feb 13;370[7]:599-609).
This conclusion has generated numerous letters to the editor from melanoma experts who took issue with the analysis and conclusion. To try to put the MSLT-1 results in perspective, Dr. Marchetti applied the results to a hypothetical cohort of 100 patients with intermediate-thickness melanomas of 1.2-3.5 mm undergoing SLNB.
Eighty of these patients would be true SLNB-negative for regional nodal disease. Five others would have a false-negative SLNB and would later develop clinically detectable nodal disease. Fifteen patients with a positive SLNB would undergo prompt complete lymph node dissection, of whom 12 or 13 would derive no mortality benefit at 10 years, assuming the MSLT-1 investigators are correct in their analysis.
“Two or three patients with a positive SLNB will derive mortality benefit at 10 years, but we have no way to identify who those people are from the original 100,” he said.
Since the MSLT-1 report, a phase III German multicenter randomized trial of 241 melanoma patients with a positive screening SLNB has reported results. The participants assigned to complete lymph node dissection didn’t differ in terms of 3-year overall survival, distant metastasis-free survival, or recurrence-free survival, compared with those assigned to observation and lymphadenectomy if nodal disease occurred (Lancet Oncol. 2016 Jun;17[6]:757-67). However, as the investigators noted, the study, known as DeCOG-SLT, was underpowered, and Dr. Marchetti’s view is that it can’t be considered definitive.
“Ultimately I don’t think we’ll have a definitive answer to this question until the final results of the MSLT-II trial in the fall of 2022,” he said.
The MSLT-II trial has the same design as DeCOG-SLT.
Dr. Marchetti reported having no financial conflicts of interest regarding his presentation.
SDEF and this news organization are owned by the same parent company.
WAILEA, HAWAII – The Eighth Edition of the American Joint Committee on Cancer Staging Manual includes significant changes in how melanoma is classified.
The manual has already been published and is available for purchase. However, its implementation will be delayed until Jan. 1, 2018, to give physicians, software vendors, and all other interested parties time to get up to speed. All cancers newly diagnosed through Dec. 31, 2017 should be staged in accord with the seventh edition, released in 2010.
The eighth edition breaks new ground, moving beyond TNM (Tumor, Node, Metastasis) anatomic staging to incorporate new evidence-based prognostic factors.
“There are some subtle differences here to be aware of. It can be a little bit tricky at first glance. You should become familiar with this,” advised Dr. Marchetti, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.
In addition to highlighting the changes in melanoma staging included in the new AJCC manual, he outlined key recommendations – some of them controversial – on the use of sentinel lymph node biopsy (SLNB) in melanoma patients incorporated in the 2017 National Comprehensive Cancer Network (NCCN) guidelines.
The biggest change for the dermatology community contained in the new edition of the AJCC staging manual is that the T1 classification of melanoma has changed. In the seventh edition, a melanoma was categorized as T1 if less than or equal to 1.0 mm thickness. The cancer was T1a if nonulcerated and had a mitosis rate of less than 1/mm2 and T1b if ulcerated or had at least 1 mitosis/mm2.
The eighth edition makes an evidence-based subcategorization of T1 based upon thickness in light of the prognostic implications of this distinction. A melanoma is defined as T1a if nonulcerated and less than 0.8 mm in thickness, and T1b if it is 0.8-1.0 mm thick or less than 0.8 mm with ulceration.
Of note, tumor mitotic rate has been dropped as a staging criterion for T1 tumors.
What this means is, for example, in 2017, a patient with a 0.9-mm nonulcerated melanoma with 1 mitosis/mm2 and a negative sentinel lymph node biopsy with wide local excision is T1bN0M0, pathologic Stage IB. Under the eighth edition of AJCC, the same patient is T1bN0M0, pathologic Stage IA, because that mitosis rate isn’t a factor.
Today, a patient with a 0.5-mm melanoma with 1 mitosis/mm2 with wide local excision is T1bN0M0, Pathologic Stage IB. Under the new system, the same tumor is downstaged to Pathologic Stage IA, Dr. Marchetti explained.
In the eighth edition, tumor thickness measurements are recorded with rounding to the nearest 0.1 mm, not to the nearest 0.01 mm as before. This change was prompted by the inherent lack of precision in measuring melanomas, especially thicker ones.
The T category definitions of primary tumors have been clarified in the eighth edition. A tumor should be classified as T0 only if there is no evidence of a primary tumor. T is utilized for melanoma in situ. TX is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained through curettage.
The N categorization of regional lymph node status has become much more complicated in the eighth edition, the dermatologist cautioned. Plus, the terminology for nodal disease has changed. The term micrometastasis has been replaced by “clinically occult disease” as detected by SLNB. Macrometastasis has been supplanted by “clinically detected disease.” And while in-transit or satellite node metastasis or microsatellite metastasis with satellite nodes was formerly listed simply as N3, in the new system there are subcategories for N3 based upon the number of metastatic nodes involved. For example, in the eighth edition, a melanoma is pathologic Stage N3a if there are four or more clinically occult regional lymph nodes and no in-transit, satellite, or matted nodes. Pathologic Stage N3b is shorthand for four or more tumor-involved regional lymph nodes, at least one of which was clinically detected, or any number of matted lymph nodes, with no in-transit or satellite nodal involvement. Stage N3c is reserved for melanomas with two or more clinically occult or clinically detected regional lymph nodes and/or any number of matted nodes, plus the presence of in-transit or satellite nodal metastasis.
As a result of the changes in the N classification, there are now four pathologic Stage III groups rather than three. Stages IIIA-C have been joined by pathologic Stage IIID, reserved for patients who are T4b, N3a, b, or c, and M0.
The M categorization of distant metastatic disease status has also become more elaborate. In the AJCC seventh edition, if serum lactate dehydrogenase (LDH) is elevated and a patient has any distant metastatic disease, that’s automatically category M1c. Not any longer, though.
Under the eighth edition, if a patient has distant metastasis to skin, soft tissue including muscle, and/or nonregional lymph nodes and the LDH is unspecified, the categorization is M1a. If serum LDH is not elevated, it’s M1a(0). If elevated, then M1a(1).
Similarly, for distant metastasis to the lung, the range of possibilities based upon LDH is M1b, M1b(0), and M1b(1). For distant metastasis to non-CNS visceral sites, the possibilities are M1c, M1c(0), and M1c(1).
M1d is a new classification, a clear departure from the seventh edition. It applies to patients with distant metastasis to the CNS. The classification is M1d if LDH isn’t recorded, M1d(0) if LDH isn’t elevated, and M1d(1) if it is.
Turning to the updated 2017 NCCN guidelines Version 1.2017 on the role of SLNB in melanoma, Dr. Marchetti noted that the procedure is not recommended in patients with melanoma in situ or Stage IA or IB disease 0.75 mm or less in thickness, regardless of features. Neither are routine imaging or lab tests. That’s because the pretest probability of a positive SLNB is so low, at around 3%.
For Clinicopathologic Stage IA disease, 0.76-1.0 mm in thickness with no ulceration and a mitotic rate of less than 1 per mm2, the guidelines recommend that physicians “discuss and consider” SLNB, which the available evidence suggests has roughly a 7% pretest probability of a positive result.
For Stage IB disease, 0.76-1.0 mm in thickness with ulceration or a mitotic rate of at least 1 per mm2, as well as for Stage IB or Stage II disease greater than 1.0 mm in thickness, with any feature, the language of the recommendation shifts to “discuss and offer” rather than “discuss and consider” SLNB, since various studies have reported pretest probabilities of a positive result as high as 35%.
“The rationale here for performing sentinel lymph node biopsy is primarily to acquire more staging information. Is it a perfect test? Absolutely not. But it’s the current standard of care in terms of providing additional information for staging,” according to Dr. Marchetti.
If the SLNB generates a positive result, by definition the patient now has Stage III melanoma. The NCCN guidelines recommend consideration of imaging to establish a baseline, and state further that the primary treatment is to discuss and offer complete lymph node dissection in order to control the regional nodal basin and because of a possible favorable impact on overall survival. But the question of a survival benefit has been controversial for many years, and it’s unlikely to be resolved soon, Dr. Marchetti predicted.
The final report from the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–1 (MSLT-1) concluded that patients with primary cutaneous melanomas 1.2 mm or more in thickness who were randomized to undergo SLNB and, if positive, immediate complete lymphadenectomy, fared significantly better in terms of 10-year disease-free survival, compared with those assigned to observation and lymphadenectomy in the event of nodal relapse (N Engl J Med. 2014 Feb 13;370[7]:599-609).
This conclusion has generated numerous letters to the editor from melanoma experts who took issue with the analysis and conclusion. To try to put the MSLT-1 results in perspective, Dr. Marchetti applied the results to a hypothetical cohort of 100 patients with intermediate-thickness melanomas of 1.2-3.5 mm undergoing SLNB.
Eighty of these patients would be true SLNB-negative for regional nodal disease. Five others would have a false-negative SLNB and would later develop clinically detectable nodal disease. Fifteen patients with a positive SLNB would undergo prompt complete lymph node dissection, of whom 12 or 13 would derive no mortality benefit at 10 years, assuming the MSLT-1 investigators are correct in their analysis.
“Two or three patients with a positive SLNB will derive mortality benefit at 10 years, but we have no way to identify who those people are from the original 100,” he said.
Since the MSLT-1 report, a phase III German multicenter randomized trial of 241 melanoma patients with a positive screening SLNB has reported results. The participants assigned to complete lymph node dissection didn’t differ in terms of 3-year overall survival, distant metastasis-free survival, or recurrence-free survival, compared with those assigned to observation and lymphadenectomy if nodal disease occurred (Lancet Oncol. 2016 Jun;17[6]:757-67). However, as the investigators noted, the study, known as DeCOG-SLT, was underpowered, and Dr. Marchetti’s view is that it can’t be considered definitive.
“Ultimately I don’t think we’ll have a definitive answer to this question until the final results of the MSLT-II trial in the fall of 2022,” he said.
The MSLT-II trial has the same design as DeCOG-SLT.
Dr. Marchetti reported having no financial conflicts of interest regarding his presentation.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM THE SDEF HAWAII DERMATOLOGY SEMINAR
Survival better with breast-conserving therapy for early cancers
AMSTERDAM – In real-life practice, women with early, localized breast cancer who underwent breast conserving therapy had better breast cancer–specific and overall survival compared with women who underwent mastectomy, according to investigators in the Netherlands.
Among nearly 130,000 patients treated over two different time periods, breast-conserving surgery and radiation (BCT) was associated with superior survival for women older than 50, patients who did not receive adjuvant chemotherapy, and those with comorbidities – irrespective of either hormonal or human epidermal growth factor receptor 2 (HER2) status, reported Mirelle Lagendijk, MD, of Erasmus Medical Center Cancer Institute in Rotterdam, the Netherlands.
For patients 50 and younger, overall survival (OS), but not breast cancer–specific survival (BCSS), was superior with the more conservative approach.
“Breast conserving therapy in these identified subgroups seems to be the preferable treatment when both treatments are optional,” Dr. Lagendijk said at an annual congress sponsored by the European Cancer Organisation.
Although recent observational studies have shown survival with BCT to be at least equivalent for women with early stage disease, there is still a lack of sufficient data on BCSS, potential confounders such as systemic therapies and comorbidities, and on the relative effects of BCT or mastectomy on subgroups, she said.
The investigators drew data from the Netherlands Cancer Registry on 129,692 patients with early, primary invasive breast cancer without metastases other than to regional lymph nodes (T1-2NO-2MO).
They compared BCT to mastectomy for BCSS and OS in the population as a whole and in subgroups based on prognostic factors. They controlled for age, tumor and nodal stage, comorbidities, systemic therapy, hormone receptor and HER2 status, differentiation grade, morphology, year of treatment, axillary lymph node dissection, and contralateral breast cancer.
They divided patients into two treatment time periods. The older cohort consisted of 60,381 patients treated from 1999 through 2005, 48% of whom underwent mastectomy, with a median follow-up of 11.1 years, and 52% of whom had BCT, with a median follow-up of 12 years.
The more recent cohort consisted of 69,311 patients, 40% of whom had mastectomy with a median follow-up of 5.9 years, and 60% of whom had BCT with a median follow-up of 6.1 years.
In both time periods, deaths from all causes were lower among patients treated with BCT. In the older cohort, 13,960 of 28,968 patients (48.2%) who underwent mastectomy had died, compared with 8,915 of 31,413 patients (28.4%) who underwent BCT. In the more recent cohort, 5,504 of 27,731 (19.8%) of patients who had mastectomies had died, compared with 3,702 of 41,580 (8.9%) who underwent BCT.
“Irrespective of the time cohort and irrespective of the treatment, around 50% of the events were breast cancer related,” Dr. Lagendijk said.
BCSS was superior with BCT in each time cohort (log-rank P less than .001 for each). In the earlier cohort, BCT was significantly superior for BCSS across all disease stages; in the later cohort, it was significant for all but stages T1N1 and T1-2N2.
BCSS was superior for patients in all age categories in the early cohort, and for patients 50 and older in the later cohort.
“The final stratification performed for comorbidities present in the patients evaluated showed, surprisingly, that especially for those patients with comorbidity, there was significantly better breast cancer-specific survival when treated by breast conserving therapy as compared to a mastectomy,” Dr. Lagendijk said.
The investigators acknowledged that the study was limited by its retrospective design, potential confounding by severity, and the inability to show causal relationship between survival and treatment type.
Dutch health agencies sponsored the study. Dr. Lagendijk and Dr. Naredi reported no conflicts of interest.
AMSTERDAM – In real-life practice, women with early, localized breast cancer who underwent breast conserving therapy had better breast cancer–specific and overall survival compared with women who underwent mastectomy, according to investigators in the Netherlands.
Among nearly 130,000 patients treated over two different time periods, breast-conserving surgery and radiation (BCT) was associated with superior survival for women older than 50, patients who did not receive adjuvant chemotherapy, and those with comorbidities – irrespective of either hormonal or human epidermal growth factor receptor 2 (HER2) status, reported Mirelle Lagendijk, MD, of Erasmus Medical Center Cancer Institute in Rotterdam, the Netherlands.
For patients 50 and younger, overall survival (OS), but not breast cancer–specific survival (BCSS), was superior with the more conservative approach.
“Breast conserving therapy in these identified subgroups seems to be the preferable treatment when both treatments are optional,” Dr. Lagendijk said at an annual congress sponsored by the European Cancer Organisation.
Although recent observational studies have shown survival with BCT to be at least equivalent for women with early stage disease, there is still a lack of sufficient data on BCSS, potential confounders such as systemic therapies and comorbidities, and on the relative effects of BCT or mastectomy on subgroups, she said.
The investigators drew data from the Netherlands Cancer Registry on 129,692 patients with early, primary invasive breast cancer without metastases other than to regional lymph nodes (T1-2NO-2MO).
They compared BCT to mastectomy for BCSS and OS in the population as a whole and in subgroups based on prognostic factors. They controlled for age, tumor and nodal stage, comorbidities, systemic therapy, hormone receptor and HER2 status, differentiation grade, morphology, year of treatment, axillary lymph node dissection, and contralateral breast cancer.
They divided patients into two treatment time periods. The older cohort consisted of 60,381 patients treated from 1999 through 2005, 48% of whom underwent mastectomy, with a median follow-up of 11.1 years, and 52% of whom had BCT, with a median follow-up of 12 years.
The more recent cohort consisted of 69,311 patients, 40% of whom had mastectomy with a median follow-up of 5.9 years, and 60% of whom had BCT with a median follow-up of 6.1 years.
In both time periods, deaths from all causes were lower among patients treated with BCT. In the older cohort, 13,960 of 28,968 patients (48.2%) who underwent mastectomy had died, compared with 8,915 of 31,413 patients (28.4%) who underwent BCT. In the more recent cohort, 5,504 of 27,731 (19.8%) of patients who had mastectomies had died, compared with 3,702 of 41,580 (8.9%) who underwent BCT.
“Irrespective of the time cohort and irrespective of the treatment, around 50% of the events were breast cancer related,” Dr. Lagendijk said.
BCSS was superior with BCT in each time cohort (log-rank P less than .001 for each). In the earlier cohort, BCT was significantly superior for BCSS across all disease stages; in the later cohort, it was significant for all but stages T1N1 and T1-2N2.
BCSS was superior for patients in all age categories in the early cohort, and for patients 50 and older in the later cohort.
“The final stratification performed for comorbidities present in the patients evaluated showed, surprisingly, that especially for those patients with comorbidity, there was significantly better breast cancer-specific survival when treated by breast conserving therapy as compared to a mastectomy,” Dr. Lagendijk said.
The investigators acknowledged that the study was limited by its retrospective design, potential confounding by severity, and the inability to show causal relationship between survival and treatment type.
Dutch health agencies sponsored the study. Dr. Lagendijk and Dr. Naredi reported no conflicts of interest.
AMSTERDAM – In real-life practice, women with early, localized breast cancer who underwent breast conserving therapy had better breast cancer–specific and overall survival compared with women who underwent mastectomy, according to investigators in the Netherlands.
Among nearly 130,000 patients treated over two different time periods, breast-conserving surgery and radiation (BCT) was associated with superior survival for women older than 50, patients who did not receive adjuvant chemotherapy, and those with comorbidities – irrespective of either hormonal or human epidermal growth factor receptor 2 (HER2) status, reported Mirelle Lagendijk, MD, of Erasmus Medical Center Cancer Institute in Rotterdam, the Netherlands.
For patients 50 and younger, overall survival (OS), but not breast cancer–specific survival (BCSS), was superior with the more conservative approach.
“Breast conserving therapy in these identified subgroups seems to be the preferable treatment when both treatments are optional,” Dr. Lagendijk said at an annual congress sponsored by the European Cancer Organisation.
Although recent observational studies have shown survival with BCT to be at least equivalent for women with early stage disease, there is still a lack of sufficient data on BCSS, potential confounders such as systemic therapies and comorbidities, and on the relative effects of BCT or mastectomy on subgroups, she said.
The investigators drew data from the Netherlands Cancer Registry on 129,692 patients with early, primary invasive breast cancer without metastases other than to regional lymph nodes (T1-2NO-2MO).
They compared BCT to mastectomy for BCSS and OS in the population as a whole and in subgroups based on prognostic factors. They controlled for age, tumor and nodal stage, comorbidities, systemic therapy, hormone receptor and HER2 status, differentiation grade, morphology, year of treatment, axillary lymph node dissection, and contralateral breast cancer.
They divided patients into two treatment time periods. The older cohort consisted of 60,381 patients treated from 1999 through 2005, 48% of whom underwent mastectomy, with a median follow-up of 11.1 years, and 52% of whom had BCT, with a median follow-up of 12 years.
The more recent cohort consisted of 69,311 patients, 40% of whom had mastectomy with a median follow-up of 5.9 years, and 60% of whom had BCT with a median follow-up of 6.1 years.
In both time periods, deaths from all causes were lower among patients treated with BCT. In the older cohort, 13,960 of 28,968 patients (48.2%) who underwent mastectomy had died, compared with 8,915 of 31,413 patients (28.4%) who underwent BCT. In the more recent cohort, 5,504 of 27,731 (19.8%) of patients who had mastectomies had died, compared with 3,702 of 41,580 (8.9%) who underwent BCT.
“Irrespective of the time cohort and irrespective of the treatment, around 50% of the events were breast cancer related,” Dr. Lagendijk said.
BCSS was superior with BCT in each time cohort (log-rank P less than .001 for each). In the earlier cohort, BCT was significantly superior for BCSS across all disease stages; in the later cohort, it was significant for all but stages T1N1 and T1-2N2.
BCSS was superior for patients in all age categories in the early cohort, and for patients 50 and older in the later cohort.
“The final stratification performed for comorbidities present in the patients evaluated showed, surprisingly, that especially for those patients with comorbidity, there was significantly better breast cancer-specific survival when treated by breast conserving therapy as compared to a mastectomy,” Dr. Lagendijk said.
The investigators acknowledged that the study was limited by its retrospective design, potential confounding by severity, and the inability to show causal relationship between survival and treatment type.
Dutch health agencies sponsored the study. Dr. Lagendijk and Dr. Naredi reported no conflicts of interest.
AT ECCO2017
Key clinical point: Breast cancer–specific survival and overall survival were better among women who had breast-conserving therapy (BCT) compared with mastectomy.
Major finding: BCT was associated with superior survival for women older than 50, patients who did not receive adjuvant chemotherapy, and those with comorbidities.
Data source: Retrospective registry data study of 129,692 women treated for early breast cancer in the Netherlands during 1999-2005 and 2006-2012.
Disclosures: Dutch health agencies sponsored the study. Dr. Langendijk and Dr. Naredi reported no conflicts of interest.
Pairing vascular reconstruction, pancreatic cancer resection
CHICAGO – More than 53,000 people will develop pancreatic ductal adenocarcinoma in the United States this year, and upwards of 41,000 will die from the disease, many of them with tumors considered unresectable because they involve adjacent vessels. However, researchers at the University of California, Irvine, have found that careful removal of the tumor around involved veins and arteries, even in borderline cases, can improve outcomes for these patients.
Roy M. Fujitani, MD, updated previously published data on a single-center study he coauthored in 2015 of 270 patients who had undergone a Whipple operation, 183 for pancreatic adenocarcinoma (J Vasc Surg. 2015;61:475-80) at a symposium on vascular surgery sponsored by Northwestern University.
Resection of pancreatic tumors without vascular involvement is fairly straightforward for surgical oncologists to perform, Dr. Fujitani said, but pancreatic tumors enter the borderline resectable category when preoperative CT scan shows portal vein abutment, for which vascular surgery should provide counsel and assist. However, even in some cases when preoperative CT scan shows unresectable, locally advanced pancreatic tumor with celiac artery encasement, neoadjuvant therapy may downstage the disease into the borderline category, he said.
“Patients with borderline resectable or stage II disease are those one should consider for reconstruction,” Dr. Fujitani said. Resectable findings of borderline disease include encasement of the portal vein, superior mesenteric vein and the confluence of the portal venous system (with suitable proximal and distal targets for reconstruction); and less-than-circumferential involvement of the common hepatic artery or right hepatic artery – but without involvement of the superior mesenteric artery or the celiac axis and “certainly not” the aorta. “This would account for about one-fourth of patients in high-volume centers as being able to receive concomitant vascular reconstruction,” Dr. Fujitani said.
In the UCI series, 60 patients with borderline lesions underwent vascular reconstruction. “As it turned out, there was no significant difference in survival between the reconstruction group and the nonreconstruction group,” Dr. Fujitani said, “but it’s important to note that these patients who had the reconstruction would never have been operated on if we were not able to do the reconstruction.” Thirty-day mortality was around 5% and 1-year survival around 70% in both groups, he said. However, at about 1.5 years the Kaplan-Meier survival curves between the two groups diverged, which Dr. Fujitani attributed to more advanced disease in the reconstruction group.
“We found lymph node status and tumor margins were most important in determining survival of these patients,” he said. “Gaining an R0 resection is the most important thing that determines favorable survivability.”
Dr. Fujitani also reviewed different techniques for vascular reconstruction, and while differences in complication rates or 1-, 2-, or 3-year survival were not statistically significant, he did note that mean survival with lateral venorrhaphy exceeded that of primary anastomosis and interposition graft – 21 months vs. 13 months vs. 4 months, suggesting the merits of a more aggressive approach to vascular resection and reconstruction.
“Improvement of survival outcomes may be achieved with concomitant advanced vascular reconstruction in carefully selected patients,” Dr. Fujitani said. “There are multiple options for vascular reconstruction for mesenteric portal venous and visceral arterial involvement using standard vascular surgical techniques.” He added that a dedicated team of experienced surgical oncologists and vascular surgeons for these reconstructions “is essential for successful outcomes.”
Dr. Fujitani had no relevant financial relationships to disclose.
CHICAGO – More than 53,000 people will develop pancreatic ductal adenocarcinoma in the United States this year, and upwards of 41,000 will die from the disease, many of them with tumors considered unresectable because they involve adjacent vessels. However, researchers at the University of California, Irvine, have found that careful removal of the tumor around involved veins and arteries, even in borderline cases, can improve outcomes for these patients.
Roy M. Fujitani, MD, updated previously published data on a single-center study he coauthored in 2015 of 270 patients who had undergone a Whipple operation, 183 for pancreatic adenocarcinoma (J Vasc Surg. 2015;61:475-80) at a symposium on vascular surgery sponsored by Northwestern University.
Resection of pancreatic tumors without vascular involvement is fairly straightforward for surgical oncologists to perform, Dr. Fujitani said, but pancreatic tumors enter the borderline resectable category when preoperative CT scan shows portal vein abutment, for which vascular surgery should provide counsel and assist. However, even in some cases when preoperative CT scan shows unresectable, locally advanced pancreatic tumor with celiac artery encasement, neoadjuvant therapy may downstage the disease into the borderline category, he said.
“Patients with borderline resectable or stage II disease are those one should consider for reconstruction,” Dr. Fujitani said. Resectable findings of borderline disease include encasement of the portal vein, superior mesenteric vein and the confluence of the portal venous system (with suitable proximal and distal targets for reconstruction); and less-than-circumferential involvement of the common hepatic artery or right hepatic artery – but without involvement of the superior mesenteric artery or the celiac axis and “certainly not” the aorta. “This would account for about one-fourth of patients in high-volume centers as being able to receive concomitant vascular reconstruction,” Dr. Fujitani said.
In the UCI series, 60 patients with borderline lesions underwent vascular reconstruction. “As it turned out, there was no significant difference in survival between the reconstruction group and the nonreconstruction group,” Dr. Fujitani said, “but it’s important to note that these patients who had the reconstruction would never have been operated on if we were not able to do the reconstruction.” Thirty-day mortality was around 5% and 1-year survival around 70% in both groups, he said. However, at about 1.5 years the Kaplan-Meier survival curves between the two groups diverged, which Dr. Fujitani attributed to more advanced disease in the reconstruction group.
“We found lymph node status and tumor margins were most important in determining survival of these patients,” he said. “Gaining an R0 resection is the most important thing that determines favorable survivability.”
Dr. Fujitani also reviewed different techniques for vascular reconstruction, and while differences in complication rates or 1-, 2-, or 3-year survival were not statistically significant, he did note that mean survival with lateral venorrhaphy exceeded that of primary anastomosis and interposition graft – 21 months vs. 13 months vs. 4 months, suggesting the merits of a more aggressive approach to vascular resection and reconstruction.
“Improvement of survival outcomes may be achieved with concomitant advanced vascular reconstruction in carefully selected patients,” Dr. Fujitani said. “There are multiple options for vascular reconstruction for mesenteric portal venous and visceral arterial involvement using standard vascular surgical techniques.” He added that a dedicated team of experienced surgical oncologists and vascular surgeons for these reconstructions “is essential for successful outcomes.”
Dr. Fujitani had no relevant financial relationships to disclose.
CHICAGO – More than 53,000 people will develop pancreatic ductal adenocarcinoma in the United States this year, and upwards of 41,000 will die from the disease, many of them with tumors considered unresectable because they involve adjacent vessels. However, researchers at the University of California, Irvine, have found that careful removal of the tumor around involved veins and arteries, even in borderline cases, can improve outcomes for these patients.
Roy M. Fujitani, MD, updated previously published data on a single-center study he coauthored in 2015 of 270 patients who had undergone a Whipple operation, 183 for pancreatic adenocarcinoma (J Vasc Surg. 2015;61:475-80) at a symposium on vascular surgery sponsored by Northwestern University.
Resection of pancreatic tumors without vascular involvement is fairly straightforward for surgical oncologists to perform, Dr. Fujitani said, but pancreatic tumors enter the borderline resectable category when preoperative CT scan shows portal vein abutment, for which vascular surgery should provide counsel and assist. However, even in some cases when preoperative CT scan shows unresectable, locally advanced pancreatic tumor with celiac artery encasement, neoadjuvant therapy may downstage the disease into the borderline category, he said.
“Patients with borderline resectable or stage II disease are those one should consider for reconstruction,” Dr. Fujitani said. Resectable findings of borderline disease include encasement of the portal vein, superior mesenteric vein and the confluence of the portal venous system (with suitable proximal and distal targets for reconstruction); and less-than-circumferential involvement of the common hepatic artery or right hepatic artery – but without involvement of the superior mesenteric artery or the celiac axis and “certainly not” the aorta. “This would account for about one-fourth of patients in high-volume centers as being able to receive concomitant vascular reconstruction,” Dr. Fujitani said.
In the UCI series, 60 patients with borderline lesions underwent vascular reconstruction. “As it turned out, there was no significant difference in survival between the reconstruction group and the nonreconstruction group,” Dr. Fujitani said, “but it’s important to note that these patients who had the reconstruction would never have been operated on if we were not able to do the reconstruction.” Thirty-day mortality was around 5% and 1-year survival around 70% in both groups, he said. However, at about 1.5 years the Kaplan-Meier survival curves between the two groups diverged, which Dr. Fujitani attributed to more advanced disease in the reconstruction group.
“We found lymph node status and tumor margins were most important in determining survival of these patients,” he said. “Gaining an R0 resection is the most important thing that determines favorable survivability.”
Dr. Fujitani also reviewed different techniques for vascular reconstruction, and while differences in complication rates or 1-, 2-, or 3-year survival were not statistically significant, he did note that mean survival with lateral venorrhaphy exceeded that of primary anastomosis and interposition graft – 21 months vs. 13 months vs. 4 months, suggesting the merits of a more aggressive approach to vascular resection and reconstruction.
“Improvement of survival outcomes may be achieved with concomitant advanced vascular reconstruction in carefully selected patients,” Dr. Fujitani said. “There are multiple options for vascular reconstruction for mesenteric portal venous and visceral arterial involvement using standard vascular surgical techniques.” He added that a dedicated team of experienced surgical oncologists and vascular surgeons for these reconstructions “is essential for successful outcomes.”
Dr. Fujitani had no relevant financial relationships to disclose.
AT THE NORTHWESTERN VASCULAR SYMPOSIUM
Key clinical point: A more aggressive vascular resection and reconstruction in pancreatic cancer may improve outcomes and palliation in these patients.
Major finding: Mean survival with lateral venorrhaphy exceeded primary anastomosis and interposition graft (21 months vs. 13 months vs. 4 months).
Data source: Updated data of previously published single-center retrospective review of 183 patients who had Whipple procedure for pancreatic adenocarcinoma.
Disclosures: Dr. Fujitani reported having no financial disclosures.
Bursectomy provides no benefit over omentectomy for gastric cancers
SAN FRANCISCO – Bursectomy was not found to be superior to omentectomy for improving survival in patients with subserosal/serosal gastric cancer in a Japanese randomized phase III study.
The procedure – the dissection of the peritoneal lining covering the pancreas and anterior plane of the transverse mesocolon to prevent peritoneal metastasis – was common worldwide and considered standard in Japan from the 1950s until the mid-1990s, but was replaced by omentectomy following publication of reports questioning its value, according to Masanori Terashima, MD, of Shizuoka Cancer Center, Nagaizumi, Japan.
However, interest in bursectomy was rekindled when a 2012 noninferiority phase II study suggested that bursectomy may improve survival; the authors concluded that it should not be abandoned as a futile procedure until more definitive data could be obtained (Gastric Cancer. 2012;15[1]:42-8).
“So based on this result, [Japanese Clinical Oncology Group] conducted a large-scale randomized phase III trial [JCOG1001] to evaluate the efficacy of bursectomy. The objective of this study was to confirm the superiority of bursectomy for clinical T3 or clinical T4a gastric cancer patients in terms of overall survival,” Dr. Terashima said at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and Society of Surgical Oncology.
At a planned interim analysis when 522 patients had been enrolled, the Data and Safety Monitoring Committee approved continued enrollment. However, at a second interim analysis when 54% of expected events had been observed, the committee recommended early release of the survival results because “there was little possibility of demonstration of the superiority of bursectomy,” he said.
Overall 3-year survival was 83.3% among 601 patients in the bursectomy arm, compared with 86% in 600 patients in the nonbursectomy arm (hazard ratio, 1.07). The predictive probability of superiority of bursectomy was 12.7%.
Study subjects were adults aged 20-80 years (median of 65-66 years) with histologically proven adenocarcinoma of the stomach and clinical T3 or T4 disease. They enrolled from 57 institutions and were intraoperatively randomized to the bursectomy or nonbursectomy arm after confirmation of tumor stage. All received adjuvant chemotherapy with S-1 for 1 year for pathologic stage II/III disease.
Patients with bulky nodal metastases, Borrmann type 4 and 8 cm or larger Borrmann type 3 tumors were excluded, as their poor prognosis made them candidates for other clinical trials, Dr. Terashima said.
Patients’ background and operative procedures were well balanced between the arms, he noted.
For those in the bursectomy group, operation time was longer (median, 254 vs. 222 minutes), and blood loss was larger (330 vs. 230 mL), although the incidence of blood transfusion was not significantly different between the groups (4.5% vs. 4.8%).
The incidence of grade 3 or higher complications was slightly higher in the bursectomy arm (13.3% vs. 11.6%). This was due largely to the incidence of pancreatic fistulas, which was nearly double in the bursectomy arm (4.8% vs. 2.5% ).
Mortality was “quite low” in both groups (0.2 vs. 0.8%).
“There was no significant difference in overall survival between the arms. Bursectomy seemed to be a bit inferior to the nonbursectomy arm. Relapse-free survival also demonstrated no significant difference between the arms. Again, bursectomy seemed to be a bit worse than nonbursectomy,” he said.
The most common site of recurrence for all patient was the peritoneum, with 63 and 56 patients in the bursectomy and nonbursectomy arms, respectively, experiencing peritoneal recurrence.
“We could not detect any subgroup who may have a benefit from bursectomy,” Dr. Terashima said.
“Bursectomy is not recommended as a standard treatment for clinical T3 or clinical T4 gastric cancer, while complete omentectomy remains a part of standard procedure,” he concluded.
Dr. Terashima reported receiving honoraria, and/or research funding from Chugai Pharma, Eisai; Lilly, Otsuka, Taiho Pharmaceutical, Takeda, and Yakult Honsha.
SAN FRANCISCO – Bursectomy was not found to be superior to omentectomy for improving survival in patients with subserosal/serosal gastric cancer in a Japanese randomized phase III study.
The procedure – the dissection of the peritoneal lining covering the pancreas and anterior plane of the transverse mesocolon to prevent peritoneal metastasis – was common worldwide and considered standard in Japan from the 1950s until the mid-1990s, but was replaced by omentectomy following publication of reports questioning its value, according to Masanori Terashima, MD, of Shizuoka Cancer Center, Nagaizumi, Japan.
However, interest in bursectomy was rekindled when a 2012 noninferiority phase II study suggested that bursectomy may improve survival; the authors concluded that it should not be abandoned as a futile procedure until more definitive data could be obtained (Gastric Cancer. 2012;15[1]:42-8).
“So based on this result, [Japanese Clinical Oncology Group] conducted a large-scale randomized phase III trial [JCOG1001] to evaluate the efficacy of bursectomy. The objective of this study was to confirm the superiority of bursectomy for clinical T3 or clinical T4a gastric cancer patients in terms of overall survival,” Dr. Terashima said at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and Society of Surgical Oncology.
At a planned interim analysis when 522 patients had been enrolled, the Data and Safety Monitoring Committee approved continued enrollment. However, at a second interim analysis when 54% of expected events had been observed, the committee recommended early release of the survival results because “there was little possibility of demonstration of the superiority of bursectomy,” he said.
Overall 3-year survival was 83.3% among 601 patients in the bursectomy arm, compared with 86% in 600 patients in the nonbursectomy arm (hazard ratio, 1.07). The predictive probability of superiority of bursectomy was 12.7%.
Study subjects were adults aged 20-80 years (median of 65-66 years) with histologically proven adenocarcinoma of the stomach and clinical T3 or T4 disease. They enrolled from 57 institutions and were intraoperatively randomized to the bursectomy or nonbursectomy arm after confirmation of tumor stage. All received adjuvant chemotherapy with S-1 for 1 year for pathologic stage II/III disease.
Patients with bulky nodal metastases, Borrmann type 4 and 8 cm or larger Borrmann type 3 tumors were excluded, as their poor prognosis made them candidates for other clinical trials, Dr. Terashima said.
Patients’ background and operative procedures were well balanced between the arms, he noted.
For those in the bursectomy group, operation time was longer (median, 254 vs. 222 minutes), and blood loss was larger (330 vs. 230 mL), although the incidence of blood transfusion was not significantly different between the groups (4.5% vs. 4.8%).
The incidence of grade 3 or higher complications was slightly higher in the bursectomy arm (13.3% vs. 11.6%). This was due largely to the incidence of pancreatic fistulas, which was nearly double in the bursectomy arm (4.8% vs. 2.5% ).
Mortality was “quite low” in both groups (0.2 vs. 0.8%).
“There was no significant difference in overall survival between the arms. Bursectomy seemed to be a bit inferior to the nonbursectomy arm. Relapse-free survival also demonstrated no significant difference between the arms. Again, bursectomy seemed to be a bit worse than nonbursectomy,” he said.
The most common site of recurrence for all patient was the peritoneum, with 63 and 56 patients in the bursectomy and nonbursectomy arms, respectively, experiencing peritoneal recurrence.
“We could not detect any subgroup who may have a benefit from bursectomy,” Dr. Terashima said.
“Bursectomy is not recommended as a standard treatment for clinical T3 or clinical T4 gastric cancer, while complete omentectomy remains a part of standard procedure,” he concluded.
Dr. Terashima reported receiving honoraria, and/or research funding from Chugai Pharma, Eisai; Lilly, Otsuka, Taiho Pharmaceutical, Takeda, and Yakult Honsha.
SAN FRANCISCO – Bursectomy was not found to be superior to omentectomy for improving survival in patients with subserosal/serosal gastric cancer in a Japanese randomized phase III study.
The procedure – the dissection of the peritoneal lining covering the pancreas and anterior plane of the transverse mesocolon to prevent peritoneal metastasis – was common worldwide and considered standard in Japan from the 1950s until the mid-1990s, but was replaced by omentectomy following publication of reports questioning its value, according to Masanori Terashima, MD, of Shizuoka Cancer Center, Nagaizumi, Japan.
However, interest in bursectomy was rekindled when a 2012 noninferiority phase II study suggested that bursectomy may improve survival; the authors concluded that it should not be abandoned as a futile procedure until more definitive data could be obtained (Gastric Cancer. 2012;15[1]:42-8).
“So based on this result, [Japanese Clinical Oncology Group] conducted a large-scale randomized phase III trial [JCOG1001] to evaluate the efficacy of bursectomy. The objective of this study was to confirm the superiority of bursectomy for clinical T3 or clinical T4a gastric cancer patients in terms of overall survival,” Dr. Terashima said at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and Society of Surgical Oncology.
At a planned interim analysis when 522 patients had been enrolled, the Data and Safety Monitoring Committee approved continued enrollment. However, at a second interim analysis when 54% of expected events had been observed, the committee recommended early release of the survival results because “there was little possibility of demonstration of the superiority of bursectomy,” he said.
Overall 3-year survival was 83.3% among 601 patients in the bursectomy arm, compared with 86% in 600 patients in the nonbursectomy arm (hazard ratio, 1.07). The predictive probability of superiority of bursectomy was 12.7%.
Study subjects were adults aged 20-80 years (median of 65-66 years) with histologically proven adenocarcinoma of the stomach and clinical T3 or T4 disease. They enrolled from 57 institutions and were intraoperatively randomized to the bursectomy or nonbursectomy arm after confirmation of tumor stage. All received adjuvant chemotherapy with S-1 for 1 year for pathologic stage II/III disease.
Patients with bulky nodal metastases, Borrmann type 4 and 8 cm or larger Borrmann type 3 tumors were excluded, as their poor prognosis made them candidates for other clinical trials, Dr. Terashima said.
Patients’ background and operative procedures were well balanced between the arms, he noted.
For those in the bursectomy group, operation time was longer (median, 254 vs. 222 minutes), and blood loss was larger (330 vs. 230 mL), although the incidence of blood transfusion was not significantly different between the groups (4.5% vs. 4.8%).
The incidence of grade 3 or higher complications was slightly higher in the bursectomy arm (13.3% vs. 11.6%). This was due largely to the incidence of pancreatic fistulas, which was nearly double in the bursectomy arm (4.8% vs. 2.5% ).
Mortality was “quite low” in both groups (0.2 vs. 0.8%).
“There was no significant difference in overall survival between the arms. Bursectomy seemed to be a bit inferior to the nonbursectomy arm. Relapse-free survival also demonstrated no significant difference between the arms. Again, bursectomy seemed to be a bit worse than nonbursectomy,” he said.
The most common site of recurrence for all patient was the peritoneum, with 63 and 56 patients in the bursectomy and nonbursectomy arms, respectively, experiencing peritoneal recurrence.
“We could not detect any subgroup who may have a benefit from bursectomy,” Dr. Terashima said.
“Bursectomy is not recommended as a standard treatment for clinical T3 or clinical T4 gastric cancer, while complete omentectomy remains a part of standard procedure,” he concluded.
Dr. Terashima reported receiving honoraria, and/or research funding from Chugai Pharma, Eisai; Lilly, Otsuka, Taiho Pharmaceutical, Takeda, and Yakult Honsha.
AT THE 2017 GASTROINTESTINAL CANCERS SYMPOSIUM
Key clinical point:
Major finding: Overall 3-year survival was 83.3% and 86% in the bursectomy and nonbursectomy arms, respectively (hazard ratio, 1.07).
Data source: The randomized phase III JCOG1001 trial with more than 1,200 subjects.
Disclosures: Dr. Terashima reported receiving honoraria, and/or research funding from Chugai Pharma, Eisai; Lilly, Otsuka, Taiho Pharmaceutical, Takeda, and Yakult Honsha.
Endoscopic resection alone sufficed in many T1 colorectal cancers
Patients with T1 colorectal cancer might not benefit from additional surgery after endoscopic resection unless they have positive or indeterminate resection margins or high-risk histology, according to a retrospective, population-based study of 1,315 patients.
After a median follow-up of 6.6 years, the rates of colorectal cancer (CRC) recurrence were 6.2% in patients who underwent endoscopic resection only and 6.4% in patients who also had additional surgery (P = .9), reported Tim D.G. Belderbos, MD, of University Medical Center Utrecht (the Netherlands). Rates of local recurrence also were similar between these groups (4.1% and 3.7%, P = .3), he and his associates reported in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.08.041).
Among high-risk patients, however, the rates of overall recurrence were 14% with endoscopic resection only and 7% with endoscopic resection plus additional surgery (P = .06), and the rates of local recurrence were 12% and 1%, respectively (P = .004). “Based on our study, we recommend performing additional surgery after initial endoscopic resection in cases of high-risk T1 CRC, determined by high-risk histology and/or positive resection margins,” the researchers concluded. Invasive CRCs confined to the colonic submucosa (T1 CRC) present a treatment dilemma – they are usually cured by complete endoscopic resection, but up to 13% involve lymph node metastases and need additional surgery, the investigators noted. To identify predictors of recurrence and metastasis, they studied all patients diagnosed with T1 CRC in the Southeast Netherlands from 1995 through 2011. A total of 370 patients (28%) underwent endoscopic resection only, 220 (17%) underwent endoscopic resection with additional surgery, and 725 (55%) had an initial surgical resection.
Surgery after endoscopic resection was more likely when patients had positive or doubtful resection margins (P less than .001), and this link remained significant after high-risk histology, tumor location, time period, age, sex, and comorbidities were controlled for. Endoscopic resection plus surgery did not reduce the risk of recurrence, compared with endoscopic resection only (P = .3), after the investigators accounted for age, sex, year of procedure, tumor location, and margin characteristics. Initial surgery was associated with significantly lower rates of overall and local recurrence, compared with endoscopic resection only, but the differences also lost significance in the multivariable analysis (P = .2).
Only the presence of positive resection margins significantly predicted recurrence among patients undergoing endoscopic resection (hazard ratio, 6.9; 95% confidence interval, 2.3-20.9). Positive or doubtful resection margins also predicted recurrence after initial surgery, with hazard ratios of 13.2 and 3.4, respectively. High-risk histology – that is, poor differentiation, deep submucosal invasion, or lymphangioinvasion – was significantly associated with lymph node metastasis (OR, 2.2; 95% CI, 1.3-3.7; P less than .002), but not with recurrence after resection margins were accounted for. This might result from missing histology data or the fact that patients with high-risk histology tended to undergo surgical rather than endoscopic resection, the researchers said.
They noted several other study limitations, including a lack of details about lesions and procedures. Also, endoscopic submucosal resection was not practiced in the Netherlands during the study period, they said.
The investigators did not report funding sources and had no disclosures.
Patients with T1 colorectal cancer might not benefit from additional surgery after endoscopic resection unless they have positive or indeterminate resection margins or high-risk histology, according to a retrospective, population-based study of 1,315 patients.
After a median follow-up of 6.6 years, the rates of colorectal cancer (CRC) recurrence were 6.2% in patients who underwent endoscopic resection only and 6.4% in patients who also had additional surgery (P = .9), reported Tim D.G. Belderbos, MD, of University Medical Center Utrecht (the Netherlands). Rates of local recurrence also were similar between these groups (4.1% and 3.7%, P = .3), he and his associates reported in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.08.041).
Among high-risk patients, however, the rates of overall recurrence were 14% with endoscopic resection only and 7% with endoscopic resection plus additional surgery (P = .06), and the rates of local recurrence were 12% and 1%, respectively (P = .004). “Based on our study, we recommend performing additional surgery after initial endoscopic resection in cases of high-risk T1 CRC, determined by high-risk histology and/or positive resection margins,” the researchers concluded. Invasive CRCs confined to the colonic submucosa (T1 CRC) present a treatment dilemma – they are usually cured by complete endoscopic resection, but up to 13% involve lymph node metastases and need additional surgery, the investigators noted. To identify predictors of recurrence and metastasis, they studied all patients diagnosed with T1 CRC in the Southeast Netherlands from 1995 through 2011. A total of 370 patients (28%) underwent endoscopic resection only, 220 (17%) underwent endoscopic resection with additional surgery, and 725 (55%) had an initial surgical resection.
Surgery after endoscopic resection was more likely when patients had positive or doubtful resection margins (P less than .001), and this link remained significant after high-risk histology, tumor location, time period, age, sex, and comorbidities were controlled for. Endoscopic resection plus surgery did not reduce the risk of recurrence, compared with endoscopic resection only (P = .3), after the investigators accounted for age, sex, year of procedure, tumor location, and margin characteristics. Initial surgery was associated with significantly lower rates of overall and local recurrence, compared with endoscopic resection only, but the differences also lost significance in the multivariable analysis (P = .2).
Only the presence of positive resection margins significantly predicted recurrence among patients undergoing endoscopic resection (hazard ratio, 6.9; 95% confidence interval, 2.3-20.9). Positive or doubtful resection margins also predicted recurrence after initial surgery, with hazard ratios of 13.2 and 3.4, respectively. High-risk histology – that is, poor differentiation, deep submucosal invasion, or lymphangioinvasion – was significantly associated with lymph node metastasis (OR, 2.2; 95% CI, 1.3-3.7; P less than .002), but not with recurrence after resection margins were accounted for. This might result from missing histology data or the fact that patients with high-risk histology tended to undergo surgical rather than endoscopic resection, the researchers said.
They noted several other study limitations, including a lack of details about lesions and procedures. Also, endoscopic submucosal resection was not practiced in the Netherlands during the study period, they said.
The investigators did not report funding sources and had no disclosures.
Patients with T1 colorectal cancer might not benefit from additional surgery after endoscopic resection unless they have positive or indeterminate resection margins or high-risk histology, according to a retrospective, population-based study of 1,315 patients.
After a median follow-up of 6.6 years, the rates of colorectal cancer (CRC) recurrence were 6.2% in patients who underwent endoscopic resection only and 6.4% in patients who also had additional surgery (P = .9), reported Tim D.G. Belderbos, MD, of University Medical Center Utrecht (the Netherlands). Rates of local recurrence also were similar between these groups (4.1% and 3.7%, P = .3), he and his associates reported in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.08.041).
Among high-risk patients, however, the rates of overall recurrence were 14% with endoscopic resection only and 7% with endoscopic resection plus additional surgery (P = .06), and the rates of local recurrence were 12% and 1%, respectively (P = .004). “Based on our study, we recommend performing additional surgery after initial endoscopic resection in cases of high-risk T1 CRC, determined by high-risk histology and/or positive resection margins,” the researchers concluded. Invasive CRCs confined to the colonic submucosa (T1 CRC) present a treatment dilemma – they are usually cured by complete endoscopic resection, but up to 13% involve lymph node metastases and need additional surgery, the investigators noted. To identify predictors of recurrence and metastasis, they studied all patients diagnosed with T1 CRC in the Southeast Netherlands from 1995 through 2011. A total of 370 patients (28%) underwent endoscopic resection only, 220 (17%) underwent endoscopic resection with additional surgery, and 725 (55%) had an initial surgical resection.
Surgery after endoscopic resection was more likely when patients had positive or doubtful resection margins (P less than .001), and this link remained significant after high-risk histology, tumor location, time period, age, sex, and comorbidities were controlled for. Endoscopic resection plus surgery did not reduce the risk of recurrence, compared with endoscopic resection only (P = .3), after the investigators accounted for age, sex, year of procedure, tumor location, and margin characteristics. Initial surgery was associated with significantly lower rates of overall and local recurrence, compared with endoscopic resection only, but the differences also lost significance in the multivariable analysis (P = .2).
Only the presence of positive resection margins significantly predicted recurrence among patients undergoing endoscopic resection (hazard ratio, 6.9; 95% confidence interval, 2.3-20.9). Positive or doubtful resection margins also predicted recurrence after initial surgery, with hazard ratios of 13.2 and 3.4, respectively. High-risk histology – that is, poor differentiation, deep submucosal invasion, or lymphangioinvasion – was significantly associated with lymph node metastasis (OR, 2.2; 95% CI, 1.3-3.7; P less than .002), but not with recurrence after resection margins were accounted for. This might result from missing histology data or the fact that patients with high-risk histology tended to undergo surgical rather than endoscopic resection, the researchers said.
They noted several other study limitations, including a lack of details about lesions and procedures. Also, endoscopic submucosal resection was not practiced in the Netherlands during the study period, they said.
The investigators did not report funding sources and had no disclosures.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point. Patients with T1 colorectal cancer might not benefit from additional surgery after endoscopic resection unless they have positive or indeterminate resection margins or high-risk histology.
Major finding: After a median follow-up of 6.6 years, rates of CRC recurrence were 6.2% in patients who underwent endoscopic resection only, and 6.4% in patients who also had additional surgery (P = .9). Among high-risk patients, these rates were 14% and 7%, respectively (P = .06).
Data source: A retrospective population-based study of 1,315 patients who underwent endoscopic or surgical resection of T1 colorectal cancer.
Disclosures: The investigators did not report funding sources and had no disclosures.