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Short sleep duration increases risk of death in patients with metastatic colorectal cancer
SAN FRANCISCO – Sleep duration influences survival in the metastatic colorectal cancer population, according to a cohort study of 236 patients who wore wrist actigraphy devices for the 72 hours leading up to chemotherapy.
Those who slept 7 hours nightly or less had a 45% higher adjusted 5-year risk of death when compared with counterparts who logged more hours, investigators reported in a poster session at the Gastrointestinal Cancers Symposium.
“If you’ve got advanced cancer, losing sleep is something to lose sleep over. It would be a good idea to view part of your overall health program as making sure you get an adequate amount of sleep,” first author Dr. David Spiegel said in an interview.
“The nice thing about this is, all of our patients could spend almost a third of their lives in bed asleep, and it’s an easy thing to advise them to do and try and help them to do,” he added. “If we had a chemotherapy that had this kind of effect in this setting, we’d be very happy about that. So it’s something we can do that is low risk, no side effects, that can actually have an effect on outcome.”
The mechanisms at play are still unclear, according to Dr. Spiegel, who is the Jack, Samuel, and Lulu Willson Professor of Medicine, Stanford (Calif.) University.
One possibility is perturbation of cortisol levels. “Cortisol has anti-inflammatory effects. Pro-inflammatory cytokines can trigger [vascular endothelial growth factor], which can provide metastatic tumors with more vascular support,” he elaborated. “Cortisol also affects tumor suppressor gene expression… So it’s conceivable that you are having different levels of cortisol throughout the day and night that may have a subtle effect on inflammation or expression of tumor suppressor genes.”
Alternately, short sleep may be a marker for other lifestyle factors negatively affecting prognosis, he proposed. “People who don’t sleep well don’t exercise as well. They may not eat as well. There are a lot of other systems that kind of get triggered,” he said at the symposium, sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
In previous research, the investigators found that subjectively reported sleep problems in chemotherapy-naïve patients with metastatic colorectal cancer were associated with increased risks of progression, death, and poor treatment response (Sleep Med. 2015 Mar;16:391-8). Additionally, patients with metastatic colorectal cancer with a longer objectively measured proportion of time in bed had better overall survival (Chronobiol Int. 2014 Oct;31:891-900).
In the new study, the median nightly sleep duration was 7.4 hours per night for the entire cohort. Compared with others, patients sleeping 7 hours nightly or less had poorer median overall survival (14.6 vs. 16.4 months, P = .04), and this association remained significant after adjusting for clinical, disease, and treatment factors (hazard ratio, 1.45; P = .012).
“What’s interesting is it’s not simply, as your disease is progressing, you are more anxious, you don’t sleep as well. You are dying anyway, so you are not sleeping well,” Dr. Spiegel commented. “This is a 5-year prediction of subsequent survival. And if you look at the curves, they stay separated pretty much throughout the ensuing 5 years. So it seems to be a strong and independent predictor of mortality.”
In contrast, short sleep duration was not significantly associated with progression-free survival, objective response rate, or grade 3 or 4 toxicity.
The findings are generally consistent with those of a study among women with metastatic breast cancer showing an impact of sleep on survival (Sleep. 2014 May 1;37:837-42). However, in that study, sleep efficiency, not duration, was associated with survival.
“My colleague Oxana Palesh has a brief behavioral intervention for sleep, and it is effective for improving sleep in the short term,” commented Dr. Spiegel. “The next thing would be to do a randomized trial to see if we can get them [short sleepers] to sleep longer and if that has an effect on outcome.”
SAN FRANCISCO – Sleep duration influences survival in the metastatic colorectal cancer population, according to a cohort study of 236 patients who wore wrist actigraphy devices for the 72 hours leading up to chemotherapy.
Those who slept 7 hours nightly or less had a 45% higher adjusted 5-year risk of death when compared with counterparts who logged more hours, investigators reported in a poster session at the Gastrointestinal Cancers Symposium.
“If you’ve got advanced cancer, losing sleep is something to lose sleep over. It would be a good idea to view part of your overall health program as making sure you get an adequate amount of sleep,” first author Dr. David Spiegel said in an interview.
“The nice thing about this is, all of our patients could spend almost a third of their lives in bed asleep, and it’s an easy thing to advise them to do and try and help them to do,” he added. “If we had a chemotherapy that had this kind of effect in this setting, we’d be very happy about that. So it’s something we can do that is low risk, no side effects, that can actually have an effect on outcome.”
The mechanisms at play are still unclear, according to Dr. Spiegel, who is the Jack, Samuel, and Lulu Willson Professor of Medicine, Stanford (Calif.) University.
One possibility is perturbation of cortisol levels. “Cortisol has anti-inflammatory effects. Pro-inflammatory cytokines can trigger [vascular endothelial growth factor], which can provide metastatic tumors with more vascular support,” he elaborated. “Cortisol also affects tumor suppressor gene expression… So it’s conceivable that you are having different levels of cortisol throughout the day and night that may have a subtle effect on inflammation or expression of tumor suppressor genes.”
Alternately, short sleep may be a marker for other lifestyle factors negatively affecting prognosis, he proposed. “People who don’t sleep well don’t exercise as well. They may not eat as well. There are a lot of other systems that kind of get triggered,” he said at the symposium, sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
In previous research, the investigators found that subjectively reported sleep problems in chemotherapy-naïve patients with metastatic colorectal cancer were associated with increased risks of progression, death, and poor treatment response (Sleep Med. 2015 Mar;16:391-8). Additionally, patients with metastatic colorectal cancer with a longer objectively measured proportion of time in bed had better overall survival (Chronobiol Int. 2014 Oct;31:891-900).
In the new study, the median nightly sleep duration was 7.4 hours per night for the entire cohort. Compared with others, patients sleeping 7 hours nightly or less had poorer median overall survival (14.6 vs. 16.4 months, P = .04), and this association remained significant after adjusting for clinical, disease, and treatment factors (hazard ratio, 1.45; P = .012).
“What’s interesting is it’s not simply, as your disease is progressing, you are more anxious, you don’t sleep as well. You are dying anyway, so you are not sleeping well,” Dr. Spiegel commented. “This is a 5-year prediction of subsequent survival. And if you look at the curves, they stay separated pretty much throughout the ensuing 5 years. So it seems to be a strong and independent predictor of mortality.”
In contrast, short sleep duration was not significantly associated with progression-free survival, objective response rate, or grade 3 or 4 toxicity.
The findings are generally consistent with those of a study among women with metastatic breast cancer showing an impact of sleep on survival (Sleep. 2014 May 1;37:837-42). However, in that study, sleep efficiency, not duration, was associated with survival.
“My colleague Oxana Palesh has a brief behavioral intervention for sleep, and it is effective for improving sleep in the short term,” commented Dr. Spiegel. “The next thing would be to do a randomized trial to see if we can get them [short sleepers] to sleep longer and if that has an effect on outcome.”
SAN FRANCISCO – Sleep duration influences survival in the metastatic colorectal cancer population, according to a cohort study of 236 patients who wore wrist actigraphy devices for the 72 hours leading up to chemotherapy.
Those who slept 7 hours nightly or less had a 45% higher adjusted 5-year risk of death when compared with counterparts who logged more hours, investigators reported in a poster session at the Gastrointestinal Cancers Symposium.
“If you’ve got advanced cancer, losing sleep is something to lose sleep over. It would be a good idea to view part of your overall health program as making sure you get an adequate amount of sleep,” first author Dr. David Spiegel said in an interview.
“The nice thing about this is, all of our patients could spend almost a third of their lives in bed asleep, and it’s an easy thing to advise them to do and try and help them to do,” he added. “If we had a chemotherapy that had this kind of effect in this setting, we’d be very happy about that. So it’s something we can do that is low risk, no side effects, that can actually have an effect on outcome.”
The mechanisms at play are still unclear, according to Dr. Spiegel, who is the Jack, Samuel, and Lulu Willson Professor of Medicine, Stanford (Calif.) University.
One possibility is perturbation of cortisol levels. “Cortisol has anti-inflammatory effects. Pro-inflammatory cytokines can trigger [vascular endothelial growth factor], which can provide metastatic tumors with more vascular support,” he elaborated. “Cortisol also affects tumor suppressor gene expression… So it’s conceivable that you are having different levels of cortisol throughout the day and night that may have a subtle effect on inflammation or expression of tumor suppressor genes.”
Alternately, short sleep may be a marker for other lifestyle factors negatively affecting prognosis, he proposed. “People who don’t sleep well don’t exercise as well. They may not eat as well. There are a lot of other systems that kind of get triggered,” he said at the symposium, sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
In previous research, the investigators found that subjectively reported sleep problems in chemotherapy-naïve patients with metastatic colorectal cancer were associated with increased risks of progression, death, and poor treatment response (Sleep Med. 2015 Mar;16:391-8). Additionally, patients with metastatic colorectal cancer with a longer objectively measured proportion of time in bed had better overall survival (Chronobiol Int. 2014 Oct;31:891-900).
In the new study, the median nightly sleep duration was 7.4 hours per night for the entire cohort. Compared with others, patients sleeping 7 hours nightly or less had poorer median overall survival (14.6 vs. 16.4 months, P = .04), and this association remained significant after adjusting for clinical, disease, and treatment factors (hazard ratio, 1.45; P = .012).
“What’s interesting is it’s not simply, as your disease is progressing, you are more anxious, you don’t sleep as well. You are dying anyway, so you are not sleeping well,” Dr. Spiegel commented. “This is a 5-year prediction of subsequent survival. And if you look at the curves, they stay separated pretty much throughout the ensuing 5 years. So it seems to be a strong and independent predictor of mortality.”
In contrast, short sleep duration was not significantly associated with progression-free survival, objective response rate, or grade 3 or 4 toxicity.
The findings are generally consistent with those of a study among women with metastatic breast cancer showing an impact of sleep on survival (Sleep. 2014 May 1;37:837-42). However, in that study, sleep efficiency, not duration, was associated with survival.
“My colleague Oxana Palesh has a brief behavioral intervention for sleep, and it is effective for improving sleep in the short term,” commented Dr. Spiegel. “The next thing would be to do a randomized trial to see if we can get them [short sleepers] to sleep longer and if that has an effect on outcome.”
AT THE GASTROINTESTINAL CANCERS SYMPOSIUM
Key clinical point: Sleep duration independently predicts overall survival in patients with metastatic colorectal cancer.
Major finding: Compared with peers logging more hours, patients sleeping 7 hours nightly or less had an elevated 5-year risk of death (hazard ratio, 1.45).
Data source: A cohort study of 236 patients receiving chemotherapy for metastatic colorectal cancer.
Disclosures: Dr. Spiegel disclosed that he had no relevant conflicts of interest.
Breast cancer patients at increased risk of colorectal cancer
Women previously diagnosed with breast cancer had a 60% increased risk of colorectal cancer, according to analysis of Swedish cancer registries, and breast cancer therapy had no effect on risk.
Women previously diagnosed with breast cancer had a higher risk of colorectal adenocarcinoma, compared with the general population (standardized incidence ratio, 1.59; 95% confidence interval, 1.53-1.65). Higher risk was observed for adenocarcinoma of the proximal colon, compared with the distal colon (SIR, 1.72; 95% CI, 1.61-1.82 vs. SIR, 1.46; 95% CI, 1.34-1.58).
Risk for adenocarcinoma of the proximal colon, the predominant subtype in women, increased with age at breast cancer diagnosis, from an SIR of 1.60 for women diagnosed between the ages of 15 and 49 years, to an SIR of 1.51 for 50-59 years, to an SIR of 1.82 for age 60 years or greater. By contrast, the SIR for general colorectal adenocarcinoma dipped in the 50-59 age group, a finding that may point to the role of estrogen in colorectal carcinoma (Cancer Epidemiol. 2016 Feb 15. doi: 10.1016/j.canep.2016.01.006).
“It is well known that estrogen levels are elevated in breast cancer patients, which may contribute to the increased risk of colorectal cancer in this population. Interestingly, our results showed that the SIRs of colorectal adenocarcinoma changed in different age groups, compared with the general population. Specifically, the SIRs showed a drop in the 50-59 age group but increased again after the age of 60,” wrote Dr. Yunxia Lu, associate professor in the department of molecular medicine and surgery, Karolinska Institute, Stockholm, and colleagues. The researchers noted previous reports of endogenous estrogen levels decreasing after menopause for a short period, while exogenous hormones may take effect some time after menopause.
The study found no association between different types of breast cancer treatment, including antihormonal therapy, and the risk of colorectal cancer.
The retrospective analysis used data from the Swedish Cancer Register, including 179,733 patients diagnosed with breast cancer from 1961 to 2010, and 2,571 colorectal cancers identified. Analysis of treatment effects on colorectal cancer risk used data from the Stockholm-Gotland Breast Cancer Register of 20,171 patients with breast cancer and relevant treatment information.
Dr. Lu and coauthors reported having no disclosures.
Women previously diagnosed with breast cancer had a 60% increased risk of colorectal cancer, according to analysis of Swedish cancer registries, and breast cancer therapy had no effect on risk.
Women previously diagnosed with breast cancer had a higher risk of colorectal adenocarcinoma, compared with the general population (standardized incidence ratio, 1.59; 95% confidence interval, 1.53-1.65). Higher risk was observed for adenocarcinoma of the proximal colon, compared with the distal colon (SIR, 1.72; 95% CI, 1.61-1.82 vs. SIR, 1.46; 95% CI, 1.34-1.58).
Risk for adenocarcinoma of the proximal colon, the predominant subtype in women, increased with age at breast cancer diagnosis, from an SIR of 1.60 for women diagnosed between the ages of 15 and 49 years, to an SIR of 1.51 for 50-59 years, to an SIR of 1.82 for age 60 years or greater. By contrast, the SIR for general colorectal adenocarcinoma dipped in the 50-59 age group, a finding that may point to the role of estrogen in colorectal carcinoma (Cancer Epidemiol. 2016 Feb 15. doi: 10.1016/j.canep.2016.01.006).
“It is well known that estrogen levels are elevated in breast cancer patients, which may contribute to the increased risk of colorectal cancer in this population. Interestingly, our results showed that the SIRs of colorectal adenocarcinoma changed in different age groups, compared with the general population. Specifically, the SIRs showed a drop in the 50-59 age group but increased again after the age of 60,” wrote Dr. Yunxia Lu, associate professor in the department of molecular medicine and surgery, Karolinska Institute, Stockholm, and colleagues. The researchers noted previous reports of endogenous estrogen levels decreasing after menopause for a short period, while exogenous hormones may take effect some time after menopause.
The study found no association between different types of breast cancer treatment, including antihormonal therapy, and the risk of colorectal cancer.
The retrospective analysis used data from the Swedish Cancer Register, including 179,733 patients diagnosed with breast cancer from 1961 to 2010, and 2,571 colorectal cancers identified. Analysis of treatment effects on colorectal cancer risk used data from the Stockholm-Gotland Breast Cancer Register of 20,171 patients with breast cancer and relevant treatment information.
Dr. Lu and coauthors reported having no disclosures.
Women previously diagnosed with breast cancer had a 60% increased risk of colorectal cancer, according to analysis of Swedish cancer registries, and breast cancer therapy had no effect on risk.
Women previously diagnosed with breast cancer had a higher risk of colorectal adenocarcinoma, compared with the general population (standardized incidence ratio, 1.59; 95% confidence interval, 1.53-1.65). Higher risk was observed for adenocarcinoma of the proximal colon, compared with the distal colon (SIR, 1.72; 95% CI, 1.61-1.82 vs. SIR, 1.46; 95% CI, 1.34-1.58).
Risk for adenocarcinoma of the proximal colon, the predominant subtype in women, increased with age at breast cancer diagnosis, from an SIR of 1.60 for women diagnosed between the ages of 15 and 49 years, to an SIR of 1.51 for 50-59 years, to an SIR of 1.82 for age 60 years or greater. By contrast, the SIR for general colorectal adenocarcinoma dipped in the 50-59 age group, a finding that may point to the role of estrogen in colorectal carcinoma (Cancer Epidemiol. 2016 Feb 15. doi: 10.1016/j.canep.2016.01.006).
“It is well known that estrogen levels are elevated in breast cancer patients, which may contribute to the increased risk of colorectal cancer in this population. Interestingly, our results showed that the SIRs of colorectal adenocarcinoma changed in different age groups, compared with the general population. Specifically, the SIRs showed a drop in the 50-59 age group but increased again after the age of 60,” wrote Dr. Yunxia Lu, associate professor in the department of molecular medicine and surgery, Karolinska Institute, Stockholm, and colleagues. The researchers noted previous reports of endogenous estrogen levels decreasing after menopause for a short period, while exogenous hormones may take effect some time after menopause.
The study found no association between different types of breast cancer treatment, including antihormonal therapy, and the risk of colorectal cancer.
The retrospective analysis used data from the Swedish Cancer Register, including 179,733 patients diagnosed with breast cancer from 1961 to 2010, and 2,571 colorectal cancers identified. Analysis of treatment effects on colorectal cancer risk used data from the Stockholm-Gotland Breast Cancer Register of 20,171 patients with breast cancer and relevant treatment information.
Dr. Lu and coauthors reported having no disclosures.
FROM CANCER EPIDEMIOLOGY
Key clinical point: Colorectal cancer risk was significantly increased in patients previously diagnosed with breast cancer.
Major finding: Standardized incidence ratio for the breast cancer cohort compared with the general population was 1.59 (95% CI, 1.53-1.65).
Data source: The Swedish Cancer Register included 179,733 patients with breast cancer; the Stockholm-Gotland Breast Cancer Register included 20,171 patients with breast cancer and relevant treatment information.
Disclosures: Dr. Lu and coauthors reported having no disclosures.
Rate of BRCA testing up among young women with breast cancer
The rate at which young women diagnosed with breast cancer are undergoing genetic testing for BRCA1 and BRCA2 mutations has increased, investigators report online in JAMA Oncology.
In a study of 897 women aged 40 years and younger diagnosed with breast cancer at any one of 11 academic or community medical centers, 780 (87%) reported undergoing BRCA testing within the first year after diagnosis, reported Dr. Ann H. Partridge of the Dana-Farber Cancer Institute, Boston, and her associates (JAMA Onc. 2016 Feb 11. doi: 10.1001/jamaoncol.2015.5941).
Among the 780 women who had BRCA testing, 59 (7.6%) reported a BRCA1 mutation, 35 (4.5%) reported a BRCA2 mutation, and 35 (4.6%) reported an indeterminate result or variant of unknown clinical significance, the investigators said.
The frequency of testing increased over time. Of 39 women diagnosed with breast cancer in 2006, 30 (76.9%) elected to have testing, but by 2013, 123 (95.3%) of 129 women diagnosed with breast cancer reported BRCA testing.
The investigators attribute the increasing frequency of BRCA testing to the fact that most women in the group were insured, educated, and treated at cancer centers where comprehensive genetic counseling and testing services were widely available, but they also acknowledged the possibility that media attention to genetic breast cancer (in other words, the Angelina Jolie effect) may have motivated more women to bring up the issue of genetic risk with their physician or genetic counselor.
The study can be found online here.
On Twitter @NikolaidesLaura
The rate at which young women diagnosed with breast cancer are undergoing genetic testing for BRCA1 and BRCA2 mutations has increased, investigators report online in JAMA Oncology.
In a study of 897 women aged 40 years and younger diagnosed with breast cancer at any one of 11 academic or community medical centers, 780 (87%) reported undergoing BRCA testing within the first year after diagnosis, reported Dr. Ann H. Partridge of the Dana-Farber Cancer Institute, Boston, and her associates (JAMA Onc. 2016 Feb 11. doi: 10.1001/jamaoncol.2015.5941).
Among the 780 women who had BRCA testing, 59 (7.6%) reported a BRCA1 mutation, 35 (4.5%) reported a BRCA2 mutation, and 35 (4.6%) reported an indeterminate result or variant of unknown clinical significance, the investigators said.
The frequency of testing increased over time. Of 39 women diagnosed with breast cancer in 2006, 30 (76.9%) elected to have testing, but by 2013, 123 (95.3%) of 129 women diagnosed with breast cancer reported BRCA testing.
The investigators attribute the increasing frequency of BRCA testing to the fact that most women in the group were insured, educated, and treated at cancer centers where comprehensive genetic counseling and testing services were widely available, but they also acknowledged the possibility that media attention to genetic breast cancer (in other words, the Angelina Jolie effect) may have motivated more women to bring up the issue of genetic risk with their physician or genetic counselor.
The study can be found online here.
On Twitter @NikolaidesLaura
The rate at which young women diagnosed with breast cancer are undergoing genetic testing for BRCA1 and BRCA2 mutations has increased, investigators report online in JAMA Oncology.
In a study of 897 women aged 40 years and younger diagnosed with breast cancer at any one of 11 academic or community medical centers, 780 (87%) reported undergoing BRCA testing within the first year after diagnosis, reported Dr. Ann H. Partridge of the Dana-Farber Cancer Institute, Boston, and her associates (JAMA Onc. 2016 Feb 11. doi: 10.1001/jamaoncol.2015.5941).
Among the 780 women who had BRCA testing, 59 (7.6%) reported a BRCA1 mutation, 35 (4.5%) reported a BRCA2 mutation, and 35 (4.6%) reported an indeterminate result or variant of unknown clinical significance, the investigators said.
The frequency of testing increased over time. Of 39 women diagnosed with breast cancer in 2006, 30 (76.9%) elected to have testing, but by 2013, 123 (95.3%) of 129 women diagnosed with breast cancer reported BRCA testing.
The investigators attribute the increasing frequency of BRCA testing to the fact that most women in the group were insured, educated, and treated at cancer centers where comprehensive genetic counseling and testing services were widely available, but they also acknowledged the possibility that media attention to genetic breast cancer (in other words, the Angelina Jolie effect) may have motivated more women to bring up the issue of genetic risk with their physician or genetic counselor.
The study can be found online here.
On Twitter @NikolaidesLaura
FROM JAMA ONCOLOGY
Study evaluates which prior cancers pose a risk for developing NSCLC
PHOENIX – Patients with a history of head and neck, lung, bladder, and hematologic malignancies had increased rates of subsequent non–small cell lung cancer (NSCLC), a large analysis of national data found.
“It is unclear to what extent the higher rate of primary NSCLC in these patients may be attributed to smoking, previous cancer history, or other lung cancer risk factors,” researchers led by Dr. Geena Wu wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons. “Further research using individual smoking data may better delineate who is at increased risk of NSCLC based on prior cancer site and smoking history.”
In a study that Dr. Wu led during a research fellowship at the City of Hope National Medical Center, Duarte, Calif., she and her associates used the Surveillance, Epidemiology, and End Results (SEER) 1992-2007 dataset to identify 32,058 patients with a prior malignancy who subsequently developed primary lung cancer at 6 months or more after their initial cancer. They calculated standardized incidence ratios (SIRs) for NSCLC as a rate of observed to expected NSCLC cases adjusted by person-years at risk, age, gender, and time of diagnosis.
The researchers found that patients with a history of the following cancers had higher rates of second primary NSCLC than expected: head and neck (SIR, 4.00), colon and rectum (SIR, 1.16), pancreas (SIR, 1.44), lung (SIR, 4.88), bladder (SIR, 1.97), kidney (SIR, 1.21), breast (SIR, 1.09), and leukemia or lymphoma (SIR, 1.40).
At the same time, patients with a history of pancreatic or breast cancer who were treated with radiation had a higher incidence of second primary NSCLC (SIR of 2.54 and SIR of 1.14, respectively), while those who were not treated with radiation did not.
Although the SEER database does not contain information about patient smoking history, the researchers evaluated adult smoking rates by state by using a national map from the Centers for Disease Control and Prevention’s 2013 Behavioral Risk Factor Surveillance System. Smoking rates were low (defined as 13.7% or less) in California, Hawaii, and Utah, and were higher in all other states, especially in Southeastern states. Dr. Wu and her associates found that patients from high smoking areas who had previous cancers of the colon and rectum, pancreas, kidney, thyroid, and breast had higher rates of a primary NSCLC, while those from low smoking areas did not. Interestingly, patients from high smoking areas who previously had uterine cancer, prostate, or melanoma had did not have higher rates of a primary NSCLC.
“Just because someone has a previous history of cancer, they’re not necessarily at increased risk of a second lung cancer,” Dr. Wu, who is now a fourth-year general surgery resident at Maricopa County Hospital in Phoenix said in an interview at the meeting. “You have to look at what kind of cancer they had and what their smoking history is – whether or not they continue to smoke, because smoking is such an important risk factor.”
Another limitation of the SEER database is that it lacks details about the type of chemotherapy patients receive, “so whether or not chemotherapy plays an impact in the elevated risk of lung cancer we can’t say.”
Dr. Wu reported having no financial disclosures.
PHOENIX – Patients with a history of head and neck, lung, bladder, and hematologic malignancies had increased rates of subsequent non–small cell lung cancer (NSCLC), a large analysis of national data found.
“It is unclear to what extent the higher rate of primary NSCLC in these patients may be attributed to smoking, previous cancer history, or other lung cancer risk factors,” researchers led by Dr. Geena Wu wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons. “Further research using individual smoking data may better delineate who is at increased risk of NSCLC based on prior cancer site and smoking history.”
In a study that Dr. Wu led during a research fellowship at the City of Hope National Medical Center, Duarte, Calif., she and her associates used the Surveillance, Epidemiology, and End Results (SEER) 1992-2007 dataset to identify 32,058 patients with a prior malignancy who subsequently developed primary lung cancer at 6 months or more after their initial cancer. They calculated standardized incidence ratios (SIRs) for NSCLC as a rate of observed to expected NSCLC cases adjusted by person-years at risk, age, gender, and time of diagnosis.
The researchers found that patients with a history of the following cancers had higher rates of second primary NSCLC than expected: head and neck (SIR, 4.00), colon and rectum (SIR, 1.16), pancreas (SIR, 1.44), lung (SIR, 4.88), bladder (SIR, 1.97), kidney (SIR, 1.21), breast (SIR, 1.09), and leukemia or lymphoma (SIR, 1.40).
At the same time, patients with a history of pancreatic or breast cancer who were treated with radiation had a higher incidence of second primary NSCLC (SIR of 2.54 and SIR of 1.14, respectively), while those who were not treated with radiation did not.
Although the SEER database does not contain information about patient smoking history, the researchers evaluated adult smoking rates by state by using a national map from the Centers for Disease Control and Prevention’s 2013 Behavioral Risk Factor Surveillance System. Smoking rates were low (defined as 13.7% or less) in California, Hawaii, and Utah, and were higher in all other states, especially in Southeastern states. Dr. Wu and her associates found that patients from high smoking areas who had previous cancers of the colon and rectum, pancreas, kidney, thyroid, and breast had higher rates of a primary NSCLC, while those from low smoking areas did not. Interestingly, patients from high smoking areas who previously had uterine cancer, prostate, or melanoma had did not have higher rates of a primary NSCLC.
“Just because someone has a previous history of cancer, they’re not necessarily at increased risk of a second lung cancer,” Dr. Wu, who is now a fourth-year general surgery resident at Maricopa County Hospital in Phoenix said in an interview at the meeting. “You have to look at what kind of cancer they had and what their smoking history is – whether or not they continue to smoke, because smoking is such an important risk factor.”
Another limitation of the SEER database is that it lacks details about the type of chemotherapy patients receive, “so whether or not chemotherapy plays an impact in the elevated risk of lung cancer we can’t say.”
Dr. Wu reported having no financial disclosures.
PHOENIX – Patients with a history of head and neck, lung, bladder, and hematologic malignancies had increased rates of subsequent non–small cell lung cancer (NSCLC), a large analysis of national data found.
“It is unclear to what extent the higher rate of primary NSCLC in these patients may be attributed to smoking, previous cancer history, or other lung cancer risk factors,” researchers led by Dr. Geena Wu wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons. “Further research using individual smoking data may better delineate who is at increased risk of NSCLC based on prior cancer site and smoking history.”
In a study that Dr. Wu led during a research fellowship at the City of Hope National Medical Center, Duarte, Calif., she and her associates used the Surveillance, Epidemiology, and End Results (SEER) 1992-2007 dataset to identify 32,058 patients with a prior malignancy who subsequently developed primary lung cancer at 6 months or more after their initial cancer. They calculated standardized incidence ratios (SIRs) for NSCLC as a rate of observed to expected NSCLC cases adjusted by person-years at risk, age, gender, and time of diagnosis.
The researchers found that patients with a history of the following cancers had higher rates of second primary NSCLC than expected: head and neck (SIR, 4.00), colon and rectum (SIR, 1.16), pancreas (SIR, 1.44), lung (SIR, 4.88), bladder (SIR, 1.97), kidney (SIR, 1.21), breast (SIR, 1.09), and leukemia or lymphoma (SIR, 1.40).
At the same time, patients with a history of pancreatic or breast cancer who were treated with radiation had a higher incidence of second primary NSCLC (SIR of 2.54 and SIR of 1.14, respectively), while those who were not treated with radiation did not.
Although the SEER database does not contain information about patient smoking history, the researchers evaluated adult smoking rates by state by using a national map from the Centers for Disease Control and Prevention’s 2013 Behavioral Risk Factor Surveillance System. Smoking rates were low (defined as 13.7% or less) in California, Hawaii, and Utah, and were higher in all other states, especially in Southeastern states. Dr. Wu and her associates found that patients from high smoking areas who had previous cancers of the colon and rectum, pancreas, kidney, thyroid, and breast had higher rates of a primary NSCLC, while those from low smoking areas did not. Interestingly, patients from high smoking areas who previously had uterine cancer, prostate, or melanoma had did not have higher rates of a primary NSCLC.
“Just because someone has a previous history of cancer, they’re not necessarily at increased risk of a second lung cancer,” Dr. Wu, who is now a fourth-year general surgery resident at Maricopa County Hospital in Phoenix said in an interview at the meeting. “You have to look at what kind of cancer they had and what their smoking history is – whether or not they continue to smoke, because smoking is such an important risk factor.”
Another limitation of the SEER database is that it lacks details about the type of chemotherapy patients receive, “so whether or not chemotherapy plays an impact in the elevated risk of lung cancer we can’t say.”
Dr. Wu reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point: Not all patients with history of cancer face an increased risk of developing subsequent NSCLC.
Major finding: Patients with a history of the following cancers had higher rates of second primary NSCLC than expected: head and neck (SIR, 4.00), colon and rectum (SIR, 1.16), pancreas (SIR, 1.44), lung (SIR, 4.88), bladder (SIR, 1.97), kidney (SIR, 1.21), breast (SIR, 1.09), and leukemia or lymphoma (SIR, 1.40).
Data source: An analysis of 32,058 patients with a prior malignancy that subsequently developed primary lung cancer at 6 months or more after their initial cancer.
Disclosures: Dr. Wu reported having no financial disclosures.
Defibrotide offers benefit for severe veno-occlusive disease and multiorgan failure
Defibrotide improved survival at 100 days after hematopoietic stem cell transplantation (HSCT) in patients with hepatic veno-occlusive disease, based on an open-label trial that compared trial participants with historical controls.
Of the 102 patients in the defibrotide group, 39 were alive 100 days after HSCT (38.2%), compared with 8 of 32 (25.0%) in the historical control group. The propensity-adjusted, between-group difference was 23.0% (95.1% confidence interval, 5.2%-40.8%; P = .0109). At 180 days post-HSCT, the difference in survival between the groups was not significant (Blood. 2016 Feb 3. doi: 10.1182/blood-2015-10-676924).
Defibrotide has Fast Track designation from the FDA and the new drug application is currently under Priority Review with a decision expected by March 31, 2016. A potentially fatal complication of HSCT, hepatic veno-occlusive disease is characterized by hepatomegaly, jaundice, rapid weight gain, fluid retention, and ascites. There are no approved therapies.
“In this context, defibrotide provides a promising treatment option for patients with a high unmet medical need,” wrote Dr. Paul G. Richardson of Dana-Farber Cancer Institute in Boston and his colleagues.
At day 100 post-HSCT, complete response was seen in 25.5% of the defibrotide group and in 12.5% of the historical control group. The propensity-adjusted, between-group difference was 19% (95.1% CI, 3.5-34.6%; P = .0160). The complete response was durable in 22 of the 26 patients. In the control group, complete response was limited in two patients, impossible to assess in one patient, and durable in one patient.
The multicenter, open-label, phase III trial prospectively enrolled 102 patients with hepatic veno-occlusive disease from 2006 to 2008. Defibrotide was administered intravenously at 25 mg/kg/day in 4 divided doses for a minimum of 21 days. Treatment continued beyond 21 days until resolution of veno-occlusive disease or until the patient was discharged from the hospital.
To identify the historical controls, 6,867 medical charts of HSCT patients hospitalized from 1995 to 2007 were reviewed, and 32 historical control patients were selected. Most (21 of 32) were diagnosed with during 2000-2006, and 11 were diagnosed before 2000. The historical controls were selected by an independent medical review committee, and met the same entry criteria as the defibrotide group.
Because recruiting for the defibrotide group and screening for historical controls occurred at the same institutions during similar time periods, patient management and supportive care were likely similar for the two groups. Propensity scores were included in the analysis to adjust for prognostic factors that were unbalanced between treatment and control groups, including ventilator and dialysis dependency at study entry, age greater or less than 16 years, prior HSCT (0 vs. 1), and allogeneic or autologous transplant.
Hypotension was the most common adverse event reported in the defibrotide and control groups (39% and 50%, respectively), followed by diarrhea (23.5% and 37.5%, respectively). The defibrotide and control groups had similar incidences of common hemorrhagic adverse events (64% and 75%, respectively). Fatal adverse events occurred in 64% of the defibrotide group and 69% of the control group, and fatal hemorrhagic events occurred in 14.7% of the defibrotide group and 6.3% of the control group.
Approved by the European Union, defibrotide is a single-stranded, deoxyribonucleic acid derivative that stabilizes damaged endothelial cells and prevents further endothelial cell damage.
Dr. Richardson reported consulting or advisory roles with Gentium/Jazz Pharmaceuticals, the maker of defibrotide.
Defibrotide improved survival at 100 days after hematopoietic stem cell transplantation (HSCT) in patients with hepatic veno-occlusive disease, based on an open-label trial that compared trial participants with historical controls.
Of the 102 patients in the defibrotide group, 39 were alive 100 days after HSCT (38.2%), compared with 8 of 32 (25.0%) in the historical control group. The propensity-adjusted, between-group difference was 23.0% (95.1% confidence interval, 5.2%-40.8%; P = .0109). At 180 days post-HSCT, the difference in survival between the groups was not significant (Blood. 2016 Feb 3. doi: 10.1182/blood-2015-10-676924).
Defibrotide has Fast Track designation from the FDA and the new drug application is currently under Priority Review with a decision expected by March 31, 2016. A potentially fatal complication of HSCT, hepatic veno-occlusive disease is characterized by hepatomegaly, jaundice, rapid weight gain, fluid retention, and ascites. There are no approved therapies.
“In this context, defibrotide provides a promising treatment option for patients with a high unmet medical need,” wrote Dr. Paul G. Richardson of Dana-Farber Cancer Institute in Boston and his colleagues.
At day 100 post-HSCT, complete response was seen in 25.5% of the defibrotide group and in 12.5% of the historical control group. The propensity-adjusted, between-group difference was 19% (95.1% CI, 3.5-34.6%; P = .0160). The complete response was durable in 22 of the 26 patients. In the control group, complete response was limited in two patients, impossible to assess in one patient, and durable in one patient.
The multicenter, open-label, phase III trial prospectively enrolled 102 patients with hepatic veno-occlusive disease from 2006 to 2008. Defibrotide was administered intravenously at 25 mg/kg/day in 4 divided doses for a minimum of 21 days. Treatment continued beyond 21 days until resolution of veno-occlusive disease or until the patient was discharged from the hospital.
To identify the historical controls, 6,867 medical charts of HSCT patients hospitalized from 1995 to 2007 were reviewed, and 32 historical control patients were selected. Most (21 of 32) were diagnosed with during 2000-2006, and 11 were diagnosed before 2000. The historical controls were selected by an independent medical review committee, and met the same entry criteria as the defibrotide group.
Because recruiting for the defibrotide group and screening for historical controls occurred at the same institutions during similar time periods, patient management and supportive care were likely similar for the two groups. Propensity scores were included in the analysis to adjust for prognostic factors that were unbalanced between treatment and control groups, including ventilator and dialysis dependency at study entry, age greater or less than 16 years, prior HSCT (0 vs. 1), and allogeneic or autologous transplant.
Hypotension was the most common adverse event reported in the defibrotide and control groups (39% and 50%, respectively), followed by diarrhea (23.5% and 37.5%, respectively). The defibrotide and control groups had similar incidences of common hemorrhagic adverse events (64% and 75%, respectively). Fatal adverse events occurred in 64% of the defibrotide group and 69% of the control group, and fatal hemorrhagic events occurred in 14.7% of the defibrotide group and 6.3% of the control group.
Approved by the European Union, defibrotide is a single-stranded, deoxyribonucleic acid derivative that stabilizes damaged endothelial cells and prevents further endothelial cell damage.
Dr. Richardson reported consulting or advisory roles with Gentium/Jazz Pharmaceuticals, the maker of defibrotide.
Defibrotide improved survival at 100 days after hematopoietic stem cell transplantation (HSCT) in patients with hepatic veno-occlusive disease, based on an open-label trial that compared trial participants with historical controls.
Of the 102 patients in the defibrotide group, 39 were alive 100 days after HSCT (38.2%), compared with 8 of 32 (25.0%) in the historical control group. The propensity-adjusted, between-group difference was 23.0% (95.1% confidence interval, 5.2%-40.8%; P = .0109). At 180 days post-HSCT, the difference in survival between the groups was not significant (Blood. 2016 Feb 3. doi: 10.1182/blood-2015-10-676924).
Defibrotide has Fast Track designation from the FDA and the new drug application is currently under Priority Review with a decision expected by March 31, 2016. A potentially fatal complication of HSCT, hepatic veno-occlusive disease is characterized by hepatomegaly, jaundice, rapid weight gain, fluid retention, and ascites. There are no approved therapies.
“In this context, defibrotide provides a promising treatment option for patients with a high unmet medical need,” wrote Dr. Paul G. Richardson of Dana-Farber Cancer Institute in Boston and his colleagues.
At day 100 post-HSCT, complete response was seen in 25.5% of the defibrotide group and in 12.5% of the historical control group. The propensity-adjusted, between-group difference was 19% (95.1% CI, 3.5-34.6%; P = .0160). The complete response was durable in 22 of the 26 patients. In the control group, complete response was limited in two patients, impossible to assess in one patient, and durable in one patient.
The multicenter, open-label, phase III trial prospectively enrolled 102 patients with hepatic veno-occlusive disease from 2006 to 2008. Defibrotide was administered intravenously at 25 mg/kg/day in 4 divided doses for a minimum of 21 days. Treatment continued beyond 21 days until resolution of veno-occlusive disease or until the patient was discharged from the hospital.
To identify the historical controls, 6,867 medical charts of HSCT patients hospitalized from 1995 to 2007 were reviewed, and 32 historical control patients were selected. Most (21 of 32) were diagnosed with during 2000-2006, and 11 were diagnosed before 2000. The historical controls were selected by an independent medical review committee, and met the same entry criteria as the defibrotide group.
Because recruiting for the defibrotide group and screening for historical controls occurred at the same institutions during similar time periods, patient management and supportive care were likely similar for the two groups. Propensity scores were included in the analysis to adjust for prognostic factors that were unbalanced between treatment and control groups, including ventilator and dialysis dependency at study entry, age greater or less than 16 years, prior HSCT (0 vs. 1), and allogeneic or autologous transplant.
Hypotension was the most common adverse event reported in the defibrotide and control groups (39% and 50%, respectively), followed by diarrhea (23.5% and 37.5%, respectively). The defibrotide and control groups had similar incidences of common hemorrhagic adverse events (64% and 75%, respectively). Fatal adverse events occurred in 64% of the defibrotide group and 69% of the control group, and fatal hemorrhagic events occurred in 14.7% of the defibrotide group and 6.3% of the control group.
Approved by the European Union, defibrotide is a single-stranded, deoxyribonucleic acid derivative that stabilizes damaged endothelial cells and prevents further endothelial cell damage.
Dr. Richardson reported consulting or advisory roles with Gentium/Jazz Pharmaceuticals, the maker of defibrotide.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Defibrotide improved survival at 100 days after hematopoietic stem cell transplantation (HSCT) in patients with hepatic veno-occlusive disease, based on an open-label trial that compared trial participants with historical controls.
Major finding: At day 100 post-HSCT, survival was 38.2% for the treatment group and 25.0% for historical controls; propensity-adjusted between-group difference, 23.0%; 95.1% CI, 5.2%-40.8%; P = .0109).
Data source: The multicenter phase III trial included 102 patients with hepatic veno-occlusive disease in the defibrotide group and 32 patients selected for the historical control group.
Disclosures: Dr. Richardson reported consulting or advisory roles with Gentium/Jazz Pharmaceuticals, the maker of defibrotide.
Epoetin alfa missed its safety endpoint in metastatic breast cancer
A randomized phase III trial failed to allay safety concerns about the use of erythropoietin-stimulating agents in cancer patients, researchers reported online Feb. 8 in the Journal of Clinical Oncology.
The analysis could not rule out a 15% increase in the risk of progressive disease or death when women with metastatic breast cancer received epoetin alfa (EPO) instead of best standard of care for anemia, said Dr. Brian Leyland-Jones of Avera Cancer Institute in Sioux Falls, S.D., and his associates. Red blood cell transfusions should remain the preferred treatment for anemia in these patients, and any use of epoetin alfa for advanced cases “should be done with caution and based on careful risk-benefit assessment,” the researchers said.
Erythropoietin-stimulating agents can effectively treat cancer-associated anemia but have been linked to worse survival and locoregional control. However, the agents were used off label in several of these trials, the researchers noted. Therefore, they studied 2,098 women undergoing first- or second-line chemotherapy for metastatic breast cancer who had less than 11 mg/dL hemoglobin, an ECOG performance status of 0 or 1, and a life expectancy of at least 6 months. They randomly assigned patients to receive either standard treatment or 40,000 IU EPO once weekly until disease progression or the end of chemotherapy (J Clin Onc. 2016 Feb 8. doi: 10.1200/JCO.2015.63.5649). Median progression-free survival (PFS) was 7.4 months in both groups, but the EPO group was 9% more likely to die or develop progressive disease during the study, and the upper bound of the hazard ratio exceeded the prespecified noninferiority margin of 1.15 (hazard ratio, 1.089; 95% confidence interval, 0.988-1.200). An independent review committee calculated a median PFS of 7.6 months for both groups, and a hazard ratio whose upper bound fell just within the prespecified noninferiority margin (1.146). The EPO group needed about half as many red blood cell transfusions as did the control group (P less than .001), but experienced twice as many thrombotic vascular events (2.8% vs. 1.4%; P = .04).
“The results of this study do not suggest any new safety signal associated with EPO treatment and are consistent with the known safety risk to patients,” the researchers concluded. An ongoing randomized phase III study comparing darbepoetin with best standard of care for anemia in patients undergoing platinum-based treatment of stage IV non–small cell lung cancer “will further inform the benefit-risk profile of erythropoietin-stimulating agents in the oncology setting,” they said.
A randomized phase III trial failed to allay safety concerns about the use of erythropoietin-stimulating agents in cancer patients, researchers reported online Feb. 8 in the Journal of Clinical Oncology.
The analysis could not rule out a 15% increase in the risk of progressive disease or death when women with metastatic breast cancer received epoetin alfa (EPO) instead of best standard of care for anemia, said Dr. Brian Leyland-Jones of Avera Cancer Institute in Sioux Falls, S.D., and his associates. Red blood cell transfusions should remain the preferred treatment for anemia in these patients, and any use of epoetin alfa for advanced cases “should be done with caution and based on careful risk-benefit assessment,” the researchers said.
Erythropoietin-stimulating agents can effectively treat cancer-associated anemia but have been linked to worse survival and locoregional control. However, the agents were used off label in several of these trials, the researchers noted. Therefore, they studied 2,098 women undergoing first- or second-line chemotherapy for metastatic breast cancer who had less than 11 mg/dL hemoglobin, an ECOG performance status of 0 or 1, and a life expectancy of at least 6 months. They randomly assigned patients to receive either standard treatment or 40,000 IU EPO once weekly until disease progression or the end of chemotherapy (J Clin Onc. 2016 Feb 8. doi: 10.1200/JCO.2015.63.5649). Median progression-free survival (PFS) was 7.4 months in both groups, but the EPO group was 9% more likely to die or develop progressive disease during the study, and the upper bound of the hazard ratio exceeded the prespecified noninferiority margin of 1.15 (hazard ratio, 1.089; 95% confidence interval, 0.988-1.200). An independent review committee calculated a median PFS of 7.6 months for both groups, and a hazard ratio whose upper bound fell just within the prespecified noninferiority margin (1.146). The EPO group needed about half as many red blood cell transfusions as did the control group (P less than .001), but experienced twice as many thrombotic vascular events (2.8% vs. 1.4%; P = .04).
“The results of this study do not suggest any new safety signal associated with EPO treatment and are consistent with the known safety risk to patients,” the researchers concluded. An ongoing randomized phase III study comparing darbepoetin with best standard of care for anemia in patients undergoing platinum-based treatment of stage IV non–small cell lung cancer “will further inform the benefit-risk profile of erythropoietin-stimulating agents in the oncology setting,” they said.
A randomized phase III trial failed to allay safety concerns about the use of erythropoietin-stimulating agents in cancer patients, researchers reported online Feb. 8 in the Journal of Clinical Oncology.
The analysis could not rule out a 15% increase in the risk of progressive disease or death when women with metastatic breast cancer received epoetin alfa (EPO) instead of best standard of care for anemia, said Dr. Brian Leyland-Jones of Avera Cancer Institute in Sioux Falls, S.D., and his associates. Red blood cell transfusions should remain the preferred treatment for anemia in these patients, and any use of epoetin alfa for advanced cases “should be done with caution and based on careful risk-benefit assessment,” the researchers said.
Erythropoietin-stimulating agents can effectively treat cancer-associated anemia but have been linked to worse survival and locoregional control. However, the agents were used off label in several of these trials, the researchers noted. Therefore, they studied 2,098 women undergoing first- or second-line chemotherapy for metastatic breast cancer who had less than 11 mg/dL hemoglobin, an ECOG performance status of 0 or 1, and a life expectancy of at least 6 months. They randomly assigned patients to receive either standard treatment or 40,000 IU EPO once weekly until disease progression or the end of chemotherapy (J Clin Onc. 2016 Feb 8. doi: 10.1200/JCO.2015.63.5649). Median progression-free survival (PFS) was 7.4 months in both groups, but the EPO group was 9% more likely to die or develop progressive disease during the study, and the upper bound of the hazard ratio exceeded the prespecified noninferiority margin of 1.15 (hazard ratio, 1.089; 95% confidence interval, 0.988-1.200). An independent review committee calculated a median PFS of 7.6 months for both groups, and a hazard ratio whose upper bound fell just within the prespecified noninferiority margin (1.146). The EPO group needed about half as many red blood cell transfusions as did the control group (P less than .001), but experienced twice as many thrombotic vascular events (2.8% vs. 1.4%; P = .04).
“The results of this study do not suggest any new safety signal associated with EPO treatment and are consistent with the known safety risk to patients,” the researchers concluded. An ongoing randomized phase III study comparing darbepoetin with best standard of care for anemia in patients undergoing platinum-based treatment of stage IV non–small cell lung cancer “will further inform the benefit-risk profile of erythropoietin-stimulating agents in the oncology setting,” they said.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: The erythropoietin-stimulating agent epoetin alfa was associated with lower rates of progression-free survival, compared with best standard of care for anemia in women with metastatic breast cancer.
Major finding: The 95% confidence interval for the hazard ratio had an upper limit of 1.20, exceeding the prespecified noninferiority margin of 1.15.
Data source: An open-label, randomized, controlled, noninferiority trial of 2,098 patients.
Disclosures: Janssen Research and Development makes epoetin alfa and supported the study. Dr. Leyland-Jones reported receiving honoraria from Janssen Research and Development, and other funding from Genentech, GlaxoSmithKline, Amgen, and Johnson & Johnson. Seven coinvestigators reported employment with Janssen Research and Development. The other 15 coinvestigators had no disclosures.
Survivors of childhood ALL show significant attention problems
Survivors of childhood acute lymphoblastic leukemia (ALL) who underwent CNS-directed chemotherapy show significant attention problems that impair their functioning 2 years later, according to a report published online Feb. 8 in the Journal of Clinical Oncology.
The attention problems were isolated from intelligence and academic performance, but they still “significantly and negatively impact real-world functioning,” said Lisa M. Jacola, Ph.D. of the department of psychology and her associates at St. Jude Children’s Research Hospital, Memphis (J Clin Oncol. 2016 Feb 8. [doi: 10.1200/JCO.2015.64.3205]).
Intrathecal chemotherapy has largely replaced cranial radiation therapy to protect the CNS in childhood ALL, but most research concerning neurocognitive outcomes after this treatment has been retrospective and has involved small sample sizes. So investigators performed a prospective study using data from an ongoing trial involving a representative cohort of more than 400 patients aged 1-18 years who were treated at a single center during a 7-year period.
These patients were classified as low- or high-risk based on comprehensive biologic and clinical factors, such as blast cell immunophenotype and genotype, presenting clinical features, and early treatment response. They then received intrathecal methotrexate, cytarabine, and hydrocortisone in doses appropriate to their risk status, as well as standardized leucovorin followed by mercaptopurine and vincristine plus dexamethasone.
The researchers focused on the 211 patients who underwent comprehensive neurocognitive assessment 2 years after diagnosis and treatment. “The overall group did not significantly differ from normative expectations on measures of global intelligence (estimated IQ), academic skills (reading, math, or spelling), and learning and memory.” However, half of them were rated as below average on several measures of attention. In addition, caregivers reported a significantly greater than expected frequency of hyperactivity, impulsivity, and learning problems in the children.
This adverse effect was strongest among children who were younger than age 5 at diagnosis and among those at high risk who received more aggressive treatment.
“Our findings ... emphasize the importance of routine neurocognitive monitoring of all survivors treated with contemporary therapy.” But early detection will only be helpful if effective interventions are developed to remediate these attention and behavior problems. Research has shown that pharmacologic therapies “have reduced acceptability among survivors of childhood cancer,” so nonpharmacologic approaches would be especially useful, the researchers added.
Survivors of childhood acute lymphoblastic leukemia (ALL) who underwent CNS-directed chemotherapy show significant attention problems that impair their functioning 2 years later, according to a report published online Feb. 8 in the Journal of Clinical Oncology.
The attention problems were isolated from intelligence and academic performance, but they still “significantly and negatively impact real-world functioning,” said Lisa M. Jacola, Ph.D. of the department of psychology and her associates at St. Jude Children’s Research Hospital, Memphis (J Clin Oncol. 2016 Feb 8. [doi: 10.1200/JCO.2015.64.3205]).
Intrathecal chemotherapy has largely replaced cranial radiation therapy to protect the CNS in childhood ALL, but most research concerning neurocognitive outcomes after this treatment has been retrospective and has involved small sample sizes. So investigators performed a prospective study using data from an ongoing trial involving a representative cohort of more than 400 patients aged 1-18 years who were treated at a single center during a 7-year period.
These patients were classified as low- or high-risk based on comprehensive biologic and clinical factors, such as blast cell immunophenotype and genotype, presenting clinical features, and early treatment response. They then received intrathecal methotrexate, cytarabine, and hydrocortisone in doses appropriate to their risk status, as well as standardized leucovorin followed by mercaptopurine and vincristine plus dexamethasone.
The researchers focused on the 211 patients who underwent comprehensive neurocognitive assessment 2 years after diagnosis and treatment. “The overall group did not significantly differ from normative expectations on measures of global intelligence (estimated IQ), academic skills (reading, math, or spelling), and learning and memory.” However, half of them were rated as below average on several measures of attention. In addition, caregivers reported a significantly greater than expected frequency of hyperactivity, impulsivity, and learning problems in the children.
This adverse effect was strongest among children who were younger than age 5 at diagnosis and among those at high risk who received more aggressive treatment.
“Our findings ... emphasize the importance of routine neurocognitive monitoring of all survivors treated with contemporary therapy.” But early detection will only be helpful if effective interventions are developed to remediate these attention and behavior problems. Research has shown that pharmacologic therapies “have reduced acceptability among survivors of childhood cancer,” so nonpharmacologic approaches would be especially useful, the researchers added.
Survivors of childhood acute lymphoblastic leukemia (ALL) who underwent CNS-directed chemotherapy show significant attention problems that impair their functioning 2 years later, according to a report published online Feb. 8 in the Journal of Clinical Oncology.
The attention problems were isolated from intelligence and academic performance, but they still “significantly and negatively impact real-world functioning,” said Lisa M. Jacola, Ph.D. of the department of psychology and her associates at St. Jude Children’s Research Hospital, Memphis (J Clin Oncol. 2016 Feb 8. [doi: 10.1200/JCO.2015.64.3205]).
Intrathecal chemotherapy has largely replaced cranial radiation therapy to protect the CNS in childhood ALL, but most research concerning neurocognitive outcomes after this treatment has been retrospective and has involved small sample sizes. So investigators performed a prospective study using data from an ongoing trial involving a representative cohort of more than 400 patients aged 1-18 years who were treated at a single center during a 7-year period.
These patients were classified as low- or high-risk based on comprehensive biologic and clinical factors, such as blast cell immunophenotype and genotype, presenting clinical features, and early treatment response. They then received intrathecal methotrexate, cytarabine, and hydrocortisone in doses appropriate to their risk status, as well as standardized leucovorin followed by mercaptopurine and vincristine plus dexamethasone.
The researchers focused on the 211 patients who underwent comprehensive neurocognitive assessment 2 years after diagnosis and treatment. “The overall group did not significantly differ from normative expectations on measures of global intelligence (estimated IQ), academic skills (reading, math, or spelling), and learning and memory.” However, half of them were rated as below average on several measures of attention. In addition, caregivers reported a significantly greater than expected frequency of hyperactivity, impulsivity, and learning problems in the children.
This adverse effect was strongest among children who were younger than age 5 at diagnosis and among those at high risk who received more aggressive treatment.
“Our findings ... emphasize the importance of routine neurocognitive monitoring of all survivors treated with contemporary therapy.” But early detection will only be helpful if effective interventions are developed to remediate these attention and behavior problems. Research has shown that pharmacologic therapies “have reduced acceptability among survivors of childhood cancer,” so nonpharmacologic approaches would be especially useful, the researchers added.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Survivors of childhood ALL who underwent CNS-directed chemotherapy show significant attention problems that impair their functioning 2 years later.
Major finding: 50% of the study participants were rated as below average on several measures of attention, and caregivers reported a significantly greater than expected frequency of hyperactivity, impulsivity, and learning problems.
Data source: A prospective longitudinal analysis of neurocognitive function in 211 ALL survivors assessed 2 years after diagnosis and treatment.
Disclosures: This study was supported by the National Cancer Institute and American Lebanese Syrian Associated Charities. Dr. Jacola reported having no relevant financial disclosures; one of her associates reported receiving research funding from Sigma Tau Pharmaceuticals.
FDA approves single-dose fosaprepitant for moderately emetogenic chemo
The Food and Drug Administration has approved single-dose fosaprepitant for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy.
Fosaprepitant for injection is the first intravenous single-dose NK1 receptor antagonist approved in the United States for both highly emetogenic chemotherapy as well as moderately emetogenic chemotherapy.
Approval was based on a 78.9% complete response rate (no vomiting and no use of rescue therapy) during the delayed phase, 25-120 hours following initiation of moderately emetogenic chemotherapy, compared with a 68.5% complete response rate among those receiving the control regimen in a phase III trial (P less than .001). The treatment group of 502 patients received fosaprepitant for injection (150 mg) as a single intravenous infusion in combination with ondansetron and dexamethasone, compared with the control group of 498 patients who received ondansetron and dexamethasone alone, according to a statement released by Merck, developers of fosaprepitant (Emend).
The most-common adverse reactions reported among the patients receiving the fosaprepitant injection versus control regimen were fatigue (15% vs. 13%), diarrhea (13% vs. 11%), neutropenia (8% vs. 7%), asthenia (4% vs. 3%), anemia (3% vs. 2%), peripheral neuropathy (3% vs. 2%), leukopenia (2% vs. 1%), dyspepsia (2% vs. 1%), urinary tract infection (2% vs. 1%), and pain in extremity (2% vs. 1%), according to Merck.
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved single-dose fosaprepitant for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy.
Fosaprepitant for injection is the first intravenous single-dose NK1 receptor antagonist approved in the United States for both highly emetogenic chemotherapy as well as moderately emetogenic chemotherapy.
Approval was based on a 78.9% complete response rate (no vomiting and no use of rescue therapy) during the delayed phase, 25-120 hours following initiation of moderately emetogenic chemotherapy, compared with a 68.5% complete response rate among those receiving the control regimen in a phase III trial (P less than .001). The treatment group of 502 patients received fosaprepitant for injection (150 mg) as a single intravenous infusion in combination with ondansetron and dexamethasone, compared with the control group of 498 patients who received ondansetron and dexamethasone alone, according to a statement released by Merck, developers of fosaprepitant (Emend).
The most-common adverse reactions reported among the patients receiving the fosaprepitant injection versus control regimen were fatigue (15% vs. 13%), diarrhea (13% vs. 11%), neutropenia (8% vs. 7%), asthenia (4% vs. 3%), anemia (3% vs. 2%), peripheral neuropathy (3% vs. 2%), leukopenia (2% vs. 1%), dyspepsia (2% vs. 1%), urinary tract infection (2% vs. 1%), and pain in extremity (2% vs. 1%), according to Merck.
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved single-dose fosaprepitant for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy.
Fosaprepitant for injection is the first intravenous single-dose NK1 receptor antagonist approved in the United States for both highly emetogenic chemotherapy as well as moderately emetogenic chemotherapy.
Approval was based on a 78.9% complete response rate (no vomiting and no use of rescue therapy) during the delayed phase, 25-120 hours following initiation of moderately emetogenic chemotherapy, compared with a 68.5% complete response rate among those receiving the control regimen in a phase III trial (P less than .001). The treatment group of 502 patients received fosaprepitant for injection (150 mg) as a single intravenous infusion in combination with ondansetron and dexamethasone, compared with the control group of 498 patients who received ondansetron and dexamethasone alone, according to a statement released by Merck, developers of fosaprepitant (Emend).
The most-common adverse reactions reported among the patients receiving the fosaprepitant injection versus control regimen were fatigue (15% vs. 13%), diarrhea (13% vs. 11%), neutropenia (8% vs. 7%), asthenia (4% vs. 3%), anemia (3% vs. 2%), peripheral neuropathy (3% vs. 2%), leukopenia (2% vs. 1%), dyspepsia (2% vs. 1%), urinary tract infection (2% vs. 1%), and pain in extremity (2% vs. 1%), according to Merck.
On Twitter @NikolaidesLaura
Cyclical hypofractionated radiotherapy technique for palliative treatment of locally advanced head and neck cancer: institutional experience and review of palliative regimens
Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.
Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.
Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.
Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.
Limitations This study is a retrospective analysis.
Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.
Click on the PDF icon at the top of this introduction to read the full article.
Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.
Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.
Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.
Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.
Limitations This study is a retrospective analysis.
Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.
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Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.
Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.
Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.
Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.
Limitations This study is a retrospective analysis.
Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.
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Thyroid nodule: not as clear-cut as it seems
Benign etiologies and primary thyroid cancers are the most common causes of incidental thyroid nodules. Clinically evident metastases to the thyroid gland are not common and account for 2%-3% of thyroid cancers, though the incidence of thyroid metastases reaches 24% in autopsy studies.1 The most common clinically detected thyroid metastases originate from renal cell carcinoma (RCC; 48.1%).2 We report here a rare case of a man with clear-cell RCC with late recurrence in the thyroid gland as a solitary metastasis, 13 years after the primary diagnosis.
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Benign etiologies and primary thyroid cancers are the most common causes of incidental thyroid nodules. Clinically evident metastases to the thyroid gland are not common and account for 2%-3% of thyroid cancers, though the incidence of thyroid metastases reaches 24% in autopsy studies.1 The most common clinically detected thyroid metastases originate from renal cell carcinoma (RCC; 48.1%).2 We report here a rare case of a man with clear-cell RCC with late recurrence in the thyroid gland as a solitary metastasis, 13 years after the primary diagnosis.
Click on the PDF icon at the top of this introduction to read the full article.
Benign etiologies and primary thyroid cancers are the most common causes of incidental thyroid nodules. Clinically evident metastases to the thyroid gland are not common and account for 2%-3% of thyroid cancers, though the incidence of thyroid metastases reaches 24% in autopsy studies.1 The most common clinically detected thyroid metastases originate from renal cell carcinoma (RCC; 48.1%).2 We report here a rare case of a man with clear-cell RCC with late recurrence in the thyroid gland as a solitary metastasis, 13 years after the primary diagnosis.
Click on the PDF icon at the top of this introduction to read the full article.