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Cancer pain management inadequate in opioid-saturated areas
Patients with cancer who live in regions with high levels of opioid misuse may be undertreated for pain, according to investigators who studied opioid prescription patterns and cancer incidence in rural southwest Virginia.
Among 4,324 patients with cancer, only 22.16% were prescribed a Controlled Schedule II (C-II) prescription opioid medication at least 3 times in 1 year, from prescribers likely to be treating cancer pain. More than 60% of patients never received a C-II opioid prescription, reported Virginia T. LeBaron, PhD, of the University of Virginia School of Nursing in Charlottesville, and colleagues.
“A clearer view of geographic patterns and predictors of both POM [prescription opioid medication] prescribing and potential harms can inform targeted interventions and policy initiatives that achieve a balanced approach to POMs – ensuring access for patients in need while reducing risk to both patients and communities. Our research makes an important contribution by exploring how the current ‘opioid epidemic’ relates to rural patients with cancer,” they wrote. Their report is in Journal of Oncology Practice.
The investigators studied the confluence of disproportionately high cancer mortality rates and opioid fatality rates in rural southwest Virginia, in the heart of Appalachia.
They conducted a longitudinal, exploratory secondary analysis of data from the Commonwealth of Virginia All Payer Claims database to look at opioid prescribing patterns and explore whether concerns about opioid misuse could result in undertreatment of pain in cancer patients.
They looked at prescribing patterns at the patient, provider, and insurance claim levels, predictors of opioid prescription frequency, opioid-related harms and patterns related to opioid prescribing, cancer incidence, and fatalities.
They identified 4,324 patients with cancer, 958 of whom (22.16%) received a C-II opioid at least three times in any study year. The majority of patients were in the 45-64 age range, and approximately 88% were diagnosed with solid malignancies, with breast cancer and lung cancer being the most frequent diagnoses.
As noted, more than 60% of patients never received a C-II prescription.
“The large percentages of cancer patients never prescribed a C-II are concerning for a number of reasons, especially when we consider the results per year,” the investigators wrote. “First, the ‘no C-II’ patients remain over 80% of the total sample, each year, even after accounting for the upscheduling (from C-III to C-II) of commonly-prescribed hydrocodone products in 2014. Second, anecdotal data and emerging empirical evidence demonstrate that patients with legitimate pain needs, including patients with cancer, experience significant difficulty accessing POMs.”
They noted that regulations regarding opioid prescriptions have become increasingly strict since the end date of their analysis in 2015, suggesting that the number of patients with cancer who are not receiving C-II opioids today may be even higher.
They also pointed to evidence of prescription practices suggesting suboptimal pain management or potential patient harm, such as frequent prescription of opioid-acetaminophen combinations that are dose-limited due to acetaminophen toxicity; coprescription of opioids and benzodiazepines, which is not recommended under current prescribing guidelines; and infrequent use of deterrent formulations of C-II opioids such as crush-resistant tablets.
The study was supported by the University of Virginia Cancer Center, Cancer Control & Population Health Division and the Virginia Tobacco Region Revitalization Commission. The authors reported having no disclaimers or conflicts of interest.
SOURCE: LeBaron VT et al. J Oncol Pract. 2019 Nov. 4. doi: 10.1200/JOP.19.00149.
Patients with cancer who live in regions with high levels of opioid misuse may be undertreated for pain, according to investigators who studied opioid prescription patterns and cancer incidence in rural southwest Virginia.
Among 4,324 patients with cancer, only 22.16% were prescribed a Controlled Schedule II (C-II) prescription opioid medication at least 3 times in 1 year, from prescribers likely to be treating cancer pain. More than 60% of patients never received a C-II opioid prescription, reported Virginia T. LeBaron, PhD, of the University of Virginia School of Nursing in Charlottesville, and colleagues.
“A clearer view of geographic patterns and predictors of both POM [prescription opioid medication] prescribing and potential harms can inform targeted interventions and policy initiatives that achieve a balanced approach to POMs – ensuring access for patients in need while reducing risk to both patients and communities. Our research makes an important contribution by exploring how the current ‘opioid epidemic’ relates to rural patients with cancer,” they wrote. Their report is in Journal of Oncology Practice.
The investigators studied the confluence of disproportionately high cancer mortality rates and opioid fatality rates in rural southwest Virginia, in the heart of Appalachia.
They conducted a longitudinal, exploratory secondary analysis of data from the Commonwealth of Virginia All Payer Claims database to look at opioid prescribing patterns and explore whether concerns about opioid misuse could result in undertreatment of pain in cancer patients.
They looked at prescribing patterns at the patient, provider, and insurance claim levels, predictors of opioid prescription frequency, opioid-related harms and patterns related to opioid prescribing, cancer incidence, and fatalities.
They identified 4,324 patients with cancer, 958 of whom (22.16%) received a C-II opioid at least three times in any study year. The majority of patients were in the 45-64 age range, and approximately 88% were diagnosed with solid malignancies, with breast cancer and lung cancer being the most frequent diagnoses.
As noted, more than 60% of patients never received a C-II prescription.
“The large percentages of cancer patients never prescribed a C-II are concerning for a number of reasons, especially when we consider the results per year,” the investigators wrote. “First, the ‘no C-II’ patients remain over 80% of the total sample, each year, even after accounting for the upscheduling (from C-III to C-II) of commonly-prescribed hydrocodone products in 2014. Second, anecdotal data and emerging empirical evidence demonstrate that patients with legitimate pain needs, including patients with cancer, experience significant difficulty accessing POMs.”
They noted that regulations regarding opioid prescriptions have become increasingly strict since the end date of their analysis in 2015, suggesting that the number of patients with cancer who are not receiving C-II opioids today may be even higher.
They also pointed to evidence of prescription practices suggesting suboptimal pain management or potential patient harm, such as frequent prescription of opioid-acetaminophen combinations that are dose-limited due to acetaminophen toxicity; coprescription of opioids and benzodiazepines, which is not recommended under current prescribing guidelines; and infrequent use of deterrent formulations of C-II opioids such as crush-resistant tablets.
The study was supported by the University of Virginia Cancer Center, Cancer Control & Population Health Division and the Virginia Tobacco Region Revitalization Commission. The authors reported having no disclaimers or conflicts of interest.
SOURCE: LeBaron VT et al. J Oncol Pract. 2019 Nov. 4. doi: 10.1200/JOP.19.00149.
Patients with cancer who live in regions with high levels of opioid misuse may be undertreated for pain, according to investigators who studied opioid prescription patterns and cancer incidence in rural southwest Virginia.
Among 4,324 patients with cancer, only 22.16% were prescribed a Controlled Schedule II (C-II) prescription opioid medication at least 3 times in 1 year, from prescribers likely to be treating cancer pain. More than 60% of patients never received a C-II opioid prescription, reported Virginia T. LeBaron, PhD, of the University of Virginia School of Nursing in Charlottesville, and colleagues.
“A clearer view of geographic patterns and predictors of both POM [prescription opioid medication] prescribing and potential harms can inform targeted interventions and policy initiatives that achieve a balanced approach to POMs – ensuring access for patients in need while reducing risk to both patients and communities. Our research makes an important contribution by exploring how the current ‘opioid epidemic’ relates to rural patients with cancer,” they wrote. Their report is in Journal of Oncology Practice.
The investigators studied the confluence of disproportionately high cancer mortality rates and opioid fatality rates in rural southwest Virginia, in the heart of Appalachia.
They conducted a longitudinal, exploratory secondary analysis of data from the Commonwealth of Virginia All Payer Claims database to look at opioid prescribing patterns and explore whether concerns about opioid misuse could result in undertreatment of pain in cancer patients.
They looked at prescribing patterns at the patient, provider, and insurance claim levels, predictors of opioid prescription frequency, opioid-related harms and patterns related to opioid prescribing, cancer incidence, and fatalities.
They identified 4,324 patients with cancer, 958 of whom (22.16%) received a C-II opioid at least three times in any study year. The majority of patients were in the 45-64 age range, and approximately 88% were diagnosed with solid malignancies, with breast cancer and lung cancer being the most frequent diagnoses.
As noted, more than 60% of patients never received a C-II prescription.
“The large percentages of cancer patients never prescribed a C-II are concerning for a number of reasons, especially when we consider the results per year,” the investigators wrote. “First, the ‘no C-II’ patients remain over 80% of the total sample, each year, even after accounting for the upscheduling (from C-III to C-II) of commonly-prescribed hydrocodone products in 2014. Second, anecdotal data and emerging empirical evidence demonstrate that patients with legitimate pain needs, including patients with cancer, experience significant difficulty accessing POMs.”
They noted that regulations regarding opioid prescriptions have become increasingly strict since the end date of their analysis in 2015, suggesting that the number of patients with cancer who are not receiving C-II opioids today may be even higher.
They also pointed to evidence of prescription practices suggesting suboptimal pain management or potential patient harm, such as frequent prescription of opioid-acetaminophen combinations that are dose-limited due to acetaminophen toxicity; coprescription of opioids and benzodiazepines, which is not recommended under current prescribing guidelines; and infrequent use of deterrent formulations of C-II opioids such as crush-resistant tablets.
The study was supported by the University of Virginia Cancer Center, Cancer Control & Population Health Division and the Virginia Tobacco Region Revitalization Commission. The authors reported having no disclaimers or conflicts of interest.
SOURCE: LeBaron VT et al. J Oncol Pract. 2019 Nov. 4. doi: 10.1200/JOP.19.00149.
FROM JOURNAL OF ONCOLOGY PRACTICE
Small nodules, big problems: AI's role in thyroid nodule diagnosis
CHICAGO – A new image-analysis algorithm for benign thyroid nodules that uses a technique similar to facial recognition showed good sensitivity and specificity, with the potential to reduce biopsies by more than 50%.
The negative predictive value of the ultrasound analysis algorithm was 93.2%, a figure approximating the false-negative rate of about 5% that is seen in fine-needle aspiration of thyroid nodules, said Johnson Thomas, MD, at the annual meeting of the American Thyroid Association.
“Millions of people have thyroid nodules,” many of which are detected incidentally, said Dr. Thomas, an endocrinologist with the Mercy health care system in Springfield, Mo. Fewer than 10% of thyroid nodules turn out to be malignant, but each year, millions of patients undergo biopsies to determine the status of their thyroid nodules.
Faced with evaluating a thyroid nodule, an endocrinologist can currently turn to a risk-stratification scheme, such as those developed by the American College of Radiology and the American Thyroid Association. However, there’s a big subjective component to risk stratification – significant inter- and intraobserver variation has been observed, said Dr. Thomas, and not all nodules are classifiable. The result is a system that still has low specificity and positive predictive value, he said.
Even after a decision to proceed to biopsy, one in seven thyroid nodule biopsies will not produce a definitive diagnosis, he said.
“We are doing millions of thyroid biopsies based on very subjective criteria to find thyroid cancer in a very small percentage of the population, with an invasive technique that may not be diagnostic one out of seven times,” Dr. Thomas said in summing up the current medical situation as he sees it.
Dr. Thomas, who writes his own computer code, said he was searching for a reliable and explainable noninvasive technique, and one that lacked subjective room for error, to address the thyroid nodule problem.
The question was whether an artificial intelligence (AI) algorithm could match radiologist performance in classifying thyroid nodules according to the characteristics of their ultrasound images.
Other algorithms use AI to predict which nodules are malignant, but they function as “black boxes” – a common criticism of AI. The outside observer cannot ordinarily see how the AI algorithm “knows” what it knows. This characteristic of AI poses at least a theoretical problem when such algorithms are used for diagnosis or medical decision making.
Dr. Thomas’s* approach was to use a set of training data to allow the algorithm he constructed to see 2,025 images from a total of 482 nodules. The thyroid nodules used for training had been subjected to biopsy or excised in surgery, so they all had a definitive status of being benign or malignant.
Then, after the algorithm was refined, a set of 103 nodules with known malignancy status was used to test the algorithm’s sensitivity and specificity.
The algorithm, dubbed AiBx, used a convolutional neural network to build a unique image vector for each nodule. The AiBx algorithm then looked at the training database to find the “nearest neighbors,” or the images it found to be the most similar to those of the nodule being examined.
For example, said Dr. Thomas, a test image of a benign nodule would have an output from the AiBx analysis of three similar images from the database – all benign. Hence, rather than making a black-box call of whether a nodule is benign or malignant, the algorithm merely says: “This nodule resembles a benign nodule in our database.” The interpreting physician can then use the algorithm as a decision aid with confidence.
The overall accuracy of AiBx was 81.5%, sensitivity was 87.8%, and specificity was 78.5%. Positive predictive value was 65.9%.
As more images are added to the database, AiBx can easily be retrained and refined, said Dr. Thomas.
“It’s intuitive and explainable,” he added, noting that the algorithm is also a good teaching tool for residents and fellows.
“This AI model can be deployed as an app, integrated with [medical imaging systems] or hosted as a website. By using image-similarity AI models we can eliminate subjectivity and decrease the number of unnecessary biopsies,” he explained in the abstract accompanying the presentation.
However, he said that the algorithm as it currently stands has limitations: It has been tested on only 103 images thus far, and there’s the potential for selection bias.
Dr. Thomas* reported that, although he developed the AiBx algorithm, he has not drawn income or royalties from it. He reported no other relevant conflicts of interest.
SOURCE: Thomas* J et al. ATA 2019, Oral Abstract 27.
*Correction, 21/11/2019: An earlier version of this story misstated Dr. Thomas's last name.
CHICAGO – A new image-analysis algorithm for benign thyroid nodules that uses a technique similar to facial recognition showed good sensitivity and specificity, with the potential to reduce biopsies by more than 50%.
The negative predictive value of the ultrasound analysis algorithm was 93.2%, a figure approximating the false-negative rate of about 5% that is seen in fine-needle aspiration of thyroid nodules, said Johnson Thomas, MD, at the annual meeting of the American Thyroid Association.
“Millions of people have thyroid nodules,” many of which are detected incidentally, said Dr. Thomas, an endocrinologist with the Mercy health care system in Springfield, Mo. Fewer than 10% of thyroid nodules turn out to be malignant, but each year, millions of patients undergo biopsies to determine the status of their thyroid nodules.
Faced with evaluating a thyroid nodule, an endocrinologist can currently turn to a risk-stratification scheme, such as those developed by the American College of Radiology and the American Thyroid Association. However, there’s a big subjective component to risk stratification – significant inter- and intraobserver variation has been observed, said Dr. Thomas, and not all nodules are classifiable. The result is a system that still has low specificity and positive predictive value, he said.
Even after a decision to proceed to biopsy, one in seven thyroid nodule biopsies will not produce a definitive diagnosis, he said.
“We are doing millions of thyroid biopsies based on very subjective criteria to find thyroid cancer in a very small percentage of the population, with an invasive technique that may not be diagnostic one out of seven times,” Dr. Thomas said in summing up the current medical situation as he sees it.
Dr. Thomas, who writes his own computer code, said he was searching for a reliable and explainable noninvasive technique, and one that lacked subjective room for error, to address the thyroid nodule problem.
The question was whether an artificial intelligence (AI) algorithm could match radiologist performance in classifying thyroid nodules according to the characteristics of their ultrasound images.
Other algorithms use AI to predict which nodules are malignant, but they function as “black boxes” – a common criticism of AI. The outside observer cannot ordinarily see how the AI algorithm “knows” what it knows. This characteristic of AI poses at least a theoretical problem when such algorithms are used for diagnosis or medical decision making.
Dr. Thomas’s* approach was to use a set of training data to allow the algorithm he constructed to see 2,025 images from a total of 482 nodules. The thyroid nodules used for training had been subjected to biopsy or excised in surgery, so they all had a definitive status of being benign or malignant.
Then, after the algorithm was refined, a set of 103 nodules with known malignancy status was used to test the algorithm’s sensitivity and specificity.
The algorithm, dubbed AiBx, used a convolutional neural network to build a unique image vector for each nodule. The AiBx algorithm then looked at the training database to find the “nearest neighbors,” or the images it found to be the most similar to those of the nodule being examined.
For example, said Dr. Thomas, a test image of a benign nodule would have an output from the AiBx analysis of three similar images from the database – all benign. Hence, rather than making a black-box call of whether a nodule is benign or malignant, the algorithm merely says: “This nodule resembles a benign nodule in our database.” The interpreting physician can then use the algorithm as a decision aid with confidence.
The overall accuracy of AiBx was 81.5%, sensitivity was 87.8%, and specificity was 78.5%. Positive predictive value was 65.9%.
As more images are added to the database, AiBx can easily be retrained and refined, said Dr. Thomas.
“It’s intuitive and explainable,” he added, noting that the algorithm is also a good teaching tool for residents and fellows.
“This AI model can be deployed as an app, integrated with [medical imaging systems] or hosted as a website. By using image-similarity AI models we can eliminate subjectivity and decrease the number of unnecessary biopsies,” he explained in the abstract accompanying the presentation.
However, he said that the algorithm as it currently stands has limitations: It has been tested on only 103 images thus far, and there’s the potential for selection bias.
Dr. Thomas* reported that, although he developed the AiBx algorithm, he has not drawn income or royalties from it. He reported no other relevant conflicts of interest.
SOURCE: Thomas* J et al. ATA 2019, Oral Abstract 27.
*Correction, 21/11/2019: An earlier version of this story misstated Dr. Thomas's last name.
CHICAGO – A new image-analysis algorithm for benign thyroid nodules that uses a technique similar to facial recognition showed good sensitivity and specificity, with the potential to reduce biopsies by more than 50%.
The negative predictive value of the ultrasound analysis algorithm was 93.2%, a figure approximating the false-negative rate of about 5% that is seen in fine-needle aspiration of thyroid nodules, said Johnson Thomas, MD, at the annual meeting of the American Thyroid Association.
“Millions of people have thyroid nodules,” many of which are detected incidentally, said Dr. Thomas, an endocrinologist with the Mercy health care system in Springfield, Mo. Fewer than 10% of thyroid nodules turn out to be malignant, but each year, millions of patients undergo biopsies to determine the status of their thyroid nodules.
Faced with evaluating a thyroid nodule, an endocrinologist can currently turn to a risk-stratification scheme, such as those developed by the American College of Radiology and the American Thyroid Association. However, there’s a big subjective component to risk stratification – significant inter- and intraobserver variation has been observed, said Dr. Thomas, and not all nodules are classifiable. The result is a system that still has low specificity and positive predictive value, he said.
Even after a decision to proceed to biopsy, one in seven thyroid nodule biopsies will not produce a definitive diagnosis, he said.
“We are doing millions of thyroid biopsies based on very subjective criteria to find thyroid cancer in a very small percentage of the population, with an invasive technique that may not be diagnostic one out of seven times,” Dr. Thomas said in summing up the current medical situation as he sees it.
Dr. Thomas, who writes his own computer code, said he was searching for a reliable and explainable noninvasive technique, and one that lacked subjective room for error, to address the thyroid nodule problem.
The question was whether an artificial intelligence (AI) algorithm could match radiologist performance in classifying thyroid nodules according to the characteristics of their ultrasound images.
Other algorithms use AI to predict which nodules are malignant, but they function as “black boxes” – a common criticism of AI. The outside observer cannot ordinarily see how the AI algorithm “knows” what it knows. This characteristic of AI poses at least a theoretical problem when such algorithms are used for diagnosis or medical decision making.
Dr. Thomas’s* approach was to use a set of training data to allow the algorithm he constructed to see 2,025 images from a total of 482 nodules. The thyroid nodules used for training had been subjected to biopsy or excised in surgery, so they all had a definitive status of being benign or malignant.
Then, after the algorithm was refined, a set of 103 nodules with known malignancy status was used to test the algorithm’s sensitivity and specificity.
The algorithm, dubbed AiBx, used a convolutional neural network to build a unique image vector for each nodule. The AiBx algorithm then looked at the training database to find the “nearest neighbors,” or the images it found to be the most similar to those of the nodule being examined.
For example, said Dr. Thomas, a test image of a benign nodule would have an output from the AiBx analysis of three similar images from the database – all benign. Hence, rather than making a black-box call of whether a nodule is benign or malignant, the algorithm merely says: “This nodule resembles a benign nodule in our database.” The interpreting physician can then use the algorithm as a decision aid with confidence.
The overall accuracy of AiBx was 81.5%, sensitivity was 87.8%, and specificity was 78.5%. Positive predictive value was 65.9%.
As more images are added to the database, AiBx can easily be retrained and refined, said Dr. Thomas.
“It’s intuitive and explainable,” he added, noting that the algorithm is also a good teaching tool for residents and fellows.
“This AI model can be deployed as an app, integrated with [medical imaging systems] or hosted as a website. By using image-similarity AI models we can eliminate subjectivity and decrease the number of unnecessary biopsies,” he explained in the abstract accompanying the presentation.
However, he said that the algorithm as it currently stands has limitations: It has been tested on only 103 images thus far, and there’s the potential for selection bias.
Dr. Thomas* reported that, although he developed the AiBx algorithm, he has not drawn income or royalties from it. He reported no other relevant conflicts of interest.
SOURCE: Thomas* J et al. ATA 2019, Oral Abstract 27.
*Correction, 21/11/2019: An earlier version of this story misstated Dr. Thomas's last name.
REPORTING FROM ATA 2019
Postcolonoscopy colorectal cancers had unique features
Postcolonoscopy colorectal cancers were more likely to arise in the proximal colon and to show microsatellite instability, according to the results of a retrospective population-based study of 168 adults with incident colorectal cancers.
In all, 64% of postcolonoscopy colorectal cancers were located in the proximal colon, compared with 44% of detected colorectal cancers (P = .016), reported Niloy Jewel Samadder, MD, of the University of Utah in Salt Lake City, together with his associates. Furthermore, microsatellite instability (MSI) was detected in 32% of postcolonoscopy colorectal cancers, versus 13% of detected colorectal cancers (P = .005). These findings may point to differences in the underlying biology of postcolonoscopy colorectal cancers and detected colorectal cancers, they said. Studies are needed “to determine if postcolonoscopy cancers arise through a specific genetic pathway that may accelerate neoplastic progression,” they wrote in Clinical Gastroenterology and Hepatology.
Postcolonoscopy colorectal cancers are a “small but clinically important subset of colorectal cancers” that are diagnosed after the patient has a colonoscopy in which no cancer is detected, the researchers noted. These cancers have an estimated global prevalence ranging from 3% to 9% and an estimated pooled prevalence of 3.7% (Am J Gastroenterol. 2014;109:1375-89). Risk factors for postcolonoscopy colorectal cancers include low adenoma detection rates, rural facilities, and care by physicians who are not gastroenterologists. However, tumor-specific and patient-specific factors, including location within the colon and superior survival, compared with detected cancers, raises the possibility of underlying molecular differences related to tumorigenesis, the researchers said.
To investigate this idea, they retrospectively analyzed data from residents of Utah between 50 and 80 years old who had a colonoscopy between, Feb. 15, 1995, and Jan. 31, 2009, at one of two large clinical facilities in Utah (Intermountain Healthcare or the University of Utah Health Sciences). Using a state population-based database, they merged medical information from these patients with cancer histories from the Utah Cancer Registry. This enabled them to compare all 84 postcolonoscopy colorectal cancers (defined as those detected within 6-60 months of colonoscopy) with tissue available for analysis with 84 detected colorectal cancers (detected within 6 months of a colonoscopy).
In the multivariable analysis, MSI was the only molecular feature that was significantly more frequent in postcolonoscopy versus detected colorectal cancers (odds ratio, 4.20; 95% confidence interval, 1.58-11.14). However, postcolonoscopy colorectal cancers were significantly more likely to be early stage (86% versus 69% for detected colorectal cancers; P = .040). Five-year survival did not significantly differ between the groups.
“The molecular signatures of postcolonoscopy colorectal cancers in our study overlap with those of sporadic MSI and serrated pathways, suggesting these mechanisms play a disproportionate role in postcolonoscopy colorectal cancers.” the researchers said. “Additional studies are needed to determine whether these postcolonoscopy colorectal cancers arise through a familial cancer pathway and/or serrated neoplastic pathway of sporadic lesions.
Funders included the American College of Gastroenterology, the National Cancer Institute, the Huntsman Cancer Foundation, the University of Utah, and the Utah Department of Health. Dr. Samadder reported consulting relationships with Cancer Prevention Pharmaceuticals and Janssen Research and Development. The other researchers reported having no conflicts of interest.
SOURCE: Samadder NJ et al. Clin Gastroenterol Hepatol. 2019 Mar 28. doi: 10.1016/j.cgh.2019.02.040.
Postcolonoscopy colorectal cancers were more likely to arise in the proximal colon and to show microsatellite instability, according to the results of a retrospective population-based study of 168 adults with incident colorectal cancers.
In all, 64% of postcolonoscopy colorectal cancers were located in the proximal colon, compared with 44% of detected colorectal cancers (P = .016), reported Niloy Jewel Samadder, MD, of the University of Utah in Salt Lake City, together with his associates. Furthermore, microsatellite instability (MSI) was detected in 32% of postcolonoscopy colorectal cancers, versus 13% of detected colorectal cancers (P = .005). These findings may point to differences in the underlying biology of postcolonoscopy colorectal cancers and detected colorectal cancers, they said. Studies are needed “to determine if postcolonoscopy cancers arise through a specific genetic pathway that may accelerate neoplastic progression,” they wrote in Clinical Gastroenterology and Hepatology.
Postcolonoscopy colorectal cancers are a “small but clinically important subset of colorectal cancers” that are diagnosed after the patient has a colonoscopy in which no cancer is detected, the researchers noted. These cancers have an estimated global prevalence ranging from 3% to 9% and an estimated pooled prevalence of 3.7% (Am J Gastroenterol. 2014;109:1375-89). Risk factors for postcolonoscopy colorectal cancers include low adenoma detection rates, rural facilities, and care by physicians who are not gastroenterologists. However, tumor-specific and patient-specific factors, including location within the colon and superior survival, compared with detected cancers, raises the possibility of underlying molecular differences related to tumorigenesis, the researchers said.
To investigate this idea, they retrospectively analyzed data from residents of Utah between 50 and 80 years old who had a colonoscopy between, Feb. 15, 1995, and Jan. 31, 2009, at one of two large clinical facilities in Utah (Intermountain Healthcare or the University of Utah Health Sciences). Using a state population-based database, they merged medical information from these patients with cancer histories from the Utah Cancer Registry. This enabled them to compare all 84 postcolonoscopy colorectal cancers (defined as those detected within 6-60 months of colonoscopy) with tissue available for analysis with 84 detected colorectal cancers (detected within 6 months of a colonoscopy).
In the multivariable analysis, MSI was the only molecular feature that was significantly more frequent in postcolonoscopy versus detected colorectal cancers (odds ratio, 4.20; 95% confidence interval, 1.58-11.14). However, postcolonoscopy colorectal cancers were significantly more likely to be early stage (86% versus 69% for detected colorectal cancers; P = .040). Five-year survival did not significantly differ between the groups.
“The molecular signatures of postcolonoscopy colorectal cancers in our study overlap with those of sporadic MSI and serrated pathways, suggesting these mechanisms play a disproportionate role in postcolonoscopy colorectal cancers.” the researchers said. “Additional studies are needed to determine whether these postcolonoscopy colorectal cancers arise through a familial cancer pathway and/or serrated neoplastic pathway of sporadic lesions.
Funders included the American College of Gastroenterology, the National Cancer Institute, the Huntsman Cancer Foundation, the University of Utah, and the Utah Department of Health. Dr. Samadder reported consulting relationships with Cancer Prevention Pharmaceuticals and Janssen Research and Development. The other researchers reported having no conflicts of interest.
SOURCE: Samadder NJ et al. Clin Gastroenterol Hepatol. 2019 Mar 28. doi: 10.1016/j.cgh.2019.02.040.
Postcolonoscopy colorectal cancers were more likely to arise in the proximal colon and to show microsatellite instability, according to the results of a retrospective population-based study of 168 adults with incident colorectal cancers.
In all, 64% of postcolonoscopy colorectal cancers were located in the proximal colon, compared with 44% of detected colorectal cancers (P = .016), reported Niloy Jewel Samadder, MD, of the University of Utah in Salt Lake City, together with his associates. Furthermore, microsatellite instability (MSI) was detected in 32% of postcolonoscopy colorectal cancers, versus 13% of detected colorectal cancers (P = .005). These findings may point to differences in the underlying biology of postcolonoscopy colorectal cancers and detected colorectal cancers, they said. Studies are needed “to determine if postcolonoscopy cancers arise through a specific genetic pathway that may accelerate neoplastic progression,” they wrote in Clinical Gastroenterology and Hepatology.
Postcolonoscopy colorectal cancers are a “small but clinically important subset of colorectal cancers” that are diagnosed after the patient has a colonoscopy in which no cancer is detected, the researchers noted. These cancers have an estimated global prevalence ranging from 3% to 9% and an estimated pooled prevalence of 3.7% (Am J Gastroenterol. 2014;109:1375-89). Risk factors for postcolonoscopy colorectal cancers include low adenoma detection rates, rural facilities, and care by physicians who are not gastroenterologists. However, tumor-specific and patient-specific factors, including location within the colon and superior survival, compared with detected cancers, raises the possibility of underlying molecular differences related to tumorigenesis, the researchers said.
To investigate this idea, they retrospectively analyzed data from residents of Utah between 50 and 80 years old who had a colonoscopy between, Feb. 15, 1995, and Jan. 31, 2009, at one of two large clinical facilities in Utah (Intermountain Healthcare or the University of Utah Health Sciences). Using a state population-based database, they merged medical information from these patients with cancer histories from the Utah Cancer Registry. This enabled them to compare all 84 postcolonoscopy colorectal cancers (defined as those detected within 6-60 months of colonoscopy) with tissue available for analysis with 84 detected colorectal cancers (detected within 6 months of a colonoscopy).
In the multivariable analysis, MSI was the only molecular feature that was significantly more frequent in postcolonoscopy versus detected colorectal cancers (odds ratio, 4.20; 95% confidence interval, 1.58-11.14). However, postcolonoscopy colorectal cancers were significantly more likely to be early stage (86% versus 69% for detected colorectal cancers; P = .040). Five-year survival did not significantly differ between the groups.
“The molecular signatures of postcolonoscopy colorectal cancers in our study overlap with those of sporadic MSI and serrated pathways, suggesting these mechanisms play a disproportionate role in postcolonoscopy colorectal cancers.” the researchers said. “Additional studies are needed to determine whether these postcolonoscopy colorectal cancers arise through a familial cancer pathway and/or serrated neoplastic pathway of sporadic lesions.
Funders included the American College of Gastroenterology, the National Cancer Institute, the Huntsman Cancer Foundation, the University of Utah, and the Utah Department of Health. Dr. Samadder reported consulting relationships with Cancer Prevention Pharmaceuticals and Janssen Research and Development. The other researchers reported having no conflicts of interest.
SOURCE: Samadder NJ et al. Clin Gastroenterol Hepatol. 2019 Mar 28. doi: 10.1016/j.cgh.2019.02.040.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
In Oregon, ‘war on melanoma’ takes flight
LAS VEGAS – with the goal of dramatically reducing melanoma deaths in the state of 4.2 million people.
Research shows that “early detection works in melanoma. And awareness seems to be important for the public in detecting melanoma early,” said Sancy Leachman, MD, PhD, professor and chair of the department of dermatology at Oregon Health & Science University, Portland, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Leachman, who is also the John D. Gray chair in melanoma research at OHSU, directs the “War on Melanoma” project, which was inspired by a project in the German state of Schleswig-Holstein that aimed to screen all residents aged over 21 years for melanoma. The project featured an education campaign and population-wide skin cancer screening, and mandated that certain patients – those at high risk and those who needed biopsies – would be referred to dermatologists (Br J Cancer. 2012 Feb 28;106[5]:970-4).
According to Dr. Leachman, the German project was initially a success, and was linked to a 50% decrease in melanoma mortality.
“In Oregon, we thought ‘that sounds very good, so we’re going to try that.’ ” But when it went national, the German project failed, she said, providing lessons for dermatologists in Oregon. “We’re going to try to improve upon the first [German] experiment by making ours controlled with a defined baseline. If it works, the plan is to extend it to select states nationwide.”
The War on Melanoma project was launched earlier this year. According to the university, the program is featuring or will feature the following elements:
- A media campaign called “Start Seeing Melanoma” that’s devoted to educating the public about the early detection of melanoma.
- The release of an iPhone app called MoleMapper that allows users to monitor moles over time.
- Education of medical professionals and partnerships with state-licensed skin care professionals such as massage therapists, cosmetologists, and tattoo artists.
In an interview at the meeting, Dr. Leachman said the project is expected to cost $1 million to $1.5 million over the first 18 months. At that time, she said, researchers will survey residents of Oregon and two control states – Washington and Utah– to see if their knowledge of melanoma has improved, compared with baseline survey results.
In 5 years, researchers plan to begin analyzing melanoma mortality in Oregon and the other states. “We hope to see a decline,” and to link it to increased awareness of melanoma, she said.
Dr. Leachman reported no relevant disclosures. She spoke during a forum on cutaneous malignancies at the meeting.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – with the goal of dramatically reducing melanoma deaths in the state of 4.2 million people.
Research shows that “early detection works in melanoma. And awareness seems to be important for the public in detecting melanoma early,” said Sancy Leachman, MD, PhD, professor and chair of the department of dermatology at Oregon Health & Science University, Portland, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Leachman, who is also the John D. Gray chair in melanoma research at OHSU, directs the “War on Melanoma” project, which was inspired by a project in the German state of Schleswig-Holstein that aimed to screen all residents aged over 21 years for melanoma. The project featured an education campaign and population-wide skin cancer screening, and mandated that certain patients – those at high risk and those who needed biopsies – would be referred to dermatologists (Br J Cancer. 2012 Feb 28;106[5]:970-4).
According to Dr. Leachman, the German project was initially a success, and was linked to a 50% decrease in melanoma mortality.
“In Oregon, we thought ‘that sounds very good, so we’re going to try that.’ ” But when it went national, the German project failed, she said, providing lessons for dermatologists in Oregon. “We’re going to try to improve upon the first [German] experiment by making ours controlled with a defined baseline. If it works, the plan is to extend it to select states nationwide.”
The War on Melanoma project was launched earlier this year. According to the university, the program is featuring or will feature the following elements:
- A media campaign called “Start Seeing Melanoma” that’s devoted to educating the public about the early detection of melanoma.
- The release of an iPhone app called MoleMapper that allows users to monitor moles over time.
- Education of medical professionals and partnerships with state-licensed skin care professionals such as massage therapists, cosmetologists, and tattoo artists.
In an interview at the meeting, Dr. Leachman said the project is expected to cost $1 million to $1.5 million over the first 18 months. At that time, she said, researchers will survey residents of Oregon and two control states – Washington and Utah– to see if their knowledge of melanoma has improved, compared with baseline survey results.
In 5 years, researchers plan to begin analyzing melanoma mortality in Oregon and the other states. “We hope to see a decline,” and to link it to increased awareness of melanoma, she said.
Dr. Leachman reported no relevant disclosures. She spoke during a forum on cutaneous malignancies at the meeting.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – with the goal of dramatically reducing melanoma deaths in the state of 4.2 million people.
Research shows that “early detection works in melanoma. And awareness seems to be important for the public in detecting melanoma early,” said Sancy Leachman, MD, PhD, professor and chair of the department of dermatology at Oregon Health & Science University, Portland, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Leachman, who is also the John D. Gray chair in melanoma research at OHSU, directs the “War on Melanoma” project, which was inspired by a project in the German state of Schleswig-Holstein that aimed to screen all residents aged over 21 years for melanoma. The project featured an education campaign and population-wide skin cancer screening, and mandated that certain patients – those at high risk and those who needed biopsies – would be referred to dermatologists (Br J Cancer. 2012 Feb 28;106[5]:970-4).
According to Dr. Leachman, the German project was initially a success, and was linked to a 50% decrease in melanoma mortality.
“In Oregon, we thought ‘that sounds very good, so we’re going to try that.’ ” But when it went national, the German project failed, she said, providing lessons for dermatologists in Oregon. “We’re going to try to improve upon the first [German] experiment by making ours controlled with a defined baseline. If it works, the plan is to extend it to select states nationwide.”
The War on Melanoma project was launched earlier this year. According to the university, the program is featuring or will feature the following elements:
- A media campaign called “Start Seeing Melanoma” that’s devoted to educating the public about the early detection of melanoma.
- The release of an iPhone app called MoleMapper that allows users to monitor moles over time.
- Education of medical professionals and partnerships with state-licensed skin care professionals such as massage therapists, cosmetologists, and tattoo artists.
In an interview at the meeting, Dr. Leachman said the project is expected to cost $1 million to $1.5 million over the first 18 months. At that time, she said, researchers will survey residents of Oregon and two control states – Washington and Utah– to see if their knowledge of melanoma has improved, compared with baseline survey results.
In 5 years, researchers plan to begin analyzing melanoma mortality in Oregon and the other states. “We hope to see a decline,” and to link it to increased awareness of melanoma, she said.
Dr. Leachman reported no relevant disclosures. She spoke during a forum on cutaneous malignancies at the meeting.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Better overall survival with nivolumab vs. chemo for advanced ESCC
BARCELONA – Nivolumab was associated with improved overall survival and a favorable safety profile, compared with chemotherapy, in patients with previously treated advanced esophageal squamous cell carcinoma (ESCC) in the open-label phase 3 ATTRACTION-3 study.
The overall survival (OS) benefit was observed regardless of tumor programmed death-ligand 1 (PD-L1) expression, Byoung Chul Cho, MD, reported at the European Society for Medical Oncology Congress.
The findings were reported online simultaneously in The Lancet Oncology.
Median OS at a minimum follow-up of 17.6 months was 10.9 vs. 8.4 months in 210 patients randomized to receive treatment with the PD-1 inhibitor nivolumab and 209 who received chemotherapy, respectively (hazard ratio, 0.77), said Dr. Cho of Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
“Notably, there was a 13% and 10% improvement in overall survival rates at 12 months (47% vs. 34%) and 18 months (31% vs. 21%), respectively,” he said, also noting that the HRs for death favored nivolumab vs. chemotherapy across multiple prespecified subgroups, including those based on tumor PD-L1 expression (HRs, 0.69 and 0.84 for PD-L1 of 1% or greater and less than 1%, respectively).
No meaningful difference was seen in progression-free survival between the nivolumab and chemotherapy groups (12% vs. 7%; HR, 1.08), or in objective response rates (19% vs. 22%), he said.
“However, responses were substantially more durable with nivolumab, compared to chemotherapy; duration of response was 6.9 months with nivolumab vs. 3.9 months in the chemotherapy arm,” he said. “Notably, 21% of patients in the nivolumab arm were still in response, compared to only 6% in the chemotherapy arm.”
Patients enrolled in the open label study had unresectable advanced or recurrent ESCC refractory or intolerant to one prior fluoropyrimidine/platinum-based therapy. They were randomized 1:1 to receive 240 mg of nivolumab every 2 weeks or investigators’ choice of paclitaxel or docetaxel.
Fewer treatment-related adverse events (TRAEs) were reported with nivolumab, Dr. Cho said.
Any grade TRAEs occurred in 66% vs. 95% of patients in the groups, respectively, and grade 3-4 TRAEs occurred in 18% vs. 63%. The majority of select TRAEs – defined as those with potential immunologic etiology, including endocrine, gastrointestinal, hepatic, pulmonary, renal, and skin effects – were grade 1 or 2, and the only difference between the nivolumab and chemotherapy groups with respect to those was in endocrine effects, which affected 11% vs. less than 1% of patients, respectively.
Grade 3/4 select TRAEs occurred in less than 2% of patients, Dr. Cho noted.
An exploratory analysis further showed significant overall improvement in health-related quality of life with nivolumab through week 42 on treatment, he added.
The findings are of note, because metastatic esophageal cancer has a 5-year relative survival rate of less than 8%, and ESCC accounts for about 90% of cases worldwide, he said, adding that current second-line chemotherapy options for ESCC offer poor long-term survival and are associated with toxicity.
Nivolumab, which showed promising antitumor activity and manageable toxicity for advanced ESCC in patients who were refractory to or intolerant of standard chemotherapies in the phase 2 ATTRACTION-1 study, is the first immune checkpoint inhibitor to demonstrate a statistically significant, clinically meaningful improvement in OS vs. chemotherapy in this setting, he said.
The findings of this final analysis of ATTRACTION-3, which shows a 23% reduction in the risk of death, a 2.5-month improvement in median OS, benefit across PD-L1 subgroups, and a favorable safety profile, suggest that nivolumab represents a new standard second-line treatment option for patients with advanced ESCC, he concluded.
ATTRACTION-3 was funded by Ono Pharmaceutical Co., in collaboration with Bristol-Myers Squibb. Dr. Cho reported relationships with Bristol-Myers Squibb, Ono Pharmaceutical, and others. He also reported stock ownership and/or patents with TheraCanVac and Champions Oncology.
SOURCE: Cho B et al. ESMO 2019, Abstract LBA11.
BARCELONA – Nivolumab was associated with improved overall survival and a favorable safety profile, compared with chemotherapy, in patients with previously treated advanced esophageal squamous cell carcinoma (ESCC) in the open-label phase 3 ATTRACTION-3 study.
The overall survival (OS) benefit was observed regardless of tumor programmed death-ligand 1 (PD-L1) expression, Byoung Chul Cho, MD, reported at the European Society for Medical Oncology Congress.
The findings were reported online simultaneously in The Lancet Oncology.
Median OS at a minimum follow-up of 17.6 months was 10.9 vs. 8.4 months in 210 patients randomized to receive treatment with the PD-1 inhibitor nivolumab and 209 who received chemotherapy, respectively (hazard ratio, 0.77), said Dr. Cho of Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
“Notably, there was a 13% and 10% improvement in overall survival rates at 12 months (47% vs. 34%) and 18 months (31% vs. 21%), respectively,” he said, also noting that the HRs for death favored nivolumab vs. chemotherapy across multiple prespecified subgroups, including those based on tumor PD-L1 expression (HRs, 0.69 and 0.84 for PD-L1 of 1% or greater and less than 1%, respectively).
No meaningful difference was seen in progression-free survival between the nivolumab and chemotherapy groups (12% vs. 7%; HR, 1.08), or in objective response rates (19% vs. 22%), he said.
“However, responses were substantially more durable with nivolumab, compared to chemotherapy; duration of response was 6.9 months with nivolumab vs. 3.9 months in the chemotherapy arm,” he said. “Notably, 21% of patients in the nivolumab arm were still in response, compared to only 6% in the chemotherapy arm.”
Patients enrolled in the open label study had unresectable advanced or recurrent ESCC refractory or intolerant to one prior fluoropyrimidine/platinum-based therapy. They were randomized 1:1 to receive 240 mg of nivolumab every 2 weeks or investigators’ choice of paclitaxel or docetaxel.
Fewer treatment-related adverse events (TRAEs) were reported with nivolumab, Dr. Cho said.
Any grade TRAEs occurred in 66% vs. 95% of patients in the groups, respectively, and grade 3-4 TRAEs occurred in 18% vs. 63%. The majority of select TRAEs – defined as those with potential immunologic etiology, including endocrine, gastrointestinal, hepatic, pulmonary, renal, and skin effects – were grade 1 or 2, and the only difference between the nivolumab and chemotherapy groups with respect to those was in endocrine effects, which affected 11% vs. less than 1% of patients, respectively.
Grade 3/4 select TRAEs occurred in less than 2% of patients, Dr. Cho noted.
An exploratory analysis further showed significant overall improvement in health-related quality of life with nivolumab through week 42 on treatment, he added.
The findings are of note, because metastatic esophageal cancer has a 5-year relative survival rate of less than 8%, and ESCC accounts for about 90% of cases worldwide, he said, adding that current second-line chemotherapy options for ESCC offer poor long-term survival and are associated with toxicity.
Nivolumab, which showed promising antitumor activity and manageable toxicity for advanced ESCC in patients who were refractory to or intolerant of standard chemotherapies in the phase 2 ATTRACTION-1 study, is the first immune checkpoint inhibitor to demonstrate a statistically significant, clinically meaningful improvement in OS vs. chemotherapy in this setting, he said.
The findings of this final analysis of ATTRACTION-3, which shows a 23% reduction in the risk of death, a 2.5-month improvement in median OS, benefit across PD-L1 subgroups, and a favorable safety profile, suggest that nivolumab represents a new standard second-line treatment option for patients with advanced ESCC, he concluded.
ATTRACTION-3 was funded by Ono Pharmaceutical Co., in collaboration with Bristol-Myers Squibb. Dr. Cho reported relationships with Bristol-Myers Squibb, Ono Pharmaceutical, and others. He also reported stock ownership and/or patents with TheraCanVac and Champions Oncology.
SOURCE: Cho B et al. ESMO 2019, Abstract LBA11.
BARCELONA – Nivolumab was associated with improved overall survival and a favorable safety profile, compared with chemotherapy, in patients with previously treated advanced esophageal squamous cell carcinoma (ESCC) in the open-label phase 3 ATTRACTION-3 study.
The overall survival (OS) benefit was observed regardless of tumor programmed death-ligand 1 (PD-L1) expression, Byoung Chul Cho, MD, reported at the European Society for Medical Oncology Congress.
The findings were reported online simultaneously in The Lancet Oncology.
Median OS at a minimum follow-up of 17.6 months was 10.9 vs. 8.4 months in 210 patients randomized to receive treatment with the PD-1 inhibitor nivolumab and 209 who received chemotherapy, respectively (hazard ratio, 0.77), said Dr. Cho of Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
“Notably, there was a 13% and 10% improvement in overall survival rates at 12 months (47% vs. 34%) and 18 months (31% vs. 21%), respectively,” he said, also noting that the HRs for death favored nivolumab vs. chemotherapy across multiple prespecified subgroups, including those based on tumor PD-L1 expression (HRs, 0.69 and 0.84 for PD-L1 of 1% or greater and less than 1%, respectively).
No meaningful difference was seen in progression-free survival between the nivolumab and chemotherapy groups (12% vs. 7%; HR, 1.08), or in objective response rates (19% vs. 22%), he said.
“However, responses were substantially more durable with nivolumab, compared to chemotherapy; duration of response was 6.9 months with nivolumab vs. 3.9 months in the chemotherapy arm,” he said. “Notably, 21% of patients in the nivolumab arm were still in response, compared to only 6% in the chemotherapy arm.”
Patients enrolled in the open label study had unresectable advanced or recurrent ESCC refractory or intolerant to one prior fluoropyrimidine/platinum-based therapy. They were randomized 1:1 to receive 240 mg of nivolumab every 2 weeks or investigators’ choice of paclitaxel or docetaxel.
Fewer treatment-related adverse events (TRAEs) were reported with nivolumab, Dr. Cho said.
Any grade TRAEs occurred in 66% vs. 95% of patients in the groups, respectively, and grade 3-4 TRAEs occurred in 18% vs. 63%. The majority of select TRAEs – defined as those with potential immunologic etiology, including endocrine, gastrointestinal, hepatic, pulmonary, renal, and skin effects – were grade 1 or 2, and the only difference between the nivolumab and chemotherapy groups with respect to those was in endocrine effects, which affected 11% vs. less than 1% of patients, respectively.
Grade 3/4 select TRAEs occurred in less than 2% of patients, Dr. Cho noted.
An exploratory analysis further showed significant overall improvement in health-related quality of life with nivolumab through week 42 on treatment, he added.
The findings are of note, because metastatic esophageal cancer has a 5-year relative survival rate of less than 8%, and ESCC accounts for about 90% of cases worldwide, he said, adding that current second-line chemotherapy options for ESCC offer poor long-term survival and are associated with toxicity.
Nivolumab, which showed promising antitumor activity and manageable toxicity for advanced ESCC in patients who were refractory to or intolerant of standard chemotherapies in the phase 2 ATTRACTION-1 study, is the first immune checkpoint inhibitor to demonstrate a statistically significant, clinically meaningful improvement in OS vs. chemotherapy in this setting, he said.
The findings of this final analysis of ATTRACTION-3, which shows a 23% reduction in the risk of death, a 2.5-month improvement in median OS, benefit across PD-L1 subgroups, and a favorable safety profile, suggest that nivolumab represents a new standard second-line treatment option for patients with advanced ESCC, he concluded.
ATTRACTION-3 was funded by Ono Pharmaceutical Co., in collaboration with Bristol-Myers Squibb. Dr. Cho reported relationships with Bristol-Myers Squibb, Ono Pharmaceutical, and others. He also reported stock ownership and/or patents with TheraCanVac and Champions Oncology.
SOURCE: Cho B et al. ESMO 2019, Abstract LBA11.
REPORTING FROM ESMO 2019
Key clinical point: Nivolumab was associated with improved OS vs. chemotherapy, in previously treated advanced ESCC.
Major finding: Median OS was 10.9 vs. 8.4 months with nivolumab vs. chemotherapy, respectively (hazard ratio, 0.77).
Study details: A randomized, open-label, phase 3 study of 419 patients.
Disclosures: ATTRACTION-3 was funded by Ono Pharmaceutical Co., in collaboration with Bristol-Myers Squibb. Dr. Cho reported relationships with Bristol-Myers Squibb, Ono Pharmaceutical, and others. He reported stock ownership and/or patents with TheraCanVac and Champions Oncology.
Source: Cho B et al. ESMO 2019, Abstract LBA11.
Melanoma incidence continues to increase, yet mortality stabilizing
LAS VEGAS – The according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Laura Korb Ferris, MD, PhD, said that SEER data project 96,480 new cases of melanoma in 2019, as well as 7,230 deaths from the disease. In 2016, SEER projected 10,130 deaths from melanoma, “so we’re actually projecting a reduction in melanoma deaths,” said Dr. Ferris, director of clinical trials at the University of Pittsburgh Medical Center’s department of dermatology. She added that the death rate from melanoma in 2016 was 2.17 per 100,000 population, a reduction from 2.69 per 100,000 population in 2011, “so it looks like melanoma mortality may be stable,” or even reduced, despite an increase in melanoma incidence.
A study of SEER data between 1989 and 2009 found that melanoma incidence is increasing across all lesion thicknesses (J Natl Cancer Inst. 2015 Nov 12. doi: 10.1093/jnci/djv294). Specifically, the incidence increased most among thin lesions, but there was a smaller increased incidence of thick melanoma. “This suggests that the overall burden of disease is truly increasing, but it is primarily stemming from an increase in T1/T2 disease,” Dr. Ferris said. “This could be due in part to increased early detection.”
Improvements in melanoma-specific survival, she continued, are likely a combination of improved management of T4 disease, a shift toward detection of thinner T1/T2 melanoma, and increased detection of T1/T2 disease.
The SEER data also showed that the incidence of fatal cases of melanoma has decreased since 1989, but only in thick melanomas. This trend may indicate a modest improvement in the management of T4 tumors. “Optimistically, I think increased detection efforts are improving survival by early detection of thin but ultimately fatal melanomas,” Dr. Ferris said. “Hopefully we are finding disease earlier and we are preventing patients from progressing to these fatal T4 melanomas.”
Disparities in melanoma-specific survival also come into play. Men have poorer survival compared with women, whites have the highest survival, and non-Hispanic whites have a better survival than Hispanic whites, Dr. Ferris said, while lower rates of survival are seen in blacks and nonblack minorities, as well as among those in high poverty and those who are separated/nonmarried. Lesion type also matters. The highest survival is seen in those with superficial spreading melanoma, while lower survival is observed in those with nodular melanoma, and acral lentiginous melanoma.
Early detection of thin nodular melanomas has the potential to significantly impact melanoma mortality, “but we want to keep in mind that the majority of ultimately fatal melanomas are superficial spreading melanomas,” Dr. Ferris said. “That is because they are so much more prevalent. As a dermatologist, I think a lot about screening and early detection. Periodic screening is a good strategy for a slower-growing superficial spreading melanoma, but it’s not necessarily a good strategy for a rapidly growing nodular melanoma. That’s going to require better education and better access to health care.”
Self-detection of melanoma is another strategy to consider. According to Dr. Ferris, results from multiple studies suggest that about 50% of all melanomas are detected by patients, but the ones they find tend to be thicker than the ones that clinicians detect during office visits. “It would be great if we can get that number higher than 50%,” Dr. Ferris said. “If patients really understood what melanoma is, what it looks like, and when they needed to seek medical attention, perhaps we could get that over 50% and see self-detection of thinner melanomas. That’s a very low-cost intervention.”
Targeted screening efforts that stratify by risk factors and by age “makes screening more efficient and more cost-effective,” she added. She cited one analysis, which found that clinicians need to screen 606 people and conduct 25 biopsies in order to find one melanoma. “That’s very resource intensive,” she said. “However, if you only screened people 50 or older or 65 or older, the number needed to screen goes down, and because your pretest probability is higher, your number need to biopsy goes down as well. If you factor in things like a history of atypical nevi or a personal history of melanoma, those patients are at a higher risk of developing melanoma.”
Dr. Ferris closed her presentation by noting that Australia leads other countries in melanoma prevention efforts. There, the combined incidence of skin cancer is higher than the incidence of any other type of cancer. Four decades ago, Australian health officials launched SunSmart, a series of initiatives intended to reduce skin cancer. These include implementation of policies for hat wearing and shade provision in schools and at work, availability of more effective sunscreens, inclusion of sun protection items as a tax-deductible expense for outdoor workers, increased availability since the 1980s of long-sleeved sun protective swimwear, a ban on the use of indoor tanning since 2014, provision of UV forecasts in weather, and a comprehensive program of grants for community shade structures (PLoSMed. 2019 Oct 8;16[10]:e1002932).
“One approach to melanoma prevention won’t fit all,” she concluded. “We need to focus on prevention, public education to improve knowledge and self-detection.”
Dr. Ferris disclosed that she is a consultant to and an investigator for DermTech and Scibase. She is also an investigator for Castle Biosciences.
SDEF and this news organization are owned by the same parent company. Dr. Ferris spoke during a forum on cutaneous malignancies at the meeting.
LAS VEGAS – The according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Laura Korb Ferris, MD, PhD, said that SEER data project 96,480 new cases of melanoma in 2019, as well as 7,230 deaths from the disease. In 2016, SEER projected 10,130 deaths from melanoma, “so we’re actually projecting a reduction in melanoma deaths,” said Dr. Ferris, director of clinical trials at the University of Pittsburgh Medical Center’s department of dermatology. She added that the death rate from melanoma in 2016 was 2.17 per 100,000 population, a reduction from 2.69 per 100,000 population in 2011, “so it looks like melanoma mortality may be stable,” or even reduced, despite an increase in melanoma incidence.
A study of SEER data between 1989 and 2009 found that melanoma incidence is increasing across all lesion thicknesses (J Natl Cancer Inst. 2015 Nov 12. doi: 10.1093/jnci/djv294). Specifically, the incidence increased most among thin lesions, but there was a smaller increased incidence of thick melanoma. “This suggests that the overall burden of disease is truly increasing, but it is primarily stemming from an increase in T1/T2 disease,” Dr. Ferris said. “This could be due in part to increased early detection.”
Improvements in melanoma-specific survival, she continued, are likely a combination of improved management of T4 disease, a shift toward detection of thinner T1/T2 melanoma, and increased detection of T1/T2 disease.
The SEER data also showed that the incidence of fatal cases of melanoma has decreased since 1989, but only in thick melanomas. This trend may indicate a modest improvement in the management of T4 tumors. “Optimistically, I think increased detection efforts are improving survival by early detection of thin but ultimately fatal melanomas,” Dr. Ferris said. “Hopefully we are finding disease earlier and we are preventing patients from progressing to these fatal T4 melanomas.”
Disparities in melanoma-specific survival also come into play. Men have poorer survival compared with women, whites have the highest survival, and non-Hispanic whites have a better survival than Hispanic whites, Dr. Ferris said, while lower rates of survival are seen in blacks and nonblack minorities, as well as among those in high poverty and those who are separated/nonmarried. Lesion type also matters. The highest survival is seen in those with superficial spreading melanoma, while lower survival is observed in those with nodular melanoma, and acral lentiginous melanoma.
Early detection of thin nodular melanomas has the potential to significantly impact melanoma mortality, “but we want to keep in mind that the majority of ultimately fatal melanomas are superficial spreading melanomas,” Dr. Ferris said. “That is because they are so much more prevalent. As a dermatologist, I think a lot about screening and early detection. Periodic screening is a good strategy for a slower-growing superficial spreading melanoma, but it’s not necessarily a good strategy for a rapidly growing nodular melanoma. That’s going to require better education and better access to health care.”
Self-detection of melanoma is another strategy to consider. According to Dr. Ferris, results from multiple studies suggest that about 50% of all melanomas are detected by patients, but the ones they find tend to be thicker than the ones that clinicians detect during office visits. “It would be great if we can get that number higher than 50%,” Dr. Ferris said. “If patients really understood what melanoma is, what it looks like, and when they needed to seek medical attention, perhaps we could get that over 50% and see self-detection of thinner melanomas. That’s a very low-cost intervention.”
Targeted screening efforts that stratify by risk factors and by age “makes screening more efficient and more cost-effective,” she added. She cited one analysis, which found that clinicians need to screen 606 people and conduct 25 biopsies in order to find one melanoma. “That’s very resource intensive,” she said. “However, if you only screened people 50 or older or 65 or older, the number needed to screen goes down, and because your pretest probability is higher, your number need to biopsy goes down as well. If you factor in things like a history of atypical nevi or a personal history of melanoma, those patients are at a higher risk of developing melanoma.”
Dr. Ferris closed her presentation by noting that Australia leads other countries in melanoma prevention efforts. There, the combined incidence of skin cancer is higher than the incidence of any other type of cancer. Four decades ago, Australian health officials launched SunSmart, a series of initiatives intended to reduce skin cancer. These include implementation of policies for hat wearing and shade provision in schools and at work, availability of more effective sunscreens, inclusion of sun protection items as a tax-deductible expense for outdoor workers, increased availability since the 1980s of long-sleeved sun protective swimwear, a ban on the use of indoor tanning since 2014, provision of UV forecasts in weather, and a comprehensive program of grants for community shade structures (PLoSMed. 2019 Oct 8;16[10]:e1002932).
“One approach to melanoma prevention won’t fit all,” she concluded. “We need to focus on prevention, public education to improve knowledge and self-detection.”
Dr. Ferris disclosed that she is a consultant to and an investigator for DermTech and Scibase. She is also an investigator for Castle Biosciences.
SDEF and this news organization are owned by the same parent company. Dr. Ferris spoke during a forum on cutaneous malignancies at the meeting.
LAS VEGAS – The according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Laura Korb Ferris, MD, PhD, said that SEER data project 96,480 new cases of melanoma in 2019, as well as 7,230 deaths from the disease. In 2016, SEER projected 10,130 deaths from melanoma, “so we’re actually projecting a reduction in melanoma deaths,” said Dr. Ferris, director of clinical trials at the University of Pittsburgh Medical Center’s department of dermatology. She added that the death rate from melanoma in 2016 was 2.17 per 100,000 population, a reduction from 2.69 per 100,000 population in 2011, “so it looks like melanoma mortality may be stable,” or even reduced, despite an increase in melanoma incidence.
A study of SEER data between 1989 and 2009 found that melanoma incidence is increasing across all lesion thicknesses (J Natl Cancer Inst. 2015 Nov 12. doi: 10.1093/jnci/djv294). Specifically, the incidence increased most among thin lesions, but there was a smaller increased incidence of thick melanoma. “This suggests that the overall burden of disease is truly increasing, but it is primarily stemming from an increase in T1/T2 disease,” Dr. Ferris said. “This could be due in part to increased early detection.”
Improvements in melanoma-specific survival, she continued, are likely a combination of improved management of T4 disease, a shift toward detection of thinner T1/T2 melanoma, and increased detection of T1/T2 disease.
The SEER data also showed that the incidence of fatal cases of melanoma has decreased since 1989, but only in thick melanomas. This trend may indicate a modest improvement in the management of T4 tumors. “Optimistically, I think increased detection efforts are improving survival by early detection of thin but ultimately fatal melanomas,” Dr. Ferris said. “Hopefully we are finding disease earlier and we are preventing patients from progressing to these fatal T4 melanomas.”
Disparities in melanoma-specific survival also come into play. Men have poorer survival compared with women, whites have the highest survival, and non-Hispanic whites have a better survival than Hispanic whites, Dr. Ferris said, while lower rates of survival are seen in blacks and nonblack minorities, as well as among those in high poverty and those who are separated/nonmarried. Lesion type also matters. The highest survival is seen in those with superficial spreading melanoma, while lower survival is observed in those with nodular melanoma, and acral lentiginous melanoma.
Early detection of thin nodular melanomas has the potential to significantly impact melanoma mortality, “but we want to keep in mind that the majority of ultimately fatal melanomas are superficial spreading melanomas,” Dr. Ferris said. “That is because they are so much more prevalent. As a dermatologist, I think a lot about screening and early detection. Periodic screening is a good strategy for a slower-growing superficial spreading melanoma, but it’s not necessarily a good strategy for a rapidly growing nodular melanoma. That’s going to require better education and better access to health care.”
Self-detection of melanoma is another strategy to consider. According to Dr. Ferris, results from multiple studies suggest that about 50% of all melanomas are detected by patients, but the ones they find tend to be thicker than the ones that clinicians detect during office visits. “It would be great if we can get that number higher than 50%,” Dr. Ferris said. “If patients really understood what melanoma is, what it looks like, and when they needed to seek medical attention, perhaps we could get that over 50% and see self-detection of thinner melanomas. That’s a very low-cost intervention.”
Targeted screening efforts that stratify by risk factors and by age “makes screening more efficient and more cost-effective,” she added. She cited one analysis, which found that clinicians need to screen 606 people and conduct 25 biopsies in order to find one melanoma. “That’s very resource intensive,” she said. “However, if you only screened people 50 or older or 65 or older, the number needed to screen goes down, and because your pretest probability is higher, your number need to biopsy goes down as well. If you factor in things like a history of atypical nevi or a personal history of melanoma, those patients are at a higher risk of developing melanoma.”
Dr. Ferris closed her presentation by noting that Australia leads other countries in melanoma prevention efforts. There, the combined incidence of skin cancer is higher than the incidence of any other type of cancer. Four decades ago, Australian health officials launched SunSmart, a series of initiatives intended to reduce skin cancer. These include implementation of policies for hat wearing and shade provision in schools and at work, availability of more effective sunscreens, inclusion of sun protection items as a tax-deductible expense for outdoor workers, increased availability since the 1980s of long-sleeved sun protective swimwear, a ban on the use of indoor tanning since 2014, provision of UV forecasts in weather, and a comprehensive program of grants for community shade structures (PLoSMed. 2019 Oct 8;16[10]:e1002932).
“One approach to melanoma prevention won’t fit all,” she concluded. “We need to focus on prevention, public education to improve knowledge and self-detection.”
Dr. Ferris disclosed that she is a consultant to and an investigator for DermTech and Scibase. She is also an investigator for Castle Biosciences.
SDEF and this news organization are owned by the same parent company. Dr. Ferris spoke during a forum on cutaneous malignancies at the meeting.
EXPERT ANALYSIS FROM THE SDEF LAS VEGAS DERMATOLOGY SEMINAR
Though metastatic breast cancer survival is improving, rates vary by region
Though survival rates of patients with metastatic breast cancer (MBC) have increased over the last 2 decades, a new study has indicated disparities exist across regions and by variables like age and race.
“It appears from these results that we may be at a crossroads for MBC treatment and survival,” wrote Judith A. Malmgren, PhD, of the University of Washington and her coauthors. The study was published in Cancer. “Access to appropriate, timely, and up‐to‐date diagnosis, care, treatment, and surveillance could turn this fatal disease into a chronic and treatable phenomenon, depending on patient factors, molecular subtype, and insurance capacity to pay for treatment,” they said.
To determine how breast cancer outcomes might vary across regions, the researchers compared breast cancer–specific survival rates (BCSS) from Surveillance, Epidemiology, and End Results-9 (SEER-9) registry data minus a regional subset from the Seattle-Puget Sound (S-PS) region (n = 12,121) to patients from that S-PS region (n = 1,931) and to an individual cohort in that area (n = 261). Five-year BCSS rates were calculated for three time periods: 1990‐1998, 1999‐2004, and 2005‐2011.
All analyzed patients were diagnosed with a first primary, de novo, stage IV breast cancer between the ages of 25 and 84 years from 1990 to 2011. Patients in the SEER-9 group and the S-PS region had a mean age of 61 years, compared with the individual cohort’s mean age of 55 years. Patients in the individual cohort were more likely to reside in a major metropolitan area of over 1 million people, compared with the SEER group and the S-PS region (86% versus 61% and 58%, respectively).
Patients in the SEER-9 group had improved BCSS rates over the study period, from 19% in 1990-1998 (95% confidence interval, 18%-21%; P less than .001) to 26% in 2005-2011 (95% CI, 24%-27%; P less than .001). Patients in the S-PS region saw even greater improvements in BCSS rates, from 21% in 1990-1998 (95% CI, 18%-24%; P less than .001) to 35% in 2005-2011 (95% CI, 32%-39%; P less than .001). But the largest improvement in survival rates came from patients in the individual cohort, who went from 29% in 1990-1998 (95% CI, 18%-37%; P less than .001) to 56% in 2005-2011 (95% CI, 45%-65%; P = .004).
In a proportional hazards model for breast cancer–specific death, reduced hazard in the SEER-9 group was associated with surgery (hazard ratio, 0.58; 95% CI, 0.55-0.61; P less than .001), an age less than 70 (HR, 0.77; 95% CI, 0.73-0.82; P less than .001) and white race (HR, 0.84; 95% CI, 0.79-0.89; P less than .001). Similar associations were seen in the S-PS region with surgery (HR, 0.57; 95% CI, 0.50-0.66; P less than .001) and an age less than 70 (HR, 0.72; 95% CI, 0.62-0.84; P less than .001), but not white race.
The study results “indicate that the stage IV population that is living longer may be benefiting from many of the same therapies used to treat early breast cancer, especially for patients who are able to handle adjuvant chemotherapy treatment and are HR‐positive,” the researchers said. “However, the lag in survival improvement across different population‐based, geographic regions suggests that some groups and regions may benefit unequally from treatment advances as well as timely diagnosis.”
The study was funded by the Kaplan Cancer Research Fund, the Metastatic Breast Cancer Alliance, and the Surveillance, Epidemiology, and End Results Cancer Surveillance System program of the National Cancer Institute. The authors reported no conflicts of interest.
SOURCE: Malmgren JA et al. Cancer. 2019 Oct 22. doi: 10.1002/cncr.32531.
Though survival rates of patients with metastatic breast cancer (MBC) have increased over the last 2 decades, a new study has indicated disparities exist across regions and by variables like age and race.
“It appears from these results that we may be at a crossroads for MBC treatment and survival,” wrote Judith A. Malmgren, PhD, of the University of Washington and her coauthors. The study was published in Cancer. “Access to appropriate, timely, and up‐to‐date diagnosis, care, treatment, and surveillance could turn this fatal disease into a chronic and treatable phenomenon, depending on patient factors, molecular subtype, and insurance capacity to pay for treatment,” they said.
To determine how breast cancer outcomes might vary across regions, the researchers compared breast cancer–specific survival rates (BCSS) from Surveillance, Epidemiology, and End Results-9 (SEER-9) registry data minus a regional subset from the Seattle-Puget Sound (S-PS) region (n = 12,121) to patients from that S-PS region (n = 1,931) and to an individual cohort in that area (n = 261). Five-year BCSS rates were calculated for three time periods: 1990‐1998, 1999‐2004, and 2005‐2011.
All analyzed patients were diagnosed with a first primary, de novo, stage IV breast cancer between the ages of 25 and 84 years from 1990 to 2011. Patients in the SEER-9 group and the S-PS region had a mean age of 61 years, compared with the individual cohort’s mean age of 55 years. Patients in the individual cohort were more likely to reside in a major metropolitan area of over 1 million people, compared with the SEER group and the S-PS region (86% versus 61% and 58%, respectively).
Patients in the SEER-9 group had improved BCSS rates over the study period, from 19% in 1990-1998 (95% confidence interval, 18%-21%; P less than .001) to 26% in 2005-2011 (95% CI, 24%-27%; P less than .001). Patients in the S-PS region saw even greater improvements in BCSS rates, from 21% in 1990-1998 (95% CI, 18%-24%; P less than .001) to 35% in 2005-2011 (95% CI, 32%-39%; P less than .001). But the largest improvement in survival rates came from patients in the individual cohort, who went from 29% in 1990-1998 (95% CI, 18%-37%; P less than .001) to 56% in 2005-2011 (95% CI, 45%-65%; P = .004).
In a proportional hazards model for breast cancer–specific death, reduced hazard in the SEER-9 group was associated with surgery (hazard ratio, 0.58; 95% CI, 0.55-0.61; P less than .001), an age less than 70 (HR, 0.77; 95% CI, 0.73-0.82; P less than .001) and white race (HR, 0.84; 95% CI, 0.79-0.89; P less than .001). Similar associations were seen in the S-PS region with surgery (HR, 0.57; 95% CI, 0.50-0.66; P less than .001) and an age less than 70 (HR, 0.72; 95% CI, 0.62-0.84; P less than .001), but not white race.
The study results “indicate that the stage IV population that is living longer may be benefiting from many of the same therapies used to treat early breast cancer, especially for patients who are able to handle adjuvant chemotherapy treatment and are HR‐positive,” the researchers said. “However, the lag in survival improvement across different population‐based, geographic regions suggests that some groups and regions may benefit unequally from treatment advances as well as timely diagnosis.”
The study was funded by the Kaplan Cancer Research Fund, the Metastatic Breast Cancer Alliance, and the Surveillance, Epidemiology, and End Results Cancer Surveillance System program of the National Cancer Institute. The authors reported no conflicts of interest.
SOURCE: Malmgren JA et al. Cancer. 2019 Oct 22. doi: 10.1002/cncr.32531.
Though survival rates of patients with metastatic breast cancer (MBC) have increased over the last 2 decades, a new study has indicated disparities exist across regions and by variables like age and race.
“It appears from these results that we may be at a crossroads for MBC treatment and survival,” wrote Judith A. Malmgren, PhD, of the University of Washington and her coauthors. The study was published in Cancer. “Access to appropriate, timely, and up‐to‐date diagnosis, care, treatment, and surveillance could turn this fatal disease into a chronic and treatable phenomenon, depending on patient factors, molecular subtype, and insurance capacity to pay for treatment,” they said.
To determine how breast cancer outcomes might vary across regions, the researchers compared breast cancer–specific survival rates (BCSS) from Surveillance, Epidemiology, and End Results-9 (SEER-9) registry data minus a regional subset from the Seattle-Puget Sound (S-PS) region (n = 12,121) to patients from that S-PS region (n = 1,931) and to an individual cohort in that area (n = 261). Five-year BCSS rates were calculated for three time periods: 1990‐1998, 1999‐2004, and 2005‐2011.
All analyzed patients were diagnosed with a first primary, de novo, stage IV breast cancer between the ages of 25 and 84 years from 1990 to 2011. Patients in the SEER-9 group and the S-PS region had a mean age of 61 years, compared with the individual cohort’s mean age of 55 years. Patients in the individual cohort were more likely to reside in a major metropolitan area of over 1 million people, compared with the SEER group and the S-PS region (86% versus 61% and 58%, respectively).
Patients in the SEER-9 group had improved BCSS rates over the study period, from 19% in 1990-1998 (95% confidence interval, 18%-21%; P less than .001) to 26% in 2005-2011 (95% CI, 24%-27%; P less than .001). Patients in the S-PS region saw even greater improvements in BCSS rates, from 21% in 1990-1998 (95% CI, 18%-24%; P less than .001) to 35% in 2005-2011 (95% CI, 32%-39%; P less than .001). But the largest improvement in survival rates came from patients in the individual cohort, who went from 29% in 1990-1998 (95% CI, 18%-37%; P less than .001) to 56% in 2005-2011 (95% CI, 45%-65%; P = .004).
In a proportional hazards model for breast cancer–specific death, reduced hazard in the SEER-9 group was associated with surgery (hazard ratio, 0.58; 95% CI, 0.55-0.61; P less than .001), an age less than 70 (HR, 0.77; 95% CI, 0.73-0.82; P less than .001) and white race (HR, 0.84; 95% CI, 0.79-0.89; P less than .001). Similar associations were seen in the S-PS region with surgery (HR, 0.57; 95% CI, 0.50-0.66; P less than .001) and an age less than 70 (HR, 0.72; 95% CI, 0.62-0.84; P less than .001), but not white race.
The study results “indicate that the stage IV population that is living longer may be benefiting from many of the same therapies used to treat early breast cancer, especially for patients who are able to handle adjuvant chemotherapy treatment and are HR‐positive,” the researchers said. “However, the lag in survival improvement across different population‐based, geographic regions suggests that some groups and regions may benefit unequally from treatment advances as well as timely diagnosis.”
The study was funded by the Kaplan Cancer Research Fund, the Metastatic Breast Cancer Alliance, and the Surveillance, Epidemiology, and End Results Cancer Surveillance System program of the National Cancer Institute. The authors reported no conflicts of interest.
SOURCE: Malmgren JA et al. Cancer. 2019 Oct 22. doi: 10.1002/cncr.32531.
FROM CANCER
ACP: Low-risk adults aged 50-75 should undergo regular screening for colorectal cancer
issued by the American College of Physicians.
Regular screening can be discontinued after age 75 years, Amir Qaseem, MD, president of clinical policy and the Center for Evidence Reviews at the American College of Physicians, and colleagues wrote in the Annals of Internal Medicine.
No one test is preferred over another, according to the guidance statement. Patients and physicians can select the test type together, based on individual needs and preferences, and each test carries its own screening interval. But regular testing has been proven time and again to reduce the risk of colorectal cancer mortality, and more people should have it, according to the guidance.
“Not enough people in the United States get screened for colorectal cancer,” ACP President Robert M. McLean, MD, said in a press statement. “Physicians should perform an individualized risk assessment for colorectal cancer in all adults. Doctors and patients should select the screening test based on a discussion of the benefits, harms, costs, availability, frequency, and patient preferences.”
The guidance is an attempt to balance existing guidelines authored by the U.S. Preventive Services Task Force and the Canadian Task Force on Preventive Health Care (CTFPHC), but it also was developed following critical review of those from the American Cancer Society and other organizations.
The ACP guidance is for adults at average risk for colorectal cancer who do not have symptoms; it does not apply to adults with a family history of colorectal cancer, a long-standing history of inflammatory bowel disease, genetic syndromes such as familial cancerous polyps, a personal history of previous colorectal cancer or benign polyps, or other risk factors.
The guidance was based on evaluations of stool-based tests, including the fecal immunochemical test (FIT), also called the immunochemical-based fecal occult blood test (FOBT), and direct visualization with endoscopic and radiologic tests, including flexible sigmoidoscopy, colonoscopy, and CT colonography. The guidance includes the following recommendations:
Clinicians should regularly screen for colorectal cancer in average-risk adults between the ages of 50 and 75 years.
This recommendation is in line with those made by the U.S. Preventive Services Task Force and the CTFPHC. Data suggest that regular screening reduces colorectal cancer–specific mortality in this age group, with those aged 65-75 years likely to garner the most benefit.
The absolute risk reduction increases with age and varies with test type. For every-other-year FOBT, it rises from 0.037% in those younger than 60 years to 0.20% in those aged 60 years or older. For flexible sigmoidoscopy, the risk reduction rises from 0.05% in the younger group to 0.29% in the older group.
Data from the CTFPHC show that the net benefit in those aged 50-59 years is small, however. This may influence the decision about when to start screening.
Clinicians should select the colorectal cancer screening test with the patient based on a discussion of benefits, harms, costs, availability, frequency, and patient preferences.
The FIT or FOBT should be performed every 2 years, colonoscopy every 10 years, and flexible sigmoidoscopy every 10 years, plus FIT every 2 years.
No data suggest a benefit of one test over another; however, “all screening tests are associated with potential benefits as well as harms,” the document states. “Clinical decisions need to be individualized using patient clinical characteristics, patient preferences, and screening test frequency and availability. Because many eligible patients have never been screened and some may not adhere to recommendations about subsequent screening or follow-up of positive findings on screening tests (such as colonoscopy after a positive result on a stool-based screening test), patient informed decision making and adherence are important factors in selection of a [colorectal cancer] screening test.”
Discussions with patients should include topics like the recommended frequency of each test, bowel preparation, anesthesia, transportation to and from testing site, time commitments, and the necessary steps if a test result is positive.
Clinicians should discontinue screening for colorectal cancer in average-risk adults older than 75 years or in adults with a life expectancy of 10 years or less.
While the benefit from screening increases with age, so do the risks for harm, especially serious harm. Data show the balance of harms and benefits reaching a tipping point at around 75 years of age. But again, this isn’t a universal recommendation, the statement says.
“Persons with no history of [colorectal cancer] screening may benefit from screening after age 75 years, whereas those who have received regular screening with negative results may not.”
Cessation of testing considers life expectancy after age 75 years. The average life expectancy for healthy 75-year-old men and women in the United States is 9.9 and 12 years, respectively. But among men and women with serious medical comorbidities, average life expectancy after age 70 years drops to 8.9 and 10.8 years, respectively.
“Therefore, most persons aged 75 years or older, as well as most adults who are younger than 75 years but have serious comorbid conditions [such as chronic renal failure], are unlikely to benefit from screening but would undergo unnecessary, burdensome, potentially harmful, and costly screening tests.”
As in any testing discussion, personal preferences are important, but not just to make patients feel comfortable about their choice. Mindset about colorectal cancer testing has a very big effect on compliance, the statement noted.
“For example, a biennial stool test is not a good screening strategy for patients who may be unwilling or unlikely to follow up every other year. In addition, given the tradeoffs between benefits and harms, some patients may want less intensive screening, such as screening that begins at a later age, stops at an earlier age, or recurs less frequently regardless of modality selected.”
SOURCE: Qassam A et al. Ann Intern Med. 2019;171:643-54.
Cost-effectiveness is one more factor in the colorectal screening discussion, Michael Pignone, MD, said in an accompanying editorial.
Two studies by Ladabaum et al. reported cost-effectiveness modeling for various CRC screening techniques: “Comparative effectiveness and cost effectiveness of a multitarget stool DNA test to screen for colorectal neoplasia” (Gastroenterology. 2019;151,:427-39.e6) and “Cost-effectiveness and national effects of initiating colorectal cancer screening for average-risk persons at age 45 years instead of 50 years” (Gastroenterology. 2019;157:137-48).
These reports concluded that annual stool testing is more effective – but also more costly – than biennial testing. However, the additional cost per unit of benefit (figured in quality-adjusted life-years) is about $33,000 per life-year gained – a reasonable cost. “Hence, annual testing is a viable screening option,” wrote Dr. Pignone.
Starting screening at age 45 years instead of 50 years also produced an additional cost per life-year, but again, it is reasonable at $33,900 for colonoscopy screening and $7,700 for stool testing.
“However, for the same amount of additional resources, increasing screening rates in 55- or 65-year-olds or improving the proportion of positive stool test results that are followed by colonoscopy from 60% to 90% would yield much more benefit in life-years gained than lowering the starting age to 45 years.”
Analyses such as these conditionally support earlier colorectal cancer screening only if the universal screening rate for 50- to 75-year-olds is more than 80%, he wrote. “They also reinforce the most important point in all of the major guidelines: Any recommended form of screening in the 50- to 75-year age range is likely to be very cost-effective (if not cost-saving) compared with no screening and should be strongly encouraged.”
Dr. Pignone is director of the program on cancer prevention and control at the LIVESTRONG Cancer Institutes at the University of Texas, Austin.
Cost-effectiveness is one more factor in the colorectal screening discussion, Michael Pignone, MD, said in an accompanying editorial.
Two studies by Ladabaum et al. reported cost-effectiveness modeling for various CRC screening techniques: “Comparative effectiveness and cost effectiveness of a multitarget stool DNA test to screen for colorectal neoplasia” (Gastroenterology. 2019;151,:427-39.e6) and “Cost-effectiveness and national effects of initiating colorectal cancer screening for average-risk persons at age 45 years instead of 50 years” (Gastroenterology. 2019;157:137-48).
These reports concluded that annual stool testing is more effective – but also more costly – than biennial testing. However, the additional cost per unit of benefit (figured in quality-adjusted life-years) is about $33,000 per life-year gained – a reasonable cost. “Hence, annual testing is a viable screening option,” wrote Dr. Pignone.
Starting screening at age 45 years instead of 50 years also produced an additional cost per life-year, but again, it is reasonable at $33,900 for colonoscopy screening and $7,700 for stool testing.
“However, for the same amount of additional resources, increasing screening rates in 55- or 65-year-olds or improving the proportion of positive stool test results that are followed by colonoscopy from 60% to 90% would yield much more benefit in life-years gained than lowering the starting age to 45 years.”
Analyses such as these conditionally support earlier colorectal cancer screening only if the universal screening rate for 50- to 75-year-olds is more than 80%, he wrote. “They also reinforce the most important point in all of the major guidelines: Any recommended form of screening in the 50- to 75-year age range is likely to be very cost-effective (if not cost-saving) compared with no screening and should be strongly encouraged.”
Dr. Pignone is director of the program on cancer prevention and control at the LIVESTRONG Cancer Institutes at the University of Texas, Austin.
Cost-effectiveness is one more factor in the colorectal screening discussion, Michael Pignone, MD, said in an accompanying editorial.
Two studies by Ladabaum et al. reported cost-effectiveness modeling for various CRC screening techniques: “Comparative effectiveness and cost effectiveness of a multitarget stool DNA test to screen for colorectal neoplasia” (Gastroenterology. 2019;151,:427-39.e6) and “Cost-effectiveness and national effects of initiating colorectal cancer screening for average-risk persons at age 45 years instead of 50 years” (Gastroenterology. 2019;157:137-48).
These reports concluded that annual stool testing is more effective – but also more costly – than biennial testing. However, the additional cost per unit of benefit (figured in quality-adjusted life-years) is about $33,000 per life-year gained – a reasonable cost. “Hence, annual testing is a viable screening option,” wrote Dr. Pignone.
Starting screening at age 45 years instead of 50 years also produced an additional cost per life-year, but again, it is reasonable at $33,900 for colonoscopy screening and $7,700 for stool testing.
“However, for the same amount of additional resources, increasing screening rates in 55- or 65-year-olds or improving the proportion of positive stool test results that are followed by colonoscopy from 60% to 90% would yield much more benefit in life-years gained than lowering the starting age to 45 years.”
Analyses such as these conditionally support earlier colorectal cancer screening only if the universal screening rate for 50- to 75-year-olds is more than 80%, he wrote. “They also reinforce the most important point in all of the major guidelines: Any recommended form of screening in the 50- to 75-year age range is likely to be very cost-effective (if not cost-saving) compared with no screening and should be strongly encouraged.”
Dr. Pignone is director of the program on cancer prevention and control at the LIVESTRONG Cancer Institutes at the University of Texas, Austin.
issued by the American College of Physicians.
Regular screening can be discontinued after age 75 years, Amir Qaseem, MD, president of clinical policy and the Center for Evidence Reviews at the American College of Physicians, and colleagues wrote in the Annals of Internal Medicine.
No one test is preferred over another, according to the guidance statement. Patients and physicians can select the test type together, based on individual needs and preferences, and each test carries its own screening interval. But regular testing has been proven time and again to reduce the risk of colorectal cancer mortality, and more people should have it, according to the guidance.
“Not enough people in the United States get screened for colorectal cancer,” ACP President Robert M. McLean, MD, said in a press statement. “Physicians should perform an individualized risk assessment for colorectal cancer in all adults. Doctors and patients should select the screening test based on a discussion of the benefits, harms, costs, availability, frequency, and patient preferences.”
The guidance is an attempt to balance existing guidelines authored by the U.S. Preventive Services Task Force and the Canadian Task Force on Preventive Health Care (CTFPHC), but it also was developed following critical review of those from the American Cancer Society and other organizations.
The ACP guidance is for adults at average risk for colorectal cancer who do not have symptoms; it does not apply to adults with a family history of colorectal cancer, a long-standing history of inflammatory bowel disease, genetic syndromes such as familial cancerous polyps, a personal history of previous colorectal cancer or benign polyps, or other risk factors.
The guidance was based on evaluations of stool-based tests, including the fecal immunochemical test (FIT), also called the immunochemical-based fecal occult blood test (FOBT), and direct visualization with endoscopic and radiologic tests, including flexible sigmoidoscopy, colonoscopy, and CT colonography. The guidance includes the following recommendations:
Clinicians should regularly screen for colorectal cancer in average-risk adults between the ages of 50 and 75 years.
This recommendation is in line with those made by the U.S. Preventive Services Task Force and the CTFPHC. Data suggest that regular screening reduces colorectal cancer–specific mortality in this age group, with those aged 65-75 years likely to garner the most benefit.
The absolute risk reduction increases with age and varies with test type. For every-other-year FOBT, it rises from 0.037% in those younger than 60 years to 0.20% in those aged 60 years or older. For flexible sigmoidoscopy, the risk reduction rises from 0.05% in the younger group to 0.29% in the older group.
Data from the CTFPHC show that the net benefit in those aged 50-59 years is small, however. This may influence the decision about when to start screening.
Clinicians should select the colorectal cancer screening test with the patient based on a discussion of benefits, harms, costs, availability, frequency, and patient preferences.
The FIT or FOBT should be performed every 2 years, colonoscopy every 10 years, and flexible sigmoidoscopy every 10 years, plus FIT every 2 years.
No data suggest a benefit of one test over another; however, “all screening tests are associated with potential benefits as well as harms,” the document states. “Clinical decisions need to be individualized using patient clinical characteristics, patient preferences, and screening test frequency and availability. Because many eligible patients have never been screened and some may not adhere to recommendations about subsequent screening or follow-up of positive findings on screening tests (such as colonoscopy after a positive result on a stool-based screening test), patient informed decision making and adherence are important factors in selection of a [colorectal cancer] screening test.”
Discussions with patients should include topics like the recommended frequency of each test, bowel preparation, anesthesia, transportation to and from testing site, time commitments, and the necessary steps if a test result is positive.
Clinicians should discontinue screening for colorectal cancer in average-risk adults older than 75 years or in adults with a life expectancy of 10 years or less.
While the benefit from screening increases with age, so do the risks for harm, especially serious harm. Data show the balance of harms and benefits reaching a tipping point at around 75 years of age. But again, this isn’t a universal recommendation, the statement says.
“Persons with no history of [colorectal cancer] screening may benefit from screening after age 75 years, whereas those who have received regular screening with negative results may not.”
Cessation of testing considers life expectancy after age 75 years. The average life expectancy for healthy 75-year-old men and women in the United States is 9.9 and 12 years, respectively. But among men and women with serious medical comorbidities, average life expectancy after age 70 years drops to 8.9 and 10.8 years, respectively.
“Therefore, most persons aged 75 years or older, as well as most adults who are younger than 75 years but have serious comorbid conditions [such as chronic renal failure], are unlikely to benefit from screening but would undergo unnecessary, burdensome, potentially harmful, and costly screening tests.”
As in any testing discussion, personal preferences are important, but not just to make patients feel comfortable about their choice. Mindset about colorectal cancer testing has a very big effect on compliance, the statement noted.
“For example, a biennial stool test is not a good screening strategy for patients who may be unwilling or unlikely to follow up every other year. In addition, given the tradeoffs between benefits and harms, some patients may want less intensive screening, such as screening that begins at a later age, stops at an earlier age, or recurs less frequently regardless of modality selected.”
SOURCE: Qassam A et al. Ann Intern Med. 2019;171:643-54.
issued by the American College of Physicians.
Regular screening can be discontinued after age 75 years, Amir Qaseem, MD, president of clinical policy and the Center for Evidence Reviews at the American College of Physicians, and colleagues wrote in the Annals of Internal Medicine.
No one test is preferred over another, according to the guidance statement. Patients and physicians can select the test type together, based on individual needs and preferences, and each test carries its own screening interval. But regular testing has been proven time and again to reduce the risk of colorectal cancer mortality, and more people should have it, according to the guidance.
“Not enough people in the United States get screened for colorectal cancer,” ACP President Robert M. McLean, MD, said in a press statement. “Physicians should perform an individualized risk assessment for colorectal cancer in all adults. Doctors and patients should select the screening test based on a discussion of the benefits, harms, costs, availability, frequency, and patient preferences.”
The guidance is an attempt to balance existing guidelines authored by the U.S. Preventive Services Task Force and the Canadian Task Force on Preventive Health Care (CTFPHC), but it also was developed following critical review of those from the American Cancer Society and other organizations.
The ACP guidance is for adults at average risk for colorectal cancer who do not have symptoms; it does not apply to adults with a family history of colorectal cancer, a long-standing history of inflammatory bowel disease, genetic syndromes such as familial cancerous polyps, a personal history of previous colorectal cancer or benign polyps, or other risk factors.
The guidance was based on evaluations of stool-based tests, including the fecal immunochemical test (FIT), also called the immunochemical-based fecal occult blood test (FOBT), and direct visualization with endoscopic and radiologic tests, including flexible sigmoidoscopy, colonoscopy, and CT colonography. The guidance includes the following recommendations:
Clinicians should regularly screen for colorectal cancer in average-risk adults between the ages of 50 and 75 years.
This recommendation is in line with those made by the U.S. Preventive Services Task Force and the CTFPHC. Data suggest that regular screening reduces colorectal cancer–specific mortality in this age group, with those aged 65-75 years likely to garner the most benefit.
The absolute risk reduction increases with age and varies with test type. For every-other-year FOBT, it rises from 0.037% in those younger than 60 years to 0.20% in those aged 60 years or older. For flexible sigmoidoscopy, the risk reduction rises from 0.05% in the younger group to 0.29% in the older group.
Data from the CTFPHC show that the net benefit in those aged 50-59 years is small, however. This may influence the decision about when to start screening.
Clinicians should select the colorectal cancer screening test with the patient based on a discussion of benefits, harms, costs, availability, frequency, and patient preferences.
The FIT or FOBT should be performed every 2 years, colonoscopy every 10 years, and flexible sigmoidoscopy every 10 years, plus FIT every 2 years.
No data suggest a benefit of one test over another; however, “all screening tests are associated with potential benefits as well as harms,” the document states. “Clinical decisions need to be individualized using patient clinical characteristics, patient preferences, and screening test frequency and availability. Because many eligible patients have never been screened and some may not adhere to recommendations about subsequent screening or follow-up of positive findings on screening tests (such as colonoscopy after a positive result on a stool-based screening test), patient informed decision making and adherence are important factors in selection of a [colorectal cancer] screening test.”
Discussions with patients should include topics like the recommended frequency of each test, bowel preparation, anesthesia, transportation to and from testing site, time commitments, and the necessary steps if a test result is positive.
Clinicians should discontinue screening for colorectal cancer in average-risk adults older than 75 years or in adults with a life expectancy of 10 years or less.
While the benefit from screening increases with age, so do the risks for harm, especially serious harm. Data show the balance of harms and benefits reaching a tipping point at around 75 years of age. But again, this isn’t a universal recommendation, the statement says.
“Persons with no history of [colorectal cancer] screening may benefit from screening after age 75 years, whereas those who have received regular screening with negative results may not.”
Cessation of testing considers life expectancy after age 75 years. The average life expectancy for healthy 75-year-old men and women in the United States is 9.9 and 12 years, respectively. But among men and women with serious medical comorbidities, average life expectancy after age 70 years drops to 8.9 and 10.8 years, respectively.
“Therefore, most persons aged 75 years or older, as well as most adults who are younger than 75 years but have serious comorbid conditions [such as chronic renal failure], are unlikely to benefit from screening but would undergo unnecessary, burdensome, potentially harmful, and costly screening tests.”
As in any testing discussion, personal preferences are important, but not just to make patients feel comfortable about their choice. Mindset about colorectal cancer testing has a very big effect on compliance, the statement noted.
“For example, a biennial stool test is not a good screening strategy for patients who may be unwilling or unlikely to follow up every other year. In addition, given the tradeoffs between benefits and harms, some patients may want less intensive screening, such as screening that begins at a later age, stops at an earlier age, or recurs less frequently regardless of modality selected.”
SOURCE: Qassam A et al. Ann Intern Med. 2019;171:643-54.
FROM THE ANNALS OF INTERNAL MEDICINE
More evidence that statins reduce HCC risk
SAN ANTONIO – The evidence that statin therapy reduces the risk of developing hepatocellular carcinoma, while not rising to the highest-level 1A strata, is nonetheless sufficiently persuasive at this point that consideration should be given to prescribing a statin in all patients with risk factors for the malignancy, regardless of their cardiovascular risk profile, Muhammad Talal Sarmini, MD, asserted at the annual meeting of the American College of Gastroenterology.
This includes individuals with hepatitis B or C virus infection as well as those with cirrhosis. The jury is still out as to whether nonalcoholic steatohepatitis is a risk factor for hepatocellular carcinoma (HCC), observed Dr. Sarmini of the Cleveland Clinic.
He presented a new meta-analysis, which concluded that patients on statin therapy had a 43% lower risk of new-onset HCC than persons not taking a statin. This meta-analysis – the largest ever addressing the issue – included 20 studies totaling more than 2.6 million patients and 24,341 cases of new-onset HCC. There were 11 retrospective case-control studies, 6 cohort studies, and 3 randomized trials. Five studies were from the United States, nine from Asia, and six were European.
In subgroup analyses aimed at assessing the consistency of the study results across various domains, there was a 45% reduction in the risk of HCC in association with statin therapy in the three studies of patients with hepatitis B virus, and significant reductions as well in Asia, Europe, and the United States when those participants were evaluated separately. The reduction was significant in both the case-control and cohort studies, but not when the three randomized, controlled trials (RCTs) were analyzed collectively. However, Dr. Sarmini shrugged off the neutral RCT results.
“It’s worth noting that the RCTs reported data from patients who were on statins with 4-5 years of follow-up. They were not at high risk for HCC. Given the nature of the disease and the relatively short period of follow-up, these studies only reported 81 cases of HCC. So they were very limited,” he said.
Audience members were eager to learn if Dr. Sarmini had found a differential preventive effect for lipophilic statins, such as atorvastatin or simvastatin, versus hydrophilic statins. He replied that, unfortunately, the published study results don’t allow for such an analysis. However, a large, propensity-matched cohort study published too recently for inclusion in his meta-analysis shed light on this matter. This Swedish national registry study included 16,668 propensity score–matched adults with chronic hepatitis B or C infection, of whom 6,554 initiated lipophilic statin therapy, 1,780 began treatment with a hydrophilic statin, and the rest were statin nonusers. The lipophilic statin users had an adjusted 44% reduction in 10-year HCC risk, compared with nonusers, while hydrophilic statins weren’t associated with a significant preventive effect (Ann Intern Med. 2019 Sep 3;171[5]:318-27).
Dr. Sarmini said that the meta-analysis results, together with the Swedish registry findings, highlight the need for additional well-designed cohort studies and RCTs of statins in populations at high risk for HCC in order to verify the existence of an HCC preventive effect and pinpoint which statins are effective at what dosages.
HCC is the fourth-leading cause of cancer-related mortality globally, accounting for 800,000 deaths annually. And the incidence is rising on a year-by-year basis.
Dr. Sarmini reported having no financial conflicts regarding his study, which was conducted free of commercial support.
SAN ANTONIO – The evidence that statin therapy reduces the risk of developing hepatocellular carcinoma, while not rising to the highest-level 1A strata, is nonetheless sufficiently persuasive at this point that consideration should be given to prescribing a statin in all patients with risk factors for the malignancy, regardless of their cardiovascular risk profile, Muhammad Talal Sarmini, MD, asserted at the annual meeting of the American College of Gastroenterology.
This includes individuals with hepatitis B or C virus infection as well as those with cirrhosis. The jury is still out as to whether nonalcoholic steatohepatitis is a risk factor for hepatocellular carcinoma (HCC), observed Dr. Sarmini of the Cleveland Clinic.
He presented a new meta-analysis, which concluded that patients on statin therapy had a 43% lower risk of new-onset HCC than persons not taking a statin. This meta-analysis – the largest ever addressing the issue – included 20 studies totaling more than 2.6 million patients and 24,341 cases of new-onset HCC. There were 11 retrospective case-control studies, 6 cohort studies, and 3 randomized trials. Five studies were from the United States, nine from Asia, and six were European.
In subgroup analyses aimed at assessing the consistency of the study results across various domains, there was a 45% reduction in the risk of HCC in association with statin therapy in the three studies of patients with hepatitis B virus, and significant reductions as well in Asia, Europe, and the United States when those participants were evaluated separately. The reduction was significant in both the case-control and cohort studies, but not when the three randomized, controlled trials (RCTs) were analyzed collectively. However, Dr. Sarmini shrugged off the neutral RCT results.
“It’s worth noting that the RCTs reported data from patients who were on statins with 4-5 years of follow-up. They were not at high risk for HCC. Given the nature of the disease and the relatively short period of follow-up, these studies only reported 81 cases of HCC. So they were very limited,” he said.
Audience members were eager to learn if Dr. Sarmini had found a differential preventive effect for lipophilic statins, such as atorvastatin or simvastatin, versus hydrophilic statins. He replied that, unfortunately, the published study results don’t allow for such an analysis. However, a large, propensity-matched cohort study published too recently for inclusion in his meta-analysis shed light on this matter. This Swedish national registry study included 16,668 propensity score–matched adults with chronic hepatitis B or C infection, of whom 6,554 initiated lipophilic statin therapy, 1,780 began treatment with a hydrophilic statin, and the rest were statin nonusers. The lipophilic statin users had an adjusted 44% reduction in 10-year HCC risk, compared with nonusers, while hydrophilic statins weren’t associated with a significant preventive effect (Ann Intern Med. 2019 Sep 3;171[5]:318-27).
Dr. Sarmini said that the meta-analysis results, together with the Swedish registry findings, highlight the need for additional well-designed cohort studies and RCTs of statins in populations at high risk for HCC in order to verify the existence of an HCC preventive effect and pinpoint which statins are effective at what dosages.
HCC is the fourth-leading cause of cancer-related mortality globally, accounting for 800,000 deaths annually. And the incidence is rising on a year-by-year basis.
Dr. Sarmini reported having no financial conflicts regarding his study, which was conducted free of commercial support.
SAN ANTONIO – The evidence that statin therapy reduces the risk of developing hepatocellular carcinoma, while not rising to the highest-level 1A strata, is nonetheless sufficiently persuasive at this point that consideration should be given to prescribing a statin in all patients with risk factors for the malignancy, regardless of their cardiovascular risk profile, Muhammad Talal Sarmini, MD, asserted at the annual meeting of the American College of Gastroenterology.
This includes individuals with hepatitis B or C virus infection as well as those with cirrhosis. The jury is still out as to whether nonalcoholic steatohepatitis is a risk factor for hepatocellular carcinoma (HCC), observed Dr. Sarmini of the Cleveland Clinic.
He presented a new meta-analysis, which concluded that patients on statin therapy had a 43% lower risk of new-onset HCC than persons not taking a statin. This meta-analysis – the largest ever addressing the issue – included 20 studies totaling more than 2.6 million patients and 24,341 cases of new-onset HCC. There were 11 retrospective case-control studies, 6 cohort studies, and 3 randomized trials. Five studies were from the United States, nine from Asia, and six were European.
In subgroup analyses aimed at assessing the consistency of the study results across various domains, there was a 45% reduction in the risk of HCC in association with statin therapy in the three studies of patients with hepatitis B virus, and significant reductions as well in Asia, Europe, and the United States when those participants were evaluated separately. The reduction was significant in both the case-control and cohort studies, but not when the three randomized, controlled trials (RCTs) were analyzed collectively. However, Dr. Sarmini shrugged off the neutral RCT results.
“It’s worth noting that the RCTs reported data from patients who were on statins with 4-5 years of follow-up. They were not at high risk for HCC. Given the nature of the disease and the relatively short period of follow-up, these studies only reported 81 cases of HCC. So they were very limited,” he said.
Audience members were eager to learn if Dr. Sarmini had found a differential preventive effect for lipophilic statins, such as atorvastatin or simvastatin, versus hydrophilic statins. He replied that, unfortunately, the published study results don’t allow for such an analysis. However, a large, propensity-matched cohort study published too recently for inclusion in his meta-analysis shed light on this matter. This Swedish national registry study included 16,668 propensity score–matched adults with chronic hepatitis B or C infection, of whom 6,554 initiated lipophilic statin therapy, 1,780 began treatment with a hydrophilic statin, and the rest were statin nonusers. The lipophilic statin users had an adjusted 44% reduction in 10-year HCC risk, compared with nonusers, while hydrophilic statins weren’t associated with a significant preventive effect (Ann Intern Med. 2019 Sep 3;171[5]:318-27).
Dr. Sarmini said that the meta-analysis results, together with the Swedish registry findings, highlight the need for additional well-designed cohort studies and RCTs of statins in populations at high risk for HCC in order to verify the existence of an HCC preventive effect and pinpoint which statins are effective at what dosages.
HCC is the fourth-leading cause of cancer-related mortality globally, accounting for 800,000 deaths annually. And the incidence is rising on a year-by-year basis.
Dr. Sarmini reported having no financial conflicts regarding his study, which was conducted free of commercial support.
REPORTING FROM ACG 2019
President to nominate oncologist to lead FDA
Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.
President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.
Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.
Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.
Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.
“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”
The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.
“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”
Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.
“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”
At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.
Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.
President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.
Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.
Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.
Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.
“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”
The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.
“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”
Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.
“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”
At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.
Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.
President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.
Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.
Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.
Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.
“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”
The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.
“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”
Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.
“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”
At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.