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Nivolumab may extend survival in HCC patients
WASHINGTON – A multinational clinical trial has found that the metastatic cancer agent nivolumab can improve long-term survival and durable tumor responses in patients with advanced hepatocellular carcinoma (HCC) whether or not they’ve had previous treatment with a chemotherapy agent already approved for advanced primary liver cancer, a principal investigator reported at the annual meeting of the American Association for the Study of Liver Diseases.
“Nivolumab has demonstrated clinically meaningful efficacy across etiologies in sorafenib-naive and -experienced patients with extended follow-up,” Bruno Sangro, MD, of the University of Navarra in Pamplona, Spain, said in reporting results of the CheckMate-040 trial. “The median overall survival is 15 and 15.6 months in patients who were sorafenib-experienced in both the dose-escalation and expansion cohorts.”
The dose-escalation cohort received 0.1 to 10 mg/kg of nivolumab (Opdivo) while the dose-expansion group received a steady dose of 3 mg/kg. In all, 262 patients participated in the trial, 80 of whom had never been on sorafenib (Nexavar) therapy. The survival outcome in these subgroups, Dr. Sangro said, “really speaks for the consistency and the robustness of the results.”
Trial participants had inoperable, usually metastatic HCC, with Child-Pugh scores up to and including 7 in the escalation group or up to and including 6 in the expansion group. Most of them were progressing to treatment with one or more prior systemic therapies, including sorafenib. Their aspartate aminotransferase and alanine aminotransferase scores were in the upper limits of normal, and bilirubin was less than or equal to 3 mg/dL. If they had hepatitis B (HBV), their viral load had to be less than 100 IU/mL and they had to be on effective antiviral therapy. Any history of hepatic encephalopathy or clinically significant ascites and an active HBV and hepatitis C (HCV) coinfection were grounds for exclusion.
“Most patients had to discontinue nivolumab because of disease progression,” Dr. Sangro noted, so that only 36 patients, or 14%, were continuing treatment at the time of this analysis. Thirteen patients in the total population that discontinued nivolumab did so because of toxicity, he said.
“Around 20% of patients achieved an objective remission that included complete responses in all subgroups of patients; 15% of progressors and 23% of sorafenib-intolerant patients had an objective response,” Dr. Sangro said. In terms of overall response, about half of all patients in the sorafenib-experienced subgroups had a complete or partial response or stable disease: 51% in the dose-escalation subgroup and 54% in the dose-expansion subgroup.
Although tumor responses were associated with declines in alpha-fetoprotein levels, “it’s unlikely that these biomarkers will be useful either for monitoring or selecting patients for treatment,” he added. “Indeed, baseline alpha-fetoprotein levels were comparable between responders and nonresponders to nivolumab” Dr. Sangro said.
“We also showed there was some impact on HCV viral kinetics in infected individuals,” Dr. Sangro noted. “The overall safety profile for the HCC population is consistent with other tumor types in which nivolumab is approved; these include patients who are infected with hepatitis B or C viruses.”
The study showed that 36% (19/53) of HCV infected patients had a greater than 1 log decrease in viral load. No signs of additional antiviral activity were detected among HBV-infected patients already on effective antiviral treatment: only 5% (3/59) posted a up to 1 log decrease in HB surface antigen levels, and 11% (7/64) of patients had increases in viral load. “These increases occurred in the setting of low-level viremia.” Dr. Sangro said. “They were asymptomatic and [nivolumab] did not result in changes in hepatic parameters or other serious adverse events.”
With regard to adverse events (AEs), 77% of all patients had some treatment-related AEs, ranging from fatigue to rash to dry mouth to increased lab levels, but only 20% were grade 3 or 4, and 88% of those resolved in an average of 8 weeks, Dr. Sangro said.
More research into nivolumab for HCC is needed, Dr. Sangro said. “Ongoing and future studies in patients with advanced tumors will evaluate nivolumab in the first-line setting or in combination with other agents,” he said.
Dr. Sangro disclosed relationships with Bayer Schering Pharma, Onxeo, Astra Zeneca, and Bristol-Myers Squibb. Bristol-Myers Squibb funded the trial, and Chrysalis Medical Communications assisted in reporting the study results.
WASHINGTON – A multinational clinical trial has found that the metastatic cancer agent nivolumab can improve long-term survival and durable tumor responses in patients with advanced hepatocellular carcinoma (HCC) whether or not they’ve had previous treatment with a chemotherapy agent already approved for advanced primary liver cancer, a principal investigator reported at the annual meeting of the American Association for the Study of Liver Diseases.
“Nivolumab has demonstrated clinically meaningful efficacy across etiologies in sorafenib-naive and -experienced patients with extended follow-up,” Bruno Sangro, MD, of the University of Navarra in Pamplona, Spain, said in reporting results of the CheckMate-040 trial. “The median overall survival is 15 and 15.6 months in patients who were sorafenib-experienced in both the dose-escalation and expansion cohorts.”
The dose-escalation cohort received 0.1 to 10 mg/kg of nivolumab (Opdivo) while the dose-expansion group received a steady dose of 3 mg/kg. In all, 262 patients participated in the trial, 80 of whom had never been on sorafenib (Nexavar) therapy. The survival outcome in these subgroups, Dr. Sangro said, “really speaks for the consistency and the robustness of the results.”
Trial participants had inoperable, usually metastatic HCC, with Child-Pugh scores up to and including 7 in the escalation group or up to and including 6 in the expansion group. Most of them were progressing to treatment with one or more prior systemic therapies, including sorafenib. Their aspartate aminotransferase and alanine aminotransferase scores were in the upper limits of normal, and bilirubin was less than or equal to 3 mg/dL. If they had hepatitis B (HBV), their viral load had to be less than 100 IU/mL and they had to be on effective antiviral therapy. Any history of hepatic encephalopathy or clinically significant ascites and an active HBV and hepatitis C (HCV) coinfection were grounds for exclusion.
“Most patients had to discontinue nivolumab because of disease progression,” Dr. Sangro noted, so that only 36 patients, or 14%, were continuing treatment at the time of this analysis. Thirteen patients in the total population that discontinued nivolumab did so because of toxicity, he said.
“Around 20% of patients achieved an objective remission that included complete responses in all subgroups of patients; 15% of progressors and 23% of sorafenib-intolerant patients had an objective response,” Dr. Sangro said. In terms of overall response, about half of all patients in the sorafenib-experienced subgroups had a complete or partial response or stable disease: 51% in the dose-escalation subgroup and 54% in the dose-expansion subgroup.
Although tumor responses were associated with declines in alpha-fetoprotein levels, “it’s unlikely that these biomarkers will be useful either for monitoring or selecting patients for treatment,” he added. “Indeed, baseline alpha-fetoprotein levels were comparable between responders and nonresponders to nivolumab” Dr. Sangro said.
“We also showed there was some impact on HCV viral kinetics in infected individuals,” Dr. Sangro noted. “The overall safety profile for the HCC population is consistent with other tumor types in which nivolumab is approved; these include patients who are infected with hepatitis B or C viruses.”
The study showed that 36% (19/53) of HCV infected patients had a greater than 1 log decrease in viral load. No signs of additional antiviral activity were detected among HBV-infected patients already on effective antiviral treatment: only 5% (3/59) posted a up to 1 log decrease in HB surface antigen levels, and 11% (7/64) of patients had increases in viral load. “These increases occurred in the setting of low-level viremia.” Dr. Sangro said. “They were asymptomatic and [nivolumab] did not result in changes in hepatic parameters or other serious adverse events.”
With regard to adverse events (AEs), 77% of all patients had some treatment-related AEs, ranging from fatigue to rash to dry mouth to increased lab levels, but only 20% were grade 3 or 4, and 88% of those resolved in an average of 8 weeks, Dr. Sangro said.
More research into nivolumab for HCC is needed, Dr. Sangro said. “Ongoing and future studies in patients with advanced tumors will evaluate nivolumab in the first-line setting or in combination with other agents,” he said.
Dr. Sangro disclosed relationships with Bayer Schering Pharma, Onxeo, Astra Zeneca, and Bristol-Myers Squibb. Bristol-Myers Squibb funded the trial, and Chrysalis Medical Communications assisted in reporting the study results.
WASHINGTON – A multinational clinical trial has found that the metastatic cancer agent nivolumab can improve long-term survival and durable tumor responses in patients with advanced hepatocellular carcinoma (HCC) whether or not they’ve had previous treatment with a chemotherapy agent already approved for advanced primary liver cancer, a principal investigator reported at the annual meeting of the American Association for the Study of Liver Diseases.
“Nivolumab has demonstrated clinically meaningful efficacy across etiologies in sorafenib-naive and -experienced patients with extended follow-up,” Bruno Sangro, MD, of the University of Navarra in Pamplona, Spain, said in reporting results of the CheckMate-040 trial. “The median overall survival is 15 and 15.6 months in patients who were sorafenib-experienced in both the dose-escalation and expansion cohorts.”
The dose-escalation cohort received 0.1 to 10 mg/kg of nivolumab (Opdivo) while the dose-expansion group received a steady dose of 3 mg/kg. In all, 262 patients participated in the trial, 80 of whom had never been on sorafenib (Nexavar) therapy. The survival outcome in these subgroups, Dr. Sangro said, “really speaks for the consistency and the robustness of the results.”
Trial participants had inoperable, usually metastatic HCC, with Child-Pugh scores up to and including 7 in the escalation group or up to and including 6 in the expansion group. Most of them were progressing to treatment with one or more prior systemic therapies, including sorafenib. Their aspartate aminotransferase and alanine aminotransferase scores were in the upper limits of normal, and bilirubin was less than or equal to 3 mg/dL. If they had hepatitis B (HBV), their viral load had to be less than 100 IU/mL and they had to be on effective antiviral therapy. Any history of hepatic encephalopathy or clinically significant ascites and an active HBV and hepatitis C (HCV) coinfection were grounds for exclusion.
“Most patients had to discontinue nivolumab because of disease progression,” Dr. Sangro noted, so that only 36 patients, or 14%, were continuing treatment at the time of this analysis. Thirteen patients in the total population that discontinued nivolumab did so because of toxicity, he said.
“Around 20% of patients achieved an objective remission that included complete responses in all subgroups of patients; 15% of progressors and 23% of sorafenib-intolerant patients had an objective response,” Dr. Sangro said. In terms of overall response, about half of all patients in the sorafenib-experienced subgroups had a complete or partial response or stable disease: 51% in the dose-escalation subgroup and 54% in the dose-expansion subgroup.
Although tumor responses were associated with declines in alpha-fetoprotein levels, “it’s unlikely that these biomarkers will be useful either for monitoring or selecting patients for treatment,” he added. “Indeed, baseline alpha-fetoprotein levels were comparable between responders and nonresponders to nivolumab” Dr. Sangro said.
“We also showed there was some impact on HCV viral kinetics in infected individuals,” Dr. Sangro noted. “The overall safety profile for the HCC population is consistent with other tumor types in which nivolumab is approved; these include patients who are infected with hepatitis B or C viruses.”
The study showed that 36% (19/53) of HCV infected patients had a greater than 1 log decrease in viral load. No signs of additional antiviral activity were detected among HBV-infected patients already on effective antiviral treatment: only 5% (3/59) posted a up to 1 log decrease in HB surface antigen levels, and 11% (7/64) of patients had increases in viral load. “These increases occurred in the setting of low-level viremia.” Dr. Sangro said. “They were asymptomatic and [nivolumab] did not result in changes in hepatic parameters or other serious adverse events.”
With regard to adverse events (AEs), 77% of all patients had some treatment-related AEs, ranging from fatigue to rash to dry mouth to increased lab levels, but only 20% were grade 3 or 4, and 88% of those resolved in an average of 8 weeks, Dr. Sangro said.
More research into nivolumab for HCC is needed, Dr. Sangro said. “Ongoing and future studies in patients with advanced tumors will evaluate nivolumab in the first-line setting or in combination with other agents,” he said.
Dr. Sangro disclosed relationships with Bayer Schering Pharma, Onxeo, Astra Zeneca, and Bristol-Myers Squibb. Bristol-Myers Squibb funded the trial, and Chrysalis Medical Communications assisted in reporting the study results.
AT THE LIVER MEETING 2017
Key clinical point: Nivolumab demonstrated long-term survival, durable tumor responses, and manageable overall and hepatic safety profiles, regardless of prior sorafenib treatment, in patients with advanced hepatocellular carcinoma.
Major finding: The 18-month overall survival rate was 57% in sorafenib-naive patients and 46% (dose-escalation) and 44% (dose-expansion) in sorafenib-experienced patients.
Data source: CheckMate-040 phase 1/2 dose-escalation and -expansion trial of 262 patients.
Disclosures: Dr. Sangro disclosed relationships with Bayer Schering Pharma, Onxeo, Astra Zeneca, and Bristol-Myers Squibb. Bristol-Myers Squibb funded the trial, and Chrysalis Medical Communications assisted in reporting the study results.
‘Facebuddha’ analyzes psychology of social media through a Buddhist lens
The new book by Ravi Chandra, MD, is a concise introduction to Buddhism, and a forceful exposition on the power and danger of social networking – deftly interwoven with a moving account of the author’s personal life and professional growth as well as his arduous quest for identity.
Social networking has exploded into a major global industry within the last decade, rapidly penetrating and dominating all aspects of our personal and social lives. Instead of promoting social interactions and connections, the lure of instant intimacy often proves illusory. For far too many, the virtual world deepens their sense of isolation and loneliness, fosters jealousy and narcissism, engenders a profound sense of insecurity, and leads to anxiety, depression, and much worse.
By juxtaposing the Buddha with social networking in the book title, Dr. Chandra expresses his hope and faith that Buddhism could serve as an effective tool for harnessing the force unleashed by these powerful new technologies, helping us to put the genie of our invention back into the bottle. Over the millenia, Buddhism has guided societies and individuals to overcome (“transcend”) crises and adversities, and could play a crucial role in negotiating these still largely uncharted territories.
Despite the popularity of terms such as Zen, meditation, transcendence, and mindfulness, Buddhism remains mysterious and exotic to most modern readers, and is laden with misconceptions and prejudices. This is regrettable, since Buddhism is the most clinically relevant of all major philosophical traditions, and its tenets are most compatible with modern neuroscience. The term philosophical is used here because, at its core, Buddhism represents an uncompromisingly rational approach to dealing with the “human condition.” Siddhartha Gautama (Buddha), its founder, admonished against speculating on questions that are “unanswerables,” such as eternity, existence after death, and the origin and ending of the universe. Instead, Siddhartha focused on identifying life’s vicissitudes (Dukkha, “bumpy rides in life,” commonly translated as “suffering”), clarifying forces responsible for these problems, delineating the ultimate goal, and specifying methods for achieving the goal (the “Four Noble Truths”). He then provided systematic paths for solving problems (the “Eightfold Noble Path”). His approaches are akin to what we clinicians strive to do on a daily basis, albeit on a grander scale: diagnosis, pathogenesis, treatment goals, and therapeutic approaches. The framework Siddhartha proposed is austere, rational, practical. It is exactly for this reason that Siddhartha has been called a great physician, a doctor, and a healer.
As a psychiatrist and a practicing Buddhist, Dr. Chandra is well positioned to critically examine these profoundly important issues (Buddhism and social networking), and he did an excellent job in “Facebuddha.” Impressively, Dr. Chandra’s discussions did not take place in a vacuum. They were not just dry intellectual exercises but were embedded in accounts of personal and clinical experiences, demonstrating the relevance of Buddhist thoughts and practices in real life.
Born in South India and raised by a physician mother in half a dozen American cities, Dr. Chandra experienced repeated uprooting and various types of racial/cultural discrimination. His childhood and adolescence were characterized by a long and arduous search for identity. That he has not only survived, but thrived, is a testament to his resilience and resourcefulness. His love of art and poetry played an important role, as did friendships and the support of Asian American communities. But, above all, it was the Buddha’s teachings and examples that have been the most significant sustaining forces in his life. His accounts are a personal testimony to the power of a 2,500-year-old tradition that is still alive and relevant in our postmodern world.
Dr. Chandra’s book is an endearing chronicle of a remarkable personal journey. Readers will appreciate the opportunity to witness glimpses of this journey and may reasonably expect that such explorations will continue, leading to new vistas that are not only fascinating to behold but also relevant to the practice of our profession.
Dr. Lin is professor emeritus of psychiatry, University of California, Los Angeles, and Distinguished Life Fellow, American Psychiatric Association. He was the founding director of the National Institute of Mental Health/Harbor-UCLA Research Center on the Psychobiology of Ethnicity, the Coastal Asian Pacific Mental Health Center, and the Long Beach Asian Pacific Mental Health Center. The honors Dr. Lin has received include the Kun-Po Soo Asian American Award, American Psychiatric Association; William Sargant Lecturer, Royal College of Psychiatrists, Great Britain; and honorary professor, Hunan (China) Medical University. Information about the book can be found at www.facebuddha.co.
The new book by Ravi Chandra, MD, is a concise introduction to Buddhism, and a forceful exposition on the power and danger of social networking – deftly interwoven with a moving account of the author’s personal life and professional growth as well as his arduous quest for identity.
Social networking has exploded into a major global industry within the last decade, rapidly penetrating and dominating all aspects of our personal and social lives. Instead of promoting social interactions and connections, the lure of instant intimacy often proves illusory. For far too many, the virtual world deepens their sense of isolation and loneliness, fosters jealousy and narcissism, engenders a profound sense of insecurity, and leads to anxiety, depression, and much worse.
By juxtaposing the Buddha with social networking in the book title, Dr. Chandra expresses his hope and faith that Buddhism could serve as an effective tool for harnessing the force unleashed by these powerful new technologies, helping us to put the genie of our invention back into the bottle. Over the millenia, Buddhism has guided societies and individuals to overcome (“transcend”) crises and adversities, and could play a crucial role in negotiating these still largely uncharted territories.
Despite the popularity of terms such as Zen, meditation, transcendence, and mindfulness, Buddhism remains mysterious and exotic to most modern readers, and is laden with misconceptions and prejudices. This is regrettable, since Buddhism is the most clinically relevant of all major philosophical traditions, and its tenets are most compatible with modern neuroscience. The term philosophical is used here because, at its core, Buddhism represents an uncompromisingly rational approach to dealing with the “human condition.” Siddhartha Gautama (Buddha), its founder, admonished against speculating on questions that are “unanswerables,” such as eternity, existence after death, and the origin and ending of the universe. Instead, Siddhartha focused on identifying life’s vicissitudes (Dukkha, “bumpy rides in life,” commonly translated as “suffering”), clarifying forces responsible for these problems, delineating the ultimate goal, and specifying methods for achieving the goal (the “Four Noble Truths”). He then provided systematic paths for solving problems (the “Eightfold Noble Path”). His approaches are akin to what we clinicians strive to do on a daily basis, albeit on a grander scale: diagnosis, pathogenesis, treatment goals, and therapeutic approaches. The framework Siddhartha proposed is austere, rational, practical. It is exactly for this reason that Siddhartha has been called a great physician, a doctor, and a healer.
As a psychiatrist and a practicing Buddhist, Dr. Chandra is well positioned to critically examine these profoundly important issues (Buddhism and social networking), and he did an excellent job in “Facebuddha.” Impressively, Dr. Chandra’s discussions did not take place in a vacuum. They were not just dry intellectual exercises but were embedded in accounts of personal and clinical experiences, demonstrating the relevance of Buddhist thoughts and practices in real life.
Born in South India and raised by a physician mother in half a dozen American cities, Dr. Chandra experienced repeated uprooting and various types of racial/cultural discrimination. His childhood and adolescence were characterized by a long and arduous search for identity. That he has not only survived, but thrived, is a testament to his resilience and resourcefulness. His love of art and poetry played an important role, as did friendships and the support of Asian American communities. But, above all, it was the Buddha’s teachings and examples that have been the most significant sustaining forces in his life. His accounts are a personal testimony to the power of a 2,500-year-old tradition that is still alive and relevant in our postmodern world.
Dr. Chandra’s book is an endearing chronicle of a remarkable personal journey. Readers will appreciate the opportunity to witness glimpses of this journey and may reasonably expect that such explorations will continue, leading to new vistas that are not only fascinating to behold but also relevant to the practice of our profession.
Dr. Lin is professor emeritus of psychiatry, University of California, Los Angeles, and Distinguished Life Fellow, American Psychiatric Association. He was the founding director of the National Institute of Mental Health/Harbor-UCLA Research Center on the Psychobiology of Ethnicity, the Coastal Asian Pacific Mental Health Center, and the Long Beach Asian Pacific Mental Health Center. The honors Dr. Lin has received include the Kun-Po Soo Asian American Award, American Psychiatric Association; William Sargant Lecturer, Royal College of Psychiatrists, Great Britain; and honorary professor, Hunan (China) Medical University. Information about the book can be found at www.facebuddha.co.
The new book by Ravi Chandra, MD, is a concise introduction to Buddhism, and a forceful exposition on the power and danger of social networking – deftly interwoven with a moving account of the author’s personal life and professional growth as well as his arduous quest for identity.
Social networking has exploded into a major global industry within the last decade, rapidly penetrating and dominating all aspects of our personal and social lives. Instead of promoting social interactions and connections, the lure of instant intimacy often proves illusory. For far too many, the virtual world deepens their sense of isolation and loneliness, fosters jealousy and narcissism, engenders a profound sense of insecurity, and leads to anxiety, depression, and much worse.
By juxtaposing the Buddha with social networking in the book title, Dr. Chandra expresses his hope and faith that Buddhism could serve as an effective tool for harnessing the force unleashed by these powerful new technologies, helping us to put the genie of our invention back into the bottle. Over the millenia, Buddhism has guided societies and individuals to overcome (“transcend”) crises and adversities, and could play a crucial role in negotiating these still largely uncharted territories.
Despite the popularity of terms such as Zen, meditation, transcendence, and mindfulness, Buddhism remains mysterious and exotic to most modern readers, and is laden with misconceptions and prejudices. This is regrettable, since Buddhism is the most clinically relevant of all major philosophical traditions, and its tenets are most compatible with modern neuroscience. The term philosophical is used here because, at its core, Buddhism represents an uncompromisingly rational approach to dealing with the “human condition.” Siddhartha Gautama (Buddha), its founder, admonished against speculating on questions that are “unanswerables,” such as eternity, existence after death, and the origin and ending of the universe. Instead, Siddhartha focused on identifying life’s vicissitudes (Dukkha, “bumpy rides in life,” commonly translated as “suffering”), clarifying forces responsible for these problems, delineating the ultimate goal, and specifying methods for achieving the goal (the “Four Noble Truths”). He then provided systematic paths for solving problems (the “Eightfold Noble Path”). His approaches are akin to what we clinicians strive to do on a daily basis, albeit on a grander scale: diagnosis, pathogenesis, treatment goals, and therapeutic approaches. The framework Siddhartha proposed is austere, rational, practical. It is exactly for this reason that Siddhartha has been called a great physician, a doctor, and a healer.
As a psychiatrist and a practicing Buddhist, Dr. Chandra is well positioned to critically examine these profoundly important issues (Buddhism and social networking), and he did an excellent job in “Facebuddha.” Impressively, Dr. Chandra’s discussions did not take place in a vacuum. They were not just dry intellectual exercises but were embedded in accounts of personal and clinical experiences, demonstrating the relevance of Buddhist thoughts and practices in real life.
Born in South India and raised by a physician mother in half a dozen American cities, Dr. Chandra experienced repeated uprooting and various types of racial/cultural discrimination. His childhood and adolescence were characterized by a long and arduous search for identity. That he has not only survived, but thrived, is a testament to his resilience and resourcefulness. His love of art and poetry played an important role, as did friendships and the support of Asian American communities. But, above all, it was the Buddha’s teachings and examples that have been the most significant sustaining forces in his life. His accounts are a personal testimony to the power of a 2,500-year-old tradition that is still alive and relevant in our postmodern world.
Dr. Chandra’s book is an endearing chronicle of a remarkable personal journey. Readers will appreciate the opportunity to witness glimpses of this journey and may reasonably expect that such explorations will continue, leading to new vistas that are not only fascinating to behold but also relevant to the practice of our profession.
Dr. Lin is professor emeritus of psychiatry, University of California, Los Angeles, and Distinguished Life Fellow, American Psychiatric Association. He was the founding director of the National Institute of Mental Health/Harbor-UCLA Research Center on the Psychobiology of Ethnicity, the Coastal Asian Pacific Mental Health Center, and the Long Beach Asian Pacific Mental Health Center. The honors Dr. Lin has received include the Kun-Po Soo Asian American Award, American Psychiatric Association; William Sargant Lecturer, Royal College of Psychiatrists, Great Britain; and honorary professor, Hunan (China) Medical University. Information about the book can be found at www.facebuddha.co.
Nemolizumab continues to crush itch in 64-week atopic dermatitis study
GENEVA – Nemolizumab, a humanized monoclonal antibody that inhibits interleukin-31 signaling, maintained its early dramatic antipruritic effect in patients with moderate to severe atopic dermatitis (AD) throughout a year-long unblinded extension of a large, high-profile, 12-week, phase 2 randomized trial, Thomas Ruzicka, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
In contrast, the 52-week extension study also showed the improvement in the dermatitis aspect of AD as measured by Eczema Area and Severity Index (EASI) scores was more gradual and less robust.
The study, 64 weeks in total, also demonstrated that what really matters to patients with moderate or severe AD is relief from the itch. Scores on the Dermatology Life Quality Index showed marked improvement even if their improvement in EASI scores was suboptimal.
“The dermatitis scores improved. But the most concerning symptom to patients is the pruritus; that’s what worsens their quality of life. And this improves dramatically very early in the course of the study,” Dr. Ruzicka explained. “If they drop their itch they are very happy. They don’t care about the redness of the skin so much as the pruritus. This is what really bothers them, as has been shown in epidemiologic studies.”
The original 12-week, phase 2, randomized, double-blind, dose-ranging trial drew extensive attention because it demonstrated convincingly for the first time that the inflammatory cytokine interleukin-31 plays a key role in the pathobiology of AD by promoting skin barrier dysfunction, pruritus, and the inflammatory response in AD – and that a biologic agent, nemolizumab, could inhibit those disease mechanisms (N Engl J Med. 2017 Mar 2;376[9]:826-35).
At a dose of 0.5 mg/kg administered by subcutaneous injection every 4 weeks, nemolizumab, a humanized monoclonal antibody directed against interleukin-31 receptor A, reduced scores on the pruritus visual-analogue scale by 60% as early as 4 weeks and maintained that effect through 12 weeks. At that point, the double-blind study ended and the 52-week extension began. Patients on nemolizumab in the double-blind phase stayed on the same dosage for the extension, while those who’d been on placebo were switched to nemolizumab at 0.1, 0.5, or 2.0 mg/kg every 4 weeks.
A total of 211 patients with moderate to severe AD inadequately controlled by topical therapies enrolled in the extension study. The combined 64-week experience convinced investigators and the sponsor, Chugai Pharmaceutical, that 0.5 mg/kg every 4 weeks is the optimal dose to take forward into planned advanced-stage clinical trials.
“At this dosage the IL-31 receptor is saturated, so higher dosages aren’t needed,” according to Dr. Ruzicka.
By week 64, patients in the 0.5-mg/kg arm of the study showed further gradual improvement in their pruritus visual-analogue score, from a 60% reduction from baseline at 12 weeks to close to an 80% reduction at week 64.
Roughly half of nemolizumab-treated patients achieved an EASI-50 response within the first 4 weeks of the double-blind phase of the study and stayed in that response zone throughout the extension study.
The EASI-75 and -90 responses followed a pattern different from EASI-50. Patients didn’t leap to those more robust levels of response early and then plateau. Instead, the EASI-75 and -90 responses were achieved via a gradual climb in efficacy throughout the study, such that by week 64 roughly 35%-40% of patients on the various nemolizumab dosages had reached EASI-75.
In the extension study, patients were permitted to use a mild topical steroid or topical calcineurin inhibitor as needed, and a potent or very potent topical steroid as rescue medication. Roughly half of participants resorted to any topical steroid at least once during the 64 months. An important new observation gleaned in the long-term study was that the patients who did use topical steroids were twice as likely to reach an EASI 75 response.
Roughly 20% of patients on the three highest dosages of nemolizumab achieved a static Investigator’s Global Assessment score of 0 or 1, meaning clear or almost clear, by week 64.
Scores on the Dermatology Life Quality Index fell steadily over the course of 64 weeks, from a baseline of about 16 to 5 at study’s close.
The side effect profile of nemolizumab was essentially the same as seen in the placebo arm during the double-blind phase. About one-quarter of patients experienced nasopharyngitis over the course of 64 weeks of treatment. A similar fraction reported exacerbations of their atopic dermatitis; however, these events were front-loaded in the first weeks of the initial double-blind study phase and appeared to have been triggered by the drug washout period prior to the patients’ receiving the first dose of nemolizumab, according to Dr. Ruzicka. No new safety signals emerged during the additional 52 weeks of treatment.
The study was funded by Chugai. Dr. Ruzicka reported serving as a paid company adviser.
GENEVA – Nemolizumab, a humanized monoclonal antibody that inhibits interleukin-31 signaling, maintained its early dramatic antipruritic effect in patients with moderate to severe atopic dermatitis (AD) throughout a year-long unblinded extension of a large, high-profile, 12-week, phase 2 randomized trial, Thomas Ruzicka, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
In contrast, the 52-week extension study also showed the improvement in the dermatitis aspect of AD as measured by Eczema Area and Severity Index (EASI) scores was more gradual and less robust.
The study, 64 weeks in total, also demonstrated that what really matters to patients with moderate or severe AD is relief from the itch. Scores on the Dermatology Life Quality Index showed marked improvement even if their improvement in EASI scores was suboptimal.
“The dermatitis scores improved. But the most concerning symptom to patients is the pruritus; that’s what worsens their quality of life. And this improves dramatically very early in the course of the study,” Dr. Ruzicka explained. “If they drop their itch they are very happy. They don’t care about the redness of the skin so much as the pruritus. This is what really bothers them, as has been shown in epidemiologic studies.”
The original 12-week, phase 2, randomized, double-blind, dose-ranging trial drew extensive attention because it demonstrated convincingly for the first time that the inflammatory cytokine interleukin-31 plays a key role in the pathobiology of AD by promoting skin barrier dysfunction, pruritus, and the inflammatory response in AD – and that a biologic agent, nemolizumab, could inhibit those disease mechanisms (N Engl J Med. 2017 Mar 2;376[9]:826-35).
At a dose of 0.5 mg/kg administered by subcutaneous injection every 4 weeks, nemolizumab, a humanized monoclonal antibody directed against interleukin-31 receptor A, reduced scores on the pruritus visual-analogue scale by 60% as early as 4 weeks and maintained that effect through 12 weeks. At that point, the double-blind study ended and the 52-week extension began. Patients on nemolizumab in the double-blind phase stayed on the same dosage for the extension, while those who’d been on placebo were switched to nemolizumab at 0.1, 0.5, or 2.0 mg/kg every 4 weeks.
A total of 211 patients with moderate to severe AD inadequately controlled by topical therapies enrolled in the extension study. The combined 64-week experience convinced investigators and the sponsor, Chugai Pharmaceutical, that 0.5 mg/kg every 4 weeks is the optimal dose to take forward into planned advanced-stage clinical trials.
“At this dosage the IL-31 receptor is saturated, so higher dosages aren’t needed,” according to Dr. Ruzicka.
By week 64, patients in the 0.5-mg/kg arm of the study showed further gradual improvement in their pruritus visual-analogue score, from a 60% reduction from baseline at 12 weeks to close to an 80% reduction at week 64.
Roughly half of nemolizumab-treated patients achieved an EASI-50 response within the first 4 weeks of the double-blind phase of the study and stayed in that response zone throughout the extension study.
The EASI-75 and -90 responses followed a pattern different from EASI-50. Patients didn’t leap to those more robust levels of response early and then plateau. Instead, the EASI-75 and -90 responses were achieved via a gradual climb in efficacy throughout the study, such that by week 64 roughly 35%-40% of patients on the various nemolizumab dosages had reached EASI-75.
In the extension study, patients were permitted to use a mild topical steroid or topical calcineurin inhibitor as needed, and a potent or very potent topical steroid as rescue medication. Roughly half of participants resorted to any topical steroid at least once during the 64 months. An important new observation gleaned in the long-term study was that the patients who did use topical steroids were twice as likely to reach an EASI 75 response.
Roughly 20% of patients on the three highest dosages of nemolizumab achieved a static Investigator’s Global Assessment score of 0 or 1, meaning clear or almost clear, by week 64.
Scores on the Dermatology Life Quality Index fell steadily over the course of 64 weeks, from a baseline of about 16 to 5 at study’s close.
The side effect profile of nemolizumab was essentially the same as seen in the placebo arm during the double-blind phase. About one-quarter of patients experienced nasopharyngitis over the course of 64 weeks of treatment. A similar fraction reported exacerbations of their atopic dermatitis; however, these events were front-loaded in the first weeks of the initial double-blind study phase and appeared to have been triggered by the drug washout period prior to the patients’ receiving the first dose of nemolizumab, according to Dr. Ruzicka. No new safety signals emerged during the additional 52 weeks of treatment.
The study was funded by Chugai. Dr. Ruzicka reported serving as a paid company adviser.
GENEVA – Nemolizumab, a humanized monoclonal antibody that inhibits interleukin-31 signaling, maintained its early dramatic antipruritic effect in patients with moderate to severe atopic dermatitis (AD) throughout a year-long unblinded extension of a large, high-profile, 12-week, phase 2 randomized trial, Thomas Ruzicka, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
In contrast, the 52-week extension study also showed the improvement in the dermatitis aspect of AD as measured by Eczema Area and Severity Index (EASI) scores was more gradual and less robust.
The study, 64 weeks in total, also demonstrated that what really matters to patients with moderate or severe AD is relief from the itch. Scores on the Dermatology Life Quality Index showed marked improvement even if their improvement in EASI scores was suboptimal.
“The dermatitis scores improved. But the most concerning symptom to patients is the pruritus; that’s what worsens their quality of life. And this improves dramatically very early in the course of the study,” Dr. Ruzicka explained. “If they drop their itch they are very happy. They don’t care about the redness of the skin so much as the pruritus. This is what really bothers them, as has been shown in epidemiologic studies.”
The original 12-week, phase 2, randomized, double-blind, dose-ranging trial drew extensive attention because it demonstrated convincingly for the first time that the inflammatory cytokine interleukin-31 plays a key role in the pathobiology of AD by promoting skin barrier dysfunction, pruritus, and the inflammatory response in AD – and that a biologic agent, nemolizumab, could inhibit those disease mechanisms (N Engl J Med. 2017 Mar 2;376[9]:826-35).
At a dose of 0.5 mg/kg administered by subcutaneous injection every 4 weeks, nemolizumab, a humanized monoclonal antibody directed against interleukin-31 receptor A, reduced scores on the pruritus visual-analogue scale by 60% as early as 4 weeks and maintained that effect through 12 weeks. At that point, the double-blind study ended and the 52-week extension began. Patients on nemolizumab in the double-blind phase stayed on the same dosage for the extension, while those who’d been on placebo were switched to nemolizumab at 0.1, 0.5, or 2.0 mg/kg every 4 weeks.
A total of 211 patients with moderate to severe AD inadequately controlled by topical therapies enrolled in the extension study. The combined 64-week experience convinced investigators and the sponsor, Chugai Pharmaceutical, that 0.5 mg/kg every 4 weeks is the optimal dose to take forward into planned advanced-stage clinical trials.
“At this dosage the IL-31 receptor is saturated, so higher dosages aren’t needed,” according to Dr. Ruzicka.
By week 64, patients in the 0.5-mg/kg arm of the study showed further gradual improvement in their pruritus visual-analogue score, from a 60% reduction from baseline at 12 weeks to close to an 80% reduction at week 64.
Roughly half of nemolizumab-treated patients achieved an EASI-50 response within the first 4 weeks of the double-blind phase of the study and stayed in that response zone throughout the extension study.
The EASI-75 and -90 responses followed a pattern different from EASI-50. Patients didn’t leap to those more robust levels of response early and then plateau. Instead, the EASI-75 and -90 responses were achieved via a gradual climb in efficacy throughout the study, such that by week 64 roughly 35%-40% of patients on the various nemolizumab dosages had reached EASI-75.
In the extension study, patients were permitted to use a mild topical steroid or topical calcineurin inhibitor as needed, and a potent or very potent topical steroid as rescue medication. Roughly half of participants resorted to any topical steroid at least once during the 64 months. An important new observation gleaned in the long-term study was that the patients who did use topical steroids were twice as likely to reach an EASI 75 response.
Roughly 20% of patients on the three highest dosages of nemolizumab achieved a static Investigator’s Global Assessment score of 0 or 1, meaning clear or almost clear, by week 64.
Scores on the Dermatology Life Quality Index fell steadily over the course of 64 weeks, from a baseline of about 16 to 5 at study’s close.
The side effect profile of nemolizumab was essentially the same as seen in the placebo arm during the double-blind phase. About one-quarter of patients experienced nasopharyngitis over the course of 64 weeks of treatment. A similar fraction reported exacerbations of their atopic dermatitis; however, these events were front-loaded in the first weeks of the initial double-blind study phase and appeared to have been triggered by the drug washout period prior to the patients’ receiving the first dose of nemolizumab, according to Dr. Ruzicka. No new safety signals emerged during the additional 52 weeks of treatment.
The study was funded by Chugai. Dr. Ruzicka reported serving as a paid company adviser.
AT THE EADV CONGRESS
Key clinical point:
Major finding: The early dramatic antipruritic effect demonstrated by nemolizumab for atopic dermatitis in a 12-week randomized trial was maintained throughout an additional 52 weeks in an extension study.
Data source: This analysis focused on 211 patients with moderate to severe atopic dermatitis who participated in a 52-week open-label extension study after completing a previously reported 12-week, double-blind, placebo-controlled phase.
Disclosures: The presenter is a paid medical adviser to Chugai Pharmaceutical, which funded the study.
Top research to be presented at AAGL
The 46th AAGL Global Congress on Minimally Invasive Gynecologic Surgery starts Nov. 12, 2017, in National Harbor, Md., and attendees will have a chance to hear presentations on more than 300 studies, plus numerous virtual posters.
Dr. Charles E. Miller, a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL, offered his top picks for not-to-be-missed research at this year’s meeting.
Cesarean-induced isthmoceles
On Wednesday, Nov. 15, at 12:17 p.m., researchers from West Virginia University in Morgantown and Universidad Autónoma de Nuevo León in Mexico will present data from a prospective study on the anatomy of cesarean-induced isthmoceles. The paper won the Golden Hysteroscope Award for best paper on hysteroscopy. It is being presented during the Open Communications 13 session on reproductive medicine.
“Isthmocele has become such a hot topic,” Dr. Miller said. “Besides the implications in terms of pelvic pain and abnormal bleeding, it can be a cause of infertility as fluid goes into the endometrial cavity and impacts implantation.”
Dr. Miller will be performing a telesurgery featuring robotic-assisted excision and repair of a cesarean section isthmocele on Thursday, Nov. 16, as part of General Session V from 8:30 a.m. to 12:30 p.m.
Rectosigmoid endometriosis
On Wednesday, Nov. 15, at 12:50 p.m., researchers from the University of Pittsburgh will show a surgical video on anterior discoid resection for rectosigmoid endometriosis. They use various laparoscopic instruments and techniques to assess and resect the nodule, including a “squeeze” technique, barbed suture, and a V-shaped closure. The video, which won the Golden Laparoscope Award for best surgical video, is being presented during the Plenary 6 session on endometriosis and adenomyosis.
“There is great debate in just how aggressively patients should be treated when a woman has deep infiltrative endometriosis involving the rectosigmoid area,” Dr. Miller said.
Most of the research in this area is from single-institution studies that do not always completely describe the procedure, leaving surgeons “unsure of which way to go,” Dr. Miller said. In addition, because many patients with endometriosis are young, surgeons need to consider how the procedure will impact them in 20 or even 50 years. While more aggressive than shaving, discoid resection is less aggressive than standard bowel resection.
Postsurgical pain control
On Tuesday, Nov. 14, at 3:46 p.m., researchers from the University of Pittsburgh, Oregon Health & Science University, Southern California Permanente Medical Group, and the University of Wisconsin, Madison, will present results from a prospective, double-blind, randomized study comparing intravenous acetaminophen with placebo for postsurgical pain control and patient satisfaction after laparoscopic hysterectomy. Their findings indicate no difference in either pain or satisfaction, casting doubt on routine use during hysterectomy. The study, which won the Jay M. Cooper Award for best paper on minimally invasive gynecology by a fellow, will be presented during the Open Communications 9 session on laparoscopy.
On Tuesday, Nov. 14, at 1:21 p.m., researchers from the University of Maryland, Baltimore; Mercy Medical Center, Baltimore; and Yoyodyne General Services, New York, will present a single-center, double-blind, randomized, placebo-controlled trial to assess the use of a single belladonna and opium suppository placed after laparoscopic or robotic hysterectomy to control postoperative pain. As with acetaminophen, they also found that the suppositories did not significantly lower pain or narcotic use. However, the belladonna/opium suppository reduced time to discharge from the postanesthesia care unit in phase I. The research, which won the Jerome J. Hoffman Award for best abstract by a resident or fellow, will be presented during Session 2 of the Virtual Posters.
“Here again are two treatments that really have minimal basis,” Dr. Miller said. “In the days of cost containment, is there really any reason for either?”
Cervical ripening
Dr. Miller also recommended that attendees take note of a randomized controlled trial evaluating whether misoprostol oral is as effective as vaginal tablets for cervical ripening. Researchers at Cairo University in Egypt considered this question among more than 350 women who were undergoing operative hysterectomy for various indications. They found no statistically significant difference in efficacy and similar adverse effects.
“There has been some concern raised about, is there a better way?” Dr. Miller said. “This is especially important as we move hysteroscopy to the office.”
The cervical priming study, which won the Robert B. Hunt Award for best paper published in the Journal of Minimally Invasive Gynecology between September 2016 and August 2017, will be presented on Tuesday, Nov. 14, at 7:10 a.m. during the journal’s editorial/advisory board breakfast. You can read the full article online (J Minim Invasive Gynecol. 2016 Nov - Dec;23[7]:1107-12).
[email protected]
On Twitter @maryellenny
The 46th AAGL Global Congress on Minimally Invasive Gynecologic Surgery starts Nov. 12, 2017, in National Harbor, Md., and attendees will have a chance to hear presentations on more than 300 studies, plus numerous virtual posters.
Dr. Charles E. Miller, a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL, offered his top picks for not-to-be-missed research at this year’s meeting.
Cesarean-induced isthmoceles
On Wednesday, Nov. 15, at 12:17 p.m., researchers from West Virginia University in Morgantown and Universidad Autónoma de Nuevo León in Mexico will present data from a prospective study on the anatomy of cesarean-induced isthmoceles. The paper won the Golden Hysteroscope Award for best paper on hysteroscopy. It is being presented during the Open Communications 13 session on reproductive medicine.
“Isthmocele has become such a hot topic,” Dr. Miller said. “Besides the implications in terms of pelvic pain and abnormal bleeding, it can be a cause of infertility as fluid goes into the endometrial cavity and impacts implantation.”
Dr. Miller will be performing a telesurgery featuring robotic-assisted excision and repair of a cesarean section isthmocele on Thursday, Nov. 16, as part of General Session V from 8:30 a.m. to 12:30 p.m.
Rectosigmoid endometriosis
On Wednesday, Nov. 15, at 12:50 p.m., researchers from the University of Pittsburgh will show a surgical video on anterior discoid resection for rectosigmoid endometriosis. They use various laparoscopic instruments and techniques to assess and resect the nodule, including a “squeeze” technique, barbed suture, and a V-shaped closure. The video, which won the Golden Laparoscope Award for best surgical video, is being presented during the Plenary 6 session on endometriosis and adenomyosis.
“There is great debate in just how aggressively patients should be treated when a woman has deep infiltrative endometriosis involving the rectosigmoid area,” Dr. Miller said.
Most of the research in this area is from single-institution studies that do not always completely describe the procedure, leaving surgeons “unsure of which way to go,” Dr. Miller said. In addition, because many patients with endometriosis are young, surgeons need to consider how the procedure will impact them in 20 or even 50 years. While more aggressive than shaving, discoid resection is less aggressive than standard bowel resection.
Postsurgical pain control
On Tuesday, Nov. 14, at 3:46 p.m., researchers from the University of Pittsburgh, Oregon Health & Science University, Southern California Permanente Medical Group, and the University of Wisconsin, Madison, will present results from a prospective, double-blind, randomized study comparing intravenous acetaminophen with placebo for postsurgical pain control and patient satisfaction after laparoscopic hysterectomy. Their findings indicate no difference in either pain or satisfaction, casting doubt on routine use during hysterectomy. The study, which won the Jay M. Cooper Award for best paper on minimally invasive gynecology by a fellow, will be presented during the Open Communications 9 session on laparoscopy.
On Tuesday, Nov. 14, at 1:21 p.m., researchers from the University of Maryland, Baltimore; Mercy Medical Center, Baltimore; and Yoyodyne General Services, New York, will present a single-center, double-blind, randomized, placebo-controlled trial to assess the use of a single belladonna and opium suppository placed after laparoscopic or robotic hysterectomy to control postoperative pain. As with acetaminophen, they also found that the suppositories did not significantly lower pain or narcotic use. However, the belladonna/opium suppository reduced time to discharge from the postanesthesia care unit in phase I. The research, which won the Jerome J. Hoffman Award for best abstract by a resident or fellow, will be presented during Session 2 of the Virtual Posters.
“Here again are two treatments that really have minimal basis,” Dr. Miller said. “In the days of cost containment, is there really any reason for either?”
Cervical ripening
Dr. Miller also recommended that attendees take note of a randomized controlled trial evaluating whether misoprostol oral is as effective as vaginal tablets for cervical ripening. Researchers at Cairo University in Egypt considered this question among more than 350 women who were undergoing operative hysterectomy for various indications. They found no statistically significant difference in efficacy and similar adverse effects.
“There has been some concern raised about, is there a better way?” Dr. Miller said. “This is especially important as we move hysteroscopy to the office.”
The cervical priming study, which won the Robert B. Hunt Award for best paper published in the Journal of Minimally Invasive Gynecology between September 2016 and August 2017, will be presented on Tuesday, Nov. 14, at 7:10 a.m. during the journal’s editorial/advisory board breakfast. You can read the full article online (J Minim Invasive Gynecol. 2016 Nov - Dec;23[7]:1107-12).
[email protected]
On Twitter @maryellenny
The 46th AAGL Global Congress on Minimally Invasive Gynecologic Surgery starts Nov. 12, 2017, in National Harbor, Md., and attendees will have a chance to hear presentations on more than 300 studies, plus numerous virtual posters.
Dr. Charles E. Miller, a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL, offered his top picks for not-to-be-missed research at this year’s meeting.
Cesarean-induced isthmoceles
On Wednesday, Nov. 15, at 12:17 p.m., researchers from West Virginia University in Morgantown and Universidad Autónoma de Nuevo León in Mexico will present data from a prospective study on the anatomy of cesarean-induced isthmoceles. The paper won the Golden Hysteroscope Award for best paper on hysteroscopy. It is being presented during the Open Communications 13 session on reproductive medicine.
“Isthmocele has become such a hot topic,” Dr. Miller said. “Besides the implications in terms of pelvic pain and abnormal bleeding, it can be a cause of infertility as fluid goes into the endometrial cavity and impacts implantation.”
Dr. Miller will be performing a telesurgery featuring robotic-assisted excision and repair of a cesarean section isthmocele on Thursday, Nov. 16, as part of General Session V from 8:30 a.m. to 12:30 p.m.
Rectosigmoid endometriosis
On Wednesday, Nov. 15, at 12:50 p.m., researchers from the University of Pittsburgh will show a surgical video on anterior discoid resection for rectosigmoid endometriosis. They use various laparoscopic instruments and techniques to assess and resect the nodule, including a “squeeze” technique, barbed suture, and a V-shaped closure. The video, which won the Golden Laparoscope Award for best surgical video, is being presented during the Plenary 6 session on endometriosis and adenomyosis.
“There is great debate in just how aggressively patients should be treated when a woman has deep infiltrative endometriosis involving the rectosigmoid area,” Dr. Miller said.
Most of the research in this area is from single-institution studies that do not always completely describe the procedure, leaving surgeons “unsure of which way to go,” Dr. Miller said. In addition, because many patients with endometriosis are young, surgeons need to consider how the procedure will impact them in 20 or even 50 years. While more aggressive than shaving, discoid resection is less aggressive than standard bowel resection.
Postsurgical pain control
On Tuesday, Nov. 14, at 3:46 p.m., researchers from the University of Pittsburgh, Oregon Health & Science University, Southern California Permanente Medical Group, and the University of Wisconsin, Madison, will present results from a prospective, double-blind, randomized study comparing intravenous acetaminophen with placebo for postsurgical pain control and patient satisfaction after laparoscopic hysterectomy. Their findings indicate no difference in either pain or satisfaction, casting doubt on routine use during hysterectomy. The study, which won the Jay M. Cooper Award for best paper on minimally invasive gynecology by a fellow, will be presented during the Open Communications 9 session on laparoscopy.
On Tuesday, Nov. 14, at 1:21 p.m., researchers from the University of Maryland, Baltimore; Mercy Medical Center, Baltimore; and Yoyodyne General Services, New York, will present a single-center, double-blind, randomized, placebo-controlled trial to assess the use of a single belladonna and opium suppository placed after laparoscopic or robotic hysterectomy to control postoperative pain. As with acetaminophen, they also found that the suppositories did not significantly lower pain or narcotic use. However, the belladonna/opium suppository reduced time to discharge from the postanesthesia care unit in phase I. The research, which won the Jerome J. Hoffman Award for best abstract by a resident or fellow, will be presented during Session 2 of the Virtual Posters.
“Here again are two treatments that really have minimal basis,” Dr. Miller said. “In the days of cost containment, is there really any reason for either?”
Cervical ripening
Dr. Miller also recommended that attendees take note of a randomized controlled trial evaluating whether misoprostol oral is as effective as vaginal tablets for cervical ripening. Researchers at Cairo University in Egypt considered this question among more than 350 women who were undergoing operative hysterectomy for various indications. They found no statistically significant difference in efficacy and similar adverse effects.
“There has been some concern raised about, is there a better way?” Dr. Miller said. “This is especially important as we move hysteroscopy to the office.”
The cervical priming study, which won the Robert B. Hunt Award for best paper published in the Journal of Minimally Invasive Gynecology between September 2016 and August 2017, will be presented on Tuesday, Nov. 14, at 7:10 a.m. during the journal’s editorial/advisory board breakfast. You can read the full article online (J Minim Invasive Gynecol. 2016 Nov - Dec;23[7]:1107-12).
[email protected]
On Twitter @maryellenny
Case study suggests maternal inheritance of PBC susceptibility
A case report involving a family with four sisters with primary biliary cholangitis (PBC) suggests that there may be a maternal inheritance of susceptibility, according to Saeam Shin, MD, and associates at Hallym University in Seoul, South Korea.
In the first case, a 56-year-old woman was diagnosed with PBC, and afterwards, her three sisters, her brother, and her half-sister born to a different mother were evaluated for PBC as well. The second and fourth sisters showed no symptoms, but they were antimitochondrial-antibody (AMA) positive and were diagnosed with PBC. The third sister had been admitted to a different hospital for acute hepatitis of unknown origin – after receiving a positive AMA test, she also was diagnosed with PBC.
The brother and half-sister evaluated for PBC showed no symptoms and had negative AMA tests. The four sisters diagnosed showed good response to ursodeoxycholic acid in liver biochemistry tests and have continued on that medication without complication.
“If one patient is diagnosed with PBC, screening with AMA and liver function tests should be recommended to other family members for the early detection and management of this condition, especially for female relatives,” the investigators wrote.
Find the full case report in the World Journal of Gastroenterology (doi: 10.3748/wjg.v23.i39.7191).
A case report involving a family with four sisters with primary biliary cholangitis (PBC) suggests that there may be a maternal inheritance of susceptibility, according to Saeam Shin, MD, and associates at Hallym University in Seoul, South Korea.
In the first case, a 56-year-old woman was diagnosed with PBC, and afterwards, her three sisters, her brother, and her half-sister born to a different mother were evaluated for PBC as well. The second and fourth sisters showed no symptoms, but they were antimitochondrial-antibody (AMA) positive and were diagnosed with PBC. The third sister had been admitted to a different hospital for acute hepatitis of unknown origin – after receiving a positive AMA test, she also was diagnosed with PBC.
The brother and half-sister evaluated for PBC showed no symptoms and had negative AMA tests. The four sisters diagnosed showed good response to ursodeoxycholic acid in liver biochemistry tests and have continued on that medication without complication.
“If one patient is diagnosed with PBC, screening with AMA and liver function tests should be recommended to other family members for the early detection and management of this condition, especially for female relatives,” the investigators wrote.
Find the full case report in the World Journal of Gastroenterology (doi: 10.3748/wjg.v23.i39.7191).
A case report involving a family with four sisters with primary biliary cholangitis (PBC) suggests that there may be a maternal inheritance of susceptibility, according to Saeam Shin, MD, and associates at Hallym University in Seoul, South Korea.
In the first case, a 56-year-old woman was diagnosed with PBC, and afterwards, her three sisters, her brother, and her half-sister born to a different mother were evaluated for PBC as well. The second and fourth sisters showed no symptoms, but they were antimitochondrial-antibody (AMA) positive and were diagnosed with PBC. The third sister had been admitted to a different hospital for acute hepatitis of unknown origin – after receiving a positive AMA test, she also was diagnosed with PBC.
The brother and half-sister evaluated for PBC showed no symptoms and had negative AMA tests. The four sisters diagnosed showed good response to ursodeoxycholic acid in liver biochemistry tests and have continued on that medication without complication.
“If one patient is diagnosed with PBC, screening with AMA and liver function tests should be recommended to other family members for the early detection and management of this condition, especially for female relatives,” the investigators wrote.
Find the full case report in the World Journal of Gastroenterology (doi: 10.3748/wjg.v23.i39.7191).
FROM THE WORLD JOURNAL OF GASTROENTEROLOGY
Does Anyone Really Understand Nutrition Labels?
In 1990, nutrition labeling—that handy chart that gives us the information we need to make healthy choices—was added to nearly all packaged foods. But according to researchers from the FDA, Tufts University, and the National Cancer Institute, many people lack the health literacy to understand the information and use it as intended.
The researchers analyzed data on 3,185 U.S. adults from the Health Information National Trends Survey, conducted in 2013. Participants were asked to view an ice-cream nutrition label and answer 4 questions that tested their ability to apply basic arithmetic and understanding of percentages to interpret the label. They also reported their intake of sugar-sweetened soft drinks, fruits, and vegetables.
About one-quarter of the participants could not determine the calorie content of the full ice-cream container; 42% could not estimate the effect on daily calorie intake of foregoing 1 serving; 41% could not calculate the percentage daily value of calories in a single serving; and 21% could not estimate the number of servings equal to 60 g of carbohydrates.
Higher scores of label understanding were associated with consuming more vegetables and fewer sugar-sweetened drinks. After adjusting for demographic factors, only the link with soft drinks remained significant.
Across all educational levels, people had the most trouble with the questions about health recommendations and daily value. As in other studies, low educational attainment was associated with poor understanding of nutrition labels. More than one-third of participants with less than a high school diploma could not correctly answer any of the questions. Less than 9% could answer all 4 correctly. However, only 54% of participants with a 4-year college degree could answer all the questions correctly.
One obvious way to improve things, the researchers suggest, is to make the nutrition label easier to use. They note that the FDA tried to do this in 2016, in addition to reflecting current nutrition science and public health research. For instance, certain label elements, like calories and serving size, are now larger and in a bold font. Serving sizes have been updated to more accurately reflect the amount of food and drink people usually consume. To help consumers better understand serving size, 2 columns are used for foods that can be eaten in 1 or multiple sittings, such as a bag of potato chips, so people will better grasp how many calories they consume in 1 sitting.
Still, understanding nutrition labels is not the same as using the nutrition information for selecting food, the researchers point out. Participants who answered all 4 questions correctly might not necessarily use the labels when buying food.
In 1990, nutrition labeling—that handy chart that gives us the information we need to make healthy choices—was added to nearly all packaged foods. But according to researchers from the FDA, Tufts University, and the National Cancer Institute, many people lack the health literacy to understand the information and use it as intended.
The researchers analyzed data on 3,185 U.S. adults from the Health Information National Trends Survey, conducted in 2013. Participants were asked to view an ice-cream nutrition label and answer 4 questions that tested their ability to apply basic arithmetic and understanding of percentages to interpret the label. They also reported their intake of sugar-sweetened soft drinks, fruits, and vegetables.
About one-quarter of the participants could not determine the calorie content of the full ice-cream container; 42% could not estimate the effect on daily calorie intake of foregoing 1 serving; 41% could not calculate the percentage daily value of calories in a single serving; and 21% could not estimate the number of servings equal to 60 g of carbohydrates.
Higher scores of label understanding were associated with consuming more vegetables and fewer sugar-sweetened drinks. After adjusting for demographic factors, only the link with soft drinks remained significant.
Across all educational levels, people had the most trouble with the questions about health recommendations and daily value. As in other studies, low educational attainment was associated with poor understanding of nutrition labels. More than one-third of participants with less than a high school diploma could not correctly answer any of the questions. Less than 9% could answer all 4 correctly. However, only 54% of participants with a 4-year college degree could answer all the questions correctly.
One obvious way to improve things, the researchers suggest, is to make the nutrition label easier to use. They note that the FDA tried to do this in 2016, in addition to reflecting current nutrition science and public health research. For instance, certain label elements, like calories and serving size, are now larger and in a bold font. Serving sizes have been updated to more accurately reflect the amount of food and drink people usually consume. To help consumers better understand serving size, 2 columns are used for foods that can be eaten in 1 or multiple sittings, such as a bag of potato chips, so people will better grasp how many calories they consume in 1 sitting.
Still, understanding nutrition labels is not the same as using the nutrition information for selecting food, the researchers point out. Participants who answered all 4 questions correctly might not necessarily use the labels when buying food.
In 1990, nutrition labeling—that handy chart that gives us the information we need to make healthy choices—was added to nearly all packaged foods. But according to researchers from the FDA, Tufts University, and the National Cancer Institute, many people lack the health literacy to understand the information and use it as intended.
The researchers analyzed data on 3,185 U.S. adults from the Health Information National Trends Survey, conducted in 2013. Participants were asked to view an ice-cream nutrition label and answer 4 questions that tested their ability to apply basic arithmetic and understanding of percentages to interpret the label. They also reported their intake of sugar-sweetened soft drinks, fruits, and vegetables.
About one-quarter of the participants could not determine the calorie content of the full ice-cream container; 42% could not estimate the effect on daily calorie intake of foregoing 1 serving; 41% could not calculate the percentage daily value of calories in a single serving; and 21% could not estimate the number of servings equal to 60 g of carbohydrates.
Higher scores of label understanding were associated with consuming more vegetables and fewer sugar-sweetened drinks. After adjusting for demographic factors, only the link with soft drinks remained significant.
Across all educational levels, people had the most trouble with the questions about health recommendations and daily value. As in other studies, low educational attainment was associated with poor understanding of nutrition labels. More than one-third of participants with less than a high school diploma could not correctly answer any of the questions. Less than 9% could answer all 4 correctly. However, only 54% of participants with a 4-year college degree could answer all the questions correctly.
One obvious way to improve things, the researchers suggest, is to make the nutrition label easier to use. They note that the FDA tried to do this in 2016, in addition to reflecting current nutrition science and public health research. For instance, certain label elements, like calories and serving size, are now larger and in a bold font. Serving sizes have been updated to more accurately reflect the amount of food and drink people usually consume. To help consumers better understand serving size, 2 columns are used for foods that can be eaten in 1 or multiple sittings, such as a bag of potato chips, so people will better grasp how many calories they consume in 1 sitting.
Still, understanding nutrition labels is not the same as using the nutrition information for selecting food, the researchers point out. Participants who answered all 4 questions correctly might not necessarily use the labels when buying food.
FDA approves first treatment for ECD
The US Food and Drug Administration (FDA) has expanded the approved use of vemurafenib (Zelboraf) to include the treatment of adults who have Erdheim-Chester disease (ECD) with BRAF V600 mutation.
Vemurafenib is a kinase inhibitor designed to inhibit some mutated forms of BRAF.
The drug was already approved by the FDA to treat patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.
Now, vemurafenib is the first FDA-approved treatment for ECD.
The FDA previously granted vemurafenib orphan drug and breakthrough therapy designations for this indication, and the supplemental new drug application for vemurafenib in ECD received priority review.
“Today’s approval of Zelboraf for patients with ECD demonstrates how we can apply knowledge of the underlying genetic characteristics of certain malignancies to other cancers,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“This product was first approved in 2011 to treat certain patients with melanoma that harbor the BRAF V600E mutation, and we are now bringing the therapy to patients with a rare cancer with no approved therapies.”
The application for vemurafenib in ECD was supported by data from the phase 2 VE-BASKET study. Initial results from this study were published in NEJM in August 2015.
VE-BASKET was designed to investigate the use of vemurafenib in patients with BRAF V600 mutation-positive diseases, including ECD.
In the 22 patients with ECD, the best overall response rate was 54.5%. Eleven patients experienced a partial response, and 1 patient achieved a complete response.
The median duration of response, progression-free survival, and overall survival were not reached at a median follow-up of 26.6 months.
The most common adverse events (>50%) were joint pain, rash, hair loss, fatigue, change in heart rhythm, and skin tags. The most common grade 3 or higher adverse events (≥10%) were new skin cancers, high blood pressure, rash, and joint pain. 
The US Food and Drug Administration (FDA) has expanded the approved use of vemurafenib (Zelboraf) to include the treatment of adults who have Erdheim-Chester disease (ECD) with BRAF V600 mutation.
Vemurafenib is a kinase inhibitor designed to inhibit some mutated forms of BRAF.
The drug was already approved by the FDA to treat patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.
Now, vemurafenib is the first FDA-approved treatment for ECD.
The FDA previously granted vemurafenib orphan drug and breakthrough therapy designations for this indication, and the supplemental new drug application for vemurafenib in ECD received priority review.
“Today’s approval of Zelboraf for patients with ECD demonstrates how we can apply knowledge of the underlying genetic characteristics of certain malignancies to other cancers,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“This product was first approved in 2011 to treat certain patients with melanoma that harbor the BRAF V600E mutation, and we are now bringing the therapy to patients with a rare cancer with no approved therapies.”
The application for vemurafenib in ECD was supported by data from the phase 2 VE-BASKET study. Initial results from this study were published in NEJM in August 2015.
VE-BASKET was designed to investigate the use of vemurafenib in patients with BRAF V600 mutation-positive diseases, including ECD.
In the 22 patients with ECD, the best overall response rate was 54.5%. Eleven patients experienced a partial response, and 1 patient achieved a complete response.
The median duration of response, progression-free survival, and overall survival were not reached at a median follow-up of 26.6 months.
The most common adverse events (>50%) were joint pain, rash, hair loss, fatigue, change in heart rhythm, and skin tags. The most common grade 3 or higher adverse events (≥10%) were new skin cancers, high blood pressure, rash, and joint pain.
The US Food and Drug Administration (FDA) has expanded the approved use of vemurafenib (Zelboraf) to include the treatment of adults who have Erdheim-Chester disease (ECD) with BRAF V600 mutation.
Vemurafenib is a kinase inhibitor designed to inhibit some mutated forms of BRAF.
The drug was already approved by the FDA to treat patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.
Now, vemurafenib is the first FDA-approved treatment for ECD.
The FDA previously granted vemurafenib orphan drug and breakthrough therapy designations for this indication, and the supplemental new drug application for vemurafenib in ECD received priority review.
“Today’s approval of Zelboraf for patients with ECD demonstrates how we can apply knowledge of the underlying genetic characteristics of certain malignancies to other cancers,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“This product was first approved in 2011 to treat certain patients with melanoma that harbor the BRAF V600E mutation, and we are now bringing the therapy to patients with a rare cancer with no approved therapies.”
The application for vemurafenib in ECD was supported by data from the phase 2 VE-BASKET study. Initial results from this study were published in NEJM in August 2015.
VE-BASKET was designed to investigate the use of vemurafenib in patients with BRAF V600 mutation-positive diseases, including ECD.
In the 22 patients with ECD, the best overall response rate was 54.5%. Eleven patients experienced a partial response, and 1 patient achieved a complete response.
The median duration of response, progression-free survival, and overall survival were not reached at a median follow-up of 26.6 months.
The most common adverse events (>50%) were joint pain, rash, hair loss, fatigue, change in heart rhythm, and skin tags. The most common grade 3 or higher adverse events (≥10%) were new skin cancers, high blood pressure, rash, and joint pain.
Ibrutinib sustains efficacy in CLL at 4-year follow-up
NEW YORK, NY—The 4-year follow-up of the RESONATE trial suggests ibrutinib may provide long-term efficacy in previously treated patients with chronic lymphocytic leukemia (CLL).
The median progression-free survival (PFS) has not yet been reached in this trial, regardless of high-risk cytogenetics, according to Jennifer Brown, MD, PhD, of the Dana-Farber Cancer Institute in Boston, Massachusetts.
She presented the update at Lymphoma & Myeloma 2017. The follow-up study was awarded the best clinical CLL abstract of the meeting.
In the phase 3 RESONATE study, investigators compared ibrutinib—the first-in-class, once-daily, oral inhibitor of Bruton tyrosine kinase—to ofatumumab in previously treated CLL/small lymphocytic lymphoma (SLL).
The primary analysis showed ibrutinib significantly improved survival, with a 78% reduction in the risk of progression and a 57% reduction in the risk of death.
The phase 3 trial randomized 195 CLL/SLL patients to oral ibrutinib at 420 mg once daily and 196 patients to intravenous ofatumumab at an initial dose of 300 mg followed by 2000 mg for 11 doses over 24 weeks.
One hundred thirty-three patients progressed on ofatumumab and crossed over to receive once-daily ibrutinib.
Patient characteristics
In each arm, the median patient age was 67, more than half of patients had an ECOG status of 1, and more than half had advanced-stage disease.
High-risk genetic abnormalities were common, Dr Brown said, with deletion 11q in a third of patients in the ibrutinib arm and 31% in the ofatumumab arm. Another third in each arm had deletion 17p, while 51% in the ibrutinib arm and 46% in the ofatumumab arm had TP53 mutation.
About a quarter of the patients in each arm had complex karyotype, and 73% and 63% in the ibrutinib and ofatumumab arms, respectively, were IGHV-unmutated.
Survival
Ibrutinib significantly extended PFS compared with ofatumumab. At a median follow-up for ibrutinib of 44 months (range, 0.33 – 53), ibrutinib led to an 87% reduction in the risk of progression or death. The 3-year PFS rate was 59% with ibrutinib and 3% with ofatumumab.
Ibrutinib conferred a benefit in PFS across all baseline patient characteristics.
Among ibrutinib-treated patients, the 3-year PFS was 53% for patients with deletion 17p, 66% for those with deletion 11q but not deletion 17p, and 58% for those with neither abnormality.
Dr Brown noted how closely complex karyotype associates with high-risk cytogenetics. Forty-two percent of patients with 17p deletion had a complex karyotype, as did 23% of patients with 11q deletion and 15% of patients with neither 17p nor 11q deletion.
For IGHV-mutation status, Dr Brown said there is no difference in PFS with this degree of follow-up.
In terms of TP53 mutation status, Dr Brown pointed out a trend toward a worse PFS in those patients with the mutation.
“We actually looked by individual p53 mutation versus 17p deletion, versus both, versus neither, in the 2-year follow-up paper and found that p53 with 17p, both abnormalities, did have worse PFS than neither,” she said.
“This may require further follow-up because we do know that most 17p patients also have a p53 mutation, particularly in the relapsed setting.”
As expected, Dr Brown said, those patients with more than 2 prior therapies had a worse PFS compared to patients with 2 or fewer prior therapies.
Multivariate analysis demonstrated that more than 2 prior lines of therapy or an elevated ß2 microglobulin were associated with decreased PFS with ibrutinib.
When the investigators adjusted the overall survival data for cross-over, ibrutinib was projected to continue the overall survival benefit compared with ofatumumab, with a hazard ratio of 0.37.
Response rates
Dr Brown noted that, early on, there’s quite a significant rate of partial response with lymphocytosis observed in patients on ibrutinib.
This “diminishes dramatically,” she said, but about 5% of patients at 3 and 4 years still have ongoing lymphocytosis.
“Similarly, initially, there’s a very low rate of complete remission, which has risen steadily to 9% at this follow-up,” she said.
And the overall response rate is 91%.
Treatment exposure and toxicity
The median duration of ibrutinib treatment is 41 months, and 46% of patients continue on treatment. Twenty-seven percent of patients discontinued due to progression, and 12% because of adverse events (AEs).
Of the 53 patients who discontinued therapy, 14 had transformation as their primary reason, 9 with diffuse large B-cell lymphoma, 3 with Hodgkin disease, and 2 with prolymphocytic lymphoma.
The most frequent AEs leading to discontinuation included pneumonia (n=3), anemia (n=2), thrombocytopenia (n=2), diarrhea (n=2), and anal incontinence (n=2).
AEs leading to discontinuation decreased over time—6% in year 0 to 1 and 4% in years 2 to 3.
“The most frequent cumulative AEs are similar to what we’ve seen in most prior studies,” Dr Brown said, including diarrhea, fatigue, and cough.
In terms of grade 3 or higher AEs, about a quarter of patients had neutropenia, 17% had pneumonia, and 8% had hypertension.
Six percent of patients had major hemorrhage, and all-grade atrial fibrillation occurred in 11% of patients.
“Now, many of the grade 3 and higher AEs did decline over time during the study,” Dr Brown noted. “You can see this is quite evident for neutropenia as well as pneumonia, and all infections declined from year 1 to subsequent years.”
Hypertension, in contrast, has been fairly steady over the later years, she said, and atrial fibrillation is highest in the first 6 months but then continues at a low rate thereafter.
The investigators believe these long-term results demonstrate that ibrutinib is tolerable and continues to show sustained efficacy in previously treated and high-genomic-risk patients with CLL. In addition, no long-term safety signals have emerged.
This study was sponsored by Pharmacyclics, LLC, an AbbVie company.
NEW YORK, NY—The 4-year follow-up of the RESONATE trial suggests ibrutinib may provide long-term efficacy in previously treated patients with chronic lymphocytic leukemia (CLL).
The median progression-free survival (PFS) has not yet been reached in this trial, regardless of high-risk cytogenetics, according to Jennifer Brown, MD, PhD, of the Dana-Farber Cancer Institute in Boston, Massachusetts.
She presented the update at Lymphoma & Myeloma 2017. The follow-up study was awarded the best clinical CLL abstract of the meeting.
In the phase 3 RESONATE study, investigators compared ibrutinib—the first-in-class, once-daily, oral inhibitor of Bruton tyrosine kinase—to ofatumumab in previously treated CLL/small lymphocytic lymphoma (SLL).
The primary analysis showed ibrutinib significantly improved survival, with a 78% reduction in the risk of progression and a 57% reduction in the risk of death.
The phase 3 trial randomized 195 CLL/SLL patients to oral ibrutinib at 420 mg once daily and 196 patients to intravenous ofatumumab at an initial dose of 300 mg followed by 2000 mg for 11 doses over 24 weeks.
One hundred thirty-three patients progressed on ofatumumab and crossed over to receive once-daily ibrutinib.
Patient characteristics
In each arm, the median patient age was 67, more than half of patients had an ECOG status of 1, and more than half had advanced-stage disease.
High-risk genetic abnormalities were common, Dr Brown said, with deletion 11q in a third of patients in the ibrutinib arm and 31% in the ofatumumab arm. Another third in each arm had deletion 17p, while 51% in the ibrutinib arm and 46% in the ofatumumab arm had TP53 mutation.
About a quarter of the patients in each arm had complex karyotype, and 73% and 63% in the ibrutinib and ofatumumab arms, respectively, were IGHV-unmutated.
Survival
Ibrutinib significantly extended PFS compared with ofatumumab. At a median follow-up for ibrutinib of 44 months (range, 0.33 – 53), ibrutinib led to an 87% reduction in the risk of progression or death. The 3-year PFS rate was 59% with ibrutinib and 3% with ofatumumab.
Ibrutinib conferred a benefit in PFS across all baseline patient characteristics.
Among ibrutinib-treated patients, the 3-year PFS was 53% for patients with deletion 17p, 66% for those with deletion 11q but not deletion 17p, and 58% for those with neither abnormality.
Dr Brown noted how closely complex karyotype associates with high-risk cytogenetics. Forty-two percent of patients with 17p deletion had a complex karyotype, as did 23% of patients with 11q deletion and 15% of patients with neither 17p nor 11q deletion.
For IGHV-mutation status, Dr Brown said there is no difference in PFS with this degree of follow-up.
In terms of TP53 mutation status, Dr Brown pointed out a trend toward a worse PFS in those patients with the mutation.
“We actually looked by individual p53 mutation versus 17p deletion, versus both, versus neither, in the 2-year follow-up paper and found that p53 with 17p, both abnormalities, did have worse PFS than neither,” she said.
“This may require further follow-up because we do know that most 17p patients also have a p53 mutation, particularly in the relapsed setting.”
As expected, Dr Brown said, those patients with more than 2 prior therapies had a worse PFS compared to patients with 2 or fewer prior therapies.
Multivariate analysis demonstrated that more than 2 prior lines of therapy or an elevated ß2 microglobulin were associated with decreased PFS with ibrutinib.
When the investigators adjusted the overall survival data for cross-over, ibrutinib was projected to continue the overall survival benefit compared with ofatumumab, with a hazard ratio of 0.37.
Response rates
Dr Brown noted that, early on, there’s quite a significant rate of partial response with lymphocytosis observed in patients on ibrutinib.
This “diminishes dramatically,” she said, but about 5% of patients at 3 and 4 years still have ongoing lymphocytosis.
“Similarly, initially, there’s a very low rate of complete remission, which has risen steadily to 9% at this follow-up,” she said.
And the overall response rate is 91%.
Treatment exposure and toxicity
The median duration of ibrutinib treatment is 41 months, and 46% of patients continue on treatment. Twenty-seven percent of patients discontinued due to progression, and 12% because of adverse events (AEs).
Of the 53 patients who discontinued therapy, 14 had transformation as their primary reason, 9 with diffuse large B-cell lymphoma, 3 with Hodgkin disease, and 2 with prolymphocytic lymphoma.
The most frequent AEs leading to discontinuation included pneumonia (n=3), anemia (n=2), thrombocytopenia (n=2), diarrhea (n=2), and anal incontinence (n=2).
AEs leading to discontinuation decreased over time—6% in year 0 to 1 and 4% in years 2 to 3.
“The most frequent cumulative AEs are similar to what we’ve seen in most prior studies,” Dr Brown said, including diarrhea, fatigue, and cough.
In terms of grade 3 or higher AEs, about a quarter of patients had neutropenia, 17% had pneumonia, and 8% had hypertension.
Six percent of patients had major hemorrhage, and all-grade atrial fibrillation occurred in 11% of patients.
“Now, many of the grade 3 and higher AEs did decline over time during the study,” Dr Brown noted. “You can see this is quite evident for neutropenia as well as pneumonia, and all infections declined from year 1 to subsequent years.”
Hypertension, in contrast, has been fairly steady over the later years, she said, and atrial fibrillation is highest in the first 6 months but then continues at a low rate thereafter.
The investigators believe these long-term results demonstrate that ibrutinib is tolerable and continues to show sustained efficacy in previously treated and high-genomic-risk patients with CLL. In addition, no long-term safety signals have emerged.
This study was sponsored by Pharmacyclics, LLC, an AbbVie company.
NEW YORK, NY—The 4-year follow-up of the RESONATE trial suggests ibrutinib may provide long-term efficacy in previously treated patients with chronic lymphocytic leukemia (CLL).
The median progression-free survival (PFS) has not yet been reached in this trial, regardless of high-risk cytogenetics, according to Jennifer Brown, MD, PhD, of the Dana-Farber Cancer Institute in Boston, Massachusetts.
She presented the update at Lymphoma & Myeloma 2017. The follow-up study was awarded the best clinical CLL abstract of the meeting.
In the phase 3 RESONATE study, investigators compared ibrutinib—the first-in-class, once-daily, oral inhibitor of Bruton tyrosine kinase—to ofatumumab in previously treated CLL/small lymphocytic lymphoma (SLL).
The primary analysis showed ibrutinib significantly improved survival, with a 78% reduction in the risk of progression and a 57% reduction in the risk of death.
The phase 3 trial randomized 195 CLL/SLL patients to oral ibrutinib at 420 mg once daily and 196 patients to intravenous ofatumumab at an initial dose of 300 mg followed by 2000 mg for 11 doses over 24 weeks.
One hundred thirty-three patients progressed on ofatumumab and crossed over to receive once-daily ibrutinib.
Patient characteristics
In each arm, the median patient age was 67, more than half of patients had an ECOG status of 1, and more than half had advanced-stage disease.
High-risk genetic abnormalities were common, Dr Brown said, with deletion 11q in a third of patients in the ibrutinib arm and 31% in the ofatumumab arm. Another third in each arm had deletion 17p, while 51% in the ibrutinib arm and 46% in the ofatumumab arm had TP53 mutation.
About a quarter of the patients in each arm had complex karyotype, and 73% and 63% in the ibrutinib and ofatumumab arms, respectively, were IGHV-unmutated.
Survival
Ibrutinib significantly extended PFS compared with ofatumumab. At a median follow-up for ibrutinib of 44 months (range, 0.33 – 53), ibrutinib led to an 87% reduction in the risk of progression or death. The 3-year PFS rate was 59% with ibrutinib and 3% with ofatumumab.
Ibrutinib conferred a benefit in PFS across all baseline patient characteristics.
Among ibrutinib-treated patients, the 3-year PFS was 53% for patients with deletion 17p, 66% for those with deletion 11q but not deletion 17p, and 58% for those with neither abnormality.
Dr Brown noted how closely complex karyotype associates with high-risk cytogenetics. Forty-two percent of patients with 17p deletion had a complex karyotype, as did 23% of patients with 11q deletion and 15% of patients with neither 17p nor 11q deletion.
For IGHV-mutation status, Dr Brown said there is no difference in PFS with this degree of follow-up.
In terms of TP53 mutation status, Dr Brown pointed out a trend toward a worse PFS in those patients with the mutation.
“We actually looked by individual p53 mutation versus 17p deletion, versus both, versus neither, in the 2-year follow-up paper and found that p53 with 17p, both abnormalities, did have worse PFS than neither,” she said.
“This may require further follow-up because we do know that most 17p patients also have a p53 mutation, particularly in the relapsed setting.”
As expected, Dr Brown said, those patients with more than 2 prior therapies had a worse PFS compared to patients with 2 or fewer prior therapies.
Multivariate analysis demonstrated that more than 2 prior lines of therapy or an elevated ß2 microglobulin were associated with decreased PFS with ibrutinib.
When the investigators adjusted the overall survival data for cross-over, ibrutinib was projected to continue the overall survival benefit compared with ofatumumab, with a hazard ratio of 0.37.
Response rates
Dr Brown noted that, early on, there’s quite a significant rate of partial response with lymphocytosis observed in patients on ibrutinib.
This “diminishes dramatically,” she said, but about 5% of patients at 3 and 4 years still have ongoing lymphocytosis.
“Similarly, initially, there’s a very low rate of complete remission, which has risen steadily to 9% at this follow-up,” she said.
And the overall response rate is 91%.
Treatment exposure and toxicity
The median duration of ibrutinib treatment is 41 months, and 46% of patients continue on treatment. Twenty-seven percent of patients discontinued due to progression, and 12% because of adverse events (AEs).
Of the 53 patients who discontinued therapy, 14 had transformation as their primary reason, 9 with diffuse large B-cell lymphoma, 3 with Hodgkin disease, and 2 with prolymphocytic lymphoma.
The most frequent AEs leading to discontinuation included pneumonia (n=3), anemia (n=2), thrombocytopenia (n=2), diarrhea (n=2), and anal incontinence (n=2).
AEs leading to discontinuation decreased over time—6% in year 0 to 1 and 4% in years 2 to 3.
“The most frequent cumulative AEs are similar to what we’ve seen in most prior studies,” Dr Brown said, including diarrhea, fatigue, and cough.
In terms of grade 3 or higher AEs, about a quarter of patients had neutropenia, 17% had pneumonia, and 8% had hypertension.
Six percent of patients had major hemorrhage, and all-grade atrial fibrillation occurred in 11% of patients.
“Now, many of the grade 3 and higher AEs did decline over time during the study,” Dr Brown noted. “You can see this is quite evident for neutropenia as well as pneumonia, and all infections declined from year 1 to subsequent years.”
Hypertension, in contrast, has been fairly steady over the later years, she said, and atrial fibrillation is highest in the first 6 months but then continues at a low rate thereafter.
The investigators believe these long-term results demonstrate that ibrutinib is tolerable and continues to show sustained efficacy in previously treated and high-genomic-risk patients with CLL. In addition, no long-term safety signals have emerged.
This study was sponsored by Pharmacyclics, LLC, an AbbVie company.
FDA approves wider use of hematology analyzer
The US Food and Drug Administration (FDA) has expanded the approved use of the XW-100 Automated Hematology Analyzer.
The analyzer can now be used at non-traditional laboratory sites by non-medical personnel.
The XW-100 Automated Hematology Analyzer is intended for use in patients age 2 and older who require a whole blood cell count and white blood cell differential.
Test results can be used with other clinical and laboratory findings to provide early alerts of patients with serious conditions, such as severe anemia and agranulocytosis, who require additional testing.
The XW-100 Automated Hematology Analyzer is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases.
The device works by using a blood sample to classify and quantify 12 hematology parameters, which provides patients with a blood component profile as part of their overall health assessment.
Expanded clearance
The FDA granted the XW-100 Automated Hematology Analyzer a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The waiver allows the device to be used by a variety of non-traditional laboratory sites, including physicians’ offices, clinics, or other types of healthcare facilities with a CLIA Certificate of Waiver.
The XW-100 Automated Hematology Analyzer was reviewed through the dual submission pathway, a streamlined regulatory pathway for 510(k) marketing clearance and CLIA Waiver by Application.
A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
The XW-100 Automated Hematology Analyzer was originally cleared through the 510(k) pathway in 2015 for use at the patient’s point-of-care.
To support the use of this device in CLIA-waived settings with non-medical personnel, the analyzer is now accompanied by simple instructions for operator actions when results are flagged or outside of a specified range.
To further ensure accurate testing in this setting and to eliminate results that are most susceptible to inaccuracy or require additional testing, the number of hematology parameters has been reduced to 12.
The FDA found this modified version of the XW-100 Automated Hematology Analyzer to be substantially equivalent to the 2015 model.
In addition, data submitted by Sysmex America, Inc. (the company marketing the analyzer) demonstrated ease of use and a low risk of false results when the modified XW-100 Automated Hematology Analyzer was used by untrained operators.
The FDA reviewed data from a study conducted on 582 samples collected from patients ages 2 to 92.
In this study, researchers compared XW-100 Automated Hematology Analyzer results collected by non-medical personnel in CLIA-waived settings to results from a hematology analyzer in an accredited clinical laboratory.
Results showed that, by following the manufacturer’s instructions for use, accurate testing can be effectively conducted by untrained personnel.
The US Food and Drug Administration (FDA) has expanded the approved use of the XW-100 Automated Hematology Analyzer.
The analyzer can now be used at non-traditional laboratory sites by non-medical personnel.
The XW-100 Automated Hematology Analyzer is intended for use in patients age 2 and older who require a whole blood cell count and white blood cell differential.
Test results can be used with other clinical and laboratory findings to provide early alerts of patients with serious conditions, such as severe anemia and agranulocytosis, who require additional testing.
The XW-100 Automated Hematology Analyzer is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases.
The device works by using a blood sample to classify and quantify 12 hematology parameters, which provides patients with a blood component profile as part of their overall health assessment.
Expanded clearance
The FDA granted the XW-100 Automated Hematology Analyzer a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The waiver allows the device to be used by a variety of non-traditional laboratory sites, including physicians’ offices, clinics, or other types of healthcare facilities with a CLIA Certificate of Waiver.
The XW-100 Automated Hematology Analyzer was reviewed through the dual submission pathway, a streamlined regulatory pathway for 510(k) marketing clearance and CLIA Waiver by Application.
A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
The XW-100 Automated Hematology Analyzer was originally cleared through the 510(k) pathway in 2015 for use at the patient’s point-of-care.
To support the use of this device in CLIA-waived settings with non-medical personnel, the analyzer is now accompanied by simple instructions for operator actions when results are flagged or outside of a specified range.
To further ensure accurate testing in this setting and to eliminate results that are most susceptible to inaccuracy or require additional testing, the number of hematology parameters has been reduced to 12.
The FDA found this modified version of the XW-100 Automated Hematology Analyzer to be substantially equivalent to the 2015 model.
In addition, data submitted by Sysmex America, Inc. (the company marketing the analyzer) demonstrated ease of use and a low risk of false results when the modified XW-100 Automated Hematology Analyzer was used by untrained operators.
The FDA reviewed data from a study conducted on 582 samples collected from patients ages 2 to 92.
In this study, researchers compared XW-100 Automated Hematology Analyzer results collected by non-medical personnel in CLIA-waived settings to results from a hematology analyzer in an accredited clinical laboratory.
Results showed that, by following the manufacturer’s instructions for use, accurate testing can be effectively conducted by untrained personnel.
The US Food and Drug Administration (FDA) has expanded the approved use of the XW-100 Automated Hematology Analyzer.
The analyzer can now be used at non-traditional laboratory sites by non-medical personnel.
The XW-100 Automated Hematology Analyzer is intended for use in patients age 2 and older who require a whole blood cell count and white blood cell differential.
Test results can be used with other clinical and laboratory findings to provide early alerts of patients with serious conditions, such as severe anemia and agranulocytosis, who require additional testing.
The XW-100 Automated Hematology Analyzer is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases.
The device works by using a blood sample to classify and quantify 12 hematology parameters, which provides patients with a blood component profile as part of their overall health assessment.
Expanded clearance
The FDA granted the XW-100 Automated Hematology Analyzer a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The waiver allows the device to be used by a variety of non-traditional laboratory sites, including physicians’ offices, clinics, or other types of healthcare facilities with a CLIA Certificate of Waiver.
The XW-100 Automated Hematology Analyzer was reviewed through the dual submission pathway, a streamlined regulatory pathway for 510(k) marketing clearance and CLIA Waiver by Application.
A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
The XW-100 Automated Hematology Analyzer was originally cleared through the 510(k) pathway in 2015 for use at the patient’s point-of-care.
To support the use of this device in CLIA-waived settings with non-medical personnel, the analyzer is now accompanied by simple instructions for operator actions when results are flagged or outside of a specified range.
To further ensure accurate testing in this setting and to eliminate results that are most susceptible to inaccuracy or require additional testing, the number of hematology parameters has been reduced to 12.
The FDA found this modified version of the XW-100 Automated Hematology Analyzer to be substantially equivalent to the 2015 model.
In addition, data submitted by Sysmex America, Inc. (the company marketing the analyzer) demonstrated ease of use and a low risk of false results when the modified XW-100 Automated Hematology Analyzer was used by untrained operators.
The FDA reviewed data from a study conducted on 582 samples collected from patients ages 2 to 92.
In this study, researchers compared XW-100 Automated Hematology Analyzer results collected by non-medical personnel in CLIA-waived settings to results from a hematology analyzer in an accredited clinical laboratory.
Results showed that, by following the manufacturer’s instructions for use, accurate testing can be effectively conducted by untrained personnel.
Intervention improves well-being in AYAs with cancer
SAN DIEGO—New research suggests an intervention can improve psychosocial health in adolescents and young adults (AYAs) living with cancer.
The intervention, Promoting Resilience in Stress Management (PRISM), is designed to help patients manage stress, set goals, and change their perspective.
Overall, PRISM improved resilience, enhanced quality of life, increased hope, and lowered distress and depression in the patients studied.
Abby R. Rosenberg, MD, of Seattle Children’s Research Institute in Seattle, Washington, presented these results at the 2017 Palliative and Supportive Care in Oncology Symposium (abstract 176*).
“The experience of cancer is stressful in all realms, but we tend to focus more on physical symptoms than the equally important social and emotional challenges,” Dr Rosenberg said.
“This is particularly true for adolescents and young adults who already struggle with normal developmental changes. When you throw cancer into the mix, it can become much harder.”
With this in mind, Dr Rosenberg and her colleagues tested PRISM in AYAs with cancer. The trial included 99 English-speaking patients, ages 12 to 25, who were diagnosed with new or newly recurrent cancer.
The patients were randomized to receive PRISM (n=49) plus standard psychosocial supportive care or standard care alone (n=50). Standard care at Seattle Children’s Research Institute includes a dedicated social worker and access to psychologists, child-life specialists, and other experts in AYA oncology care, as needed.
PRISM targets 4 topics:
- Managing stress with skills based on mindfulness and relaxation
- Setting goals that are specific and realistic, as well as planning for roadblocks
- Positive reframing, or recognizing and replacing negative self-talk
- Making meaning, or identifying benefits, gratitude, purpose, and legacy.
Each of the 4 topics were discussed with patients in separate, one-on-one sessions with a trained research associate. The sessions lasted 30 minutes to an hour. Patients also received boosters and worksheets for practicing the skills discussed in the meetings.
After all 4 sessions had been completed, patients could participate in an optional family meeting. During this meeting, patients could discuss with their family members which aspects of PRISM worked.
Results
Patients completed surveys at study enrollment, 2 months, 4 months, and 6 months. There were 74 participants who were still alive and well enough to complete the 6-month survey—36 in the PRISM group and 38 in the control group.
At the 6-month mark, PRISM was associated with (sometimes significant) improvements in resilience (P=0.02), generic quality of life (P=0.08), cancer-specific quality of life (P=0.01), hope (P=0.34), and distress (P=0.03). (P values are for absolute difference from baseline to 6 months.)
In addition, the incidence of depression at 6 months was lower in the PRISM group than the control group—6% and 21%, respectively (odds ratio=0.09, 95% CI 0.01, 1.09).
All but 4 of the PRISM recipients chose to participate in the family meeting following their one-on-one sessions.
“We included the family meeting because teens told us they wanted to share with their parents, and parents told us they wanted to know what their children had learned,” Dr Rosenberg said. “While the specific impact of this meeting is yet to be determined, we hope it will guide families so that there is continued support of teen or young adult patients.”
Now, Dr Rosenberg and her colleagues would like to test PRISM in other patient populations.
“We need to include a much larger cultural demographic in future studies,” Dr Rosenberg noted. “Beyond that, we also need to determine if this type of intervention could translate to other centers where usual care may not be as comprehensive as what we have here.”
*Some data in the abstract differ from the presentation.
SAN DIEGO—New research suggests an intervention can improve psychosocial health in adolescents and young adults (AYAs) living with cancer.
The intervention, Promoting Resilience in Stress Management (PRISM), is designed to help patients manage stress, set goals, and change their perspective.
Overall, PRISM improved resilience, enhanced quality of life, increased hope, and lowered distress and depression in the patients studied.
Abby R. Rosenberg, MD, of Seattle Children’s Research Institute in Seattle, Washington, presented these results at the 2017 Palliative and Supportive Care in Oncology Symposium (abstract 176*).
“The experience of cancer is stressful in all realms, but we tend to focus more on physical symptoms than the equally important social and emotional challenges,” Dr Rosenberg said.
“This is particularly true for adolescents and young adults who already struggle with normal developmental changes. When you throw cancer into the mix, it can become much harder.”
With this in mind, Dr Rosenberg and her colleagues tested PRISM in AYAs with cancer. The trial included 99 English-speaking patients, ages 12 to 25, who were diagnosed with new or newly recurrent cancer.
The patients were randomized to receive PRISM (n=49) plus standard psychosocial supportive care or standard care alone (n=50). Standard care at Seattle Children’s Research Institute includes a dedicated social worker and access to psychologists, child-life specialists, and other experts in AYA oncology care, as needed.
PRISM targets 4 topics:
- Managing stress with skills based on mindfulness and relaxation
- Setting goals that are specific and realistic, as well as planning for roadblocks
- Positive reframing, or recognizing and replacing negative self-talk
- Making meaning, or identifying benefits, gratitude, purpose, and legacy.
Each of the 4 topics were discussed with patients in separate, one-on-one sessions with a trained research associate. The sessions lasted 30 minutes to an hour. Patients also received boosters and worksheets for practicing the skills discussed in the meetings.
After all 4 sessions had been completed, patients could participate in an optional family meeting. During this meeting, patients could discuss with their family members which aspects of PRISM worked.
Results
Patients completed surveys at study enrollment, 2 months, 4 months, and 6 months. There were 74 participants who were still alive and well enough to complete the 6-month survey—36 in the PRISM group and 38 in the control group.
At the 6-month mark, PRISM was associated with (sometimes significant) improvements in resilience (P=0.02), generic quality of life (P=0.08), cancer-specific quality of life (P=0.01), hope (P=0.34), and distress (P=0.03). (P values are for absolute difference from baseline to 6 months.)
In addition, the incidence of depression at 6 months was lower in the PRISM group than the control group—6% and 21%, respectively (odds ratio=0.09, 95% CI 0.01, 1.09).
All but 4 of the PRISM recipients chose to participate in the family meeting following their one-on-one sessions.
“We included the family meeting because teens told us they wanted to share with their parents, and parents told us they wanted to know what their children had learned,” Dr Rosenberg said. “While the specific impact of this meeting is yet to be determined, we hope it will guide families so that there is continued support of teen or young adult patients.”
Now, Dr Rosenberg and her colleagues would like to test PRISM in other patient populations.
“We need to include a much larger cultural demographic in future studies,” Dr Rosenberg noted. “Beyond that, we also need to determine if this type of intervention could translate to other centers where usual care may not be as comprehensive as what we have here.”
*Some data in the abstract differ from the presentation.
SAN DIEGO—New research suggests an intervention can improve psychosocial health in adolescents and young adults (AYAs) living with cancer.
The intervention, Promoting Resilience in Stress Management (PRISM), is designed to help patients manage stress, set goals, and change their perspective.
Overall, PRISM improved resilience, enhanced quality of life, increased hope, and lowered distress and depression in the patients studied.
Abby R. Rosenberg, MD, of Seattle Children’s Research Institute in Seattle, Washington, presented these results at the 2017 Palliative and Supportive Care in Oncology Symposium (abstract 176*).
“The experience of cancer is stressful in all realms, but we tend to focus more on physical symptoms than the equally important social and emotional challenges,” Dr Rosenberg said.
“This is particularly true for adolescents and young adults who already struggle with normal developmental changes. When you throw cancer into the mix, it can become much harder.”
With this in mind, Dr Rosenberg and her colleagues tested PRISM in AYAs with cancer. The trial included 99 English-speaking patients, ages 12 to 25, who were diagnosed with new or newly recurrent cancer.
The patients were randomized to receive PRISM (n=49) plus standard psychosocial supportive care or standard care alone (n=50). Standard care at Seattle Children’s Research Institute includes a dedicated social worker and access to psychologists, child-life specialists, and other experts in AYA oncology care, as needed.
PRISM targets 4 topics:
- Managing stress with skills based on mindfulness and relaxation
- Setting goals that are specific and realistic, as well as planning for roadblocks
- Positive reframing, or recognizing and replacing negative self-talk
- Making meaning, or identifying benefits, gratitude, purpose, and legacy.
Each of the 4 topics were discussed with patients in separate, one-on-one sessions with a trained research associate. The sessions lasted 30 minutes to an hour. Patients also received boosters and worksheets for practicing the skills discussed in the meetings.
After all 4 sessions had been completed, patients could participate in an optional family meeting. During this meeting, patients could discuss with their family members which aspects of PRISM worked.
Results
Patients completed surveys at study enrollment, 2 months, 4 months, and 6 months. There were 74 participants who were still alive and well enough to complete the 6-month survey—36 in the PRISM group and 38 in the control group.
At the 6-month mark, PRISM was associated with (sometimes significant) improvements in resilience (P=0.02), generic quality of life (P=0.08), cancer-specific quality of life (P=0.01), hope (P=0.34), and distress (P=0.03). (P values are for absolute difference from baseline to 6 months.)
In addition, the incidence of depression at 6 months was lower in the PRISM group than the control group—6% and 21%, respectively (odds ratio=0.09, 95% CI 0.01, 1.09).
All but 4 of the PRISM recipients chose to participate in the family meeting following their one-on-one sessions.
“We included the family meeting because teens told us they wanted to share with their parents, and parents told us they wanted to know what their children had learned,” Dr Rosenberg said. “While the specific impact of this meeting is yet to be determined, we hope it will guide families so that there is continued support of teen or young adult patients.”
Now, Dr Rosenberg and her colleagues would like to test PRISM in other patient populations.
“We need to include a much larger cultural demographic in future studies,” Dr Rosenberg noted. “Beyond that, we also need to determine if this type of intervention could translate to other centers where usual care may not be as comprehensive as what we have here.”
*Some data in the abstract differ from the presentation.