Lymphoma & Plasma Cell Disorders

Clinician and cancer patient

Photo courtesy of NCI Clinical

Center/Mathews Media Group

Expectations may not correspond to reality for cancer patients considering enrollment in phase 1 trials, according to a study published in Cancer.

The study showed that, even after consulting with clinicians, nearly half of patients expected their tumors would shrink during the trial, and some patients expected to be cured.

In reality, the typical response rates of phase 1 cancer trials range from 4% to 20%, and patients survive for a median of 6 months.

Udai Banerji, MD, PhD, of The Institute of Cancer Research in London, England, and his colleagues conducted this study.

The team explored patients’ motivations for considering participation in phase 1 trials and assessed their expectations both before and after they consulted with clinicians.

The study included 396 patients who were considering enrollment in a phase 1 trial. All of these patients completed questionnaires prior to a consultation with a clinician, and 301 completed an abbreviated follow-up questionnaire after their consultation.

A majority of the patients said they were willing to enroll in a trial—72% pre-consultation and 84% after.

Before their consultation, 84% of patients ranked the possibility of tumor shrinkage as the most important reason for considering a phase 1 trial.

Fifty-six percent of patients said the most important reason was a lack of alternative treatments, 44% said it was their physician’s recommendation, and 38% said it was the possibility that the research might benefit others. (Patients could give the same rank to multiple reasons.)

Before their consultation, 43% of patients predicted their tumors would shrink if they participated in a trial. After the consultation, this increased to 47%, and 14% of patients thought they would be cured by participating in the trial. (Patients were not asked about the possibility of cure in the pre-consultation questionnaire.)

Before their consultation, 71% of patients said they expected moderate side effects related to the treatment being tested. This increased to 77% after the consultation. Only 11% of patients expected severe side effects pre-consultation, a figure that decreased to 7% after consultation.

Before consultation, about half of patients did not expect that weekly hospital visits would be required for participation in the trial. After the consultation, 93% of patients expected weekly visits.

“There is a positive message in this [study], which is that 84% of patients are willing to participate in phase 1 oncology studies after a discussion with clinical and nursing staff who lay out the conservative estimates of benefit and requirements of hospital visits,” Dr Banerji said.

“This is good for current and future patients and cancer medicine in general. [However,] the high percentage of patients expecting their tumors to shrink was a sobering finding. This creates a challenge for healthcare professionals to manage expectations but to do so without being patronizing or dismissing human hope.”

Clinician and cancer patient

Photo courtesy of NCI Clinical

Center/Mathews Media Group

Expectations may not correspond to reality for cancer patients considering enrollment in phase 1 trials, according to a study published in Cancer.

The study showed that, even after consulting with clinicians, nearly half of patients expected their tumors would shrink during the trial, and some patients expected to be cured.

In reality, the typical response rates of phase 1 cancer trials range from 4% to 20%, and patients survive for a median of 6 months.

Udai Banerji, MD, PhD, of The Institute of Cancer Research in London, England, and his colleagues conducted this study.

The team explored patients’ motivations for considering participation in phase 1 trials and assessed their expectations both before and after they consulted with clinicians.

The study included 396 patients who were considering enrollment in a phase 1 trial. All of these patients completed questionnaires prior to a consultation with a clinician, and 301 completed an abbreviated follow-up questionnaire after their consultation.

A majority of the patients said they were willing to enroll in a trial—72% pre-consultation and 84% after.

Before their consultation, 84% of patients ranked the possibility of tumor shrinkage as the most important reason for considering a phase 1 trial.

Fifty-six percent of patients said the most important reason was a lack of alternative treatments, 44% said it was their physician’s recommendation, and 38% said it was the possibility that the research might benefit others. (Patients could give the same rank to multiple reasons.)

Before their consultation, 43% of patients predicted their tumors would shrink if they participated in a trial. After the consultation, this increased to 47%, and 14% of patients thought they would be cured by participating in the trial. (Patients were not asked about the possibility of cure in the pre-consultation questionnaire.)

Before their consultation, 71% of patients said they expected moderate side effects related to the treatment being tested. This increased to 77% after the consultation. Only 11% of patients expected severe side effects pre-consultation, a figure that decreased to 7% after consultation.

Before consultation, about half of patients did not expect that weekly hospital visits would be required for participation in the trial. After the consultation, 93% of patients expected weekly visits.

“There is a positive message in this [study], which is that 84% of patients are willing to participate in phase 1 oncology studies after a discussion with clinical and nursing staff who lay out the conservative estimates of benefit and requirements of hospital visits,” Dr Banerji said.

“This is good for current and future patients and cancer medicine in general. [However,] the high percentage of patients expecting their tumors to shrink was a sobering finding. This creates a challenge for healthcare professionals to manage expectations but to do so without being patronizing or dismissing human hope.”

Clinician and cancer patient

Photo courtesy of NCI Clinical

Center/Mathews Media Group

Expectations may not correspond to reality for cancer patients considering enrollment in phase 1 trials, according to a study published in Cancer.

The study showed that, even after consulting with clinicians, nearly half of patients expected their tumors would shrink during the trial, and some patients expected to be cured.

In reality, the typical response rates of phase 1 cancer trials range from 4% to 20%, and patients survive for a median of 6 months.

Udai Banerji, MD, PhD, of The Institute of Cancer Research in London, England, and his colleagues conducted this study.

The team explored patients’ motivations for considering participation in phase 1 trials and assessed their expectations both before and after they consulted with clinicians.

The study included 396 patients who were considering enrollment in a phase 1 trial. All of these patients completed questionnaires prior to a consultation with a clinician, and 301 completed an abbreviated follow-up questionnaire after their consultation.

A majority of the patients said they were willing to enroll in a trial—72% pre-consultation and 84% after.

Before their consultation, 84% of patients ranked the possibility of tumor shrinkage as the most important reason for considering a phase 1 trial.

Fifty-six percent of patients said the most important reason was a lack of alternative treatments, 44% said it was their physician’s recommendation, and 38% said it was the possibility that the research might benefit others. (Patients could give the same rank to multiple reasons.)

Before their consultation, 43% of patients predicted their tumors would shrink if they participated in a trial. After the consultation, this increased to 47%, and 14% of patients thought they would be cured by participating in the trial. (Patients were not asked about the possibility of cure in the pre-consultation questionnaire.)

Before their consultation, 71% of patients said they expected moderate side effects related to the treatment being tested. This increased to 77% after the consultation. Only 11% of patients expected severe side effects pre-consultation, a figure that decreased to 7% after consultation.

Before consultation, about half of patients did not expect that weekly hospital visits would be required for participation in the trial. After the consultation, 93% of patients expected weekly visits.

“There is a positive message in this [study], which is that 84% of patients are willing to participate in phase 1 oncology studies after a discussion with clinical and nursing staff who lay out the conservative estimates of benefit and requirements of hospital visits,” Dr Banerji said.

“This is good for current and future patients and cancer medicine in general. [However,] the high percentage of patients expecting their tumors to shrink was a sobering finding. This creates a challenge for healthcare professionals to manage expectations but to do so without being patronizing or dismissing human hope.”

 

 

Cancer patient receives therapy

Photo by Rhoda Baer

 

A new report highlights recent advances made in the fight against cancer but suggests the burden of cancer in the US is still on the rise.

The AACR Cancer Progress Report 2016 states that the number of cancer survivors in the US rose by 1 million from 2014 to 2016, reaching an estimated 15.5 million.

Meanwhile, the US Food and Drug Administration (FDA) approved new treatments for a range of cancers.

Between August 1, 2015, and July 31, 2016, the FDA approved 13 new anticancer therapies and new uses for 11 previously approved anticancer therapies.

Six of these drugs were approved to treat hematologic malignancies:

• Venetoclax for chronic lymphocytic leukemia
• Daratumumab for multiple myeloma
• Elotuzumab for multiple myeloma
• Ixazomib for multiple myeloma
• Obinutuzumab for follicular lymphoma
• Nivolumab for classical Hodgkin lymphoma.

The report notes that the use of immunotherapy, in particular, is on the rise. For example, on August 1, 2015, checkpoint inhibitors were approved for just 2 cancers—melanoma and lung cancer.

As of September 1, 2016, checkpoint inhibitors have been approved for 6 cancers—Hodgkin lymphoma, bladder cancer, head and neck cancer, kidney cancer, lung cancer, and melanoma.

“The promise of immunotherapy for cancer therapy has never been greater, and the opportunity to make significant progress in this critical area is real,” said Nancy E. Davidson, MD, president of the AACR and director of the University of Pittsburgh Cancer Institute in Pennsylvania.

“However, continued progress is going to require a sustained federal commitment to the research agenda. And in fact, if the necessary funding is provided, we will accelerate the pace of progress and, in turn, markedly reduce morbidity and mortality from cancer.”

Growing burden of cancer

The report emphasizes that although advances are being made against cancers, these diseases continue to exert an immense personal and economic toll, and the burden of cancer is expected to grow in the coming decades.

According to the report:

• More than 595,000 people in the US are projected to die from cancer in 2016
• Cancer is the number one cause of disease-related death among US children
• The number of new cancer cases in the US is predicted to rise from 1.7 million in 2015 to 2.4 million in 2035
• It is estimated that the direct medical costs of cancer care in the US in 2010 were nearly $125 billion, and these costs will rise to $156 billion in 2020.

The report states that the increasing economic and personal burden of cancer underscores the need for more research to develop new approaches to cancer prevention and treatment.

The report also highlights the recommendations of the National Cancer Moonshot Initiative Blue Ribbon Panel for accelerating the pace of progress in cancer research.

“Research has made tremendous advances against cancer,” said Margaret Foti, PhD, MD, chief executive officer of the AACR.

“However, we need to accelerate the pace of progress because it is unacceptable that 1 American will die of cancer every minute of every day this year.”

 

 

Cancer patient receives therapy

Photo by Rhoda Baer

 

A new report highlights recent advances made in the fight against cancer but suggests the burden of cancer in the US is still on the rise.

The AACR Cancer Progress Report 2016 states that the number of cancer survivors in the US rose by 1 million from 2014 to 2016, reaching an estimated 15.5 million.

Meanwhile, the US Food and Drug Administration (FDA) approved new treatments for a range of cancers.

Between August 1, 2015, and July 31, 2016, the FDA approved 13 new anticancer therapies and new uses for 11 previously approved anticancer therapies.

Six of these drugs were approved to treat hematologic malignancies:

• Venetoclax for chronic lymphocytic leukemia
• Daratumumab for multiple myeloma
• Elotuzumab for multiple myeloma
• Ixazomib for multiple myeloma
• Obinutuzumab for follicular lymphoma
• Nivolumab for classical Hodgkin lymphoma.

The report notes that the use of immunotherapy, in particular, is on the rise. For example, on August 1, 2015, checkpoint inhibitors were approved for just 2 cancers—melanoma and lung cancer.

As of September 1, 2016, checkpoint inhibitors have been approved for 6 cancers—Hodgkin lymphoma, bladder cancer, head and neck cancer, kidney cancer, lung cancer, and melanoma.

“The promise of immunotherapy for cancer therapy has never been greater, and the opportunity to make significant progress in this critical area is real,” said Nancy E. Davidson, MD, president of the AACR and director of the University of Pittsburgh Cancer Institute in Pennsylvania.

“However, continued progress is going to require a sustained federal commitment to the research agenda. And in fact, if the necessary funding is provided, we will accelerate the pace of progress and, in turn, markedly reduce morbidity and mortality from cancer.”

Growing burden of cancer

The report emphasizes that although advances are being made against cancers, these diseases continue to exert an immense personal and economic toll, and the burden of cancer is expected to grow in the coming decades.

According to the report:

• More than 595,000 people in the US are projected to die from cancer in 2016
• Cancer is the number one cause of disease-related death among US children
• The number of new cancer cases in the US is predicted to rise from 1.7 million in 2015 to 2.4 million in 2035
• It is estimated that the direct medical costs of cancer care in the US in 2010 were nearly $125 billion, and these costs will rise to $156 billion in 2020.

The report states that the increasing economic and personal burden of cancer underscores the need for more research to develop new approaches to cancer prevention and treatment.

The report also highlights the recommendations of the National Cancer Moonshot Initiative Blue Ribbon Panel for accelerating the pace of progress in cancer research.

“Research has made tremendous advances against cancer,” said Margaret Foti, PhD, MD, chief executive officer of the AACR.

“However, we need to accelerate the pace of progress because it is unacceptable that 1 American will die of cancer every minute of every day this year.”

 

 

Cancer patient receives therapy

Photo by Rhoda Baer

 

A new report highlights recent advances made in the fight against cancer but suggests the burden of cancer in the US is still on the rise.

The AACR Cancer Progress Report 2016 states that the number of cancer survivors in the US rose by 1 million from 2014 to 2016, reaching an estimated 15.5 million.

Meanwhile, the US Food and Drug Administration (FDA) approved new treatments for a range of cancers.

Between August 1, 2015, and July 31, 2016, the FDA approved 13 new anticancer therapies and new uses for 11 previously approved anticancer therapies.

Six of these drugs were approved to treat hematologic malignancies:

• Venetoclax for chronic lymphocytic leukemia
• Daratumumab for multiple myeloma
• Elotuzumab for multiple myeloma
• Ixazomib for multiple myeloma
• Obinutuzumab for follicular lymphoma
• Nivolumab for classical Hodgkin lymphoma.

The report notes that the use of immunotherapy, in particular, is on the rise. For example, on August 1, 2015, checkpoint inhibitors were approved for just 2 cancers—melanoma and lung cancer.

As of September 1, 2016, checkpoint inhibitors have been approved for 6 cancers—Hodgkin lymphoma, bladder cancer, head and neck cancer, kidney cancer, lung cancer, and melanoma.

“The promise of immunotherapy for cancer therapy has never been greater, and the opportunity to make significant progress in this critical area is real,” said Nancy E. Davidson, MD, president of the AACR and director of the University of Pittsburgh Cancer Institute in Pennsylvania.

“However, continued progress is going to require a sustained federal commitment to the research agenda. And in fact, if the necessary funding is provided, we will accelerate the pace of progress and, in turn, markedly reduce morbidity and mortality from cancer.”

Growing burden of cancer

The report emphasizes that although advances are being made against cancers, these diseases continue to exert an immense personal and economic toll, and the burden of cancer is expected to grow in the coming decades.

According to the report:

• More than 595,000 people in the US are projected to die from cancer in 2016
• Cancer is the number one cause of disease-related death among US children
• The number of new cancer cases in the US is predicted to rise from 1.7 million in 2015 to 2.4 million in 2035
• It is estimated that the direct medical costs of cancer care in the US in 2010 were nearly $125 billion, and these costs will rise to $156 billion in 2020.

The report states that the increasing economic and personal burden of cancer underscores the need for more research to develop new approaches to cancer prevention and treatment.

The report also highlights the recommendations of the National Cancer Moonshot Initiative Blue Ribbon Panel for accelerating the pace of progress in cancer research.

“Research has made tremendous advances against cancer,” said Margaret Foti, PhD, MD, chief executive officer of the AACR.

“However, we need to accelerate the pace of progress because it is unacceptable that 1 American will die of cancer every minute of every day this year.”

Doctor and patient in hospital

Photo courtesy of CDC

New research suggests that many patients who die of cancer do not receive strong opioid medications in their last year of life, despite the fact that these drugs are the recommended treatment for cancer-related pain.

Researchers used UK Cancer Registry Data to study more than 6000 cancer patients who died over a 7-year period.

Less than half of these patients received prescriptions for strong opioid medications in their last year of life.

Among those patients who did receive such prescriptions, many received them late.

Lucy Ziegler, PhD, of the University of Leeds in the UK, and her colleagues conducted this study and reported the results in PAIN.

The study included 6080 cancer patients who died between 2005 and 2012.

About 76% (n=4610) of these patients had received one or more prescriptions for analgesics, including 48% (n=2919) who received a strong opioid and 28% (n=1691) who received a non-opioid or weak opioid. The remaining 24% (n=1470) did not receive any prescription analgesic.

The chance of receiving strong opioids was not affected by patients’ age or sex.

However, patients who died in a hospital were 60% less likely to have a prescription for strong opioids during the last year of life, when compared with those who died in hospice.

And patients who received chemotherapy in the last year of life were 30% more likely to receive a strong opioid than patients who did not receive chemotherapy.

Timing of therapy

Among the patients who did receive strong opioids, the median time between receiving the medication and death was 9 weeks. By 6 weeks before death, just 30% of patients had been prescribed a strong opioid.

The researchers noted that these figures don’t match up with previous studies reporting that severe pain can occur “much earlier in the cancer trajectory.”

Older patients were more likely to receive their strong opioid prescription late (defined as later than 9 weeks before death). After other factors were taken into account, patients age 60 or older were about 2 to 4 times more likely to be in the late-prescribing group, compared with those age 50 or younger.

Compared to patients who died in hospice, patients who died in a hospital were 40% more likely to receive a late prescription for a strong opioid. Patients who died in their own home were 2.6 times more likely to receive a late prescription, and patients who died in a care home were 2.8 times more likely to receive a late prescription.

Patients who had surgery were 40% more likely to receive a late prescription than patients who did not undergo surgery.

But patients who received chemotherapy and/or radiotherapy were 30% more likely to have received an early prescription for a strong opioid than patients who did not receive chemo/radiotherapy.

Dr Ziegler and her colleagues noted that this study had its limitations; in particular, the lack of data on pain severity.

Still, the researchers believe their results support the hypothesis of potential under-treatment of cancer pain and suggest that many more patients with advanced cancer and pain may benefit from a strong opioid analgesic.

Doctor and patient in hospital

Photo courtesy of CDC

New research suggests that many patients who die of cancer do not receive strong opioid medications in their last year of life, despite the fact that these drugs are the recommended treatment for cancer-related pain.

Researchers used UK Cancer Registry Data to study more than 6000 cancer patients who died over a 7-year period.

Less than half of these patients received prescriptions for strong opioid medications in their last year of life.

Among those patients who did receive such prescriptions, many received them late.

Lucy Ziegler, PhD, of the University of Leeds in the UK, and her colleagues conducted this study and reported the results in PAIN.

The study included 6080 cancer patients who died between 2005 and 2012.

About 76% (n=4610) of these patients had received one or more prescriptions for analgesics, including 48% (n=2919) who received a strong opioid and 28% (n=1691) who received a non-opioid or weak opioid. The remaining 24% (n=1470) did not receive any prescription analgesic.

The chance of receiving strong opioids was not affected by patients’ age or sex.

However, patients who died in a hospital were 60% less likely to have a prescription for strong opioids during the last year of life, when compared with those who died in hospice.

And patients who received chemotherapy in the last year of life were 30% more likely to receive a strong opioid than patients who did not receive chemotherapy.

Timing of therapy

Among the patients who did receive strong opioids, the median time between receiving the medication and death was 9 weeks. By 6 weeks before death, just 30% of patients had been prescribed a strong opioid.

The researchers noted that these figures don’t match up with previous studies reporting that severe pain can occur “much earlier in the cancer trajectory.”

Older patients were more likely to receive their strong opioid prescription late (defined as later than 9 weeks before death). After other factors were taken into account, patients age 60 or older were about 2 to 4 times more likely to be in the late-prescribing group, compared with those age 50 or younger.

Compared to patients who died in hospice, patients who died in a hospital were 40% more likely to receive a late prescription for a strong opioid. Patients who died in their own home were 2.6 times more likely to receive a late prescription, and patients who died in a care home were 2.8 times more likely to receive a late prescription.

Patients who had surgery were 40% more likely to receive a late prescription than patients who did not undergo surgery.

But patients who received chemotherapy and/or radiotherapy were 30% more likely to have received an early prescription for a strong opioid than patients who did not receive chemo/radiotherapy.

Dr Ziegler and her colleagues noted that this study had its limitations; in particular, the lack of data on pain severity.

Still, the researchers believe their results support the hypothesis of potential under-treatment of cancer pain and suggest that many more patients with advanced cancer and pain may benefit from a strong opioid analgesic.

Doctor and patient in hospital

Photo courtesy of CDC

New research suggests that many patients who die of cancer do not receive strong opioid medications in their last year of life, despite the fact that these drugs are the recommended treatment for cancer-related pain.

Researchers used UK Cancer Registry Data to study more than 6000 cancer patients who died over a 7-year period.

Less than half of these patients received prescriptions for strong opioid medications in their last year of life.

Among those patients who did receive such prescriptions, many received them late.

Lucy Ziegler, PhD, of the University of Leeds in the UK, and her colleagues conducted this study and reported the results in PAIN.

The study included 6080 cancer patients who died between 2005 and 2012.

About 76% (n=4610) of these patients had received one or more prescriptions for analgesics, including 48% (n=2919) who received a strong opioid and 28% (n=1691) who received a non-opioid or weak opioid. The remaining 24% (n=1470) did not receive any prescription analgesic.

The chance of receiving strong opioids was not affected by patients’ age or sex.

However, patients who died in a hospital were 60% less likely to have a prescription for strong opioids during the last year of life, when compared with those who died in hospice.

And patients who received chemotherapy in the last year of life were 30% more likely to receive a strong opioid than patients who did not receive chemotherapy.

Timing of therapy

Among the patients who did receive strong opioids, the median time between receiving the medication and death was 9 weeks. By 6 weeks before death, just 30% of patients had been prescribed a strong opioid.

The researchers noted that these figures don’t match up with previous studies reporting that severe pain can occur “much earlier in the cancer trajectory.”

Older patients were more likely to receive their strong opioid prescription late (defined as later than 9 weeks before death). After other factors were taken into account, patients age 60 or older were about 2 to 4 times more likely to be in the late-prescribing group, compared with those age 50 or younger.

Compared to patients who died in hospice, patients who died in a hospital were 40% more likely to receive a late prescription for a strong opioid. Patients who died in their own home were 2.6 times more likely to receive a late prescription, and patients who died in a care home were 2.8 times more likely to receive a late prescription.

Patients who had surgery were 40% more likely to receive a late prescription than patients who did not undergo surgery.

But patients who received chemotherapy and/or radiotherapy were 30% more likely to have received an early prescription for a strong opioid than patients who did not receive chemo/radiotherapy.

Dr Ziegler and her colleagues noted that this study had its limitations; in particular, the lack of data on pain severity.

Still, the researchers believe their results support the hypothesis of potential under-treatment of cancer pain and suggest that many more patients with advanced cancer and pain may benefit from a strong opioid analgesic.

Lenalidomide monotherapy demonstrated “meaningful” antitumor activity in patients with relapsed or recurrent aggressive adult T-cell leukemia/lymphoma (ATL), according to new findings.

Among 26 patients enrolled in the study, 11 responses were observed, for an overall response rate of 42% (95% CI, 23%-63%). This included four complete responses and one unconfirmed complete response.

The tumor control rate was 73%, achieved in 19 patients, and the toxicity profile was manageable. Overall, these findings hint at the potential of lenalidomide to “become a treatment option in this patient population,” wrote Takashi Ishida, MD, of Nagoya City University Graduate School of Medical Sciences, Aichi, Japan, and his colleagues (J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.67.7732).

ATL is a difficult disease to treat, and it has a poor prognosis, as it is resistant to conventional chemotherapeutic agents and treatment options are currently limited. Lenalidomide, an oral immunomodulatory agent, has demonstrated both antiproliferative and antineoplastic activity in B-cell lymphomas in preclinical studies, and a previous phase I trial established a maximum tolerated dosage (25 mg/d) in a small cohort of Japanese patients with relapsed ATL or other peripheral T-cell lymphomas (PTCL).

Based on these preliminary results, Dr. Ishida and his coauthors designed the current multicenter phase II study, to evaluate the efficacy and safety of lenalidomide monotherapy in 26 patients with relapsed or recurrent ATL.­­­

At a median follow-up of 3.9 months, responses were observed in 33% of patients (5 of 15) with acute disease, 57% (4 of 7) with lymphoma, and 50% (2 of 4) for unfavorable chronic ATL. Patient responses according to disease site were 31% for target (nodal and extranodal) lesions, 75% for cutaneous lesions, and 60% for peripheral blood. 

The median time to relapse was 1.9 months (range, 1.8-3.7 months), while the median time to progression was 3.8 months (95% CI, 1.9 to not estimable [NE]). The median and mean duration of response for the entire cohort were NE (95% CI, 0.5 months to NE) and 5.2 months (range, 0 to 16.6 months), respectively.

Progression-free survival was 3.8 months (95% CI, 1.9 months to NE) and for overall survival, it was 20.3 months (95% CI, 9.1 months to NE).

Adverse events occurred in more than 20% of patients and the most common hematologic event was thrombocytopenia (77%). The most common nonhematologic event was increased C-reactive protein (42%), and hypoalbuminemia and hypoproteinemia were observed in about a third of patients, as were constipation, hyponatremia, and hypocalcemia (all 31%).

Dr. Ishida and several coauthors reported multiple relationships with industry, including Celgene K.K. (Tokyo), the study’s sponsor.

Lenalidomide monotherapy demonstrated “meaningful” antitumor activity in patients with relapsed or recurrent aggressive adult T-cell leukemia/lymphoma (ATL), according to new findings.

Among 26 patients enrolled in the study, 11 responses were observed, for an overall response rate of 42% (95% CI, 23%-63%). This included four complete responses and one unconfirmed complete response.

The tumor control rate was 73%, achieved in 19 patients, and the toxicity profile was manageable. Overall, these findings hint at the potential of lenalidomide to “become a treatment option in this patient population,” wrote Takashi Ishida, MD, of Nagoya City University Graduate School of Medical Sciences, Aichi, Japan, and his colleagues (J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.67.7732).

ATL is a difficult disease to treat, and it has a poor prognosis, as it is resistant to conventional chemotherapeutic agents and treatment options are currently limited. Lenalidomide, an oral immunomodulatory agent, has demonstrated both antiproliferative and antineoplastic activity in B-cell lymphomas in preclinical studies, and a previous phase I trial established a maximum tolerated dosage (25 mg/d) in a small cohort of Japanese patients with relapsed ATL or other peripheral T-cell lymphomas (PTCL).

Based on these preliminary results, Dr. Ishida and his coauthors designed the current multicenter phase II study, to evaluate the efficacy and safety of lenalidomide monotherapy in 26 patients with relapsed or recurrent ATL.­­­

At a median follow-up of 3.9 months, responses were observed in 33% of patients (5 of 15) with acute disease, 57% (4 of 7) with lymphoma, and 50% (2 of 4) for unfavorable chronic ATL. Patient responses according to disease site were 31% for target (nodal and extranodal) lesions, 75% for cutaneous lesions, and 60% for peripheral blood. 

The median time to relapse was 1.9 months (range, 1.8-3.7 months), while the median time to progression was 3.8 months (95% CI, 1.9 to not estimable [NE]). The median and mean duration of response for the entire cohort were NE (95% CI, 0.5 months to NE) and 5.2 months (range, 0 to 16.6 months), respectively.

Progression-free survival was 3.8 months (95% CI, 1.9 months to NE) and for overall survival, it was 20.3 months (95% CI, 9.1 months to NE).

Adverse events occurred in more than 20% of patients and the most common hematologic event was thrombocytopenia (77%). The most common nonhematologic event was increased C-reactive protein (42%), and hypoalbuminemia and hypoproteinemia were observed in about a third of patients, as were constipation, hyponatremia, and hypocalcemia (all 31%).

Dr. Ishida and several coauthors reported multiple relationships with industry, including Celgene K.K. (Tokyo), the study’s sponsor.

Lenalidomide monotherapy demonstrated “meaningful” antitumor activity in patients with relapsed or recurrent aggressive adult T-cell leukemia/lymphoma (ATL), according to new findings.

Among 26 patients enrolled in the study, 11 responses were observed, for an overall response rate of 42% (95% CI, 23%-63%). This included four complete responses and one unconfirmed complete response.

The tumor control rate was 73%, achieved in 19 patients, and the toxicity profile was manageable. Overall, these findings hint at the potential of lenalidomide to “become a treatment option in this patient population,” wrote Takashi Ishida, MD, of Nagoya City University Graduate School of Medical Sciences, Aichi, Japan, and his colleagues (J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.67.7732).

ATL is a difficult disease to treat, and it has a poor prognosis, as it is resistant to conventional chemotherapeutic agents and treatment options are currently limited. Lenalidomide, an oral immunomodulatory agent, has demonstrated both antiproliferative and antineoplastic activity in B-cell lymphomas in preclinical studies, and a previous phase I trial established a maximum tolerated dosage (25 mg/d) in a small cohort of Japanese patients with relapsed ATL or other peripheral T-cell lymphomas (PTCL).

Based on these preliminary results, Dr. Ishida and his coauthors designed the current multicenter phase II study, to evaluate the efficacy and safety of lenalidomide monotherapy in 26 patients with relapsed or recurrent ATL.­­­

At a median follow-up of 3.9 months, responses were observed in 33% of patients (5 of 15) with acute disease, 57% (4 of 7) with lymphoma, and 50% (2 of 4) for unfavorable chronic ATL. Patient responses according to disease site were 31% for target (nodal and extranodal) lesions, 75% for cutaneous lesions, and 60% for peripheral blood. 

The median time to relapse was 1.9 months (range, 1.8-3.7 months), while the median time to progression was 3.8 months (95% CI, 1.9 to not estimable [NE]). The median and mean duration of response for the entire cohort were NE (95% CI, 0.5 months to NE) and 5.2 months (range, 0 to 16.6 months), respectively.

Progression-free survival was 3.8 months (95% CI, 1.9 months to NE) and for overall survival, it was 20.3 months (95% CI, 9.1 months to NE).

Adverse events occurred in more than 20% of patients and the most common hematologic event was thrombocytopenia (77%). The most common nonhematologic event was increased C-reactive protein (42%), and hypoalbuminemia and hypoproteinemia were observed in about a third of patients, as were constipation, hyponatremia, and hypocalcemia (all 31%).

Dr. Ishida and several coauthors reported multiple relationships with industry, including Celgene K.K. (Tokyo), the study’s sponsor.

Cancer patient

Photo by Bill Branson

Brain cancer has overtaken leukemia to become the deadliest childhood cancer in the US, according to a report from the US Centers for Disease Control and Prevention’s National Center for Health Statistics.

The report includes cancer mortality statistics from 1999 to 2014 pertaining to children and adolescents (ages 1 to 19).

In both 1999 and 2014, more than half of all cancer deaths in this population were attributable to leukemias or brain cancers.

In 1999, a greater percentage of deaths were attributed to leukemias than to brain cancers—29.7% and 23.7%, respectively.

But in 2014, brain cancer deaths exceeded leukemia deaths—29.9% and 24.9%, respectively.

The data also showed that, overall, cancer mortality has decreased among children and adolescents in the US.

The cancer death rate was 20% lower in 2014 than in 1999—2.28 deaths per 100,000 persons and 2.85 deaths per 100,000 persons, respectively.

Cancer death rates declined from 1999 to 2014 for all of the age groups studied (divided by 5-year increments) and for both sexes. However, cancer death rates were consistently higher for males than females.

In 2014, 54.8% of cancer deaths among children and adolescents were attributable to either leukemias or brain cancers.

The 2014 death rates by cancer site, from most common to least, were as follows:

• Brain cancers (29.9%)
• Leukemias (24.9%)
• Bone and articular cartilage cancers (10.1%)
• Cancers of the thyroid and other endocrine glands (9.0%)
• Mesothelial and soft tissue cancers (7.7%)
• Non-Hodgkin lymphomas (3.9%)
• Cancers of the liver and intrahepatic bile ducts (2.0%)
• Cancers of the kidney and renal pelvis (1.8%).

Data on the remaining cancer sites were not shown separately.

For more information, see the full report, “Declines in Cancer Death Rates Among Children and Adolescents in the United States, 1999–2014.”

Cancer patient

Photo by Bill Branson

Brain cancer has overtaken leukemia to become the deadliest childhood cancer in the US, according to a report from the US Centers for Disease Control and Prevention’s National Center for Health Statistics.

The report includes cancer mortality statistics from 1999 to 2014 pertaining to children and adolescents (ages 1 to 19).

In both 1999 and 2014, more than half of all cancer deaths in this population were attributable to leukemias or brain cancers.

In 1999, a greater percentage of deaths were attributed to leukemias than to brain cancers—29.7% and 23.7%, respectively.

But in 2014, brain cancer deaths exceeded leukemia deaths—29.9% and 24.9%, respectively.

The data also showed that, overall, cancer mortality has decreased among children and adolescents in the US.

The cancer death rate was 20% lower in 2014 than in 1999—2.28 deaths per 100,000 persons and 2.85 deaths per 100,000 persons, respectively.

Cancer death rates declined from 1999 to 2014 for all of the age groups studied (divided by 5-year increments) and for both sexes. However, cancer death rates were consistently higher for males than females.

In 2014, 54.8% of cancer deaths among children and adolescents were attributable to either leukemias or brain cancers.

The 2014 death rates by cancer site, from most common to least, were as follows:

• Brain cancers (29.9%)
• Leukemias (24.9%)
• Bone and articular cartilage cancers (10.1%)
• Cancers of the thyroid and other endocrine glands (9.0%)
• Mesothelial and soft tissue cancers (7.7%)
• Non-Hodgkin lymphomas (3.9%)
• Cancers of the liver and intrahepatic bile ducts (2.0%)
• Cancers of the kidney and renal pelvis (1.8%).

Data on the remaining cancer sites were not shown separately.

For more information, see the full report, “Declines in Cancer Death Rates Among Children and Adolescents in the United States, 1999–2014.”

Cancer patient

Photo by Bill Branson

Brain cancer has overtaken leukemia to become the deadliest childhood cancer in the US, according to a report from the US Centers for Disease Control and Prevention’s National Center for Health Statistics.

The report includes cancer mortality statistics from 1999 to 2014 pertaining to children and adolescents (ages 1 to 19).

In both 1999 and 2014, more than half of all cancer deaths in this population were attributable to leukemias or brain cancers.

In 1999, a greater percentage of deaths were attributed to leukemias than to brain cancers—29.7% and 23.7%, respectively.

But in 2014, brain cancer deaths exceeded leukemia deaths—29.9% and 24.9%, respectively.

The data also showed that, overall, cancer mortality has decreased among children and adolescents in the US.

The cancer death rate was 20% lower in 2014 than in 1999—2.28 deaths per 100,000 persons and 2.85 deaths per 100,000 persons, respectively.

Cancer death rates declined from 1999 to 2014 for all of the age groups studied (divided by 5-year increments) and for both sexes. However, cancer death rates were consistently higher for males than females.

In 2014, 54.8% of cancer deaths among children and adolescents were attributable to either leukemias or brain cancers.

The 2014 death rates by cancer site, from most common to least, were as follows:

• Brain cancers (29.9%)
• Leukemias (24.9%)
• Bone and articular cartilage cancers (10.1%)
• Cancers of the thyroid and other endocrine glands (9.0%)
• Mesothelial and soft tissue cancers (7.7%)
• Non-Hodgkin lymphomas (3.9%)
• Cancers of the liver and intrahepatic bile ducts (2.0%)
• Cancers of the kidney and renal pelvis (1.8%).

Data on the remaining cancer sites were not shown separately.

For more information, see the full report, “Declines in Cancer Death Rates Among Children and Adolescents in the United States, 1999–2014.”

The Food and Drug Administration has modified the dosage regimen for nivolumab for indications of renal cell carcinoma, metastatic melanoma, and non–small cell lung cancer.

The single-dose regimen of nivolumab (3 mg/kg IV every 2 weeks) is replaced with the new recommended regimen of 240 mg IV every 2 weeks until disease progression or intolerable toxicity, the FDA said in a written statement.

The nivolumab (Opdivo) dosing regimen in combination with ipilimumab for melanoma will stay the same (nivolumab 1 mg/kg IV, followed by ipilimumab on the same day, every 3 weeks for four doses); however, after completion of ipilimumab, the recommended nivolumab dose is modified to 240 mg every 2 weeks until disease progression or intolerable toxicity. The recommended dose for classical Hodgkin lymphoma remains at 3 mg/kg IV every 2 weeks until disease progression or intolerable toxicity.

The change was made based on analyses demonstrating the comparability of the pharmacokinetics exposure, safety, and efficacy of the proposed new dosing regimen with the previously approved regimen. “Based on simulations by the population pharmacokinetics model, [the] FDA determined that the overall exposure at 240 mg every 2 weeks flat dose is similar (less than 6% difference) to 3 mg/kg every 2 weeks. These differences in exposure are not likely to have a clinically meaningful effect on safety and efficacy, since dose/exposure response relationships appear to be relatively flat in these three indications,” the FDA said.

llaubach@frontlinemedcom.com

The Food and Drug Administration has modified the dosage regimen for nivolumab for indications of renal cell carcinoma, metastatic melanoma, and non–small cell lung cancer.

The single-dose regimen of nivolumab (3 mg/kg IV every 2 weeks) is replaced with the new recommended regimen of 240 mg IV every 2 weeks until disease progression or intolerable toxicity, the FDA said in a written statement.

The nivolumab (Opdivo) dosing regimen in combination with ipilimumab for melanoma will stay the same (nivolumab 1 mg/kg IV, followed by ipilimumab on the same day, every 3 weeks for four doses); however, after completion of ipilimumab, the recommended nivolumab dose is modified to 240 mg every 2 weeks until disease progression or intolerable toxicity. The recommended dose for classical Hodgkin lymphoma remains at 3 mg/kg IV every 2 weeks until disease progression or intolerable toxicity.

The change was made based on analyses demonstrating the comparability of the pharmacokinetics exposure, safety, and efficacy of the proposed new dosing regimen with the previously approved regimen. “Based on simulations by the population pharmacokinetics model, [the] FDA determined that the overall exposure at 240 mg every 2 weeks flat dose is similar (less than 6% difference) to 3 mg/kg every 2 weeks. These differences in exposure are not likely to have a clinically meaningful effect on safety and efficacy, since dose/exposure response relationships appear to be relatively flat in these three indications,” the FDA said.

llaubach@frontlinemedcom.com

The Food and Drug Administration has modified the dosage regimen for nivolumab for indications of renal cell carcinoma, metastatic melanoma, and non–small cell lung cancer.

The single-dose regimen of nivolumab (3 mg/kg IV every 2 weeks) is replaced with the new recommended regimen of 240 mg IV every 2 weeks until disease progression or intolerable toxicity, the FDA said in a written statement.

The nivolumab (Opdivo) dosing regimen in combination with ipilimumab for melanoma will stay the same (nivolumab 1 mg/kg IV, followed by ipilimumab on the same day, every 3 weeks for four doses); however, after completion of ipilimumab, the recommended nivolumab dose is modified to 240 mg every 2 weeks until disease progression or intolerable toxicity. The recommended dose for classical Hodgkin lymphoma remains at 3 mg/kg IV every 2 weeks until disease progression or intolerable toxicity.

The change was made based on analyses demonstrating the comparability of the pharmacokinetics exposure, safety, and efficacy of the proposed new dosing regimen with the previously approved regimen. “Based on simulations by the population pharmacokinetics model, [the] FDA determined that the overall exposure at 240 mg every 2 weeks flat dose is similar (less than 6% difference) to 3 mg/kg every 2 weeks. These differences in exposure are not likely to have a clinically meaningful effect on safety and efficacy, since dose/exposure response relationships appear to be relatively flat in these three indications,” the FDA said.

llaubach@frontlinemedcom.com

Minimal residual disease negativity following treatment for newly diagnosed multiple myeloma is associated with long-term survival, according to findings from a meta-analysis of relevant data.

The findings suggest that assessment for minimal residual disease (MRD) should be included as an end point in clinical trials of multiple myeloma, Nikhil C. Munshi, MD, of Harvard Medical School, Boston, and his colleagues reported online Sept. 15 in JAMA Oncology.

Dana-Farber Cancer Institute

“This large cohort meta-analysis confirms that MRD status has prognostic value and is a valid surrogate marker for both PFS [progression-free survival] and OS [overall survival] in patients with multiple myeloma, including those who had achieved a CR [complete response],” the researchers wrote, noting that all of the studies confirmed the impact of MRD status on outcome, indicating that the predictive value of MRD status was independent of the type of treatment used.

Of 1,273 patients from 14 studies that looked at the impact of MRD status on PFS, 660 were MRD-negative and 613 were MRD-positive. Of 1,100 patients from 12 studies that looked at the impact of MRD on OS, 599 were MRD-negative, and 501 were MRD-positive. MRD-negative vs. -positive status was associated with better PFS and OS (hazard ratio, 0.41 and 0.57, respectively).

“Median PFS was 54 months for MRD-negative patients and 26 months for MRD-positive patients; median OS was 98 and 82 months, respectively,” the researchers wrote (JAMA Oncol. 2016 Sep 15. doi: 10.1001/jamaoncol.2016.3160).

Further, to evaluate the impact of MRD status on PFS and OS in patients who achieved conventional CR, they analyzed data from five studies looking at PFS in 396 MRD-negative and 178 MRD-positive patients, and 6 studies looking at OS in 430 MRD-negative and 186 MRD-positive patients. In patients achieving CR, the presence of MRD predicted shorter PFS (HR, 0.44) and shorter OS (HR, 0.47), they said.

“Median PFS was 56 months for MRD-negative patients and 34 months for MRD-positive patients, and median OS was 112 and 82 months, respectively. The OS rate was higher for MRD-negative patients, compared with MRD-positive patients at 3 years (94% vs. 80%), 5 years (80% vs. 61%), and 7 years (67% vs. 47%),” they wrote.

Although none of the studies included in the analysis compared the effect of two different treatment approaches on MRD status, five did evaluate MRD status before and after autologous stem cell transplantation, and all indicated that the treatment increased the proportion of MRD-negative patients.

Maintenance therapy also appeared, based on some of the studies, to have a beneficial effect on MRD status. In one study, MRD-negative status was maintained in 96% of patients receiving thalidomide maintenance therapy vs. 69% of MRD-negative patients receiving no maintenance therapy.

Minimal residual disease status is already considered an important prognostic factor in patients with multiple myeloma, and testing could be used to monitor response to therapy and guide subsequent treatment decisions, the investigators wrote, noting that “recent development of multiparameter flow cytometry– and next-generation sequencing–based methods has allowed for MRD assessment in larger studies.”

The findings provide quantitative evidence to support the conceptual basis for integrating MRD assessment after initial treatment in clinical trials as a surrogate end point for PFS and/or OS and in clinical practice to aid in prognostication and to guide treatment. However, “integration of MRD testing into standard practice requires optimization and standardization of MRD assessment and standardization of its timing,” they said.

This study was supported by the National Institutes of Health, the Medical Research Council, and Celgene. Dr. Munshi reported consultancy positions and advisory committee memberships with Celgene, Takeda, Janssen, and Merck.

sworcester@frontlinemedcom.com

Minimal residual disease negativity following treatment for newly diagnosed multiple myeloma is associated with long-term survival, according to findings from a meta-analysis of relevant data.

The findings suggest that assessment for minimal residual disease (MRD) should be included as an end point in clinical trials of multiple myeloma, Nikhil C. Munshi, MD, of Harvard Medical School, Boston, and his colleagues reported online Sept. 15 in JAMA Oncology.

Dana-Farber Cancer Institute

“This large cohort meta-analysis confirms that MRD status has prognostic value and is a valid surrogate marker for both PFS [progression-free survival] and OS [overall survival] in patients with multiple myeloma, including those who had achieved a CR [complete response],” the researchers wrote, noting that all of the studies confirmed the impact of MRD status on outcome, indicating that the predictive value of MRD status was independent of the type of treatment used.

Of 1,273 patients from 14 studies that looked at the impact of MRD status on PFS, 660 were MRD-negative and 613 were MRD-positive. Of 1,100 patients from 12 studies that looked at the impact of MRD on OS, 599 were MRD-negative, and 501 were MRD-positive. MRD-negative vs. -positive status was associated with better PFS and OS (hazard ratio, 0.41 and 0.57, respectively).

“Median PFS was 54 months for MRD-negative patients and 26 months for MRD-positive patients; median OS was 98 and 82 months, respectively,” the researchers wrote (JAMA Oncol. 2016 Sep 15. doi: 10.1001/jamaoncol.2016.3160).

Further, to evaluate the impact of MRD status on PFS and OS in patients who achieved conventional CR, they analyzed data from five studies looking at PFS in 396 MRD-negative and 178 MRD-positive patients, and 6 studies looking at OS in 430 MRD-negative and 186 MRD-positive patients. In patients achieving CR, the presence of MRD predicted shorter PFS (HR, 0.44) and shorter OS (HR, 0.47), they said.

“Median PFS was 56 months for MRD-negative patients and 34 months for MRD-positive patients, and median OS was 112 and 82 months, respectively. The OS rate was higher for MRD-negative patients, compared with MRD-positive patients at 3 years (94% vs. 80%), 5 years (80% vs. 61%), and 7 years (67% vs. 47%),” they wrote.

Although none of the studies included in the analysis compared the effect of two different treatment approaches on MRD status, five did evaluate MRD status before and after autologous stem cell transplantation, and all indicated that the treatment increased the proportion of MRD-negative patients.

Maintenance therapy also appeared, based on some of the studies, to have a beneficial effect on MRD status. In one study, MRD-negative status was maintained in 96% of patients receiving thalidomide maintenance therapy vs. 69% of MRD-negative patients receiving no maintenance therapy.

Minimal residual disease status is already considered an important prognostic factor in patients with multiple myeloma, and testing could be used to monitor response to therapy and guide subsequent treatment decisions, the investigators wrote, noting that “recent development of multiparameter flow cytometry– and next-generation sequencing–based methods has allowed for MRD assessment in larger studies.”

The findings provide quantitative evidence to support the conceptual basis for integrating MRD assessment after initial treatment in clinical trials as a surrogate end point for PFS and/or OS and in clinical practice to aid in prognostication and to guide treatment. However, “integration of MRD testing into standard practice requires optimization and standardization of MRD assessment and standardization of its timing,” they said.

This study was supported by the National Institutes of Health, the Medical Research Council, and Celgene. Dr. Munshi reported consultancy positions and advisory committee memberships with Celgene, Takeda, Janssen, and Merck.

sworcester@frontlinemedcom.com

Minimal residual disease negativity following treatment for newly diagnosed multiple myeloma is associated with long-term survival, according to findings from a meta-analysis of relevant data.

The findings suggest that assessment for minimal residual disease (MRD) should be included as an end point in clinical trials of multiple myeloma, Nikhil C. Munshi, MD, of Harvard Medical School, Boston, and his colleagues reported online Sept. 15 in JAMA Oncology.

Dana-Farber Cancer Institute

“This large cohort meta-analysis confirms that MRD status has prognostic value and is a valid surrogate marker for both PFS [progression-free survival] and OS [overall survival] in patients with multiple myeloma, including those who had achieved a CR [complete response],” the researchers wrote, noting that all of the studies confirmed the impact of MRD status on outcome, indicating that the predictive value of MRD status was independent of the type of treatment used.

Of 1,273 patients from 14 studies that looked at the impact of MRD status on PFS, 660 were MRD-negative and 613 were MRD-positive. Of 1,100 patients from 12 studies that looked at the impact of MRD on OS, 599 were MRD-negative, and 501 were MRD-positive. MRD-negative vs. -positive status was associated with better PFS and OS (hazard ratio, 0.41 and 0.57, respectively).

“Median PFS was 54 months for MRD-negative patients and 26 months for MRD-positive patients; median OS was 98 and 82 months, respectively,” the researchers wrote (JAMA Oncol. 2016 Sep 15. doi: 10.1001/jamaoncol.2016.3160).

Further, to evaluate the impact of MRD status on PFS and OS in patients who achieved conventional CR, they analyzed data from five studies looking at PFS in 396 MRD-negative and 178 MRD-positive patients, and 6 studies looking at OS in 430 MRD-negative and 186 MRD-positive patients. In patients achieving CR, the presence of MRD predicted shorter PFS (HR, 0.44) and shorter OS (HR, 0.47), they said.

“Median PFS was 56 months for MRD-negative patients and 34 months for MRD-positive patients, and median OS was 112 and 82 months, respectively. The OS rate was higher for MRD-negative patients, compared with MRD-positive patients at 3 years (94% vs. 80%), 5 years (80% vs. 61%), and 7 years (67% vs. 47%),” they wrote.

Although none of the studies included in the analysis compared the effect of two different treatment approaches on MRD status, five did evaluate MRD status before and after autologous stem cell transplantation, and all indicated that the treatment increased the proportion of MRD-negative patients.

Maintenance therapy also appeared, based on some of the studies, to have a beneficial effect on MRD status. In one study, MRD-negative status was maintained in 96% of patients receiving thalidomide maintenance therapy vs. 69% of MRD-negative patients receiving no maintenance therapy.

Minimal residual disease status is already considered an important prognostic factor in patients with multiple myeloma, and testing could be used to monitor response to therapy and guide subsequent treatment decisions, the investigators wrote, noting that “recent development of multiparameter flow cytometry– and next-generation sequencing–based methods has allowed for MRD assessment in larger studies.”

The findings provide quantitative evidence to support the conceptual basis for integrating MRD assessment after initial treatment in clinical trials as a surrogate end point for PFS and/or OS and in clinical practice to aid in prognostication and to guide treatment. However, “integration of MRD testing into standard practice requires optimization and standardization of MRD assessment and standardization of its timing,” they said.

This study was supported by the National Institutes of Health, the Medical Research Council, and Celgene. Dr. Munshi reported consultancy positions and advisory committee memberships with Celgene, Takeda, Janssen, and Merck.

sworcester@frontlinemedcom.com

Micrograph showing

mycosis fungoides

The US Food and Drug Administration (FDA) has granted fast track designation to Resimmune® (A-dmDT390-bisFv[UCHT1]) for the treatment of mycosis fungoides (MF).

Resimmune is an anti-CD3 immunotoxin that targets and transiently depletes a high percentage of malignant and normal T cells.

Researchers believe this high rate of T-cell depletion may “reset” a patient’s immune system, leading to immunomodulation. However, the safety and efficacy of Resimmune has not been established.

Resimmune is being developed by Angimmune LLC.

Resimmune research

The FDA’s fast track designation for Resimmune is based on results from a phase 1 trial, which were published in haematologica last year.

The trial included 25 patients with cutaneous T-cell lymphoma (CTCL)—17 with stage IB-IIB disease and 8 with stage III-IV disease. The patients received Resimmune at varying doses—between 2.5 µg/kg and 11.25 µg/kg.

Safety

Drug-related adverse events for the entire study cohort (n=30) included:

• Grade 2-3 AST/ALT elevations (n=6)
• Grade 2 chills (n=10)
• Grade 5 EBV infection (n=1)
• Grade 3 EBV/CMV infection (n=5)
• Grade 2 fever (n=6)
• Grade 5 heart failure (n=2)
• Grade 2-3 hypoalbuminemia (n=11)
• Grade 2 hypomagnesemia (n=1)
• Grade 3 hypophosphatemia (n=3)
• Grade 2-4 hypotension (n=3)
• Grade 4 hypoxia (n=1)
• Grade 4 liver failure (n=1)
• Grade 4 metabolic acidosis (n=1)
• Grade 3 supraventricular tachycardia (n=2)
• Grade 3-4 uremia (n=3)
• Grade 2-4 vascular leak syndrome (n=5).

Efficacy and phase 2

Nine of the CTCL patients (36%) responded to Resimmune, and 4 (16%) had complete responses (CRs). The duration of CR was more than 38 months for 1 patient, more than 60 months for another, and more than 72 months for 2 patients.

Of the 5 partial responses, 2 lasted 3 months, 1 lasted more than 3 months, 1 lasted more than 6 months, and the longest lasted 14 months.

The researchers said this trial revealed a subgroup of CTCL patients with a very high response rate.

When they excluded patients whose mSWAT scores never exceeded 50 and who never had lymph node involvement or stage III disease, the researchers were left with 9 patients. This subgroup had an overall response rate of 89% and a CR rate of 50% (at 6 months of follow-up).

“Results from our phase 1 trial demonstrated a particularly robust response among certain patients with early stage disease, and the randomized phase 2 trial is designed to further explore this potential therapeutic benefit,” said David Neville, MD, president and chief scientific officer of Angimmune.

The objective of this phase 2 trial is to document the incidence of CRs with Resimmune compared to oral vorinostat after a maximum of 12 months of treatment. The trial will enroll patients with stage IB/IIB MF with mSWAT < 50 who have never had lymphoid disease or a prior hematopoietic stem cell transplant.

About fast track designation

The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.

Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.

Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers.

Micrograph showing

mycosis fungoides

The US Food and Drug Administration (FDA) has granted fast track designation to Resimmune® (A-dmDT390-bisFv[UCHT1]) for the treatment of mycosis fungoides (MF).

Resimmune is an anti-CD3 immunotoxin that targets and transiently depletes a high percentage of malignant and normal T cells.

Researchers believe this high rate of T-cell depletion may “reset” a patient’s immune system, leading to immunomodulation. However, the safety and efficacy of Resimmune has not been established.

Resimmune is being developed by Angimmune LLC.

Resimmune research

The FDA’s fast track designation for Resimmune is based on results from a phase 1 trial, which were published in haematologica last year.

The trial included 25 patients with cutaneous T-cell lymphoma (CTCL)—17 with stage IB-IIB disease and 8 with stage III-IV disease. The patients received Resimmune at varying doses—between 2.5 µg/kg and 11.25 µg/kg.

Safety

Drug-related adverse events for the entire study cohort (n=30) included:

• Grade 2-3 AST/ALT elevations (n=6)
• Grade 2 chills (n=10)
• Grade 5 EBV infection (n=1)
• Grade 3 EBV/CMV infection (n=5)
• Grade 2 fever (n=6)
• Grade 5 heart failure (n=2)
• Grade 2-3 hypoalbuminemia (n=11)
• Grade 2 hypomagnesemia (n=1)
• Grade 3 hypophosphatemia (n=3)
• Grade 2-4 hypotension (n=3)
• Grade 4 hypoxia (n=1)
• Grade 4 liver failure (n=1)
• Grade 4 metabolic acidosis (n=1)
• Grade 3 supraventricular tachycardia (n=2)
• Grade 3-4 uremia (n=3)
• Grade 2-4 vascular leak syndrome (n=5).

Efficacy and phase 2

Nine of the CTCL patients (36%) responded to Resimmune, and 4 (16%) had complete responses (CRs). The duration of CR was more than 38 months for 1 patient, more than 60 months for another, and more than 72 months for 2 patients.

Of the 5 partial responses, 2 lasted 3 months, 1 lasted more than 3 months, 1 lasted more than 6 months, and the longest lasted 14 months.

The researchers said this trial revealed a subgroup of CTCL patients with a very high response rate.

When they excluded patients whose mSWAT scores never exceeded 50 and who never had lymph node involvement or stage III disease, the researchers were left with 9 patients. This subgroup had an overall response rate of 89% and a CR rate of 50% (at 6 months of follow-up).

“Results from our phase 1 trial demonstrated a particularly robust response among certain patients with early stage disease, and the randomized phase 2 trial is designed to further explore this potential therapeutic benefit,” said David Neville, MD, president and chief scientific officer of Angimmune.

The objective of this phase 2 trial is to document the incidence of CRs with Resimmune compared to oral vorinostat after a maximum of 12 months of treatment. The trial will enroll patients with stage IB/IIB MF with mSWAT < 50 who have never had lymphoid disease or a prior hematopoietic stem cell transplant.

About fast track designation

The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.

Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.

Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers.

Micrograph showing

mycosis fungoides

The US Food and Drug Administration (FDA) has granted fast track designation to Resimmune® (A-dmDT390-bisFv[UCHT1]) for the treatment of mycosis fungoides (MF).

Resimmune is an anti-CD3 immunotoxin that targets and transiently depletes a high percentage of malignant and normal T cells.

Researchers believe this high rate of T-cell depletion may “reset” a patient’s immune system, leading to immunomodulation. However, the safety and efficacy of Resimmune has not been established.

Resimmune is being developed by Angimmune LLC.

Resimmune research

The FDA’s fast track designation for Resimmune is based on results from a phase 1 trial, which were published in haematologica last year.

The trial included 25 patients with cutaneous T-cell lymphoma (CTCL)—17 with stage IB-IIB disease and 8 with stage III-IV disease. The patients received Resimmune at varying doses—between 2.5 µg/kg and 11.25 µg/kg.

Safety

Drug-related adverse events for the entire study cohort (n=30) included:

• Grade 2-3 AST/ALT elevations (n=6)
• Grade 2 chills (n=10)
• Grade 5 EBV infection (n=1)
• Grade 3 EBV/CMV infection (n=5)
• Grade 2 fever (n=6)
• Grade 5 heart failure (n=2)
• Grade 2-3 hypoalbuminemia (n=11)
• Grade 2 hypomagnesemia (n=1)
• Grade 3 hypophosphatemia (n=3)
• Grade 2-4 hypotension (n=3)
• Grade 4 hypoxia (n=1)
• Grade 4 liver failure (n=1)
• Grade 4 metabolic acidosis (n=1)
• Grade 3 supraventricular tachycardia (n=2)
• Grade 3-4 uremia (n=3)
• Grade 2-4 vascular leak syndrome (n=5).

Efficacy and phase 2

Nine of the CTCL patients (36%) responded to Resimmune, and 4 (16%) had complete responses (CRs). The duration of CR was more than 38 months for 1 patient, more than 60 months for another, and more than 72 months for 2 patients.

Of the 5 partial responses, 2 lasted 3 months, 1 lasted more than 3 months, 1 lasted more than 6 months, and the longest lasted 14 months.

The researchers said this trial revealed a subgroup of CTCL patients with a very high response rate.

When they excluded patients whose mSWAT scores never exceeded 50 and who never had lymph node involvement or stage III disease, the researchers were left with 9 patients. This subgroup had an overall response rate of 89% and a CR rate of 50% (at 6 months of follow-up).

“Results from our phase 1 trial demonstrated a particularly robust response among certain patients with early stage disease, and the randomized phase 2 trial is designed to further explore this potential therapeutic benefit,” said David Neville, MD, president and chief scientific officer of Angimmune.

The objective of this phase 2 trial is to document the incidence of CRs with Resimmune compared to oral vorinostat after a maximum of 12 months of treatment. The trial will enroll patients with stage IB/IIB MF with mSWAT < 50 who have never had lymphoid disease or a prior hematopoietic stem cell transplant.

About fast track designation

The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.

Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.

Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers.

Micrograph showing ATLL

Researchers say lenalidomide exhibited clinically meaningful antitumor activity and an acceptable safety profile in a phase 2 study of patients with relapsed adult T-cell leukemia/lymphoma (ATLL).

Of the 26 patients enrolled in the trial, 42% responded to lenalidomide, and 35% experienced serious adverse events (AEs).

Results from this trial were published in the Journal of Clinical Oncology. Data were previously presented at the 8th Annual T-cell Lymphoma Forum. The study was sponsored by Celgene K.K.

Patients and treatment

All 26 patients had relapsed ATLL—15 with the acute subtype, 7 with the lymphoma subtype, and 4 with the unfavorable chronic subtype. The patients’ median age was 68.5 (range, 53-81), all were Japanese, and 54% were male.

The median number of prior treatment regimens was 2 (range, 1-4). Thirty-five percent of patients had prior mogamulizumab (n=9), 35% had received LSG15 (n=3) or modified LSG15 (n=6), and 27% had prior CHOP (n=7).

The patients received lenalidomide at 25 mg per day, given continuously until disease progression or intolerability.

Results

Five patients (19%) were still receiving lenalidomide at the data cutoff, which was November 20, 2014.

Thirteen patients (50%) stopped treatment due to progression, 6 (23%) because of AEs, 1 (4%) due to investigator decision, and 1 (4%) because of concerns about the increased possibility of disease recurrence.

The median follow-up was 3.9 months. Eleven patients (42%) responded to lenalidomide, including 4 complete responses and 1 unconfirmed complete response.

The median duration of response was not reached (range, 0.5 months to not reached), and the mean duration of response was 5.2 months (range, 0 to 16.6 months).

The median progression-free survival was 3.8 months (range, 1.9 months to not reached), and the median overall survival was 20.3 months (range, 9.1 months to not reached).

Nine patients (35%) experienced serious AEs. The only serious AE that occurred in more than 1 patient was thrombocytopenia, which occurred in 2 patients.

The most frequent AEs of any grade were thrombocytopenia (77%), neutropenia (73%), lymphopenia (69%), anemia (54%), and leukopenia (50%).

The most frequent grade 3 or higher AEs were neutropenia (65%), leukopenia (38%), lymphopenia (38%), and thrombocytopenia (23%). These events were all manageable and reversible, according to the researchers.

Based on these results, the team concluded that lenalidomide warrants further investigation as a treatment for ATLL.

Micrograph showing ATLL

Researchers say lenalidomide exhibited clinically meaningful antitumor activity and an acceptable safety profile in a phase 2 study of patients with relapsed adult T-cell leukemia/lymphoma (ATLL).

Of the 26 patients enrolled in the trial, 42% responded to lenalidomide, and 35% experienced serious adverse events (AEs).

Results from this trial were published in the Journal of Clinical Oncology. Data were previously presented at the 8th Annual T-cell Lymphoma Forum. The study was sponsored by Celgene K.K.

Patients and treatment

All 26 patients had relapsed ATLL—15 with the acute subtype, 7 with the lymphoma subtype, and 4 with the unfavorable chronic subtype. The patients’ median age was 68.5 (range, 53-81), all were Japanese, and 54% were male.

The median number of prior treatment regimens was 2 (range, 1-4). Thirty-five percent of patients had prior mogamulizumab (n=9), 35% had received LSG15 (n=3) or modified LSG15 (n=6), and 27% had prior CHOP (n=7).

The patients received lenalidomide at 25 mg per day, given continuously until disease progression or intolerability.

Results

Five patients (19%) were still receiving lenalidomide at the data cutoff, which was November 20, 2014.

Thirteen patients (50%) stopped treatment due to progression, 6 (23%) because of AEs, 1 (4%) due to investigator decision, and 1 (4%) because of concerns about the increased possibility of disease recurrence.

The median follow-up was 3.9 months. Eleven patients (42%) responded to lenalidomide, including 4 complete responses and 1 unconfirmed complete response.

The median duration of response was not reached (range, 0.5 months to not reached), and the mean duration of response was 5.2 months (range, 0 to 16.6 months).

The median progression-free survival was 3.8 months (range, 1.9 months to not reached), and the median overall survival was 20.3 months (range, 9.1 months to not reached).

Nine patients (35%) experienced serious AEs. The only serious AE that occurred in more than 1 patient was thrombocytopenia, which occurred in 2 patients.

The most frequent AEs of any grade were thrombocytopenia (77%), neutropenia (73%), lymphopenia (69%), anemia (54%), and leukopenia (50%).

The most frequent grade 3 or higher AEs were neutropenia (65%), leukopenia (38%), lymphopenia (38%), and thrombocytopenia (23%). These events were all manageable and reversible, according to the researchers.

Based on these results, the team concluded that lenalidomide warrants further investigation as a treatment for ATLL.

Micrograph showing ATLL

Researchers say lenalidomide exhibited clinically meaningful antitumor activity and an acceptable safety profile in a phase 2 study of patients with relapsed adult T-cell leukemia/lymphoma (ATLL).

Of the 26 patients enrolled in the trial, 42% responded to lenalidomide, and 35% experienced serious adverse events (AEs).

Results from this trial were published in the Journal of Clinical Oncology. Data were previously presented at the 8th Annual T-cell Lymphoma Forum. The study was sponsored by Celgene K.K.

Patients and treatment

All 26 patients had relapsed ATLL—15 with the acute subtype, 7 with the lymphoma subtype, and 4 with the unfavorable chronic subtype. The patients’ median age was 68.5 (range, 53-81), all were Japanese, and 54% were male.

The median number of prior treatment regimens was 2 (range, 1-4). Thirty-five percent of patients had prior mogamulizumab (n=9), 35% had received LSG15 (n=3) or modified LSG15 (n=6), and 27% had prior CHOP (n=7).

The patients received lenalidomide at 25 mg per day, given continuously until disease progression or intolerability.

Results

Five patients (19%) were still receiving lenalidomide at the data cutoff, which was November 20, 2014.

Thirteen patients (50%) stopped treatment due to progression, 6 (23%) because of AEs, 1 (4%) due to investigator decision, and 1 (4%) because of concerns about the increased possibility of disease recurrence.

The median follow-up was 3.9 months. Eleven patients (42%) responded to lenalidomide, including 4 complete responses and 1 unconfirmed complete response.

The median duration of response was not reached (range, 0.5 months to not reached), and the mean duration of response was 5.2 months (range, 0 to 16.6 months).

The median progression-free survival was 3.8 months (range, 1.9 months to not reached), and the median overall survival was 20.3 months (range, 9.1 months to not reached).

Nine patients (35%) experienced serious AEs. The only serious AE that occurred in more than 1 patient was thrombocytopenia, which occurred in 2 patients.

The most frequent AEs of any grade were thrombocytopenia (77%), neutropenia (73%), lymphopenia (69%), anemia (54%), and leukopenia (50%).

The most frequent grade 3 or higher AEs were neutropenia (65%), leukopenia (38%), lymphopenia (38%), and thrombocytopenia (23%). These events were all manageable and reversible, according to the researchers.

Based on these results, the team concluded that lenalidomide warrants further investigation as a treatment for ATLL.

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.

The survey showed that caregivers can spend more than 8 hours a day providing care.

And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.

These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).

“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.

“When they put their own health and well-being on the back burner, it can affect their care to the patient.”

Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.

The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.

The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).

Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).

Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.

Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.” 

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.

The survey showed that caregivers can spend more than 8 hours a day providing care.

And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.

These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).

“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.

“When they put their own health and well-being on the back burner, it can affect their care to the patient.”

Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.

The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.

The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).

Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).

Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.

Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.” 

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.

The survey showed that caregivers can spend more than 8 hours a day providing care.

And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.

These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).

“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.

“When they put their own health and well-being on the back burner, it can affect their care to the patient.”

Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.

The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.

The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).

Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).

Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.

Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.”