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Research and Reviews for the Practicing Oncologist
Repeated measures analysis of patient-reported outcomes in prostate cancer after abiraterone acetate
Background Metastatic castration-resistant prostate cancer (mCRPC) is typically associated with declining health-related quality of life (HR-QoL).
Objective To assess patient experience with abiraterone acetate (hereafter abiraterone) plus prednisone longitudinally.
Methods COU-AA-302 was a phase 3, multinational, randomized, double-blind study that enrolled asymptomatic or mildly symptomatic, chemotherapy-naïve patients with mCRPC. Patients were randomized to 1 g abiraterone daily plus 5 mg prednisone BID (n = 546) or placebo plus prednisone (n = 542) in continuous 28-day cycles. Patient-reported outcomes (PROs) were collected using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, consisting of 4 well-being subscales (physical, social/family, emotional, functional) and a prostate cancer-specific subscale (PCS). The trial outcome index (TOI) is a composite of the physical well-being, functional well-being, and PCS scores. Least squares mean change from baseline at each cycle up to 1 year (cycle13) was compared between treatment arms using a mixed-effects model for repeated measures, which assumed that data were “missing at random.” A pattern-mixture model (PMM) with multiple imputation was performed to address the assumption that data were “missing not at random.”
Results Significant differences favoring abiraterone-prednisone were observed for FACT-P total, TOI, and PCS scores, and for all well-being subscales except social/family well-being over the first year of treatment. These results were supported by the PMM with multiple imputation.
Limitations Attrition after 1 year limited our ability to analyze the PRO data beyond that time point.
Conclusions Abiraterone-prednisone confers sustained HR-QoL benefits over the course of treatment.
Funding Janssen Research & Development
Click on the PDF icon at the top of this introduction to read the full article.
Background Metastatic castration-resistant prostate cancer (mCRPC) is typically associated with declining health-related quality of life (HR-QoL).
Objective To assess patient experience with abiraterone acetate (hereafter abiraterone) plus prednisone longitudinally.
Methods COU-AA-302 was a phase 3, multinational, randomized, double-blind study that enrolled asymptomatic or mildly symptomatic, chemotherapy-naïve patients with mCRPC. Patients were randomized to 1 g abiraterone daily plus 5 mg prednisone BID (n = 546) or placebo plus prednisone (n = 542) in continuous 28-day cycles. Patient-reported outcomes (PROs) were collected using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, consisting of 4 well-being subscales (physical, social/family, emotional, functional) and a prostate cancer-specific subscale (PCS). The trial outcome index (TOI) is a composite of the physical well-being, functional well-being, and PCS scores. Least squares mean change from baseline at each cycle up to 1 year (cycle13) was compared between treatment arms using a mixed-effects model for repeated measures, which assumed that data were “missing at random.” A pattern-mixture model (PMM) with multiple imputation was performed to address the assumption that data were “missing not at random.”
Results Significant differences favoring abiraterone-prednisone were observed for FACT-P total, TOI, and PCS scores, and for all well-being subscales except social/family well-being over the first year of treatment. These results were supported by the PMM with multiple imputation.
Limitations Attrition after 1 year limited our ability to analyze the PRO data beyond that time point.
Conclusions Abiraterone-prednisone confers sustained HR-QoL benefits over the course of treatment.
Funding Janssen Research & Development
Click on the PDF icon at the top of this introduction to read the full article.
Background Metastatic castration-resistant prostate cancer (mCRPC) is typically associated with declining health-related quality of life (HR-QoL).
Objective To assess patient experience with abiraterone acetate (hereafter abiraterone) plus prednisone longitudinally.
Methods COU-AA-302 was a phase 3, multinational, randomized, double-blind study that enrolled asymptomatic or mildly symptomatic, chemotherapy-naïve patients with mCRPC. Patients were randomized to 1 g abiraterone daily plus 5 mg prednisone BID (n = 546) or placebo plus prednisone (n = 542) in continuous 28-day cycles. Patient-reported outcomes (PROs) were collected using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, consisting of 4 well-being subscales (physical, social/family, emotional, functional) and a prostate cancer-specific subscale (PCS). The trial outcome index (TOI) is a composite of the physical well-being, functional well-being, and PCS scores. Least squares mean change from baseline at each cycle up to 1 year (cycle13) was compared between treatment arms using a mixed-effects model for repeated measures, which assumed that data were “missing at random.” A pattern-mixture model (PMM) with multiple imputation was performed to address the assumption that data were “missing not at random.”
Results Significant differences favoring abiraterone-prednisone were observed for FACT-P total, TOI, and PCS scores, and for all well-being subscales except social/family well-being over the first year of treatment. These results were supported by the PMM with multiple imputation.
Limitations Attrition after 1 year limited our ability to analyze the PRO data beyond that time point.
Conclusions Abiraterone-prednisone confers sustained HR-QoL benefits over the course of treatment.
Funding Janssen Research & Development
Click on the PDF icon at the top of this introduction to read the full article.
Olanzapine versus fosaprepitant for the prevention of concurrent chemotherapy radiotherapy-induced nausea and vomiting
Background Concurrent chemotherapy radiation therapy may result in significant nausea and vomiting. There have been few studies reporting effective interventions for preventing treatment-related nausea and vomiting.
Objective To compare olanzapine with fosaprepitant for the prevention of nausea and vomiting in patients receiving concurrent highly emetogenic chemotherapy (HEC) and radiotherapy for locally advanced head and neck or esophageal cancer.
Methods 120 chemotherapy and radiotherapy naïve patients with head and neck cancer who were receiving concurrent local radiation and cisplatin were randomized to receive either olanzapine or fosaprepitant in combination with palonosetron and dexamethasone for the prevention of chemotherapy- and radiation-induced nausea and vomiting. The olanzapine, palonosetron, dexamethasone (OPD) regimen was 10 mg oral olanzapine , 0.25 mg IV palonosetron, and 20 mg IV dexamethasone before chemotherapy on day 1, and 10 mg/day of oral olanzapine before chemotherapy on days 2-4. The fosaprepitant, palonosetron, dexamethasone (FPD) regimen was 150 mg IV fosaprepitant, 0.25 mg IV palonosetron, and 12 mg IV dexamethasone before chemotherapy on day 1, and 4 mg dexamethasone PO BID, before chemotherapy days 2 and 3.
Results 101 of the 120 patients were evaluable. In 51 patients who received the OPD regimen, the complete response (CR; no emesis, no rescue medication) rate was 88% for the acute period (24 h after chemotherapy), 76% for the delayed period (days 2-5), and 76% for the overall period (0-120 h). In 50 patients who received the FPD regimen, the CR was 84% acute, 74% delayed, and 74% overall (P > .01 for all periods). Patients with no nausea (0, on a scale 0-10, visual analogue scale) were: OPD: 86% acute, 71% delayed, 71% overall; FPD: 78% acute, 40% delayed, 40% overall (P > .01 for acute; P < .01 for delayed and overall) There were no grade 3 or 4 toxicities.
Conclusions CR was similar for OPD and FPD; nausea in the delayed and overall periods was signifcantly improved with OPD compared with FPD (P < .01).
Funding Reich Endowment for the Care of the Whole Patient
Click on the PDF icon at the top of this introduction to read the full article.
Background Concurrent chemotherapy radiation therapy may result in significant nausea and vomiting. There have been few studies reporting effective interventions for preventing treatment-related nausea and vomiting.
Objective To compare olanzapine with fosaprepitant for the prevention of nausea and vomiting in patients receiving concurrent highly emetogenic chemotherapy (HEC) and radiotherapy for locally advanced head and neck or esophageal cancer.
Methods 120 chemotherapy and radiotherapy naïve patients with head and neck cancer who were receiving concurrent local radiation and cisplatin were randomized to receive either olanzapine or fosaprepitant in combination with palonosetron and dexamethasone for the prevention of chemotherapy- and radiation-induced nausea and vomiting. The olanzapine, palonosetron, dexamethasone (OPD) regimen was 10 mg oral olanzapine , 0.25 mg IV palonosetron, and 20 mg IV dexamethasone before chemotherapy on day 1, and 10 mg/day of oral olanzapine before chemotherapy on days 2-4. The fosaprepitant, palonosetron, dexamethasone (FPD) regimen was 150 mg IV fosaprepitant, 0.25 mg IV palonosetron, and 12 mg IV dexamethasone before chemotherapy on day 1, and 4 mg dexamethasone PO BID, before chemotherapy days 2 and 3.
Results 101 of the 120 patients were evaluable. In 51 patients who received the OPD regimen, the complete response (CR; no emesis, no rescue medication) rate was 88% for the acute period (24 h after chemotherapy), 76% for the delayed period (days 2-5), and 76% for the overall period (0-120 h). In 50 patients who received the FPD regimen, the CR was 84% acute, 74% delayed, and 74% overall (P > .01 for all periods). Patients with no nausea (0, on a scale 0-10, visual analogue scale) were: OPD: 86% acute, 71% delayed, 71% overall; FPD: 78% acute, 40% delayed, 40% overall (P > .01 for acute; P < .01 for delayed and overall) There were no grade 3 or 4 toxicities.
Conclusions CR was similar for OPD and FPD; nausea in the delayed and overall periods was signifcantly improved with OPD compared with FPD (P < .01).
Funding Reich Endowment for the Care of the Whole Patient
Click on the PDF icon at the top of this introduction to read the full article.
Background Concurrent chemotherapy radiation therapy may result in significant nausea and vomiting. There have been few studies reporting effective interventions for preventing treatment-related nausea and vomiting.
Objective To compare olanzapine with fosaprepitant for the prevention of nausea and vomiting in patients receiving concurrent highly emetogenic chemotherapy (HEC) and radiotherapy for locally advanced head and neck or esophageal cancer.
Methods 120 chemotherapy and radiotherapy naïve patients with head and neck cancer who were receiving concurrent local radiation and cisplatin were randomized to receive either olanzapine or fosaprepitant in combination with palonosetron and dexamethasone for the prevention of chemotherapy- and radiation-induced nausea and vomiting. The olanzapine, palonosetron, dexamethasone (OPD) regimen was 10 mg oral olanzapine , 0.25 mg IV palonosetron, and 20 mg IV dexamethasone before chemotherapy on day 1, and 10 mg/day of oral olanzapine before chemotherapy on days 2-4. The fosaprepitant, palonosetron, dexamethasone (FPD) regimen was 150 mg IV fosaprepitant, 0.25 mg IV palonosetron, and 12 mg IV dexamethasone before chemotherapy on day 1, and 4 mg dexamethasone PO BID, before chemotherapy days 2 and 3.
Results 101 of the 120 patients were evaluable. In 51 patients who received the OPD regimen, the complete response (CR; no emesis, no rescue medication) rate was 88% for the acute period (24 h after chemotherapy), 76% for the delayed period (days 2-5), and 76% for the overall period (0-120 h). In 50 patients who received the FPD regimen, the CR was 84% acute, 74% delayed, and 74% overall (P > .01 for all periods). Patients with no nausea (0, on a scale 0-10, visual analogue scale) were: OPD: 86% acute, 71% delayed, 71% overall; FPD: 78% acute, 40% delayed, 40% overall (P > .01 for acute; P < .01 for delayed and overall) There were no grade 3 or 4 toxicities.
Conclusions CR was similar for OPD and FPD; nausea in the delayed and overall periods was signifcantly improved with OPD compared with FPD (P < .01).
Funding Reich Endowment for the Care of the Whole Patient
Click on the PDF icon at the top of this introduction to read the full article.
More success for immunotherapy with nivolumab approval for metastatic RCC
Change, challenge, and a farewell
David Henry's JCSO podcast, March 2016
In the March podcast for The Journal of Community and Supportive Oncology, Dr David Henry discusses a number of articles that center on patient quality of life and overall quality of care, among them, an article on opioid risk assessment in palliative care and three Original Reports, one on the impact of trimodality treatment on arm function and QoL in patients with superior sulcus tumors, a second on patient perceptions and the challenges of oral anticancer therapy, and a third on the use of voluntary reporting to assess symptom burden in cancer patients. A Review article by Jose de Souza and colleagues on financial toxicity in cancer care spans the QoL and quality of care spectrum as it details the implications of the increasing cost of cancer care for the delivery of high-quality, patient-centered care and discusses potential predictors of financial toxicity and instruments that could help quantify financial burden. Also in the line-up are articles on encapsulated irinotecan for hard-to-treat cancer and Case Reports on an uncommon presentation of lung cancer and on acute promyelocytic leukemia presenting as a paraspinal mass.
Listen to the podcast below.
In the March podcast for The Journal of Community and Supportive Oncology, Dr David Henry discusses a number of articles that center on patient quality of life and overall quality of care, among them, an article on opioid risk assessment in palliative care and three Original Reports, one on the impact of trimodality treatment on arm function and QoL in patients with superior sulcus tumors, a second on patient perceptions and the challenges of oral anticancer therapy, and a third on the use of voluntary reporting to assess symptom burden in cancer patients. A Review article by Jose de Souza and colleagues on financial toxicity in cancer care spans the QoL and quality of care spectrum as it details the implications of the increasing cost of cancer care for the delivery of high-quality, patient-centered care and discusses potential predictors of financial toxicity and instruments that could help quantify financial burden. Also in the line-up are articles on encapsulated irinotecan for hard-to-treat cancer and Case Reports on an uncommon presentation of lung cancer and on acute promyelocytic leukemia presenting as a paraspinal mass.
Listen to the podcast below.
In the March podcast for The Journal of Community and Supportive Oncology, Dr David Henry discusses a number of articles that center on patient quality of life and overall quality of care, among them, an article on opioid risk assessment in palliative care and three Original Reports, one on the impact of trimodality treatment on arm function and QoL in patients with superior sulcus tumors, a second on patient perceptions and the challenges of oral anticancer therapy, and a third on the use of voluntary reporting to assess symptom burden in cancer patients. A Review article by Jose de Souza and colleagues on financial toxicity in cancer care spans the QoL and quality of care spectrum as it details the implications of the increasing cost of cancer care for the delivery of high-quality, patient-centered care and discusses potential predictors of financial toxicity and instruments that could help quantify financial burden. Also in the line-up are articles on encapsulated irinotecan for hard-to-treat cancer and Case Reports on an uncommon presentation of lung cancer and on acute promyelocytic leukemia presenting as a paraspinal mass.
Listen to the podcast below.
A line-up of new therapies and expanded combinations
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Management of cancer-related pain
Acute promyelocytic leukemia presenting as a paraspinal mass
Acute promyelocytic leukemia (APL) is a distinct subtype of acute myeloid leukemia (AML) that is characterized by a balanced translocation between chromosomes 15 and 17 [t(15;17)], which results in the fusion of the promyelocytic leukemia (PML) and retinoic acid receptor α (RARA) genes.1,2 Historically, APL was a fatal disease because of the high relapse rates with cytotoxic chemotherapy alone and a significant bleeding risk secondary to disseminated intravascular coagulation (DIC).
Click on the PDF icon at the top of this introduction to read the full article.
Acute promyelocytic leukemia (APL) is a distinct subtype of acute myeloid leukemia (AML) that is characterized by a balanced translocation between chromosomes 15 and 17 [t(15;17)], which results in the fusion of the promyelocytic leukemia (PML) and retinoic acid receptor α (RARA) genes.1,2 Historically, APL was a fatal disease because of the high relapse rates with cytotoxic chemotherapy alone and a significant bleeding risk secondary to disseminated intravascular coagulation (DIC).
Click on the PDF icon at the top of this introduction to read the full article.
Acute promyelocytic leukemia (APL) is a distinct subtype of acute myeloid leukemia (AML) that is characterized by a balanced translocation between chromosomes 15 and 17 [t(15;17)], which results in the fusion of the promyelocytic leukemia (PML) and retinoic acid receptor α (RARA) genes.1,2 Historically, APL was a fatal disease because of the high relapse rates with cytotoxic chemotherapy alone and a significant bleeding risk secondary to disseminated intravascular coagulation (DIC).
Click on the PDF icon at the top of this introduction to read the full article.
An uncommon presentation of non-small-cell lung cancer with acrometastases to the great toe and index finger
Case presentation and summary
A 71-year-old white woman was referred to the emergency department by her primary care physician for necrosis and swelling of the left great toe for work-up of possible osteomyelitis (Figure 1). Before she presented to her physician, she had been complaining of severe pain, swelling, and erythema of the left great toe that had lasted for 1-2 months. Infection was initially suspected. She completed 2 courses of oral antibiotics with no improvement. She was also complaining of similar symptoms on the left index finger and attributed her symptoms to an injury a month earlier (Figure 2). The pain was so severe that she was not able to bear weight on her left foot. An outpatient X-ray of her left great toe raised her physician’s concerns that it might be osteomyelitis so she was referred to the emergency department.
Click on the PDF icon at the top of this introduction to read the full article.
Case presentation and summary
A 71-year-old white woman was referred to the emergency department by her primary care physician for necrosis and swelling of the left great toe for work-up of possible osteomyelitis (Figure 1). Before she presented to her physician, she had been complaining of severe pain, swelling, and erythema of the left great toe that had lasted for 1-2 months. Infection was initially suspected. She completed 2 courses of oral antibiotics with no improvement. She was also complaining of similar symptoms on the left index finger and attributed her symptoms to an injury a month earlier (Figure 2). The pain was so severe that she was not able to bear weight on her left foot. An outpatient X-ray of her left great toe raised her physician’s concerns that it might be osteomyelitis so she was referred to the emergency department.
Click on the PDF icon at the top of this introduction to read the full article.
Case presentation and summary
A 71-year-old white woman was referred to the emergency department by her primary care physician for necrosis and swelling of the left great toe for work-up of possible osteomyelitis (Figure 1). Before she presented to her physician, she had been complaining of severe pain, swelling, and erythema of the left great toe that had lasted for 1-2 months. Infection was initially suspected. She completed 2 courses of oral antibiotics with no improvement. She was also complaining of similar symptoms on the left index finger and attributed her symptoms to an injury a month earlier (Figure 2). The pain was so severe that she was not able to bear weight on her left foot. An outpatient X-ray of her left great toe raised her physician’s concerns that it might be osteomyelitis so she was referred to the emergency department.
Click on the PDF icon at the top of this introduction to read the full article.
Voluntary reporting to assess symptom burden among Yemeni cancer patients: common symptoms are frequently missed
Objective To assess the symptom burden experienced by Yemeni cancer patients by using VR and systematic assessment (SA).
Methods 50 cancer patients were asked an open question to voluntarily report their symptoms. This was followed by an SA of a list of 20 common physical symptoms that was drawn up based on the literature.
Results From 375 symptom entries related to the 20 symptoms, VR accounted for 66 entries (18%) and SA for 309 (82%). The mean number of VR symptoms/patient was 1.3, and the mean number of VR plus SA symptoms was 7.5 (P < .001). In all, 74% of VR symptoms and 57% of SA symptoms were moderate or severe. For each symptom, the percentage of patients who experienced it and did not report it voluntarily (missed) was 100% for bleeding, constipation, early satiety, hoarseness, taste changes, and weight loss. These were followed by anorexia (97%), skin symptoms (92%), dry mouth (91%), edema (89%), dyspnea (88%), sore mouth (88%), fatigue/weakness (85%), diarrhea (80%), dysphagia (80%), nausea (76%), cough (75%), urinary symptoms (75%), vomiting (62%), and pain (18%). Pain was the most common voluntarily reported symptom (56% of patients), the most commonly distressing (42%), and the least under-reported (18%).
Limitations Relatively small sample size; the SA included only 20 symptoms.
Conclusions SA of symptoms yields a more accurate estimation of symptom burden than does VR. As with many developing countries where the majority of cancer patients present at an incurable disease stage, Yemeni cancer patients suffer a high symptom burden, especially pain.
Click on the PDF icon at the top of this introduction to read the full article.
Objective To assess the symptom burden experienced by Yemeni cancer patients by using VR and systematic assessment (SA).
Methods 50 cancer patients were asked an open question to voluntarily report their symptoms. This was followed by an SA of a list of 20 common physical symptoms that was drawn up based on the literature.
Results From 375 symptom entries related to the 20 symptoms, VR accounted for 66 entries (18%) and SA for 309 (82%). The mean number of VR symptoms/patient was 1.3, and the mean number of VR plus SA symptoms was 7.5 (P < .001). In all, 74% of VR symptoms and 57% of SA symptoms were moderate or severe. For each symptom, the percentage of patients who experienced it and did not report it voluntarily (missed) was 100% for bleeding, constipation, early satiety, hoarseness, taste changes, and weight loss. These were followed by anorexia (97%), skin symptoms (92%), dry mouth (91%), edema (89%), dyspnea (88%), sore mouth (88%), fatigue/weakness (85%), diarrhea (80%), dysphagia (80%), nausea (76%), cough (75%), urinary symptoms (75%), vomiting (62%), and pain (18%). Pain was the most common voluntarily reported symptom (56% of patients), the most commonly distressing (42%), and the least under-reported (18%).
Limitations Relatively small sample size; the SA included only 20 symptoms.
Conclusions SA of symptoms yields a more accurate estimation of symptom burden than does VR. As with many developing countries where the majority of cancer patients present at an incurable disease stage, Yemeni cancer patients suffer a high symptom burden, especially pain.
Click on the PDF icon at the top of this introduction to read the full article.
Objective To assess the symptom burden experienced by Yemeni cancer patients by using VR and systematic assessment (SA).
Methods 50 cancer patients were asked an open question to voluntarily report their symptoms. This was followed by an SA of a list of 20 common physical symptoms that was drawn up based on the literature.
Results From 375 symptom entries related to the 20 symptoms, VR accounted for 66 entries (18%) and SA for 309 (82%). The mean number of VR symptoms/patient was 1.3, and the mean number of VR plus SA symptoms was 7.5 (P < .001). In all, 74% of VR symptoms and 57% of SA symptoms were moderate or severe. For each symptom, the percentage of patients who experienced it and did not report it voluntarily (missed) was 100% for bleeding, constipation, early satiety, hoarseness, taste changes, and weight loss. These were followed by anorexia (97%), skin symptoms (92%), dry mouth (91%), edema (89%), dyspnea (88%), sore mouth (88%), fatigue/weakness (85%), diarrhea (80%), dysphagia (80%), nausea (76%), cough (75%), urinary symptoms (75%), vomiting (62%), and pain (18%). Pain was the most common voluntarily reported symptom (56% of patients), the most commonly distressing (42%), and the least under-reported (18%).
Limitations Relatively small sample size; the SA included only 20 symptoms.
Conclusions SA of symptoms yields a more accurate estimation of symptom burden than does VR. As with many developing countries where the majority of cancer patients present at an incurable disease stage, Yemeni cancer patients suffer a high symptom burden, especially pain.
Click on the PDF icon at the top of this introduction to read the full article.