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Research and Reviews for the Practicing Oncologist
David Henry's JCSO podcast, October 2015
Dr David Henry’s October podcast for The Journal of Community and Supportive Oncology, begins with a discussion of the recent approval of panobinostat for the treatment of relapsed and refractory multiple myeloma and of dinutuximab combination therapy as a first-line option for high-risk neuroblastoma in children. He also highlights two Review articles, one on cancer-related pain management, and another on current practice with endocrine therapy in metastatic breast cancer, both of which provide the reader with detailed, up-to-date overviews of current literature on the topics and clinical practice. Two Original Reports examine drugs costs and outcomes as they pertain to the practicing oncologist. The first article looks at the value of anticancer drugs in metastatic castrate-resistant prostate cancer; the second examines the implications of hospitalizations of 5 or more days on outcomes among patients with head and neck cancer who have received radiotherapy. Dr Henry rounds off his podcast with Case Reports on zoledronic acid-induced hypocalcemia in hyercalcemia of malignancy and neuroendocrine carcinaoma of the larynx with metastasis to the eyelid.
Click on the download icon at the top of this introduction to listen to the podcast.
Dr David Henry’s October podcast for The Journal of Community and Supportive Oncology, begins with a discussion of the recent approval of panobinostat for the treatment of relapsed and refractory multiple myeloma and of dinutuximab combination therapy as a first-line option for high-risk neuroblastoma in children. He also highlights two Review articles, one on cancer-related pain management, and another on current practice with endocrine therapy in metastatic breast cancer, both of which provide the reader with detailed, up-to-date overviews of current literature on the topics and clinical practice. Two Original Reports examine drugs costs and outcomes as they pertain to the practicing oncologist. The first article looks at the value of anticancer drugs in metastatic castrate-resistant prostate cancer; the second examines the implications of hospitalizations of 5 or more days on outcomes among patients with head and neck cancer who have received radiotherapy. Dr Henry rounds off his podcast with Case Reports on zoledronic acid-induced hypocalcemia in hyercalcemia of malignancy and neuroendocrine carcinaoma of the larynx with metastasis to the eyelid.
Click on the download icon at the top of this introduction to listen to the podcast.
Dr David Henry’s October podcast for The Journal of Community and Supportive Oncology, begins with a discussion of the recent approval of panobinostat for the treatment of relapsed and refractory multiple myeloma and of dinutuximab combination therapy as a first-line option for high-risk neuroblastoma in children. He also highlights two Review articles, one on cancer-related pain management, and another on current practice with endocrine therapy in metastatic breast cancer, both of which provide the reader with detailed, up-to-date overviews of current literature on the topics and clinical practice. Two Original Reports examine drugs costs and outcomes as they pertain to the practicing oncologist. The first article looks at the value of anticancer drugs in metastatic castrate-resistant prostate cancer; the second examines the implications of hospitalizations of 5 or more days on outcomes among patients with head and neck cancer who have received radiotherapy. Dr Henry rounds off his podcast with Case Reports on zoledronic acid-induced hypocalcemia in hyercalcemia of malignancy and neuroendocrine carcinaoma of the larynx with metastasis to the eyelid.
Click on the download icon at the top of this introduction to listen to the podcast.
Neuroendocrine carcinoma of the larynx with metastasis to the eyelid
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.
Prolonged zoledronic acid-induced hypocalcemia in hypercalcemia of malignancy
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.
Hospitalizations of more than 5 days predict for worse outcomes after radiotherapy for head and neck cancer
Background Patients undergoing chemoradiation for head and neck squamous cell carcinoma (HNSCC) are predisposed to unplanned hospitalizations.
Objective To assess the factors associated with prolonged hospitalization and its impact on patient outcomes.
Methods We assessed the outcomes of patients hospitalized for ≥5 days or <5 days in 251 patients with advanced HNSCC who were undergoing radiotherapy during 2000-2012.
Results Patients who had been hospitalized for ≥5 days were more likely to be admitted for infection, acute renal failure, and/ or dehydration. We found no other patient, tumor, or treatment characteristics associated with prolonged hospitalizations. Hospitalizations of ≥5 days were associated with a higher incidence of delays in radiotherapy (RT; odds ratio [OR], 2.49; 95% confidence index [CI], 1.09-5.69; P = .03) and worse performance status after RT (OR, 5.76; 95% CI, 1.85-18.38; P = .003). On multivariate analysis, hospitalization of ≥5 days predicted for worse local-regional control (hazard ratio [HR], 1.85; 95% CI, 1.08-3.17; P = .03) and time to treatment failure (HR, 1.64; 95% CI, 1.03-2.61; P = .04), and performance status after RT predicted for worse local-regional control, time to treatment failure, progression-free survival, and overall survival.
Limitations As a retrospective review, we report only hypothesis-generating observations, which may have been affected by having incomplete patient information.
Conclusions Hospitalizations of ≥5 days was associated with infections and/or dehydration and predicted for worse disease control. Our results suggest that patients may benefit from efforts to reduce hospitalization length by minimizing precipitators of hospitalizations as well as interventions to reduce the length of hospital stays.
Click on the PDF icon at the top of this introduction to read the full article.
Background Patients undergoing chemoradiation for head and neck squamous cell carcinoma (HNSCC) are predisposed to unplanned hospitalizations.
Objective To assess the factors associated with prolonged hospitalization and its impact on patient outcomes.
Methods We assessed the outcomes of patients hospitalized for ≥5 days or <5 days in 251 patients with advanced HNSCC who were undergoing radiotherapy during 2000-2012.
Results Patients who had been hospitalized for ≥5 days were more likely to be admitted for infection, acute renal failure, and/ or dehydration. We found no other patient, tumor, or treatment characteristics associated with prolonged hospitalizations. Hospitalizations of ≥5 days were associated with a higher incidence of delays in radiotherapy (RT; odds ratio [OR], 2.49; 95% confidence index [CI], 1.09-5.69; P = .03) and worse performance status after RT (OR, 5.76; 95% CI, 1.85-18.38; P = .003). On multivariate analysis, hospitalization of ≥5 days predicted for worse local-regional control (hazard ratio [HR], 1.85; 95% CI, 1.08-3.17; P = .03) and time to treatment failure (HR, 1.64; 95% CI, 1.03-2.61; P = .04), and performance status after RT predicted for worse local-regional control, time to treatment failure, progression-free survival, and overall survival.
Limitations As a retrospective review, we report only hypothesis-generating observations, which may have been affected by having incomplete patient information.
Conclusions Hospitalizations of ≥5 days was associated with infections and/or dehydration and predicted for worse disease control. Our results suggest that patients may benefit from efforts to reduce hospitalization length by minimizing precipitators of hospitalizations as well as interventions to reduce the length of hospital stays.
Click on the PDF icon at the top of this introduction to read the full article.
Background Patients undergoing chemoradiation for head and neck squamous cell carcinoma (HNSCC) are predisposed to unplanned hospitalizations.
Objective To assess the factors associated with prolonged hospitalization and its impact on patient outcomes.
Methods We assessed the outcomes of patients hospitalized for ≥5 days or <5 days in 251 patients with advanced HNSCC who were undergoing radiotherapy during 2000-2012.
Results Patients who had been hospitalized for ≥5 days were more likely to be admitted for infection, acute renal failure, and/ or dehydration. We found no other patient, tumor, or treatment characteristics associated with prolonged hospitalizations. Hospitalizations of ≥5 days were associated with a higher incidence of delays in radiotherapy (RT; odds ratio [OR], 2.49; 95% confidence index [CI], 1.09-5.69; P = .03) and worse performance status after RT (OR, 5.76; 95% CI, 1.85-18.38; P = .003). On multivariate analysis, hospitalization of ≥5 days predicted for worse local-regional control (hazard ratio [HR], 1.85; 95% CI, 1.08-3.17; P = .03) and time to treatment failure (HR, 1.64; 95% CI, 1.03-2.61; P = .04), and performance status after RT predicted for worse local-regional control, time to treatment failure, progression-free survival, and overall survival.
Limitations As a retrospective review, we report only hypothesis-generating observations, which may have been affected by having incomplete patient information.
Conclusions Hospitalizations of ≥5 days was associated with infections and/or dehydration and predicted for worse disease control. Our results suggest that patients may benefit from efforts to reduce hospitalization length by minimizing precipitators of hospitalizations as well as interventions to reduce the length of hospital stays.
Click on the PDF icon at the top of this introduction to read the full article.
The value of anticancer drugs in metastatic castrate-resistant prostate cancer: economic tools for the community oncologist
Background Community oncologists need a simplified methodology for assessing the value of anticancer drugs. In the United States and Europe, costs of anticancer drug were previously estimated at US$50,000 to >US$100,000 per quality-adjusted life-year (QALY). The National Institute for Health and Care Excellence in the United Kingdom states that the average cost-effectiveness ratios intervention of >US$50,000 per QALY must be questioned.
Objectives To design a drug model to estimate the amount in United States dollars (US$) paid for life-year gain (LYG) and QALY, and to apply that model in the treatment of chemo-naïve and chemo-treated patients with castrate-resistant metastatic prostate cancer (mCRPC).
Methods Cost per LYG (cost/LYG) was compared with cost per probability of survival (cost/PoS) calculated as [1.0 minus HR]. Results were expressed in relative values (RV) calculated as US$50,000 or US$100,000 per cost/outcome.
Results In patients with mCRPC, generic docetaxel demonstrated the lowest cost/LYG (US$26,330), lowest cost/ PoS (US$21,942), and the highest RV (3.80-4.56). Cost/LYG of sipuleucel-T was US$272,195, with an RV of 0.37. Significant variation between cost/LYG and cost/ PoS was noted among drugs with borderline survival and HR. In previously treated patients, the cost/LYG of cabazitaxel was US$207,240; of abiraterone, US$194,087; enzalutamide, US$223,500; and radium-223 dichloride, US$230,000, all with RVs <0.5.
Conclusions A simplified drug model to weigh cost, survival, and HR with imposed limits on cost/outcome was proposed and applied to patients with mCRPC. The results among that patient population suggested that generic docetaxel had the lowest costs, cost/outcome and the highest RV. Sipuleucel-T, abiraterone, enzalutamide, radium-223 dichloride, and cabazitaxel were overpriced for their values. Drugs with RVs of <0.5 should be scrutinized, costs negotiated, or other drugs considered, and those with RVs of <0.25, rejected.
Click on the PDF icon at the top of this introduction to read the full article.
Background Community oncologists need a simplified methodology for assessing the value of anticancer drugs. In the United States and Europe, costs of anticancer drug were previously estimated at US$50,000 to >US$100,000 per quality-adjusted life-year (QALY). The National Institute for Health and Care Excellence in the United Kingdom states that the average cost-effectiveness ratios intervention of >US$50,000 per QALY must be questioned.
Objectives To design a drug model to estimate the amount in United States dollars (US$) paid for life-year gain (LYG) and QALY, and to apply that model in the treatment of chemo-naïve and chemo-treated patients with castrate-resistant metastatic prostate cancer (mCRPC).
Methods Cost per LYG (cost/LYG) was compared with cost per probability of survival (cost/PoS) calculated as [1.0 minus HR]. Results were expressed in relative values (RV) calculated as US$50,000 or US$100,000 per cost/outcome.
Results In patients with mCRPC, generic docetaxel demonstrated the lowest cost/LYG (US$26,330), lowest cost/ PoS (US$21,942), and the highest RV (3.80-4.56). Cost/LYG of sipuleucel-T was US$272,195, with an RV of 0.37. Significant variation between cost/LYG and cost/ PoS was noted among drugs with borderline survival and HR. In previously treated patients, the cost/LYG of cabazitaxel was US$207,240; of abiraterone, US$194,087; enzalutamide, US$223,500; and radium-223 dichloride, US$230,000, all with RVs <0.5.
Conclusions A simplified drug model to weigh cost, survival, and HR with imposed limits on cost/outcome was proposed and applied to patients with mCRPC. The results among that patient population suggested that generic docetaxel had the lowest costs, cost/outcome and the highest RV. Sipuleucel-T, abiraterone, enzalutamide, radium-223 dichloride, and cabazitaxel were overpriced for their values. Drugs with RVs of <0.5 should be scrutinized, costs negotiated, or other drugs considered, and those with RVs of <0.25, rejected.
Click on the PDF icon at the top of this introduction to read the full article.
Background Community oncologists need a simplified methodology for assessing the value of anticancer drugs. In the United States and Europe, costs of anticancer drug were previously estimated at US$50,000 to >US$100,000 per quality-adjusted life-year (QALY). The National Institute for Health and Care Excellence in the United Kingdom states that the average cost-effectiveness ratios intervention of >US$50,000 per QALY must be questioned.
Objectives To design a drug model to estimate the amount in United States dollars (US$) paid for life-year gain (LYG) and QALY, and to apply that model in the treatment of chemo-naïve and chemo-treated patients with castrate-resistant metastatic prostate cancer (mCRPC).
Methods Cost per LYG (cost/LYG) was compared with cost per probability of survival (cost/PoS) calculated as [1.0 minus HR]. Results were expressed in relative values (RV) calculated as US$50,000 or US$100,000 per cost/outcome.
Results In patients with mCRPC, generic docetaxel demonstrated the lowest cost/LYG (US$26,330), lowest cost/ PoS (US$21,942), and the highest RV (3.80-4.56). Cost/LYG of sipuleucel-T was US$272,195, with an RV of 0.37. Significant variation between cost/LYG and cost/ PoS was noted among drugs with borderline survival and HR. In previously treated patients, the cost/LYG of cabazitaxel was US$207,240; of abiraterone, US$194,087; enzalutamide, US$223,500; and radium-223 dichloride, US$230,000, all with RVs <0.5.
Conclusions A simplified drug model to weigh cost, survival, and HR with imposed limits on cost/outcome was proposed and applied to patients with mCRPC. The results among that patient population suggested that generic docetaxel had the lowest costs, cost/outcome and the highest RV. Sipuleucel-T, abiraterone, enzalutamide, radium-223 dichloride, and cabazitaxel were overpriced for their values. Drugs with RVs of <0.5 should be scrutinized, costs negotiated, or other drugs considered, and those with RVs of <0.25, rejected.
Click on the PDF icon at the top of this introduction to read the full article.
Endocrine therapy in metastatic breast cancer: a closer look at the current clinical practice
Cancer-related pain management in clinical oncology
Uncontrolled pain is one of the most feared and debilitating symptoms among cancer patients, and many suffer unnecessarily from suboptimal pain control. Cancer-related pain is often multidimensional and can affect all aspects of a patient’s life. Hence, achieving adequate pain relief among cancer patients involves a proper assessment of psychosocial, spiritual, and physical pain issues, matched with an individualized treatment plan involving pharmacologic, nonpharmacologic, and procedural therapies when appropriate. Providing effective pain relief can help ease the overall burden of disease among oncology patients while helping them tolerate cancer-directed therapies and achieve the most optimal quality of life throughout all phases of the disease continuum. In this review, the authors will discuss the syndromes, assessment of, and treatment for cancer-related pain in the outpatient setting.
Click on the PDF icon at the top of this introduction to read the full article.
Uncontrolled pain is one of the most feared and debilitating symptoms among cancer patients, and many suffer unnecessarily from suboptimal pain control. Cancer-related pain is often multidimensional and can affect all aspects of a patient’s life. Hence, achieving adequate pain relief among cancer patients involves a proper assessment of psychosocial, spiritual, and physical pain issues, matched with an individualized treatment plan involving pharmacologic, nonpharmacologic, and procedural therapies when appropriate. Providing effective pain relief can help ease the overall burden of disease among oncology patients while helping them tolerate cancer-directed therapies and achieve the most optimal quality of life throughout all phases of the disease continuum. In this review, the authors will discuss the syndromes, assessment of, and treatment for cancer-related pain in the outpatient setting.
Click on the PDF icon at the top of this introduction to read the full article.
Uncontrolled pain is one of the most feared and debilitating symptoms among cancer patients, and many suffer unnecessarily from suboptimal pain control. Cancer-related pain is often multidimensional and can affect all aspects of a patient’s life. Hence, achieving adequate pain relief among cancer patients involves a proper assessment of psychosocial, spiritual, and physical pain issues, matched with an individualized treatment plan involving pharmacologic, nonpharmacologic, and procedural therapies when appropriate. Providing effective pain relief can help ease the overall burden of disease among oncology patients while helping them tolerate cancer-directed therapies and achieve the most optimal quality of life throughout all phases of the disease continuum. In this review, the authors will discuss the syndromes, assessment of, and treatment for cancer-related pain in the outpatient setting.
Click on the PDF icon at the top of this introduction to read the full article.
Dinutuximab combination therapy becomes first approval for high-risk neuroblastoma
The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.
The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.
The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.
How to fix clinical trial accrual
Editor Jame Abraham argues that once there is appropriate clinical trial infrastructure, there is only one person who can increase the clinical trial accrual: the treating oncologist.
Click on the PDF icon at the top of this introduction to read the full article.
Editor Jame Abraham argues that once there is appropriate clinical trial infrastructure, there is only one person who can increase the clinical trial accrual: the treating oncologist.
Click on the PDF icon at the top of this introduction to read the full article.
Editor Jame Abraham argues that once there is appropriate clinical trial infrastructure, there is only one person who can increase the clinical trial accrual: the treating oncologist.
Click on the PDF icon at the top of this introduction to read the full article.
