6 research outputs found
Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study
Background Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Methods In this randomised, phase 3, open-label, multicentre study, patients with relapsed or refractory multiple myeloma who had one to three previous treatments were randomly assigned (1: 1) using a blocked randomisation scheme (block size of four) to receive carfilzomib with dexamethasone (carfilzomib group) or bortezomib with dexamethasone (bortezomib group). Randomisation was stratified by previous proteasome inhibitor therapy, previous lines of treatment, International Staging System stage, and planned route of bortezomib administration if randomly assigned to bortezomib with dexamethasone. Patients received treatment until progression with carfilzomib (20 mg/m(2) on days 1 and 2 of cycle 1; 56 mg/m(2) thereafter; 30 min intravenous infusion) and dexamethasone (20 mg oral or intravenous infusion) or bortezomib (1.3 mg/m(2); intravenous bolus or subcutaneous injection) and dexamethasone (20 mg oral or intravenous infusion). The primary endpoint was progression-free survival in the intention-to-treat population. All participants who received at least one dose of study drug were included in the safety analyses. The study is ongoing but not enrolling participants; results for the interim analysis of the primary endpoint are presented. Findings Between June 20, 2012, and June 30, 2014, 929 patients were randomly assigned (464 to the carfilzomib group; 465 to the bortezomib group). Median follow-up was 11.9 months (IQR 9.3-16.1) in the carfilzomib group and 11.1 months (8.2-14.3) in the bortezomib group. Median progression-free survival was 18.7 months (95% CI 15.6-not estimable) in the carfilzomib group versus 9.4 months (8.4-10.4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0.53 [95% CI 0.44-0.65]; p<0.0001). On-study death due to adverse events occurred in 18 (4%) of 464 patients in the carfilzomib group and in 16 (3%) of 465 patients in the bortezomib group. Serious adverse events were reported in 224 (48%) of 463 patients in the carfilzomib group and in 162 (36%) of 456 patients in the bortezomib group. The most frequent grade 3 or higher adverse events were anaemia (67 [14%] of 463 patients in the carfilzomib group vs 45 [10%] of 456 patients in the bortezomib group), hypertension (41 [9%] vs 12 [3%]), thrombocytopenia (39 [8%] vs 43 [9%]), and pneumonia (32 [7%] vs 36 [8%]). Interpretation For patients with relapsed or refractory multiple myeloma, carfilzomib with dexamethasone could be considered in cases in which bortezomib with dexamethasone is a potential treatment option
Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): And randomised, phase 3, open-label, multicentre study
Background: Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Methods: In this randomised, phase 3, open-label, multicentre study, patients with relapsed or refractory multiple myeloma who had one to three previous treatments were randomly assigned (1:1) using a blocked randomisation scheme (block size of four) to receive carfilzomib with dexamethasone (carfilzomib group) or bortezomib with dexamethasone (bortezomib group). Randomisation was stratified by previous proteasome inhibitor therapy, previous lines of treatment, International Staging System stage, and planned route of bortezomib administration if randomly assigned to bortezomib with dexamethasone. Patients received treatment until progression with carfilzomib (20 mg/m2 on days 1 and 2 of cycle 1; 56 mg/m2 thereafter; 30 min intravenous infusion) and dexamethasone (20 mg oral or intravenous infusion) or bortezomib (1·3 mg/m2; intravenous bolus or subcutaneous injection) and dexamethasone (20 mg oral or intravenous infusion). The primary endpoint was progression-free survival in the intention-to-treat population. All participants who received at least one dose of study drug were included in the safety analyses. The study is ongoing but not enrolling participants; results for the interim analysis of the primary endpoint are presented. The trial is registered at ClinicalTrials.gov, number NCT01568866. Findings: Between June 20, 2012, and June 30, 2014, 929 patients were randomly assigned (464 to the carfilzomib group; 465 to the bortezomib group). Median follow-up was 11·9 months (IQR 9·3-16·1) in the carfilzomib group and 11·1 months (8·2-14·3) in the bortezomib group. Median progression-free survival was 18·7 months (95% CI 15·6-not estimable) in the carfilzomib group versus 9·4 months (8·4-10·4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0·53 [95% CI 0·44-0·65]; p<0·0001). On-study death due to adverse events occurred in 18 (4%) of 464 patients in the carfilzomib group and in 16 (3%) of 465 patients in the bortezomib group. Serious adverse events were reported in 224 (48%) of 463 patients in the carfilzomib group and in 162 (36%) of 456 patients in the bortezomib group. The most frequent grade 3 or higher adverse events were anaemia (67 [14%] of 463 patients in the carfilzomib group vs 45 [10%] of 456 patients in the bortezomib group), hypertension (41 [9%] vs 12 [3%]), thrombocytopenia (39 [8%] vs 43 [9%]), and pneumonia (32 [7%] vs 36 [8%]). Interpretation: For patients with relapsed or refractory multiple myeloma, carfilzomib with dexamethasone could be considered in cases in which bortezomib with dexamethasone is a potential treatment option. Funding: Onyx Pharmaceuticals, Inc., an Amgen subsidiary
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Dersimelagon in Erythropoietic Protoporphyrias
In a phase 2 trial, once-daily oral treatment with dersimelagon safely improved tolerance to sun exposure in patients with erythropoietic protoporphyria and X-linked protoporphyria
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Who is the average patient presenting with prostate cancer?
Prostate cancer screening, diagnosis, and treatment have changed dramatically in the last 20 years. Patients with newly diagnosed prostate cancer have many treatment options available. We attempted to determine how patient demographics and quality of life (QOL) have changed, and we describe the average patient with newly diagnosed prostate cancer in the early 21st century. From the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) we identified 3003 men with prostate cancer diagnosed between 1997 and 2003 for whom pretreatment demographic and QOL data were available. All patients completed both the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) and the Rand Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) as self-administered questionnaires at the time of diagnosis. We compared demographic variables (age at diagnosis, race/ethnicity, education, number of comorbidities, body mass index [BMI], and insurance type), treatment choice, and pretreatment QOL scores on the SF-36 and UCLA-PCI scales for the periods 1997 to 1999 or 2000 to 2003. Stratified analysis by risk category was performed for demographic and QOL data for the 2 periods. Race/ethnicity and insurance demographics were statistically different for the 2 periods. Low-risk patients also showed a statistically increased BMI in the 2000 to 2003 period. Risk category predicted performance on both inventories, with low-risk patients having better function than intermediate-risk patients and high-risk patients in the areas of urinary bother, bowel function and bother, and sexual function and bother, as well as in many general well-being and emotional health scales on the SF-36. We conclude that the "average" prostate cancer patient is white, 65 years of age, overweight, educated at a college level, and has 1 to 2 comorbidities. Patients report average or above-average pretreatment health-related QOL for all scales based on 2 validated instruments. In this cohort, more patients chose radical prostatectomy than any other form of treatment
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Who is the average patient presenting with prostate cancer?
Prostate cancer screening, diagnosis, and treatment have changed dramatically in the last 20 years. Patients with newly diagnosed prostate cancer have many treatment options available. We attempted to determine how patient demographics and quality of life (QOL) have changed, and we describe the average patient with newly diagnosed prostate cancer in the early 21st century. From the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) we identified 3003 men with prostate cancer diagnosed between 1997 and 2003 for whom pretreatment demographic and QOL data were available. All patients completed both the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) and the Rand Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) as self-administered questionnaires at the time of diagnosis. We compared demographic variables (age at diagnosis, race/ethnicity, education, number of comorbidities, body mass index [BMI], and insurance type), treatment choice, and pretreatment QOL scores on the SF-36 and UCLA-PCI scales for the periods 1997 to 1999 or 2000 to 2003. Stratified analysis by risk category was performed for demographic and QOL data for the 2 periods. Race/ethnicity and insurance demographics were statistically different for the 2 periods. Low-risk patients also showed a statistically increased BMI in the 2000 to 2003 period. Risk category predicted performance on both inventories, with low-risk patients having better function than intermediate-risk patients and high-risk patients in the areas of urinary bother, bowel function and bother, and sexual function and bother, as well as in many general well-being and emotional health scales on the SF-36. We conclude that the "average" prostate cancer patient is white, 65 years of age, overweight, educated at a college level, and has 1 to 2 comorbidities. Patients report average or above-average pretreatment health-related QOL for all scales based on 2 validated instruments. In this cohort, more patients chose radical prostatectomy than any other form of treatment
Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study
Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma