Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial

Dimopoulos, Meletios Α.; Goldschmidt, Hartmut; Niesvizky, Rubén; Joshua, Douglas; Chng, Wee Joo; Oriol, Albert; Orłowski, Robert Z.; Ludwig, Heinz; Façon, Thierry; Hájek, Roman; Weisel, Katja; Hungria, Vânia; Minuk, Leonard; Feng, Shibao; Zahlten-Kumeli, Anita; Kimball, Amy; Moreau, Philippe

doi:10.1016/s1470-2045(17)30578-8

Cited by 342 publications

(333 citation statements)

References 25 publications

Supporting

Mentioning

311

Contrasting

Unclassified

Order By: Relevance

“…10,15 More recently, OS data showed superiority of Kd vs Vd and KRd vs Rd, with a nearly 8-month increase in median OS in patients treated with carfilzomib. 11,28 Carfilzomib-based regimens have been generally well tolerated, but concerns for CV toxicity have been raised. 10,[13][14][15]29 Here, we assessed carfilzomib-associated CV AEs in phase 1-3 clinical trials.…”

Section: Discussionmentioning

confidence: 99%

“…9 In the head-to-head ENDEAVOR study comparing carfilzomib plus dexamethasone (Kd) with bortezomib plus dexamethasone (Vd), Kd improved the complete response rate, doubled progression-free survival (PFS), and reduced the risk for death by 21%. 10,11 Carfilzomib-based combinations have significantly improved PFS and overall survival (OS) by ;9 and 8 months, respectively, compared with standard treatments (lenalidomide plus dexamethasone [Rd] and Vd) in RRMM patients. Moreover, at first relapse, Kd and carfilzomib, lenalidomide, and dexamethasone (KRd) have improved PFS by 12 months compared with Rd and Vd.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials

et al. 2018

Self Cite

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials

et al. 2018

Self Cite

View full text Add to dashboard Cite

“…OS analysis showed that the carfilzomib/dexamethasone group lived 7.6 months longer (median OS, 47.6 months for carfilzomib vs 40 for bortezomib; HR, 0.791; 95% CI, 0.648-0.964; P=.010). 29 A phase II study in patients with R/R MM (n=104) evaluated safety and efficacy of weekly dosing 30 of carfilzomib (70 mg/m 2 ) with dexamethasone. 31 The observed ORR was 77% (95% CI, 68- 31 Based on the data from the ENDEAVOR trial, the NCCN MM Panel included the combination of carfilzomib (twice weekly) and dexamethasone as a category 1, preferred option for patients with R/R MM.…”

Section: Updates To Maintenance Therapy Recommendationsmentioning

confidence: 99%

NCCN Guidelines Insights: Multiple Myeloma, Version 3.2018

Kumar¹,

Callander²,

Alsina³

et al. 2018

J Natl Compr Canc Netw

149

View full text Add to dashboard Cite

The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, evaluation, treatment, including supportivecare, and follow-up for patients with myeloma. These NCCN Guidelines Insights highlight the important updates/changes specific to the myeloma therapy options in the 2018 version of the NCCN Guidelines. J Natl Compr Canc Netw 2018;16(1):11-20 doi: 10.6004/jnccn.2018.0002 © JNCCN-Journal of the National Comprehensive Cancer Network | NCCN: Continuing EducationTarget Audience: This activity is designed to meet the educational needs of physicians, nurses, and pharmacists involved in the management of patients with cancer.

show abstract

“…The next-generation proteasome inhibitor carfilzomib is reported to increase the frequency and depth of responses, and improves survival in heavily pretreated patients with multiple myeloma. 4,5 In addition to improvements in clinical outcomes, carfilzomib has not been associated with the debilitating and life-altering side effect of neuropathy, which frequently has been reported with bortezomib. The overall response rate in this heavily pretreated population was 23%, with a median duration of response of 7.8 months.…”

Section: Introductionmentioning

confidence: 99%

Measuring cardiopulmonary complications of carfilzomib treatment and associated risk factors using the SEER‐Medicare database

Fakhri

Fiala

Shah

et al. 2019

Cancer

View full text Add to dashboard Cite

BACKGROUND: Carfilzomib improves survival in patients with recurrent myeloma. Given the strict eligibility criteria in clinical trials, the actual frequency of cardiac adverse events (CAEs) and pulmonary adverse events (PAEs) and the risk factors associated with these AEs in the general population need to be established. METHODS: The authors extracted myeloma cases in the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database from 2000 through 2013 and corresponding claims through 2014. They then identified patients who received carfilzomib during their disease course. Subsequently, the International Classification of Diseases, Ninth Revision (ICD-9) was used to identify all the codes for CAEs, PAEs, and respiratory infections associated with carfilzomib use. Preexisting diagnoses corresponding to the CAEs and PAEs of interest were excluded to distinguish toxicity from comorbidity. Multivariate Cox regression was performed to determine those variables independently associated with the development of CAEs and PAEs. RESULTS: Of the 635 patients analyzed, the median age was 72 years (range, 36-94 years); 55% of the patients were male and 79% were white. The median duration of carfilzomib treatment was 58 days (range, 1-716 days). Overall, approximately 66% of the patients had codes for either CAEs or PAEs. In terms of CAEs, approximately 22% of patients developed hypertension, 15% developed peripheral edema, and 14% experienced heart failure. With regard to PAEs, approximately 28% of patients developed dyspnea, 15% developed cough, and 15% developed pneumonia. Only chronic obstructive pulmonary disease (COPD) was found to be independently associated with the development of CAEs. Patients with preexisting COPD were found to have a 40% increase in their hazard of developing CAEs (adjusted hazard ratio, 1.40; 95% CI, 1.03-1.90). CONCLUSIONS: In older adults with myeloma who are undergoing treatment with carfilzomib, new cardiac and pulmonary diagnoses were common. Patients with preexisting COPD were found to be at an increased risk of developing CAEs. Cancer 2020;126:808-813.

show abstract

Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial

Cited by 342 publications

References 25 publications

Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials

Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials

NCCN Guidelines Insights: Multiple Myeloma, Version 3.2018

Measuring cardiopulmonary complications of carfilzomib treatment and associated risk factors using the SEER‐Medicare database

Contact Info

Product

Resources

About