Attrition and withdrawal in multiple myeloma randomized controlled trials: A systematic review

Author:

Hentzen Stijn1ORCID,Meirson Tomer2,Koehn Kelly1,Goodman Aaron3,Chakraborty Rajshekhar4,Sborov Douglas5,Rubinstein Samuel6,Mohyuddin Ghulam Rehman5ORCID

Affiliation:

1. Department of Internal Medicine Kansas University Medical Center Kansas City Kansas USA

2. Davidoff Cancer Center Petah Tikva Israel

3. Division of Hematology University of California San Diego La Jolla California USA

4. Division of Hematology Columbia University Medical Center New York New York USA

5. Division of Hematology and Hematological Malignancies Huntsman Cancer Institute at the University of Utah Salt Lake City Utah USA

6. Division of Hematology Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill North Carolina USA

Abstract

AbstractObjectivesPatients with multiple myeloma (MM) enrolled in randomized control trials (RCTs) discontinue treatment for various reasons; however, no prior study has analyzed reasons for discontinuation. We performed a systematic review of MM RCTs to investigate reasons for treatment discontinuation, imbalances between trial cohorts, and reporting practices.MethodsA comprehensive search for RCTs in MM from 2015 to 2021 identified 45 studies meeting inclusion criteria.ResultsOf 21 236 randomized patients, 10 161 (47.8%) discontinued therapy by primary endpoint ascertainment. Causes of discontinuation included progression (n = 4790; 22.6% of randomized patients); toxicity (n = 2569; 12.1%); patient/physician withdrawal (n = 1200; 5.7%) and death (n = 495; 2.3%). Of randomized patients, 20 914 (98.5%) were included in the RCT analysis. Imbalances of attrition, defined as trials with greater than 5% absolute difference in discontinuation rate for reasons other than death, progression, and toxicity between intervention and control arms, were found in 11 (24.4%) studies.ConclusionsAlthough progression is the most common reason for RCT treatment discontinuation in patients with MM, over 10% discontinued due to toxicity. Furthermore, 24.4% of trials showed substantial imbalances between trial cohorts; raising concern for informative censoring and emphasizes the importance of detailed characterization of withdrawal in MM RCTs.

Publisher

Wiley

Subject

Hematology,General Medicine

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