Comment on “Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma”

摘要

We read with interest the paper by Dimopoulos et al . concerning a comparison of bortezomib plus dexamethasone (BzD) versus bortezomib monotherapy in relapsed multiple myeloma (MM).~(~(1)) In their manuscript the authors presented a post hoc matched-pair analysis of patients treated in three separate clinical studies: MMY-2045 (patients treated with BzD),~(~(2)) APEX (patients treated with single-agent bortezomib)~(~(3)) and the single-agent bortezomib arm of the DOXIL-MMY-3001 trial.~(~(4)) They found that BzD is associated with a significantly higher response rate and time to progression but has no impact on survival.We recently published the results of the BoMER study,~(~(5)) which involved 100 patients and recapitulated the original APEX study design (i.e. patients with relapsed or refractory MM who were bortezomib-nave, required second- or subsequent therapy and were not dexamethasone-resistant. In our BoMER trial, patients were treated with eight 21-day cycles of intravenous bortezomib (1.3 mg/m~(2); days 1, 4, 8, and 11) and three 35-day cycles of bortezomib (1.3 mg/m~(2); days 1, 8, 15, and 22) with the incorporation of dexamethasone from cycle 1. Our study also examined subsequent maintenance BzD; patients with stable disease or better continued on BzD therapy every 2 weeks until progression or unacceptable toxicity. The study design included a prospectively planned analysis comparing the BoMER results to those of a matched cohort in the APEX study. While our study agrees with the overall conclusions of Dimopoulos et al . - that BzD improves the depth and duration of response in patients with refractory or relapsed MM, with no compromise in the safety profile of the therapy and no impact on overall survival - we have a number of comments on the design and methodology of the study by Dimopoulos et al .