Once-weekly vs. twice-weekly carfilzomib dosing in a subgroup of Japanese relapsed and refractory multiple myeloma patie
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ORIGINAL ARTICLE
Once‑weekly vs. twice‑weekly carfilzomib dosing in a subgroup of Japanese relapsed and refractory multiple myeloma patients from a randomized phase 3 trial (A.R.R.O.W.) and comparison with ENDEAVOR Naoki Takezako1 · Hirohiko Shibayama2 · Hiroshi Handa3 · Shotaro Hagiwara4 · Shuji Ozaki5 · Kenshi Suzuki6 · Hiroshi Kosugi7 · Masaki Ri8 · Isamu Sugiura9 · Ilseung Choi10 · Toshihiro Miyamoto11 · Shinsuke Iida8 Received: 29 June 2020 / Revised: 26 August 2020 / Accepted: 24 September 2020 © Japanese Society of Hematology 2020
Abstract A.R.R.O.W. evaluated the superiority of once-weekly carfilzomib plus dexamethasone (Kd) 20/70 mg/m2 vs. twice-weekly Kd 20/27 mg/m2 based on progression-free survival (PFS) in relapsed and/or refractory multiple myeloma patients. Forty Japanese patients (once-weekly arm, n = 26; twice-weekly arm, n = 14) were randomized in A.R.R.O.W. In the Japanese subgroup of A.R.R.O.W., median PFS was 14.8 months (95% confidence interval [CI], 7.5–not evaluable [NE]) and 9.7 months (95% CI, 3.8–NE) in the once- and twice-weekly arms, respectively. The overall response rate (ORR) was 73.1% (19/26; 95% CI, 52.2–88.4) and 57.1% (8/14; 95% CI, 28.9–82.3) in each arm. The adverse events (AEs) incidence was 100% in both arms. Grade ≥ 3 AE incidence was 80.8% (21/26) and 78.6% (11/14) in each arm. Two fatal treatment-related AEs (acute lung injury and acute respiratory distress syndrome) occurred in the once-weekly arm. In exploratory unadjusted analyses of A.R.R.O.W. (once-weekly Kd 20/70 mg/m2) vs. ENDEAVOR (twice-weekly Kd 20/56 mg/m2), median PFS was 14.8 months vs. NE due to not yet being reached, and ORR was 73.1% (19/26) vs. 42.9% (3/7). In the Japanese subgroup, once-weekly Kd tended to improve ORR vs. twice-weekly Kd. Results from A.R.R.O.W. tended to be consistent with results from ENDEAVOR. Keywords Carfilzomib · Japanese · Kyprolis · Once-weekly · Relapsed and refractory multiple myeloma
Introduction Some results of this study were previously published: Moreau P, Mateos MV, Berenson JR, Weisel K, Lazzaro A, Song K, et al. Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018 Jul;19(7):953–964. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12185-020-03013-6) contains supplementary material, which is available to authorized users.
Multiple myeloma (MM) comprises approximately 10% of all hematological malignancies. In Japan, the annual incidence and 5-year prevalence rates of MM were reported to be 1.3–5.4 and 9.7 per 100,000 persons, respectively [1]. Given the better understanding of the disease and the advent of new treatments during the past decades, the overall survival (OS) of patients with MM has remarkably increased
* Naoki Takezako [email protected]
6
Japanese Red Cross Medical Center, Tokyo, Japan
7
Ogaki Municipal Hospital, Ogaki, Japan
1
Nagoya City U
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