萩原　將太郎
   Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine
   Position  
Article types Original article
Language English
Peer review Peer reviewed
Title 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.
Journal Formal name：International journal of hematology
Abbreviation：Int J Hematol
ISSN code：18653774/09255710
Domestic / ForeginForegin
Volume, Issue, Page 113(2),pp.219-230
Author and coauthor Takezako Naoki†, Shibayama Hirohiko, Handa Hiroshi, Hagiwara Shotaro, Ozaki Shuji, Suzuki Kenshi, Kosugi Hiroshi, Ri Masaki, Sugiura Isamu, Choi Ilseung, Miyamoto Toshihiro, Iida Shinsuke
Publication date 2021/02
Summary 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.
DOI 10.1007/s12185-020-03013-6
PMID 33037990