TY - JOUR
T1 - 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
AU - Takezako, Naoki
AU - Shibayama, Hirohiko
AU - Handa, Hiroshi
AU - Hagiwara, Shotaro
AU - Ozaki, Shuji
AU - Suzuki, Kenshi
AU - Kosugi, Hiroshi
AU - Ri, Masaki
AU - Sugiura, Isamu
AU - Choi, Ilseung
AU - Miyamoto, Toshihiro
AU - Iida, Shinsuke
N1 - Funding Information:
The authors wish to thank all study participants and their families and all study sites and investigators. We thank the contributions and critical review of the manuscript by Jiafen Shu and Anita Zahlten-Kuemeli (Amgen, Thousand Oaks), as well as that from Yutaro Ueno (Ono Pharmaceutical). We also acknowledge the statistical support of Toshiaki Ozaki (Ono Pharmaceutical, Osaka). The authors thank Keyra Martinez Dunn, MD of Edanz Medical Writing, for providing medical writing support, which was funded by Ono Pharmaceutical through EMC K.K. in accordance with Good Publication Practice (GPP3) guidelines ( https://www.ismpp.org/gpp3 ). This research was funded by Amgen Inc. and Ono Pharmaceutical. Ono Pharmaceutical supported this manuscript using the data provided by Amgen.
Funding Information:
The authors wish to thank all study participants and their families and all study sites and investigators. We thank the contributions and critical review of the manuscript by Jiafen Shu and Anita Zahlten-Kuemeli (Amgen, Thousand Oaks), as well as that from Yutaro Ueno (Ono Pharmaceutical). We also acknowledge the statistical support of Toshiaki Ozaki (Ono Pharmaceutical, Osaka). The authors thank Keyra Martinez Dunn, MD of Edanz Medical Writing, for providing medical writing support, which was funded by Ono Pharmaceutical through EMC K.K. in accordance with Good Publication Practice (GPP3) guidelines (https://www.ismpp.org/gpp3 ). This research was funded by Amgen Inc. and Ono Pharmaceutical. Ono Pharmaceutical supported this manuscript using the data provided by Amgen.
Publisher Copyright:
© 2020, Japanese Society of Hematology.
PY - 2021/2
Y1 - 2021/2
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85092337777&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85092337777&partnerID=8YFLogxK
U2 - 10.1007/s12185-020-03013-6
DO - 10.1007/s12185-020-03013-6
M3 - Article
C2 - 33037990
AN - SCOPUS:85092337777
SN - 0925-5710
VL - 113
SP - 219
EP - 230
JO - International journal of hematology
JF - International journal of hematology
IS - 2
ER -