PMID- 33037990
OWN - NLM
STAT- MEDLINE
DCOM- 20210618
LR  - 20220218
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Print)
IS  - 0925-5710 (Linking)
VI  - 113
IP  - 2
DP  - 2021 Feb
TI  - 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.
PG  - 219-230
LID - 10.1007/s12185-020-03013-6 [doi]
AB  - A.R.R.O.W. evaluated the superiority of once-weekly carfilzomib plus 
      dexamethasone (Kd) 20/70 mg/m(2) vs. twice-weekly Kd 20/27 mg/m(2) 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/m(2)) vs. ENDEAVOR 
      (twice-weekly Kd 20/56 mg/m(2)), 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.
FAU - Takezako, Naoki
AU  - Takezako N
AD  - National Hospital Organization Disaster Medical Center, 3256 Midori, Tachikawa, 
      Tokyo, 190-0014, Japan. ntakezak@tdmc.hosp.go.jp.
FAU - Shibayama, Hirohiko
AU  - Shibayama H
AD  - Osaka University Graduate School of Medicine, Suita, Japan.
FAU - Handa, Hiroshi
AU  - Handa H
AD  - Gunma University Graduate School, Maebashi, Japan.
FAU - Hagiwara, Shotaro
AU  - Hagiwara S
AD  - Tokyo Women's University, Tokyo, Japan.
FAU - Ozaki, Shuji
AU  - Ozaki S
AD  - Tokushima Prefectural Central Hospital, Tokushima, Japan.
FAU - Suzuki, Kenshi
AU  - Suzuki K
AD  - Japanese Red Cross Medical Center, Tokyo, Japan.
FAU - Kosugi, Hiroshi
AU  - Kosugi H
AD  - Ogaki Municipal Hospital, Ogaki, Japan.
FAU - Ri, Masaki
AU  - Ri M
AD  - Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
FAU - Sugiura, Isamu
AU  - Sugiura I
AD  - Toyohashi Municipal Hospital, Toyohashi, Japan.
FAU - Choi, Ilseung
AU  - Choi I
AD  - National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
FAU - Miyamoto, Toshihiro
AU  - Miyamoto T
AD  - Kyushu University Hospital, Fukuoka, Japan.
FAU - Iida, Shinsuke
AU  - Iida S
AD  - Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
LA  - eng
PT  - Journal Article
DEP - 20201010
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Oligopeptides)
RN  - 0 (Proteasome Inhibitors)
RN  - 72X6E3J5AR (carfilzomib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Clinical Trials, Phase III as Topic
MH  - Drug Administration Schedule
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/diagnosis/*drug therapy/etiology
MH  - Neoplasm Grading
MH  - Neoplasm Staging
MH  - Oligopeptides/*administration & dosage/adverse effects
MH  - Proteasome Inhibitors/*administration & dosage/adverse effects
MH  - Recurrence
MH  - Retreatment
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7547551
OTO - NOTNLM
OT  - Carfilzomib
OT  - Japanese
OT  - Kyprolis
OT  - Once-weekly
OT  - Relapsed and refractory multiple myeloma
COIS- Dr. N. Takezako, Dr. H. Handa, Dr. S. Ozaki, Dr. Ilseung Choi, Dr. T Miyamoto, 
      and Dr. S. Hagiwara report grants and personal fees from Ono Pharmaceutical 
      during the conduct of the study. Dr. T Miyamoto reports lecture fees from 
      Bristol-Myers Squibb, Otsuka Pharmaceutical, MSD, Astellas Pharmaceutical, 
      Astellas Amgen Pharmaceutical, Celgene, Abbvie Pharmaceutical, and Takeda 
      Pharmaceutical. Dr. H. Shibayama reports grants and personal fees from Ono 
      Pharmaceutical during the conduct of the study; grants from Astellas, Teijin, 
      Shionogi, Taiho, Merck Sharp & Dohme, and Sumitomo Dainippon; grants and personal 
      fees from Eisai, Celgene, Takeda, Nippon Shinyaku, and Daiichi Sankyo; and 
      personal fees from Novartis, Janssen, Chugai, Kyowa Kirin, Otsuka, Bristol-Myers 
      Squibb, Pfizer, Fujimoto Pharmaceutical, AbbVie, and AstraZeneca outside the 
      submitted work. Dr. K. Suzuki reports grants and personal fees from Ono 
      Pharmaceutical during the conduct of the study; grants and personal fees from 
      Bristol-Myers Squibb, Celgene, and Amgen; and personal fees from Janssen, Takeda, 
      Novartis, Sanofi, and AbbVie outside the submitted work. Dr. H. Kosugi reports 
      grants and personal fees from Ono during the conduct of the study; and personal 
      fees from Chugai, Celgene, Novartis, Bioverative Japan, Merck Sharp & Dohme, 
      Takeda, Janssen, Japan Blood Products Organization, Bristol-Myers Squibb, and Ono 
      Pharmaceutical outside the submitted work. Dr. M. Ri reports grants and personal 
      fees from Ono Pharmaceutical during the conduct of the study; grants and personal 
      fees from Celgene, Janssen, Takeda, Ono Pharmaceutical, Bristol-Myers Squibb, and 
      Sanofi; and grants from Kyowa Kirin outside the submitted work. Dr. I. Sugiura 
      reports no conflict of interest. Dr. S. Iida reports grants and personal fees 
      from Ono Pharmaceutical during the conduct of the study; grants and personal fees 
      from Takeda, Celgene, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Sanofi, and 
      AbbVie; and grants from Merck Sharp & Dohme, Gilead, and GlaxoSmithKline outside 
      the submitted work.
EDAT- 2020/10/11 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/10/10
CRDT- 2020/10/10 12:04
PHST- 2020/06/29 00:00 [received]
PHST- 2020/09/24 00:00 [accepted]
PHST- 2020/08/26 00:00 [revised]
PHST- 2020/10/11 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/10/10 12:04 [entrez]
PHST- 2020/10/10 00:00 [pmc-release]
AID - 10.1007/s12185-020-03013-6 [pii]
AID - 3013 [pii]
AID - 10.1007/s12185-020-03013-6 [doi]
PST - ppublish
SO  - Int J Hematol. 2021 Feb;113(2):219-230. doi: 10.1007/s12185-020-03013-6. Epub 
      2020 Oct 10.