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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

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...

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Autores principales: Takezako, Naoki, Shibayama, Hirohiko, Handa, Hiroshi, Hagiwara, Shotaro, Ozaki, Shuji, Suzuki, Kenshi, Kosugi, Hiroshi, Ri, Masaki, Sugiura, Isamu, Choi, Ilseung, Miyamoto, Toshihiro, Iida, Shinsuke
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Singapore 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7547551/
https://www.ncbi.nlm.nih.gov/pubmed/33037990
http://dx.doi.org/10.1007/s12185-020-03013-6
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author Takezako, Naoki
Shibayama, Hirohiko
Handa, Hiroshi
Hagiwara, Shotaro
Ozaki, Shuji
Suzuki, Kenshi
Kosugi, Hiroshi
Ri, Masaki
Sugiura, Isamu
Choi, Ilseung
Miyamoto, Toshihiro
Iida, Shinsuke
author_facet Takezako, Naoki
Shibayama, Hirohiko
Handa, Hiroshi
Hagiwara, Shotaro
Ozaki, Shuji
Suzuki, Kenshi
Kosugi, Hiroshi
Ri, Masaki
Sugiura, Isamu
Choi, Ilseung
Miyamoto, Toshihiro
Iida, Shinsuke
author_sort Takezako, Naoki
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12185-020-03013-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-75475512020-10-14 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 Takezako, Naoki Shibayama, Hirohiko Handa, Hiroshi Hagiwara, Shotaro Ozaki, Shuji Suzuki, Kenshi Kosugi, Hiroshi Ri, Masaki Sugiura, Isamu Choi, Ilseung Miyamoto, Toshihiro Iida, Shinsuke Int J Hematol Original Article 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12185-020-03013-6) contains supplementary material, which is available to authorized users. Springer Singapore 2020-10-10 2021 /pmc/articles/PMC7547551/ /pubmed/33037990 http://dx.doi.org/10.1007/s12185-020-03013-6 Text en © Japanese Society of Hematology 2020 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Original Article
Takezako, Naoki
Shibayama, Hirohiko
Handa, Hiroshi
Hagiwara, Shotaro
Ozaki, Shuji
Suzuki, Kenshi
Kosugi, Hiroshi
Ri, Masaki
Sugiura, Isamu
Choi, Ilseung
Miyamoto, Toshihiro
Iida, Shinsuke
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7547551/
https://www.ncbi.nlm.nih.gov/pubmed/33037990
http://dx.doi.org/10.1007/s12185-020-03013-6
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