ID | 61063 |
FullText URL | |
Author |
Tsurutani, Junji
Advanced Cancer Translational Research Institute, Showa University
Hara, Fumikata
Department of Breast Medical Oncology, Cancer Institute Hospital of JFCR
Kitada, Masahiro
Department of Breast Disease Center, Asahikawa Medical University Hospital
Takahashi, Masato
NHO Hokkaido Cancer Center
Kikawa, Yuichiro
Department of Breast Surgery, Kobe City Medical Center General Hospita
Kato, Hiroaki
Teine Keijinkai Hospital
Sakata, Eiko
Niigata City General Hospital
Naito, Yoichi
Department of Breast and Medical Oncology, National Cancer Center Hospital East
Hasegawa, Yoshie
Department of Breast Surgery, Hirosaki Municipal Hospital
Saito, Tsuyoshi
Japanese Red Cross Saitama Hospital
Iwasa, Tsutomu
Department of Medical Oncology, Kindai University Faculty of Medicine
Takashima, Tsutomu
Osaka City University Graduate School of Medicine
Kashiwabara, Kosuke
Clinical Research Promotion Center, The University of Tokyo Hospital
Aihara, Tomohiko
Breast Center, Aihara Hospital
Mukai, Hirofumi
National Cancer Center Hospital East, Kashiwa
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Abstract | Background
Chemotherapy-induced peripheral neuropathy is commonly observed in patients treated with nanoparticle albumin–bound paclitaxel (nab-PTX). We conducted a multicenter randomized controlled study to evaluate the optimal dose of nab-PTX.
Methods
We compared three different doses of q3w nab-PTX (Standard: 260 mg/m2 [SD260] vs Medium: 220 mg/m2 [MD220] vs Low: 180 mg/m2 [LD180]) in patients with HER2-negative metastatic breast cancer (MBC). Primary endpoint was progression-free survival (PFS). Grade 3/4 neuropathy rates in the three doses were estimated using the logistic regression model. The optimal dose was selected in two steps. Initially, if the hazard ratio (HR) for PFS was <0.75 or >1.33, the inferior dose was excluded, and we proceeded with the non-inferior dose. Then, if the estimated incidence rate of grade 3/4 neurotoxicity exceeded 10%, that dose was also excluded.
Results
One hundred forty-one patients were randomly assigned to SD260 (n = 47), MD220 (n = 46), and LD180 (n = 48) groups, and their median PFS was 6.66, 7.34, and 6.82 months, respectively. The HRs were 0.73 (95% confidence interval [CI]: 0.42–1.28) in MD220 vs SD260, 0.77 (95% CI 0.47–1.28) in LD180 vs SD260, and 0.96 (95% CI 0.56–1.66) in LD180 vs MD220. SD260 was inferior to MD220 and was excluded. The estimated incidence rate of grade 3/4 neurotoxicity was 29.5% in SD260, 14.0% in MD220, and 5.9% in LD180. The final selected dose was LD180.
Conclusions
Intravenous administration of low-dose nab-PTX at 180 mg/m2 q3w may be the optimal therapy with meaningful efficacy and favorable toxicity in patients with MBC.
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Keywords | Nab-paclitaxel
Nanoparticle albumin–bound paclitaxel
Metastatic breast cancer
Solvent-base paclitaxel
Chemotherapy-induced peripheral neuropathy
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Published Date | 2020-12-09
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Publication Title |
The Breast
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Volume | volume55
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Publisher | Elsevier
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Start Page | 63
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End Page | 68
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ISSN | 0960-9776
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NCID | AA10844161
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Content Type |
Journal Article
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language |
English
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OAI-PMH Set |
岡山大学
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Copyright Holders | © 2020 The Authors.
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File Version | publisher
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DOI | |
Related Url | isVersionOf https://doi.org/10.1016/j.breast.2020.12.002
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License | http://creativecommons.org/licenses/by-nc-nd/4.0/
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