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ID 61063
フルテキストURL
著者
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
Taira, Naruto Okayama University Hospital Kaken ID publons
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
抄録
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.
キーワード
Nab-paclitaxel
Nanoparticle albumin–bound paclitaxel
Metastatic breast cancer
Solvent-base paclitaxel
Chemotherapy-induced peripheral neuropathy
発行日
2020-12-09
出版物タイトル
The Breast
55巻
出版者
Elsevier
開始ページ
63
終了ページ
68
ISSN
0960-9776
NCID
AA10844161
資料タイプ
学術雑誌論文
言語
English
OAI-PMH Set
岡山大学
著作権者
© 2020 The Authors.
論文のバージョン
publisher
DOI
関連URL
isVersionOf https://doi.org/10.1016/j.breast.2020.12.002
ライセンス
http://creativecommons.org/licenses/by-nc-nd/4.0/