Treatment Rationale and Design for J-AXEL: A Randomized Phase 3 Study Comparing Nab-Paclitaxel With Docetaxel in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer

Yasuto Yoneshima, Satoshi Morita, Masahiko Ando, Satoru Miura, Hiroshige Yoshioka, Tetsuya Abe, Terufumi Kato, Masashi Kondo, Yukio Hosomi, Katsuyuki Hotta, Nobuyuki Yamamoto, Junji Kishimoto, Yoichi Nakanishi, Isamu Okamoto

研究成果: Contribution to journalArticle査読

3 被引用数 (Scopus)

抄録

Background Nanoparticle albumin-bound (nab) paclitaxel is a promising new therapeutic agent for all histologic types of non–small-cell lung cancer (NSCLC). We recently performed a phase 2 study of weekly nab-paclitaxel in patients with previously treated advanced NSCLC, finding promising activity and acceptable toxicity for this regimen. We have now designed a randomized phase 3 intergroup study (J-AXEL, UMIN000017487) to examine the clinical benefit and safety of nab-paclitaxel compared to docetaxel in patients with previously treated advanced NSCLC. Patients and Methods Patients are randomized to receive either docetaxel (60 mg/m2 on day 1 every 3 weeks, control arm) or nab-paclitaxel (100 mg/m2 on days 1, 8, and 15 every 3 weeks, experimental arm), with each drug being administered until disease progression or unacceptable toxicity. The study will evaluate the noninferiority of nab-paclitaxel relative to docetaxel for the primary end point of overall survival. Conclusion If the primary objective is achieved, this study will provide evidence for a new alternative treatment option for patients with previously treated advanced NSCLC.

本文言語英語
ページ(範囲)100-103
ページ数4
ジャーナルClinical Lung Cancer
18
1
DOI
出版ステータス出版済み - 1 1 2017

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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