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

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• 作者：Yasuto Yoneshima¹ ; ² ; Satoshi Morita³ ; Masahiko Ando⁴ ; Satoru Miura⁵ ; Hiroshige Yoshioka⁶ ; Tetsuya Abe⁷ ; Terufumi Kato⁸ ; Masashi Kondo⁹ ; Yukio Hosomi¹⁰ ; Katsuyuki Hotta¹¹ ; Nobuyuki Yamamoto¹² ; Junji Kishimoto¹³ ; Yoichi Nakanishi² ; Isamu Okamoto² ; ^{okamotoi@kokyu.med.kyushu-u.ac.jp}
• 关键词：Intergroup study ; Noninferiority ; Overall survival ; Previously treated advanced NSCLC ; Weekly nab-paclitaxel
• 刊名：Clinical Lung Cancer
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：18
• 期：1
• 页码：100-103
• 全文大小：218 K
• 卷排序：18

文摘

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 MethodsPatients 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.ConclusionIf the primary objective is achieved, this study will provide evidence for a new alternative treatment option for patients with previously treated advanced NSCLC.