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

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)100-103
Number of pages4
JournalClinical Lung Cancer
Volume18
Issue number1
DOIs
Publication statusPublished - Jan 1 2017

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docetaxel
Non-Small Cell Lung Carcinoma
Nanoparticles
Therapeutics
Disease Progression
130-nm albumin-bound paclitaxel
Albumin-Bound Paclitaxel
Safety
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

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

In: Clinical Lung Cancer, Vol. 18, No. 1, 01.01.2017, p. 100-103.

Research output: Contribution to journalArticle

Yoneshima, Yasuto ; Morita, Satoshi ; Ando, Masahiko ; Miura, Satoru ; Yoshioka, Hiroshige ; Abe, Tetsuya ; Kato, Terufumi ; Kondo, Masashi ; Hosomi, Yukio ; Hotta, Katsuyuki ; Yamamoto, Nobuyuki ; Kishimoto, Junji ; Nakanishi, Yoichi ; Okamoto, Isamu. / 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. In: Clinical Lung Cancer. 2017 ; Vol. 18, No. 1. pp. 100-103.
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