Phase 3 Trial Comparing Nanoparticle Albumin-Bound Paclitaxel With Docetaxel for Previously Treated Advanced NSCLC

Yasuto Yoneshima, Satoshi Morita, Masahiko Ando, Atsushi Nakamura, Shunichiro Iwasawa, Hiroshige Yoshioka, Yasuhiro Goto, Masafumi Takeshita, Toshiyuki Harada, Katsuya Hirano, Tetsuya Oguri, Masashi Kondo, Satoru Miura, Yukio Hosomi, Terufumi Kato, Toshio Kubo, Junji Kishimoto, Nobuyuki Yamamoto, Yoichi Nakanishi, Isamu Okamoto

Research output: Contribution to journalArticlepeer-review

62 Citations (Scopus)


Introduction: We aimed to evaluate the efficacy and safety of nanoparticle albumin-bound (nab-) paclitaxel for previously treated patients with advanced NSCLC. Methods: In this randomized, open-label, noninferiority phase 3 trial, we enrolled patients with advanced NSCLC previously treated with cytotoxic chemotherapy. Patients were randomly allocated (1:1) to receive docetaxel (60 mg/m2) on day 1 or nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of a 21-day cycle. The primary end point was overall survival (OS) analyzed on an intention-to-treat basis. Results: Between May 22, 2015, and March 12, 2018, a total of 503 patients were randomly allocated to the treatment. Median OS was 16.2 months (95% confidence interval [CI]: 14.4–19.0) for the 252 patients allocated to nab-paclitaxel and 13.6 months (95% CI: 10.9–16.5) for the 251 patients allocated to docetaxel (hazard ratio = 0.85, 95.2% CI: 0.68–1.07). Median progression-free survival was 4.2 months (95% CI: 3.9–5.0) for the nab-paclitaxel group versus 3.4 months (95% CI: 2.9–4.1) for the docetaxel group (hazard ratio = 0.76, 95% CI: 0.63–0.92, p = 0.0042). The objective response rate was 29.9% (95% CI: 24.0–36.2) for the nab-paclitaxel group and 15.4% (95% CI: 10.9–20.7) for the docetaxel group (p = 0.0002). Adverse events of grade greater than or equal to 3 included febrile neutropenia (5 of 245 patients [2%] in the nab-paclitaxel group versus 55 of 249 patients [22%] in the docetaxel group) and peripheral sensory neuropathy (24 [10%] versus 2 [1%], respectively). Conclusions: Nab-paclitaxel was noninferior to docetaxel in terms of OS. It should, thus, be considered a standard treatment option for previously treated patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)1523-1532
Number of pages10
JournalJournal of Thoracic Oncology
Issue number9
Publication statusPublished - 09-2021

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine


Dive into the research topics of 'Phase 3 Trial Comparing Nanoparticle Albumin-Bound Paclitaxel With Docetaxel for Previously Treated Advanced NSCLC'. Together they form a unique fingerprint.

Cite this