Phase 3 trial comparing nab-paclitaxel with docetaxel for previously treated advanced non-small cell lung cancer.

Abstract Introduction We aimed to assess the efficacy and safety of nanoparticle albumin-bound (nab-) paclitaxel for previously treated patients with advanced non–small cell lung cancer (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 analyzed on an intention-to-treat basis. Results Between 22 May 2015 and 12 March 2018, 503 patients were randomly allocated to treatment. Median overall survival was 16.2 months (95% 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), and it showed a significant improvement for nab-paclitaxel versus docetaxel regardless of tumor histology. Adverse events of grade ≥3 included febrile neutropenia (5 [2%] of 245 patients in the nab-paclitaxel group versus 55 [22%] of 249 patients in the docetaxel group) and peripheral sensory neuropathy (24 [10%] versus 2 [1%], respectively). Conclusions Nab-paclitaxel was noninferior to docetaxel in terms of overall survival. It should thus be considered a standard treatment option for previously treated patients with advanced NSCLC.