OA03.05 Phase III Study Comparing Nab-Paclitaxel With Docetaxel in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer

Abstract

Nanoparticle albumin-bound (nab-) paclitaxel showed promising efficacy for treatment of advanced non–small cell lung cancer (NSCLC) in a phase 2 study. We aimed to assess the efficacy and safety of nab-paclitaxel for previously treated patients with advanced NSCLC. In this multicenter, 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. Adverse events were assessed according to treatment received. Between 22 May 2015 and 12 March 2018, 503 patients were randomly allocated to treatment. Median overall survival was 13.6 months (95% CI, 10.9–16.5) for the 251 patients allocated to docetaxel and 16.2 months (95% CI, 14.4–19.0) for the 252 patients allocated to nab-paclitaxel (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 (55 [22%] of 249 patients in the docetaxel group versus 5 [2%] of 245 patients in the nab-paclitaxel group) and peripheral sensory neuropathy (2 [1%] versus 24 [10%], respectively). The trial showed that nab-paclitaxel was noninferior to docetaxel in terms of overall survival. Nab-paclitaxel should thus be considered a standard treatment option for previously treated patients with advanced NSCLC.