Nab-paclitaxel was not only found to be noninferior to docetaxel for overall survival (OS) but also to result in superior rates of objective response (ORR) and progression-free survival (PFS) in patients with previously treated advanced non-small cell lung cancer (NSCLC), according to the results of a phase 3 study presented at the 2020 World Conference on Lung Cancer in Singapore.
Data from a previous phase 2 trial suggested that nab-paclitaxel had promising antitumor efficacy in patients with previously treated advanced NSCLC. The aim of this study was to determine if nab-paclitaxel was noninferior to docetaxel in this patient population.
The phase 3 J-AXEL trial (UMIN000017487) randomly assigned 503 patients with stage IIIB/IV or recurrent NSCLC who had previously received chemotherapy to treatment with either nab-paclitaxel or docetaxel. The noninferiority margin was 1.33 hierarchically; a hazard ratio (HR) of 1.25 (95.2% CI) was used. Nab-paclitaxel’s superiority was tested only if noninferiority for OS was achieved.
At baseline, the median patient age was 67 years in the nab-paclitaxel arm and 68 years in the docetaxel arm. 69.0% and 68.9% of patients in both groups were male, respectively. In both subsets, most patients had nonsquamous histology.
OS was noninferior, but not superior, to nab-paclitaxel. The median OS was 16.2 months with nab-paclitaxel compared with 13.6 months with docetaxel (stratified HR, 0.85; 95% CI, 0.68-1.07). PFS was superior with nab-paclitaxel with a median of 4.2 months vs 3.4 months with docetaxel (unstratified HR, 0.76; 95% CI, 0.63-0.92; P =.0042).
Among all patients, the ORR was 29.9% with nab-paclitaxel compared with 15.4% with docetaxel, which reached superiority (P =.0002). This benefit was observed regardless of histology, with nab-paclitaxel resulting in an ORR of 30.4% and 29.7% among patients with squamous or nonsquamous histology, respectively, compared with 10.4% and 16.7% with docetaxel, respectively.
Grade 3 to 4 hematologic and nonhematologic adverse events (AEs) generally occurred more frequently with docetaxel, including leukopenia, neutropenia, febrile neutropenia, and anorexia. Peripheral sensory neuropathy occurred more frequently with nab-paclitaxel.
“Nab-paclitaxel should be considered a standard option for previously treated patient with advanced NSCLC,” concluded lead author Atsushi Nakamura, MD, PhD, who presented the findings.
Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study.
Nakamura A, Yoneshima Y, Morita S, et al. Phase III study comparing nab-paclitaxel with docetaxel in patients with previously treated advanced non-small cell lung cancer_J-AXEL. Presented at: 2020 World Conference on Lung Cancer Singapore; January 28-31, 2020.