A randomized phase III study comparing carboplatin with nab-paclitaxel versus docetaxel for elderly patients with squamous-cell lung cancer: Capital study.

9031 Background: Cytotoxic monotherapy is one of the standard treatments for elderly patients with advanced non-small cell lung cancer (NSCLC). Carboplatin plus nab-paclitaxel demonstrated significantly higher objective response rate (ORR) than carboplatin plus paclitaxel in patients with squamous histology and could improve overall survival (OS) in patients aged ≥70 years. Here, we compared carboplatin plus nab-paclitaxel with docetaxel in elderly patients with squamous NSCLC. Methods: The CAPITAL study is a multicenter, open-label, phase 3, randomized trial at 92 institutions in Japan. Eligible patients had advanced squamous NSCLC with no prior systemic chemotherapy, aged ≥70 years, and had an ECOG performance status of 0 or 1. Patients were randomized 1:1 to docetaxel 60 mg/m 2 (D arm) or carboplatin AUC 6 mg/mL/min plus nab-paclitaxel 100 mg/m 2 weekly (nab-PC arm) for each 21-day cycle. The primary endpoint was OS. This trial is registered with the UMIN Clinical Trials Registry (UMIN000019843) and the Japan Registry of Clinical Trials (jRCTs041180110). Results: Between December 2015 and August 2020, 196 patients were randomly assigned to the two treatment arms (D arm, n=98; nab-PC arm, n=98). The median follow-up and age were 11.5 months and 76 years (range: 70–88 years), respectively, and 87% of the patients were male. After the planned interim analysis, the independent data monitoring committee confirmed that the study met the primary endpoint of improved OS in August 2020, and this report represents the final analysis. The nab-PC arm showed significant superiority in OS versus the D arm (hazard ratio [HR], 0.52; 90% CI, 0.38-0.70; median, 16.9 vs. 10.9 months; p<0.001). There were also significant improvements in progression-free survival (median, 5.8 vs. 4.0 months; HR, 0.42; 95% CI, 0.30-0.58; p<0.001) and objective response rate (66.3 vs. 28.0 %; p<0.001) in the nab-PC arm versus the D arm. The most common grade 3 or 4 adverse events were leukopenia (46.3 %), neutropenia (63.2 %), and anemia (38.9 %) in the nab-PC arm, and leukopenia (56.7 %), neutropenia (77.3 %), and febrile neutropenia (17.5 %) in the D arm. As notable adverse events, grade ≥2 sensory peripheral neuropathy was observed in 15 (15.8%) and 1 (1.0%) patient in the nab-PC and D arms, respectively. Moreover, serious treatment-related adverse events and treatment-related deaths occurred in 14 (14.7%) and 12 (12.4%) patients and in two and one patient in the nab-PC and D arms, respectively. Conclusions: The nab-PC arm had a significantly improved OS than the D arm among elderly patients with squamous NSCLC. Carboplatin plus nab-paclitaxel became a new standard treatment for these patients. Clinical trial information: UMIN000019843.