Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer.

ABSTRACT

BACKGROUND: This analysis compared the efficacy and safety outcomes by histology of nab-paclitaxel (nab-P) plus carboplatin (C) versus solvent-based paclitaxel (sb-P) plus C in patients with advanced non-small-cell lung cancer (NSCLC) based on preplanned stratification factors specified in the phase III trial protocol. PATIENTS AND METHODS: Patients with untreated stage III/IV NSCLC received 100 mg/m(2) nab-P weekly and C (area under the curve, AUC = 6) every 3 weeks (q3w) or 200 mg/m(2) sb-P plus C (AUC = 6) q3w. Primary end point was objective overall response rate (ORR). RESULTS: nab-P/C versus sb-P/C produced a significantly higher ORR (41% versus 24%; response rate ratio [RRR] 1.680; P < 0.001) in patients with squamous cell (SCC) NSCLC. For nab-P/C versus sb-P/C, ORRs were 26% versus 27% (RRR 0.966; P = 0.814) in patients with adenocarcinoma, 33% versus 15% (RRR 2.167; P = 0.323) in patients with large cell carcinoma (LC), and 24% versus 15% (RRR 1.593; P = 0.372) in patients with not otherwise specified histology. Median overall survival for nab-P/C versus sb-P/C in patients with SCC was 10.7 versus 9.5 months (HR 0.890; P = 0.310), and 12.4 versus 10.6 months (HR 1.208; P = 0.721) for patients with LC. nab-P/C produced significantly (P < 0.05) less grade 3/4 neuropathy and arthralgia, whereas sb-P/C produced less thrombocytopenia and anemia. CONCLUSION(S) First-line nab-P/C demonstrated a favorable risk-benefit profile in patients with NSCLC regardless of histology.