Weekly nab-Paclitaxel in Combination With Carboplatin as First-Line Therapy in Patients With Advanced Non-Small-Cell Lung Cancer: Analysis of Safety and Efficacy in Patients With Renal Impairment

Treatment options are limited for patients with cancer and renal impairment. In a subset analysis of patients with advanced nonesmall-cell lung cancer (NSCLC) and renal impairment in a phase III trial of nab-paclitaxel plus carboplatin (nab-P/C) versus solvent-based paclitaxel plus carboplatin, nab-P/C was well tolerated and offered a feasible treatment option for patients with renal impairment and advanced NSCLC. Introduction: Renal impairment in cancer patients can affect treatment tolerability and outcomes. This analysis evaluated the safety and efficacy of nab-paclitaxel (nab-P) versus solvent-based paclitaxel (sb-P), both in combination with carboplatin (C), in patients with advanced nonesmall-cell lung cancer (NSCLC) and renal impairment. Methods: Untreated patients with stage IIIB/IV disease with NSCLC and a performance status of 0/1 were randomly assigned (1:1) to receive 100 mg/m(2) nab-P weekly plus C (under the curve = 6, every 3 weeks) or 200 mg/m(2) sb-P plus C (under the curve = 6) every 3 weeks. The primary end point was overall response rate. Results: Of 1038 treated patients in the phase III trial, 38% had mild renal impairment (creatinine clearance > 50 to <= 80 mL/min; n = 198 for nab-P/C and n = 206 for sb-P/C) and 5% had moderate renal impairment (creatinine clearance <= 50 mL/min: n = 26 for nab-P/C and n = 27 for sb-P/C). For nab-P/C versus sb-P/C, the treatment difference in efficacy in patients with either level of renal impairment was comparable to the overall population but did not reach statistical significance, with an overall response rate of 35% versus 27% (response rate ratio, 1.324; P = .060) in patients with mild renal impairment, and 31% versus 19% (response rate ratio, 1.662; P = .300) in patients with moderate renal impairment. Overall survival and progression-free survival were nonsignificantly longer for nab-P/C versus sb-P/C in these subsets. Patients with renal impairment experienced less grade 3 or higher neutropenia and sensory neuropathy, but more thrombocytopenia and anemia with nab-P/C versus sb-P/C. Conclusion: nab-P/C proved beneficial and tolerable in patients with advanced NSCLC and mild and moderate renal impairment. (C) 2015 Elsevier Inc. All rights reserved.