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Socinski MA , Langer CJ , Okamoto I , Hon JK , Hirsh V , Dakhil SR , Page RD , Orsini J , Zhang H , Renschler MF
Safety and efficacy of weekly nab((R))-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer
Annals of Oncology. 2013 Feb;24(2) :314-321
AbstractThis analysis evaluates safety and efficacy in elderly (>= 70 years old) versus younger patients enrolled in a phase III advanced non-small-cell lung cancer (NSCLC) trial. Untreated stage IIIB/IV patients with PS 0/1 were randomly assigned (1:1) to carboplatin AUC6, day 1 every 3 weeks, and either nab-paclitaxel (Abraxane) 100 mg/m(2) weekly (nab-P/C) or solvent-based paclitaxel (Taxol) 200 mg/m(2) day 1 every 3 weeks (sb-P/C). The primary end-point was overall response rate (ORR). Fifteen percent of 1052 enrolled patients were elderly: nab-P/C, n = 74; sb-P/C, n = 82. In both age cohorts, the ORR was higher with nab-P/C versus sb-P/C (age >= 70: 34% versus 24%, P = 0.196; age < 70: 32% versus 25%, P = 0.013). In elderly patients, progression-free survival (PFS) trended in favor of nab-P/C (median 8.0 versus 6.8 months, hazard ratio (HR) 0.687, P = 0.134), and overall survival (OS) was significantly improved (median 19.9 versus 10.4 months, HR 0.583, P = 0.009). In younger patients, PFS (median 6.0 versus 5.8 months, HR 0.903, P = 0.256) and OS (median 11.4 versus 11.3 months, HR 0.999, P = 0.988) were similar in both arms. Adverse events were similar in both age groups, with less neutropenia (P = 0.015), neuropathy (P = 0.001), and arthralgia (P = 0.029), and increased anemia (P = 0.007) with nab-P/C versus sb-P/C. In elderly NSCLC patients, nab-P/C as first-line therapy was well tolerated and improved the ORR and PFS, with substantially longer OS versus sb-PC.
NotesTimes Cited: 0 Socinski, M. A. Langer, C. J. Okamoto, I. Hon, J. K. Hirsh, V. Dakhil, S. R. Page, R. D. Orsini, J. Zhang, H. Renschler, M. F.