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A. Ko
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-065 - <em>nab</em>-Paclitaxel + Carboplatin in Advanced NSCLC: Analysis of Age and Renal Function (ID 1559)
09:30 - 17:00 | Author(s): A. Ko
- Abstract
Background:
Renal impairment increases with age and can impact treatment decisions. In a phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) significantly improved the overall response rate (ORR; primary endpoint) compared with solvent-based paclitaxel plus C (sb-P/C) in patients with advanced NSCLC (Socinski et al. J Clin Oncol. 2012;30:2055-2062). In a subgroup analysis of this phase III trial, nab-P/C demonstrated promising efficacy and was well tolerated in patients with or without renal impairment (Langer et al. Clin Lung Cancer. 2015;16:112-120). This analysis examined outcomes of patients in the phase III trial stratified by age and renal function.
Methods:
Patients with histologically or cytologically confirmed stage IIIB/IV NSCLC and no prior chemotherapy for metastatic disease received either nab-P 100 mg/m[2] on days 1, 8, and 15 or sb-P 200 mg/m[2] on day 1 in combination with C AUC 6 on day 1 every 21 days (randomized 1:1). Treatment continued until disease progression. Baseline renal function (creatinine clearance [CrCl]) was assessed in a central lab. ORR and progression-free survival (PFS) were assessed by blinded, centralized review. P values for ORR were based on the chi-square test, and those for overall survival (OS) and PFS were based on the log-rank test.
Results:
Treatment with nab-P/C resulted in improved outcomes compared with sb-P/C in patients with mild renal impairment, regardless of age (Table). nab-P/C also consistently demonstrated greater treatment effect compared with sb-P/C for ORR and similar or better PFS and OS in patients ≥ 60 years, regardless of renal function. In patients with either mild renal impairment or normal renal function, the toxicity profiles in each treatment arm were similar to those of the intent-to-treat population.
Conclusion:
These results suggest that, in general, clinical outcomes in patients with advanced NSCLC and mild renal impairment are better with nab-P/C vs sb-P/C, regardless of age. It should be noted that these were small subset analyses and results should be interpreted with caution. Figure 1
