Author of

• 11692

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  P2.10 - Poster Session 2 - Chemotherapy (ID 207)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11730

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    P2.10-038 - nab-Paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC): analysis of predictive factors (ID 2462)

    09:30 - 09:30  |  Author(s): R. Page
    • Abstract

    Background
    Identification of predictive factors is critical for appropriate selection of patients and chemotherapy regimen. In a phase III trial, nab-paclitaxel (nab-P, 130 nm albumin-bound paclitaxel particles) + carboplatin (C) vs solvent-based paclitaxel (sb-P) + C significantly improved ORR (primary endpoint; 33% vs 25%, P = 0.005), with a trend toward improved OS and PFS in patients with advanced NSCLC. nab-P/C vs sb-P/C was associated with less severe peripheral neuropathy, arthralgia, and myalgia, but more anemia and thrombocytopenia. This exploratory analysis examined the correlation between several key patient and clinical factors and clinical outcomes with nab-P/C vs sb-P/C.

    Methods
    Patients with untreated stage IIIB/IV NSCLC were randomized 1:1 to nab-P 100 mg/m[2] on d 1, 8, 15 or sb-P 200 mg/m[2] d 1 q21d; both arms received C AUC 6 d 1 q21d. ORR and PFS were assessed by blinded, centralized review. P values for ORR were based on chi-square test, and those for OS and PFS were based on log-rank test. Factors, including sex, age (< 70 and ≥ 70 y), histology (squamous and nonsquamous), stage (IIIB/IV), and geographic region (North America, Eastern Europe, and Asia/Pacific), baseline ECOG score, smoking status, diabetes, body mass index, number and location of metastatic sites, were analyzed for association with outcomes; of these, the first 5 were prespecified stratification factors for the trial.

    Results
    The hazard ratio (HR)/risk ratio favored nab-P/C for ORR, PFS, and OS for most factors analyzed. Significant quantitative treatment-by-predictive factor interactions were noted for several key factors, including number of metastatic sites, diabetes, histology, and age, with respect to outcomes, and the comparative treatment effect was maintained in all other subgroups. In patients with ≥ 4 metastatic sites, significant treatment differences favoring nab-P/C were noted for ORR (response rate ratio [RRR] 3.40; P = 0.003) and OS (HR 0.562; P = 0.009) and trended in favor of nab-P/C for PFS (HR 0.735; P = NS). In patients with diabetes, significant treatment differences favoring nab-P/C were noted for ORR (RRR 1.935; P = 0.046) and PFS (HR 0.416; P = 0.016) and trended in favor of nab-P/C for OS (HR 0.553; P = NS). In patients with squamous NSCLC, significant treatment differences favoring nab-P/C were noted for ORR (RRR 1.68; P < 0.001) and trended in favor of nab-P/C for OS (HR 0.890; P = NS). In patients ≥ 70 y, significant treatment differences favoring nab-P/C were noted for OS (HR 0.583; P = 0.009) and trended in favor of nab-P/C for ORR (RRR 1.385; P = 0.196) and PFS (HR 0.687; P = NS). No treatment differences significantly favoring sb-P/C were observed.

    Conclusion
    A trend toward improved outcomes was noted with nab-P/C vs sb-P/C in most factors analyzed. Squamous NSCLC, diabetes, age ≥ 70 y, and ≥ 4 metastatic sites were predictive of improved outcomes with nab-P/C vs sb-P/C. These predictive factors should be taken into consideration when selecting the appropriate treatment for patients with advanced NSCLC.