Elderly Subgroup Analysis of a Randomized Phase III Study of Docetaxel Plus Platinum Combinations Versus Vinorelbine Plus Cisplatin for First-line Treatment of Advanced Nonsmall Cell Lung Carcinoma (TAX 326)

Background: Controversy continues over whether elderly patients with advanced nonsmall cell lung carcinoma (NSCLC) should receive platinum-based chemotherapy. TAX 326 reported improved survival with docetaxel-cisplatin (DC) versus vinorelbine-cisplatin (VC) for advanced NSCLC. DC and docetaxel-carboplatin (DCb) were better tolerated than VC. We analyzed the efficacy and toxicity in patients ages < 65 and > or = 65 years.

Methods: Chemotherapy-naive, TNM Stage IIIB-IV NSCLC patients were randomized to DC (docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2), d1 q3w), DCb (docetaxel 75 mg/m(2) and carboplatin area under the concentration-time curve 6 mg/mL.min, d1 q3w), or VC (vinorelbine 25 mg/m(2), d1, 8, 15, and 22 and cisplatin 100 mg/m(2), d1 q4w).

Results: Of 1218 patients, 401 were age > or = 65 years (149/118/134 DC/DCb/VC arms). In the elderly, median survival was 12.6 versus 9.9 months, 1-year survival was 52% versus 41%, 2-year survival was 24% versus 17% for DC versus VC, respectively. DCb survival results were similar to those for VC: median, 9.0 months; 1-year, 38%; 2-year, 19%. Survival outcomes were similar between elderly and younger patients across treatment arms. Compared with younger patients, elderly patients reported moderately higher incidences of NCI CTC (version 1.0) Grade 3-4 asthenia, infection, and pulmonary toxicities across treatment arms, and diarrhea and sensory neurotoxicity for cisplatin-containing arms. Most hematologic toxicities occurred with similar incidences between elderly and younger patients, although neutropenia was slightly increased in elderly patients.

Conclusion: First-line docetaxel-cisplatin chemotherapy showed similar activity in elderly and younger patients with advanced/metastatic NSCLC; elderly patients tolerated docetaxel-platinum well despite experiencing slightly more toxicity than younger patients.