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)

Abstract

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 ≥ 65 years. METHODS Chemotherapy‐naive, TNM Stage IIIB–IV NSCLC patients were randomized to DC (docetaxel 75 mg/m² and cisplatin 75 mg/m², d1 q3w), DCb (docetaxel 75 mg/m² and carboplatin area under the concentration–time curve 6 mg/mL.min, d1 q3w), or VC (vinorelbine 25 mg/m², d1, 8, 15, and 22 and cisplatin 100 mg/m², d1 q4w). RESULTS Of 1218 patients, 401 were age ≥ 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. Cancer 2005. © 2005 American Cancer Society.