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)

Cancer. 2005 Dec 15;104(12):2766-74. doi: 10.1002/cncr.21495.

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 > 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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Carcinoma, Non-Small-Cell Lung / pathology*
  • Cisplatin / administration & dosage
  • Docetaxel
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / mortality
  • Lung Neoplasms / pathology*
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Staging
  • Risk Assessment
  • Survival Analysis
  • Taxoids / administration & dosage
  • Treatment Outcome
  • Vinblastine / administration & dosage
  • Vinblastine / analogs & derivatives
  • Vinorelbine

Substances

  • Taxoids
  • Docetaxel
  • Vinblastine
  • Cisplatin
  • Vinorelbine