Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: The TAX 326 Study Group

Frank Fossella, Jose R. Pereira, Joachim von Pawel, Anna Pluzanska, Vera Gorbounova, Eckhard Kaukel, Karin V. Mattson, Rodryg Ramlau, Aleksandra Szczȩsna, Panagiotis Fidias, Michael Millward, Chandra P. Belani

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830 Scopus citations

Abstract

Purpose: To investigate whether docetaxel plus platinum regimens improve survival and affect quality of life (QoL) in advanced non-small-cell lung cancer (NSCLC) compared with vinorelbine plus cisplatin as first-line chemotherapy. Patients and Methods: Patients (n = 1,218) with stage IIIB to IV NSCLC were randomly assigned to receive docetaxel 75 mg/m2 and cisplatin 75 mg/m2 every 3 weeks (DC); docetaxel 75 mg/m2 and carboplatin area under the curve of 6 mg/mL · min every 3 weeks (DCb); or vinorelbine 25 mg/ m2/wk and cisplatin 100 mg/m2 every 4 weeks (VC). Results: Patients treated with DC had a median survival of 11.3 v 10.1 months for VC-treated patients (P = .044; hazard ratio, 1.183 [97.2% confidence interval, 0.989 to 1.416]). The 2-year survival rate was 21% for DC-treated patients and 14% for VC-treated patients. Overall response rate was 31.6% for DC-treated patients v 24.5% for VC-treated patients (P = .029). Median survival (9.4 v 9.9 months [for VC]; P = .657; hazard ratio, 1.048 [97.2 confidence interval, 0.877 to 1.253]) and response (23.9%) with DCb were similar to those results for VC. Neutropenia, thrombocytopenia, infection, and febrile neutropenia were similar with all three regimens. Grade 3 to 4 anemia, nausea, and vomiting were more common (P < .01 ) with VC than with DC or DCb. Patients treated with either docetaxel regimen had consistently improved QoL compared with VC-treated patients, who experienced deterioration in QoL. Conclusion: DC resulted in a more favorable overall response and survival rate than VC. Both DC and DCb were better tolerated and provided patients with consistently improved QoL compared with VC. These findings demonstrate that a docetaxel plus platinum combination is an effective treatment option with a favorable therapeutic index for firstline treatment of advanced or metastatic NSCLC.

Original languageEnglish (US)
Pages (from-to)3016-3024
Number of pages9
JournalJournal of Clinical Oncology
Volume21
Issue number16
DOIs
StatePublished - Aug 15 2003

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    Fossella, F., Pereira, J. R., von Pawel, J., Pluzanska, A., Gorbounova, V., Kaukel, E., Mattson, K. V., Ramlau, R., Szczȩsna, A., Fidias, P., Millward, M., & Belani, C. P. (2003). Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: The TAX 326 Study Group. Journal of Clinical Oncology, 21(16), 3016-3024. https://doi.org/10.1200/JCO.2003.12.046