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Originally published as JCO Early Release 10.1200/JCO.2003.12.046 on July 1 2003

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Journal of Clinical Oncology, Vol 21, Issue 16 (August), 2003: 3016-3024
© 2003 American Society for Clinical Oncology

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 Szczesna, Panagiotis Fidias, Michael Millward, Chandra P. Belani

From the M.D. Anderson Cancer Center, Houston, TX; Instituto do Câncer Arnaldo Vieira de Carvalho, Sao Paulo, Brazil; Asklepios Fachkliniken München-Gauting, Gauting, Germany; M. Kopernik Memorial Hospital, Lodz, Poland; Cancer Research Center RAMS, Moscow, Russia; AK-Hamburg-Harbug, Hamburg, Germany; Helsinki University Central Hospital, Helsinki, Finland; Regional Lung Diseases Center, Poznan; Regional Lung Diseases Hospital, Otwock, Poland; Massachusetts General Hospital, Boston, MA; Sydney Cancer Centre, Camperdown, Australia; University of Pittsburgh Cancer Institute, Pittsburgh, PA.

Address reprint requests to Chandra P. Belani, MD, Division of Medical Oncology, University of Pittsburgh Cancer Institute, University of Pittsburgh Medical Center Cancer Pavilion, 5150 Center Ave, Suite 570, Pittsburgh, PA 15232; email: belanicp{at}msx.upmc.edu.

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 first-line treatment of advanced or metastatic NSCLC.

Supported by a grant from Aventis Pharma.

Previously presented in part at the Annual Meeting of the American Society of Clinical Oncology (ASCO), San Francisco, CA, May 12–15, 2001; the Annual Meeting of ASCO, Orlando, FL, May 18–21, 2002; and the Congress of the European Society for Medical Oncology, Nice, France, October 18–22, 2002.


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Related Correspondence

  • Should We Discard Vinorelbine Plus Cisplatin From the First-Line Therapy of Advanced Non–Small-Cell Lung Cancer?
    Mircea Dediu
    JCO 2004 22: 1345-1347 [Full Text]

Related Reply

  • In Reply:
    Peter Harper, Tim Plunkett, and David Khayat
    JCO 2004 22: 1347 [Full Text]


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S. Dubey and J. H. Schiller
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R. R. Jennens, R. de Boer, L. Irving, D. L. Ball, and M. A. Rosenthal
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K. Hotta, K. Matsuo, H. Ueoka, K. Kiura, M. Tabata, and M. Tanimoto
Meta-Analysis of Randomized Clinical Trials Comparing Cisplatin to Carboplatin in Patients With Advanced Non-Small-Cell Lung Cancer
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V. Georgoulias, A. Ardavanis, A. Agelidou, M. Agelidou, V. Chandrinos, E. Tsaroucha, M. Toumbis, C. Kouroussis, K. Syrigos, A. Polyzos, et al.
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M. A. Socinski
Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Review of Standard Treatment Paradigms
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J. R. Rigas
Taxane-Platinum Combinations in Advanced Non-Small Cell Lung Cancer: A Review
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P. Harper, T. Plunkett, and D. Khayat
In Reply:
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M. Dediu
Should We Discard Vinorelbine Plus Cisplatin From the First-Line Therapy of Advanced Non-Small-Cell Lung Cancer?
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T. L. Evans
Highlights from the Tenth World Conference on Lung Cancer
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P. Harper, T. Plunkett, and D. Khayat
Quality Trials and Quality of Life in Non-Small-Cell Lung Cancer
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