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 Belani

Research output: Contribution to journalArticle

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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

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docetaxel
Platinum
Non-Small Cell Lung Carcinoma
Cisplatin
Quality of Life
Survival
vinorelbine
Survival Rate
Confidence Intervals
Febrile Neutropenia

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Fossella, Frank ; Pereira, Jose R. ; von Pawel, Joachim ; Pluzanska, Anna ; Gorbounova, Vera ; Kaukel, Eckhard ; Mattson, Karin V. ; Ramlau, Rodryg ; Szczȩsna, Aleksandra ; Fidias, Panagiotis ; Millward, Michael ; Belani, Chandra. / 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. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 16. pp. 3016-3024.
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title = "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",
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.",
author = "Frank Fossella and Pereira, {Jose R.} and {von Pawel}, Joachim and Anna Pluzanska and Vera Gorbounova and Eckhard Kaukel and Mattson, {Karin V.} and Rodryg Ramlau and Aleksandra Szczȩsna and Panagiotis Fidias and Michael Millward and Chandra Belani",
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doi = "10.1200/JCO.2003.12.046",
language = "English (US)",
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Fossella, F, Pereira, JR, von Pawel, J, Pluzanska, A, Gorbounova, V, Kaukel, E, Mattson, KV, Ramlau, R, Szczȩsna, A, Fidias, P, Millward, M & Belani, C 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, vol. 21, no. 16, pp. 3016-3024. https://doi.org/10.1200/JCO.2003.12.046

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

In: Journal of Clinical Oncology, Vol. 21, No. 16, 15.08.2003, p. 3016-3024.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer

T2 - The TAX 326 Study Group

AU - Fossella, Frank

AU - Pereira, Jose R.

AU - von Pawel, Joachim

AU - Pluzanska, Anna

AU - Gorbounova, Vera

AU - Kaukel, Eckhard

AU - Mattson, Karin V.

AU - Ramlau, Rodryg

AU - Szczȩsna, Aleksandra

AU - Fidias, Panagiotis

AU - Millward, Michael

AU - Belani, Chandra

PY - 2003/8/15

Y1 - 2003/8/15

N2 - 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.

AB - 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.

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