Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: A Southwest Oncology Group trial

K. Kelly, J. Crowley, Jr Bunn P.A., C. A. Presant, P. K. Grevstad, C. M. Moinpour, S. D. Ramsey, A. J. Wozniak, G. R. Weiss, D. F. Moore, V. K. Israel, Robert B Livingston, D. R. Gandara

Research output: Contribution to journalArticle

1004 Citations (Scopus)

Abstract

Purpose: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus cisplatin (VC) for patients with advanced non-small-cell lung cancer. Secondary objectives were to compare toxicity, tolerability, quality of life (QOL), and resource utilization. Patients and Methods: Two hundred two patients received VC (vinorelbine 25 mg/m2/wk and cisplatin 100 mg/m2/d, day 1 every 28 days) and 206 patients received PC (paclitaxel 225 mg/m2 over 3 hours with carboplatin area under the curve of 6, day 1 every 21 days). Patients completed QOL questionnaires at baseline, 13 weeks, and 25 weeks. Resource utilization forms were completed at five time points through 24 months. Results: Patient characteristics were similar between the groups. The objective response rate was 28% in the VC arm and 25% in the PC arm. Median survival was 8 months in both arms, with 1-year survival rates of 36% and 38%, respectively. Grade 3 and 4 leukopenia (P = .002) and neutropenia (P = .008) occurred more frequently on the VC arm. Grade 3 nausea and vomiting were higher on the VC arm (P = .001, P = .007), and grade 3 peripheral neuropathy was higher on the PC arm (P < .001). More patients on the VC arm discontinued therapy because of toxicity (P = .001). No difference in QOL was observed. Overall costs on the PC arm were higher than on the VC arm because of drug costs. Conclusion: PC is equally efficacious as VC for the treatment of advanced non-small-cell lung cancer. PC is less toxic and better tolerated but more expensive than VC. New treatment strategies should be pursued.

Original languageEnglish (US)
Pages (from-to)3210-3218
Number of pages9
JournalJournal of Clinical Oncology
Volume19
Issue number13
StatePublished - Jul 1 2001
Externally publishedYes

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Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Cisplatin
Therapeutics
Quality of Life
vinorelbine
Drug Costs
Survival
Poisons
Leukopenia
Peripheral Nervous System Diseases
Neutropenia
Nausea
Area Under Curve
Vomiting
Survival Rate
Costs and Cost Analysis

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer : A Southwest Oncology Group trial. / Kelly, K.; Crowley, J.; Bunn P.A., Jr; Presant, C. A.; Grevstad, P. K.; Moinpour, C. M.; Ramsey, S. D.; Wozniak, A. J.; Weiss, G. R.; Moore, D. F.; Israel, V. K.; Livingston, Robert B; Gandara, D. R.

In: Journal of Clinical Oncology, Vol. 19, No. 13, 01.07.2001, p. 3210-3218.

Research output: Contribution to journalArticle

Kelly, K, Crowley, J, Bunn P.A., J, Presant, CA, Grevstad, PK, Moinpour, CM, Ramsey, SD, Wozniak, AJ, Weiss, GR, Moore, DF, Israel, VK, Livingston, RB & Gandara, DR 2001, 'Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: A Southwest Oncology Group trial', Journal of Clinical Oncology, vol. 19, no. 13, pp. 3210-3218.
Kelly, K. ; Crowley, J. ; Bunn P.A., Jr ; Presant, C. A. ; Grevstad, P. K. ; Moinpour, C. M. ; Ramsey, S. D. ; Wozniak, A. J. ; Weiss, G. R. ; Moore, D. F. ; Israel, V. K. ; Livingston, Robert B ; Gandara, D. R. / Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer : A Southwest Oncology Group trial. In: Journal of Clinical Oncology. 2001 ; Vol. 19, No. 13. pp. 3210-3218.
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title = "Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: A Southwest Oncology Group trial",
abstract = "Purpose: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus cisplatin (VC) for patients with advanced non-small-cell lung cancer. Secondary objectives were to compare toxicity, tolerability, quality of life (QOL), and resource utilization. Patients and Methods: Two hundred two patients received VC (vinorelbine 25 mg/m2/wk and cisplatin 100 mg/m2/d, day 1 every 28 days) and 206 patients received PC (paclitaxel 225 mg/m2 over 3 hours with carboplatin area under the curve of 6, day 1 every 21 days). Patients completed QOL questionnaires at baseline, 13 weeks, and 25 weeks. Resource utilization forms were completed at five time points through 24 months. Results: Patient characteristics were similar between the groups. The objective response rate was 28{\%} in the VC arm and 25{\%} in the PC arm. Median survival was 8 months in both arms, with 1-year survival rates of 36{\%} and 38{\%}, respectively. Grade 3 and 4 leukopenia (P = .002) and neutropenia (P = .008) occurred more frequently on the VC arm. Grade 3 nausea and vomiting were higher on the VC arm (P = .001, P = .007), and grade 3 peripheral neuropathy was higher on the PC arm (P < .001). More patients on the VC arm discontinued therapy because of toxicity (P = .001). No difference in QOL was observed. Overall costs on the PC arm were higher than on the VC arm because of drug costs. Conclusion: PC is equally efficacious as VC for the treatment of advanced non-small-cell lung cancer. PC is less toxic and better tolerated but more expensive than VC. New treatment strategies should be pursued.",
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T1 - Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer

T2 - A Southwest Oncology Group trial

AU - Kelly, K.

AU - Crowley, J.

AU - Bunn P.A., Jr

AU - Presant, C. A.

AU - Grevstad, P. K.

AU - Moinpour, C. M.

AU - Ramsey, S. D.

AU - Wozniak, A. J.

AU - Weiss, G. R.

AU - Moore, D. F.

AU - Israel, V. K.

AU - Livingston, Robert B

AU - Gandara, D. R.

PY - 2001/7/1

Y1 - 2001/7/1

N2 - Purpose: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus cisplatin (VC) for patients with advanced non-small-cell lung cancer. Secondary objectives were to compare toxicity, tolerability, quality of life (QOL), and resource utilization. Patients and Methods: Two hundred two patients received VC (vinorelbine 25 mg/m2/wk and cisplatin 100 mg/m2/d, day 1 every 28 days) and 206 patients received PC (paclitaxel 225 mg/m2 over 3 hours with carboplatin area under the curve of 6, day 1 every 21 days). Patients completed QOL questionnaires at baseline, 13 weeks, and 25 weeks. Resource utilization forms were completed at five time points through 24 months. Results: Patient characteristics were similar between the groups. The objective response rate was 28% in the VC arm and 25% in the PC arm. Median survival was 8 months in both arms, with 1-year survival rates of 36% and 38%, respectively. Grade 3 and 4 leukopenia (P = .002) and neutropenia (P = .008) occurred more frequently on the VC arm. Grade 3 nausea and vomiting were higher on the VC arm (P = .001, P = .007), and grade 3 peripheral neuropathy was higher on the PC arm (P < .001). More patients on the VC arm discontinued therapy because of toxicity (P = .001). No difference in QOL was observed. Overall costs on the PC arm were higher than on the VC arm because of drug costs. Conclusion: PC is equally efficacious as VC for the treatment of advanced non-small-cell lung cancer. PC is less toxic and better tolerated but more expensive than VC. New treatment strategies should be pursued.

AB - Purpose: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus cisplatin (VC) for patients with advanced non-small-cell lung cancer. Secondary objectives were to compare toxicity, tolerability, quality of life (QOL), and resource utilization. Patients and Methods: Two hundred two patients received VC (vinorelbine 25 mg/m2/wk and cisplatin 100 mg/m2/d, day 1 every 28 days) and 206 patients received PC (paclitaxel 225 mg/m2 over 3 hours with carboplatin area under the curve of 6, day 1 every 21 days). Patients completed QOL questionnaires at baseline, 13 weeks, and 25 weeks. Resource utilization forms were completed at five time points through 24 months. Results: Patient characteristics were similar between the groups. The objective response rate was 28% in the VC arm and 25% in the PC arm. Median survival was 8 months in both arms, with 1-year survival rates of 36% and 38%, respectively. Grade 3 and 4 leukopenia (P = .002) and neutropenia (P = .008) occurred more frequently on the VC arm. Grade 3 nausea and vomiting were higher on the VC arm (P = .001, P = .007), and grade 3 peripheral neuropathy was higher on the PC arm (P < .001). More patients on the VC arm discontinued therapy because of toxicity (P = .001). No difference in QOL was observed. Overall costs on the PC arm were higher than on the VC arm because of drug costs. Conclusion: PC is equally efficacious as VC for the treatment of advanced non-small-cell lung cancer. PC is less toxic and better tolerated but more expensive than VC. New treatment strategies should be pursued.

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