Prospective randomized study of four novel chemotherapy regimens in patients with advanced nonsmall cell lung carcinoma
Open Access
- 5 September 2002
- Vol. 95 (6) , 1279-1285
- https://doi.org/10.1002/cncr.10810
Abstract
BACKGROUND The authors compared the toxicity, response rate, and progression free survival of four chemotherapy regimens for patients with advanced (Stage IIIB and IV) nonsmall cell lung carcinoma. METHODS A total of 267 patients entered this randomized Phase II trial on one of four arms: paclitaxel, carboplatin, and gemcitabine (Arm A); paclitaxel, carboplatin, and vinorelbine (Arm B); paclitaxel and gemcitabine (Arm C); and gemcitabine and vinorelbine (Arm D). Patient characteristics were similar in all treatment arms. At the time of tumor progression, patients were removed from study and were treated at the discretion of their physician. RESULTS Patients received a median of four courses of chemotherapy in all arms, and there was no difference in the dose delivered. There were no statistical differences in response rates (range, 32–45%), median progression free survival (range, 4.9–6.6 months), or progression free survival at 1 year (range, 8–19%). Actuarial survival in all four arms was not different, with a median survival ranging from 8.7 months to 10.7 months and a 1‐year survival rate of 38–44%. Each arm was compared with a historic control with a median survival of 8 months. Arm D (gemcitabine and vinorelbine) approached significance at the 0.05 level. CONCLUSIONS Two‐drug combinations containing the newer drugs without a platinum drug were less toxic than three‐drug, platinum‐based regimens. There were no significant differences in objective response rates or progression free survival when the four regimens were compared. The two‐drug combination of gemcitabine and vinorelbine was the least toxic and, thus, may be superior. A Phase III trial comparing combined gemcitabine and vinorelbine with combined paclitaxel, carboplatin, and gemcitabine is ongoing. Cancer 2002;95:1279–85. © 2002 American Cancer Society. DOI 10.1002/cncr.10810Keywords
This publication has 10 references indexed in Scilit:
- Presalvage prostate‐specific antigen (PSA) and PSA doubling time as predictors of biochemical failure of salvage cryotherapy in patients with locally recurrent prostate cancer after radiotherapyCancer, 2006
- 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 TrialJournal of Clinical Oncology, 2001
- Paclitaxel and Gemcitabine Chemotherapy for Advanced Transitional-Cell Carcinoma of the Urothelial Tract: A Phase II Trial of the Minnie Pearl Cancer Research NetworkJournal of Clinical Oncology, 2001
- Activity and toxicity of gemcitabine and gemcitabine+vinorelbine in advanced non-small-cell lung cancer elderly patientsLung Cancer, 2001
- Vinorelbine—gemcitabine in advanced non-small-cell lung cancer (NSCLC): An AASLC phase II trialAnnals of Oncology, 2000
- Gemcitabine Plus Vinorelbine Versus Vinorelbine Alone in Elderly Patients With Advanced Non–Small-Cell Lung CancerJournal of Clinical Oncology, 2000
- Gemcitabine and vinorelbine in the second-line treatment of nonsmall cell lung carcinoma patientsCancer, 2000
- Phase I/II trial of paclitaxel by 1-hour infusion, carboplatin, and gemcitabine in the treatment of patients with advanced nonsmall cell lung carcinomaCancer, 1999
- Application of the triangular test to phase II cancer clinical trialsStatistics in Medicine, 1990
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958