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- Title
A Randomized Phase II Study Comparing Two Schedules of the 21-Day Regimen of Gemcitabine and Carboplatin in Advanced Non-Small Cell Lung Cancer.
- Authors
Surmont, V.; Aerts, J. G. J. V.; Van Klaveren, R. J.; Tournoy, K.; Tan, K. Y.; Vernhout, R. M.; Schmitz, P. I. M.; Legrand, C.; Hoogsteden, H. C.; Van Meerbeeck, J. P.
- Abstract
Purpose: Carboplatin area under the curve (AUC) 5 ml/min on day 1 with gemcitabine 1,250 mg/m2 on day 1 and day 8 is a widely used regimen in advanced non-small cell lung cancer. Grade 3–4 thrombocytopenia and neutropenia are frequent. The aim of this study is to investigate whether toxicity of gemcitabine/carboplatin could be reduced by administering carboplatin on day 8 instead of day 1 without a decrease in response rate (RR). Methods: Patients received gemcitabine 1,250 mg/m2 on days 1 and 8, carboplatin AUC 5 on day 1 (arm A) or day 8 (arm B). Drugs were administered over a 21-day cycle. Toxicity and RR were evaluated weekly and every second cycle, respectively. Results: 71 patients were enrolled into the study. We found 79% (95% CI 61–91%) grade 3–4 toxicity (neutropenia and thrombocytopenia) in arm A and 50% (95% CI 32–68%) in arm B; 66% grade 3–4 thrombocytopenia in arm A and 26% in arm B. We observed 30% grade 4 hematological toxicity in arm A and 3% in arm B. In arm A an overall RR of 20% (95% CI 7.7–38.6%) was seen, and 18.2% (95% CI 7–35.5%) in arm B. Conclusions: Although the study was prematurely closed, the current data are of interest. The schedule with carboplatin on day 8 is associated with substantially lower grade 3–4 neutropenia and thrombocytopenia with comparable dose intensity and RR. Copyright © 2010 S. Karger AG, Basel
- Subjects
THROMBOCYTOPENIA; NEUTROPENIA; LUNG cancer; CANCER cells; DRUG therapy
- Publication
Oncology, 2010, Vol 78, Issue 3/4, p267
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000315733