A randomized phase II study comparing two schedules of the 21-day regime of Gemcitabine and Carboplatin in advanced NSCLC
(2010) Oncology : international journal of cancer research and treatment — Vol. 78, n° 3/4, p. 267-270 (2010)
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- 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 tox- icity of gemcitabine/carboplatin could be reduced by ad- ministering 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 throm- bocytopenia with comparable dose intensity and RR.
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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., & et al. (2010). A randomized phase II study comparing two schedules of the 21-day regime of Gemcitabine and Carboplatin in advanced NSCLC. Oncology : international journal of cancer research and treatment, 78(3/4), 267-270. https://doi.org/10.1159/000315733 (Original work published 2010)