Published in:
01-02-2007
Cisplatin plus gemcitabine on days 1 and 4 every 21 days for solid tumors: Result of a dose-intensity study
Published in: Investigational New Drugs | Issue 1/2007
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Background: Three and 4-week cisplatin-gemcitabine schedules have shown similar dose-intensity (DI) and activity in non-small-cell lung cancer (NSCLC). The 3-week schedule is generally preferred because it enables better treatment compliance. To improve DI and compliance further, we delivered gemcitabine plus cisplatin over 4 days every 21 days.
Methods: Patients with any stage NSCLC or epithelial neoplasms and an ECOG PS ≤2 were given gemcitabine 1000 mg/m2 on days 1 and 4 plus cisplatin 70 mg/m2 on day 2 of a 21-day cycle. Minimax design was used and a received DI for gemcitabine of ≥580 mg/m2/wk was considered successful.
Results: Thirty-nine patients (34 NSCLC, 5 epithelial neoplasias) were enrolled. SWOG grade 3–4 neutropenia and thrombocytopenia were observed in 17.9% and 12.8% of patients, respectively. Nonhematological toxicity was minimal. Twenty-eight (18%) of 158 cycles required dose modifications and/or delays. Twenty-five patients received a gemcitabine dose intensity of ≥580 mg/m2/wk. The received DIs were 601.8 mg/m2/wk for gemcitabine and 21.0 for cisplatin, with a relative DIs of 90.3% and 90.1%, respectively. The response rate of 27 evaluable patients with NSCLC was 44% (95% confidence interval [CI], 25.3 to 62.7%).
Conclusions: The shorter schedule of gemcitabine on days 1 and 4 plus cisplatin on day 2 produces an effective DI and a toxicity profile comparable to that of weekly regimens.