Single-agent gemeitabine versus cisplatln-etoposlde: Early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer

Abstract

Background: This randomised study was designed to determine the response rate, survival and toxicity of single-agent gemcitabine and cisplatin etoposide in chemo-nai've patients with locally advanced or metastatic non-small-cell king cancer. Patients and methods: Gemcitabine 1,000 mg/rrr was given as a 30 min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m2 on day 1. and etoposide 100 mg/nr on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included hislologicaily confirmed non-small-cell lung cancer, measurable disease, Zubrod PS 0-2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS métastases. Results: 146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin etoposide patients were évaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8-30) and 11 cisplatin-etoposlde patients (15.3%; 95% CI: 7.9-25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematoiogical toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HTj antiemetics during the first cycle of cisplaiin- etoposide), and alopecia (grade 3 and 4: 3% gemcitabine vs. 62% cispiatin- etoposide). Conclusions: In this randomised study, single-agent gemchabine was at least as active but better tolerated than the combination cispiatin-etoposide. © 1997 Kluwer Academic Publishers.