Single-agent gemcitabine versus cisplatin-etoposide: Early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer

Background: This randomised study was designed to determine the responserate, survival and toxicity of single-agent gemcitabine andcisplatin–etoposide in chemo-naïve patients with locally advancedor metastatic non-small-cell lung cancer.Patients and methods: Gemcitabine 1,000 mg/m² was given asa 30 min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin100 mg/m² on day 1, and etoposide 100 mg/m²on days 1 (following cisplatin), 2 and 3. Major eligibility criteria includedhistologically confirmed non-small-cell lung cancer, measurable disease,Zubrod PS 0–2; no prior chemotherapy, no prior radiation of the measuredlesion, and no CNS metastases.Results: 146 patients were enrolled, 71 patients on gemcitabine and 75patients on cisplatin–etoposide. Patient characteristics were wellmatched across both arms. Sixty-six gemcitabine patients and 72cisplatin–etoposidepatients were evaluable. Partial responses were seen in 12 gemcitabinepatients (18.2%; 95% CI: 9.8–30) and 11cisplatin–etoposide patients (15.3%; 95% CI:7.9–25.7).Early indications show no statistical differences between the two treatmentswith respect to time to disease progression or survival. Haematological andlaboratory toxicity were moderate and manageable. However, hospitalisationbecause of neutropenic fever was required for 6 (8%)cisplatin–etoposide patients but not for any gemcitabine patients.Non-haematological toxicity was more pronounced with significant differencesin nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29%cisplatin–etoposide; despite the allowance for 5-HT^-3antiemetics during the first cycle of cisplatin–etoposide), and alopecia(grade 3 and 4: 3% gemcitabine vs. 62%cisplatin–etoposide).Conclusions: In this randomised study, single-agent gemcitabine was atleast as active but better tolerated than the combinationcisplatin–etoposide.