Gemcitabine plus etoposide in chemonaive extensive disease small-cell lungcancer: A multi-centre phase II study

Background: Both gemcitabine and etoposide are active in the treatment of s mall-cell lung cancer (SCLC), and are characterised by mild toxicity profil es. The combination of both drugs was found to be feasible and active in a phase I dose-finding study in solid tumours. Therefore, a phase II trial wa s initiated to examine the activity and toxicity of this schedule in extens ive disease SCLC. Patients and methods: Forty-two chemo-naive extensive dis ease SCLC patients were enrolled to receive gemcitabine 1000 mg/m2, days i, 8 and 15, and etoposide 80 mg/m2, days 8, 9 and 10 of a 28-day cycle. Resu lts: Thirty-seven patients were evaluable for efficacy (five received less than one cycle). No complete responses were observed, but partial responses were seen in 17 patients, yielding an overall response rate of 46%. The me dian duration of response was 5.8 months. Disease stabilisation was obtaine d in another 10 patients (27%). The median survival of the 37 protocol-qual ified patients was 10.5 months (95% confidence interval (CI): 7.512.0). The levels of WHO grade 3 and 4 toxicities were low and clinically manageable. Conclusion: In comparison with standard platinum-based regimens, this comb ination of gemcitabine and etoposide resulted in a somewhat lower response rate, but a similar median survival time. Haematological toxicity was more pronounced than expected from the toxicity data of each agent individually. However, because of its mild non-haematological toxicity, and its ability to be administered in an outpatient setting, this combination provides a re asonable palliative option for patients with extensive disease SCLC.