PHASE-II STUDY OF DAILY ORAL ETOPOSIDE PLUS IFOSFAMIDE PLUS CISPLATIN FOR PREVIOUSLY TREATED RECURRENT SMALL-CELL LUNG-CANCER - A HOOSIER ONCOLOGY GROUP TRIAL

Purpose: The study was undertaken to determine the activity and toxicity of oral etoposide (VP-16), ifosfamide, and cisplatin combination chemotherapy for previously treated, recurrent small-cell lung cancer (SCLC). Patients and Methods: In this phase II trial, 46 patients were enrolled to receive oral VP-16, 37.5 mg/m(2)/d for 21 days, ifosfamide 1.2 g/m(2)/d for 4 days, and cisplatin 20 mg/m(2)/d for 4 days, with courses repeated every 28 days. Response, survival, and toxicity data were then noted. Results: Forty-two of 46 patients were assessable for response, survival, and toxicity. Thirty-six of 42 patients had received prior cisplatin plus VP-16. The first 22 patients received oral VP-16 for 21 days, but the subsequent 20 patients received oral VP-16 for 14 days after an interim analysis showed marked myelosuppression. Twenty-three of 42 patients (55%) had an objective response, with six complete responses (CRs; 14%), and 17 partial responses (PRs; 40%). The median progression-free survival time ws 20 weeks (range, 2 to 66) and the overall median survival duration was 29 weeks (range, 1 to 76). Myelosuppression was significant, with six treatment-related deaths, four as a result of sepsis. Conclusion: The combination of oral VP-16, ifosfamide, and cisplatin is an active regimen in the treatment of recurrent SCLC. However, hematologic toxicity was severe in this pretreated patient population.