RANDOMIZED TRIAL COMPARING INDUCTION CHEMOTHERAPY VERSUS INDUCTION CHEMOTHERAPY FOLLOWED BY MAINTENANCE CHEMOTHERAPY IN SMALL-CELL LUNG-CANCER

Purpose and Methods: The European Lung Cancer Working Party (ELCWP) pe rformed a randomized trial with the primary end point to determine if maintenance chemotherapy with 12 courses of etoposide (120 mg/m(2) on days 1 and 3) and vindesine (3 mg/m(2) on day 3) could improve progres sion-free survival in small-cell lung cancer (SCLC) patients who respo nded to six courses of induction chemotherapy with ifosfamide, etoposi de, and an anthracycline (doxorubicin or epirubicin). Results: Among 2 35 eligible patients initially registered, 91 were randomized to recei ve maintenance therapy, including seven patients who were no longer re sponding. Among 84 randomized responders, progression-free survival wa s significantly improved (P=.003) by maintenance therapy, with median durations (maintenance v follow-up) of 25 versus 12 weeks after the se cond randomization, but survival was not significantly increased (P=.1 0), with median durations of 48 and 38 weeks. However, in a multivaria te analysis that took into account disease extent, maintenance therapy , Karnofsky performance status (PS), and absolute dose-intensity (ADI) of anthracycline given during induction, limited disease (LD) and mai ntenance were found to be independent positive predictors of survival. Conclusion: We conclude that maintenance chemotherapy in responding p atients is beneficial in SCLC. (C) 1996 by American Society of Clinica l Oncology.