PHASE-III TRIAL OF RECOMBINANT INTERFERON-GAMMA IN COMPLETE RESPONDERS WITH SMALL-CELL LUNG-CANCER

Purpose: We evaluated the effect of recombinant interferon gamma (rIFN -gamma) on survival and toxicity in small-cell lung cancer (SCLC) pati ents in complete remission (CR). Patients and Methods: One hundred pat ients in CR following treatment with six cycles of combination chemoth erapy, thoracic radiotherapy (TRT), and prophylactic cranial irradiati on (PCI) were studied. All patients had been enrolled onto a cooperati ve group trial (North Central Cancer Treatment Group [NCCTG] 86-20-51) . patients received observation only or rIFN-gamma at a dose of 4 x 10 (6) U subcutaneously per day for 6 months. Results: Six patients (12%) did not comply with rIFN-gamma treatment. Substantial nonhematologic toxicities consisting of chills, myalgia, lethargy, and alteration of mood-personality were observed. No patient experienced life-threatenin g or fatal toxicity. The median times to progression for rIFN-gamma tr eatment or observation were 6.9 and 8.1 months (P = .54). The median s urvival times were 13.3 and 18.8 months, respectively (P = .43). Appro ximately 70% of all patients relapsed within 2 years. Conclusion: Time to progression and survival were inferior in patients treated with rI FN-gamma compared with randomized control subjects, although this diff erence was not statistically significant. These data indicate that rIF N-gamma treatment is not associated with a 33% improvement in survival (P = .04). Because of the high rate of relapse, SCLC patients in CR a re an ideal group in which to evaluate novel and minimally toxic agent s. (C) 1994 by American Society of Clinical Oncology.