INTERFERON ALPHA-2A AND COMBINED CHEMOTHERAPY AS FIRST LINE TREATMENTIN SCLC PATIENTS - A RANDOMIZED TRIAL

Background: Interferons (IFNs) are known to act synergistically with a ntineoplastic agents when applied to SCLC cell cultures. This study wa s conducted in order to detect the clinical benefits, if any, of the a ddition of IFN-alpha in the induction chemotherapy (CT) of SCLC patien ts. Patients and method: Ninety previously untreated patients with SCL C were randomly assigned to receive either CT alone (arm A) or CT plus IFN alpha-2a in a dose of 3 MU/m(2) twice weekly (arm B). CT for both arms consisted of carboplatin 420 mg/m(2), etoposide 200 mg/m(2) and ifosfamide 3.5 g/m(2) or epirubicin 80 mg/m(2) every 28 days for a tot al of eight cycles. Responding patients received primary site and prop hylactic cranial irradiation and then had maintenance CT with cyclopho sphamide 100 mg/m(2)/day for 20 days every month. Patients in arm B re ceived IFN throughout these treatments. Results: Eighty-one patients w ere evaluable for response, 39 in arm A and 42 in arm B. Both arms wer e comparable in terms of age, performance status and extent of disease . Overall response rates were not significantly different between the two arms (90% vs. 86%), although complete response rate was higher in arm B (38% vs. 28%). More importantly, Kaplan-Meier analysis disclosed a clear survival benefit in the arm receiving IFN-alpha (P < 0.05). F or limited disease the difference was even more significant (P < 0.006 7), while for extensive disease no significant difference was found (P < 0.35). Fever, fatigue and anorexia were more frequent in arm B (P < 0.001), as also leukopenia (P < 0.01). Conclusion: The addition of IF N-alpha to induction CT appears to confer a survival benefit to SCLC p atients but optimal dosing schedule has yet to be defined.