TREATMENT OF LOCALLY ADVANCED NONSMALL CELL LUNG-CANCER, STAGE IIIB WITH IRRADIATION AND INTERFERON-BETA - PRELIMINARY-RESULTS OF A PHASE-II STUDY

Background: In-vitro and in-vivo studies demonstrated the radiosensiti zing effect of interferon beta on malignant tumor tissue as well as si multaneously a radioprotective effect on normal lung tissue, In this p hase II study the outcome of combining radiotherapy with interferon be ta in patients with advanced non-small cell lung cancer was evaluated. Patients and Method: From February 1994 until November 1996 14 patien ts with non-small cell lung cancer, stage IIIB were treated with locor egional radiation up to 59.4 Gy, with daily doses of 1.8 Gy and 5 frac tions per week. Five million units of interferon beta (Fiblaferon((R)) ) were given intravenously immediately preceding radiotherapy on the f irst 3 days of week 1, 3 and 5. Results: Four of 14 patients (28.6%) s howed complete response and 7 patients (50%) partial response, resulti ng in an overall response rate of 78.6%. After a mean follow-up time o f 23.3 months the 1-, 2- and 3-year survival rates were 56.3%. 37.5% a nd 37.5%, respectively. The median survival time was 13 months. Three of 14 patients (21.4%) suffered from 7 Grade-3 acute side effects and 2 patients (14.3%) from 1 Grade-3 late toxicity in each case. One furt her patient, whose right lung was resected 3 months after completion o f radiotherapy. developed as a consequence of this operation 2 Grade-4 complications. Conclusion: Considering the toxicity and the prelimina ry results of combining irradiation and interferon beta in the treatme nt of locally advanced non-small cell lung cancer it seems, that this procedure is worth to be tested in a phase III study.