[Treatment of stage IIIB loco-regionally advanced non-small-cell bronchial carcinomas with radiation and interferon-beta. Preliminary results of a phase II study].

BACKGROUND

In-vitro and in-vivo studies demonstrated the radiosensitizing effect of interferon beta on malignant tumor tissue as well as simultaneously a radioprotective effect on normal lung tissue. In this phase II study the outcome of combining radiotherapy with interferon beta in patients with advanced non-small cell lung cancer was evaluated.

PATIENTS AND METHOD

From February 1994 until November 1996 14 patients with non-small cell lung cancer, stage IIIB were treated with locoregional radiation up to 59.4 Gy, with daily doses of 1.8 Gy and 5 fractions per week. Five million units of interferon beta (Fiblaferon) were given intravenously immediately preceding radiotherapy on the first 3 days of week 1, 3 and 5.

RESULTS

Four of 14 patients (28.6%) showed complete response and 7 patients (50%) partial response, resulting in an overall response rate of 78.6%. After a mean follow-up time of 23.3 months the 1-, 2- and 3-year survival rates were 56.3%, 37.5% and 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 further patient, whose right lung was resected 3 months after completion of radiotherapy, developed as a consequence of this operation 2 Grade-4 complications.

CONCLUSION

Considering the toxicity and the preliminary results of combining irradiation and interferon beta in the treatment of locally advanced non-small cell lung cancer it seems, that this procedure is worth to be tested in a phase III study.