A randomized study of radiation treatment in small cell bronchial carcinoma treated with two types of four-drug chemotherapy regimens.

Of an unselected series of 133 patients with small cell bronchial carcinoma, 110 patients (54 with extensive disease and 56 with limited disease) were randomly allocated to receive either chemotherapy with cyclophosphamide, doxorubicin, vincristine, and methotrexate, alternating after four cycles with cyclophosphamide, lomustine, vincristine, and methotrexate, or the same chemotherapy combinations together with irradiation at 40 Gy to the primary tumor area and the adjacent mediastinum. In patients with extensive disease the total response rates were 70% and 86% and the median survival 7.6 and 9.2 months, respectively. There were no long-term survivors, and no advantage was gained from radiation combination treatment. The results confirm previously reported findings. In limited disease the complete remission rates were 68% and 64%, the partial remission rates 26% and 28%, and the median survival was 14.8 and 15.4 months, respectively. There were no statistically significant differences favoring either treatment regimen. The disease-free survival exceeding 2 years in the two respective groups was 6.5% and 25%; this difference was not statistically significant. A slight advantage of combined radiation and chemotherapy in the direction of better long-term survival was confirmed by the 4-year disease-free survival rate of 12% as compared with 0% in the nonirradiation group. This difference was statistically significant. There was considerable toxicity with both treatment regimens. The addition of radiation treatment to the chemotherapy most likely benefits patients with limited disease. The overall median survival of all the unselected 133 patients (nonrandomized included) was 10.3 months, and the cure rate was 3%.

RCT Entities:   Population Interventions Outcomes