A RANDOMIZED TRIAL TO ASSESS THE EFFICACY OF SURGERY IN ADDITION TO RADIOTHERAPY IN PATIENTS WITH A SINGLE CEREBRAL METASTASIS

BACKGROUND. Cerebral metastasis is a common oncologic problem that occ urs in 15-30% of cancer patients; approximately half such metastases a re single. Previous retrospective studies and two randomized trials re ported that the addition of surgical extirpation prior to radiation th erapy increased survival, neurologic function, and quality of life com pared with radiation alone in patients with a single brain metastasis. METHODS. A randomized controlled trial was conducted in which patient s with a single brain metastasis were allocated to undergo radiation a lone or surgery plus radiation. Radiation consisted of 3000 centigray to the whole brain in 10 fractions. RESULTS. Forty-three patients rece ived radiation alone and 41 patients surgery plus radiation. All but t wo of the study patients died. No difference in survival was detected between the groups; the median survival for the radiation group was 6. 3 months (95% confidence interval, 3-11.4) compared with 5.6 months fo r the surgery plus radiation group (95% confidence interval, 3.9-7.2) (P = 0.24). Most patients died within the first year (69.8% in the rad iation arm vs. 87.8% in the surgery plus radiation arm). There were no significant differences in the 30-day mortality, morbidity, or causes of death. Extracranial metastases was an important predictor of morta lity (relative risk, 2.3). The mean proportion of days that the Karnof sky performance status was greater than or equal to 70% did not differ between the 2 groups. CONCLUSIONS. This trial failed to demonstrate t hat the addition of surgery to radiation therapy improved outcome of p atients with a single brain metastasis. Thus, the efficacy of surgery plus radiation compared with radiation alone needs to be addressed by further clinical trials and/or a meta-analysis. (C) 1996 American Canc er Society.