CONTROLLED CLINICAL-TRIAL OF PROPHYLACTIC CRANIAL IRRADIATION FOR PATIENTS WITH SMALL-CELL LUNG-CANCER IN COMPLETE REMISSION

We conducted a randomised clinical trial on 211 patients with small-ce ll lung cancer in complete remission (CR). The aim of this trial was t o evaluate the effect of prophylactic cranial irradiation (PCI) on ove rall survival. Eligible patients were randomly assigned to receive eit her PCI (100 patients) or no PCI (111 patients). Each centre was allow ed to use its own PCI protocol as long as the total dose was within th e range of 24-30 Gy and delivered in less than 3 weeks with fractions of 3 Gy or less. The mean follow-up is 5 years. The survival curves do not differ significantly (P = 0.25) between the two groups. The 4-yea r overall survival rate (95% confidence interval) is 22% [15-32%] in t he PCI group versus 16% [10-25%] in the control group. The relative ri sk of death in the PCI group compared to the control group is 0.84 (95 % CI = [0.62-1.13]). The incidence of brain metastasis is lower in the PCI group, but the difference is not statistically significant (P = 0 .14). The 4-year cumulative rate of brain metastasis is 44% [32-57%] i n the PCI group compared to 51% [38-63%] in the control group. In conc lusion, in this study, which had to be closed prematurely, no signific ant difference was found in terms of the incidence of brain metastases nor in survival. (C) 1998 Elsevier Science Ireland Ltd. All rights re served.