ACCEPTABILITY OF PATIENTS WITH BRAIN METASTASES FOR CLINICAL-TRIALS OF CHEMOTHERAPY FOR METASTATIC NON-SMALL-CELL LUNG-CANCER

This study was conducted to determine whether patients with brain meta stases from non-small-cell lung cancer (NSCLC) should be included in c linical trials of chemotherapy. Patients with metastatic NSCLC and goo d performance status were studied. The survival of patients with brain metastases was compared with that of patients without brain metastase s. Of 100 eligible patients, 22 had brain metastases at diagnosis. The median survival time was poorer in patients with brain metastases tha n in other patients with metastatic NSCLC (96.5 vs. 181.5 days). Howev er, the difference in survival was not significant on univariate analy sis (p = 0.106). Multivariate analysis confirmed that the prognostic v alue of brain metastases was limited in this sample (p = 0.129). There was little difference in survival curves during the first 8 weeks. Pa tients with brain metastases who have good performance status and mini mal neurologic symptoms can be observed for similar to 8 weeks in clin ical trials to determine their response to chemotherapy. However, it i s doubtful that patients with brain metastases would be eligible for p hase III trials, in which survival is an endpoint.