NSCLC patients with 1 to 3 brain metastases were randomized to receive WBRT (2.5 Gy ¡Á 15 to 37.5 Gy) and SRS alone, versus WBRT + SRS + TMZ (75 mg/m2/day ¡Á 21 days) or ETN (150 mg/day). ETN (150 mg/day) or TMZ (150-200 mg/m2/day ¡Á 5 days/month) could be continued for as long as 6 months after WBRT + SRS. The primary endpoint was OS.
After 126 patients were enrolled, the study closed because of accrual limitations. The?median survival times (MST) for WBRT + SRS, WBRT + SRS + TMZ, and WBRT + SRS + ETN were qualitatively different (13.4, 6.3, and 6.1 months, respectively), although the differences were not statistically significant. Time to central nervous system progression and performance status at 6 months were better in the WBRT + SRS arm. Grade 3 to 5 toxicity was 11 % , 41 % , and 49 % in arms 1, 2, and 3, respectively (P<.001).
The addition of TMZ or ETN to WBRT + SRS in NSCLC patients with 1 to 3 brain metastases did not improve survival and possibly had a deleterious effect. Because the analysis is underpowered, these data suggest but do not prove that increased toxicity was the cause of inferior survival in the drug arms.