e13008 Background: Brain metastases cause increasingly morbidity and mortality in patients with NSCLC. In a multicentric Austrian phase II study, we investigated feasibility and toxicity of the addition of temozolomide to whole brain radiotherapy (WBRT) in patients with multiple brain metastases of NSCLC. Methods: Consenting patients with previously untreated, multiple, and measurable brain metastases from histologically confirmed NSCLC were eligible if they were 18 years or older, were at least in RPA (recursive partitioning analysis class) class II and showed adequate organ function. Treatment consisted of WBRT (arm A) +TMZ 75mg/m2 during radiation, followed at day 28 by TMZ 100 mg/m2 day 1–14, q28 for six cycles (arm B). The primary endpoint was objective radiographic response in CNS 10 weeks after the end of WBRT. Results: 35 patients (14 women) aged 35 to 86 years, median 65 years were randomized. Eight patients were in RPA class I and 27 were in RPA class II. 13 patients were enrolled in arm A and 22 in arm B. Toxicity was mainly haematological with WHO grade 3 and 4 thrombocytopenia observed in 0/13 versus 3/22 patients, leucocytopenia in 0/13 versus 1/22 patients, and lymphocytepenia in 12/13 and 7/22 patients respectively. No severe nonhematologic toxicity occured in arm A, whereas two episodes of transient hepatic toxicity were reported in arm B. 10/13 patients of arm A and 13/22 patients of arm B showed progressive disease and dropped out of study before restaging 10 weeks after completion of WBRT. Two patients of arm A had progressive disease in CNS, all other progresses noted were systemic. At restaging there were 2 PR, 1 SD in arm A, and 1 CR, 3 PR, 6 SD in arm B. Median time to progression was 40 days in arm A and 74 days in arm B (p = 0.027). Conclusions: The addition of temozolomide to WBRT in patients with brain metastases of NSCLC yielded acceptable toxicity and promising activity, although systemic progression remained the main cause of morbidity and mortality. [Table: see text]
EP-1291: Short course accelerated radiation therapy (SHARON) for complicated bone metastases: results of a phase ii study
