Treatment of supratentorial glioblastoma multiforme with radiotherapy and a combination of BCNU and tamoxifen: a phase II study

From May 1990 to November 1994, 70 consecutive patients suffering from glio blastoma multiforme were treated following surgery with conventional radiot herapy and adjuvant IV BCNU administered alone or in combination with tamox ifen. Twenty-five patients received BCNU alone (control group A) while 24 p atients also received 40 mg of tamoxifen (TMX) PO daily (group B) and 21 re ceived 100 mg of TMX PO daily (group C). There were no significant differen ces between the 3 groups concerning age, type of resection and median post- operative Karnofsky performance status (KPS). Blood toxicity over grade II occurred in 33.5% of patients receiving TMX versus 12% of patients treated with BCNU alone (p < 0.05). Deep venous thrombosis complications were observed in 4 patients of each TM X group, whereas they were not observed in the control group (p < 0.04). Me dian time to tumor progression (MTTP) was 35 weeks in the control group and 27 weeks in both TMX groups B and C. Median survival time (MST) was 56, 66 and 51 weeks, respectively. These results suggest that the addition of TMX to standard treatment of gli oblastomas does not affect the time to tumor progression and overall surviv al but may increase the risk of deep venous thrombosis or nitrosourea-induc ed blood toxicity.