258 A phase III multi-institutional randomised trial of lonidamine (L) and post-operative radiotherapy (RT) in supratentorial malignant glioma

Abstract

Lonidamine, an indazole carboxylic acid derivative, was reported in Phase II/III trials to have efficacy as radiopotentiator in malignant glioma. Between October 1990 and August 1994, 191 pts. with supratentorial malignant glioma were randomly allocated to treatment with RT or RT + L, following surgical resection. Prior to randomisation patients were stratified according to age. One patient was ineligible and excluded from the study (not malignant glioma). Patients (pts) in arm A (98 pts) received RT alone (50 Gy whole bram plus 14 Gy coned-down boost to the tumour volume, 2 Gy/day for 5 days a week), those in arm B (92 pts) received RT + L (150 mg 3 times daily for 1 year starting from 3 days before irradiation). The groups were comparable in median age, performance status, TNM classes, sex, residual tumour size after surgery and histologic grade. Median follow up was 49 weeks. Intention to treat analysis failed to demonstrate significance difference in the survival rates and shapes of the survival curves between the two treatment arms. Cumulative survival at 12 and 24 months calculated by the Kaplan Meier method were 50% ± 5% and 13.4% ± 4% for arm A, 49% ± 5% and 13.4% ± 4% for arm B. (P> 0.4). The Cox proportional hazards model confirmed the prognostic variables of age ( P P P