The effect of sequential radiochemotherapy in preirradiated malignant gliomas in a phase II study.

The optimum treatment strategy for recurrent high-grade gliomas in preirradiated areas remains undefined. This prospective non-randomized phase II study was undertaken to evaluate a radiochemotherapy protocol against this disease. Fourteen patients (median age 61 years) were treated according to a standardized treatment protocol consisting of sequential radiochemotherapy. The chemotherapy (temozolomide) was carried out over a duration of five sequential days (Mon.-Fri.) with a dose of 200 mg/m2/d. Chemotherapy courses were repeated in 4-week intervals (days 1, 29, 57, etc.) until clinical progression. Radiotherapy with 30 Gy over 3 weeks (5 x 2 Gy/week) was interposed between the first two chemotherapy courses (days 8-26). Eleven/fourteen patients had no acute side effects. One patient suffered from acute thrombocytopenia/leucocytopenia, one patient developed mental degradation (treatment stopped at 24 Gy) and another severe cephalgia. Until now, 10 out of 14 patients have died due to disease progression. Median survival (Kaplan-Meier method) amounts to 30 weeks with a 6-months progression-free survival of 30%. Four of fourteen patients are still alive 8, 10, 11 and 12 months after therapy. Late treatment toxicities have not been observed so far. The reported radiochemotherapy protocol seems to be feasible for these patients with only few treatment alternatives and does not lead to a remarkable increase in acute toxicity. Palliative and survival benefits are modest. Evaluation of late toxicities needs further investigations.