E.J.N.S. Vol. 21 No. 2 June 2006 69 A Phase II Study of Cisplatin as Radiosensitizer During Standard Radiotherapy for High Grade Gliomas, Followed by Lomustine based Chemotherapy Khaled Abdel Karim*, Amro Lotfy*, Ahmed Refae*, Khaled Elhusseiny*, Khaled Saoud** *Radiation Oncology and Nuclear Medicine, and**Neurosurgery Departments, Ain-shams University, Cairo, Egypt ABSTRACT Purpose: Treating patients with malignant gliomas has always been a difficult task. We are investigating the efficacy of using cisplatin as radiosensitizer during standard course of radiotherapy followed by Lomustine (CCNU), and Vincristine (Oncovine) chemotherapy and the possible improve survival. The primary end of this study was time to progression, the secondary end points were response, toxicity, and the overall survival. Patients and Methods: After surgery (open debulking surgery, stereotactic craniotomy, or stereotactic biopsy), the adult chemo-naïve patients who were pathologically proven to have high-grade glioma i.e. anaplastic astrocytoma (AA), and Glioblastoma multiforme (GBM) were eligible. They received cisplatin 35mg/m 2 weekly during radiotherapy, which was given conventionally 5 days a week, 200 cGY per treatment to a maximum dose of 6400 cGY. This was followed by 6 cycles of chemotherapy that consisted of CCNU 100 mg/m 2 D1 every 6 weeks and vincristine 1.4 mg/m 2 D2 and 23. Results: Thirty- two patients were evaluable (the mean age was 50.97 years, range 19-70 years; Karnofsky performance status KPS was 90 in 11 patients, 80 in 10, 70 in 5, and 60 in 6 patients. The median time to progression TTP was 11.5 months (range 4- 20 months), the mean was 15.66 months (range 4-28 months). Among the 32 patients, 5 complete responses and 25 partial responses were obtained, with an over all response rate of 93.7%. Among 175 doses of chemotherapy delivered, the most common grade 3and 4 toxicities reported were Neutropenia in 5 patients(15.7%), thrombocytopenia in 3 patients (9.4%), nephrotoxicity in one (3.1%), and ototoxicity in another one patient. Conclusion: This protocol of using Cisplatin as a radiosensitizer during radiotherapy followed by CV chemotherapy appears to be active in the patients with high-grade gliomas with an acceptable toxicity profile. Key words: Cisplatin, radiosensitizer, high-grade gliomas. INTRODUCTION Gliomas are considered the most frequent brain tumors in the adult age group. The world Health Organization (WHO) criteria is universally accepted for classification and grading of such group of tumors (1) High-grade astrocytomas, with its types, anaplastic astrocytoma (AA, WHO GIII), and Glioblastoma multiforme (GBM, WHO G IV) were treated conventionally for the last three decades with surgery and radiotherapy. The surgical excision of an intracranial tumor relieves the increased intracranial pressure with the subsequent improvements in the neurological symptoms (2) . The median survival is between 2 and 4 years for anaplastic astrocytoma and for the glioblastoma it drops to only 12-15 months. The surgical resection for these tumors is never (radical) due to the infiltrative nature of those tumors (3) . Some phase III studies in addition to a meta analysis study have proven the marginal benefit of adding adjuvant chemotherapy to the radiotherapy treatment in the patients with high grade gliomas using the PVC protocol