Local chemotherapy with cisplatin-depot for glioblastoma multiforme.

Glioblastoma multiforme (GBM) makes up as many as 30% of all primary brain tumors. Despite the employment of multimodal antitumor treatment, the overall survival is less than one year. Between 06/01/1998 and 06/01/2000 17 patients (Group A) with GBM (11 males, 6 females; median age 54.3 years) were administered local chemotherapy with cisplatin incorporated into biodegradable 6-carboxylcellulose polymer (cisplatin-depot (CDDP-D)). After the subtotal removal of GBM, twenty 1.5 x 1.5 cm polymer plates with a total area of 45 cm2 (the density of cisplatin immobilization on 6-carboxylcellulose being 1 mg/cm2, a total cisplatin dose of 45 mg) were implanted into the tumor bed. Group B (21 patients with GBM; 11 males, 10 females; median age 53.2 years) was control: the subtotal tumor ablation without CDDP-D implantation. Two to three weeks after the surgery all the patients of Groups A and B started a course of radiation therapy. A total dose of cranial irradiation was 20 Gy (1 fraction/day, 5 days/week; a daily dose of 2 Gy) followed by a boost tumor bed irradiation (1 fraction/day, 5 days/week; a daily dose of 2 Gy) up to the conventional dose of 60 Gy. Survival data for the patients were processed using the Kaplan-Meier method and analyzed by logrank test. All the patients of Group A tolerated surgical ablation of the brain tumor without side effects (brain edema, seizures, etc.). No patient of Group A had a reduction in blood cell counts during six weeks that would indicate systemic exposure to cisplatin. Blood chemistry and urinalysis did not show evidence of renal injury. No side effects of radiotherapy were registered in Group B either, regarding both the psychoneurological status of the patients and the basic values of homeostasis. Karnofsky performance scale (KPS) score of Group A and Group B patients demonstrated no significant differences before and after the surgery. The median overall survivals for patients of Group A and Group B were 427.5 and 211.0 days respectively (p = 0.00001; overall logrank test). Conclusion. Local chemotherapy of GBM with CDDP-D followed by irradiation is well tolerated and effective.

RCT Entities:   Population Interventions Outcomes