Abstract
In glioblastoma multiforme (GBM), both temozolomide (TMZ) and cisplatin are very active at various toxic levels. Previous studies demonstrated that cisplatin with the standard regimen of TMZ is active in patients suffering from recurrent GBM, generating a moderate level of toxicity. Also, continuous dose-intense TMZ is a helpful therapy for patients with recurrent GBM. We have conducted a research to evaluate the security and effectiveness of cisplatin with constant dose-intense TMZ for reduplicative GBM. The time to progression (TTP) and progression-free survival (PFS) at 6 months (PFS-6) was the major end point. Toxicity, overall survival, and response are the secondary end points. GBM patients who suffered from progression or relapse after surgery, radiotherapy, and chemotherapy were qualified. Cisplatin 40, 30, and 30 mg were given on days 1, 2, and 3 before the corresponding TMZ doses, respectively. Without interruption, TMZ was given at a dose of 50 mg/m on everyday basis (dose-intense) until development or progression of unacceptable side effects. A cycle was defined as 28 days. Response Assessment in Neuro-Oncology criteria were utilized to evaluate the response. Twenty-seven patients in total (median Karnofsky performance status-80, ranging from 60 to 100; average age-56 years, ranging from 24 to 78 years) were accrued in the research. PFS-12 was 11.1% (95% confidence interval [CI], -0.7% to 22.9%), and PFS-6 was 37% (95% CI, 18.8%-55.2%). Twenty-three weeks was the median TTP (95% CI, 17-29 weeks). In the 27 evaluative patients, 6 partial responses were observed with an overall response rate of 22.2% (95% CI, 6.5%-37.9%), while no complete response was obtained. Toxicity was mostly of grades 1 to 2 amongst 116 therapy cycles. Hematological and gastroenterological toxicities were the major limiting side effect found in the research. One patient has received leukopenia World Health Organization grade 4 at cycle 5 during her treatment. Eight percent of patients had grades 3 to 4 vomiting/nausea. As a valuable therapeutic option, the innovative cisplatin with continuous dose-intense regimen of TMZ incurs an acceptable level of toxicity and shows active performance in patients with recurrent GBM.