Didem Karacetin, MD, consultant, oncology service, Sisli Etfal Hospital, Istanbul, Turkey, and associates presented results in 18 patients who were treated postoperatively with concomitant radiotherapy plus temozolomide chemotherapy.

"Glioblastoma multiforme, among the most common primary brain tumors, are very aggressive tumors which carry a poor prognosis and which are generally considered incurable despite a multi-modality treatment approach including surgery, radiotherapy, and chemotherapy," Dr. Karacetin pointed out in his presentation on February 7^th.

The median survival time is 5 to 12 months from the time of diagnosis, he said.

Standard treatment for newly diagnosed GBM previously consisted of resection followed by radiotherapy; chemotherapy was long considered controversial and was associated with marginal efficacy "at best," he added.

Subjects in the trial had a Karnofsky index (0 to 100) greater than 60, which denotes that the patient requires occasional assistance with activities but is able to care for needs. Patients had normal hematologic, hepatic, and renal function.

Radiotherapy was delivered at Gy per fraction, for a total of 60 to 66 Gy. All patients were treated with temozolomide 70 mg/m² at the same time as radiotherapy and 200 mg/m² daily for 5 days every 28 days starting 4 weeks after the end of radiotherapy. Overall, there were 6 treatment cycles.

Results showed a median survival of 10 months. Overall, 72% of patients were alive at 1 year. A complete response was documented in 1 patient, a partial response in 6, stable disease in 7, and progressive disease in 4 patients.

There were 3 cases of grade 1/2 thrombocytopenia and 3 cases of grade 3/4 thrombocytopenia. One patient had grade 1/2 neutropenia and 1 patient had grade 3/4 neutropenia. Nausea and vomiting were mild and were controlled in most cases using standard antiemetics.

"This study is in agreement with other studies of temozolomide in which serious side effects were relatively uncommon," Dr. Karacetin said.


[Presentation title: Concomitant Chemoradiotherapy and Then Sequential Temozolomide in Patients With Glioblastome Multiforme. Abstract 8]

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