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Elderly patients tolerated temozolomide for glioblastoma

Pérez-Larraya JG. J Clin Oncol. 2011;doi:10.1200/JCO.2011.34.8086.

Issue: August 10, 2011

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Older patients with newly diagnosed glioblastoma and poor performance status tolerated temozolomide well, according to results from a phase 2 study.

Additionally, patients assigned to temozolomide (Temodar, Schering-Plough) had superior OS and PFS compared with those assigned to supportive care.

Seventy patients with newly diagnosed glioblastoma and a Karnofsky performance score of less than 70 were enrolled in the study from July 2007 to February 2009. The median age was 77 years, and the median Karnofsky performance score was 60.

All patients underwent prior surgery. Chemotherapy with up to 12 cycles of temozolomide began within the first month after diagnostic biopsy or resection. The first dose was 150 mg/m² for 5 consecutive days every 28 days, with dose escalation up to 200 mg/m² at the second cycle in the absence of hematologic toxic effects.

Fourteen patients (20%) had dose delays and 17 patients (24%) had dose reductions caused by acute or prolonged hematologic toxicity. Treatment-related toxicity did not lead to permanent discontinuation of chemotherapy. Five patients refused to continue treatment after completing at least one cycle of chemotherapy.

All patients had died by final analysis. Sixty-one patients (87.1%) died of tumor progression. Three of the remaining patients died of pulmonary embolism, two of aspiration pneumonia, one each from diabetic ketoacidosis and septic shock, and two of unknown causes.

The median OS was 25 weeks (95% CI, 19-28). The 6-month survival rate was 44.3% (95% CI, 32.7-55.9) and the 12-month survival rate was 11.4% (95% CI, 3.9-18.8). The median PFS was 16.1 weeks (95% CI, 10.2-20). The 6-month PFS rate was 29.9% (95% CI, 18.9-40.9) and the 12-month PFS rate was 6.5% (95% CI, 0.6-12.3).

Four patients experienced grade-3 nonhematologic adverse events. Three patients had severe infections, and one patient died of septic shock before beginning treatment. Three patients experienced thromboembolic events.

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