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Extended-schedule dose-dense temozolomide in refractory gliomas
Journal of Neuro-Oncology, 08/13/09

Berrocal A et al. - In a study to evaluate the activity of temozolomide in pts with temozolomide-refractory malignant glioma, it was concluded that the extended dose-dense schedule of temozolomide appears to have modest activity in pts refractory to previous treatment with temozolomide and is associated with manageable toxicity.

Methods

Adult pts (≥18 yrs of age) with WHO grade III or IV glioma and a Karnofsky Performance Status of 60 or higher were treated with temozolomide (85 mg/m2/day) for 21 consecutive days every 28-day cycle until disease progression or unacceptable toxicity.

Results

All pts had developed progressive disease either during or <3 mos after completing previous temozolomide treatment.
47 pts were treated with a median of 2 (range, 1–13) cycles of temozolomide.
Before study entry, pts had received a median of 6 cycles of temozolomide: 39 (83%) as part of initial therapy and 23 (49%) as second-line therapy.
3 pts (6.4%) had a partial response with durations of 8.0, 3.5, and 3.2 mos; 15 pts (31.9%) had stable disease with median duration of 2.1 mos, including 2 pts with stable disease (SD) for >6 mos (14 and 16 mos).
Median time to progression was 2 mos, and median overall survival from study entry was 5.1 mos.
6-mo progression-free survival rate was 16.7%.
Most common hematologic toxicities were lymphopenia, thrombocytopenia, and leukopenia.
Lymphopenia occurred in 83% of pts and was grade 3 in 28%, but no opportunistic infections occurred.

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