By Ed Susman
STOCKHOLM, Sweden -- September 18, 2008 -- Treating patients with temozolomide monotherapy is not more effective than the standard therapy of procarbazine, lomustine, and vincristine (PCV) in a clinical trial involving patients with high-grade gliomas, according to a study presented here at the 33rd European Society for Medical Oncology Congress (ESMO).
Patients in the study who were assigned to temozolomide achieved 7.2 months of progression-free survival compared with 6.7 months among patients assigned to the PCV regimen, a 9% decreased risk of disease progression.
Ming Lee, MD, University College Hospitals, London, United Kingdom, presented the study results during the late-breaker symposium on September 15.
Median time to progression was 4.7 months in the temozolomide patients and 3.6 months in the PCV patients, a nonsignificant difference (P = .23) for the secondary endpoint outcome.
Dr. Lee and colleagues also subdivided the temozolomide patients into 2 groups: a 5-day treatment of 200 mg/m2 every 28 days or a 21-day treatment of 100 mg/m2 in a 28-day cycle. Patients were given a maximum of 9 cycles or until disease progression occurred.
After 12 weeks, 63.6% of patients receiving the 5-day treatment exhibited no signs of progression compared with 65.7% the patients on the 21-day treatment with temozolomide, again showing no significant difference (P = .75). However, there was a difference in progression-free survival among the 5-day temozolomide patients and those getting the longer treatment.
Dr. Lee said patients on the shorter therapy had a 5-month progression-free survival compared with a median of 4.2 months for those patients on the prolonged treatment (P = .02). There was also a strong trend (P = .06) for a longer survival among patients who received the 5-day treatment (8.5 months) compared with 6.8 months for patients on the 21-day regimen.
"Temozolomide-5 was superior to temozolomide-21 schedule with respect to progression-free survival and overall survival," Dr. Lee said. "These results question the current basis of increasing temozolomide dose intensity by prolonging scheduling."
[Presentation title: A Randomised Trial of Procarbazine, CCNU and Vincristine (PCV) vs Temozolomide (5-Day or 21-Day Schedule) for Recurrent High Grade Glioma (MRC BR12, ISRCTN83176944). LBA5]