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| |  No Benefit for Extended-Schedule Temozolomide in Treating Advanced Melanoma: Presented at ESMO By Janet Fricker STOCKHOLM, Sweden -- September 15, 2008 -- In stage IV malignant melanoma, the extended-schedule temozolomide regimen produced no improvement in overall survival or progression-free survival compared to the standard-of-care treatment, dacarbazine, according to a study presented here at the 33rd European Society for Medical Oncology Congress (ESMO). "We were hoping to see a difference, since temozolomide allows us to give the same active ingredient as dacarbazine at twice the dose," said presenter Poulam Patel, MBBS, PhD, Nottingham University, Nottingham, United Kingdom, and Vice Chair of the European Organisation for Research and Treatment of Cancer (EORTC) Melanoma Study Group. "But I'm not too surprised by this result," Dr. Patel added, presenting the late-breaking data at a poster presentation here on September 15. "In the last 20 years, no new drug has been shown to increase survival for patients with stage IV malignant melanoma." In this phase 3, EORTC study -- the largest ever carried out in melanoma research -- 859 patients with stage IV melanoma were randomised to receive either intravenous dacarbazine (1,000 mg/m2 every 21 days -- the current standard treatment) or the dose-intense oral temozolomide 150 mg/m2 on days 1 through 7 and repeated every 14 days (1 week on; 1 week off). Results demonstrated that the median overall survival was 9.13 months in the temozolomide arm, compared to 9.36 months in the dacarbazine arm (hazard ratio [HR] = 1.00, P = 1.0). Furthermore, the progression-free survival was shown to be a median of 2.30 months in the temozolomide arm versus 2.17 months in the dacarbazine arm (HR = 0.92, P = .27). The study found slightly more grade 3 and 4 toxicity in the temozolomide arm. "The results show that extended-schedule, escalated-dose temozolomide is feasible and has an acceptable safety profile, but produces no improvement in overall survival or progression-free survival when compared to standard-dose dacarbazine," said Dr. Patel. "The bottom line," he noted, "is that some patients will prefer oral agents and others intravenous agents." Patients in this study were recruited from 92 institutions in Europe, the United States, and Latin America. [Presentation title: Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Malignant Melanoma: Final Results of the Randomised Phase III study (EORTC 18032). Abstract LBA8]
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