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No improvement was seen in OS or PFS for the temozolomide group, and this dose and schedule resulted in more toxicity than standard-dose, single-agent dacarbazine.[48][Level of evidence A1] Two randomized phase III trials in previously untreated patients with metastatic melanoma (resulting in FDA approval for vemurafenib [21] and ipilimumab [6]) included dacarbazine as the standard therapy arm