HEM/ONC

摘要

In February 2013, the US Food and Drug Administration (FDA) approved regorafenib (Stivarga, Bayer) for the treatment of patients with unresectable metastatic gastrointestinal stromal tumors (GIST) that no longer respond to imatinib (Gleevec, Novartis) and sunitinib (Sutent, Pfizer). Approval was based on results from GRID (GIST-Regorafenib in Progressive Disease), a randomized, phase III trial that involved 199 patients with metastatic and/or unresectable GIST that had become resistant to imatinib and sunitinib. Demetri and associates published results of the trial in the February issue of The Lancet. Patients were randomized to receive best supportive care plus regorafenib (160 mg orally once daily on a 3-weeks-on, 1-week-off cycle; 133 patients) or placebo (66 patients). For patients randomized to placebo, crossover to open-label regorafenib was allowed upon disease progression.