Regorefanib for GIST (Gastrointenstinal Stromal Tumor) – pro

Senior man getting his heart beat checked by a doctor

GIST is the most common form of sarcoma that is found in the gastrointestinal tract. There are thought to be 4,000-5,000 new cases of GIST diagnosed each year in the USA, of them about 1,500 metastatic. New treatments for GIST continue to appear. The most recent candidate for accelerated approval before FDA is regorefanib, recenlty approved as Stivarga for colon cancer. The application for approval is based on the recent GRIP study of 132 patients randomly assigned to receive regorafenib 160 mg once daily or placebo. There was no overall survival difference, possibly related to the crossover design of the study (85% crossed over to regrefanib). Progression-free survival was almost five times greater in the regorafenib group at 4.8 months compared with 0.9 months in the placebo group. The disease control rate was also significantly greater  – 52.6% compared with 9.1% for placebo-treated patients.

Efficacy is also supported by a phase II trial by S. George et al.  Bayer has began to offer regarafenib to patients with GIST on a compassionate use basis.

George D Demetri Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial The Lancet, Early Online Publication, 22 November 2012doi:10.1016/S0140-6736(12)61857

George S, Wang Q, Heinrich MC, Corless CL, Zhu M, Butrynski JE, Morgan JA, Wagner AJ, Choy E, Tap WD, Yap JT, Van den Abbeele AD, Manola JB, Solomon SM, Fletcher JA, von Mehren M, Demetri GD.Efficacy and safety of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of imatinib and sunitinib: a multicenter phase II trial.J Clin Oncol. 2012 Jul 1;30(19):2401-7.

Sivarga, Prescribing Information, 2012

For Lay version see here

For other articles on recent advances in GIST see here and here


For Lay version see here

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