Info
Regorafenib
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Multitarget TKI; third line; activity in exon 17/18 acquired resistance Mts
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GRID trial → Phase III RCT of GIST pts w/ failure to imatinib/sunitinib to regorafenib vs. placebo; regorafenib w/ ↑ PFS compared to placebo (∼5 mos vs. 1 mo) (Lancet 2013;381:295)
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160 mg(40mg/tab)once daily on days 1-21 of each 28-day cycle. Figure -
continue therapy until disease progression or unacceptable toxicity occurs.
Treatment of metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing regimens; a vascular endothelial growth factor inhibitor (anti-VEGF therapy); and, in patients with tumors bearing wild-type (nonmutated) KRAS gene, an epidermal growth factor receptor inhibitor (anti-EGFR therapy).
CORRECT
- Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial - PubMed
- Patients were randomised to receive oral regorafenib 160 mg or matching placebo once daily for the first 3 weeks of each 4 week cycle until disease progression, death, unacceptable toxic effects, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient’s best interest.
- Median overall survival was 6.4 months in the regorafenib group versus 5.0 months in the placebo group
CORRECT American Society of Clinical Oncology (ASCO) states that regorafenib or trifluridine/tipiracil may be considered in the third- or fourth-line setting in patients with late-stage colorectal cancer with any RAS/BRAF status; however, the drugs are recommended in patients with wild-type RAS metastatic colorectal cancer previously treated with fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, and anti-EGFR therapy.