Preliminary safety results of regorafenib (REG) as a single agent for first-line treatment of frail and/or unfit for polychemotherapy patients (pts) with metastatic colorectal cancer (mCRC): A phase II study of the Spanish Cooperative Group for Digestive Tumor Therapy (TTD).

e14524 Background: Around 15-20% of pts diagnosed of mCRC do not qualify to receive polychemotherapy as first-line therapy, due to age and/or comorbidities, and their optimal treatment strategy has not been defined. REG is an oral multikinase inhibitor currently used as standard of care for fit pts with pretreated mCRC. This trial will assess the efficacy and safety of REG as a single agent in the first-line setting of this group of pts. Primary endpoint is progression-free survival rate at 6 months. Methods: Phase II, single-arm, open-label study in mCRC pts who were frail and/or unfit to receive polychemotherapy. Main inclusion criteria: pts > 18 years, ECOG PS ≤ 2, adequate organ function, and at least one of the following criteria: dependence in activities of daily living, presence of three or more comorbidities or geriatric syndromes. Pts received regorafenib 160 mg PO, 3 weeks on/1 week off in a 4-week cycle. Results: Forty-four pts have been analyzed. Median age was 80 years, 36.4% had ECOG 2, 57% ...