Regorafenib as a single agent for first-line treatment of frail and/or unfit for polychemotherapy patients with metastatic colorectal cancer (mCRC): A study of the Spanish Cooperative Group for digestive tumor therapy (TTD).

3527Background: A 15-20% of pts diagnosed of mCRC do not qualify to receive PChT 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 indicated for pretreated mCRC. We aimed to assess the efficacy and safety of REG as a single agent in first-line setting of this frail and/or unfit patient population. Methods: Phase II, single-arm study in frail and/or unfit to receive PChT, mCRC pts. Inclusion criteria: pts ≥ 18 years, ECOG PS ≤ 2, adequate organ function, at least one of the following: dependence in activities of daily living, presence of 3 or more comorbidities or geriatric syndromes. Primary endpoint was progression-free survival (PFS) rate at 6 months. Pts received REG 160 mg PO, 3 weeks on/1 week off, in a 4-week cycle. Results: Forty-seven pts were included. Median age was 80 years (range 63-89), 36% had ECOG 2, 55% were dependent, 38% had geriatric syndromes and 57% ≥ 3 comorbidities; 63.8% had ≥ 2-af...