Oral capecitabine maintenance versus active monitoring for mCRC with response or stable disease after 16 weeks first-line treatment

The multicenter (88 UK hospitals) FOCUS4-N trial randomized patients with response or stable disease after 16 weeks of first-line treatment for mCRC to oral capecitabine (Cp) maintenance or active monitoring (AM). The median PFS was 3.88 months with Cp versus 1.87 months with AM (HR 0.40; p<0.0001). The median OS was 13.9 months with Cp versus 13.3 months with AM (HR 0.87; p=0.37). The authors conclude that despite strong evidence for prolongation of PFS with maintenance therapy, OS remained unaffected, and that FOCUS4-N provided additional evidence to support the use of treatment breaks after first-line treatment resulting in good response or disease stability.