Review of Capecitabine Versus Active Monitoring in Stable or Responding Metastatic Colorectal Cancer After 16 Weeks of First-Line Therapy: Results of the Randomized FOCUS4-N Trial - adams 2021
This is a brief audio review. In the article Capecitabine Versus Active Monitoring in Stable or Responding Metastatic Colorectal Cancer After 16 Weeks of First-Line Therapy: Results of the Randomized FOCUS4-N Trial published, 2021 by Adams and Colleagues, The outcomes and key points are as noted: Despite significant randomized evidence supporting treatment breaks in metastatic colorectal cancer (mCRC), they are not universally administered to patients despite increases in quality of life and overall survival. FOCUS4-N was created to study oral maintenance therapy in first-line responders. FOCUS4 included patients with newly diagnosed mCRC. Patients without a targeted subtrial or with failed biomarker tests were provided FOCUS4-N. Maintenance capecitabine and active monitoring were randomly assigned 1:1 active monitoring. Secondary results were overall survival, toxicity, and tolerability. 254 patients were randomly given capecitabine or active monitoring at 88 UK sites between March 2014 and March 2020. Balanced baselines progression-free survival showed considerable efficacy (hazard ratio = 0.40; 95% CI, 0.21 to 0.75; P < .0001), overall survival showed no significant improvement (hazard ratio, 0.93; 95% CI, 0.69 to 1.27; P =.66). Good treatment compliance, and capecitabine toxicity was as expected with grade 2 fatigue (25% vs. 12%), diarrhea (23% vs. 13%), and hand-foot syndrome (26% v 3% ). The groups had similar life quality. CONCLUSION: Despite significant evidence of disease control with maintenance therapy, overall survival remains unaltered. FOCUS4-N adds more evidence to support treatment pauses as safe management alternatives for stable or responding mCRC patients. After 16 weeks of first-line therapy, capecitabine without bevacizumab can extend progression-free survival.
Adams RA, Fisher DJ, Graham J, Seligmann JF, Seymour M, Kaplan R, Yates E, Parmar M, Richman SD, Quirke P, Butler R, Brown E, Collinson F, Falk S, Wasan H, Shiu KK, Middleton G, Samuel L, Wilson RH, Brown LC, Maughan TS; FOCUS4 Trial Investigators. Capecitabine Versus Active Monitoring in Stable or Responding Metastatic Colorectal Cancer After 16 Weeks of First-Line Therapy: Results of the Randomized FOCUS4-N Trial. J Clin Oncol. 2021 Nov 20;39(33):3693-3704. doi: 10.1200/JCO.21.01436. Epub 2021
