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Maintenance Capecitabine Improved Progression-Free but Not Overall Survival in Metastatic Colorectal Cancer
Recent randomized trials have indicated that maintenance therapy after initial chemotherapy for metastatic colorectal cancer (mCRC) may improve progression-free survival, with an unclear impact on overall survival. Proposed maintenance therapies include fluoropyrimidine monotherapy with or without a vascular endothelial growth factor (VEGF) or epidermal growth factor receptor (EGFR)–targeted agent.
Investigators in the U.K. report results from the multicenter, open-label, randomized FOCUS4-N trial comparing maintenance treatment with oral capecitabine versus observation alone after initial treatment with a fluorinated pyrimidine doublet regimen. Patients with mCRC were eligible after 16 weeks of therapy if they achieved a response or stable disease. Bevacizumab, which is not reimbursed for treatment of mCRC in the U.K., was not used. Patients eligible for EGFR-targeted therapy were not enrolled because U.K. guidelines do not allow treatment breaks for patients receiving these agents.
Among 254 patients randomized, median age was 64; there was roughly equal distribution of right (36%), left (26%), and rectal primaries (38%); 46% of patients had the primary resected; 66% had two or more metastatic sites; 54% had a RAS mutation; and 57% received irinotecan-based therapy.
The primary endpoint of progression-free survival favored capecitabine over observation (3.88 vs. 1.87 months; adjusted hazard ratio, 0.40; P<0.001). There was no difference between arms in the secondary endpoint of overall survival (14.8 and 15.2 months, respectively; adjusted HR, 0.93; P=0.66). Cumulative toxicities were less in the observation arm.
Comment
These results support a strategy of observation off-treatment as an alternative to maintenance therapy in select patients with mCRC. Survival was poor, potentially due to lack of use of bevacizumab or EGFR-targeted agents and to early crossover to maintenance or observation after only 4 months of treatment.
Citation(s)
Author:
Adams RA et al.
Title:
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.
Source:
J Clin Oncol
2021
Sep
13; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
David H. Ilson, MD, PhD