The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Capecitabine maintenance improved progression-free survival (PFS), but not overall survival (OS), when compared with active monitoring in patients with metastatic colorectal cancer (mCRC), according to data from the FOCUS4-N trial.

The data were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting by Richard Adams, MD, of Cardiff University in the United Kingdom.

Dr Adams explained that the FOCUS4-N study falls under the umbrella of FOCUS4, a molecularly stratified trial program that enrolled patients with newly diagnosed, inoperable mCRC.

Continue Reading

FOCUS4 researchers performed biomarker analysis on patients’ tumors during the first 16 weeks of first-line chemotherapy. The patients were then stratified based on their molecular subtypes and enrolled in trials of therapies targeting their subtype, including BRAF-mutant, PIK3CA-mutant, KRAS– and TP53-mutant, and wild-type mCRC.

The FOCUS4-N trial was offered to patients who did not fit into the aforementioned subgroups. FOCUS4-N included 254 patients who were randomly assigned to receive capecitabine (n = 127) or active monitoring (n = 127) after induction. There were no significant differences in baseline characteristics between the 2 groups.

Capecitabine conferred an improvement in PFS compared with active monitoring. The median PFS was 3.84 months with capecitabine and 1.87 months with active monitoring (hazard ratio [HR], 0.38; 95% CI, 0.28-0.51; P <.0001).

There was no significant difference in OS between the arms. The median OS was 14.8 months in the capecitabine arm and 15.2 months in the active monitoring arm (HR, 0.93; 95% CI, 0.69-1.27; P =.66).

Adverse events that were more frequent in the capecitabine arm than the active monitoring arm were fatigue, diarrhea, nausea, and hand-foot syndrome. There were no significant differences in quality of life between the arms.

“Capecitabine maintenance strategy is a reasonable option for a clinician to discuss with their patients at the end of their first-line induction chemotherapy, as it essentially doubles the time until the need to return to full-dose/induction systemic anticancer therapy,” Dr Adams said.

“There was no significant difference seen in overall survival, but our trial was underpowered to demonstrate a difference,” he added. “Improved cost-effectiveness of capecitabine monotherapy over capecitabine and bevacizumab is likely, secondary to the higher drug acquisition and administration costs in relation to bevacizumab.”

Disclosures: This research was supported by Cancer Research UK. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Read more of Cancer Therapy Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.


Adams R, Fisher D, Graham J, et al. Oral maintenance capecitabine versus active monitoring for patients with metastatic colorectal cancer (mCRC) who are stable or responding after 16 weeks of first-line treatment: results from the randomized FOCUS4-N trial. J Clin Oncol. 2021;39:(suppl 15; abstr 3504). doi:10.1200/JCO.2021.39.15_suppl.3504