Capecitabine maintenance, active monitoring both options for metastatic colorectal cancer
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Overall survival of patients with metastatic colorectal cancer who completed 16 weeks of first-line chemotherapy treatment was unaffected by oral maintenance of capecitabine compared with no treatment, according to data from phase 3 trial presented at ASCO21.
This has led researchers to suggest that treatment breaks may be beneficial for patients who have shown a stable response to first line treatment.
"In terms of an overall survival analysis, we see that the adjusted hazard ratio of 0.93 was not statistically significantly different between the two arms. The median overall survival in an active monitoring arm was 15.2 months, vs. 14.8 months in capecitabine," Richard Adams, BS, MRCP, FRCR, MD, professor and honorary consultant clinical oncologist at Cardiff University and Velindre Cancer Centre, said. He described the trial as an assessment of an intermittent strategy of therapy.
"The maintenance strategy might be considered currently the standard of care, and this is based upon results from the two trials, AIO 0207 German trial, and the CAIRO3 Netherlands trial," he said.
Results of these trials pointed toward a maintenance strategy of capecitabine in combination with IV bevacizumab over the course of 3 weeks.
Speaking of his study, Adams said, "the trial demonstrated improvement in impression-free survival, but did not demonstrate significant improvement in overall survival, even when the data were combined."
The research was part of a series of trials that looked at wild type patients, the use of aspirin in patient populations with PIK3CA mutation, the use of WI-1 inhibitor in populations with a KRAS mutation, and other biomarker analyses of primary tumors in patients during their first course of chemotherapy.
Adams and colleagues compared treatment with 1,250 mg/m2 twice a day of capecitabine, over a 14-day period, every 3 weeks against no treatment in patients with metastatic colorectal cancer who completed 16 weeks of first-line hemotherapy treatment. They randomly assigned 254 patients into the capecitabine or active monitoring groups.
"Capecitabine maintenance strategy is a reasonable option for a clinician to discuss with their patient at the end of their first-line induction chemotherapy. It essentially doubles the time until the need to return to full day's induction systemic anticancer therapy. FOCUS4-N lays out choices between increased toxicity and progression-free survival, which help and inform that discussion," Adams said.
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Adams R, et al. Abstract 3504. Presented at: ASCO Annual Meeting; June 4-8, 2021 (virtual meeting).
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