A phase 3 study from Shegan Gao, MD, PhD, and colleagues investigated the safety and efficacy of capecitabine or capecitabine plus oxaliplatin (XELOX) versus fluorouracil plus cisplatin in concordance with definitive concurrent chemoradiotherapy for patients with inoperable locally advanced esophageal squamous cell carcinoma (ESCC).
Their research was published in the Journal of Clinical Oncology.
Dr. Gao and colleagues randomly assigned participants to undergo either 2 cycles of capecitabine, XELOX, or fluorouracil plus cisplatin in combination with concurrent intensity-modulated radiation therapy. Following the first cycles, some patients were randomly assigned to undergo 2 cycles of consolidation chemotherapy.
The study’s primary end points included 2-year overall survival (OS) and the number of grade 3 or higher treatment-related adverse events (TRAEs).
Of the 246 patients, 80 received capecitabine, 85 received XELOX, and 81 underwent treatment with fluorouracil plus cisplatin. The 2-year OS rate was 75.0% in the capecitabine cohort, 66.7% in the XELOX cohort, and 70.9% in the fluorouracil plus cisplatin cohort, while the median OS was 40.9 (95% CI, 34.4-49.9), 41.9 (95% CI, 28.6-52.1), and 35.4 (95% CI, 30.4-45.4) months, respectively.
Throughout treatment, the rate of grade 3 or higher TRAEs in the capecitabine, XELOX, and fluorouracil plus cisplatin groups was 28.8%, 36.5%, and 45.7%, respectively.
Dr. Gao and colleagues compared the median OS of the consolidation chemotherapy cohort, which was 41.9 (95% CI, 34.6-52.8) months, with 36.9 (95% CI, 28.5-44.0) months in the nonconsolidation chemotherapy cohort (P=.0403).
“Capecitabine or XELOX did not significantly improve the 2-year OS rate over fluorouracil plus cisplatin in definitive concurrent chemoradiotherapy for inoperable locally advanced ESCC,” the investigators wrote. “Capecitabine showed a lower incidence of grade 3 or higher TRAEs than fluorouracil plus cisplatin did.”
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