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Adjuvant Capecitabine After Chemoradiotherapy Improves Failure-Free Survival in Nasopharyngeal Carcinoma
A randomized clinical trial found that adjuvant capecitabine following concurrent chemoradiotherapy was associated with improved failure-free survival (FFS) and had a manageable safety profile for patients with nasopharyngeal carcinoma.
This trial enrolled 180 patients with locoregionally advanced nasopharyngeal carcinoma between March 31, 2014, and July 27, 2018, across 3 institutions in China. Patients were randomized on a 1:1 basis to receive either 1000 mg/m2 capecitabine twice daily for 14 days every 3 weeks for 8 cycles (n = 90) or observation (n = 90) following concurrent chemoradiotherapy. There were 84.4% of patients with ≥2 high-risk factor in the capecitabine group and 88.9% in the observation group. The primary end point was FFS in the intention-to-treat cohort.
At the data cutoff date was February 9, 2022, the median follow-up duration was 58 months. The 3-year and 5-year FFS was 83.3% and 78.5% in the adjuvant capecitabine group, respectively, compared to and 72.2% and 65.9% in the observation group (hazard ratio, 0.53; 95% confidence interval, 0.30 to 0.94; P = .03).
In the capecitabine group, 60% of patients reported a grade 3 treatment-related adverse event, compared to 51.1% in the observation group. The most common treatment-related adverse events in both groups were xerostomia (18.9% in the capecitabine arm vs 10% in the observation group), mucositis (23.3% vs 16.7%), and anorexia (8.9% vs 4.4%).
The study authors concluded, “Adjuvant capecitabine in at the full dose following [concurrent chemoradiotherapy was well tolerated and improved failure-free survival among patients with [locoregionally advanced nasopharyngeal carcinoma] and high-risk factors.”
Source:
Miao J, Wang L, Tan SH, et al. Adjuvant capecitabine following concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: A randomized clinical trial. JAMA Oncol. Published online October 13, 2022. doi:10.1001/jamaoncol.2022.4656
