CLASSIC: adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy
Six months of capecitabine and oxaliplatin after a D2 gastrectomy raised three-year disease-free survival from 59 to 74 percent in East Asian patients with stage II to III stomach cancer.
Overview
Open-label phase 3 trial at 37 centres in South Korea, China and Taiwan: 1,035 patients with stage II to IIIB gastric cancer after curative D2 gastrectomy were randomised to eight cycles of capecitabine and oxaliplatin (520) or observation (515).
Three-year disease-free survival was 74 percent with chemotherapy against 59 percent with surgery alone (hazard ratio 0.56). Grade 3 or 4 adverse events occurred in 56 percent of chemotherapy patients against 6 percent of surgery-only patients, most commonly nausea, neutropenia and decreased appetite.
- Three-year disease-free survival 74 percent (95% CI 69 to 79) versus 59 percent (53 to 64); hazard ratio 0.56 (0.44 to 0.72), p < 0.0001.
- Grade 3 or 4 adverse events 56 percent versus 6 percent.
Adjuvant CAPOX after D2 gastrectomy is a standard option for operable stage II to III gastric cancer, alongside S-1 in Japan.
- East Asian population with D2 surgery; Western practice relies on perioperative chemotherapy (FLOT) instead.
- Open-label design.
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