According to a new study published in the journal The Lancet Oncology, adjuvant capecitabine in combination with oxaliplatin after undergoing a D2 gastrectomy is a viable option for patients with operable stage 2 or 3 gastric cancer.
For the phase 3, open-label CLASSIC trial, researchers sought to investigate whether adjuvant capecitabine plus oxaliplatin compared with observation after D2 gastrectomy improves survival in patients with stage 2 or 3 gastric cancer.
Researchers randomly assigned 1,035 patients with stage 2-3B gastric cancer who underwent curative D2 gastrectomy to receive either adjuvant chemotherapy or observation. Participants that received chemotherapy received eight 3-week cycles of capecitabine 1,000mg/m2 twice daily for 2 weeks and oxaliplatin 130mg/m2 on day 1.
Results showed that 27% of patients in the adjuvant chemotherapy group achieved a 3-year disease-free survival compared with 39% among those that received observation only (HR = 0.58, 95% CI, 0.47 - 0.72; P < 0.0001).
Among those in the chemotherapy group, 68% were estimated to achieve a 5-year disease-free survival versus 53% in the observation group. Estimated 5-year overall survival rates were 78% and 69% in the adjuvant chemotherapy group and observation group, respectively.
The planned interim analysis of CLASSIC showed that adjuvant capecitabine plus oxaliplatin significantly improved disease–free survival, the primary endpoint, compared with observation after D2 gastrectomy. The authors report the 5–year follow–up data from the trial. Adjuvant treatment with capecitabine plus oxaliplatin after D2 gastrectomy should be considered for patients with operable stage II or III gastric cancer.