Abstract
BackgroundAdjuvant chemotherapy with XELOX (capecitabine plus oxaliplatin) has been shown to be beneficial following resection of gastric cancer in South Korean, Chinese, and Taiwanese patients. This phase II study (J-CLASSIC-PII) was undertaken to evaluate the feasibility of XELOX in Japanese patients with resected gastric cancer.MethodsPatients with stage II or III gastric cancer who underwent curative D2 gastrectomy received adjuvant XELOX (eight 3-week cycles of oral capecitabine, 1000 mg/m2 twice daily on days 1–14, plus intravenous oxaliplatin 130 mg/m2 on day 1). The primary endpoint was dose intensity. Secondary endpoints were safety, proportion of patients completing treatment, and 1-year disease-free survival (DFS) rate.ResultsOne hundred patients were enrolled, 76 of whom completed the study as planned. The mean dose intensity was 67.2 % (95 % CI, 61.9–72.5 %) for capecitabine and 73.4 % (95 % CI, 68.4–78.4 %) for oxaliplatin, which were higher than the predefined age-adjusted threshold values of 63.4 % and 69.4 %, respectively, and the study therefore met its primary endpoint. The 1-year DFS rate was 86 % (95 % CI, 77–91 %). No new safety signals were identified.ConclusionsThe feasibility of adjuvant XELOX in Japanese patients with resected gastric cancer is similar to that observed in South Korean, Chinese, and Taiwanese patients in the Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer (CLASSIC) study. Based on findings from this study and the CLASSIC study, the XELOX regimen can be considered an adjuvant treatment option for Japanese gastric cancer patients who have undergone curative resection.
Highlights
Gastric cancer is prevalent in Asian countries including Japan, South Korea, and China, as well as in South America [1]
The mean dose intensity was 67.2 % for capecitabine and 73.4 % for oxaliplatin, which were higher than the predefined age-adjusted threshold values of 63.4 % and 69.4 %, respectively, and the study met its primary endpoint
The capecitabine and oxaliplatin adjuvant study in stomach cancer (CLASSIC) study conducted in South Korea, China, and Taiwan demonstrated a survival benefit for capecitabine plus oxaliplatin (XELOX) in patients with stage II– IIIB gastric cancer following curative D2 gastrectomy, with an hazard ratio (HR) for disease-free survival (DFS) of 0.56 for XELOX compared with surgery alone at the 3-year analysis [13] and an HR for death of 0.66 for XELOX versus surgery alone at the 5-year analysis [14]
Summary
Gastric cancer is prevalent in Asian countries including Japan, South Korea, and China, as well as in South America [1]. In Japan, the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer (ACTS-GC) study, in which more than 1000 patients with stage II/III gastric cancer after R0 resection were randomized to postoperative S-1 (tegafur, gimeracil, and oteracil) or surgery alone, demonstrated a statistically significant benefit for adjuvant chemotherapy. The capecitabine and oxaliplatin adjuvant study in stomach cancer (CLASSIC) study conducted in South Korea, China, and Taiwan demonstrated a survival benefit for capecitabine plus oxaliplatin (XELOX) in patients with stage II– IIIB gastric cancer following curative D2 gastrectomy, with an HR for disease-free survival (DFS) of 0.56 (95 % CI, 0.44–0.72) for XELOX compared with surgery alone at the 3-year analysis [13] and an HR for death of 0.66 (95 % CI, 0.51–0.85) for XELOX versus surgery alone at the 5-year analysis [14]. This phase II study (JCLASSIC-PII) was undertaken to evaluate the feasibility of XELOX in Japanese patients with resected gastric cancer
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