In the Asian phase III REGATTA trial reported in The Lancet Oncology, Fujitani et al found that the addition of gastrectomy to chemotherapy did not improve overall survival in patients with advanced gastric cancer with a single noncurable factor.
In this open-label trial conducted at 44 sites in Japan, South Korea, and Singapore, 175 patients aged 20 to 75 years with a single noncurable factor consisting of liver, peritoneal, or para-aortic lymph node metastasis were randomized between February 2008 and September 2013 to receive chemotherapy alone (n = 86) or gastrectomy followed by chemotherapy (n = 89). Chemotherapy consisted of oral S-1 at 80 mg/m²/d on days 1 to 21 and cisplatin at 60 mg/m² on day 8 of 5-week cycles. Gastrectomy was limited to D1 lymphadenectomy without resection of metastatic lesions. The primary endpoint was overall survival.
Treatment groups were balanced with regard to baseline characteristics except for primary tumor location; middle-third tumors were more common in the chemotherapy group (57% vs 34%), and upper-third tumors were more common in the surgery-plus-chemotherapy group (34% vs 19%). Peritoneal metastasis was the noncurable factor in 75% of all patients.
No Survival Benefit
The study was closed for futility in September 2013. Overall survival at 2 years was 31.7% (95% confidence interval [CI] = 21.7%–42.2%) in the chemotherapy group vs 25.1% (95% CI = 16.2%–34.9%) in the gastrectomy-plus-chemotherapy group. Median overall survival was 16.6 months (95% CI = 13.7–19.8 months) vs 14.3 months (95% CI = 11.8–16.3 months; hazard ratio = 1.09, P = .70).
Grade 3 or 4 chemotherapy-related adverse events occurred more frequently in the gastrectomy-plus-chemotherapy group, including leukopenia (18% vs 3%), anorexia (29% vs 12%), nausea (15% vs 5%), and hyponatremia (9% vs 5%). One death considered related to treatment occurred in each group.
The investigators concluded: “Since gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor, gastrectomy cannot be justified for treatment of patients with these tumours.”
The study was funded by the Ministry of Health, Labour and Welfare of Japan and the Korean Gastric Cancer Association.
Toshimasa Tsujinaka, MD, of Kaizuka City Hospital, Osaka, Japan, is the corresponding author of The Lancet Oncology article.
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