Adding gastrectomy before chemotherapy did not demonstrate a survival benefit compared with chemotherapy alone in patients with advanced gastric cancer and a single non-curable factor, a study published in The Lancet Oncology has shown.1
Although chemotherapy is the standard of care for incurable advanced gastric cancer, whether the addition of gastrectomy plus chemotherapy improves survival for those with a single non-curable factor remains unclear. Therefore, researchers sought to evaluate whether gastrectomy followed by chemotherapy is superior to chemotherapy alone.
For the international, open-label, phase 3 trial, researchers enrolled 175 patients aged 20 to 75 years with advanced gastric cancer with a single non-curable factor limited to the liver, peritoneum, or para-aortic lymph nodes. Participants were randomly assigned to undergo gastrectomy followed by chemotherapy or chemotherapy alone.
The study was ultimately terminated early on the basis of futility after an interim analysis determined that the likelihood of surgery plus chemotherapy being superior was only 13.2%.
Results showed that median overall survival was 14.3 months (95% CI, 11.8 – 16.3) for surgery plus chemotherapy compared with 16.6 months (95% CI, 13.7 – 19.8) for chemotherapy alone (HR, 1.09; 95% CI, 0.78 – 1.52; P = .70). The 2-year overall survival rate was 31.7% (95% CI, 21.7 – 42.2) and 25.1% (95% CI, 16.2 – 34.9), respectively.
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With respect to safety, grade 3 or 4 chemotherapy-related adverse events were more frequently reported in patients in the gastrectomy plus chemotherapy group than in the chemotherapy-alone arm. The most common grade 3 or 4 chemotherapy-associated adverse events were anorexia, leukopenia, nausea, and hyponatremia.
“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 [tumors],” the authors concluded.
- Fujitani K, Yang H-K, Mizusawa J, et al. Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial [published online ahead of print January 25, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00553-7.