Interim analysis of a phase II trial evaluating the safety and efficacy of capecitabine plus oxaliplatin (XELOX) as adjuvant therapy in Japanese patients with operated stage III colon cancer.

PURPOSE: Adjuvant oxaliplatin plus oral capecitabine (XELOX) is recommended for patients with curatively resected colon cancer. However, its safety and tolerability in Asian patients is unclear; therefore, we evaluated the safety and efficacy of adjuvant XELOX in Japanese patients with curatively resected stage III colon cancer (MCSCO-1024) and present the interim safety data. METHODS: This prospective, multi-center, open-label, single-arm phase II study recruited patients with curatively resected stage III colon cancer. The protocol was a 120-min intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and oral capecitabine (2000 mg/m2/day) in two divided doses for 14 days of a 3-week cycle, for a total of eight cycles (24 weeks). The primary endpoint was the 3-year disease-free survival, and secondary endpoints were the treatment completion rate, safety profile (rate and severity of adverse events), and correlation of adverse events, such as peripheral sensory neuropathy (PSN), with the administration period of oxaliplatin, etc. RESULTS: From November 2011 to August 2014 (34 months), 196 patients were enrolled. Safety was analyzed in 190 patients. The median total doses of capecitabine and oxaliplatin were 215,586.9 and 777.2 mg/m2, respectively, while the median relative dose intensities were 82.5 and 76.0%, respectively. The overall treatment completion rate was 73.7%. The most frequent treatment-related adverse event was PSN (88.4%), while the most frequent grade ≥3 treatment-related adverse events were neutropenia (12.6%), PSN (6.3%), diarrhea (4.2%), and thrombocytopenia (4.2%). There were no treatment-related deaths. CONCLUSIONS: Adjuvant XELOX is tolerable for Japanese patients with Stage III colon cancer.

[A case report of neuroendocrine carcinoma of the stomach with liver metastases curatively resected after neoadjuvant chemotherapy].

The patient was a 73-year-old male with advanced gastric cancer in the lesser curvature of the antrum.Abdominal computed tomography revealed multiple liver metastases(S5, S8).He was diagnosed with clinical Stage IV gastric cancer (cT3N0M1H1).He received 3 courses of combined neoadjuvant chemotherapy with capecitabine, cisplatin, and trastuzumab because immunostaining indicated the tumor was human epidermal growth factor receptor 2(HER2)-positive.The therapeutic response, as assessed by imaging studies, was partial for the primary lesions and stable for liver metastases.Distal gastrectomy, D2 lymph node dissection, and S5 extended subsegmentectomy of the liver were performed.Histopathological findings indicated that both the primary tumor and liver metastases were neuroendocrine carcinoma.The patient declined post-operative adjuvant chemotherapy and he is alive 6 months after the surgery with no evidence of recurrence.Surgery with neoadjuvant chemotherapy appears to be a promising option for advanced gastric cancer with liver metastases.