A Phase II Study of Systemic Chemotherapy with Capecitabine and Cisplatin Followed by Surgery for Advanced Gastric Cancer with Extensive Lymph Node Metastasis(OGSG1401)

BACKGROUND: Gastric cancer with extensive lymph node metastasis(ELM)is commonly considered unresectable and has a poor prognosis. We conducted a phase Ⅱ study to evaluate the safety and efficacy of capecitabine and cisplatin(XP)as preoperative chemotherapy for gastric cancer with ELM. METHODS: The patients received 2 21-day cycles of XP therapy(ca- pecitabine at 2,000mg/m2 twice daily for 2 weeks and cisplatin at 80 mg/m2 on day 1)followed by gastrectomy with D2 plus para-aortic nodal dissection. After R0 resection, S-1 chemotherapy was administered for 1 year. The primary end point was response rate(RR). The planned sample size was 30. RESULTS: Between April 2015 and November 2016, 4 patients were enrolled, but the enrollment was terminated because of poor patient recruitment. The clinical RR was 50%, and R0 resection was achieved in 75% of the patients. The common Grade 3 adverse events during XP therapy were leukocytopenia(25%), anemia(25%), and hyperlipidemia(25%). The common Grade 3 surgical morbidity was abdominal abscess(33%)and pancreatic fistula(33%). The pathological RR was 25%. CONCLUSIONS: Preoperative XP therapy was feasible, but its efficacy was difficult to evaluate because of the small sample size.