Clinical outcomes of endoscopic submucosal dissection for lesions on the proximal location of the stomach

Abstract

60mg/m2(level III) according to phase I classical "3 þ 3" protocol. DLT was determined in cycle I. IV cisplatin was administered at a fixed dose of 60mg/m2 on day 1 and oral S-1 was administered twice daily according to BSA on day 1-14 every 3 weeks. Patients were treated for three cycles unless unacceptable toxicities or patient withdrawal. Reassessment upper endoscopy and CT scan was performed 3 weeks after completion of chemotherapy. Staging laparoscopy was performed for all patients unless disease progression. In cases of no macroscopic residual PC, gastrectomy with D2 lymph node dissection was performed. Cases with residual PC continued chemotherapy and gastrectomy would not be performed. The primary objective was to determine the maximum-tolerated dose (MTD) and the recommended dose (RD) of intraperitoneal docetaxel in gastric cancer patients with PC. Results: Twelve patients were enrolled from Dec 2013 to Mar 2017. Eight patients were female and the median age was 57.5 years. 3 patients were treated at level I and no DLT was observed. One patient treated at level II was hospitalised for syncopy. Although this was determined to be unlikely treatment-related, additional three more patients were treated at level II and confirmed no DLT. Three patients were treated at level III and no DLT was observed. All but one patients completed 3 cycles of treatment. In cycle II and III, four patients had delay of treatment cycle and one patient had dose reduction. The commonest > ¼G3 hematological toxicity was leucopenia and non-hematological toxicity was hyponatraemia. No treatment-related death was observed. Five out of 11 patients (45.5%) who have completed 3 cycles of treatment had no gross PC seen at restaging diagnostic laparoscopy and they had gastrectomy with D2 LND done. The median PFS and OS for the overall population was 11 and 15 months, respectively.OS was not reached. The median NLR pre and NLR post were 2.42 (range, 1.00-17.4) and 2.84 (range, 1.27-12.3), respectively. Stratified with high NLR (!5) and low NLR (<5), the median PFS was shorter in the high NLR pre arm (57 days vs. 45 days; p ¼ 0.161) and significantly shorter in the high NLR post arm (67 days vs. 21 days; p ¼ 0.015). The median OS was also shorter in the high NLR pre arm (not reached vs. 175 days; p ¼ 0.068) and significantly shorter in the high NLR post arm (not reached vs. 111 days; p ¼ 0.012). Conclusion: NLR, especially NLR post, might be effective as a predictive or prognostic factor in gastric cancer treated with nivolumab monotherapy. Further study is warranted to develop this finding to detect progression cases as early as possible.P À 068 Clinical outcomes of endoscopic submucosal dissection for lesions on the proximal location of the stomach