Phase I Study Of Biweekly Docetaxel, Cisplatin, And S-1 Combination Neoadjuvant Chemotherapy For Stage Iii Gastric Cancer.

153 Background: It is unclear neoadjuvant chemotherapy for stage III gastric cancer can provide satisfactory outcomes. Therefore, we conducted a phase I study to clarify recommend dose (RD) of biweekly docetaxel, cisplatin, and S1 combination neoadjuvant chemotherapy for stage III gastric cancer. Methods: A dose escalation method was employed. S1 (80mg/m 2 /day; day1-7, 15-21) and docetaxel (20mg/m 2 /day; day1, 15) were fixed and cisplatin (day1, 15) was increased by 5mg/m 2 from level I (20mg/m 2 /day). Each course was lasted for one month. Toxicity was examined by the CTCAE version 4.0 during two courses. Results: A total of 21 patients (male/female=14/7, mean age=63 years) was enrolled in this study. Of these, nine stage IIIA, nine stage IIIB, and three stage IIIC were included. In level I, There was no DLT case. In level II, we encountered perforation of gastric cancer in one case without any other DLT in the remaining five cases. In level III, IV, V, and VI, we did not encounter any cases with DLT. So, we decided that the RD of cisplatin was 50mg/m 2 /day (Level VI), which is regarded as maximum safety dose in the outpatient clinic. Response status was as follows: one PR case, 19 non CR/non-PD cases and one PD case. Total gastrectomy was performed in 14 cases, and distal gastrectomy in seven cases. Histologically, grade 1a was found in 13 cases, grade 1b in three cases, grade 2 in four cases, and grade 3 was one case. Five cases (23.8%) suffered from postoperative complications (two anastomotic leakage; one pneumonia; one pancreatic fistula; one chyloascites) although all cases recovered conservatively. Conclusions: RD of cisplatin was 50mg/m 2 /day in biweekly docetaxel, cisplatin, and S1 combination neoadjuvant chemotherapy for stage III gastric cancer. Phase II study is now going on to confirm the usefulness of this treatment.