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Phase II trial of neoadjuvant chemotherapy with intraperitoneal paclitaxel, S‐1, and intravenous cisplatin and paclitaxel for stage IIIA or IIIB gastric cancer
Author(s) -
Shinkai Masayuki,
Imano Motohiro,
Chiba Yasutaka,
Iwama Mitsuru,
Shiraisi Osamu,
Yasuda Atsushi,
Tsubaki Masanobu,
Nishida Shozo,
Kimura Yutaka,
Yasuda Takushi
Publication year - 2019
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/jso.25295
Subject(s) - medicine , paclitaxel , leukopenia , chemotherapy , neutropenia , clinical endpoint , cisplatin , oncology , cancer , surgery , neoadjuvant therapy , gastroenterology , breast cancer , clinical trial
Background We carried out a phase II trial to evaluate the feasibility and efficacy of neoadjuvant chemotherapy comprising a single intraperitoneal administration of paclitaxel, followed by intravenous administrations of paclitaxel and cisplatin with S‐1 for clinical stage III gastric cancer. Methods Patients with potentially resectable gastric cancer were eligible. A laparoscopic survey was performed to confirm CY0 and P0. Intraperitoneal paclitaxel (60 mg/m 2 ) was administered, followed by systemic chemotherapy. Surgery was performed after two cycles of chemotherapy. The primary endpoint was the response rate of chemotherapy. Secondary endpoints were adverse events, pathological response rate, and overall survival rate. Results Twenty patients were enrolled. Planned cycles were completed in all patients. Grade 3/4 leukopenia and grade 3/4 neutropenia were observed in four (20%) and seven (35%) patients, respectively. The overall response rate was 70% (partial response: 14, stable disease: 5, progressive disease: 1). All patients underwent R0 gastrectomy with D2 lymph‐node dissection, with no surgery‐related deaths. The pathological response rate was 65% (13 of 20). The 3‐ and 5‐year overall survival rates were 90.0% and 77.1%, respectively. Conclusions Neoadjuvant chemotherapy including intraperitoneal paclitaxel followed by sequential intravenous paclitaxel and cisplatin with S‐1 for resectable advanced gastric cancer is feasible and effective.