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A phase II trial of perioperative chemotherapy involving a single intraperitoneal administration of paclitaxel followed by sequential S‐1 plus intravenous paclitaxel for serosa‐positive gastric cancer
Author(s) -
Peng YingFeng,
Imano Motohiro,
Itoh Tatsuki,
Satoh Takao,
Chiba Yasutaka,
Imamoto Haruhiko,
Tsubaki Masahiro,
Nishida Shozo,
Yasuda Takushi,
Furukawa Hiroshi
Publication year - 2015
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.23928
Subject(s) - medicine , perioperative , chemotherapy , tolerability , paclitaxel , cancer , clinical endpoint , surgery , lymph node , gastroenterology , metastasis , gastrectomy , randomized controlled trial , adverse effect
Background and Objectives We carried out a phase II trial to evaluate the feasibility, efficacy, and tolerability of perioperative chemotherapy including single intraperitoneal(IP) administration of paclitaxel(PTX) followed by intravenous(IV) administrations of PTX with S‐1 in a neoadjuvant setting for serosa‐positive gastric cancer. Methods Patients with cT4a gastric cancer were enrolled. A laparoscopic survey was performed before study inclusion for the confirmation of serosal invasion, negative lavage cytology, and negative peritoneal metastasis. IP PTX (80 mg/m 2 ) was administered, followed by systemic chemotherapy. Surgery was performed after the completion of chemotherapy. The primary endpoint was the treatment completion rate. Results 37 patients were recruited. The treatment completion rate was 67.6% (25/37; 90% CI, 52.8–80.1%), which was significantly higher than 50%; we set this as a threshold value ( P = 2.4% [one‐sided]). 14 patients had target lesions; of these, 10 showed a partial response (71.4%), three had stable disease (21.4%), and one had progressive disease(7.2%). The response rate was 71.4% (10/14). All patients underwent gastrectomy with D2 lymph node dissection. The 3‐ and 5‐year OS rates were 78.0 and 74.9%, respectively. Conclusions Perioperative chemotherapy including neoadjuvant IP PTX followed by sequential IV PTX with S‐1 for serosa‐positive gastric cancer is feasible, safe, and efficient. J. Surg. Oncol. 2015 111:1041–1046 . © 2015 Wiley Periodicals, Inc.