title: A phase II study of preoperative chemotherapy with modified FOLFOX6 followed by surgery and postoperative chemoradiation in patients with localized gastric adenocarcinoma.
abstract: The optimal neoadjuvant and adjuvant treatment for gastric cancer remains controversial. We conducted a phase II study using preoperative chemotherapy with modified FOLFOX6 followed by surgical resection and postoperative chemoradiation in patients with gastric carcinoma. Preoperative chemotherapy (two or three cycles) consisted of a 2-h infusion of oxaliplatin (100 mg/m2) and folinic acid (100 mg/m2) followed by a 46-h continuous infusion of 5-fluorouracil (5-FU; 2,400 mg/m2). Surgical resection was planned 4 weeks after the last chemotherapy cycle. Patients underwent postsurgical chemoradiation, receiving a total dose of 45 Gy and 5-FU continuous infusion (350 mg/m2/day). The primary end points were feasibility, overall response rate, and R0 resectability rate after preoperative chemotherapy. The secondary end points were tolerability, treatment-associated complications, disease-free survival, and overall survival. Nineteen patients were enrolled in this study. After neoadjuvant treatment, four patients (21.1%) experienced progressive disease, six patients (31.6%) showed partial remission, and nine patients (47.3%) showed stable disease. In 15 patients (78.9%) R0 resectability could be achieved. Eleven of these patients (73.3%) were able to undergo postoperative chemoradiation. Notably, eight (72.7%) of these patients were disease free and alive at median follow-up of 60 months. Chemotherapy associated neutropenia, neutropenic fever, and anastomotic dehiscence were observed. The combination of preoperative chemotherapy and postoperative chemoradiation is feasible in a significant subset of gastric cancer patients.
authors.affiliation: Department of Oncology, Affiliated Hospital of Binzhou Medical University, Binzhou, China. chenshaoshui@yeah.net
authors.forename: Shao-Shui
authors.initials: SS
authors.lastname: Chen
authors.forename: Xiao-Chun
authors.initials: XC
authors.lastname: Yang
authors.forename: Feng
authors.initials: F
authors.lastname: Chi
authors.forename: Wen-Zheng
authors.initials: WZ
authors.lastname: Yu
authors.forename: Zhen-Bo
authors.initials: ZB
authors.lastname: Wang
authors.forename: Fang-Ling
authors.initials: FL
authors.lastname: Ning
authors.forename: Ze-Shun
authors.initials: ZS
authors.lastname: Yu
authors.forename: Yan-Zhang
authors.initials: YZ
authors.lastname: Hao
authors.forename: Mian-Li
authors.initials: ML
authors.lastname: Li
authors.forename: Feng
authors.initials: F
authors.lastname: Wang
authors.forename: Dian-Zhong
authors.initials: DZ
authors.lastname: Geng
authors.forename: Li-Hua
authors.initials: LH
authors.lastname: Liu
authors.forename: Xin-Jun
authors.initials: XJ
authors.lastname: Dong
authors.forename: Xian-Zhong
authors.initials: XZ
authors.lastname: Peng
authors.forename: Chun-Xiang
authors.initials: CX
authors.lastname: Ji
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods*; D013505:Digestive System Surgical Procedures; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil; D006801:Humans; D053208:Kaplan-Meier Estimate; D002955:Leucovorin; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods*; D009944:Organoplatinum Compounds; D013274:Stomach Neoplasms / Q000401:mortality / Q000628:therapy*
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil