title: Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma.
abstract: The Intergroup 0116 study has demonstrated a significant survival benefit for completely resected (R0) gastric cancer patients treated with a fluorouracil/leucovorin chemoradiotherapy regimen. However, this regimen is also toxic and less effective in terms of distant disease control. Therefore, a more efficacious and safer regimen is urgently needed.
  
  
  
  Patients with R0 resected gastric carcinoma received up to two 21-day cycles of postoperative adjuvant preradiation and postradiation DCF chemotherapy (docetaxel 37.5 mg/m on days 1 and 8, cisplatin 25 mg/m on days 1 to 3, and a continuous infusion of fluorouracil 750 mg/m on days 1 to 5), respectively. Chemoradiotherapy between preradiation and postradiation chemotherapy was initiated on day 43 and consisted of intensity-modulated radiotherapy (45 Gy) plus concurrent docetaxel 20 mg/m weekly for 5 weeks.
  
  
  
  A total of 55 patients were evaluated and 76% (42) of patients completed the prescribed therapy. With a median follow-up of 61 months, the 3- and 5-year progression-free survival rates were 67% (95% confidence interval [CI], 54%-80%) and 59% (95% CI, 46%-72%), respectively; and the 3- and 5-year overall survival rates were 72% (95% CI, 60%-84%) and 61% (95% CI, 48%-74%), respectively. The most common grade 3 or greater toxicity, during the chemotherapy phase, was neutropenia (24%). Common grade 3/4 toxicities during concurrent chemoradiotherapy were nausea (32%), vomiting (26%), fatigue (15%), and anorexia (19%).
  
  
  
  These results demonstrate that this adjuvant regimen is active with an acceptable toxicity profile. A randomized phase 3 trial comparing the Intergroup 0116 chemoradiotherapy regimen with this regimen is underway.
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Yong
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Guoqi
authors.initials: G
authors.lastname: Zhao
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Yi
authors.initials: Y
authors.lastname: Xu
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Tiening
authors.initials: T
authors.lastname: Zhang
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Zhixiao
authors.initials: Z
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Ge
authors.initials: G
authors.lastname: Yan
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Wenzhi
authors.initials: W
authors.lastname: Tu
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Ye
authors.initials: Y
authors.lastname: Hu
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Ying
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Jiangsu Cancer Hospital.
authors.forename: Xia
authors.initials: X
authors.lastname: He
authors.affiliation: Department of Radiation Oncology, Nanjing BenQ Medical Center.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Radiation Oncology, Nanjing Jiangning Hospital, Nanjing Medical University, Nanjing, P.R. China.
authors.forename: Hui
authors.initials: H
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Shengyu
authors.initials: S
authors.lastname: Yao
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Zhekai
authors.initials: Z
authors.lastname: Hu
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Xuming
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai.
authors.forename: Tingfeng
authors.initials: T
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000401:mortality*; D059186:Chemoradiotherapy, Adjuvant / Q000401:mortality*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D013274:Stomach Neoplasms / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D055815:Young Adult
chemical_list: D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil