title: Toxicity and survival results of a phase II study investigating the role of postoperative chemo-radioimmunotherapy for gastric adenocarcinoma.
abstract: OBJECTIVE
  To investigate the role of postoperative concomitant chemo-radioimmunotherapy in gastric adenocarcinoma patients.
  
  
  METHODS
  59 patients, who underwent total or subtotal gastrectomy, with lymph node involvement, positive microscopic surgical margins or serosal involvement were included in the study. Radiotherapy started concomitantly with chemotherapy and levamisole. Extended-field radiotherapy was given to gastric bed and regional lymphatics via two anterior-posterior/posterior-anterior fields. A total dose of 45 Gy in 25 fractions with a fraction size of 1.8 Gy was planned. In 28 patients (48%) with positive surgical margins a 10-Gy boost dose was given to the anastomosis site. An adjuvant i.v. bolus of 450 mg/m(2)/day 5-fluorouracil (5-FU) was administered concomitantly during the first 3 days and at the 20th day of irradiation. After completion of radiotherapy, i.v. boluses of 450 mg/m(2)/day 5-FU and 25 mg/m(2)/day rescuvorin were continued for 6 months once a week. Levamisole 40 mg/day orally was started at the 1st day of radiotherapy and also continued for 6 months. Median follow-up was 37 months (7-112 months).
  
  
  RESULTS
  Median survival was 23 months. Overall 3- and 5-year survival rates amounted to 35% and 14%, respectively. Median survival of the patients with positive surgical margins was 22 months. The 3- and 5-year locoregional control rates were 59% and 55%, respectively. The most common toxicity was upper gastrointestinal system toxicity, which was observed in 42 patients (71%). Four patients (7%) died on account of early toxic effects, and six (10%) could not complete treatment.
  
  
  CONCLUSIONS
  Although 48% of the study population involved patients with microscopic residual disease, the survival results as a whole were satisfactory. However, due to high toxicity, radiotherapy must be delivered with the most proper techniques along with adequate nutrition and supportive care.
authors.affiliation: Department of Radiation Oncology, Istanbul University, Cerrahpaşa Medical School, Istanbul, Turkey. nuranbese@superonline.com
authors.forename: Nuran Senel
authors.initials: NS
authors.lastname: Beşe
authors.forename: Evin
authors.initials: E
authors.lastname: Büyükünal
authors.forename: Mustafa
authors.initials: M
authors.lastname: Ozgüroğlu
authors.forename: Gökhan
authors.initials: G
authors.lastname: Demir
authors.forename: Ayşe
authors.initials: A
authors.lastname: Yildirim
authors.forename: Nil Molinas
authors.initials: NM
authors.lastname: Mandel
authors.forename: Fuat
authors.initials: F
authors.lastname: Demirelli
authors.forename: Süheyla
authors.initials: S
authors.lastname: Serdengeçti
authors.forename: Ahmet
authors.initials: A
authors.lastname: Ober
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery*; D000328:Adult; D000368:Aged; D003037:Cobalt Radioisotopes / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016499:Radioimmunotherapy; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery*; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003037:Cobalt Radioisotopes