title: The toxicity and outcomes of continuous 5-fluorouracil/cisplatin-based chemotherapy followed by chemoradiation in patients with resected high-risk gastric cancer: results of a single institute.
abstract: BACKGROUND
  The majority of patients with gastric cancer relapse after definitive surgery and 5-year survival after surgery is very poor. The Intergroup 0116 study showed a modest survival benefit for postoperative bolus 5-fluorouracil-based chemoradiation with a high rate of toxicity. We hypothesised that treatment outcome could be further improved with feasible toxicity using a combination of bolus 5-fluorouracil, continuous 5-fluorouracil, and cisplatin followed by chemoradiation after 3 months of chemotherapy.
  
  
  METHODS
  Thirty-six patients with stages Ib through IV adenocarcinoma of the stomach or gastrooesophageal junction who had undergone gastric resection and negative margins were assigned to postoperative chemoradiation. The treatment consisted of 6 cycles of continuous 5-fluorouracil (600 mg/m2) for 24 hours, push 5-fluorouracil (400 mg/m2) and leucoverin (LCV) (200 mg/m2) on day 1 to 2 every 2 weeks, cisplatin (60 mg/m2) every 4 weeks followed by combined modality therapy using 45 Gy at 1.8 Gy per day concomitant with weekly bolus 5-fluorouracil (600 mg/m2) and LCV (50 mg).
  
  
  RESULTS
  The median age was 59 years (range, 29 to 75) and 25 patients were male. Thirty-five per cent had proximal tumour, T3 or T4 were diagnosed in 92% of the patients and lymph nodes metastases were confirmed in 83%. Grade 3 or 4 neutropaenia was documented in 25%, and gastrointestinal toxicity in 16%. There was no toxic death, but 1 patient had long-term complications. The median disease-free survival was 37.4 months and the overall survival was 40.3 months.
  
  
  CONCLUSIONS
  Postoperative chemoradiation with combination of bolus 5-fluorouracil, continuous 5-fluorouracil and cisplatin is a feasible and well-tolerated approach. Larger clinical trials should be conducted to further evaluate the toxicity and the efficacy of this regimen.
authors.affiliation: Department of Oncology, Hebrew University-Hadassah Medical Center, Jerusalem, Israel. Ryakir@hadassah.org.il
authors.forename: Rottenberg
authors.initials: R
authors.lastname: Yakir
authors.forename: Kadouri
authors.initials: K
authors.lastname: Luna
authors.forename: Wygoda
authors.initials: W
authors.lastname: Marc
authors.forename: Sella
authors.initials: S
authors.lastname: Tamar
authors.forename: Rivkind
authors.initials: R
authors.lastname: Avraham
authors.forename: Hubert
authors.initials: H
authors.lastname: Ayala
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*
chemical_list: D002945:Cisplatin; D005472:Fluorouracil