title: Postoperative intraperitoneal 5-fluoro-2'-deoxyuridine added to chemoradiation in patients curatively resected (R0) for locally advanced gastric and gastroesophageal junction adenocarcinoma.
abstract: OBJECTIVE
  Chemoradiation after surgery for locally advanced gastric cancer improves overall and relapse-free survival compared with observation. However, locoregional recurrences remain high. Accordingly, we instituted this pilot/feasibility study, including intraperitoneal 5-fluoro-2'-deoxyuridine (IP FUDR) as part of the treatment.
  
  
  METHODS
  Gastric/gastroesophageal junction adenocarcinoma stage Ib-IV (M0) patients who underwent R(0) resection were eligible and had IP catheters inserted at time of surgery. IP FUDR (3 g/dose/day) was given during study days 1-3 and 15-17 before combined 5-fluorouracil, leucovorin, and external beam radiation (45 Gy). Endpoints included toxicity, completion rate, locoregional recurrence, and survival.
  
  
  RESULTS
  Twenty-eight patients (22 men) were enrolled from 2002-2006 at two institutions; their median age was 59.5 years. After R(0) resection, a median 22 (range, 8-102) lymph nodes were examined, and 22 patients had positive nodes. AJCC stages were IB (n = 8), II (n = 10), IIIA (n = 5), IIIB (n = 1), and IV (n = 4). Full-dose IP FUDR and chemoradiation treatment was completed in 20 and 25 patients, respectively. At nearly 4-year median follow-up, 11 patients were disease-free, 5 were alive with disease, 7 were dead of disease, and 1 was dead from other cause; 4 have been lost to follow-up. Recurrences were local in one, intra-abdominal in six, distant in two, multiple sites in two, and unknown in one. The median relapse-free survival is 65.3 months, and the median overall survival has not yet been reached.
  
  
  CONCLUSIONS
  IP FUDR before chemoradiation after R(0) gastric cancer resection is well tolerated without compromising completion of postoperative adjuvant treatment. Larger randomized trials studying IP FUDR as part of gastric cancer multidisciplinary treatment are needed to prove efficacy in reducing regional recurrence and improving survival.
authors.affiliation: Division of Medical Oncology, New York University Cancer Center, NYU Medical Center, New York, NY, USA. deirdre.cohen@nyumc.org
authors.forename: Deirdre J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Elliot
authors.initials: E
authors.lastname: Newman
authors.forename: Syma
authors.initials: S
authors.lastname: Iqbal
authors.forename: Richard Y
authors.initials: RY
authors.lastname: Chang
authors.forename: Milan
authors.initials: M
authors.lastname: Potmesil
authors.forename: Theresa
authors.initials: T
authors.lastname: Ryan
authors.forename: Bernadine
authors.initials: B
authors.lastname: Donahue
authors.forename: Anurag
authors.initials: A
authors.lastname: Chandra
authors.forename: Mengling
authors.initials: M
authors.lastname: Liu
authors.forename: Minerva
authors.initials: M
authors.lastname: Utate
authors.forename: Spiros
authors.initials: S
authors.lastname: Hiotis
authors.forename: Leon H
authors.initials: LH
authors.lastname: Pachter
authors.forename: Howard
authors.initials: H
authors.lastname: Hochster
authors.forename: Franco
authors.initials: F
authors.lastname: Muggia
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D004943:Esophagogastric Junction / Q000473:pathology*; D005240:Feasibility Studies; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D005743:Gastrectomy; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D010865:Pilot Projects; D011184:Postoperative Period; D011379:Prognosis; D011879:Radiotherapy Dosage; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate
chemical_list: D005467:Floxuridine; D002955:Leucovorin; D005472:Fluorouracil