title: Phase II trial of preoperative irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for resectable locally advanced gastric and esophagogastric junction adenocarcinoma.
abstract: OBJECTIVE
  To determine in a Phase II trial whether preoperative irinotecan-cisplatin (IC) followed by concurrent IC therapy and radiotherapy (IC/RT) improved outcome in patients with resectable, locally advanced gastric adenocarcinoma (GC) or esophagogastric junction cancer (EGJC).
  
  
  METHODS
  Patients with resectable Stage II-IV, M0 GC or EGJC made up the study population. The primary endpoint was pathologic complete response (pCR). Two courses of IC (irinotecan, 65 mg/m(2); cisplatin, 30 mg/m(2) on Days 1 and 8 every 21 days) were given. Patients without progression then received IC/RT, consisting of daily radiotherapy (45Gy) with concurrent IC (irinotecan, 65 mg/m(2); cisplatin, 30 mg/m(2) on Days 1, 8, 15, and 22). Surgical resection was performed, if feasible, 5-8 weeks after the end of radiotherapy.
  
  
  RESULTS
  Twenty-three patients were included in the study: 10 with EGJC and 13 with GC. Two patients (9%) achieved pCR. The incidences of Grade 3-4 toxicities were as follows: IC: neutropenia 35% (febrile 13%), anemia 22%, diarrhea 22%, emesis 8%; IC/RT: neutropenia 52% (febrile 5%), asthenia 19%, anemia 9%, emesis 9%, diarrhea 5%, cardiotoxicity 5%. No patients died during IC or IC/RT. R0 resection was achieved in 15 patients (65%). Median survival was 14.5 months, and the actuarial 2-year survival rate was 35%.
  
  
  CONCLUSIONS
  Preoperative IC followed by IC/RT resulted in moderate response and resection rates with mild toxicity in patients with GC and EGJC.
authors.affiliation: Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain. oncrhf@humv.es
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivera
authors.forename: Maica
authors.initials: M
authors.lastname: Galán
authors.forename: Josep
authors.initials: J
authors.lastname: Tabernero
authors.forename: Andres
authors.initials: A
authors.lastname: Cervantes
authors.forename: M Eugenia
authors.initials: ME
authors.lastname: Vega-Villegas
authors.forename: Javier
authors.initials: J
authors.lastname: Gallego
authors.forename: Berta
authors.initials: B
authors.lastname: Laquente
authors.forename: Edith
authors.initials: E
authors.lastname: Rodríguez
authors.forename: Alfredo
authors.initials: A
authors.lastname: Carrato
authors.forename: Pilar
authors.initials: P
authors.lastname: Escudero
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Massutí
authors.forename: Vicente
authors.initials: V
authors.lastname: Alonso-Orduña
authors.forename: Adelaida
authors.initials: A
authors.lastname: Cardenal
authors.forename: Alberto
authors.initials: A
authors.lastname: Sáenz
authors.forename: Jordi
authors.initials: J
authors.lastname: Giralt
authors.forename: Ana Lucia
authors.initials: AL
authors.lastname: Yuste
authors.forename: Antonio
authors.initials: A
authors.lastname: Antón
authors.forename: Enrique
authors.initials: E
authors.lastname: Aranda
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D000465:Algorithms; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D004943:Esophagogastric Junction; D006801:Humans; D000077146:Irinotecan; D057234:Preoperative Period; D011446:Prospective Studies; D012074:Remission Induction; D013030:Spain; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D015996:Survival Rate
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin