title: Phase II trial of induction irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for unresectable, locally advanced gastric and oesophageal-gastric junction adenocarcinoma.
abstract: OBJECTIVE
  The prognosis of patients with unresectable M0 gastric cancer remains very poor. We performed a phase II trial to explore the efficacy and toxicity of induction irinotecan-cisplatin (IC) followed by concurrent irinotecan-cisplatin and radiotherapy (IC/RT) in this setting.
  
  
  METHODS
  Patients with unresectable M0 gastric (GC) or oesophageal-gastric junction (EGJC) adenocarcinomas were treated with two courses of IC (irinotecan, 65 mg/m(2); cisplatin, 30 mg/m(2) on days 1 and 8 every 21 days) followed by IC/RT (daily radiotherapy-45 Gy-with concurrent IC: irinotecan, 65 mg/m(2), and cisplatin, 30 mg/m(2), on days 1, 8, 15, and 22). Resectability was reassessed after this treatment, and surgical resection was performed if feasible. The primary endpoint was the R0 resection rate after induction treatment.
  
  
  RESULTS
  Seventeen patients were included in the study (EGJC: 6; GC: 11). An R0 resection was achieved in only 5 patients (29%), and according to the design of the trial (Simon's optimal two-stage) accrual of patients was terminated after the first stage. No patient died during IC, whereas 3 patients (24%) died during IC/RT and one of 5 resected patients (20%) died during the first 30 days after resection. The median survival was 10.5 months, and the actuarial 2-year survival rate was 27%.
  
  
  CONCLUSIONS
  Induction IC followed by IC/RT showed poor efficacy and significant toxicity in patients with unresectable GC/EGJC.
authors.affiliation: Medical Oncology Department, H. U. 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: Maria 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; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D004943:Esophagogastric Junction / Q000473:pathology*; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D015996:Survival Rate
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin