Phase II trial of induction irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for unresectable, locally advanced gastric and oesophageal-gastric junction adenocarcinoma.
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.
Rivera
Fernando
F
Medical Oncology Department, H. U. Marqués de Valdecilla, Santander, Spain. oncrhf@humv.es
Galán
Maica
M
Tabernero
Josep
J
Cervantes
Andres
A
Vega-Villegas
Maria Eugenia
ME
Gallego
Javier
J
Laquente
Berta
B
Rodríguez
Edith
E
Carrato
Alfredo
A
Escudero
Pilar
P
Massutí
Bartomeu
B
Alonso-Orduña
Vicente
V
Cardenal
Adelaida
A
Sáenz
Alberto
A
Giralt
Jordi
J
Yuste
Ana Lucia
AL
Antón
Antonio
A
Aranda
Enrique
E
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
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin