1. Phase II trial of induction irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for unresectable, locally advanced gastric and oesophageal-gastric junction adenocarcinoma
- Author
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Bartomeu Massuti, Javier Gallego, Maica Galán, Ana Lucia Yuste, Pilar Escudero, Alfredo Carrato, Adelaida Cardenal, Berta Laquente, Jordi Giralt, A. Sáenz, Maria Eugenia Vega-Villegas, Fernando Rivera, Enrique Aranda, Antonio Antón, Andrés Cervantes, Josep Tabernero, Edith Rodríguez, and Vicente Alonso-Orduña
- Subjects
Oncology ,Cancer Research ,medicine.medical_specialty ,Esophageal Neoplasms ,medicine.medical_treatment ,Adenocarcinoma ,Irinotecan ,Toxicology ,Gastroenterology ,Stomach Neoplasms ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Clinical endpoint ,Humans ,Pharmacology (medical) ,Stage (cooking) ,Survival rate ,Pharmacology ,Cisplatin ,business.industry ,Cancer ,medicine.disease ,Combined Modality Therapy ,Survival Rate ,Radiation therapy ,Camptothecin ,Esophagogastric Junction ,business ,Follow-Up Studies ,medicine.drug - Abstract
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.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.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%.Induction IC followed by IC/RT showed poor efficacy and significant toxicity in patients with unresectable GC/EGJC.
- Published
- 2010
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