Phase II trial of induction irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for unresectable, locally advanced gastric and oesophageal-gastric junction adenocarcinoma |
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Authors: | Fernando Rivera Maica Gal??n Josep Tabernero Andres Cervantes Ma Eugenia Vega-Villegas Javier Gallego Berta Laquente Edith Rodr??guez Alfredo Carrato Pilar Escudero Bartomeu Massut?? Vicente Alonso-Ordu?a Adelaida Cardenal Alberto S??enz Jordi Giralt Ana Lucia Yuste Antonio Ant??n Enrique Aranda |
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Institution: | 1. Medical Oncology Department, H. U. Marqu??s de Valdecilla, Santander, Spain 12. Medical Oncology Department, Marqu??s de Valdecilla University Hospital, Avda, Valdecilla s/n, 39008, Santander, Spain 2. Medical Oncology Department, ICO L??Hospitalet, Barcelona, Spain 3. Medical Oncology Department, Vall d??Hebron University Hospital, Barcelona, Spain 4. Hematology and Medical Oncology Department, University Hospital, University of Valencia, Valencia, Spain 5. Medical Oncology Department, H. General U, Elche, Alicante, Spain 6. Medical Oncology Department, H. Cl??nico U, Lozano Blesa, Zaragoza, Spain 7. Medical Oncology Department, H. General U, Alicante, Spain 8. Medical Oncology Department, H. Miguel Servet, Zaragoza, Spain 9. Radiotherapy Department, H.U. Marqu??s de Valdecilla, Santander, Spain 10. Radiotherapy Department, Vall d??Hebron University Hospital, Barcelona, Spain 11. Medical Oncology Department, H.U. Reina Sof??a, C??rdoba, Spain
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Abstract: | Purpose 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 and materials Patients with unresectable M0 gastric (GC) or oesophageal-gastric junction (EGJC) adenocarcinomas were treated with two courses of IC (irinotecan, 65?mg/m2; cisplatin, 30?mg/m2 on days 1 and 8 every 21?days) followed by IC/RT (daily radiotherapy??45?Gy??with concurrent IC: irinotecan, 65?mg/m2, and cisplatin, 30?mg/m2, 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. |
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