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GOCCHI 2000-01 RATÓNES

Los resultados de este estudio fueron presentados recientemente en el Congreso de la Sociedad Europeo de Radioterapia y Oncología (European Society for Therapeutic Radiology and Oncology) ESTRO 29

RAToNES es un estudio multicéntrico nacional, fase III randomizado, en que su Investigador Principal es el Dr. Ramón Baeza.

Este estudio compara el esquema INT 0116 en pacientes con cáncer gástrico (radioterapia localizada y quimioterapia con 5FU) con el esquema de irradiación abdominal total y 5FU con el que varios grupos chilenos han desarrollado una razonable experiencia.

Abstract

ADJUVANT TREATMENT OF LOCALLY ADVANCED GASTRIC CANCER COMPLETELY RESECTED. A PHASE III STUDY: TOTAL ABDOMINAL IRRADIATION WITH CONCOMITANT CHEMOTHERAPY OR EXTENDED NODAL (RATONES) WITH CONCOMITANT CHEMOTHERAPY.

M. González-Domingo1, M. R. Baeza B.2, O. Giannini T.1, C. del Castillo2
1 INSTITUTO ONCOLÓGICO, Viña del Mar, Chile.
2 INSTITUTO DE RADIOMEDICINA (IRAM), Santiago, Chile

Purpose: Adjuvant radio-chemotherapy after resection is routinely administered in locally advanced gastric cancer. The recurrence post-treatment are fundamentally intra-abdominal. We investigated the effect of abdominal irradiation with concomitant chemotherapy in patients with resectable adenocarcinoma of the stomach.

Materials: From 2000 to 2006, 108 patients with completely resected locally advanced gastric adenocarcinoma were randomly assigned in a 1:1 ratio to receive total abdominal irradiation (RAT) or extended nodal irradiation (NES) both with concomitant chemotherapy. Treatment was either total-or sub-total gastrectomy, followed by RAT, 2100 cGy/21 fractions plus a 2400 cGy/16 fractions boost to the tumor bed or tumor bed plus nodal irradiation, 4500 cGy/25 fractions. Concomitant chemotherapy consisted of either 5-uorouracil (5-FU) 300 mg/m2 i.v. for 5 days rst and 5th week or 225 mg/m2 continuous infusion during irradiation in RAT group. NES received similar chemotherapy followed by two additional cycles. The primary endpoint was overall survival (OS). Analysis was by intention to treat.

Results: 53 patients (median age 58 years, range 35-74) were randomized to NES and 55 patients (57 years, range 26-78) to RAT. 46/55 (84%) of patients in RAT group completed treatment and 49/53 (92%) in NES group did so. There were none treatment related deaths. With a median follow-up of 38 months, 5 years overall survival was 47.3% in RAT group and 37.7% in NES (hazard ratio for death (HR) 0.88; 95 percent confidence interval, 0.54 to 1.42; P = 0.624). The median overall survival in RAT group was 46 months, as compared with 37 months in NES group. In a exploratory analysis, the 5- years overall survival in patients with involvement less than six lymph node and serosa (T3N_5) was 76.5% for those who received RAT, which was signicantly better than the 44.4% 5-year survival observed in NES group (p=0.04) Conclusions: Adjuvant radiotherapy with concomitant chemotherapy either total abdominal irradiation or tumor bed plus nodal irradiation are effective and safe treatment options for patients with locally advanced gastric cancer completely resected.

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