During postoperative treatment, gradeģ and 4 adverse events occurred in 113 (48%) and 22 (9%) of 233 patients in the chemotherapy (n=8), and functional bowel obstruction (n=1). (n=2), dihydropyrimidine deficiency (n=1), sudden death (n=1), cardiovascular events Causes of death during preoperative treatment were diarrhoea Together), there were 368 (47%) grade 3 adverse events 130 (17%) grade 4 adverseĮvents, and 13 (2%) deaths. Preoperative chemotherapy, in the total safety population of 781 patients (assessed Group (hazard ratio from stratified analysis 1♰1 (95% CI 0♸4–1♲2 p=0♹0). (95% CI 31–57) in the chemotherapy group and 37 months (30–48) in the chemoradiotherapy Median follow-up of 61♴ months (IQR 43♳–82♸), median overall survival was 43 months Patients started chemotherapy and 245 (62%) of 395 started chemoradiotherapy. After preoperativeĬhemotherapy, 372 (95%) of 393 patients in the chemotherapy group and 369 (93%) ofģ95 patients in the chemoradiotherapy group proceeded to surgery, with a potentiallyĬurative resection done in 310 (79%) of 393 patients in the chemotherapy group andģ26 (83%) of 395 in the chemoradiotherapy group. Findingsīetween Jan 11, 2007, and April 17, 2015, 788 patients were enrolled and randomlyĪssigned to chemotherapy (n=393) or chemoradiotherapy (n=395). Was overall survival, analysed by intention-to-treat. (575 mg/m 2 orally twice daily on radiotherapy days) and cisplatin (20 mg/m 2 intravenously on day 1 of each 5 weeks of radiation treatment). Of 1♸ Gy, for 5 weeks, five daily fractions per week, combined with capecitabine Chemoradiotherapy consisted of 45 Gy in 25 fractions Or 625 mg/m 2 orally as tablets twice daily for 21 days in combination with epirubicin and oxaliplatin), Of three preoperative 21-day cycles and three postoperative cycles of intravenousĮpirubicin (50 mg/m 2 on day 1), cisplatin (60 mg/m 2 on day 1) or oxaliplatin (130 mg/m 2 on day 1), and capecitabine (1000 mg/m 2 orally as tablets twice daily for 14 days in combination with epirubicin and cisplatin, Postoperative treatment started within 4–12 weeks after surgery. Of a radical resection of the primary tumour and at least a D1+ lymph node dissection. Patients and investigators were not masked to treatment allocation. Treatment and was stratified by histological subtype, tumour localisation, and hospital. Randomisation was done before patients were given any preoperative chemotherapy Group) or preoperative chemotherapy with postoperative chemoradiotherapy (chemoradiotherapy Programme with a random element to either perioperative chemotherapy (chemotherapy Sweden, and Denmark, and were randomly assigned (1:1) with a computerised minimisation Patients were enrolled from 56 hospitals in the Netherlands,
With a WHO performance status of 0 or 1, and adequate cardiac, bone marrow, liver,Īnd kidney function. Patients aged 18 years or older who had stage IB– IVA resectable gastric or gastro-oesophagealĪdenocarcinoma (as defined by the American Joint Committee on Cancer, sixth edition), In this investigator-initiated, open-label, randomised phase 3 trial, we enrolled The Lancet Regional Health – Western Pacific.The Lancet Regional Health – Southeast Asia.The Lancet Gastroenterology & Hepatology.
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