Objective:To compare the safety of radiotherapy combined with capecitabine or sequential radiotherapy as adjuvant therapy of gastric cancer.Patients and Methods:A total of 98 patients with resected ad-enocarcinoma of the stomach or gastroesophageal junction were randomly assigned to postoperative chemoradiotherapy group or sequential radiotherapy group.The adjuvant treatment consisted of three cycles modified FOLFOX.regimen (Oxaliplatin 130mg/m2, L-leucovorin 400mg/m2, the first day,5-fluorouracil:2.6g/m2,46 hours continuous infusion), followed by 4500 cGy of radiation at 180 cGy per day, given five days per week for five weeks, the study group synchronous oral Xeloda 625mg/m2, twice per day during the radio-herapy, The control group received sequential radiotherapy alone.One month after the completion of radiotherapy, three cycles modified FOLFOX program were given to all patients.Results:A total of 98 patients for safety analysis. Compared with the control group,The concurrent chemoradiotherapy group experienced more neutropenia, nausea/vomiting, loss of appetite, and diarrhea (P<0.05). The rates of Other adverse events such as peripheral nerve toxicity,abdominal pain, fatigue,alopecia,,stomatitis and the albuminuria are similar in two groups.The study group experienced more grade 3 or 4 neutropenia (28% vs 20.8%, P=0.41), nausea/vomiting (26% vs 16.7%, P=0.26), appetite decreased (28% vs 16.7%, P= 0.26) and diarrhea (18% vs 10.4%, P=0.41),But there was no significant difference(P>0.05). Subgroup analysis showed that in the concurrent chemoradiotherapy group, Severe gastrointestinal events were more common in women (P<0.05), no treatment-related death occurred.Conclusion:Capecitabine combined with radiotherapy has a manageable tolerability profile, and it is worthy to be generalized as a standard adjuvant treatment for gastric cancer. |