Purpose:
Aim of this prospective, phase III trial was to compare the efficacy and toxicity of intravenous fluorouracil and oral capecitabine when given concurrently with radiation in adjuvant sitting for adenocarcinoma of the stomach after surgery.
Patients and method:
The study included 60 patients having histologically proven adenocarcinoma of the stomach or gastroesophageal junction; stage T2-4 N0-3 M0 after gastrectomy with D2 lymph node dissection. Eligible patients were randomly assigned to receive adjuvant radiotherapy concurrently with intravenous fluorouracil [arm A] or oral capecitabine [arm B].
Results:
Ten patients cannot complete their whole treatment course because of either progressive [4 patients; 2 arm A and 2 arm B ] or G 3 toxicity [1 patient] or refuse to complete their treatment [5 patients; 3 arm A and 2 arm B]. Patients received fluorouracil have significant increase grade 3 or 4 hematological [neutropenia] and gastrointestinal (diarrhoea, anorexia, and vomiting)
During a median follow-up period of 24 months, the 2-year disease free and overall survivals in this study were 60% and 63.3%, for group A and B respectively, while overall survival were 63.3% and 70% for group A and B respectively without significant differences.
Conclusion:
Oral capecitabine concurrently with radiation therapy has comparable efficacy and favourable toxicity profile when compared to infusion fluorouracil as postoperative adjuvant therapy for gastric adenocarcinoma.