The Phase 2 Study of "(TOX) Preoperative Chemotherapy" Response Rate and Side Effects in [Locally Advanced Operable Gastric Adenocarcinoma] Patients With Docetaxel, Oxaliplatin and Capcitabine

BACKGROUND: Early stage gastric cancer diagnosis has ensued different approaches in resection strategies. In order to increase the proportion of cases which have undergone radical resection or have reduced the recurrence rate, different pre-operative treatments have introduced. Here, we have verified an active preoperative chemotherapeutic regimen in locally advanced gastric cancer patients. METHODS: Forty nine patients who have found eligible to enter this phase 2 trial have treated with oxaliplatin 100 mg/m2 IV, docetaxel 50 mg/m2 IV, plus capecitabine 625 mg/m2 PO (TOX). Clinical staging has been following the first 2 cycles of induction chemotherapy. Patients that have further undergone radical surgery, have evaluated for pathological response rate. RESULTS: Anemia (10.2%), nausea (10.2%) and vomiting (6.1%) were the most frequent grade 3 or 4 adverse effects. Regarding the pathologic staging, 6 patients (12.2%) had complete response (95% CI 3% to 21.4%), 18 of them (36.7%) had partial response (95% CI 23.2% to 50.2%), then 3 patients (6.1%) had stable disease (95% CI 0%-12.8%). Among the patients who had surgery, 22% had pathologic complete response. CONCLUSION: Preoperative chemotherapeutic regimen of TOX seems to be an active and safe neoadjuvant therapy in non metastatic gastric cancer. It should further be considered with concurrent radiotherapy.