Efficacy of oxaliplatin plus 5-fluorouracil/leucovorin calcium combined with concurrent radiotherapy for local advanced gastric cancer

Abstract

To evaluate the efficacy of r oxaliplatin plus 5-fluorouracil/leucovorin calcium (LV) combined with concurrent radiotherapy in the treatment of local advanced gastric cancer. 83 patients with local advanced gastric cancer were randomized into 2 groups. Group I (n = 40) underwent irradiation at the dose of 40 - 45 Gy 5 times a week on the primary tumor and the lymph nodes with the size > or = 10 mm in short axis, and receiving intravenous drip of OXA 85 mg/m2 for 2 h, intravenous injection of LV 200 mg/m2, and then intravenous injection of 5-fu 300 mg/m2, followed by continuous intravenous infusion of 5-fu 500 mg/m2, for 22 h, with 2 weeks as a cycle. Three cycles of chemotherapy were given during the radiotherapy. Then operative evaluation was conducted. Those resectable underwent operation and then 3 cycles of adjuvant chemotherapy. Those un-resectable underwent continuous 3 cycles of chemotherapy. Group II (n = 43) received only chemotherapy. The treatment was repeated until disease progression or prohibitive toxicity. 38 patients were evaluated in Group I, the result showed complete remission (CR) in 4 patients (10.5%), partial remission (PR) in 23(60.5%), no-change (NC) in 7(18.4%), progressive disease (PD) in 5(13.2%), with the remission rate (RR) of 71% (27/40). 42 patients were evaluated in Group II, the result showed CR in 3 patients (7.14%), PR in 16(14.3%), NC in 13(30.9%), and PD in 9(26.2%)with the RR of 45% (19/43). The resection rates of Groups I and II were 32.5% and 27.9% respectively (P = 0.649). The R0 resection rates of Groups I and II were 77.8% and 57.1% respectively (P = 0.161). The mean survival times of the resectable patients in Groups I and II were 45 months and 28 months respectively, and the 2-year overall survival (OS) of the resectable patients in Groups I and II were 65.8% and 56.3% respectively (P = 0.371). The mean survival times of the un-resectable patients in Groups I and II were 14 months and 9 months respectively, and the 2-year OS rates of the un-resectable patients in Groups I and II were 28.3% and 20.7% respectively (P = 0.017). The toxic and adverse effects included gastrointestinal and hematological toxicity. There was no treatment-related death. Radiotherapy combined with concurrent chemotherapy may be an effective and well-tolerated regimen in patients with advanced and metastatic gastric cancer.