Purpose: In RTOG0114 trial, 2-year disease-free survival (DFS) of taxol-based regimen failed to exceed lower bound of 52.9% and can’t be recommended for future trial. We analyze 2 year results to evaluate postoperative concurrent chemoradiation of capecitabine combined with intensity-modulated radiotherapy (IMRT) in gastric cancer.
Methods: Analysis were performed in stage II/III (AJCC 7th) gastric cancer patients who underwent macroscopically radical (R0/R1) gastric surgery and postoperative concurrent chemoradiation of capcitabine combined with IMRT. Whole group were admitted with average 4 cycles fluorouracil-based chemotherapy and concurrent chemoradiation of IMRT (45 Gy/25f) combined with capecitabine (1,600 mg/m2/day for 5 weeks), those who underwent R1 resection were admitted with extra boost of 5-10 Gy to pathologically positive margin. Two-years DFS 52% was lower bound for phase II study. Toxicities of whole group were graded according CTC-AE (v3.0).
Result: Until 2011, altogether 43 were evaluable, including 12 stage II and 31 stage III patients. With a median follow-up of 21 months, 2-year DFS and OS is 55.6% and 82.3% for the whole group, respectively. Patients who underwent R0 resection (n=35) versus R1 resection (n=8) showed improvement in 2-year DFS in R0 (70.4% v 18.8%; P=0.001), but no significant difference in 2-year OS (86.3% v 70.0%; P=0.176). Patients who underwent D1 versus D2 dissection demonstrated no significant difference. Acute toxicities (≥ grade 3) of global, GI and hematology were 27.9%, 13.9% and 9.3%, respectively.
Conclusions: Capecitabine combined with IMRT can be recommended as adjuvant treatment for resected gastric cancer in our future trial.
