There is no standard treatment strategy for liver metastases of gastric cancer in NCCN guideline and results of neoadjuvant chemotherapy from several previous studies are controversial. This study is to determine the overall survival, radical resection rate, objective response rate and safety of neoadjuvant capecitabine plus paclitaxel in gastric cancer patients with liver metastasis.
Patients diagnosed as gastric adenocarcinoma with liver metastasis were enrolled. Patients were treated with three cycles of capecitabine (1000mg/m2 PO, bid on day 1 to day 14) plus paclitaxel (80mg/m2IV on day1 and day 8 every three weeks) followed by radical resection. Primary endpoint was overall survival (OS) and secondary endpoints were radical resection rate, objective response rate (ORR), time to progression (TTP), and safety. All patients were evaluated every six weeks during chemotherapy. Radical resection was performed four to six weeks after termination of neoadjuvant chemotherapy.
30 patients were eligible for the study, and the median age was 59.5 years (range, 44 to 76 years). 23 patients died after follow-up of 2 years. The median OS was 11.4 months (95% CI: 9.0 ∼ 15.3), whereas it was 13.9 months (95% CI: 4.8 to not estimated) in surgery group and 10.1 months (95% CI: 5.7 to 14.8) in non-surgery group, respectively. The ORR was 53.3% (complete response, 0%; partial response, 53.3%), and the radical resection rate was 23.3% (95% Clopper-Pearson CI: 9.9 ∼ 42.3). ORR of neoadjuvant therapy was a significant independent factor associated with overall survival (hazard ratio: 0.363, 95% CI: 0.140 ∼ 0.943; p = 0.0374). The median TTP was 6.1 months (95% CI: 4.8 ∼ 11.0), while chemotherapy cycles was significantly associated with TTP (HR = 2.770, 95% CI: 1.043 ∼ 7.355; p = 0.0409). Based on criterion of CTCAE 3.0, only 5 patients (16.7%) reported grade 3 adverse events and no grade 4/5 adverse event was reported.
Neoadjuvant capecitabine plus paclitaxel is effective and safe to improve the overall survival and resection rate of gastric cancer patients with liver metastasis.
Clinical trial identification
All authors have declared no conflicts of interest.