| Purpose To evaluate the efficacy and toxicity of combination chemotherapy with paclitaxel, 5-fluorouracil and leucovorin(TFL) as first-line treatment in patients with advanced gastric cancer.Methods One hundred and nineteen patients were enrolled in the study who were confirmed with advanced(recurrent or metastatic) gastric cancer by histopathology. Those patients were treated with paclitaxel, 5- fluorouracil and leucovorin; paclitaxel at a dose of 135mg/m2 was administrated in 500 ml of normal saline or 5% glucose solution as a 3-hour intravenous infusion on day 1 and followed by administration of leucovorin at 400mg/m2 in 250 ml of normal saline on day-1. This was followed by 2,400mg/m2 5-FU in normal saline solution put into a chemotherapy pump as an infusion of over a 46-hour period on days 1-3. Cycles were repeated every two weeks. The survival curves was drew by Kaplan-Meier method, the response was evaluated by RECIST(Response evaluation criteria in solid tumours) 1.1 guidelines and the adverse events were evaluated according to the National Cancer Institute common toxicity criteria(NCI-CTC) version 3.0 toxicity scale. The Cox proportion-hazard regression mode was performed to assess the influence of the clinicopathological characteristics on TTP and OS.Results Among 119 patients enrolled, 6 patients could not be evaluated for responses because of the early discontinuation of therapy. A total of 113 patients were assessed for their response to therapy. There were 3 patients who achieved complete responses(CR) and 46 patients who achieved partial responses(PR), giving an overall objective response rate of 43.4%(95%CI, 34.3-52.5%). Fifty-four cases of stable disease(SD) and 10 cases of progressive disease(PD) were observed in the remaining patients. Therefore the overall disease control rate was91.2%(95%CI, 86.9-96.4%). The median follow-up period was 13 months(range, 3-50 months). The median time to progression and overall survival were 5.2 months(95%CI, 4.7-5.8 months) and 14.1 months(95%CI, 12.5-15.8 months), respectively. A total of 682 cycles of treatment were received, with a median of six cycles per patient(range, 2-12 cycles). The most common Grade 3-4 toxicities included leucopenia(16.8%), neutropenia(17.7%), anemia(7.9%), thrombocytopenia(5.3%) and fatigue(6.2%). No febrile neutropenia was observed and no treatment-related deaths occurred. The peritoneal seeding(P<0.001), the number of metastatic sites(P<0.001), the histological differentiation(P<0.001) had a significant influence on the response rate to chemotherapy with TFL. The univariate analysis of Cox proportion-hazard regression mode revealed that peritoneal seeding, the first-line chemotherapy efficacy, the number of metastases, the histological differentiation, second-line chemotherapy, the level of serum LDH before chemotherapy were relevant to progonsis(P<0.05). The multivariate analysis showed that the first-line chemotherapy efficacy(HR=1.822, 95%CI:1.245-2.666, P=0.002), the number of metastases(HR=1.555, 95%CI:1.158-2.088, P=0.003), second-line chemotherapy(HR=0.323, 95%CI:0.183-0.571, P<0.001), the level of serum LDH before chemotherapy(HR=1.842, 95%CI:1.111-3.051, P=0.018) are the independent prognostic factors in patients with advanced gastric cancer.Conclusions 1. The regimens of Paclitaxel, 5-fluorouracil and leucovorin(TFL) combination chemotherapy in advanced gastric cancer showed higher ORR and DCR with good tolerance. It is valauable to be first-line chemotherapy in the clinical application and further study was needed. 2. The first-line chemotherapy efficacy, the number of metastases, second-line chemotherapy, the level of serum LDH before chemotherapy are the independent prognostic factors in patients with advanced gastric cancer. |
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