Dataset Information

Combination Use of Tegafur and Apatinib as First-Line Therapy in Treatment of Advanced Gastric Cancer: A Single-Blinded Randomized Study.

ABSTRACT: Objective:To investigate the efficacy and safety of the combination use of tegafur and apatinib as a first-line therapy strategy in advanced gastric cancer (GC). Methods:The present study included a total of 62 advanced GC patients. The patients were randomized into the combined group (treated with both tegafur and apatinib) and the control group (treated with only tegafur). Treatment efficacy, KPS score, nutrition condition, and progression-free survival time (PFS) were recorded. Results:Both the response and disease control rates were significantly higher in the combined group. The PFS time was remarkably higher and the KPS score was significantly reduced in the combined group after treatment. After treatment, both groups showed significantly increased nutrition risk, but the rates of patients with nutrition risk or innutrition were remarkably higher in the combined group. The ADR rates were also significantly higher in the combined group. Conclusion:The combination use could achieve good efficacy and prolong patients' PFS time; however, apatinib also reduced the patients' quality of life and enhanced the nutrition risk and adverse drug reactions.

SUBMITTER: Li C

PROVIDER: S-EPMC7165347 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Combination Use of Tegafur and Apatinib as First-Line Therapy in Treatment of Advanced Gastric Cancer: A Single-Blinded Randomized Study.

Li Chaofeng C Tang Tao T Wang Wenyue W

Gastroenterology research and practice 20200406

<h4>Objective</h4>To investigate the efficacy and safety of the combination use of tegafur and apatinib as a first-line therapy strategy in advanced gastric cancer (GC).<h4>Methods</h4>The present study included a total of 62 advanced GC patients. The patients were randomized into the combined group (treated with both tegafur and apatinib) and the control group (treated with only tegafur). Treatment efficacy, KPS score, nutrition condition, and progression-free survival time (PFS) were recorded. ...[more]

PMID: 32328095

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Project description:Lessons learnedApatinib combined with S-1 was not superior to other chemotherapy regimens as first-line therapy for advanced gastric cancer. There was a tendency for patients with lymph node metastasis to have prolonged median progression-free survival and median overall survival, compared with patients with liver metastasis.BackgroundThe best choice of first-line chemotherapy regimen for patients with metastatic gastric cancer is still debated. We combined apatinib and S-1 as a new first-line therapy to treat advanced gastric cancer. The efficacy and safety of the combination were assessed, with the goal of determining the most appropriate subgroup of patients who could benefit from this new regimen.MethodsThis study was an open, exploratory single-arm, phase II trial. Enrolled patients received apatinib plus S-1 treatment (apatinib, 500 mg, once a day [qd], days 1-21; S-1, 40 mg/m2 , bid, days 1-14). The primary endpoints were progression-free survival (PFS) and safety of this new regimen. Next-generation sequencing was used to explore potential biomarkers.ResultsA total of 30 patients were enrolled. The median progression-free survival (mPFS) was 4.21 months (95% confidence interval [CI], 2.29-6.13 months). The median overall survival (mOS) was 7.49 months (95% CI, 4.81-10.17 months). Patients with lymph node metastasis had prolonged mPFS and mOS when compared with those with liver metastasis (mPFS, 4.21 vs. 1.84 months; mOS, 8.21 vs. 6.31 months, p = .08). The most common grade 3 to 4 adverse events were abdominal pain, dizziness, and diarrhea. Gene mutation profiles between the two subgroups were significantly different.ConclusionApatinib combined with S-1 was not superior to other chemotherapy regimens as first-line therapy for advanced gastric cancer. Toxicity was consistent with known profiles when given as monotherapy. There was a tendency toward prolonged mPFS and mOS in patients with lymph node metastasis compared with patients with liver metastasis, which could support the need to design a future clinical trial with a better defined patient population.

Project description:The current study aimed to evaluate the efficacy and safety of neoadjuvant apatinib plus tegafur/gimeracil/oteracil potassium (S-1) plus oxaliplatin (SOX) chemotherapy in patients with locally advanced gastric carcinoma (LAGC). Therefore, patients with LAGC treated with neoadjuvant apatinib plus SOX chemotherapy (apatinib + SOX group; n=25) or SOX chemotherapy (SOX group; n=35) were enrolled in the present study. Subsequently, the objective response (ORR) and disease control rates (DCR), pathological response, disease-free survival (DFS), overall survival (OS) and adverse events were recorded. The results showed that patients in the apatinib + SOX group exhibited a higher ORR (64.0 vs. 37.1%; P=0.040), but a similar DCR (96.0 vs. 88.6%; P=0.580), compared with those in the SOX group. The pathological response rates in patients with grade 0, 1, 2 and 3 LAGC were 0.0, 20.8, 62.5 and 16.7%, respectively, in the apatinib + SOX group, while in those treated with SOX alone they were 9.1, 39.4, 42.4 and 9.1%, respectively. By contrast, the pathological response was elevated in the apatinib + SOX group compared with the SOX group (P=0.030). During a median follow-up period of 21.0 months (range, 6.4-38.1 months), median DFS and OS were not reached. More specifically, the 1-, 2- and 3-year DFS rates were 91.7, 75.2 and 75.2% in the apatinib + SOX group and 71.8, 59.6 and 44.7% in the SOX group, respectively. In addition, the 1-, 2- and 3-year OS rates were 100.0, 89.6 and 78.4% in the apatinib + SOX group, while those in the SOX group were 90.3, 69.2 and 55.4%, respectively. However, no differences in DFS (P=0.094) or OS (P=0.155) were observed between the two groups. Additionally, the most common adverse events in the SOX group were mild leukopenia (42.9%) and fatigue (34.3%), while those in the apatinib + SOX group were tolerable leukopenia (44.0%) and hypertension (44.0%). In conclusion, the present study suggested that neoadjuvant apatinib plus SOX chemotherapy could be more effective and tolerable compared with SOX chemotherapy alone in patients with LAGC.

Dataset Information

Combination Use of Tegafur and Apatinib as First-Line Therapy in Treatment of Advanced Gastric Cancer: A Single-Blinded Randomized Study.

Publications

Combination Use of Tegafur and Apatinib as First-Line Therapy in Treatment of Advanced Gastric Cancer: A Single-Blinded Randomized Study.

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