S-1 Combined With Docetaxel (Sd) Versus S-1 Combined With Cisplatin (Sp) In The Treatment Of Advanced Gastric Cancer: Randomized, Controlled, Multicenter And Clinical Study

Purpose: This study was conducted to evaluate the differences in the efficacy and safety of S-1 combined with docetaxel versus S-1 combined with cisplatin as a treatment for advanced gastric cancer (GC) patients. Patients and Methods: Three-hundred advanced GC patients who had recurrence or metastasis were enrolled in this study. All of the patients were randomly assigned to receive S-1 combined with docetaxel (experimental group) or S-1 combined with cisplatin (control group). All patients were evaluated and given an ECOG score of 0-1 points with the expectation of a survival of greater than 3 months. We then provided continued chemotherapeutic drugs for 4-6 cycles or until the disease progressed. Tumors were evaluated every 8 weeks until the use of other antitumor drugs, disease progression, death, or the end of the study prohibited further evaluation. The primary endpoint was progression-free survival (PFS), and the secondary endpoint was overall survival (OS), overall remission rate (ORR), 1-year survival rate, and safety. Results: The remission rate in the subjects given drug combinations was 86.33%. After the end of the second, fourth, and sixth cycles, the remission rate and the clinical yield of the experimental group was higher than that of the control group. The median progression-free survival (mPFS) duration of the test group was 180 days, whereas the control group was 171 days. The median overall survival (mOS) rates of the experimental group and the control group were 405 days and 378 days, respectively. There were 77 people in the test group whose survival rate was more than 1 year, and the 1-year survival rate was 51.33%; there were 72 people in the control group whose survival rate was more than 1 year, and the 1-year survival rate was 48.00%. The total 1-year survival rate was 49.67%. Adverse effects were similar in the experimental group and the control group. The main adverse effects were gastrointestinal reactions and bone marrow toxicity, which could be tolerated and relieved without symptomatic treatment. Conclusion: There was no significant difference between the treatment efficacy of the experimental group and the control group. However, regarding safety and tolerance, the experimental group subjects fared better than the control group subjects. Adverse effects were mainly grade I-II, and grade III-IV adverse effects could be relieved by symptomatic treatment with no unexpected adverse effects. This study further verified that S-1 combined with docetaxel had better efficacy and safety in the treatment of advanced GC compared to the treatment method of S-1 combined with cisplatin.