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中华消化病与影像杂志(电子版)

中华消化病与影像杂志(电子版) ›› 2024, Vol. 14 ›› Issue (01) : 67 -71. doi: 10.3877/cma.j.issn.2095-2015.2024.01.012

论著

SOX与mFOLFOX6化疗方案对晚期胃癌的疗效与安全性
葛雪梅1,†()   
  1. 1. 236600　安徽阜阳，太和县人民医院肿瘤内科
  • 收稿日期:2023-08-21 出版日期:2024-02-01
  • 通信作者: 葛雪梅

Efficacy and safety of SOX and mFOLFOX6 chemotherapy regimen for advanced gastric cancer

Xuemei Ge1,†()   

  1. 1. Department of Medical Oncology, Taihe County People's Hospital, Fuyang 236600, China
  • Received:2023-08-21 Published:2024-02-01
  • Corresponding author: Xuemei Ge
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葛雪梅. SOX与mFOLFOX6化疗方案对晚期胃癌的疗效与安全性[J]. 中华消化病与影像杂志(电子版), 2024, 14(01): 67-71.

Xuemei Ge. Efficacy and safety of SOX and mFOLFOX6 chemotherapy regimen for advanced gastric cancer[J]. Chinese Journal of Digestion and Medical Imageology(Electronic Edition), 2024, 14(01): 67-71.

目的

分析对比替吉奥＋奥沙利铂（SOX）与奥沙利铂＋亚叶酸钙＋氟尿嘧啶（mFOLFOX6）化疗方案对晚期胃癌一线化疗的临床疗效与安全性。

方法

本研究前瞻性纳入2018年1月1日至2022年3月31日太和县人民医院收治的80例晚期胃癌患者为研究对象，按照随机字母表法分为对照组（使用mFOLFOX6化疗方案）和研究组（使用SOX化疗方案），各40例，两组患者均化疗2个周期。对比两组患者化疗后的临床疗效、化疗前后血清肿瘤标志物水平和生活质量，随访1年观察化疗结束患者的生存情况，通过Kaplan-Meier生存曲线计算疾病无进展生存期。同时比较两组患者化疗期间的不良反应发生率。

结果

研究组的临床总有效率和总疾病控制率优于对照组（P<0.05），两组患者的完全缓解率和部分缓解率差异无统计学意义（P>0.05）。化疗前，两组患者的CEA、CA199水平和KPS评分比较，差异均无统计学意义（P>0.05）；化疗后，两组患者的CEA、CA199水平均显著下降，且研究组低于对照组（P<0.05），两组患者的KPS评分均显著提高，且研究组高于对照组（P<0.05）。随访1年，研究组的疾病无进展生存期显著长于对照组（P<0.001），两组患者在化疗期间的不良反应总发生率，差异无统计学意义（P>0.05）。

结论

晚期胃癌患者使用SOX方案较mFOLFOX6方案的临床疗效更好，患者生活质量得到改善，无进展生存期得到延长。

关键词: 晚期胃癌, 化学治疗, 临床疗效, 无进展生存期, 不良反应
Objective

To analyze and compare the clinical efficacy and safety of SOX chemotherapy regimen (tegafur+oxaliplatin) and mFOLFOX6 chemotherapy regimen (oxaliplatin+ calcium folinate+ fluorouracil) for first-line chemotherapy of advanced gastric cancer.

Methods

A total of 80 patients with advanced gastric cancer admitted to Taihe County People's Hospital from January 1, 2018 to March 31, 2022 were prospectively included in this study, and all the patients were divided into control group (using mFOLFOX6 chemotherapy regimen) and research group (using SOX chemotherapy regimen) according to the random alphabet method, with 40 cases in each group. Patients of the two groups were treated with chemotherapy for 2 cycles. The clinical efficacy, serum tumor marker level and quality of life were compared between the two groups after chemotherapy. The patients were followed up for 1 year to observe the survival of the patients after chemotherapy, and the progression-free survival was calculated by Kaplan-Meier survival curve. Meanwhile, the incidence of adverse reactions during chemotherapy was compared between the two groups.

Results

The total clinical effective rate and total disease control rate of the study group were better than those of the control group (P<0.05), and there were no statistically significant difference in the complete remission rate and partial remission rate between the two groups (P>0.05). Before chemotherapy, there were no statistically significant differences in CEA, CA199 and KPS score between the two groups (P>0.05). After chemotherapy, CEA and CA199 levels of the two groups were significantly decreased, and the study group was lower than the control group (P<0.05), and the KPS scores of the two groups were significantly increased, and the study group was higher than the control group (P<0.05). After 1-year follow-up, the progression-free survival of the study group was significantly longer than that of the control group (P<0.001), and the total incidence of adverse reactions during chemotherapy was not statistically significant when comparing the two groups (P>0.05).

Conclusion

Compared with mFOLFOX6 chemotherapy regimen, the treatment of advanced gastric cancer patients with SOX chemotherapy regimen has better clinical efficacy, quality of life is improved, progression-free survival is prolonged.

Key words: Advanced gastric cancer, Chemotherapy, Clinical efficacy, Progression-free survival, Adverse effects
表1 两组患者一般基线资料对比
组别 例数 性别[例(%)] 年龄(岁,±s) ECOG评分(±s) 转移情况[例(%)] 病理类型[例(%)]
男 女 单一 2个及以上 低分化 高分化
对照组 40 30(75.00) 10(25.00) 69.77±10.96 65.15±2.75 28(70.00) 12(30.00) 30(75.00) 10(25.00)
研究组 40 29(72.5) 11(27.5) 63.75±10.99 67.52±11.73 24(60.00) 16(40.00) 23(57.50) 17(42.50)
t/χ2   0.065 4.6472) 5.279 0.879 2.739
P   0.799 0.162 0.792 0.348 0.097
表2 两组患者化疗后疗效对比[例（%）]
组别 例数 完全缓解 部分缓解 稳定 病情进展 总有效率 总疾病控制率
对照组 40 10(25.00) 13(32.50) 6(15.00) 11(27.50) 23(57.50) 29(72.50)
研究组 40 15(37.50) 16(40.00) 8(20.00) 1(2.50) 31(77.50) 39(97.50)
χ2   00.938 0.310 0.286 8.333 1.185 3.374
P   0.317 0.577 0.592 0.003 0.276 0.046
表3 两组患者化疗前后血清肿瘤标志物水平对比（±s）
组别 例数 CEA(ng/mL) CA199(IU/mL)
化疗前 化疗后 t Pa 化疗前 化疗后 t Pa
对照组 40 47.16±5.34 29.37±3.67 5.617 0.032 81.63±8.52 46.01±4.77 4.611 0.023
研究组 40 46.61±4.26 25.10±3.42 3.384 0.046 81.81±8.72 42.51±4.05 6.682 0.015
t   3.482 6.334   1.471 7.439  
P   0.273 0.023   0.602 0.018  
表4 两组患者化疗前后KPS评分对比（±s）
组别 例数 化疗前 化疗后 t Pa
对照组 40 62.67±3.73 80.02±2.68 5.671 0.034
研究组 40 63.21±4.17 86.31±3.15 6.892 0.021
t   3.264 6.395  
P   0.218 0.028  
表5 两组患者化疗期间不良反应比较[例（%）]
组别 例数 白细胞减少 血小板减少 腹泻 恶心呕吐 口腔黏膜炎 肝功能损害 总不良反应发生率
Ⅰ Ⅱ Ⅲ Ⅳ Ⅰ Ⅱ Ⅲ Ⅰ Ⅱ Ⅲ 轻度 中度 重度
对照组 40 4(10.00) 5(12.50) 1(2.50) 1(2.50) 1(2.50) 0 2(5.00) 1(2.50) 0 3(7.50) 1(2.50) 0 1(2.50) 1(2.50) 0 21(52.50)
研究组 40 3(7.50) 3(7.50) 2(5.00) 1(2.50) 0 0 2(5.00) 0 0 1(2.50) 1(2.50) 0 1(2.50) 0 0 14(35.00)a
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