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西妥昔单抗联合化疗治疗转移性结直肠癌的效果及其预后分析。

Effect of cetuximab combined with chemotherapy in treating metastatic colorectal cancer and its prognostic analysis.

机构信息

Department of Thoracic Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430079, China.

出版信息

J BUON. 2021 Jan-Feb;26(1):101-108.

PMID:33721439
Abstract

PURPOSE

To explore the efficacy and safety of cetuximab plus chemotherapy in the treatment of metastatic colorectal cancer (mCRC), and to analyze the possible factors affecting the prognosis.

METHODS

Clinical data were collected from 136 patients who were definitely diagnosed with mCRC in our hospital from January 2015 to December 2016, and whose genetic test showed wild-type (WT) Kirsten Ras (KRAS), and they were randomly divided into two groups and underwent cetuximab plus chemotherapy (n=68, Cetuximab group) or only chemotherapy (n=68, Chemotherapy group). The clinical short-term efficacy, incidence of adverse reactions and quality-of-life score of patients were compared between the two groups, and the survival and disease progression were recorded during follow-up.

RESULTS

After treatment, there were statistically significant differences between Cetuximab group and Chemotherapy group regarding objective response rate (ORR) and disease control rate (DCR) [69.1% (47/68) vs. 60.3% (41/68), 85.3% (58/68) vs. 79.4% (54/68)] (p=0.282, p=0.368). After treatment, Cetuximab group exhibited notably higher physical and emotional functioning scores on the function subscale [(92.53±12.11) points vs. (88.39±11.78) points, p=0.045, (94.63±12.72) points vs. (89.06±12.40) points, p=0.011] and rash score on the symptom subscale [(39.35±9.73) vs. (35.51±9.09) points, p=0.019)] than Chemotherapy group. According to the follow-up results, the median overall survival (mOS) and median progression-free survival (mPFS) were 25.1 months and 9.5 months, respectively, in Cetuximab group, and 19.8 months and 7.4 months, respectively, in Chemotherapy group. It was found through log-rank test that the OS and PFS in Cetuximab group were dramatically longer than those in Chemotherapy group (p=0.038, p=0.013). Based on the results of multivariate analysis, poor tumor differentiation was an independent risk factor for the mPFS and mOS of patients [hazard ratio (HR) =0.894, 95% confidence interval (CI) (0.581-0.987), p=0.034, HR=0.907, 95%CI (0.603-0.960), p=0.041].

CONCLUSION

Cetuximab plus chemotherapy has exact efficacy in treating mCRC, and it results in a higher long-term survival rate and a lower disease progression rate than chemotherapy alone, improves the quality of life of patients and produces tolerable adverse reactions. Besides, poor tumor differentiation is an independent risk factor for the mPFS and mOS of patients.

摘要

目的

探讨西妥昔单抗联合化疗治疗转移性结直肠癌(mCRC)的疗效和安全性,并分析可能影响预后的因素。

方法

收集我院 2015 年 1 月至 2016 年 12 月明确诊断为 mCRC 的患者临床资料,基因检测显示野生型(WT)Kirsten Ras(KRAS),并随机分为两组,分别采用西妥昔单抗联合化疗(n=68,西妥昔单抗组)或单纯化疗(n=68,化疗组)。比较两组患者的临床近期疗效、不良反应发生率和生活质量评分,随访记录生存和疾病进展情况。

结果

治疗后,西妥昔单抗组客观缓解率(ORR)和疾病控制率(DCR)[69.1%(47/68)比 60.3%(41/68),85.3%(58/68)比 79.4%(54/68)]明显高于化疗组(p=0.282,p=0.368)。治疗后,西妥昔单抗组在功能子量表上的身体和情绪功能评分[(92.53±12.11)分比(88.39±11.78)分,p=0.045,(94.63±12.72)分比(89.06±12.40)分,p=0.011]和症状子量表上的皮疹评分[(39.35±9.73)分比(35.51±9.09)分,p=0.019]均显著高于化疗组。根据随访结果,西妥昔单抗组的中位总生存期(mOS)和中位无进展生存期(mPFS)分别为 25.1 个月和 9.5 个月,化疗组分别为 19.8 个月和 7.4 个月。Log-rank 检验发现,西妥昔单抗组的 OS 和 PFS 明显长于化疗组(p=0.038,p=0.013)。多因素分析结果显示,肿瘤分化差是患者 mPFS 和 mOS 的独立危险因素[风险比(HR)=0.894,95%置信区间(CI)(0.581-0.987),p=0.034,HR=0.907,95%CI(0.603-0.960),p=0.041]。

结论

西妥昔单抗联合化疗治疗 mCRC 疗效确切,其长期生存率高于单纯化疗,疾病进展率降低,能提高患者生活质量,且不良反应可耐受。此外,肿瘤分化差是影响患者 mPFS 和 mOS 的独立危险因素。

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