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1.武汉大学人民医院:,肿瘤科,湖北武汉
2.武汉大学人民医院:,药学部,湖北武汉
赵文思,Email: wensizhao@whu.edu.cn
收稿日期:2025-04-05,
修回日期:2025-05-18,
纸质出版日期:2025-07-15
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赵文思,宋健.免疫治疗联合靶向治疗及化疗在微卫星稳定型转移性结直肠癌患者三线治疗中的疗效和安全性[J].陆军军医大学学报,2025,47(13):1512-1521.DOI:10.16016/j.2097-0927.202504016.
ZHAO W S,SONG J.Efficacy and safety of immunotherapy combined with targeted therapy and chemotherapy in third-line treatment of microsatellite stable metastatic colorectal cancer[J].J Army Med Univ,2025,47(13):1512-1521.DOI:10.16016/j.2097-0927.202504016.
赵文思,宋健.免疫治疗联合靶向治疗及化疗在微卫星稳定型转移性结直肠癌患者三线治疗中的疗效和安全性[J].陆军军医大学学报,2025,47(13):1512-1521.DOI:10.16016/j.2097-0927.202504016. DOI:
ZHAO W S,SONG J.Efficacy and safety of immunotherapy combined with targeted therapy and chemotherapy in third-line treatment of microsatellite stable metastatic colorectal cancer[J].J Army Med Univ,2025,47(13):1512-1521.DOI:10.16016/j.2097-0927.202504016. DOI:
目的
2
评估免疫治疗联合靶向治疗及化疗在微卫星稳定(microsatellite stable, MSS)型转移性结直肠癌(metastatic colorectal cancer, mCRC)患者三线治疗中的疗效和安全性。
方法
2
本研究为回顾性队列研究,选取2020年1月至2023年12月在武汉大学人民医院肿瘤科接受三线免疫治疗联合靶向及化疗的MSS型mCRC患者为研究对象。收集患者的临床资料,采用Kaplan-Meier法绘制无进展生存(progression-free survival,PFS)和总生存(overall survival,OS)曲线,统计客观缓解率(objective response rate,ORR)和疾病控制率(disease control rate,DCR)等指标以评价临床疗效,记录治疗过程中出现的不良反应及严重程度以评估安全性。
结果
2
共80例患者纳入分析,其中免疫+靶向组55例,免疫+靶向+化疗组25例。与免疫+靶向组相比,免疫+靶向+化疗组的中位PFS(6.3
vs
4.4个月,
HR
=0.58,95%
CI
:0.35~0.96,
P
=0.031)和OS(15.5
vs
10.1个月,
HR
=0.47,95%
CI
:0.27~0.81;
P
=0.006)均更长,ORR(32.0%
vs
10.9%,
OR
=0.26,95%
CI
:0.07~0.79;
P
=0.021)和DCR(92.0%
vs
78.2%,
OR
=0.31,95%
CI
:0.07~1.52,
P
=0.132)也相对更高。所有级别和3级及以上不良事件发生率在免疫+靶向组为96.4%和32.7%,在免疫+靶向+化疗组为100.0%和36.0%,主要包括骨髓造血功能抑制、手足皮肤反应、肝功能损害和甲状腺功能异常。
结论
2
免疫联合靶向及化疗的三联疗法相比于免疫联合靶向二联疗法是一种有效且安全的联合治疗方案。
Objective To evaluate the efficacy and safety of the combination of immunotherapy and targeted therapy and chemotherapy in third-line treatment of patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC). Methods A retrospective cohort trial was conducted on patients with MSS mCRC treated with third-line immunotherapy combined with targeted therapy and chemotherapy in our hospital from January 2020 to December 2023. The clinical data were collected. Kaplan-Meier survival analysis was employed to analyze progression-free survival (P
FS) and overall survival (OS). Objective response rate (ORR)
disease control rate (DCR) and other indicators were statistically analyzed to evaluate the clinical efficacy. The incidence and severity of adverse events during the treatment process were recorded to assess the safety. Results A total of 80 patients were included in the analysis
55 in the group of immunotherapy plus targeted therapy and 25 in the group of immunotherapy combined with targeted therapy and chemotherapy. The group of immunotherapy combined with targeted therapy and chemotherapy had significantly longer median PFS (6.3
vs
4.4 months;
HR
=0.58
95%
CI
: 0.35~0.96;
P
=0.031) and OS (15.5
vs
10.1 months;
HR
=0.47
95%
CI
: 0.27~0.81;
P
=0.006)
and obviously higher ORR (32.0%
vs
10.9%;
OR
=0.26
95%
CI
: 0.07~0.79;
P
=0.021) and DCR (92.0%
vs
78.2%;
OR
=0.31
95%
CI
: 0.07~1.52;
P
=0.132) when compared to the group of immunotherapy plus targeted therapy. The incidence of adverse events at all grade and at grade 3 and above was 96.4% and 32.7% in the group of immunotherapy plus targeted therapy
and 100.0% and 36.0% in the group of immunotherapy combined with targeted therapy and chemotherapy
which mainly included bone marrow hematopoietic inhibition
hand-foot skin reaction
liver function impairment and thyroid function abnormality. Conclusion The triple therapy of immunotherapy plus targeted therapy and chemotherapy is a more effective and safer treatment than the double therapy of immunotherapy plus targeted therapy in treatment of MSS mCRC patients.
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