【摘要】 目的 探讨呋喹替尼联合信迪利单抗治疗微卫星稳定（MSS）的转移性结直肠癌（mCRC）的疗效。方法 回顾性收集安阳市肿瘤医院2020年1月至2024年12月收治的78例MSS型mCRC患者的临床资料。患者均接受呋喹替尼胶囊联合信迪利单抗注射液治疗，每21 d为1个周期，治疗直至疾病进展或因不可耐受不良反应停药或患者死亡。采用免疫治疗实体瘤的疗效评价标准（iRECIST）评价患者的近期疗效，采用肿瘤治疗常见不良反应分级5.0版（CTCAE5.0）评价不良反应，随访患者的总生存期（OS）及无进展生存期（PFS）。结果 MSS型mCRC患者客观缓解率（ORR）为23.08%，疾病控制率（DCR）为62.82%。MSS型mCRC患者1年、3年总生存率分别为62.82%、17.95%，无进展生存率分别为23.08%、8.97%，中位OS为12.53个月，中位PFS为6.39个月。Ras/Raf野生型、无肝转移患者的3年总生存率分别为27.50%、33.33%，均高于Ras/Raf突变型（7.89%）、伴肝转移患者（8.33%）;Ras/Raf野生型MSS型mCRC患者的1年无进展生存率（32.50%）高于突变型患者（13.16%）(P<0.05)。Ras/Raf野生型MSS型mCRC患者的中位OS为18.18个月，长于突变型患者的11.48个月（Log-rankχ~2=15.494,P<0.05）。无肝转移MSS型mCRC患者的中位OS、中位PFS分别为15.91、12.56个月，长于伴肝转移患者的11.50、4.43个月（Log-rankχ~2=7.164、45.520,P<0.05）。肿瘤原发部位为左侧的MSS型m CRC患者的中位PFS为6.60个月，长于右侧患者的4.24个月（Log-rankχ~2=18.130,P<0.05）。MSS型mCRC患者中常见的3级治疗相关不良事件（TRAE）包括皮疹和手足综合征。结论 MSS型mCRC患者应用呋喹替尼联合信迪利单抗治疗的临床获益良好，且该治疗方案可延长Ras/Raf基因野生型、无肝转移及左侧患者的生存时间，且治疗相关不良反应可控，安全性良好。更多还原

【Abstract】 Objective To investigate the efficacy of fruquintinib combined with sintilimab in the treatment of microsatellite stable(MSS) metastatic colorectal cancer(mCRC).Methods The clinical medical records of 78 patients with MSS-type mCRC admitted to Anyang Cancer Hospital from January 2020 to December 2024 were retrospectively collected.All patients received treatment with fruquintinib capsules combined with sintilimab injection.Each 21-day period was one cycle.The treatment continued until disease progression or due to intolerable adverse reactions or patient death.The short-term efficacy of patients was evaluated using the efficacy evaluation criteria for solid tumors in immunotherapy(iRECIST),and adverse reactions were evaluated using the Common Terminology Criteria for Adverse Events version 5.0(CTCAE5.0).The overall survival(OS) and progression-free survival(PFS) of patients were followed up.Results The objective response rate(ORR) of MSS-type mCRC patients was23.08%,and the disease control rate(DCR) was 62.82%.The 1-year and 3-year overall survival rates of MSS-type mCRC patients were 62.82% and 17.95%,respectively,and the progression-free survival rates were 23.08% and 8.97%,with a median OS of 12.5 3months and a median PFS of 6.39 months.The 3-year overall survival rates of MSS-type mCRC patients with wild-type Ras/Raf and without liver metastasis(27.50% and 33.33%) were higher than those of patients with mutant Ras/Raf and with liver metastasis(7.89% and 8.33%);the 1-year progression-free survival rate of MSS-type mCRC patients with wild-type Ras/Raf was 32.50%,which was higher than that of patients with mutant Ras/Raf(13.16%)(P<0.05).The median OS of MSS-type mCRC patients with wild-type Ras/Raf was 18.18 months,which was longer than that of patients with mutant Ras/Raf(11.48 months)(Log-rankχ~2=15.494,P<0.05).The median OS and PFS of MSS-type mCRC patients without liver metastasis were 15.91 and 12.56 months,respectively,which were longer than those of patients with liver metastasis(11.50 and 4.43 months)(Log-rank χ~2=7.164,45.520,P<0.05).The median PFS of MSS-type mCRC patients with the primary tumor on the left was 6.60 months,which was longer than that of patients on the right(4.24 months)(Log-rank χ~2=18.130,P<0.05).The median OS and PFS of MSS-type mCRC patients with the primary tumor on the right were 11.09 and 4.24 months,respectively,which were shorter than those of patients with the primary tumor on the left(13.78 and 6.60 months)(Log-rank χ~2=7.164,45.520,P<0.05).Common grade 3 treatment-related adverse events(TRAE) in MSS-type mCRC patients included Rash and hand-foot syndrome.Conclusion The clinical benefit of fruquintinib combined with sintilimab in the treatment of MSS-type mCRC patients is good,and this treatment regimen can prolong the survival time of patients with wild-type Ras/Raf,without liver metastasis,and on the left side.At the same time,the adverse reactions of patients are good.更多还原