舒尼替尼联合信迪利单抗治疗晚期肾细胞癌的疗效及安全性分析

Efficacy and safety of sunitinib combined with cindilimab in treatment of advanced renal cell carcinoma

摘要:

目的 探究舒尼替尼联合信迪利单抗治疗晚期肾细胞癌的疗效及安全性。方法 回顾性分析2017年7月—2019年12月海南省肿瘤医院收治的48例晚期肾细胞癌患者的病历资料，根据治疗方法分为单一组（26例）和联合组（22例），单一组予以口服舒尼替尼治疗，联合组在对照组基础上联合信迪利单抗治疗。比较两组治疗2个月后的临床疗效，记录药物不良反应，查阅患者复诊资料并电话跟踪随访3年，记录患者预后生存状况。结果 联合组疾病控制率（DCR）高于单一组（P <0.05），两组客观缓解率（ORR）差异无统计学意义（P >0.05）。联合组肺部感染、贫血发生率高于单一组（P <0.05）。联合组和单一组手足综合征、乏力、消化道反应、白细胞降低、血小板降低、中性粒细胞计数降低、甲状腺功能减退、γ-谷氨酰转移酶升高及高血压发生率比较，差异均无统计学意义（P >0.05）。截止随访期，单一组死亡14例，3年总生存率为41.67%，中位无进展生存期（PFS）为15个月，中位总生存期（OS）为22个月。联合组死亡8例，3年总生存率61.90%，中位PFS为18个月，中位OS为29个月。两组PFS曲线比较，差异无统计学意义（P >0.05）；两组OS曲线比较，差异有统计学意义（P <0.05），联合组高于单一组。结论 舒尼替尼联合信迪利单抗治疗晚期肾细胞癌，更有助于提升临床疗效，延长患者预后的总生存时间，且耐受性良好。

Abstract:

Objective To investigate the efficacy and safety of sunitinib combined with cindilimab in the treatment of advanced renal cell carcinoma.Methods Retrospective analysis was made on the medical records of 48 patients with advanced renal cell carcinoma admitted to our hospital from July 2017 to December 2019. According to the treatment methods, they were divided into a combination group (22 cases) and a single group (26 cases). The single group was treated with sunitinib orally, and the combined group was treated with cindilimab on the basis of the control group. To compare the clinical efficacy of the two groups after 2 months of treatment, we recorded adverse drug reactions, consulted the patient's follow-up data, and recorded the prognosis and survival of the patients.Results The disease control rate (DCR) of the combined group was higher than that of the single group (P < 0.05), and there was no significant difference in the objective response rate (ORR) between the two groups (P > 0.05). The incidence of pulmonary infection and anemia in the combined group was higher than that in the single group (P < 0.05). There was no significant difference between the combined group and the single group in hand foot syndrome, fatigue, digestive tract reaction, leukopenia, thrombocytopenia, neutrophil count, hypothyroidism, γ-Elevated glutamyltransferase, and hypertension (P > 0.05). As of the follow-up date, 14 patients died in the single group, with 41.67% 3-year overall survival rate, 15-month median PFS, and 22-month median OS. Eight patients died in the combined group, with 61.90% three-year overall survival rate, 18-month median PFS, and 29-month median OS. There was no significant difference in PFS curve between the two groups (P > 0.05); The OS curve of the combined group indicated better prognosis than that of the single group (P < 0.05).Conclusion Sunitinib combined with cindilimab in the treatment of advanced renal cell carcinoma is helpful to improve the clinical efficacy, and prolong the total survival time of patients with good tolerance.