背景:免疫检查点抑制剂(ICI)的出现在免疫原性肿瘤的治疗中带来了重大转变。2015年11月23日,美国食品和药物管理局批准Nivolumab用于治疗转移性肾细胞癌(RCC)。我们旨在评估Nivolumab批准后在人群水平上转移性肾癌患者生存率的潜在变化。
方法:我们使用了最新版本的监测数据,流行病学,和最终结果(SEER)数据库,其中包含截至2020年的数据。我们纳入了从2011年到2020年被诊断为“远端”RCC的年龄≥20岁的患者。基于Nivolumab的批准,2011-2020年期间进一步分为2011-2015年(ICI前时代)和2016-2020年(ICI时代).
结果:ICI前时代的中位总生存期(OS)为8个月,而ICI时代为11个月(对数秩检验,χ2=102.53,p<0.001)。与ICI前时代诊断的患者相比,ICI时代诊断为转移性RCC的患者死亡风险显著降低[Cox比例风险比为0.77,95%CI(0.74-0.80)]。此外,与75岁或以上的患者相比,75岁以下的患者死亡风险较低.接受化疗(全身治疗)的患者,放射治疗,或手术面临显著较低的死亡风险。转移到大脑的人,骨头,肝脏,与没有转移到这些位置的患者相比,肺或肺的死亡风险明显更高。婚姻状况也起了作用,因为与离婚的人相比,已婚的人死亡风险显著降低,分离,或在诊断时丧偶。此外,收入水平影响生存,与年收入在50,000美元至74,000美元之间的患者相比,家庭年收入中位数超过75,000美元的患者的死亡风险显着降低。在非西班牙裔黑人和非西班牙裔白人之间观察到的存活率没有显着差异。
结论:免疫检查点抑制剂的出现使被诊断为转移性肾细胞癌的个体的中位总生存期有了实质性的改善。
BACKGROUND: The advent of immune checkpoint inhibitors (ICI) has brought about a significant transformation in the treatment of immunogenic tumors. On November 23, 2015, the United States Food and Drug Administration approved Nivolumab to treat metastatic renal cell carcinoma (RCC). We aimed to assess potential changes in the survival rates of patients with metastatic RCC at a population level after the approval of Nivolumab.
METHODS: We used data from the latest version of the Surveillance, Epidemiology, and End Results (SEER) database which encompasses data up to the year 2020. We included patients with age ≥ 20 years who were diagnosed with \'distant\' RCC from 2011 through 2020. Based on the approval of Nivolumab, the period from 2011 to 2020 was further grouped into 2011-2015 (pre-ICI era) and 2016-2020 (ICI era).
RESULTS: The median overall survival (OS) was 8 months in the pre-ICI era compared to 11 months in the ICI era (log-rank test, χ2 = 102.53, p < 0.001). Patients diagnosed with metastatic RCC in the ICI era had a significantly lower risk of dying [Cox proportional Hazard Ratio of 0.77, 95 % CI (0.74-0.80)] compared to patients diagnosed in the pre-ICI era. Additionally, patients under the age of 75 had a lower risk of death compared to those aged 75 years or older. Patients who received chemotherapy (systemic therapy), radiotherapy, or surgery faced a significantly lower risk of mortality. Individuals with metastasis to the brain, bone, liver, or lung had a significantly higher risk of death than those without metastasis to these locations. Marital status also played a role, as married individuals had a significantly lower risk of death compared to those who were divorced, separated, or widowed at the time of diagnosis. Furthermore, income level influenced survival, with patients earning a median annual household income of more than USD 75,000 exhibiting a significantly lower risk of mortality compared to those earning between USD 50,000 and USD 74,000. There was no significant difference in survival observed between non-Hispanic blacks and non-Hispanic whites.
CONCLUSIONS: The advent of immune checkpoint inhibitors has led to a substantial improvement in the median overall survival of individuals diagnosed with metastatic renal cell carcinoma.