中国晚期黑色素瘤患者抗癌治疗和预后因素的实际临床结果

C. Cui, Xieqiao Yan, Ben Li, L. Si, C. Zhihong, X. Sheng, B. Lian, Xuan Wang, L. Mao, B. Tang, Li Zhou, X. Bai, Si-ming Li, Jun Guo
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引用次数: 1

摘要

目的:中国黑色素瘤患者的5年生存率远低于西方国家。本回顾性研究描述了中国局部晚期/转移性黑色素瘤的真实临床结果和预后因素。材料和方法:纳入2014年1月1日至2015年12月31日在北京肿瘤医院接受治疗的无法切除的III期或IV期黑色素瘤成人患者(数据截止日期:2017年12月31日)。Kaplan-Meier法和Log-Rank检验用于估计事件发生时间结局的中位数。模拟Cox比例风险模型来评估患者特征与生存的关系。结果:总体而言,分别有221名和116名中国局部晚期和/或转移性黑色素瘤患者入组一线(1L)和二线(2L)治疗。真实世界客观有效率<10% (1L: 6.3%;2 l: 3.4%);中位无进展生存期低于4个月(1L: 3.5;2 l: 2.3);中位总生存期(OS) <1年(1L: 10.5;2L: 7.5), 12个月OS率低(1L为43.5%,2L为30.5%)。基于单因素分析,在1L组中ECOG表现状态≥2 (vs. ECOG=0),在1L/2L组中接受2L治疗(vs. 1L治疗)或ECOG≥2 (vs. ECOG=1)的患者预后较差,具有统计学意义。结论:目前中国晚期黑色素瘤患者的临床预后较差。高ECOG表现评分独立地增加了1L和2L治疗的死亡风险,表明晚期黑色素瘤免疫治疗的医疗需求未得到满足。
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Real-world clinical outcomes of anticancer treatments and prognostic factors in patients with advanced melanoma in China
Purpose: China has much lower 5-year survival rates among melanoma patients than Western countries. This retrospective study describes real-world clinical outcomes and prognostic factors in locally advanced/metastatic melanoma in China. Materials and methods: Adults patients with unresectable stage III or IV melanoma treated between January 1, 2014 and December 31, 2015, at the Beijing Cancer Hospital were eligible (data cutoff: December 31, 2017). The Kaplan-Meier method and Log-Rank test were used to estimate the median value of time-to-event outcomes. A Cox proportional hazards model was simulated to evaluate associations of patients’ characteristics with survival. Results: Overall, there were 221 and 116 Chinese locally advanced and/or metastatic melanoma patients were enrolled in the first line (1L) and the second line (2L) treatments, respectively. The real-world objective response rate was <10% (1L: 6.3%; 2L: 3.4%); median progression-free survival was under 4 months (1L: 3.5; 2L: 2.3); median overall survival (OS) was <1 year (1L: 10.5; 2L: 7.5) with a low 12-month OS rate (43.5% for 1L, 30.5% for 2L). Based on univariate analyses, those with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2 (vs. ECOG=0) in 1L, and 2L treatment (vs. 1L treatment) or ECOG ≥2 (vs. ECOG=1) among 1L/2L were associated with statistically significantly worse outcomes. Conclusion: The current clinical outcomes in advanced melanoma patients in China are poor. High ECOG performance score independently increase risk of death both from 1L and 2L treatments, suggesting a high unmet medical need for immunotherapy in advanced melanoma.
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