影响中国晚期黑色素瘤患者抗PD-1治疗疗效的因素
Factors Influencing the Efficacy of Anti-PD-1 Therapy in Chinese Patients with Advanced Melanoma.
作者信息
Zhao Lingdi, Yang Yonghao, Ma Baozhen, Li Wei, Li Tiepeng, Han Lu, Zhang Yong, Shang Yi-Man, Lin Hongwei, Gao Quanli
机构信息
Department of Immunotherapy, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou City, Henan Province, China.
出版信息
J Oncol. 2019 Sep 26;2019:6454989. doi: 10.1155/2019/6454989. eCollection 2019.
PURPOSE
Anti-PD-1 antibody improves the survival of patients with advanced melanoma. However, the efficacy and safety of anti-programmed death protein 1 (PD-1) antibody have not been fully elucidated in Chinese melanoma patients, who show high frequency of mucosal and acral melanoma subtypes; besides, the factors influencing the efficacy of anti-PD-1 antibody have not been evaluated broadly.
PATIENTS AND METHODS
Patients with advanced melanoma treated with regimens containing anti-PD-1 antibody from June 2016 to January 2019 were evaluated. Baseline characteristics and blood parameters were assessed, and outcome and adverse events were evaluated according to different regimens. The Cox proportional hazards regression model was used for univariate and multivariate analyses.
RESULTS
A total of 51 patients with advanced melanoma were included in this study. The overall objective response rate (ORR) was 17.6%, the disease control rate was 58.5%, and the median time to progression was 5.2 months. The ORR of patients with PD-1 blockade-based combination therapy, without liver metastases and higher level of C-reactive protein (CRP) before PD-1 blockade, is higher than that of those not. Univariate analysis based on clinical features showed that ECOG scores, liver metastasis, elevated lactate dehydrogenase (LDH), and CRP levels were the factors affecting time to progression (TTP). Multivariate analysis showed that elevated CRP before PD-1 blockade was an independent predictive factor for ORR of PD-1 blockade therapy (=0.009), while only Eastern Cooperative Oncology Group (ECOG) score was an independent predictor for TTP (=0.032). The treatment was well tolerated in these cohort patients, and there was no treatment-related death.
CONCLUSION
Anti-PD-1 antibody-containing regimen was safe and effective in Chinese patients with advanced melanoma, and elevated CRP and ECOG score were independent factors predicting the efficacy of anti-PD-1 therapy.
目的
抗程序性死亡蛋白1（PD-1）抗体可提高晚期黑色素瘤患者的生存率。然而，抗PD-1抗体在中国黑色素瘤患者中的疗效和安全性尚未完全阐明，中国黑色素瘤患者黏膜和肢端黑色素瘤亚型的发生率较高；此外，尚未广泛评估影响抗PD-1抗体疗效的因素。
患者与方法
对2016年6月至2019年1月接受含抗PD-1抗体方案治疗的晚期黑色素瘤患者进行评估。评估基线特征和血液参数，并根据不同方案评估结局和不良事件。采用Cox比例风险回归模型进行单因素和多因素分析。
结果
本研究共纳入51例晚期黑色素瘤患者。总体客观缓解率（ORR）为17.6%，疾病控制率为58.5%，中位疾病进展时间为5.2个月。基于PD-1阻断的联合治疗、无肝转移且PD-1阻断前C反应蛋白（CRP）水平较高的患者的ORR高于未接受此类治疗的患者。基于临床特征的单因素分析表明，东部肿瘤协作组（ECOG）评分、肝转移、乳酸脱氢酶（LDH）升高和CRP水平是影响疾病进展时间（TTP）的因素。多因素分析表明，PD-1阻断前CRP升高是PD-1阻断治疗ORR的独立预测因素（P=0.009），而只有ECOG评分是TTP的独立预测因素（P=0.032）。这些队列患者对治疗耐受性良好，且无治疗相关死亡。
结论
含抗PD-1抗体的方案在中国晚期黑色素瘤患者中安全有效，CRP升高和ECOG评分是预测抗PD-1治疗疗效的独立因素。
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