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晚期皮肤黑色素瘤的真实临床管理与生存情况:意大利国家黑色素瘤临床登记处的经验

Real Life Clinical Management and Survival in Advanced Cutaneous Melanoma: The Italian Clinical National Melanoma Registry Experience.

作者信息

Crispo Anna, Corradin Maria Teresa, Giulioni Erika, Vecchiato Antonella, Del Fiore Paolo, Queirolo Paola, Spagnolo Francesco, Vanella Vito, Caracò Corrado, Tosti Giulio, Pennacchioli Elisabetta, Giudice Giuseppe, Nacchiero Eleonora, Quaglino Pietro, Ribero Simone, Giordano Monica, Marussi Desire, Barruscotti Stefania, Guida Michele, De Giorgi Vincenzo, Occelli Marcella, Grosso Federica, Cairo Giuseppe, Gatti Alessandro, Massa Daniela, Atzori Laura, Calvani Nicola, Fabrizio Tommaso, Mastrangelo Giuseppe, Toffolutti Federica, Celentano Egidio, Budroni Mario, Gandini Sara, Rossi Carlo Riccardo, Testori Alessandro, Palmieri Giuseppe, Ascierto Paolo A

机构信息

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.

Dermatology Department, Azienda Sanitaria Friuli Occidentale, Pordenone, Italy.

出版信息

Front Oncol. 2021 Jul 8;11:672797. doi: 10.3389/fonc.2021.672797. eCollection 2021.

Abstract

BACKGROUND

Cutaneous melanoma (CM) is one of the most aggressive types of skin cancer. Currently, innovative approaches such as target therapies and immunotherapies have been introduced in clinical practice. Data of clinical trials and real life studies that evaluate the outcomes of these therapeutic associations are necessary to establish their clinical utility. The aim of this study is to investigate the types of oncological treatments employed in the real-life clinical management of patients with advanced CM in several Italian centers, which are part of the Clinical National Melanoma Registry (CNMR).

METHODS

Melanoma-specific survival and overall survival were calculated. Multivariate Cox regression models were used to estimate the hazard ratios adjusting for confounders and other prognostic factors.

RESULTS

The median follow-up time was 36 months (range 1.2-185.1). 787 CM were included in the analysis with completed information about therapies. All types of immunotherapy showed a significant improved survival compared with all other therapies (p=0.001). 75% was the highest reduction of death reached by anti-PD-1 (HR=0.25), globally immunotherapy was significantly associated with improved survival, either for anti-CTLA4 monotherapy or combined with anti-PD-1 (HR=0.47 and 0.26, respectively) and BRAFI+MEKI (HR=0.62).

CONCLUSIONS

The nivolumab/pembrolizumab in combination of ipilimumab and the addition of ant-MEK to the BRAFi can be considered the best therapies to improve survival in a real-world-population. The CNMR can complement clinical registries with the intent of improving cancer management and standardizing cancer treatment.

摘要

背景

皮肤黑色素瘤(CM)是最具侵袭性的皮肤癌类型之一。目前,诸如靶向治疗和免疫治疗等创新方法已被引入临床实践。评估这些联合治疗效果的临床试验和真实世界研究数据对于确定其临床实用性是必要的。本研究的目的是调查意大利几个中心在晚期CM患者真实临床管理中采用的肿瘤治疗类型,这些中心是国家临床黑色素瘤登记处(CNMR)的一部分。

方法

计算黑色素瘤特异性生存率和总生存率。使用多变量Cox回归模型估计调整混杂因素和其他预后因素后的风险比。

结果

中位随访时间为36个月(范围1.2 - 185.1个月)。787例CM纳入分析,且有关于治疗的完整信息。与所有其他治疗相比,所有类型的免疫治疗均显示生存率显著提高(p = 0.001)。抗PD - 1达到的最高死亡降低率为75%(HR = 0.25),总体而言,免疫治疗与生存率提高显著相关,无论是抗CTLA4单药治疗还是与抗PD - 1联合使用(HR分别为0.47和0.26)以及BRAF抑制剂 + MEK抑制剂联合使用(HR = 0.62)。

结论

纳武单抗/派姆单抗联合伊匹单抗以及在BRAF抑制剂基础上加用MEK抑制剂可被认为是在真实世界人群中提高生存率的最佳治疗方法。CNMR可以补充临床登记信息,以改善癌症管理并规范癌症治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f752/8298066/67a53dc7c90d/fonc-11-672797-g001.jpg

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