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抗PD-1抗体免疫疗法在肢端黑色素瘤患者中的疗效不佳:来自西班牙黑色素瘤研究组(GEM)登记处的结果

Poor efficacy of anti PD-1 antibody based immunotherapy in patients with acral melanoma: results from the Spanish Melanoma Group (GEM) registry.

作者信息

Gonzalez-Cao Maria, Berciano-Guerrero Miguel-Ángel, Muñoz-Couselo Eva, Manzano José Luis, Cerezuela-Fuentes Pablo, Crespo Guillermo, Soria Ainara, de Miguel Pablo Ayala, Gutiérrez Sanz Lourdes, de la Rosa Carlos Aguado, García Castaño Almudena, Puértolas Teresa, Espinosa Enrique, Medina Javier, Bellido Lorena, Berrocal Alfonso, Majem Margarita, López Castro Rafael, Fernandez Luis Antonio, Garcia Francisco, de la Borbolla Maria Rodriguez, Martín Algarra Salvador, Márquez-Rodas Iván

机构信息

Medical Oncology Department, Instituto Oncologico Dr Rosell, Dexeus University Hospital, Carrer de Sabino Arana, 5, Les Corts, 08028, Barcelona, Spain.

Medical Oncology Department, Hospital Regional Universitario de Málaga (HRU), Instituto de Investigaciones Biomédicas de Málaga (IBIMA), Málaga, Spain.

出版信息

Clin Transl Oncol. 2025 Aug 21. doi: 10.1007/s12094-025-04018-5.

Abstract

BACKGROUND

Acral melanoma (AM) is uncommon in non-Asian race. Limited data exist in non-Asian population.

OBJECTIVE

To analyze the activity of immunotherapy in patients diagnosed with AM in Spain.

METHODS

We analyzed clinical outcomes of AM in the nationwide Spanish Melanoma Group Registry.

RESULTS

69 AM (17 stage III; 52 stage IV) and 724 cutaneous melanoma (CM) (190 stage III; 534 stage IV), predominantly non-Hispanic white. Regarding stage IV, AM patients were older (median 73.6 vs. 66.6 years, p = 0.001) and less often BRAF mutant (9.6% vs. 60.7%, p = 0.0001). First line immunotherapy (49 AM; 316 CM), response rate was 15.0% vs 39.1% (p = 0.0033), median progression free survival was 5.5 (95% CI 3.97-8.23) vs 15.3 months (95% CI 8.97- 26.3) (p = 0.001) and median OS was 17.3 (95% CI 13.32-39.97) versus 43.0 months (95% CI 30.81, NR) (p = 0.007), for AM and CM, respectively. Stage III AM were deeper (T4b in 52.9% vs. 25.3%, p = 0.02). In adjuvant anti PD-1-treated patients (14 AM; 156 CM) median RFS was 10.23 months (95% CI 6.0-NR) in AM versus NR (54.5-NR) in CM (p = 0.017) and 5 year OS was 36.1% vs. 75.8% (p = 0.034).

CONCLUSIONS

Our data confirms a poor outcome of AM in the Spanish population.

摘要

背景

肢端黑色素瘤(AM)在非亚洲人种中并不常见。非亚洲人群中的相关数据有限。

目的

分析西班牙确诊为AM的患者接受免疫治疗的疗效。

方法

我们在全国性的西班牙黑色素瘤研究组登记处分析了AM的临床结果。

结果

69例AM患者(17例III期;52例IV期)和724例皮肤黑色素瘤(CM)患者(190例III期;534例IV期),主要为非西班牙裔白人。在IV期患者中,AM患者年龄更大(中位年龄73.6岁对66.6岁,p = 0.001),BRAF突变的比例更低(9.6%对60.7%,p = 0.0001)。一线免疫治疗(49例AM;316例CM),AM组的缓解率为15.0%,CM组为39.1%(p = 0.0033),AM组的无进展生存期(PFS)中位数为5.5个月(95%置信区间3.97 - 8.23),CM组为15.3个月(95%置信区间8.97 - 26.3)(p = 0.001),总生存期(OS)中位数分别为17.3个月(95%置信区间13.32 - 39.97)和43.0个月(95%置信区间30.81,未达到)(p = 0.007)。III期AM更厚(T4b比例为52.9%对25.3%,p = 0.02)。在接受辅助抗PD - 1治疗的患者中(14例AM;156例CM),AM组的无复发生存期(RFS)中位数为10.23个月(95%置信区间6.0 - 未达到),CM组未达到(54.5 - 未达到)(p = 0.017),5年总生存率分别为36.1%和75.8%(p = 0.034)。

结论

我们的数据证实了西班牙人群中AM的预后较差。

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