新辅助治疗黑色素瘤的病理反应和生存：来自国际新辅助黑色素瘤联盟（INMC）的汇总分析。
Pathological response and survival with neoadjuvant therapy in melanoma: a pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC).
机构信息
Melanoma Institute Australia, The University of Sydney, Sydney, Australia.
Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
出版信息
Nat Med. 2021 Feb;27(2):301-309. doi: 10.1038/s41591-020-01188-3. Epub 2021 Feb 8.
The association among pathological response, recurrence-free survival (RFS) and overall survival (OS) with neoadjuvant therapy in melanoma remains unclear. In this study, we pooled data from six clinical trials of anti-PD-1-based immunotherapy or BRAF/MEK targeted therapy. In total, 192 patients were included; 141 received immunotherapy (104, combination of ipilimumab and nivolumab; 37, anti-PD-1 monotherapy), and 51 received targeted therapy. A pathological complete response (pCR) occurred in 40% of patients: 47% with targeted therapy and 33% with immunotherapy (43% combination and 20% monotherapy). pCR correlated with improved RFS (pCR 2-year 89% versus no pCR 50%, P < 0.001) and OS (pCR 2-year OS 95% versus no pCR 83%, P = 0.027). In patients with pCR, near pCR or partial pathological response with immunotherapy, very few relapses were seen (2-year RFS 96%), and, at this writing, no patient has died from melanoma, whereas, even with pCR from targeted therapy, the 2-year RFS was only 79%, and OS was only 91%. Pathological response should be an early surrogate endpoint for clinical trials and a new benchmark for development and approval in melanoma.
新辅助治疗后黑色素瘤的病理缓解、无复发生存（RFS）和总生存（OS）与抗 PD-1 免疫治疗或 BRAF/MEK 靶向治疗之间的关联仍不清楚。在这项研究中，我们汇集了 6 项基于抗 PD-1 免疫治疗或 BRAF/MEK 靶向治疗的临床试验数据。共有 192 例患者纳入研究；141 例接受免疫治疗（104 例为伊匹单抗和纳武单抗联合治疗；37 例为抗 PD-1 单药治疗），51 例接受靶向治疗。病理完全缓解（pCR）的发生率为 40%：靶向治疗组为 47%，免疫治疗组为 33%（联合治疗组为 43%，单药治疗组为 20%）。pCR 与改善 RFS（pCR 组 2 年 RFS 为 89%，无 pCR 组为 50%，P<0.001）和 OS（pCR 组 2 年 OS 为 95%，无 pCR 组为 83%，P=0.027）相关。在 pCR、接近 pCR 或免疫治疗部分缓解的患者中，很少有复发（2 年 RFS 为 96%），并且截至撰写本文时，没有患者因黑色素瘤死亡，而即使接受靶向治疗达到 pCR，2 年 RFS 也仅为 79%，OS 仅为 91%。病理缓解应该成为临床试验的早期替代终点，并为黑色素瘤的研发和审批提供新的基准。
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