小柯机器人

澳大利亚悉尼大学Georgina V. Long研究组揭示老人黑色素瘤新辅助疗法的病理反应和生存率。相关论文于2021年2月8日在线发表在《自然—医学》杂志上。

研究人员表示，黑色素瘤新辅助治疗的病理反应、无复发生存期（RFS）和总生存期（OS）之间的关系尚不清楚。

研究人员汇总了基于抗PD-1的免疫疗法或BRAF/MEK靶向疗法的六项临床试验数据，总共包括192例患者。141例患者接受了免疫疗法（104例，ipilimumab和nivolumab的组合；37例，抗PD-1单一疗法），而51例接受了靶向疗法。40％的患者发生了病理完全缓解（pCR）：靶向治疗为47％，免疫治疗为33％（联合治疗为43％，单药治疗为20％）。pCR与改善的RFS相关（pCR 2年OS为89％，无pCR为50％，P<0.001）和OS（pCR 2年OS为95％，无pCR为83％，P=0.027）。

在患有pCR，接近pCR或采用免疫疗法引起部分病理反应的患者中，几乎没有观察到复发（两年RFS 96％），并且没有患者死于黑色素瘤，而即使使用靶向治疗的pCR，2年的RFS仅为79％，而OS仅为91％。病理反应应该是临床试验的早期替代终点，并且是黑色素瘤疗法发展和批准的新基准。 

附：英文原文

Title: Pathological response and survival with neoadjuvant therapy in melanoma: a pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC)

Author: Alexander M. Menzies, Rodabe N. Amaria, Elisa A. Rozeman, Alexander C. Huang, Michael T. Tetzlaff, Bart A. van de Wiel, Serigne Lo, Ahmad A. Tarhini, Elizabeth M. Burton, Thomas E. Pennington, Robyn P. M. Saw, Xiaowei Xu, Giorgos C. Karakousis, Paolo A. Ascierto, Andrew J. Spillane, Alexander C. J. van Akkooi, Michael A. Davies, Tara C. Mitchell, Hussein A. Tawbi, Richard A. Scolyer, Jennifer A. Wargo, Christian U. Blank, Georgina V. Long

Issue&Volume: 2021-02-08

Abstract: 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.

DOI: 10.1038/s41591-020-01188-3

Source: https://www.nature.com/articles/s41591-020-01188-3

Nature Medicine：《自然—医学》，创刊于1995年。隶属于施普林格·自然出版集团，最新IF：87.241
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