期刊
NATURE MEDICINE
卷 27, 期 2, 页码 301-+出版社
NATURE PORTFOLIO
DOI: 10.1038/s41591-020-01188-3
关键词
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资金
- Cancer Institute NSW Fellowship
- Melanoma Institute Australia
- NIH/NCI [1 P50 CA221703-02]
- NHMRC Practitioner Fellowships
- University of Sydney Medical Foundation
- Dr. Miriam and Sheldon G. Adelson Medical Research Foundation
A pooled analysis of neoadjuvant immunotherapy trials in melanoma revealed that the degree of pathological response is correlated with patient survival, serving as a potential surrogate marker for long-term outcomes. Patients with pathological complete response (pCR) after immunotherapy showed significantly improved recurrence-free survival (RFS) and overall survival (OS) compared to those without pCR. Pathological response, particularly pCR, could be an early surrogate endpoint for clinical trials and a new benchmark for development and approval in melanoma.
A pooled analysis of neoadjuvant immunotherapy trials in melanoma shows that the degree of pathological response associates with patient survival and might represent a surrogate marker for long-term outcomes. 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.
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