Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• Nature medicine, 2021-02, Vol.27 (2), p.301-309

Ort / Verlag

New York: Nature Publishing Group US

Erscheinungsjahr

2021

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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.