학술논문
Adjuvant dendritic cell therapy in stage IIIB/C melanoma: the MIND-DC randomized phase III trial
Document Type
article
Author
Kalijn F. Bol; Gerty Schreibelt; Martine Bloemendal; Wouter W. van Willigen; Simone Hins-de Bree; Anna L. de Goede; Annemiek J. de Boer; Kevin J. H. Bos; Tjitske Duiveman-de Boer; Michel A. M. Olde Nordkamp; Tom G. M. van Oorschot; Carlijn J. Popelier; Jeanne M. Pots; Nicole M. Scharenborg; Mandy W. M. M. van de Rakt; Valeska de Ruiter; Wilmy S. van Meeteren; Michelle M. van Rossum; Sandra J. Croockewit; Bouke J. Koeneman; Jeroen H. A. Creemers; Inge M. N. Wortel; Caroline Angerer; Mareke Brüning; Katja Petry; Andrzej Dzionek; Astrid A. van der Veldt; Dirk J. van Grünhagen; Johanna E. M. Werner; Johannes J. Bonenkamp; John B. A. G. Haanen; Marye J. Boers-Sonderen; Rutger H. T. Koornstra; Martijn F. Boomsma; Erik H. J. Aarntzen; Martin Gotthardt; James Nagarajah; Theo J. M. de Witte; Carl G. Figdor; Johannes H. W. de Wilt; Johannes Textor; Jan Willem B. de Groot; Winald R. Gerritsen; I. Jolanda M. de Vries
Source
Nature Communications, Vol 15, Iss 1, Pp 1-10 (2024)
Subject
Language
English
ISSN
2041-1723
Abstract
Abstract Autologous natural dendritic cells (nDCs) treatment can induce tumor-specific immune responses and clinical responses in cancer patients. In this phase III clinical trial (NCT02993315), 148 patients with resected stage IIIB/C melanoma were randomized to adjuvant treatment with nDCs (n = 99) or placebo (n = 49). Active treatment consisted of intranodally injected autologous CD1c+ conventional and plasmacytoid DCs loaded with tumor antigens. The primary endpoint was the 2-year recurrence-free survival (RFS) rate, whereas the secondary endpoints included median RFS, 2-year and median overall survival, adverse event profile, and immunological response The 2-year RFS rate was 36.8% in the nDC treatment group and 46.9% in the control group (p = 0.31). Median RFS was 12.7 months vs 19.9 months, respectively (hazard ratio 1.25; 90% CI: 0.88−1.79; p = 0.29). Median overall survival was not reached in both treatment groups (hazard ratio 1.32; 90% CI: 0.73−2.38; p = 0.44). Grade 3−4 study-related adverse events occurred in 5% and 6% of patients. Functional antigen-specific T cell responses could be detected in 67.1% of patients tested in the nDC treatment group vs 3.8% of patients tested in the control group (p