A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis

García-Rodríguez, J. (Javier); Castañon, E. (Eduardo); Perez-Gracia, J.L. (Jose Luis); Rodriguez, I. (Inmaculada); Viudez, A. (A.); Alfaro, C. (Carlos); Oñate, C. (Carmen); Perez, G. (Guiomar); Rotellar, F. (Fernando); Inoges, S. (Susana); Lopez-Diaz-de-Cerio, A. (Ascensión); Resano, L. (Leyre); Ponz-Sarvise, M. (Mariano); Rodriguez-Ruiz, M.E. (María E.); Chopitea, A. (Ana); Vera, R. (Ruth); Melero, I. (Ignacio)

Keywords:

Dendritic cell
Colon cancer
Vaccine
Relapse prevention
Randomized clinical trial

Issue Date:

2018

Publisher:

National Library of Medicine

ISSN:

2051-1426

Note:

This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Citation:

García-Rodríguez, J. (Javier); Castañon, E. (Eduardo); Perez-Gracia, J.L. (Jose Luis); et al. "A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis". JOURNAL FOR IMMUNOTHERAPY OF CANCER. 6, 2018, 96

Abstract

Surgically resectable synchronic and metachronic liver metastases of colon cancer have high risk of relapse in spite of standard-of-care neoadjuvant and adjuvant chemotherapy regimens. Dendritic cell vaccines loaded with autologous tumor lysates were tested for their potential to avoid or delay disease relapses (NCT01348256). Patients with surgically amenable liver metastasis of colon adenocarcinoma (n = 19) were included and underwent neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. Fifteen patients with disease-free resection margins were randomized 1:1 to receive two courses of four daily doses of dendritic cell intradermal vaccinations versus observation. The trial had been originally designed to include 56 patients but was curtailed due to budgetary restrictions. Follow-up of the patients indicates a clear tendency to fewer and later relapses in the vaccine arm (median disease free survival –DFS-) 25.26 months, 95% CI 8. 74-n.r) versus observation arm (median DFS 9.53 months, 95% CI 5.32–18.88).

URI:

https://hdl.handle.net/10171/64389

DOI:

10.1186/s40425-018-0405-z

Appears in Collections:

DA - CUN - Oncología médica - Artículos de revista

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