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).
Highlights
In spite of high expectations, cancer vaccines have found little applicability in oncology clinical practice [1]
We have developed a clinical-grade product based on autologous CD14+ monocytes differentiated to DC by means of 7-day cultures in the presence of GM-CSF and IL-4
Patient selection and treatment This is an open label randomized phase II trial (Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma registered on May 11th 2011 in https://www.clinicaltrials.gov/ct2/ show/NCT01348256) evaluating the efficacy of dendritic cell vaccination versus observation in patients with potentially resectable liver metastases from colon cancer who underwent a complete scheme of neoadjuvant chemotherapy, surgery and adjuvant chemotherapy
Summary
In spite of high expectations, cancer vaccines have found little applicability in oncology clinical practice [1]. Dendritic cell vaccines harness the antigen-presenting functions of these leukocyte subsets to induce antitumor CD8 and CD4 T cell responses [3]. The only exception of a FDA-approved cancer vaccine is a monocyte-derived dendritic cell product pulsed with a prostate serum antigen. We have developed a clinical-grade product based on autologous CD14+ monocytes differentiated to DC by means of 7-day cultures in the presence of GM-CSF and IL-4. Such cultures are incubated with autologous tumor lysate and activated by a cocktail of agents combining TNFα, poly-ICLC (Hiltonoltm) and IFNα [12].
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