Treatment of metastatic renal cell carcinoma comprises metastasectomy±systemic medical treatment. Specific immunotherapy after metastasectomy could be a complementary option. In this phase 1/2 study, safety and tolerability of an adjuvant multi-peptide vaccine (UroRCC) after metastasectomy was evaluated together with immune response and efficacy, compared with a contemporary cohort of patients (n=44) treated with metastasectomy only. Nineteen metastatic renal cell carcinoma patients received UroRCC via intradermal or subcutaneous application randomized to immunoadjuvants (granulocyte-macrophage colony-stimulating factor or Montanide). Adverse events of UroRCC were mainly grade I and II; frequency of immune response was higher for major histocompatibility complex class II peptides (17/19, 89.5%) than for major histocompatibility complex class I peptides (8/19, 42.1%). Median overall survival was not reached in the UroRCC group (mean: 112.6 mo, 95% confidence interval [CI]: 92.1-133.1) and 58.0 mo (95% CI: 32.7-83.2) in the control cohort (p=0.015). UroRCC was an independent prognosticator of overall survival (hazard ratio=0.19, 95% CI: 0.05-0.69, p=0.012). Adjuvant UroRCC multi-peptide vaccine after metastasectomy was well tolerated, immunogenic, and indicates potential clinical benefit when compared with a contemporary control cohort (NCT02429440).
The application of a patient-specific peptide vaccine after complete resection of metastases in metastatic renal cell carcinoma patients resulted in favorable tolerability and outcome.
European urology focus. 2017 Oct 04 [Epub ahead of print]
Steffen Rausch, Cécile Gouttefangeas, Jörg Hennenlotter, Karoline Laske, Kerstin Walter, Susan Feyerabend, Premachandran Anoop Chandran, Stephan Kruck, Harpreet Singh-Jasuja, Annemarie Frick, Nils Kröger, Stefan Stevanović, Arnulf Stenzl, Hans-Georg Rammensee, Jens Bedke
Department of Urology, Eberhard Karls University, Tübingen, Germany., Department of Immunology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany., Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany., Department of Immunology, Eberhard Karls University, Tübingen, Germany., Department of Urology, University of Greifswald, Greifswald, Germany., Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: .