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Eur Urol Focus. 2017 Oct 4. pii: S2405-4569(17)30213-4. doi: 10.1016/j.euf.2017.09.009. [Epub ahead of print]

Results of a Phase 1/2 Study in Metastatic Renal Cell Carcinoma Patients Treated with a Patient-specific Adjuvant Multi-peptide Vaccine after Resection of Metastases.

Author information

1
Department of Urology, Eberhard Karls University, Tübingen, Germany.
2
Department of Immunology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.
3
Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany.
4
Department of Immunology, Eberhard Karls University, Tübingen, Germany.
5
Department of Urology, University of Greifswald, Greifswald, Germany.
6
Department of Urology, Eberhard Karls University, Tübingen, Germany; German Cancer Consortium (DKTK), Partnerstandort Tübingen, German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: jens.bedke@med.uni-tuebingen.de.

Abstract

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).

PATIENT SUMMARY:

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.

KEYWORDS:

Adjuvant; GM-CSF; Immunotherapy; Metastasectomy; Metastasis; Renal cell carcinoma; Synthetic peptides; TKI; Vaccination

PMID:
28988765
DOI:
10.1016/j.euf.2017.09.009

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