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    Vaccination of Metastatic Renal Cancer Patients with MVA-5T4: A Randomized, Double-Blind, Placebo-Controlled Phase III Study.

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    Authors
    Amato, R J
    Hawkins, Robert E
    Kaufman, H L
    Thompson, J A
    Tomczak, P
    Szczylik, C
    McDonald, M
    Eastty, S
    Shingler, W H
    De Belin, J
    Goonewardena, M
    Naylor, S
    Harrop, R
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    Affiliation
    Authors' Affiliations: The University of Texas/Memorial Hermann Hospital, Houston, Texas; Christie Hospital, Withington, Manchester, United Kingdom; Rush University Medical Center, Chicago, Illinois; University of Washington, Seattle, Washington; Lord's Transfiguration Independent Public Clinical Hospital, Poznan, Poland; Military Institute of Medicine, Department of Oncology, Warsaw, Poland; and Oxford BioMedica (UK) Ltd., The Medawar Centre, Oxford, United Kingdom.
    Issue Date
    2010-11-15
    
    Metadata
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    Abstract
    PURPOSE: The TroVax Renal Immunotherapy Survival Trial was a randomized, placebo-controlled phase III study that investigated whether modified vaccinia Ankara encoding the tumor antigen 5T4 (MVA-5T4) prolonged survival of patients receiving first-line standard-of-care (SOC) treatment for metastatic renal cell cancer. EXPERIMENTAL DESIGN: Patients with metastatic clear cell renal cancer, prior nephrectomy, and good or intermediate prognosis were randomized 1:1 to receive up to 13 immunizations of MVA-5T4/placebo in combination with either sunitinib, interleukin-2 or interferon-α. The primary end point was overall survival. Secondary end points included progression-free survival, overall response rate, and safety. RESULTS: Seven hundred thirty-three patients were recruited (365 MVA-5T4 and 368 placebo). Treatment arms were well balanced for SOC and prognosis. No significant difference in the incidence of adverse events or serious adverse events was observed. No significant difference in overall survival was evident in the two treatment arms (median 20.1 months MVA-5T4 versus 19.2 months placebo; P = 0.55). The magnitude of the 5T4-specific antibody response induced by vaccination with MVA-5T4 was associated with enhanced patient survival. Furthermore, exploratory analyses suggested a number of pretreatment hematologic factors that could identify patients who derive significant benefit from this vaccine. CONCLUSION: MVA-5T4 in combination with SOC was well tolerated, but no difference in survival was observed in the overall study population. Exploratory analyses indicate that there may be subsets of patients who could gain significant benefit from MVA-5T4, but such results would need to be confirmed in future randomized clinical studies. Clin Cancer Res; 16(22); 5539-47. ©2010 AACR.
    Citation
    Vaccination of Metastatic Renal Cancer Patients with MVA-5T4: A Randomized, Double-Blind, Placebo-Controlled Phase III Study. 2010, 16 (22):5539-5547 Clin Cancer Res
    Journal
    Clinical Cancer Research
    URI
    http://hdl.handle.net/10541/115722
    DOI
    10.1158/1078-0432.CCR-10-2082
    PubMed ID
    20881001
    Type
    Article
    Language
    en
    ISSN
    1078-0432
    ae974a485f413a2113503eed53cd6c53
    10.1158/1078-0432.CCR-10-2082
    Scopus Count
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    All Paterson Institute for Cancer Research

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