Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer

A concurrent multicenter, randomized Phase II trial employing a recombinant poxviral vaccine provided evidence of enhanced median overall survival (OS) (p = 0.0061) in patients with metastatic castrate-resistant prostate cancer (mCRPC). The study reported here employed the identical vaccine in mCRPC...

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Bibliographic Details
Published in:	Cancer Immunology, Immunotherapy Immunotherapy, 2010-05, Vol.59 (5), p.663-674
Main Authors:	Gulley, James L, Arlen, Philip M, Madan, Ravi A, Tsang, Kwong-Yok, Pazdur, Mary P, Skarupa, Lisa, Jones, Jacquin L, Poole, Diane J, Higgins, Jack P, Hodge, James W, Cereda, Vittore, Vergati, Matteo, Steinberg, Seth M, Halabi, Susan, Jones, Elizabeth, Chen, Clara, Parnes, Howard, Wright, John J, Dahut, William L, Schlom, Jeffrey
Format:	Article
Language:	eng
Subjects:	Aged Androgen Antagonists - therapeutic use Antigens, Neoplasm - immunology Antigens, Neoplasm - therapeutic use Antineoplastic agents Antineoplastic Agents - therapeutic use Biological and medical sciences Cancer Research Cancer vaccines Cancer Vaccines - immunology Cancer Vaccines - therapeutic use Cell survival Costimulator Docetaxel Fowlpox Granulocyte-macrophage colony-stimulating factor Granulocyte-Macrophage Colony-Stimulating Factor - immunology Granulocyte-Macrophage Colony-Stimulating Factor - therapeutic use Gynecology. Andrology. Obstetrics Humans Immunology Immunotherapy Kaplan-Meier Estimate Lymphocytes T Male Male genital diseases Medical prognosis Medical sciences Medicine Medicine & Public Health Metastases Metastasis Nephrology. Urinary tract diseases Nomograms Oncology Original Article Pharmacology. Drug treatments Poxviridae - genetics Prognosis Prostate cancer Prostate-specific antigen Prostate-Specific Antigen - genetics Prostate-Specific Antigen - immunology Prostatic Neoplasms - immunology Prostatic Neoplasms - pathology Prostatic Neoplasms - therapy Taxoids - therapeutic use Transgenes Tumors Tumors of the urinary system Urinary tract. Prostate gland Vaccination Vaccines Vaccinia
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Summary:	A concurrent multicenter, randomized Phase II trial employing a recombinant poxviral vaccine provided evidence of enhanced median overall survival (OS) (p = 0.0061) in patients with metastatic castrate-resistant prostate cancer (mCRPC). The study reported here employed the identical vaccine in mCRPC to investigate the influence of GM-CSF with vaccine, and the influence of immunologic and prognostic factors on median OS. Thirty-two patients were vaccinated once with recombinant vaccinia containing the transgenes for prostate-specific antigen (PSA) and three costimulatory molecules. Patients received boosters with recombinant fowlpox containing the same four transgenes. Twelve of 32 patients showed declines in serum PSA post-vaccination and 2/12 showed decreases in index lesions. Median OS was 26.6 months (predicted median OS by the Halabi nomogram was 17.4 months). Patients with greater PSA-specific T-cell responses showed a trend (p = 0.055) toward enhanced survival. There was no difference in T-cell responses or survival in cohorts of patients receiving GM-CSF versus no GM-CSF. Patients with a Halabi predicted survival of
ISSN:	0340-7004 1432-0851