{"corpus_id":2144044,"paper_sha":"bfb8a849f51eb4eaaa4de7b6834228fcfd9eff31","doi":"10.1200/JCO.2009.25.0597","arxiv_id":null,"pmid":20100959,"pmcid":"PMC2834462","mag_id":2155846302,"dblp_id":null,"acl_id":null,"title":"Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer.","year":2010,"publication_date":"2010-03-01","venue":"Journal of Clinical Oncology","journal":{"name":"Journal of clinical oncology : official journal of the American Society of Clinical Oncology","pages":"\n          1099-105\n        ","volume":"28 7"},"journal_issn":null,"journal_title":null,"publication_types":["Study","JournalArticle","ClinicalTrial"],"pubmed_pub_types":["Clinical Trial, Phase II","Journal Article","Multicenter Study","Randomized Controlled Trial","Research Support, N.I.H., Extramural"],"s2_fields_of_study":["Medicine"],"reference_count":24,"citation_count":946,"influential_citation_count":46,"is_open_access":true,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":[{"d":"Aged","mj":false,"ui":"D000368"},{"d":"Aged, 80 and over","mj":false,"ui":"D000369"},{"d":"Cancer Vaccines","mj":false,"qs":[{"q":"immunology","mj":true,"ui":"Q000276"}],"ui":"D019496"},{"d":"Double-Blind Method","mj":false,"ui":"D004311"},{"d":"Genetic Vectors","mj":false,"qs":[{"q":"immunology","mj":false,"ui":"Q000276"}],"ui":"D005822"},{"d":"Humans","mj":false,"ui":"D006801"},{"d":"Immunization","mj":false,"ui":"D007114"},{"d":"Male","mj":false,"ui":"D008297"},{"d":"Middle Aged","mj":false,"ui":"D008875"},{"d":"Neoplasm Metastasis","mj":false,"ui":"D009362"},{"d":"Orchiectomy","mj":false,"ui":"D009919"},{"d":"Poxviridae","mj":false,"qs":[{"q":"immunology","mj":true,"ui":"Q000276"}],"ui":"D011212"},{"d":"Prostate-Specific Antigen","mj":false,"qs":[{"q":"antagonists & inhibitors","mj":false,"ui":"Q000037"},{"q":"immunology","mj":true,"ui":"Q000276"}],"ui":"D017430"},{"d":"Prostatic Neoplasms","mj":false,"qs":[{"q":"mortality","mj":false,"ui":"Q000401"},{"q":"pathology","mj":false,"ui":"Q000473"},{"q":"therapy","mj":true,"ui":"Q000628"}],"ui":"D011471"},{"d":"Vaccines, Synthetic","mj":false,"qs":[{"q":"immunology","mj":false,"ui":"Q000276"}],"ui":"D014614"}],"chemicals":[{"n":"Cancer Vaccines","ui":"D019496","reg":"0"},{"n":"Vaccines, Synthetic","ui":"D014614","reg":"0"},{"n":"Prostate-Specific Antigen","ui":"D017430","reg":"EC 3.4.21.77"}],"comments_corrections":null,"source_flags":5,"s2_open_access_pdf_url":"https://europepmc.org/articles/pmc2834462?pdf=render","s2_open_access_landing_url":"https://www.semanticscholar.org/paper/bfb8a849f51eb4eaaa4de7b6834228fcfd9eff31","s2_open_access_license":null,"s2_open_access_status":"GREEN","pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"PURPOSE: Therapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study. PATIENTS AND METHODS: In total, 125 patients were randomly assigned in a multicenter trial of vaccination series. Eligible patients had minimally symptomatic castration-resistant metastatic prostate cancer (mCRPC). PROSTVAC-VF comprises two recombinant viral vectors, each encoding transgenes for PSA, and three immune costimulatory molecules (B7.1, ICAM-1, and LFA-3). Vaccinia-based vector was used for priming followed by six planned fowlpox-based vector boosts. Patients were allocated (2:1) to PROSTVAC-VF plus granulocyte-macrophage colony-stimulating factor or to control empty vectors plus saline injections. RESULTS: Eighty-two patients received PROSTVAC-VF and 40 received control vectors. Patient characteristics were similar in both groups. The primary end point was PFS, which was similar in the two groups (P = .6). However, at 3 years post study, PROSTVAC-VF patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls, longer median survival by 8.5 months (25.1 v 16.6 months for controls), an estimated hazard ratio of 0.56 (95% CI, 0.37 to 0.85), and stratified log-rank P = .0061. CONCLUSION: PROSTVAC-VF immunotherapy was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median OS in men with mCRPC. These provocative data provide preliminary evidence of clinically meaningful benefit but need to be confirmed in a larger phase III study.","claims":[{"public_id":"cl_b12821fadcd22728840b045efe6c6ff5","status":"active","text":"PROSTVAC-VF comprises two recombinant viral vectors encoding transgenes for PSA and three immune costimulatory molecules (B7.1, ICAM-1, LFA-3), using a vaccinia-based vector for priming followed by six fowlpox-based vector boosts.","confidence":0.95,"contributors":[{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["extraction"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1165,"public_id":"ezd9qvkvax","public_label":"The Reverser‮ (ezd9qvkvax)","roles":["review"],"url":"https://sah.borca.ai/u/ezd9qvkvax"},{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale 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a stratified log-rank P = .0061 favoring the PROSTVAC-VF group.","confidence":0.95,"contributors":[{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["extraction"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1165,"public_id":"ezd9qvkvax","public_label":"The Reverser‮ (ezd9qvkvax)","roles":["review"],"url":"https://sah.borca.ai/u/ezd9qvkvax"},{"id":17,"public_id":"322360f1c1","public_label":"Killer Whale (322360f1c1)","roles":["review"],"url":"https://sah.borca.ai/u/322360f1c1"}],"url":"https://sah.borca.ai/claims/cl_858728c042d709b769923413969982c1"}],"concepts":[{"public_id":"co_0225a28e8fa7002962581f8f588a4a8e","status":"active","name":"PSA","description":"Prostate-specific antigen, the tumor antigen targeted by the immunotherapy vectors.","types":["antigen","biomarker"],"aliases":["prostate-specific antigen"],"contributors":[{"id":2,"public_id":"4715169a40","public_label":"AK 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