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dc.contributor.author
Mordoh, Jose
dc.contributor.author
Pampena, María Betina
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Aris, Mariana
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Blanco, Paula Alejandra
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Lombardo, Mónica
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Von Euw, Erika María
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Mac Keon, Soledad
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Yepez Crow, Michelle
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Bravo, Alicia Inés
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O'Connor, Juan Manuel
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Orlando, Ana Gabriela
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Ramello, Franco
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Levy, Estrella Mariel
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Barrio, Maria Marcela
dc.date.available
2018-10-26T21:40:35Z
dc.date.issued
2017-05
dc.identifier.citation
Mordoh, Jose; Pampena, María Betina; Aris, Mariana; Blanco, Paula Alejandra; Lombardo, Mónica; et al.; Phase II Study of Adjuvant Immunotherapy with the CSF-470 Vaccine Plus Bacillus Calmette–Guerin Plus Recombinant Human Granulocyte Macrophage-Colony Stimulating Factor vs Medium-Dose Interferon Alpha 2B in Stages IIB, IIC, and III Cutaneous Melanoma Patients: A Single Institution, Randomized Study; Frontiers Research Foundation; Frontiers in Immunology; 8; MAY; 5-2017; 1-15
dc.identifier.issn
1664-3224
dc.identifier.uri
http://hdl.handle.net/11336/63153
dc.description.abstract
The irradiated, allogeneic, cellular CSF-470 vaccine plus Bacillus Calmette-Guerin (BCG) and recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF) is being tested against medium-dose IFN-α2b in stages IIB-III cutaneous melanoma (CM) patients (pts) after surgery in an open, randomized, Phase II/III study. We present the results of the Phase II part of the ongoing CASVAC-0401 study (ClinicalTrials.gov: NCT01729663). Thirty-one pts were randomized to the CSF-470 vaccine (n = 20) or to the IFN-α2b arm (n = 11). During the 2-year treatment, immunized pts should receive 13 vaccinations. On day 1 of each visit, 1.6 × 107 irradiated CSF-470 cells plus 106 colony-forming units BCG plus 100 μg rhGM-CSF were administered intradermally, followed on days 2-4 by 100 μg rhGM-CSF. IFN-α2b pts should receive 10 million units (MU)/day/5 days a week for 4 weeks; then 5 MU thrice weekly for 23 months. Toxicity and quality of life (QOL) were evaluated at each visit. With a mean and a maximum follow-up of 39.4 and 83 months, respectively, a significant benefit in the distant metastasis-free survival (DMFS) for CSF-470 was observed (p = 0.022). Immune monitoring showed an increase in antitumoral cellular and humoral response in vaccinated pts. CSF-470 was well tolerated; 20/20 pts presented grades 1-2 dermic reactions at the vaccination site; 3/20 pts presented grade 3 allergic reactions. Other adverse events (AEs) were grade 1. Pts in the IFN-α2b arm presented grades 2-3 hematological (7/11), hepatic (2/11), and cardiac (1/11) toxicity; AEs in 9/11 pts forced treatment interruptions. QOL was significantly superior in the vaccine arm (p < 0.0001). Our results suggest that CSF-470 vaccine plus BCG plus GM-CSF can significantly prolong, with lower toxicity, the DMFS of high-risk CM pts with respect to medium-dose IFN-α2b. The continuation of a Phase III part of the CASVAC-0401 study is encouraged.
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application/pdf
dc.language.iso
eng
dc.publisher
Frontiers Research Foundation
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
Bacillus Calmette-Guerin
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Csf-470 Allogeneic Cell Vaccine
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Cutaneous Melanoma
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Ifn-Α2b
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Phase Ii Clinical Study
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Rhgm-Csf
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Medicina Critica y de Emergencia
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Medicina Clínica
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CIENCIAS MÉDICAS Y DE LA SALUD
dc.title
Phase II Study of Adjuvant Immunotherapy with the CSF-470 Vaccine Plus Bacillus Calmette–Guerin Plus Recombinant Human Granulocyte Macrophage-Colony Stimulating Factor vs Medium-Dose Interferon Alpha 2B in Stages IIB, IIC, and III Cutaneous Melanoma Patients: A Single Institution, Randomized Study
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2018-10-19T20:43:12Z
dc.journal.volume
8
dc.journal.number
MAY
dc.journal.pagination
1-15
dc.journal.pais
Estados Unidos
dc.description.fil
Fil: Mordoh, Jose. Instituto Médico Especializado Alexander Fleming; Argentina. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Instituto de Investigaciones Bioquímicas de Buenos Aires. Fundación Instituto Leloir. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina
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Fil: Pampena, María Betina. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Aris, Mariana. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Blanco, Paula Alejandra. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina
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Fil: Lombardo, Mónica. Nobeltri; Argentina
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Fil: Von Euw, Erika María. University of California at Los Angeles; Estados Unidos. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Mac Keon, Soledad. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Instituto de Investigaciones Bioquímicas de Buenos Aires. Fundación Instituto Leloir. Instituto de Investigaciones Bioquímicas de Buenos Aires; Argentina
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Fil: Yepez Crow, Michelle. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina
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Fil: Bravo, Alicia Inés. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
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Fil: O'Connor, Juan Manuel. Instituto Médico Especializado Alexander Fleming; Argentina
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Fil: Orlando, Ana Gabriela. Gobierno de Santa Fe. Hospital Central Olga Rizzi; Argentina. Instituto Oncológico Mater Dei; Argentina
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Fil: Ramello, Franco. Centro Médico San Lucas; Argentina
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Fil: Levy, Estrella Mariel. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
dc.description.fil
Fil: Barrio, Maria Marcela. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
dc.journal.title
Frontiers in Immunology
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://www.frontiersin.org/articles/10.3389/fimmu.2017.00625/full
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.3389/fimmu.2017.00625
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