PMID- 28620382
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191120
IS  - 1664-3224 (Print)
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 8
DP  - 2017
TI  - 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.
PG  - 625
LID - 10.3389/fimmu.2017.00625 [doi]
LID - 625
AB  - 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-alpha2b 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-alpha2b arm (n = 11). 
      During the 2-year treatment, immunized pts should receive 13 vaccinations. On day 
      1 of each visit, 1.6 x 10(7) irradiated CSF-470 cells plus 10(6) colony-forming 
      units BCG plus 100 microg rhGM-CSF were administered intradermally, followed on days 
      2-4 by 100 microg rhGM-CSF. IFN-alpha2b 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-alpha2b 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-alpha2b. The continuation of 
      a Phase III part of the CASVAC-0401 study is encouraged.
FAU - Mordoh, Jose
AU  - Mordoh J
AD  - Instituto Medico Especializado Alexander Fleming, Buenos Aires, Argentina.
AD  - Centro de Investigaciones Oncologicas-Fundacion Cancer, Buenos Aires, Argentina.
AD  - Fundacion Instituto Leloir, IIBBA-CONICET, Buenos Aires, Argentina.
FAU - Pampena, Maria Betina
AU  - Pampena MB
AD  - Centro de Investigaciones Oncologicas-Fundacion Cancer, Buenos Aires, Argentina.
FAU - Aris, Mariana
AU  - Aris M
AD  - Centro de Investigaciones Oncologicas-Fundacion Cancer, Buenos Aires, Argentina.
FAU - Blanco, Paula Alejandra
AU  - Blanco PA
AD  - Centro de Investigaciones Oncologicas-Fundacion Cancer, Buenos Aires, Argentina.
FAU - Lombardo, Monica
AU  - Lombardo M
AD  - Nobeltri, Buenos Aires, Argentina.
FAU - von Euw, Erika Maria
AU  - von Euw EM
AD  - UCLA JCCC-Translational Oncology Research Labs, Los Angeles, CA, United States.
FAU - Mac Keon, Soledad
AU  - Mac Keon S
AD  - Fundacion Instituto Leloir, IIBBA-CONICET, Buenos Aires, Argentina.
FAU - Yepez Crow, Michelle
AU  - Yepez Crow M
AD  - Centro de Investigaciones Oncologicas-Fundacion Cancer, Buenos Aires, Argentina.
FAU - Bravo, Alicia Ines
AU  - Bravo AI
AD  - Unidad de Inmunopatologia, Hospital Interzonal General de Agudos Eva Peron, San 
      Martin, Argentina.
FAU - O'Connor, Juan Manuel
AU  - O'Connor JM
AD  - Instituto Medico Especializado Alexander Fleming, Buenos Aires, Argentina.
FAU - Orlando, Ana Gabriela
AU  - Orlando AG
AD  - Hospital Central Olga Rizzi, Reconquista, Argentina.
AD  - Instituto Oncologico Mater Dei, Reconquista, Argentina.
FAU - Ramello, Franco
AU  - Ramello F
AD  - Centro Medico San Lucas, Gualeguaychu, Argentina.
FAU - Levy, Estrella Mariel
AU  - Levy EM
AD  - Centro de Investigaciones Oncologicas-Fundacion Cancer, Buenos Aires, Argentina.
FAU - Barrio, Maria Marcela
AU  - Barrio MM
AD  - Centro de Investigaciones Oncologicas-Fundacion Cancer, Buenos Aires, Argentina.
LA  - eng
SI  - ClinicalTrials.gov/NCT01729663
PT  - Journal Article
DEP - 20170531
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
PMC - PMC5449770
OTO - NOTNLM
OT  - Bacillus Calmette-Guerin
OT  - CSF-470 allogeneic cell vaccine
OT  - IFN-alpha2b
OT  - Phase II clinical study
OT  - cutaneous melanoma
OT  - rhGM-CSF
EDAT- 2017/06/18 06:00
MHDA- 2017/06/18 06:01
PMCR- 2017/01/01
CRDT- 2017/06/17 06:00
PHST- 2016/11/11 00:00 [received]
PHST- 2017/05/10 00:00 [accepted]
PHST- 2017/06/17 06:00 [entrez]
PHST- 2017/06/18 06:00 [pubmed]
PHST- 2017/06/18 06:01 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2017.00625 [doi]
PST - epublish
SO  - Front Immunol. 2017 May 31;8:625. doi: 10.3389/fimmu.2017.00625. eCollection 
      2017.