title: Superior Efficacy and Safety of a Nonemulsive Variant of the NGcGM3/VSSP Vaccine in Advanced Breast Cancer Patients.
abstract: NGcGM3 ganglioside is a tumor-specific antigen expressed in human breast tumors. The NGcGM3/VSSP vaccine, consisting in very small-sized proteoliposomes (VSSP) obtained by the incorporation of NGcGM3 into the outer membrane protein complex of Neisseria meningitidis, has been previously tested in a Phase II trial in patients with metastatic breast cancer (MBC) but emulsified with Montanide ISA 51. An Expanded Access study was carried out in MBC patients aiming to find if a nonemulsive formulation of NGcGM3/VSSP, without Montanide ISA 51, could be more safe and effective. A total of 104 patients were vaccinated with the nonemulsive formulation (900 μg), subcutaneously (SC), or with the emulsive formulation (200 μg), intramuscularly (IM). An intent-to-treat analysis of efficacy was performed with all patients, and 93 patients were split off according to the site of metastases (visceral/nonvisceral). Of note, SC-treated patients exhibited a superior median overall survival (OS) than IM-treated patients (23.6 vs. 8.2 months; log rank P = 0.001). Even though in the subset of patients with nonvisceral metastases SC vaccination duplicated the median OS compared to the alternative option (31.6 vs. 16.5 months), this difference did not reach statistical significance (log rank P = 0.118). Curiously, in patients with visceral metastases, the advantage of the nonemulsive formulation was more apparent (median OS 21.0 vs. 6.2 months; log rank P = 0.005). The vaccine was safe for both formulations.
authors.affiliation: Celestino Hernández Robau Hospital, Villa Clara, Cuba.
authors.forename: Ana
authors.initials: A
authors.lastname: de la Torre
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Kirenia
authors.initials: K
authors.lastname: Pérez
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Aliz M
authors.initials: AM
authors.lastname: Vega
authors.affiliation: José Ramón López Tabranes Hospital, Matanzas, Cuba.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Santiesteban
authors.affiliation: Ramón González Coro Hospital, Havana, Cuba.
authors.forename: Raiza
authors.initials: R
authors.lastname: Ruiz
authors.affiliation: María Curie Hospital, Camagüey, Cuba.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Hernández
authors.affiliation: Conrado Benítez Hospital, Santiago de Cuba, Cuba.
authors.forename: Dayamí
authors.initials: D
authors.lastname: Durrutí
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Carmen E
authors.initials: CE
authors.lastname: Viada
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Liset
authors.initials: L
authors.lastname: Sánchez
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Mabel
authors.initials: M
authors.lastname: Álvarez
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Yunier
authors.initials: Y
authors.lastname: Durán
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Yoisbel G
authors.initials: YG
authors.lastname: Moreno
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Maylén
authors.initials: M
authors.lastname: Arencibia
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Meylán
authors.initials: M
authors.lastname: Cepeda
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Milagros
authors.initials: M
authors.lastname: Domecq
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Leticia
authors.initials: L
authors.lastname: Cabrera
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Jorge L
authors.initials: JL
authors.lastname: Sánchez
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: José J
authors.initials: JJ
authors.lastname: Hernández
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Ana R
authors.initials: AR
authors.lastname: Valls
authors.affiliation: Center of Molecular Immunology, Havana, Cuba.
authors.forename: Luis E
authors.initials: LE
authors.lastname: Fernández
keywords: NGcGM3/VSSP vaccine; breast cancer; survival