| Autor: |
de la Torre A; Celestino Hernández Robau Hospital, Villa Clara, Cuba., Pérez K; Center of Molecular Immunology, Havana, Cuba., Vega AM; Center of Molecular Immunology, Havana, Cuba., Santiesteban E; José Ramón López Tabranes Hospital, Matanzas, Cuba., Ruiz R; Ramón González Coro Hospital, Havana, Cuba., Hernández L; María Curie Hospital, Camagüey, Cuba., Durrutí D; Conrado Benítez Hospital, Santiago de Cuba, Cuba., Viada CE; Center of Molecular Immunology, Havana, Cuba., Sánchez L; Center of Molecular Immunology, Havana, Cuba., Álvarez M; Center of Molecular Immunology, Havana, Cuba., Durán Y; Center of Molecular Immunology, Havana, Cuba., Moreno YG; Center of Molecular Immunology, Havana, Cuba., Arencibia M; Center of Molecular Immunology, Havana, Cuba., Cepeda M; Center of Molecular Immunology, Havana, Cuba., Domecq M; Center of Molecular Immunology, Havana, Cuba., Cabrera L; Center of Molecular Immunology, Havana, Cuba., Sánchez JL; Center of Molecular Immunology, Havana, Cuba., Hernández JJ; Center of Molecular Immunology, Havana, Cuba., Valls AR; Center of Molecular Immunology, Havana, Cuba., Fernández LE; Center of Molecular Immunology, Havana, Cuba. |
| Abstrakt: |
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. |
