HeberFERON, formulation based on IFNs alpha2b and gamma for the treatment of non-melanoma skin cancer
Lorenzo Anasagasti-Angulo, Yanelda Garcia-Vega, Sonia Collazo, Yanisel Jimenez-Barban, Edgar Tijerino-Arrieta, Yoddali Ballester-Caballero, Vladimir Sánchez-Linares, Jorge Marin-Guerra, Katherine Batista, Yaquelin Duncan-Roberts, Carmen Valenzuela-Silva, Angela Tuero-Iglesias, Leovaldo Álvarez-Falcon, Iraldo Bello-Rivero
Abstract
Background
Surgery remains the procedure of election for the treatment of non-melanoma skin cancer (NMSC). However, after recurrence, or under surgical complex scenarios, other therapeutic modalities have to be indicated. Immune suppression is associated to NMSC; thus, immunotherapy is a rational approach to treat the high spread form of skin tumour.
Aims
We propose a summary of the most relevant clinical results with the combination of IFNs alpha2b and gamma in the treatment of non-melanoma skin cancer.
Methods
In several clinical trials (Open prospective trial; phase 2 double-blind randomized studies: InCarbacel-II and InCarbacel-III; retrospective study and ongoing phase IV trial, InCarbacel-IV) more than 200 patients with histological diagnostic of non-melanoma skin cancer were recruited to be treated with the combination of IFNs in Cuban health institutions at primary, secondary or tertiary care levels. All the studies were approved by institutional ethic committees and all the patients given their written informed consent. HeberFERON was administered, peri- or intralesionally, three times per week, during 3 weeks. Clinical and histological responses were evaluated by RECIST (1.0), three months after the end of treatment.
Results
HeberFERON promoted more rapid and higher number of CRs than separated IFNs (InCarbacel-II study). The open-label prospective study showed 46.7 per cent CR in locally advanced BCC after application of HeberFERON. Patients with periocular BCC or SCSC received benefits from HeberFERON treatment (71.4 per cent OR). Overall, HeberFERON has been administered to patients with non-melanoma skin cancer obtaining a 65 per cent of histological CR together with an excellent safety profile.
Conclusion
HeberFERON is a novel, non-surgical, effective and safe option to treat advanced, high risk or recurrent non-melanoma skin cancer.
Full Text:
Surgery remains the procedure of election for the treatment of non-melanoma skin cancer (NMSC). However, after recurrence, or under surgical complex scenarios, other therapeutic modalities have to be indicated. Immune suppression is associated to NMSC; thus, immunotherapy is a rational approach to treat the high spread form of skin tumour.
Aims
We propose a summary of the most relevant clinical results with the combination of IFNs alpha2b and gamma in the treatment of non-melanoma skin cancer.
Methods
In several clinical trials (Open prospective trial; phase 2 double-blind randomized studies: InCarbacel-II and InCarbacel-III; retrospective study and ongoing phase IV trial, InCarbacel-IV) more than 200 patients with histological diagnostic of non-melanoma skin cancer were recruited to be treated with the combination of IFNs in Cuban health institutions at primary, secondary or tertiary care levels. All the studies were approved by institutional ethic committees and all the patients given their written informed consent. HeberFERON was administered, peri- or intralesionally, three times per week, during 3 weeks. Clinical and histological responses were evaluated by RECIST (1.0), three months after the end of treatment.
Results
HeberFERON promoted more rapid and higher number of CRs than separated IFNs (InCarbacel-II study). The open-label prospective study showed 46.7 per cent CR in locally advanced BCC after application of HeberFERON. Patients with periocular BCC or SCSC received benefits from HeberFERON treatment (71.4 per cent OR). Overall, HeberFERON has been administered to patients with non-melanoma skin cancer obtaining a 65 per cent of histological CR together with an excellent safety profile.
Conclusion
HeberFERON is a novel, non-surgical, effective and safe option to treat advanced, high risk or recurrent non-melanoma skin cancer.
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