Basal cell carcinoma treated with HeberFERON. A real world retrospective study

Background Basal cell carcinoma is the most common type of skin cancer with major impact in health-related quality of life. The use of the formulation based on the combination of IFN-alpha 2b and IFN-gamma (HeberFERON) is an effective alternative in the treatment of basal cell carcinoma, immunogenic tumor, potentially responsible to immunotherapies. The aim of this report is to record, retrospectively, the effect of HeberFERON patients with BCC in the Cuban real word condition. Methods This is a retrospectively study of the use of HeberFERON in real world conditions. Eligible patients were adults with histologic diagnosis of single or multiple basal cell carcinoma of any skin phototype, lesions of any size, subtype, location, recurrent or not, with or without specific prior treatments. Adult patients, who signed the informed consent to receive the treatment with HeberFERON, were identified from the data bases. The evaluation of clinical effectiveness was carried out according to RECIST 1.1. Ethical committee of participating institutions approved the study. Results In clinical practice evaluated patients the nose was the region of higher frequency of tumors (36.3%) and the nodular clinical subtype was the predominant (45.3%). Clinical response rate differences (p=0. 000) were found, with complete response of 61.9%, and partial response of 32.7%; with an overall response rate of 94.2% The HeberFERON exerted a 100% disease control, with no progression reported in 640 treated patients. The best responder tumor subtypes to HeberFERON were the more aggressive tumors, morpheaform with complete response of 72% (overall response=96%), followed by the infiltrative with complete response of 66.7% (overall response=100%). Tumor with larger size and patients with more than four tumors had lesser response to the anti-tumor effect of HeberFERON. Conclusions HeberFERON was highly effective in basal cell carcinomas in real world conditions. In the context of resistance of skin tumors to hedgehog and immune check point inhibitors the combination of IFNs alpha 2b and IFN gamma appears as a plausible therapeutic option for a wide number of basal cell carcinomas. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial The study was not registered ### Funding Statement Non funding to declare ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Study execution conformed to the ethical principles of the Declaration of Helsinki and the International Council for Harmonization of Good Clinical Practice guidelines. The authors were responsible for designing the trial and for collecting and analyzing the data. The following ethical and/or research institutional committee waived the approval of the study in their respectively institutions in Cuba. 1.Jose Avila Serrano Polyclinic Ethical Committee waived ethical oversight of the study. Municipality of Gibara, Holguin Province. 2.Center Polyclinic Ethical Committee waived ethical oversight of the study. Santi Spiritus City, Santi Spiritus Province. 3.Antonio Luaces Iraola Hospital Ethical and Research Committee waived ethical oversight of the study. Ciego de Avila City, Ciego de Avila Province. 4.Faustino Perez Hospital Ethical Committee waived ethical oversight of the study. Matanzas City, Matanzas Province. 5.Carlos J. Finlay Polyclinic Ethical Committee waived ethical oversight of the study Municipality of Colon, Matanzas Province. 6. Arnaldo Milian Castro Hospital Ethical and Research Committee waived ethical oversight of the study. Villa Clara City; Villa Clara Province. 7.Maria Curi Oncological Hospital and Amalia Simoni Hospital Ethical and Research Committees waived ethical oversight of the study. Camaguey City, Camaguey Province. 8.Gustavo Aldereguia Hospital, Ethical and Research Committee waived ethical oversight of the study. Cienfuegos City, Cienfuegos Province. 9.Pablo Noriega Polyclinic Ethical Committee waived ethical oversight of the study. Mayabeque Province. 10. Comandante Pinares Hospital Ethical and Research Committee waived ethical oversight of the study, Municipality of San Cristobal, Artemisa Province. 11.Heroes del Baire Hospital Ethical Committee waived ethical oversight of the study. Nueva Gerona City, Special Municipality Island of Youth, Cuba. 12. Celia Sanchez Manduley Hospital Ethical Committee waived ethical oversight of the study, Manzanillo City, Granma Province. 13. Juan Bruno Zayas Hospital Ethical and Research Committee waived ethical oversight of the study, Santiago de Cuba City, Santiago de Cuba Province. 14.Ernesto Guevara Hospital Ethical and Research Committee waived ethical oversight of the study. Las Tunas City, Las Tunas Province. 15.Leon Cuervo Rubio Hospital Ethical and Research Committee waived ethical oversight of the study. Pinar del Rio City, Pinar del Rio Province. 16.Agustinho Neto Hospital Ethical Committee waived ethical oversight of the study. Guantanamo City, Guantanamo Province. 17.Calixto Garcia Hospital Ethical and Research Committee waived ethical oversight of the study. Havana City, Havana Province. 18.Center of Medical Surgical Investigations Ethical and Research Committee waived ethical oversight of the study. Havana City, Havana Province. 19. Salvador Allende Hospital Ethical and Research Committee waived ethical oversight of the study. Havana City, Havana Province. 20.Manuel Fajardo Hospital Ethical and Research Committee waived ethical oversight of the study. Havana City, Havana Province. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Qualified individuals may request access to the de-identified participant data, anonymized clinical study reports, informed consent forms, through submission of a proposal with a defined research question to the corresponding author, Bello-Rivero Iraldo, provided that the necessary data protection and ethical committee approvals are in compliance with the trial. An agreement for transfer of these data will be required.