Safety and effectiveness of CIMAvax-EGF administered in community polyclinics

In spite of the advances in immunotherapy and targeted therapies, lung cancer continues to be the leading cause of cancer-related death. The epidermal growth factor receptor is an established target for non-small cell lung cancer (NSCLC), and its overactivation by the ligands can induce accelerated...

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Published in:	Frontiers in oncology Vol. 13; p. 1287902
Main Authors:	Ortiz Carrodeguas, Ramón A, Lorenzo Monteagudo, Geidy, Guerra Chaviano, Pedro P, Álvarez Montané, Irene, Salomón Saldívar, Eva E, Lobaina Lambert, Leonardo, Camacho Sosa, Kirenia, Bermúdez Pino, Raúl, Blanco Mustelier, Poncio, Valdés Rodríguez, Elba, González Piloto, Shairis, Guerra de la Vega, Arelys, Valdés Sánchez, Lizet, Montes De Santis, Arasay, Parra Zabala, Jenelly, Viada González, Carmen, Calvo Aguilera, Nadia, Saavedra Hernández, Danay, Santos Morales, Orestes, Crombet Ramos, Tania
Format:	Journal Article
Language:	English
Published:	Switzerland Frontiers Media S.A 18-01-2024
Subjects:	CIMAvax-EGF community polyclinics NSCLC Oncology primary health care institutions realworld-data (RWD) CIMAvax-EGF realworld-data (RWD) NSCLC primary health care institutions community polyclinics
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Summary:	In spite of the advances in immunotherapy and targeted therapies, lung cancer continues to be the leading cause of cancer-related death. The epidermal growth factor receptor is an established target for non-small cell lung cancer (NSCLC), and its overactivation by the ligands can induce accelerated proliferation, angiogenesis, and metastasis as well as proinflammatory or immunosuppressive signals. CIMAvax-EGF is an epidermal growth factor (EGF)-depleting immunotherapy that is approved for the treatment of NSCLC patients in Cuba. The study was designed as a phase IV trial to characterize the safety and effectiveness of CIMAvax-EGF in advanced NSCLC patients treated in 119 community polyclinics and 24 hospitals. CIMAvax-EGF treatment consisted of four bi-weekly doses followed by monthly boosters. Overall, 741 NSCLC patients ineligible for further cancer-specific treatment were enrolled. CIMAvax-EGF was safe, and the most common adverse events consisted of mild-to-moderate injection site reactions, fever, chills, tremors, and headache. For patients completing the loading doses, the median survival was 9.9 months. For individuals achieving at least stable disease to the frontline and completing vaccination induction, the median survival was 12 months. Most of the functional activities and symptoms evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire improved over time. In conclusion, this real-world trial demonstrated that CIMAvax-EGF was safe and effective in patients who were vaccinated in the maintenance scenario. A larger effect was seen in subjects with poor prognosis like those with squamous tumors and high EGF levels. Remarkably, this community-based intervention was very important because it demonstrated the feasibility of treating advanced lung cancer patients with active immunotherapy in primary care institutions. In addition to CIMAvax-EGF, patients received supportive care at the community clinic. Vaccine administration by the family doctors at the polyclinics reduced the patients' burden on the medical oncology services that continued providing chemotherapy and other complex therapies. We conclude that community polyclinics constitute the optimal scenario for administering those cancer vaccines that are safe and require prolonged maintenance in patients with advanced cancer, despite the continuous deterioration of their general condition. https://rpcec.sld.cu/trials/RPCEC00000205-En, identifier RPCEC00000205.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Reviewed by: Paul Zarogoulidis, Euromedica General Clinic, Greece These authors have contributed equally to this work and share first authorship Rocio Fuentes Mateos, University of Groningen, Netherlands ORCID: Tania Crombet Ramos, orcid.org/0000-0002-2550-7292 Edited by: Xinhui Wu, University of Groningen, Netherlands
ISSN:	2234-943X 2234-943X
DOI:	10.3389/fonc.2023.1287902