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
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Abstract 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.
AbstractList 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.
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.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.Clinical trial registrationhttps://rpcec.sld.cu/trials/RPCEC00000205-En, identifier RPCEC00000205.
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.
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.Clinical trial registrationhttps://rpcec.sld.cu/trials/RPCEC00000205-En, identifier RPCEC00000205.
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. Clinical trial registration https://rpcec.sld.cu/trials/RPCEC00000205-En , identifier RPCEC00000205.
Author Camacho Sosa, Kirenia
Crombet Ramos, Tania
Álvarez Montané, Irene
Parra Zabala, Jenelly
Lobaina Lambert, Leonardo
Ortiz Carrodeguas, Ramón A
González Piloto, Shairis
Viada González, Carmen
Calvo Aguilera, Nadia
Montes De Santis, Arasay
Santos Morales, Orestes
Lorenzo Monteagudo, Geidy
Valdés Rodríguez, Elba
Blanco Mustelier, Poncio
Saavedra Hernández, Danay
Salomón Saldívar, Eva E
Valdés Sánchez, Lizet
Guerra de la Vega, Arelys
Guerra Chaviano, Pedro P
Bermúdez Pino, Raúl
AuthorAffiliation 7 “Faustino Pérez” Hospital, Medical Oncology Department , Matanzas , Cuba
10 “Octavio de la Concepción y la Pedraja” Polyclinic, Family Medicine Department. Santa Clara , Villa Clara , Cuba
1 “Celestino Hernández Robau” Hospital, Medical Oncology Department. Santa Clara , Villa Clara , Cuba
8 “Mario Gutiérrez Ardaya” Polyclinic, Family Medicine Department , Holguín , Cuba
9 “José Luis Dubrocq” Polyclinic, Family Medicine Department , Matanzas , Cuba
6 “Saturnino Lora” Hospital, Medical Oncology Department , Santiago de Cuba , Cuba
11 “Camilo Cienfuegos” Polyclinic, Family Medicine Department , Artemisa , Cuba
2 Center of Molecular Immunology, Clinical Research Direction , Havana , Cuba
5 “Joaquín Albarrán” Hospital, Medical Oncology Department , Havana , Cuba
12 “Previsora” Polyclinic, Family Medicine Department , Camagüey , Cuba
3 National Coordinating Center for Clinical Trials, Clinical Research Department , Havana , Cuba
4 “María Curie” Hospital, Medical Oncology Department , Camagüey , Cuba
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  organization: Center of Molecular Immunology, Clinical Research Direction, Havana, Cuba
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  surname: Crombet Ramos
  fullname: Crombet Ramos, Tania
  organization: Center of Molecular Immunology, Clinical Research Direction, Havana, Cuba
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ContentType Journal Article
Copyright Copyright © 2024 Ortiz Carrodeguas, Lorenzo Monteagudo, Guerra Chaviano, Álvarez Montané, Salomón Saldívar, Lobaina Lambert, Camacho Sosa, Bermúdez Pino, Blanco Mustelier, Valdés Rodríguez, González Piloto, Guerra de la Vega, Valdés Sánchez, Montes De Santis, Parra Zabala, Viada González, Calvo Aguilera, Saavedra Hernández, Santos Morales and Crombet Ramos.
Copyright © 2024 Ortiz Carrodeguas, Lorenzo Monteagudo, Guerra Chaviano, Álvarez Montané, Salomón Saldívar, Lobaina Lambert, Camacho Sosa, Bermúdez Pino, Blanco Mustelier, Valdés Rodríguez, González Piloto, Guerra de la Vega, Valdés Sánchez, Montes De Santis, Parra Zabala, Viada González, Calvo Aguilera, Saavedra Hernández, Santos Morales and Crombet Ramos 2024 Ortiz Carrodeguas, Lorenzo Monteagudo, Guerra Chaviano, Álvarez Montané, Salomón Saldívar, Lobaina Lambert, Camacho Sosa, Bermúdez Pino, Blanco Mustelier, Valdés Rodríguez, González Piloto, Guerra de la Vega, Valdés Sánchez, Montes De Santis, Parra Zabala, Viada González, Calvo Aguilera, Saavedra Hernández, Santos Morales and Crombet Ramos
Copyright_xml – notice: Copyright © 2024 Ortiz Carrodeguas, Lorenzo Monteagudo, Guerra Chaviano, Álvarez Montané, Salomón Saldívar, Lobaina Lambert, Camacho Sosa, Bermúdez Pino, Blanco Mustelier, Valdés Rodríguez, González Piloto, Guerra de la Vega, Valdés Sánchez, Montes De Santis, Parra Zabala, Viada González, Calvo Aguilera, Saavedra Hernández, Santos Morales and Crombet Ramos.
– notice: Copyright © 2024 Ortiz Carrodeguas, Lorenzo Monteagudo, Guerra Chaviano, Álvarez Montané, Salomón Saldívar, Lobaina Lambert, Camacho Sosa, Bermúdez Pino, Blanco Mustelier, Valdés Rodríguez, González Piloto, Guerra de la Vega, Valdés Sánchez, Montes De Santis, Parra Zabala, Viada González, Calvo Aguilera, Saavedra Hernández, Santos Morales and Crombet Ramos 2024 Ortiz Carrodeguas, Lorenzo Monteagudo, Guerra Chaviano, Álvarez Montané, Salomón Saldívar, Lobaina Lambert, Camacho Sosa, Bermúdez Pino, Blanco Mustelier, Valdés Rodríguez, González Piloto, Guerra de la Vega, Valdés Sánchez, Montes De Santis, Parra Zabala, Viada González, Calvo Aguilera, Saavedra Hernández, Santos Morales and Crombet Ramos
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Keywords CIMAvax-EGF
realworld-data (RWD)
NSCLC
primary health care institutions
community polyclinics
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License Copyright © 2024 Ortiz Carrodeguas, Lorenzo Monteagudo, Guerra Chaviano, Álvarez Montané, Salomón Saldívar, Lobaina Lambert, Camacho Sosa, Bermúdez Pino, Blanco Mustelier, Valdés Rodríguez, González Piloto, Guerra de la Vega, Valdés Sánchez, Montes De Santis, Parra Zabala, Viada González, Calvo Aguilera, Saavedra Hernández, Santos Morales and Crombet Ramos.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
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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
OpenAccessLink https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10830698/
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Rodriguez (B18) 2016; 22
Sheikine (B7) 2016; 17
Shao (B32) 2020; 40
Mencoboni (B6) 2021; 13
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Snippet 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...
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community polyclinics
NSCLC
Oncology
primary health care institutions
realworld-data (RWD)
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