An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece
Giannis Mountzios,1 Sofia Lampaki,2 Georgia-Angeliki Koliou,3 Athanassios Vozikis,4 Ioannis Kontogiorgos,4 Panagiotis Papantoniou,4 Margarita-Ioanna Koufaki,4 Eleni Res,5 Anastasios Boutis,6 Athina Christopoulou,7 Nicoleta Pastelli,8 Anastasios Grivas,9 Gerasimos Aravantinos,10 Efthalia Lalla,11 Geo...
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2021
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lung cancer epidermal growth factor receptor (egfr) afatinib molecular epidemiol-ogy cost-effectiveness Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 |
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lung cancer epidermal growth factor receptor (egfr) afatinib molecular epidemiol-ogy cost-effectiveness Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Mountzios G Lampaki S Koliou GA Vozikis A Kontogiorgos I Papantoniou P Koufaki MI Res E Boutis A Christopoulou A Pastelli N Grivas A Aravantinos G Lalla E Oikonomopoulos G Koumarianou A Spyratos D Bafaloukos Snr D Rigakos G Papakotoulas P Fountzilas G Linardou H An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece |
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Giannis Mountzios,1 Sofia Lampaki,2 Georgia-Angeliki Koliou,3 Athanassios Vozikis,4 Ioannis Kontogiorgos,4 Panagiotis Papantoniou,4 Margarita-Ioanna Koufaki,4 Eleni Res,5 Anastasios Boutis,6 Athina Christopoulou,7 Nicoleta Pastelli,8 Anastasios Grivas,9 Gerasimos Aravantinos,10 Efthalia Lalla,11 Georgios Oikonomopoulos,12 Anna Koumarianou,13 Dionisios Spyratos,2 Dimitrios Bafaloukos Snr,14 Georgios Rigakos,15 Pavlos Papakotoulas,6 George Fountzilas,16– 18 Helena Linardou19 1Fourth Department of Medical Oncology and Clinical Trials Unit Henry Dunant Hospital Center, Athens, Greece; 2Pulmonary Department, Lung Cancer Oncology Unit, Aristotle University of Thessaloniki, G. Papanicolaou Hospital, Thessaloniki, Greece; 3Section of Biostatistics, Hellenic Cooperative Oncology Group, Athens, Greece; 4Laboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; 5Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece; 6First Department of Clinical Oncology, Theagenio Hospital, Thessaloniki, Greece; 7Medical Oncology Unit, S. Andrew Hospital, Patras, Greece; 8Department of Pathology, G. Papanicolaou Hospital, Thessaloniki, Greece; 9Second Department of Internal Medicine, Agios Savvas Cancer Hospital, Athens, Greece; 10Second Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece; 11Third Department of Clinical Oncology, Theagenio Hospital, Thessaloniki, Greece; 12Second Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece; 13Hematology-Oncology Unit, Fourth Department of Internal Medicine, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece; 14First Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece; 15Third Department of Medical Oncology, Hygeia Hospital, Athens, Greece; 16Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece; 17Aristotle University of Thessaloniki, Thessaloniki, Greece; 18Department of Medical Oncology, German Oncology Center, Limassol, Cyprus; 19Fourth Oncology Department, Metropolitan Hospital, Athens, GreeceCorrespondence: Giannis MountziosFourth Department of Medical Oncology and Clinical Trials Unit, Henry Dunant Hospital Center, Messoghion Av. 107, Athens, 11526, GreeceTel +2106972000Email gmountzios@gmail.comPurpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the preferred first-line option for patients with advanced, EGFR-mutant non-small cell lung cancer (NSCLC). Afatinib, a second-generation irreversible EGFR-TKI, has been extensively used in Greece in this setting; however, real-world data regarding molecular epidemiology and financial implications of afatinib use are lacking.Materials and Methods: This was an observational, non-interventional, multicenter, retrospective cohort study, based on real-world data collected from the medical charts/records of patients treated with afatinib between 15/03/2015 and 25/06/2020 and were recorded on a web-based data capture system. Cox models were used to assess the prognostic significance of clinicopathological parameters with respect to clinical outcomes of interest. Cost analysis was conducted from a public third-payer perspective, and only direct medical costs reimbursed by the payer were considered.Results: A total of 59 patients were treated with afatinib for their EGFR mutation-positive advanced NSCLC; the median age was 61 years (range: 37– 91). Performance status was zero in 61%, and brain metastases were present in 13.6%. Forty-four patients (74.6%) had a deletion in exon 19 only, while nine (15.3%) had a mutation in exon 21, 8 of them in L858R and one in L861Q. At a median follow-up of 41.8 months (95% CI 35.9– 51.4), the median PFS was 14.3 months (95% CI 12.2– 16.4), and the median OS was 29 months (95% CI 25.6– 33.4). Corresponding values for patients with deletion 19 only were 14.3 months (95% CI 11.5– 18.5) and 28.1 months (95% CI 21.1– 32.6), respectively. The mean expenditure for the treatment of each patient equals € 25,333.68; with € 21,865.06 being attributed to drug acquisition costs, € 3325.35 to monitoring costs and € 143.27 to adverse event treatment-related costs.Conclusion: Long-term data in the real-world setting in Greece confirm activity, tolerability and cost-effectiveness of afatinib as first-line treatment of patients with advanced EGFR-mutant NSCLC.Clinical Trial Registration: Clinicaltrials.gov NCT04640870.Keywords: lung cancer, epidermal growth factor receptor, EGFR, afatinib, molecular epidemiology, cost-effectiveness |
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article |
| author |
Mountzios G Lampaki S Koliou GA Vozikis A Kontogiorgos I Papantoniou P Koufaki MI Res E Boutis A Christopoulou A Pastelli N Grivas A Aravantinos G Lalla E Oikonomopoulos G Koumarianou A Spyratos D Bafaloukos Snr D Rigakos G Papakotoulas P Fountzilas G Linardou H |
| author_facet |
Mountzios G Lampaki S Koliou GA Vozikis A Kontogiorgos I Papantoniou P Koufaki MI Res E Boutis A Christopoulou A Pastelli N Grivas A Aravantinos G Lalla E Oikonomopoulos G Koumarianou A Spyratos D Bafaloukos Snr D Rigakos G Papakotoulas P Fountzilas G Linardou H |
| author_sort |
Mountzios G |
| title |
An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece |
| title_short |
An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece |
| title_full |
An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece |
| title_fullStr |
An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece |
| title_full_unstemmed |
An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece |
| title_sort |
observational study to assess the molecular epidemiology and direct medical costs of epidermal growth factor receptor (egfr) mutations in patients with advanced egfr mutation-positive non-small cell lung cancer treated with afatinib in real-world clinical settings in greece |
| publisher |
Dove Medical Press |
| publishDate |
2021 |
| url |
https://doaj.org/article/6a71618649294982a297524620b76668 |
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oai:doaj.org-article:6a71618649294982a297524620b766682021-12-02T16:34:31ZAn Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece1179-2728https://doaj.org/article/6a71618649294982a297524620b766682021-08-01T00:00:00Zhttps://www.dovepress.com/an-observational-study-to-assess-the-molecular-epidemiology-and-direct-peer-reviewed-fulltext-article-LCTThttps://doaj.org/toc/1179-2728Giannis Mountzios,1 Sofia Lampaki,2 Georgia-Angeliki Koliou,3 Athanassios Vozikis,4 Ioannis Kontogiorgos,4 Panagiotis Papantoniou,4 Margarita-Ioanna Koufaki,4 Eleni Res,5 Anastasios Boutis,6 Athina Christopoulou,7 Nicoleta Pastelli,8 Anastasios Grivas,9 Gerasimos Aravantinos,10 Efthalia Lalla,11 Georgios Oikonomopoulos,12 Anna Koumarianou,13 Dionisios Spyratos,2 Dimitrios Bafaloukos Snr,14 Georgios Rigakos,15 Pavlos Papakotoulas,6 George Fountzilas,16– 18 Helena Linardou19 1Fourth Department of Medical Oncology and Clinical Trials Unit Henry Dunant Hospital Center, Athens, Greece; 2Pulmonary Department, Lung Cancer Oncology Unit, Aristotle University of Thessaloniki, G. Papanicolaou Hospital, Thessaloniki, Greece; 3Section of Biostatistics, Hellenic Cooperative Oncology Group, Athens, Greece; 4Laboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; 5Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece; 6First Department of Clinical Oncology, Theagenio Hospital, Thessaloniki, Greece; 7Medical Oncology Unit, S. Andrew Hospital, Patras, Greece; 8Department of Pathology, G. Papanicolaou Hospital, Thessaloniki, Greece; 9Second Department of Internal Medicine, Agios Savvas Cancer Hospital, Athens, Greece; 10Second Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece; 11Third Department of Clinical Oncology, Theagenio Hospital, Thessaloniki, Greece; 12Second Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece; 13Hematology-Oncology Unit, Fourth Department of Internal Medicine, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece; 14First Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece; 15Third Department of Medical Oncology, Hygeia Hospital, Athens, Greece; 16Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece; 17Aristotle University of Thessaloniki, Thessaloniki, Greece; 18Department of Medical Oncology, German Oncology Center, Limassol, Cyprus; 19Fourth Oncology Department, Metropolitan Hospital, Athens, GreeceCorrespondence: Giannis MountziosFourth Department of Medical Oncology and Clinical Trials Unit, Henry Dunant Hospital Center, Messoghion Av. 107, Athens, 11526, GreeceTel +2106972000Email gmountzios@gmail.comPurpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the preferred first-line option for patients with advanced, EGFR-mutant non-small cell lung cancer (NSCLC). Afatinib, a second-generation irreversible EGFR-TKI, has been extensively used in Greece in this setting; however, real-world data regarding molecular epidemiology and financial implications of afatinib use are lacking.Materials and Methods: This was an observational, non-interventional, multicenter, retrospective cohort study, based on real-world data collected from the medical charts/records of patients treated with afatinib between 15/03/2015 and 25/06/2020 and were recorded on a web-based data capture system. Cox models were used to assess the prognostic significance of clinicopathological parameters with respect to clinical outcomes of interest. Cost analysis was conducted from a public third-payer perspective, and only direct medical costs reimbursed by the payer were considered.Results: A total of 59 patients were treated with afatinib for their EGFR mutation-positive advanced NSCLC; the median age was 61 years (range: 37– 91). Performance status was zero in 61%, and brain metastases were present in 13.6%. Forty-four patients (74.6%) had a deletion in exon 19 only, while nine (15.3%) had a mutation in exon 21, 8 of them in L858R and one in L861Q. At a median follow-up of 41.8 months (95% CI 35.9– 51.4), the median PFS was 14.3 months (95% CI 12.2– 16.4), and the median OS was 29 months (95% CI 25.6– 33.4). Corresponding values for patients with deletion 19 only were 14.3 months (95% CI 11.5– 18.5) and 28.1 months (95% CI 21.1– 32.6), respectively. The mean expenditure for the treatment of each patient equals € 25,333.68; with € 21,865.06 being attributed to drug acquisition costs, € 3325.35 to monitoring costs and € 143.27 to adverse event treatment-related costs.Conclusion: Long-term data in the real-world setting in Greece confirm activity, tolerability and cost-effectiveness of afatinib as first-line treatment of patients with advanced EGFR-mutant NSCLC.Clinical Trial Registration: Clinicaltrials.gov NCT04640870.Keywords: lung cancer, epidermal growth factor receptor, EGFR, afatinib, molecular epidemiology, cost-effectivenessMountzios GLampaki SKoliou GAVozikis AKontogiorgos IPapantoniou PKoufaki MIRes EBoutis AChristopoulou APastelli NGrivas AAravantinos GLalla EOikonomopoulos GKoumarianou ASpyratos DBafaloukos Snr DRigakos GPapakotoulas PFountzilas GLinardou HDove Medical Pressarticlelung cancerepidermal growth factor receptor (egfr)afatinibmolecular epidemiol-ogycost-effectivenessNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENLung Cancer: Targets and Therapy, Vol Volume 12, Pp 93-102 (2021) |