Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study
Abstract Background We evaluated treatment decisions and outcomes in a cohort of predominately Caucasian patients with EGFR mutation-positive (EGFR Mut+) non-small-cell lung cancer (NSCLC). Methods REASON (NCT00997230) was a non-interventional study in German patients with stage IIIB/IV NSCLC. Secon...
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doaj-cac53fc992d244659adde34115d808272020-11-24T21:14:20ZengBMCBMC Cancer1471-24072018-02-0118111010.1186/s12885-018-4032-3Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational studyWolfgang Schuette0Peter Schirmacher1Wilfried E. E. Eberhardt2Manfred Dietel3Ute Zirrgiebel4Lars Muehlenhoff5Michael Thomas6Krankenhaus Martha-Maria Halle-Doelau gGmbH, Klinik für Innere Medizin IIPathologisches Institut, Universitätklinik HeidelbergDepartment of Medical Oncology, West German Tumor Centre, University Hospital Essen, Rurhlandlkinik, University Duisburg-EssenPathologisches Institut Humboldt, Universität BerliniOMEDICO AGMedical Affairs, AstraZenecaInternistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung ResearchAbstract Background We evaluated treatment decisions and outcomes in a cohort of predominately Caucasian patients with EGFR mutation-positive (EGFR Mut+) non-small-cell lung cancer (NSCLC). Methods REASON (NCT00997230) was a non-interventional study in German patients with stage IIIB/IV NSCLC. Secondary endpoints for EGFR Mut + NSCLC included progression-free survival (PFS), overall survival (OS), adverse event (AE) management, and pharmacoeconomic outcomes. Results Among 334 patients with EGFR Mut + NSCLC, tyrosine kinase inhibitors (TKIs) were the most common first-line therapy (56.6%, 53.0% gefitinib). Among patients who received TKIs/gefitinib before first disease progression, PFS was longer compared with those who did not receive a TKI (median 10.1/10.0 vs. 7.0 months; HR 0.67/0.69; log-rank p = 0.012/p = 0.022). OS was longer for those patients who ever received a TKI/gefitinib during their complete therapy course compared with those who never received a TKI (median 18.4/18.1 vs. 13.6 months; HR 0.53/0.55; p = 0.003/p = 0.005). Total mean first-line treatment healthcare costs per person were higher for those receiving TKIs (€46,443) compared with those who received chemotherapy (€27,182). Mean outpatient and inpatient costs were highest with chemotherapy. Rash, diarrhea, and dry skin were the most commonly reported AEs for patients receiving gefitinib. Conclusions In REASON, TKI therapy was the most common first- and second-line treatment for EGFR Mut + NSCLC, associated with increased drug costs compared with chemotherapy. Patients who received gefitinib or a TKI ever during their complete therapy course had prolonged PFS and OS compared with patients who did not receive a TKI. Trial registration The trial was registered on October, 2009 with ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT00997230?term=NCT00997230&rank=1http://link.springer.com/article/10.1186/s12885-018-4032-3EGFR-mutationsNon-small cell lung cancer (NSCLC)EGFR tyrosine kinase inhibitorObservationalREASON study |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Wolfgang Schuette Peter Schirmacher Wilfried E. E. Eberhardt Manfred Dietel Ute Zirrgiebel Lars Muehlenhoff Michael Thomas |
spellingShingle |
Wolfgang Schuette Peter Schirmacher Wilfried E. E. Eberhardt Manfred Dietel Ute Zirrgiebel Lars Muehlenhoff Michael Thomas Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study BMC Cancer EGFR-mutations Non-small cell lung cancer (NSCLC) EGFR tyrosine kinase inhibitor Observational REASON study |
author_facet |
Wolfgang Schuette Peter Schirmacher Wilfried E. E. Eberhardt Manfred Dietel Ute Zirrgiebel Lars Muehlenhoff Michael Thomas |
author_sort |
Wolfgang Schuette |
title |
Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study |
title_short |
Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study |
title_full |
Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study |
title_fullStr |
Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study |
title_full_unstemmed |
Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study |
title_sort |
treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with egfr mutated stage iii/iv nsclc in germany: an observational study |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2018-02-01 |
description |
Abstract Background We evaluated treatment decisions and outcomes in a cohort of predominately Caucasian patients with EGFR mutation-positive (EGFR Mut+) non-small-cell lung cancer (NSCLC). Methods REASON (NCT00997230) was a non-interventional study in German patients with stage IIIB/IV NSCLC. Secondary endpoints for EGFR Mut + NSCLC included progression-free survival (PFS), overall survival (OS), adverse event (AE) management, and pharmacoeconomic outcomes. Results Among 334 patients with EGFR Mut + NSCLC, tyrosine kinase inhibitors (TKIs) were the most common first-line therapy (56.6%, 53.0% gefitinib). Among patients who received TKIs/gefitinib before first disease progression, PFS was longer compared with those who did not receive a TKI (median 10.1/10.0 vs. 7.0 months; HR 0.67/0.69; log-rank p = 0.012/p = 0.022). OS was longer for those patients who ever received a TKI/gefitinib during their complete therapy course compared with those who never received a TKI (median 18.4/18.1 vs. 13.6 months; HR 0.53/0.55; p = 0.003/p = 0.005). Total mean first-line treatment healthcare costs per person were higher for those receiving TKIs (€46,443) compared with those who received chemotherapy (€27,182). Mean outpatient and inpatient costs were highest with chemotherapy. Rash, diarrhea, and dry skin were the most commonly reported AEs for patients receiving gefitinib. Conclusions In REASON, TKI therapy was the most common first- and second-line treatment for EGFR Mut + NSCLC, associated with increased drug costs compared with chemotherapy. Patients who received gefitinib or a TKI ever during their complete therapy course had prolonged PFS and OS compared with patients who did not receive a TKI. Trial registration The trial was registered on October, 2009 with ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT00997230?term=NCT00997230&rank=1 |
topic |
EGFR-mutations Non-small cell lung cancer (NSCLC) EGFR tyrosine kinase inhibitor Observational REASON study |
url |
http://link.springer.com/article/10.1186/s12885-018-4032-3 |
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