Skip to main content
Top
Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Research article

Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study

Authors: Wolfgang Schuette, Peter Schirmacher, Wilfried E. E. Eberhardt, Manfred Dietel, Ute Zirrgiebel, Lars Muehlenhoff, Michael Thomas

Published in: BMC Cancer | Issue 1/2018

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
go back to reference Novello S, Barlesi F, Califano R, et al. Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v1–v27.CrossRefPubMed Novello S, Barlesi F, Califano R, et al. Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v1–v27.CrossRefPubMed
2.
go back to reference Li T, Kung HJ, Mack PC, Gandara DR. Genotyping and genomic profiling of non-small-cell lung cancer: implications for current and future therapies. J Clin Oncol. 2013;31:1039–49.CrossRefPubMedPubMedCentral Li T, Kung HJ, Mack PC, Gandara DR. Genotyping and genomic profiling of non-small-cell lung cancer: implications for current and future therapies. J Clin Oncol. 2013;31:1039–49.CrossRefPubMedPubMedCentral
3.
go back to reference Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013;49:1374–403.CrossRefPubMed Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013;49:1374–403.CrossRefPubMed
4.
go back to reference Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362:2380–8.CrossRefPubMed Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362:2380–8.CrossRefPubMed
6.
go back to reference Schuette W, Schirmacher P, Eberhardt WE, et al. EGFR mutation status and first-line treatment in patients with stage III/IV non-small cell lung cancer in Germany: an observational study. Cancer Epidemiol Biomark Prev. 2015;24:1254–61.CrossRef Schuette W, Schirmacher P, Eberhardt WE, et al. EGFR mutation status and first-line treatment in patients with stage III/IV non-small cell lung cancer in Germany: an observational study. Cancer Epidemiol Biomark Prev. 2015;24:1254–61.CrossRef
7.
go back to reference Reck M, Hagiwara K, Han B, et al. ctDNA determination of EGFR mutation status in European and Japanese patients with advanced NSCLC: the ASSESS study. J Thorac Oncol. 2016;11(10):1682–9.CrossRefPubMed Reck M, Hagiwara K, Han B, et al. ctDNA determination of EGFR mutation status in European and Japanese patients with advanced NSCLC: the ASSESS study. J Thorac Oncol. 2016;11(10):1682–9.CrossRefPubMed
8.
go back to reference Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361:947–57.CrossRefPubMed Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361:947–57.CrossRefPubMed
10.
go back to reference Clinical Lung Cancer Genome Project (CLCGP), Network Genomic Medicine (NGM). A genomics-based classification of human lung tumors. Sci Transl Med. 2013;5(209):ra153. Clinical Lung Cancer Genome Project (CLCGP), Network Genomic Medicine (NGM). A genomics-based classification of human lung tumors. Sci Transl Med. 2013;5(209):ra153.
11.
go back to reference Carrato A, Vergnenegre A, Thomas M, McBride K, Medina J, Cruciani G. Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-lung study. Curr Med Res Opin. 2014;30:447–61.CrossRefPubMed Carrato A, Vergnenegre A, Thomas M, McBride K, Medina J, Cruciani G. Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-lung study. Curr Med Res Opin. 2014;30:447–61.CrossRefPubMed
12.
go back to reference Knetki-Wroblewska M, Kowalski DM, Zajda K, et al. Gefitinib in patients with advanced non-small-cell lung cancer. Pneumonol Alergol Pol. 2012;80:439–49.PubMed Knetki-Wroblewska M, Kowalski DM, Zajda K, et al. Gefitinib in patients with advanced non-small-cell lung cancer. Pneumonol Alergol Pol. 2012;80:439–49.PubMed
13.
go back to reference Lu RL, Hu CP, Yang HP, Li YY, Gu QH, Wu L. Biological characteristics and epidermal growth factor receptor tyrosine kinase inhibitors efficacy of EGFR mutation and its subtypes in lung adenocarcinoma. Pathol Oncol Res. 2014;20:445–51.CrossRefPubMed Lu RL, Hu CP, Yang HP, Li YY, Gu QH, Wu L. Biological characteristics and epidermal growth factor receptor tyrosine kinase inhibitors efficacy of EGFR mutation and its subtypes in lung adenocarcinoma. Pathol Oncol Res. 2014;20:445–51.CrossRefPubMed
14.
go back to reference Souquet P-J, Fournel P, Locher C, et al. MUTACT: an observational study of EGFR mutation status and management of patients with non-small cell lung cancer (NSCLC) adenocarcinoma. Ann Oncol. 2012;23(Suppl 9):ix400–46. (Abstract 1270P) Souquet P-J, Fournel P, Locher C, et al. MUTACT: an observational study of EGFR mutation status and management of patients with non-small cell lung cancer (NSCLC) adenocarcinoma. Ann Oncol. 2012;23(Suppl 9):ix400–46. (Abstract 1270P)
15.
go back to reference Sharma SV, Bell DW, Settleman J, Haber DA. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer. 2007;7:169–81.CrossRefPubMed Sharma SV, Bell DW, Settleman J, Haber DA. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer. 2007;7:169–81.CrossRefPubMed
18.
go back to reference Eberhardt W, Thomas M, Graf von der Schulenberg J-M, et al. EGFR mutation testing and first-line treatment of patients with advanced NSCLC and positive EGFR mutation status: results from a German registry. Eur J Cancer. 2011;47:S636.CrossRef Eberhardt W, Thomas M, Graf von der Schulenberg J-M, et al. EGFR mutation testing and first-line treatment of patients with advanced NSCLC and positive EGFR mutation status: results from a German registry. Eur J Cancer. 2011;47:S636.CrossRef
19.
go back to reference Lee JK, Kim DW, Keam B, et al. The impact of molecularly targeted treatment on direct medical costs in patients with advanced non-small cell lung cancer. Cancer Res Treat. 2015;47:182–8.CrossRefPubMed Lee JK, Kim DW, Keam B, et al. The impact of molecularly targeted treatment on direct medical costs in patients with advanced non-small cell lung cancer. Cancer Res Treat. 2015;47:182–8.CrossRefPubMed
Metadata
Title
Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study
Authors
Wolfgang Schuette
Peter Schirmacher
Wilfried E. E. Eberhardt
Manfred Dietel
Ute Zirrgiebel
Lars Muehlenhoff
Michael Thomas
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4032-3

Other articles of this Issue 1/2018

BMC Cancer 1/2018 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine