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

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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

Electronic supplementary material

The online version of this article (10.1186/s12885-018-4032-3) contains supplementary material, which is available to authorized users.

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Most cited references 10

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Genotyping and genomic profiling of non-small-cell lung cancer: implications for current and future therapies.

Tianhong Li, Hsing-Jien Kung, Philip C Mack … (2013)

Substantial advances have been made in understanding critical molecular and cellular mechanisms driving tumor initiation, maintenance, and progression in non-small-cell lung cancer (NSCLC). Over the last decade, these findings have led to the discovery of a variety of novel drug targets and the development of new treatment strategies. Already, the standard of care for patients with advanced-stage NSCLC is shifting from selecting therapy empirically based on a patient's clinicopathologic features to using biomarker-driven treatment algorithms based on the molecular profile of a patient's tumor. This approach is currently best exemplified by treating patients with NSCLC with first-line tyrosine kinase inhibitors when their cancers harbor gain-of-function hotspot mutations in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene rearrangements. These genotype-based targeted therapies represent the first step toward personalizing NSCLC therapy. Recent technology advances in multiplex genotyping and high-throughput genomic profiling by next-generation sequencing technologies now offer the possibility of rapidly and comprehensively interrogating the cancer genome of individual patients from small tumor biopsies. This advance provides the basis for categorizing molecular-defined subsets of patients with NSCLC in whom a growing list of novel molecularly targeted therapeutics are clinically evaluable and additional novel drug targets can be discovered. Increasingly, practicing oncologists are facing the challenge of determining how to select, interpret, and apply these new genetic and genomic assays. This review summarizes the evolution, early success, current status, challenges, and opportunities for clinical application of genotyping and genomic tests in therapeutic decision making for NSCLC.

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A genomics-based classification of human lung tumors.

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We characterized genome alterations in 1255 clinically annotated lung tumors of all histological subgroups to identify genetically defined and clinically relevant subtypes. More than 55% of all cases had at least one oncogenic genome alteration potentially amenable to specific therapeutic intervention, including several personalized treatment approaches that are already in clinical evaluation. Marked differences in the pattern of genomic alterations existed between and within histological subtypes, thus challenging the original histomorphological diagnosis. Immunohistochemical studies confirmed many of these reassigned subtypes. The reassignment eliminated almost all cases of large cell carcinomas, some of which had therapeutically relevant alterations. Prospective testing of our genomics-based diagnostic algorithm in 5145 lung cancer patients enabled a genome-based diagnosis in 3863 (75%) patients, confirmed the feasibility of rational reassignments of large cell lung cancer, and led to improvement in overall survival in patients with EGFR-mutant or ALK-rearranged cancers. Thus, our findings provide support for broad implementation of genome-based diagnosis of lung cancer.

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Is Open Access

ctDNA Determination of EGFR Mutation Status in European and Japanese Patients with Advanced NSCLC: The ASSESS Study.

Martin Reck, Koichi Hagiwara, Baohui Han … (2016)

To offer patients with EGFR mutation-positive advanced NSCLC appropriate EGFR tyrosine kinase inhibitor treatment, mutation testing of tumor samples is required. However, tissue/cytologic samples are not always available or evaluable. The large, noninterventional diagnostic ASSESS study (NCT01785888) evaluated the utility of circulating free tumor-derived DNA (ctDNA) from plasma for EGFR mutation testing.

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Author and article information

Contributors

Wolfgang Schuette: +49 345 559 1440 , Wolfgang.Schuette@Martha-Maria.de , Studiensekretariat.Schuette@nicsys.de

Peter Schirmacher: Peter.Schirmacher@med.uni-heidelberg.de

Wilfried E. E. Eberhardt: wilfried.eberhardt@uni-duisburg-essen.de

Manfred Dietel: manfred.dietel@charite.de

Ute Zirrgiebel: Ute.Zirrgiebel@iomedico.com

Lars Muehlenhoff: Lars.Muehlenhoff@astrazeneca.com

Michael Thomas: Michael.Thomas@med.uni-heidelberg.de

Journal

Journal ID (nlm-ta): BMC Cancer

Journal ID (iso-abbrev): BMC Cancer

Title: BMC Cancer

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2407

Publication date (Electronic): 5 February 2018

Publication date PMC-release: 5 February 2018

Publication date Collection: 2018

Volume: 18

Electronic Location Identifier: 135

Affiliations

[1 ]Krankenhaus Martha-Maria Halle-Doelau gGmbH, Klinik für Innere Medizin II, Roentgenstr, 106120 Halle, Germany

[2 ]ISNI 0000 0001 0328 4908, GRID grid.5253.1, Pathologisches Institut, , Universitätklinik Heidelberg, ; Heidelberg, Germany

[3 ]Department of Medical Oncology, West German Tumor Centre, University Hospital Essen, Rurhlandlkinik, University Duisburg-Essen, Essen, Germany

[4 ]ISNI 0000 0000 9116 4836, GRID grid.14095.39, Pathologisches Institut Humboldt, , Universität Berlin, ; Berlin, Germany

[5 ]GRID grid.476932.d, iOMEDICO AG, ; Freiburg, Germany

[6 ]ISNI 0000 0004 0554 7566, GRID grid.487186.4, Medical Affairs, , AstraZeneca, ; Wedel, Germany

[7 ]ISNI 0000 0001 0328 4908, GRID grid.5253.1, Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, , Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research, ; Heidelberg, Germany

Article

Publisher ID: 4032

DOI: 10.1186/s12885-018-4032-3

PMC ID: 5799904

PubMed ID: 29402243

SO-VID: dd3749f8-b11b-4474-9e83-377778c8f2a1

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 29 November 2016

Date accepted : 23 January 2018

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ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: egfr-mutations,non-small cell lung cancer (nsclc),egfr tyrosine kinase inhibitor,observational,reason study

Data availability:

ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: egfr-mutations, non-small cell lung cancer (nsclc), egfr tyrosine kinase inhibitor, observational, reason study

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

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Conclusions

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Karger: Oncology

Most cited references 10

Genotyping and genomic profiling of non-small-cell lung cancer: implications for current and future therapies.

A genomics-based classification of human lung tumors.

ctDNA Determination of EGFR Mutation Status in European and Japanese Patients with Advanced NSCLC: The ASSESS Study.

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