Abstract
Purpose
The controlled phase III trial SATURN demonstrated that maintenance therapy with erlotinib after the first-line platinum-based chemotherapy prolonged progression-free survival (PFS) and overall survival (OS) of non-small cell lung cancer (NSCLC) patients with advanced, non-progressive disease. We conducted the non-interventional study SATURN NIS to investigate the effectiveness and tolerability of erlotinib maintenance in daily clinical practice.
Methods
This single-arm NIS screened 290 patients with locally advanced or metastatic NSCLC (stage IIIB or IV) and stable disease after standard platinum-based first-line chemotherapy in 95 institutions across Germany. Erlotinib was dosed and administered corresponding to the terms of the marketing authorization at the time of recruitment. The main effectiveness endpoint was subjects’ OS at 1 year. Subgroup analyses of survival estimates of OS and PFS were performed.
Results
272 patients were eligible for analysis (median age 66 years, 37.1% females, 99.6% Caucasian, median ECOG performance status 1, 61.8% adenocarcinoma, 96.3% of patients with stable disease). Maintenance therapy with erlotinib resulted in median OS comparable to that of the SATURN phase III trial 10.4 months [95% CI: (8.8; 12.5) vs. 11.9 months]. The 1-year survival rate was 45.6% [95% CI: (37.5%; 53.6%)]. No new safety signals were observed. As expected, patients with epidermal growth factor receptor (EGFR) mutations derived a greater benefit concerning OS and PFS than EGFR–wild-type patients. Moreover, a significant association of OS and PFS and the smoking status was observed.
Conclusions
The results of this non-interventional study support the current clinical practice of erlotinib switch maintenance in EGFR-mutation-positive patients.
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Funding
Roche Pharma AG, Grenzach-Wyhlen, Germany provided financial support for this study and for manuscript services by AMS Advanced Medical Services with regard to drafting of the manuscript and editing.
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MF has performed clinical phase IB-IV trials sponsored by Roche, Boehringer Ingelheim, and AstraZeneca, and received honoraria from Roche, Boehringer Ingelheim, and AstraZeneca in the past. JA reports personal fees from AstraZeneca, Bristol-Myers Squibb (BMS), Boehringer Ingelheim, Novartis, and Roche outside the submitted work. US and HWT have nothing to disclose. PS reports grants, personal fees, and non-financial support from Roche and Celgene, and grants from Astra Zeneca during the conduct of the study. In addition, outside the submitted work, PS reports grants, personal fees, and non-financial support from Pfizer, Novartis, Amgen, grants from MSD and BMS, and grants and personal fees from Astellas. VG reports personal fees from Roche Pharma AG outside the submitted work. WB reports personal fees from Roche, Boehringer Ingelheim, Lilly, AstraZeneca, BMS, Merck, Novartis, and Pfizer outside the submitted work.
Ethical Approval
The observation plan for this non-interventional study was approved by the local Ethics Committee (Landesärztekammer Baden-Württemberg, F-2010-038). The study was performed in accordance with the 1964 Declaration of Helsinki and its later amendments and Good Clinical Practice guidelines.
Research involving human participants and/or animals
This article does not contain any studies with animals performed by any of the authors.
Informed consent
Informed consent was obtained from all individual participants included in the non-interventional study concerning collection and processing of their personal data.
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Faehling, M., Achenbach, J., Staib, P. et al. Erlotinib in routine clinical practice for first-line maintenance therapy in patients with advanced non-small cell lung cancer (NSCLC). J Cancer Res Clin Oncol 144, 1375–1383 (2018). https://doi.org/10.1007/s00432-018-2649-x
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DOI: https://doi.org/10.1007/s00432-018-2649-x