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. 2024 Dec 1;15(12):e00773.
doi: 10.14309/ctg.0000000000000773.

Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Gastric Cancer in a Real-World Setting: A Nationwide Cohort Study

Hugo Jourdain  1 , Nicolas Albin  2   3 , Adrien Monard  2   3 , David Desplas  1 , Mahmoud Zureik  1   4 , Nadia Haddy  1
Affiliations

Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Gastric Cancer in a Real-World Setting: A Nationwide Cohort Study

Hugo Jourdain et al. Clin Transl Gastroenterol. .

Abstract

Introduction: Trastuzumab deruxtecan (T-DXd) has been approved for human epidermal growth factor receptor 2-positive locally advanced or metastatic gastric and gastroesophageal junction (HER2+ mG/GEJ) cancer since July 2022 in France, through an accelerated approval. The aim of this study was to evaluate its real-world use.

Methods: We characterized T-DXd users treated for HER2+ mG/GEJ cancer using data from the French National Health Insurance database.

Results: The cohort included 196 patients, mostly men (78.1%), with a median age of 65 years. Median overall survival reached 7.7 months (95% CI: 6.2-9.0).

Discussion: Patients treated with T-DXd for HER2+ mG/GEJ cancer in the real world showed lower outcomes than those in pivotal clinical trials, consistent with previous reports on accelerated approvals.

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Conflict of interest statement

Guarantor of the article: Nadia Haddy, PhD.

Specific author contributions: H.J., N.A., A.M., and N.H.: literature search. H.J. and N.H.: study design. H.J. and D.D.: data extraction and collection. H.J.: statistical analysis. H.J., N.A., A.M., M.Z., and N.H.: interpretation of the results. H.J. and N.H.: drafting of the manuscript. All authors: revision of the manuscript. N.H. and MZ.: supervision. H.J., N.H., and M.Z.: confirm that they had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. H.J., N.H., and M.Z.: have final responsibility for the decision to submit the manuscript for publication.

Financial support: The authors are employees of the French National Health Insurance (CNAM), the French National Agency for Medicines and Health Products Safety (ANSM), and the Avec Groupe Hospitalier Mutualiste, Grenoble, and received no funding for this study.

Potential competing interests: None to report.

Data sharing statement, consent, ethics approval: The French National Health Data System (SNDS) is a strictly anonymous database set, including all mandatory health insurance reimbursement data of the French population, in particular data from the processing of healthcare reimbursements (electronic or paper treatment sheet) and data from health establishments (PMSI). EPI-PHARE has permanent regulatory access to the data from the French National Health Data System (SNDS) via its constitutive bodies ANSM and CNAM, in application of the provisions of the French Decree No. 2016-1871 of December 26, 2016 relating to the processing of personal data called the “National Health Data System”15, the French law articles Art. R. 1461-1316 and R. 1461-1417 from the French Public Health Code and the French Data Protection Authority (CNIL) decision CNIL-2016-316.18. In accordance with the permanent regulatory access granted to EPI-PHARE via ANSM and CNAM, this work did not require any specific opinion from the French Ethical and Scientific Committee for Research, Studies and Evaluations health (CESREES) nor approval from the CNIL. All requests in the database were made by duly authorized people. The study was registered on the study register of EPI-PHARE concerning studies from SNDS data under the reference T-2024-05-517. In accordance with data protection legislation and the French regulation, the authors are not allowed to release or make public the data from the SNDS. However, any person or structure, public or private, for-profit or nonprofit, is able to access SNDS data in order to carry out a study, research or an evaluation in the public interest, upon authorization from the French Data Protection Office (CNIL), via the French Health Data Hub (https://www.health-datahub.fr/). All information for data subject is available on the EPI-PHARE website at https://www.epi-phare.fr/en/regulation-snds/.

Patient and public involvement: The patients and public were not involved in this research.

Figures

Figure 1.
Figure 1.
Overall survival (a) and treatment continuation (b) probabilities. Crosses represent censored patients. CI, confidence interval; mOS, median overall survival; mTTD, median time to treatment discontinuation.
See this image and copyright information in PMC

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