Trastuzumab deruxtecan in previously treated HER2-positive metastatic or unresectable breast cancer: Real-life data from the temporary use authorization program in France.

Autor: Petit T; Département d'Oncologie Médicale, Centre Paul Strauss, Strasbourg, France., Hajjaji N; Département de Cancérologie Sénologique, Centre Oscar Lambret, INSERM U1192, Laboratoire PRISM, Lille, France., Antoine EC; Département d'Oncologie Médicale, Clinique Hartmann, Neuilly-sur-Seine, France., Benderra MA; Département d'Oncologie Médicale, Hôpital Tenon, Paris, France., Gozy M; Département de Radiothérapie-Oncologie, Clinique de l'Europe, Amiens, France., Foa C; Département d'Oncologie Médicale, Hôpital Saint-Joseph, Marseille, France., Mouysset JL; Département de Cancérologie, Hôpital Privé de Provence, Aix-en-Provence, France., Grenier J; Unité Oncologie Sein-Gynécologie, Institut Sainte-Catherine, Avignon, France., Mousseau M; Département d'Oncologie Médicale, CHU Grenoble, Grenoble, France., Mailliez A; Département de Cancérologie Sénologique, Centre Oscar Lambret, INSERM U1192, Laboratoire PRISM, Lille, France., Saghatchian M; Département d'Oncologie Médicale, Hôpital Américain de Paris, Neuilly-sur-Seine, France., Lachaier E; Département d'Oncologie Médicale, CHU Amiens, Amiens, France., Desmoulins I; Département d'Oncologie Médicale, Centre Georges François Leclerc, Dijon, France., Hennequin A; Département d'Oncologie Médicale, Centre Georges François Leclerc, Dijon, France., Maes P; Département d'Oncologie, Hôpital Privé Le Bois, Lille, France., Loirat D; Département d'Oncologie Médicale, Institut Curie, Paris, France., Ricci F; Département d'Oncologie Médicale, Institut Curie, Paris, France., Diéras V; Département d'Oncologie Médicale, Centre Eugène Marquis, Rennes, France., Berton D; Département d'Oncologie Médicale, Institut de Cancérologie de l'Ouest, Saint-Herblain, France., Tiong FL; Département d'Hémato-Oncologie, CHU Sud Réunion, Saint-Pierre, France., Teixeira L; Breast Disease Unit, APHP, Hôpital Saint-Louis, Pathophysiology of Breast Cancer Team, Université de Paris, INSERM U976, HIPI, Paris, France., Dohollou N; Service d'Oncologie Médicale, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France., Lévy C; Département d'Oncologie Médicale, Centre François Baclesse, Caen, France., Bachelot T; Département d'Oncologie Médicale, Centre Léon Bérard, Lyon, France., Pierga JY; Département d'Oncologie Médicale, Institut Curie, Paris, France.; Université Paris Cité, Paris, France.
Jazyk: angličtina
Zdroj: Cancer medicine [Cancer Med] 2024 May; Vol. 13 (9), pp. e7168.
DOI: 10.1002/cam4.7168
Abstrakt: Background: Early access program (formerly cohort Temporary Authorization for Use) was granted for trastuzumab deruxtecan (T-DXd) in France based on DESTINY-Breast01 trial which demonstrated its efficacy and safety in HER2-positive metastatic/unresectable breast cancer after ≥2 anti-HER2-based regimens received at metastatic stage.
Methods: This multicenter real-world early access program included HER2-positive metastatic/unresectable breast patients pretreated with at least two lines of anti-HER2 regimens who received T-DXd 5.4 mg/kg intravenously in monotherapy every 3 weeks.
Results: Four hundred and fifty-nine patients (median age, 58 years; hormone receptor-positive, 67%; brain metastases, 28.1%) received T-DXd. Before inclusion, 81.7% of patients had radiation therapy and 76.5% had undergone surgery. Median number of prior metastatic treatment lines was four (range, 2-22); 99.8% patients had received trastuzumab, 94.8% trastuzumab emtansine and 79.3% pertuzumab. Follow-up was performed from September 30, 2020 to March 30, 2021; when the early access program stopped, the median duration of T-DXd treatment was 3.4 (range, 0-7.8) months. In 160 patients with available tumor assessment, objective response rate was 56.7% and 12.1% had progression. In 57 patients with available brain tumor assessment, complete or partial intracranial response was reported for 35.7% patients and 5.4% had progression. A total of 17 (3.7%) patients with interstitial lung disease (ILD) was reported with no cases of ILD-related death.
Conclusions: In this early access program in patients with heavily pretreated HER2-positive metastatic/unresectable breast cancer, T-DXd had antitumor activity with a similar response to that reported in previous clinical studies. T-DXd was well tolerated and no new safety signals were observed.
(© 2024 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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