Titre
Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Kristeleit, R.
Auteure/Auteur
Leary, A.
Auteure/Auteur
Delord, J.P.
Auteure/Auteur
Moreno, V.
Auteure/Auteur
Oaknin, A.
Auteure/Auteur
Castellano, D.
Auteure/Auteur
Shappiro, G.I.
Auteure/Auteur
Fernández, C.
Auteure/Auteur
Kahatt, C.
Auteure/Auteur
Alfaro, V.
Auteure/Auteur
Siguero, M.
Auteure/Auteur
Rueda, D.
Auteure/Auteur
Zeaiter, A.
Auteure/Auteur
Awada, A.
Auteure/Auteur
Santaballa, A.
Auteure/Auteur
Zaman, K.
Auteure/Auteur
Sehouli, J.
Auteure/Auteur
Subbiah, V.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
1573-0646
Statut éditorial
Publié
Date de publication
2023-10
Volume
41
Numéro
5
Première page
677
Dernière page/numéro d’article
687
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Résumé
Second-line treatment of endometrial cancer is an unmet medical need. Lurbinectedin showed promising antitumor activity in a phase I study in combination with doxorubicin in advanced endometrial cancer. This phase 2 Basket trial evaluated lurbinectedin 3.2 mg/m <sup>2</sup> 1-h intravenous infusion every 3 weeks in a cohort of 73 patients with pretreated endometrial cancer. The primary endpoint was overall response rate (ORR) according to RECIST v1.1. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and an exploratory translational study. Confirmed complete (CR) and partial response (PR) was reported in two and six patients, respectively (ORR = 11.3%; 95%CI, 5.0-21.0%). Median DoR was 9.2 months (95%CI, 3.4-18.0 months), median PFS was 2.6 months (95%CI, 1.4-4.0 months) and median OS was 9.3 months (95%CI, 6.1-12.8 months). Molecular subtypes showed differences in PFS rate at 6 months (p53abn 23.7% vs. "No Specific Molecular Profile" [NSMP] 42.9%) and median OS (p53abn 6.6 months vs. NSMP 16.1 months). The most common treatment-related adverse events (mostly grade 1/2) were fatigue (54.8% of patients), nausea (50.7%), vomiting (26.0%) decreased appetite (17.8%). and constipation, (19.2%). The most common grade 3/4 toxicity was neutropenia (43.8%; grade 4, 19.2%; febrile neutropenia, 4.1%). In conclusion, considering the exploratory aim of this trial and the hints of antitumor activity observed together with a predictable and manageable safety profile, further biomarker-based development of lurbinectedin is recommended in this indication in combination with other agents. Clinicaltrials.gov identifier: NCT02454972.
PID Serval
serval:BIB_124EFD9C766F
PMID
Open Access
Oui
Date de création
2023-08-10T12:24:26.003Z
Date de création dans IRIS
2025-05-20T17:15:29Z
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Nom
37556023_BIB_124EFD9C766F.pdf
Version du manuscrit
published
Licence
https://creativecommons.org/licenses/by/4.0
Taille
1.72 MB
Format
Adobe PDF
PID Serval
serval:BIB_124EFD9C766F.P001
URN
urn:nbn:ch:serval-BIB_124EFD9C766F0
Somme de contrôle
(MD5):06de84de0632da302285c6e004177409