Phase II Study of Olaparib and Temozolomide for Advanced Uterine Leiomyosarcoma (NCI Protocol 10250)

Mené sur 22 patientes atteintes d'un léiomyosarcome utérin de stade avancé (âge médian : 55 ans), cet essai multicentrique de phase II évalue l'efficacité, du point de vue du taux de réponse objective et de la survie sans progression, et la toxicité de l'olaparib en combinaison avec le témozolomide

Résumé en anglais

PURPOSE : Uterine leiomyosarcoma (uLMS) is an aggressive subtype of soft-tissue sarcoma with frequent metastatic relapse after curative surgery. Chemotherapy provides limited benefit for advanced disease. Multiomics profiling studies have identified homologous recombination deficiency in uLMS. In preclinical studies where olaparib and temozolomide provided modest activity, the combination was highly effective for inhibiting uLMS tumor growth.

PATIENTS AND METHODS : NCI Protocol 10250 is a single-arm, open-label, multicenter, phase II study evaluating olaparib and temozolomide in advanced uLMS. Patients with progression on