Radiation Therapy Followed by Intrathecal Trastuzumab-Pertuzumab for ERBB2-Positive Breast Leptomeningeal Disease: A Phase 1 Nonrandomized Controlled Trial

Cet essai de phase I évalue la sécurité d'une radiothérapie suivie d'un traitement combinant trastuzumab par voie intrathécale et pertuzumab chez des patientes atteintes d'un cancer du sein ERBB2+ et présentant une maladie leptoméningée

Résumé en anglais

Trastuzumab has been studied in the management of ERBB2 (formerly HER2)-positive leptomeningeal disease (LMD) via intrathecal delivery. In a previous phase 1/2 study, Kumthekar et al assessed the safety and efficacy of intrathecal trastuzumab in the management of ERBB2-positive LMD. Trastuzumab and pertuzumab delivered systemically with chemotherapy demonstrated improved overall survival (OS) and progression-free survival (PFS) over chemotherapy with trastuzumab alone in patients with ERBB2-positive breast cancer.Radiation therapy (RT) has a well-defined role in symptom control for LMD and may improve the flow of intrathecal therapies through the cerebrospinal fluid (CSF). In this phase 1 study, we assessed the safety of RT with intrathecal trastuzumab (80 mg) combined with pertuzumab.