Interest of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Meningeal Metastasis of Breast Cancer

Phase 3 Completed 74 enrolled Centre Oscar Lambret

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the impact of Depocyte® IT combined with the systemic standard treatment in terms of clinical and/or radiological neuromeningeal progression free survival (SSPN)

Timeline

Start: 2011-08-30
Primary completion: 2018-08
Completion: 2019-03-01

Outcome

Met primary endpoint

paper median LM-PFS was 2.2 months (95% CI: 1.3-3.1) in the control versus 3.8 months (95% CI: 2.3-6.8) in the experimental group PMID 31637444 ↗

paper hazard ratio 0.61, 95% CI: 0.38-0.98) (P = 0.04). PMID 31637444 ↗

Publications

Le Rhun E, Wallet J, Mailliez A, Le Deley MC, Rodrigues I, Boulanger T, Lorgis V, Barriere J, Robin YM, Weller M, Bonneterre J. Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone for newly diagnosed leptomeningeal metastasis from breast cancer. Neuro Oncol. 2020 Apr 15;22(4):524-538. doi: 10.1093/neuonc/noz201.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cytarabine	Small molecule	50 mg	Intrathecal