TY - JOUR
T1 - Phase II Study of Systemic High-dose Methotrexate and Intrathecal Liposomal Cytarabine for Treatment of Leptomeningeal Carcinomatosis From Breast Cancer
AU - Mrugala, Maciej M.
AU - Kim, Bryan
AU - Sharma, Akanksha
AU - Johnson, Natalie
AU - Graham, Carrie
AU - Kurland, Brenda F.
AU - Gralow, Julie
N1 - Funding Information:
All patients provided written informed consent to study treatment after being informed of alternative therapies and of potential risks of IT Depocyt and HD-MTX. The study was approved by the Fred Hutchinson Cancer Consortium Institutional Review Board and the University of Washington Human Subjects Division and funded by Sigma Tau Pharmaceuticals, Inc (currently Leadiant Biosciences).
Funding Information:
Dr. Mrugala was a consultant and received research funding from Sigma-Tau Pharmaceuticals. The remaining authors have stated that they have no conflicts of interest.The authors would like to thank the patients who participated in this study and their families. Funding was provided by Sigma-Tau (currently Leadiant Biosciences), and the authors are grateful for the support. This project used the Biostatistics Shared Resource Facilities of the Fred Hutchinson Cancer Research Center (P30CA015704) and the UPMC Hillman Cancer Center (P30CA047904). The authors would also like to thank Fereshteh Assadian, Joanna Haug, and Sandra Johnston for assistance at different stages of this project.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/10
Y1 - 2019/10
N2 - Metastatic breast cancer frequently leads to brain metastases and, less commonly, leptomeningeal carcinomatosis (LC). Once cerebrospinal fluid involvement occurs, the prognosis is poor. There are limited treatment options available, but none offer significant survival benefit. Methotrexate, given systemically at high doses (3.5-8 gm/m2), achieves cytotoxic concentrations in the CSF and has been shown to prolong survival in patients with LC. Intrathecal liposomal cytarabine has been shown to increase time to neurologic progression in patients with breast cancer and LC. The combination of these 2 agents in LC has not been studied extensively. Here, we present the results of the phase II study with this combination showing promising efficacy and very good tolerability.
AB - Metastatic breast cancer frequently leads to brain metastases and, less commonly, leptomeningeal carcinomatosis (LC). Once cerebrospinal fluid involvement occurs, the prognosis is poor. There are limited treatment options available, but none offer significant survival benefit. Methotrexate, given systemically at high doses (3.5-8 gm/m2), achieves cytotoxic concentrations in the CSF and has been shown to prolong survival in patients with LC. Intrathecal liposomal cytarabine has been shown to increase time to neurologic progression in patients with breast cancer and LC. The combination of these 2 agents in LC has not been studied extensively. Here, we present the results of the phase II study with this combination showing promising efficacy and very good tolerability.
KW - Breast cancer metastasis
KW - High-dose methotrexate
KW - Intrathecal chemotherapy
KW - Leptomeningeal carcinomatosis
KW - Liposomal cytarabine
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U2 - 10.1016/j.clbc.2019.04.004
DO - 10.1016/j.clbc.2019.04.004
M3 - Article
C2 - 31175053
AN - SCOPUS:85066430843
SN - 1526-8209
VL - 19
SP - 311
EP - 316
JO - Clinical breast cancer
JF - Clinical breast cancer
IS - 5
ER -