Use of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Leptomeningeal Metastases of Breast Cancer Versus no Intrathecal Treatment
Inclusion Criteria:
- Histologically confirmed breast cancer
- New diagnosis of leptomeningeal involvement confirmed by CSF cytology or clinical
signs and symptoms associated with MRI features
- Received first-line chemotherapy (in neoadjuvant or metastatic setting) co
- Age ≥ 18 ans
- Performance Status (ECOG) ≤ 2
- Life expectancy > 2 months
- Brain metastases allowed if asymptomatic
- study of CSF flux (isotopic method) if suspicion of CSF blockage, or after a local
radiotherapy for lifting blocking CSF to confirm absence of blocking CSF
- recovered from prior toxicities
- Adequate hematological, renal, hepatic parameters:
- Total bilirubin ≤ 3 ULN
- SGPT/ALT and SGOT/AST ≤ 2.5 ULN ; ≤ 5 ULN if hepatic metastases
- Effective contraceptive methods for non menopausal woman
- Patient covered by health insurance
- Informed consent form signed by the patient
Exclusion Criteria:
- leptomeningeal metastases other than from breast cancer
- prior cancer (> 5 years) except for cervix carcinoma, basocellular carcinoma, skin
spinocellular
- contre indication for MRI
- MRI : meningeal metastase > 1cm, obstruction of CSF
- contre indication for lumbar puncture, or for ventricular catheterization
- progressive brain metastases necessitating a radiotherapy
- prior cranio spinal radiotherapy
- prior intra tumoral treatment
- prior treatment with ARA-C or methotrexate
- concomitant treatment high dose methotrexate
- ventriculo peritoneal derivation
- active infection
- hypersensitivity for ARA-C or DepoCyte
- other severe or non controlled pathology
- patient already included in another therapeutic trial with experimental molecule (30
days prior first administration of DepoCyte ®)
- pregnancy or breast feeding woman
- unable to undergo medical follow up for geographic, social or psychological reasons