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Two randomized, multi-center clinical trials in patients were conducted. Patients were treated with 50mg of DepoCyt or unencapsulated intrathecal cytarabine administered twice weekly.
Results of the studies show that the DepoCyt sustained-release formulation provides once-every-2-week dosing with:
- Unparalled complete response rates from 33%-41%
- Compared to 6%-17% with unencapsulated cytarabine
- Extended half-life of up to 82.4 hours compared to 3.4 hours for cytarabine
- For cytotoxic CSF concentrations maintained >14 days
- Increased median time to neurologic progression of 78.5 days*
*There are no controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms, increased time to disease progression, or increased survival.
In the controlled clinical trials, the most common severe adverse event was arachnoiditis. Other reported adverse events included headaches, nausea and vomiting; these adverse events are manageable and consistent with those commonly seen with intrathecal chemotherapy. Dexamethasone should be concomitantly administered with DepoCyt(e) to reduce the risk and severity of chemical arachnoiditis.
Indication: DepoCyt(e) (cytarabine liposome injection) is indicated for the intrathecal treatment of lymphomatous meningitis.
WARNING: DepoCyt(e)® (cytarabine liposome injection) should be administered only under the supervision of a qualified physician experienced in the use of intrathecal cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event. If left untreated, chemical arachnoiditis may be fatal. The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone (see WARNINGS). Patients receiving DepoCyt(e)® should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis (see DOSAGE AND ADMINISTRATION).
DEPOCYT HIGHLIGHT:
LYMPHOMATOUS MENINGITIS
Lymphomatous meningitis (LM) is cancer that started as primary lymphoma and has spread to the lining of the spinal cord and brain (this lining is the meninges). LM is reported in 5-15% of patients with diffuse high-grade non-Hodgkin’s lymphoma.
LM is rarely curable. However, research has shown that treatment that starts soon after the disease is detected can help many patients. In some patients, early treatment can prevent or slow worsening of symptoms caused by growth of cancer in the meninges.