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| |  DG DISPATCH - ASH: DepoCyt Effective Against Solid Tumor Neoplastic Meningitis By Angela Lorio Special to DG News NEW ORLEANS, LA -- December 6, 1999 -- DepoCyt(TM), a novel slow-release formulation of cytarabine (ara-C), appears safe and effective for treating solid tumor neoplastic meningitis, according to a multi-center Phase IV trial presented at the 41st Annual Meeting of American Society of Hematology, held December 3rd through 7th.
The trial confirms previous favorable findings in patients with lymphomatous and solid tumor neoplastic meningitis that led to FDA approval of the drug for treatment of lymphomatous meningitis last June. The DepoCyt(TM) Consortium - led by Dr. Stephen B. Howell, professor of medicine at the University of California at San Diego - presented their study, "A Phase IV Trial of DepoCyt(TM) for the Treatment of Neoplastic Meningitis." Eighty-nine patients with solid tumor neoplastic meningitis - documented by positive cerebrospinal fluid cytology in 72 patients or other sufficient findings in 17 patients - were given DepoCyt(TM) (50 mg q2w) for one month and then monthly for a total of three months consolidation. Dexamethasone (4 mg po bid) was given on days 1 through 5 of each cycle. Each cycle was based on the DepoCyt(TM)dosing interval. Response was defined as conversion from a positive to negative cerebrospinal cytology at all sites known to be positive; absence of neurologic progression at the time of cytologic conversion was documented. Among the 58 patients with sufficient cerebrospinal sampling that could be evaluated, the consortium reported a 26 percent response rate. The intent-to-treat response rate, among the entire group of 89 patients, was 17 percent. These rates are comparable to methotrexate response and confirms the response seen in the previous randomized trial, the researchers note. Among the patients who attained a response, 77 percent did so within two cycles and the remaining patients attained a response within four cycles. A total of 82 percent were able to complete the planned induction before meningeal disease progression or death and 19 percent were able to complete the planned consolidation therapy. Among patients with neurologic deficits at baseline, 18 percent had improvement after two cycles. The investigators noted that the major drug-related adverse events were headache (11.8 percent) and arachnoiditis (15 percent), but they characterized these events as low grade, transient, reversible and easily manageable. There was no evidence of cumulative toxicity of any type, they said. The fact that DepoCyt can be given just once every two weeks is of substantial benefit to this very ill group of patients whose neurologic deficits often impair mobility, the investigators concluded.
Related Link: DepoCyt.
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