Cladribine Achieves High Response Rates in Mantle Cell Lymphoma

By Martha Kerr

NEW YORK JUL 31, 2008 (Reuters Health) - The purine nucleoside analogue cladribine (2-CDA) achieves high response rates and significantly improves survival in elderly patients with mantle cell lymphoma, even in those with recurrent disease, according to a report in the July 1 issue of Cancer.

Mantle cell lymphoma (MCL), a disease with a "predilection for elderly men," typically has a very poor prognosis, Dr. David J. Inwards of the Mayo Clinic in Rochester, Minnesota, and colleagues point out.

The researchers conducted two sequential phase I/II multicenter studies of cladribine, one as monotherapy and the other as combination therapy with rituximab, for elderly patients with MCL.

In the first study, 26 treatment-naïve patients given cladribine monotherapy had an overall response rate of 81% and a complete response rate of 42%. Median progression-free survival (PFS) was 13.6 months. At two years, 81% of patients were alive.

In previously treated patients with recurrent disease, the overall response rate to monotherapy was 46%, and the complete response rate was 21%. Median progression-free survival was 5.4 months and 36% of patients were alive at two years.

In the second study, 29 patients with MCL, median age 70 years, received cladribine plus rituximab. The overall response rate was 66%. The complete response rate was 52%. At a median follow-up of 21.5 months, only three patients with a complete response had recurrent disease.

"This drug is well tolerated, even by elderly patients, and has a high single-agent response rate in mantle cell lymphoma. It is particularly helpful for patients in whom a transplant is not planned as part of the initial therapy," Dr. Inwards told Reuters Health. "The primary caution is to watch for lowered blood counts after therapy."

Even though monotherapy showed good efficacy, Dr. Inwards commented that "I would start it together with rituximab, based on the information available to date...The addition of rituximab to (cladribine) may increase the duration of response."

The data are promising, but Dr. Inwards issued a caution. "There have not been phase III trials comparing this to other treatment options for mantle cell lymphoma, so it is premature to make claims regarding survival and disease-free survival."

SOURCE:

"Reuters content is the intellectual property of Reuters Limited. Any copying, republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in content, or for any actions taken in reliance thereon."