Chronic Lymphocytic Leukaemia - Combination Treatment Raises Progression-Free Survival And Response

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Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 20 Jul 2007 - 0:00 PDT

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Combination therapy with fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia (CLL) improves progression-free survival and response rates significantly, in comparison to monotherapy with just fludarabine or chlorambucil, according to a report in The Lancet this week. The authors say that this combination therapy should become the standard treatment for CLL, as well as becoming the basis for new protocols that include monoclonal antibodies.

In the industrial world CLL is the most common leukemia and currently incurable.

Prof. Daniel Catovsky, Intsitute of Cancer Research, Sutton, England, and team carried out a study of 777 CLL patients.

They were divided into three groups:

• 196 received a combination of fludarabine plus chlorambucil
• 194 received just fludarabine
• 386 received just chlorambucil

There was no significant difference in overall survival rates, said the authors. However, 36% of those on the combination therapy experienced progression-free survival at five years, compared to just 10% in either monotherapy group.

Here are some more results of their findings:

• Complete response rate in combination therapy group - 38%
• Complete response rate in fludarabine monotherapy group - 15%
• Complete response rate in chlorambucil monotherapy group - 7%
• Overall response rate in combination therapy group - 94%
• Overall response rate in fludarabine monotherapy group - 80%
• Overall response rate in chlorambucil monotherapy group - 72%

All age groups benefited the best from the combination therapy, including those over 70. Quality of life was reported as better for those that responded to treatment. There was no significant difference between treatment regimens.

Side effects:

• Combined Treatment and fludarabine monotherapy - more neutropenia (low numbers of neutrophils) and days in hospital, compared to chlorambucil monotherapy.
• Hermolytic anemia in combination therapy group - 5%
• Hermolytic anemia in fludarabine monotherapy group - 11%
• Hermolytic anemia in chlorambucil monotherapy group - 12%

"We have shown that the combination treatment of fludarabine plus cyclophosphamide produces a substantial improvement in both response rates and progression-free survival compared with either single-agent chlorambucil or fludarabine. Fludarabine plus cyclophosphamide should now become the standard treatment for chronic lymphocytic leukaemia and the basis for new protocols that incorporate monoclonal antibodies," the authors concluded.

"These findings are consistent with the results of similar studies recently reported by the German CLL Study Group and the North American Intergroup (NAIG), which also found superior progression free survival in patients with fludarabine/cyclophosphamide."
Accompanying Comment
Dr Tait Shanafelt and Dr Neil Kay, Mayo Clinic College of Medicine, Rochester, Minnesota, USA.

The study was funded by Leukaemia Research.

http://www.thelancet.com

Written by: Christian Nordqvist
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