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Rituximab Added to Fludarabine in Untreated CLL Patients

Rituximab Added to Fludarabine in Untreated CLL Patients

SAN FRANCISCO—Preliminary results from the Cancer and Leukemia Group B
(CALGB)-9712 trial indicate that rituximab (Rituxan) given concurrently with
fludarabine (Fludara) improves response in previously untreated chronic
lymphocytic leukemia (CLL) patients, compared with a sequential approach.
The results were presented at the 37th Annual Meeting of the American
Society of Clinical Oncology (ASCO abstract 1116).

Rituximab is a chimeric monoclonal antibody directed against CD20 that is
very effective in the treatment of non-Hodgkin’s lymphoma. "Rituximab
is clearly synergistic with chemotherapy and has a favorable toxicity
profile, including minimal myelosuppression and a low rate of
infection," said John C. Byrd, MD, director, Hematologic Malignancy
Program, Ohio State University Medical Center.

In 1998, CALGB initiated this phase II clinical trial on the hypothesis
that, as in non-Hodgkin’s lymphoma, rituximab will improve response in CLL
patients receiving fludarabine-based therapy.

The study randomized previously untreated, symptomatic CLL patients to
receive either concurrent fludarabine and rituximab for six monthly cycles,
followed after 2 months by consolidation rituximab (weekly for 4 weeks) or a
sequential approach of fludarabine alone for six cycles followed 2 months
later with 4 weeks of rituximab consolidation.

A total of 104 patients were enrolled; 51 were randomized to the
concurrent arm and 55 to the sequential arm. The median patient age was 64
years (range, 36 to 86 years). Dr. Byrd noted that 41% of the patients were
high risk.

Response Rates

Response rates in each arm were assessed 2 months after induction
therapy. In the concurrent arm, there was a complete response rate of 33%
and a partial response rate of 57%, for an overall response rate of 90%. The
sequential arm had a 15% complete response, a partial response of 62%, and
an overall response rate of 77%, "similar to what has been seen in
other phase II and III trials of fludarabine alone," Dr. Byrd reported.

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