Rituximab plus chemotherapy for untreated CLL: "highly effective"

NEW YORK (Reuters Health) - Rituximab immunotherapy combined with fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) is a highly effective regimen for previously untreated chronic lymphocytic leukemia (CLL), new research shows.

"R-FCM is a well-tolerated regimen that produces the highest complete response rate reported to date, including minimal residual disease-negative complete responses, in previously untreated patients with active chronic lymphocytic leukemia," Dr. Francesc Bosch, from Hospital Clinic, Barcelona, and colleagues conclude.

According to their report in the Journal of Clinical Oncology for August 20, 72 patients, 70 years of age or younger, were treated with up to 6 cycles of R-FCM at 4-week intervals, supported with colony-stimulating factor. Treatment responders continued to receive rituximab every 3 months for 2 years.

The overall response rate was 93%. minimal residual disease-negative complete responses were achieved in 46%, minimal residual disease-positive complete responses in 36%, and partial responses in 11%, the authors report.

Severe neutropenia developed in 13% of patients, and major and minor infections were noted with 8% and 5% of cycles, respectively.

Predictors of a lower complete response rate were advanced clinical stage, del(17p), and increased beta2-microglobulin, according to the article.

Given the effectiveness of R-FCM, and its "82% complete response rate," the researchers conclude that "randomized trials comparing R-FCM with other forms of chemoimmunotherapy are clearly warranted."

J Clin Oncol 2009.

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