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Rituximab Improves Efficacy of Fludarabine-Based Therapy in Chronic Lymphocytic Leukaemia: Presented at NHL

By Chris Berrie

PRAGUE, CZECH REPUBLIC -- September 14, 2004 -- The addition of rituximab to fludarabine-based therapy (R-fludarabine) for previously untreated patients with chronic lymphocytic leukaemia (CLL) improves progression-free survival (PFS) and overall survival (OS), according to a historical comparison of 2 multicentre Cancer and Leukaemia Group B studies.

The results were presented here September 12^th at The Role of Immunotherapy in NHL: Optimising Treatment Outcomes, sponsored by Roche, and have just achieved online publication (Byrd et al., Blood, 2004, epub)

In the absence of relevant prospective randomised studies, and following the update of the results from the randomised CALGB 9712 study of sequential versus concurrent R-fludarabine, Thomas Lin, MD, investigator for CALGB, and assistant professor of internal medicine, division of Haematology and oncology, Ohio State University, Columbus, Ohio, United States, said they recently completed a retrospective comparison of response and survival data of R-fludarabine (CALGB 9712) and fludarabine alone (CALGB 9011).

In giving the background to CALGB 9712, Dr. Lin indicated that 104 patients had been randomised to the "sequential" or "concurrent" arms. The former consisted of 6 courses of fludarabine 25 mg/m² on days 1 to 5 every 4 weeks followed by consolidation therapy of rituximab 4 x 375 mg/m² per week in patients with response or stable disease. The latter was the same, except the patients received additional rituximab 375 mg/m² on days 1 and 4 of the first cycle, and on day 1 of cycles 2 to 6.

At a median follow-up of 43 months, the median PFS and OS remained similar between the 2 arms of CALGB 9712, and hence the researchers decided to combine these 104 patients (as R-fludarabine) in this new retrospective analysis with 178 fludarabine-alone patients from CALGB 9001. The patient enrolment criteria and characteristics were comparable between the 2 trials, and there were no significant differences between their demographics and infections.

Using this historical comparison, R-fludarabine showed a higher incidence of complete response (38% vs 20%; P =.002) and OS (84% vs 63%; P =.0003) when compared with fludarabine alone. Similarly, the 2-year PFS (67% vs 45%; P <.0001) and OS (93% vs 81%; P =.0009) were also significantly better with the rituximab plus fludarabine treatment.

In concluding, Dr. Lin stressed that although these findings come from a cross-trial analysis, they represent a significant advance in therapy for CLL as they suggest that the addition of rituximab to fludarabine-based therapy significantly improves the complete response, the overall response, progression-free survival, and overall survival, with minimal increased toxicity. Further prospective randomised trials are under way to confirm these findings, he said.


[Presentation title: Sequential Versus Concurrent Fludarabine and Rituximab in Previously Untreated Chronic Lymphocytic Leukaemia. Abstract 424]

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