Abstract
Elderly patients with chronic lymphocytic leukemia (CLL) are underrepresented in trials evaluating fludarabine, cyclophosphamide, and rituximab (FCR). We assessed four cycles of FCR with two additional rituximab doses on day 14 of cycles 1 and 2 in 194 untreated CLL patients > 65 years (median age 71.2) without del17p. Four FCR cycles were administered to 90.7% (176/194), with (n = 74) or without (n = 102) dose-delay and/or dose-reduction. A total of 50% grade 3/4 neutropenia occurred after each cycle. Only 6.2% cycles were associated with severe infection. Complete remission (CR) was achieved in 19.7%, and partial remission (PR) in 73.9% of patients. Minimal residual disease (MRD) was negative in 36.7%. Overall survival at 36 months was estimated at 87.4%. Oral FC and dose-dense rituximab is feasible and active in fit elderly CLL patients. However, myelosuppression is significant and frequent dose adaptations are required implying that these results cannot be generalized to unfit or frail elderly CLL.
Acknowledgements
The authors wish to express their gratitude to all patients, physicians, and hospital staff for their participation in the study. The authors are indebted to Kamel Laribi, Jean-Pierre Vilque, Olivier Tournilhac, Vincent Lévy and Xavier Troussard, as well as to the members of the MRD group. This study was funded by a grant from the French Ministry of Health. The authors thank Roche France and Chugai Pharma France for supporting the trial.
Potential conflict of interest
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