The ECOG 1912 trial has demonstrated both a progression-free survival (PFS) and an overall survival (OS) benefit for ibrutinib plus rituximab (IR) compared with fludarabine, cyclophosphamide, and rituximab (FCR) chemotherapy in younger patients with previously untreated chronic lymphocytic leukemia (CLL). Patients in this study were 70 years of age or younger. Patients with deletion 17p were excluded based on data suggesting that they would have a poor response to FCR. Patients were randomly assigned to receive IR or FCR. They received ibrutinib orally once a day plus rituximab, which was given intravenously for 7 cycles. Ibrutinib was continued until disease progression or unacceptable toxicity. FCR was given for 6 cycles.
After median follow-up of 45 months, 73% of 354 patients who received IR remained on ibrutinib. Severe side effects were noted in 70% of IR patients, compared with 80% of FCR-treated patients. Among 95 patients who discontinued ibrutinib, reasons for discontinuation were side effects or complications (51%), withdrawal of consent (25%), and progression or death (24%). Roughly 1 in 4 patients discontinued ibrutinib for a reason other than progression or death.
Assessments of efficacy, including both PFS and OS, favored IR over FCR. When PFS findings were analyzed by patients’ IGHV mutation status, IR was shown to be more effective than FCR for IGHV-unmutated patients. IR was not shown to be more effective than FCR in patients with the IGHV mutation.
In conclusion, after more follow-up time, the combination of ibrutinib and rituximab (IR) continues to be more effective than FCR for younger patients with previously untreated CLL.
Abstract 33. ASH 2019.
Learn more about our family of publications.
View Our Publications