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Ibrutinib versus FCR
Source: Chronic Lymphocytic Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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Ibrutinib is a selective irreversible inhibitor of BTK, a signaling molecule located upstream in the B-cell receptor-signaling cascade.
Evidence (ibrutinib vs. FCR):
ECOG-E1912 (NCT02048813) was a prospective randomized trial that compared ibrutinib and rituximab with FCR. A total of 529 patients previously untreated for CLL were randomly assigned in a 2:1 ratio to receive either ibrutinib and rituximab followed by ibrutinib maintenance (354 patients) or six cycles of FCR (175 patients).[12,13]
Source links and citations
ECOG-E1912 (NCT02048813) was a prospective randomized trial that compared ibrutinib and rituximab with FCR. A total of 529 patients previously untreated for CLL were randomly assigned in a 2:1 ratio to receive either ibrutinib and rituximab followed by ibrutinib maintenance (354 patients) or six cycles of FCR (175 patients).[12,13]
With a median follow-up of 5.8 years, the 5-year OS rate favored the ibrutinib arm (95% vs. 89%) (HR, 0.47; 95% CI, 0.25–0.89; P = .018).[13][Level of evidence A1]
Source links and citations
ECOG-E1912 (NCT02048813) was a prospective randomized trial that compared ibrutinib and rituximab with FCR. A total of 529 patients previously untreated for CLL were randomly assigned in a 2:1 ratio to receive either ibrutinib and rituximab followed by ibrutinib maintenance (354 patients) or six cycles of FCR (175 patients).[12,13]
In 281 patients without IGH pathogenic variants, the 5-year PFS rate favored ibrutinib plus rituximab versus FCR (75% vs. 33%) (HR, 0.27; 95% CI, 0.18−0.41; P < .0001). In 114 patients with IGH pathogenic variants, the 5-year PFS rate was also significantly different, at 83% for the ibrutinib arm and 68% for the FCR arm (HR, 0.27; 95% CI, 0.11−0.62; P = .001).[12-14]
ECOG-E1912 (NCT02048813) was a prospective randomized trial that compared ibrutinib and rituximab with FCR. A total of 529 patients previously untreated for CLL were randomly assigned in a 2:1 ratio to receive either ibrutinib and rituximab followed by ibrutinib maintenance (354 patients) or six cycles of FCR (175 patients).[12,13]
Although undetectable measurable residual disease (MRD) was less than 10% between 12 and 36 months follow-up, patients with detectable MRD did not have significantly worse PFS (P = .14 at 12 months, P = .90 at 24 months, and P = .53 at 36 months).[15]
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Preserved source evidence · Not medical advice