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Association details:
Biomarker:TP53 mutation
Cancer:Small Lymphocytic Lymphoma
Drug:ibrutinib (BTK inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
CLL/SLL with del(17p)/TP53 mutation: First-line therapy...Preferred regimens…Ibrutinib
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Outcomes of First-Line Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and High-Risk Genomic Features with up to 6.5 Years Follow-up: Integrated Analysis of Two Phase 3 Studies (RESONATE-2 and iLLUMINATE)

Published date:
11/04/2020
Excerpt:
At 42 mo, PFS rates were significantly higher across high-risk genomic subgroups in ibr-treated pts (63-82%) compared with clb-treated pts (6-34%), and consistent PFS benefit with ibr was observed across all high-risk genomic subgroups....Improved outcome was also noted for pts with del(17p)/TP53 mutated/BIRC3 mutated, the highest risk category per Rossi 2013 (HR 1.05, 95% CI 0.54-2.04).
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Excerpt:
...Cohort 1: Treated and untreated patients age 65 or older and need for therapy Cohort 2: Treated (maximum accrual n=16) and untreated (n=27, evaluable) patients at least 18 years old with 17p deletion or p53 expression by immunohistochemistry or p53 mutation by sequencing analysis....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

4447 Overall and Subgroup Results from the Third Interim Analysis of FIRE, a Real-World Study of Ibrutinib Treatment for CLL/SLL in France

Published date:
11/03/2022
Excerpt:
Eligible patients were ≥ 18 years, with a confirmed diagnosis of CLL/SLL, and who initiated ibrutinib therapy...in previously untreated patients with del17p and/or TP53 mutation, or in patients with relapsed or refractory disease R/R….Median PFS was 47.5 months (48.5/51.6 months in pro/ret). LOT and age (≤ 75 vs > 75 years) were statistically significant predictive factors for PFS. In patients with 0, 1, 2, and ≥ 3 prior LOT, median PFS was: not estimable (NE), 53.9 months, 47.5 months, and 33.5 months, respectively (Figure). At 48 months’ follow-up, ORR was 91.4%....In this longer follow-up of the real-world FIRE study reflecting clinical practice in France, ibrutinib was shown to be an effective treatment for patients with CLL/SLL, and patients who received ibrutinib in earlier LOT achieved better PFS.