Portuguese Real‐life Experience With Ibrutinib Outside Clinical Trials – A Multicenter Analysis

Abstract

the onset and progression of CLL. MYD88 mutations independently associate with shorter TTT in M-CLL subgroup, identifying cases with rapid progression. Introduction: Chronic lymphocytic leukemia (CLL) is a chronic lymphoproliferative disease characterized by highly biological heterogeneity and variable clinical course. Previous researches showed that 30%-40% of patients with CLL could survive for decades of years without initial need for treatment, while some patients rapidly succumb to the progression of disease. In recent years, data on prognostic value of molecular mutations and viral infections on CLL continue accumulating. Our study was determined to define variables correlated with time-to-treatment (TTT) in Chinese with chronic lymphocytic leukemia (CLL) and use these variables to develop a prognostic score. We determined correlation of the prognostic score with survival and compared this score with those developed for persons of predominately European descent with CLL in this study. Methods:We collected clinical, molecular, serologic and virological parameters of 334 newly diagnosed and untreated CLL patients. Utilizing Chi-square test, survival analysis, log-rank test and Cox hazard regression analysis, we checked the correlations between variables and prognosis of our patients.Results: By analyzing 334 newly diagnosed and untreated CLL patients without treatment indication, we demonstrated that Binet stage B/C, lymphocyte level, TP53 abnormality, IGHV non-mutation and evidence of HBV and EBV infection were independently associated with TTT in multivariate analyses. We used these data to construct a prognostic scoring system that divided subjects into three cohorts of low, intermediate and high risks with median TTTs of 102 months (95% confidence interval 50-154 months), 15 months (5-25 months) and 6 months (3-9 months; p-value for trend <0.001). Corresponding median OS from diagnosis were not reached, not reached and 73 months (55-91 months; p-value for trend <0.001).Conclusions: We improved current risk stratification for patients with untreated CLL using combined clinical, molecular and virological variables and defined three different risk groups with this novel stratifica- PORTUGUESE REAL-LIFE EXPERIENCE WITH IBRUTINIB OUTSIDE CLINICAL TRIALS -A MULTICENTER ANALYSIS