A prognostic model for use in the treatment of patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) was recently developed by researchers and presented in a report in the Lancet Haematology.
According to the researchers, the model is the first of its kind to be validated for use with patients who have R/R CLL. Out of 28 possible risk factors that were examined, the researchers identified 4 features predictive of overall survival (OS) in this condition, 3 of which were based on laboratory values.
The factors related to survival that were identified in model development included serum b2-microglobulin (B2M) level, lactate dehydrogenase (LDH) level, hemoglobin level, and the length of time since initiating the last treatment.
The model was developed from a retrospective, pooled cohort analysis of data from 2475 adults with CLL who were treated with targeted therapies or chemoimmunotherapy. Included data came from 6 phase 3 clinical trials and from the Mayo Clinic CLL Database.
The training dataset used in model development included data for 727 patients who received either ibrutinib or chemoimmunotherapy. Multivariate analysis was used to identify the most useful factors for prognosis.
Internal model validation utilized data from 242 patients who received either ibrutinib or chemoimmunotherapy. External validation involved 3 datasets, including from patients treated with venetoclax or chemoimmunotherapy (389 patients), patients treated with idelalisib or chemoimmunotherapy (897 patients), and patients with records in the Mayo Clinic CLL Database (220 patients).
Analyses from each dataset showed that assigning patients to OS risk groups was optimal with risk factor thresholds of serum B2M of at least 5 mg/dL, LDH above the normal limit, a duration of less than 24 months since the start of the last treatment, and hemoglobin below 110 g/L in women or 120 g/L in men (P <.05 for each analysis).
“The risk score could be a useful tool to stratify patients in future clinical trials, and investigators can address the unmet need of higher-risk patients with R/R CLL by designing prospective trials targeting these patients,” the authors wrote.
- Soumerai JD, Ni A, Darif M, et al. Prognostic risk score for patients with relapsed or refractory chronic lymphocytic leukaemia treated with targeted therapies or chemoimmunotherapy: a retrospective, pooled cohort study with external validations [published online May 17, 2019]. Lancet Haematol. doi:10.1016/S2352-3026