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Molica S.,Pugliese Ciaccio Hospital Center | Giannarelli D.,Regina Elena Cancer Institute | Levato L.,Pugliese Ciaccio Hospital Center | Gentile M.,Complex Operative Hematology Unit | And 2 more authors.
Clinical Lymphoma, Myeloma and Leukemia | Year: 2015

Background We investigated the clinical relevance of classic and new prognostic markers, immunoglobulin heavy-chain variable (IGHV) gene mutational status, and chromosomal abnormalities in clinical monoclonal B lymphocytosis (cMBL) compared with chronic lymphocytic leukemia (CLL) Rai stage 0. Patients and Methods We analyzed the clinical outcomes in terms of the time to the first treatment (TTFT) of a prospective cohort, including 125 patients with cMBL and 197 patients with CLL Rai stage 0. Results In the overall patient population, prognostic parameters such as IGHV gene mutational status (P <.0001), CD38 expression (P <.0001), 70-kDa zeta-associated protein (ZAP-70) expression (P <.0001), and cytogenetic abnormalities (P =.01) predicted for TTFT on univariate analysis. IGHV gene identity was significant on multivariate analysis (P <.0001), regardless of the B-cell cutoff (5.0 or 10 × 109 B cells/L). A prognostic stratification using the combination of IGHV mutational status and absolute B-cell lymphocytosis identified 3 different groups that were significantly different with respect to the TTFT (P <.0001). Conclusion In the present series of patients with cMBL and CLL Rai stage 0, we have confirmed that IGHV mutation status appeared to be the best predictor of TTFT. In addition, when associated with the B-cell count, IGHV mutational status might help to better stratify patients into more precise subgroups. © 2015 Elsevier Inc. All rights reserved.

Molica S.,Pugliese Ciaccio Hospital Center | Giannarelli D.,Regina Elena Cancer Institute | Gentile M.,Complex Operative Hematology Unit | Cutrona G.,Italian National Cancer Institute | And 6 more authors.
Cancer | Year: 2013

Background: A nomogram that incorporates traditional and newer prognostic factors to identify patients with chronic lymphocytic leukemia (CLL) who are at high risk of receiving therapy was developed by investigators at The University of Texas M. D. Anderson Cancer Center (MDACC). Because the model required validation before its extensive use could be recommended, the authors sought to externally validate the nomogram in an independent, community-based cohort of patients with CLL. METHODS: In total, 328 previously untreated patients with newly diagnosed, asymptomatic, Binet stage A CLL from different primary hematology centers who were registered on a prospective basis during 2006 to 2010 on an observational database of the Italian Lymphoma Study Group were considered suitable for external validation of the model. RESULTS: A total point score was calculated for each patient using a formula proposed by MDACC investigators, and the median score was 19.9 (range, 0-69.5). Furthermore, when the score was evaluated as continuous variable (ie, by measuring the risk of each point increase), the total point score was associated with the time to first treatment (hazard ratio [HR], 1.04; 95% confidence interval [CI], 1.02-1.05; P <.0001). Receiver operating characteristic analysis identified a point score of 25 (area under curve; 0.64; sensitivity, 61.5; specificity, 72.1; P <.0001) as the best threshold capable of separating patients who needed therapy from patients who did not (HR, 3.27; 95% CI, 2,07-5.18; P <.0001). The prognostic index category also remained a predictor of the time to first treatment when the analysis was limited to patients with Rai stage 0 disease (HR, 4.05; 95% CI, 2.25-7.52; P <.0001). Finally, a goodness-of-fit test demonstrated that the nomogram model had a significantly good fit at 2 years (correlation coefficient [r2] = 0.966; P =.002). CONCLUSIONS: The current results confirmed the ability of a newly developed prognostic index to predict the time to first treatment among previously untreated patients with CLL who had early disease and extended the utility of the model to those with Rai stage 0 disease. In addition, the actual and predicted time to first treatment outcomes revealed good agreement, suggesting that, externally, the results provided by the model are well calibrated. Cancer 2013. © 2012 American Cancer Society.

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