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Caocci G.,University of Cagliari | Voso M.T.,University Of Rome Cattolica ore | Angelucci E.,A Businco Hospital | Stauder R.,Innsbruck Medical University | And 21 more authors.
Leukemia Research | Year: 2015

Higher-risk myelodysplastic syndromes (MDS) are rarely curable and have a poor prognosis. We investigated the accuracy of physicians' perception of patients' health status and the patients' preferences for involvement in treatment decisions.We examined 280 newly diagnosed higher-risk elderly MDS patients paired with their physicians. Survey tools included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the Control Preference Scale.Overall concordance was 49% for physician perception of patient preferences for involvement in treatment decisions. In 36.4% of comparisons there were minor differences and in 14.6% there were major differences. In 44.7% of the patients preferring a passive role, physicians perceived them as preferring an active or collaborative role. Absence of the patient's request for prognostic information ( P = 0.001) and judging the patient as having a poor health status ( P = 0.036) were factors independently associated with the physicians' attitude toward a lower degree of patient involvement in clinical decisions. Agreement on health status was found in 27.5% of cases. Physicians most frequently tended to overestimate health status of patients who reported low-level health status.The value of decision aid-tools in the challenging setting of higher-risk MDS should be investigated to further promote patient-centered care. © 2015 Elsevier Ltd. Source

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. Source

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. Source

Molica S.,Pugliese Ciaccio Hospital Center | Giannarelli D.,Biostatistic Unit | Levato L.,Pugliese Ciaccio Hospital Center | Mirabelli R.,Pugliese Ciaccio Hospital Center | And 3 more authors.
International Journal of Hematology | Year: 2014

We propose an algorithm based on a slightly modified version of MD Anderson Cancer Center (MDACC) score (i.e., mutational status of IgVH, LDH, presence of high-risk FISH abnormalities), β2-microglobulin and separation of clinical monoclonal B-cell lymphocytosis (cMBL) from chronic lymphocytic leukemia (CLL) to predict time to first treatment (TTFT) of a prospective multicentre cohort including 83 cMBL and 136 CLL Rai stage 0 patients. Patients with MDACC score point ≥38, at any level of β2-microglobulin and irrespective of whether they fulfilled 2008 International Workshop on CLL (IWCLL) criteria for CLL Rai stage 0 or cMBL, experienced the worst clinical outcome (5-year TTFT, 24 %) and formed the high-risk group. In contrast, subjects with a diagnosis of cMBL, MDACC score point <38 and β2-microglobulin ≤ UNL had the best clinical outcome (5-year TTFT, 100 %) and constituted the low-risk group. The intermediate group included patients in Rai stage 0, MDACC score point <38, and any level of β2-microglobulin, and patients with cMBL, MDACC score point <38, and β2-microglobulin ≥ UNL. Cases showing these features can be grouped together to form the intermediate-risk group (5-year TTFT, 65 %). Although the separation between cMBL and Rai stage 0, as proposed by the 2008 IWCLL guidelines, has clinical implications, the model we propose may help to classify patients with cMBL and Rai stage 0 into more precise subgroups suggesting that a prognostic separation of these entities based solely on clonal B-cell threshold may be unsatisfactory. © 2014, The Japanese Society of Hematology. Source

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