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• W2066090136 abstract "In the last decade a number of investigations have been performed to identify clinical, laboratory or molecular parameters, predictive of response to therapy, prognosis and survival in malignant lymphoma. These studies attempted to define risk groups and tailor therapy more effectively. Patients with diffuse large B cell lymphoma (DLBCL) have a heterogeneous clinical course and therapeutic response but, despite advances in immuno-chemotherapy, not all patients are cured. In this context, evaluation of the prognostic and predictive value of a simple laboratory parameter at diagnosis, such as the absolute lymphocyte count (ALC), could provide useful additional information in addition to the International Prognostic Index (IPI) score. The prognostic power of an abnormally low ALC (lymphopenia) at diagnosis and at different time points has been examined in Hodgkin lymphoma and T and B cell non-Hodgkin lymphoma (NHL), and shown to have negative impact on survival (Hasenclever & Diehl, 1998; Siddiqui et al, 2006; Kim et al, 2007; Mitrovic et al, 2012). Most investigators considered a cut-off value of 1 × 109/l to best define lymphopenia in NHL (Siddiqui et al, 2006; Kim et al, 2007; Song et al, 2010). However, in the era of more effective immuno-chemotherapy this threshold needs to be critically re-evaluated, because most the available data summarizes single-centre experience and generally included only modest numbers of patients with a short follow-up. Our research originated from a recent study of patients with DLBCL, where ALC ≤1 × 109/l only had a marginal significance on survival and lost its prognostic impact in patients receiving immuno-chemotherapy (Tadmor et al, 2013). Furthermore, earlier studies showed that ALC ≤0·84 × 109/l was a more appropriate value to use (Cox et al, 2008; Bari et al, 2010). In an attempt to re-examine the prognostic significance of lymphopenia and determine the best cut-off value, we performed a multi-centre collaborative retrospective analysis on a large database of patients with de novo DLCBL that contained data from medical records in Italy and Israel. All studies were performed in accordance with the principles of the declaration of Helsinki, applying Good Clinical Practice guidelines. The merged database contained a total of 521 patients treated with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone), CHOP-like, or third-generation anthracycline-containing regimens plus rituximab; median follow-up was 54 months (range 1–120) and 5-year overall survival (OS) 68%; 30% had IPI 0–1, 27% IPI 2 and 43% had IPI 3–5. The entire cohort median ALC at diagnosis was 1·42 × 109/l (range 0·105–9·28) and decreasing values of lymphocytes correlated with higher IPI risk (Kruskal–Wallis test, P < 0·001). Three different cut-off values were examined: 1 × 109/l (most frequently used reference value), 0·84 × 109/l (Cox et al, 2008; Bari et al, 2010) and 0·65 × 109/l [derived from Receiver Operating Characteristic (ROC) analysis of this database]. With an ALC threshold of 1 × 109/l, lymphopenia was identified in 39% of patients, compared to 22% with ALC ≤0·84 × 109/l and 15% with ALC ≤0·65 × 109/l. The difference in OS with ALC values ≤ or >1 × 109/l was not statistically significant in both univariate (P = 0·354) and multivariate analyses (P = 0·642). However, both univariate and multivariate analysis showed a statistically significant difference with an ALC threshold of 0·84 × 109/l in (Table 1). The threshold value derived by ROC curve (0·65 × 109/l) also showed a statistically significant difference, with a higher Hazard Ratio (HR) than the other values both in univariate and multivariate analyses. Analysis of ALC as a continuous covariate adjusted by IPI showed that the HR increased rapidly when ALC was at a lower level. The value of 0·65 × 109/l seemed the best cut-off level; however this is a data-driving value and would require further external validation. Results from different studies have shown that ALC adjusted by IPI (Porrata et al, 2005), or the follicular lymphoma IPI (Mitrovic et al, 2012) is an independent prognostic factor, providing significant additional information on outcome. However, conflicting results regarding OS in DLBCL patients treated with CHOP + rituximab have been reported when using ALC cut-off value of 1 × 109/l. Song et al (2010) evaluated 136 patients with DLBCL and showed a statistically significant difference in OS, when comparing ALC > and <1 × 109/l, whereas Batty et al (2013), studying 245 patients, reported that low ALC (<1 × 109/l) was not associated with a lower OS rate. Our retrospective study examined and compared ALC cut-off levels of 1, 0·84 and 0·65 × 109/l in a large multicentre database of DLBCL, with a median follow-up of 54 months. ALC ≤0·84 × 109/l and ≤0·65 × 109/l were found to predict poor survival, while there was no difference in OS between the patient groups with ALC ≤ or >1 × 109/l (Fig 1). In addition, multivariate analysis showed that the 0·84 and 0·65 × 109/l thresholds both maintained their prognostic power after interaction with rituximab use and adjustment by IPI score. The results of this study confirm that ALC can significantly predict survival outcome, but at a different cut-off value than the one most widely used in the evaluation of patients with DLBCL treated with immuno-chemotherapy. In contrast to other reports, our results validate that an ALC ≤0·65 × 109/l seemed to be the best cut-off point to define lymphopenia and implies that the reference value utilized for ALC in the rituximab era still needs to be re-evaluated. The addition of rituximab to chemotherapy has clearly influenced clinical outcome and also affected the significance of previously recognized prognostic parameters for DLBCL, illustrating that prognostic models change according to the efficacy of any given treatment. We can only speculate on why addition of rituximab to chemotherapy is able to better discriminate subgroups of patients based on ALC. This observation probably relates to the fact that, in patients with DLBCL and low ALC, the mechanism of action of rituximab via the pathway of cytotoxic T-lymphocytes and/or NK-cells is impaired. Another possible explanation for this finding could be that those patients with low ALC at diagnosis already have impaired immunity, and the addition of rituximab may aggravate their pre-existing lymphopenia, contributing even further to their decreased anti-tumour immunity status. We believe that a larger collaborative study may provide an answer to the question of whether a low specific lymphocyte subset, rather than the total number of circulating lymphocytes, could serve as a better predictive surrogate marker for response to immuno-chemotherapy in DLBCL patients." @default.
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• W2066090136 date "2014-05-03" @default.
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• W2066090136 title "Defining the best cut-off value for lymphopenia in diffuse large B cell lymphoma treated with immuno-chemotherapy" @default.
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• W2066090136 doi "https://doi.org/10.1111/bjh.12930" @default.
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