Tadeusz Robak

University of Lodz, Łódź, Łódź Voivodeship, Poland

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Publications (536)1637.53 Total impact

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  • Anna Korycka-Wołowiec · Dariusz Wołowiec · Tadeusz Robak ·
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    ABSTRACT: Introduction: Ofatumumab, the first fully human IgG1κ, belongs to the second generation of the first class of anti-CD20 monoclonal antibodies. The drug used alone and in combination with drugs having different mechanisms of action has shown a favorable toxicity profile and significant benefit especially in relapsed/refractory chronic lymphocytic leukemia (CLL) patients in doses up to 2000 mg. Areas covered: This article reviews pharmacokinetic, clinical application for CLL treatment, and safety profile of ofatumumab as well as differences and similarity between ofatumumab and rituximab. Publications in English from 2010 through October 2015 were surveyed on the MEDLINE database for articles. Proceedings of the American Society of Hematology held during the last 5 years were also included. Expert opinion: Ofatumumab more effectively than rituximab enhanced complement-dependent cytotoxicity playing the crucial role for its therapeutic activity. The drug is highly effective in the first-line and salvage treatment of CLL, essentially as a part of immunochemotherapy, and probably also as maintenance therapy. Its safety profile is very advantageous, since adverse events are usually limited to grade 1 and 2 infusion-related reactions, which tend to decrease throughout the treatment. Its advantage over the other anti-CD20 monoclonal antibodies in the treatment of CLL remains to be determined in the direct head-to-head trials.
    Expert Opinion on Drug Safety 11/2015; DOI:10.1517/14740338.2015.1113253 · 2.91 Impact Factor
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    ABSTRACT: Chronic lymphocytic leukemia (CLL) is a heterogeneous disease. Various disease-related and patient-related factors have been shown to influence the course of the disease. The aim of this study was to identify novel biomarkers of significant clinical relevance. Pretreatment CD19-separated lymphocytes (n=237; discovery set) and peripheral blood mononuclear cells (n=92; validation set) from the REACH trial, a randomized phase III trial in relapsed CLL comparing rituximab plus fludarabine plus cyclophosphamide with fludarabine plus cyclophosphamide alone, underwent gene expression profiling. By using Cox regression survival analysis on the discovery set, we identified inositol polyphosphate-5-phosphatase F (INPP5F) as a prognostic factor for progression-free survival (P<0.001; hazard ratio (HR), 1.63; 95% confidence interval (CI), 1.35–1.98) and overall survival (P<0.001; HR, 1.47; 95% CI, 1.18–1.84), regardless of adjusting for known prognostic factors. These findings were confirmed on the validation set, suggesting that INPP5F may serve as a novel, easy-to-assess future prognostic biomarker for fludarabine-based therapy in CLL.
    Blood Cancer Journal 10/2015; 5(10):e353. DOI:10.1038/bcj.2015.82 · 3.47 Impact Factor
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    ABSTRACT: Badania in vitro nad wpływem bendamustyny zastosowanej pojedynczo lub w skojarzeniu z rytuksymabem na komórki przewlekłej białaczki limfocytowej z uwzględnieniem stanu mutacyjnego IGVH. Warunki hodowli komórkowych Komórki PBL inkubowano z badanymi lekami przez 48 godzin w medium hodowlanym RPMI 1640, zawierającym 10% (v/v) inaktywowanej FCS + 10% (v/v) surowicy autologicznej, w temperaturze 37 °C, w atmosferze 5% CO 2 i pełnej wilgotności. Hodowlę kontrolną wykonywano bez dodatku badanych leków. Ocena wpływu leków na apoptozę Odsetek komórek apoptotycznych oceniono cytometrycznie testem z aneksyną-V (ANN) i jodkiem propidyny (JP) po 48-godzinnej inkubacji. Apoptoza indukowana lekiem (AIL) = (% komórek apoptotycznych po inkubacji z badanymi lekami) – (% komórek apoptotycznych w hodowli kontrolnej). Nekroza indukowana lekiem (NIL) = (% komórek nekrotycznych po inkubacji z lekami) – (% komórek nekrotycznych w hodowli kontrolnej). Ocena zmian potencjału mitochondrialnego(∆Ψm) ∆Ψm oceniono przy użyciu zestawu MitoTracker Red CMX Ros (inkubacja 30 min., 37°C) i analizowano w cytometrze przepływowym (FACSCalibour, Becton Dickinson, USA). ∆Ψm indukowane lekiem (∆ΨmIL) = (% komórek wykazujących ∆Ψm po inkubacji z lekami) – (% komórek wykazujących ∆Ψm w hodowli kontrolnej).
    XXVI Zjazd Polskiego Towarzystwa Hematologów i Transfuzjologów, Szczecin; 09/2015
  • Piotr Smolewski · Magdalena Witkowska · Tadeusz Robak ·
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    ABSTRACT: Introduction: In this article, we provide an accurate overview of both standard treatment option and novel promising therapeutics. Major impact is on novel agents now being tested in randomized clinical trials. While the initial data are promising, they may rapidly expand treatment options, change existing paradigms and further improve outcomes for mantle cell lymphoma (MCL) patients. Areas covered: MCL is a disease with indolent histology, but aggressive clinical course. However, for now, MCL remains incurable and the search for the most effective and tumor-specific treatment still represents a great challenge for oncohematologists. However, the implementation of chemotherapy together with the anti-CD20 antibody rituximab, as well as the growing use of autologous stem cell transplantation in first remission, have improved effects of treatment in MCL, including even some improvement in overall survival. Recently, treatment modalities for MCL have been expanded by strategies based on several biologically targeted agents, including m-TOR kinase or proteasome inhibitors and immunomodulatory agents, such as lenalidomide. B-cell receptor pathway inhibitors, such as ibrutinib and idelalisib, and histone deacetylase or cyclin-dependent kinase inhibitors have also shown promising activity in resistant or relapsed disease. Expert opinion: Although enormous progress was made in the treatment of MCL over the last year, the disease remains incurable. One chance for the significant life prolongation is intensive treatment with consolidative auto SCT. However, real progress may be afforded by developing the novel agents described in this article. In this way, MCL may soon become another potentially curable oncological malignancy.
    Expert Opinion on Pharmacotherapy 09/2015; 16(16):1-11. DOI:10.1517/14656566.2015.1087507 · 3.53 Impact Factor
  • Tadeusz Robak ·
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    ABSTRACT: Mantle cell lymphoma (MCL) is a hematological malignancy with unfavorable prognosis. Bortezomib, a potent, selective and reversible inhibitor of the 26S proteasome, was shown to be active in MCL and is currently implemented in therapeutic combinations. Single-agent bortezomib has demonstrated clinical efficacy in relapsed and refractory MCL with objective response in up to 47% of the patients. However, complete remission rates are low and duration of response is relatively short. In previously untreated patients, the addition of bortezomib to induction chemotherapy is also promising. Further evaluation of bortezomib alone or in combination with other drugs for the treatment of MCL is warranted to improve the quality of life and survival of patients. This review explores bortezomib as therapy in patients with MCL.
    Future Oncology 09/2015; 11(20). DOI:10.2217/fon.15.191 · 2.48 Impact Factor

  • Acta haematologica Polonica 09/2015; 46:187-188. DOI:10.1016/j.achaem.2015.07.311

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    ABSTRACT: European Scientific Journal Background Many prognostic factors have been identified in chronic lymphocytic leukemia (CLL) but new ones are still desired. The biological characterization of CLL is now being translated into novel treatment strategies. One new prognostic factor, and therapeutic target, may be BFL1. It is both a serum and a molecular marker that contributes to the progression of CLL and its resistance to chemotherapy. The aim of this study was to evaluate the prognostic value of BFL1 and to assess its correlation with other known prognostic markers in CLL for the cladribine and cyclophosphamide regimen (CC). Methods qPCR TaqMan® Low Density Array was used for gene expression measurements. Assessment of CD38, ZAP70 and BFL-1 proteins expression was done by means of flow cytometry. Serum TK activity was measured by immunoassay. Results Protein BFL1 expression was found to be significantly higher in CLL patients than healthy volunteers (p=0.001). Moreover its level was significantly higher in patients with no response (NR) to CC therapy (p=0.009). The expression of BFL1 was considerably down regulated during CC treatment and BFL1 mRNA levels were inversely correlated with apoptotic response. In addition, protein BFL1 expression was found to be similar to thymidine kinase (TK) concentration regarding treatment response. As far as other markers are concerned, a positive correlation was identified between BFL1 and TK (r=0.52, p=0.01). Conclusions Our findings suggest that BFL1 contributes to chemoresistance and may be a co-existing prognostic factor in CLL in the future.
  • Tadeusz Robak · Anna Wolska · Pawel Robak ·
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    ABSTRACT: Introduction: Hairy cell leukemia (HCL) is a rare subtype of B-cell chronic lymphoid leukemia. It is characterized by progressive pancytopenia, splenomegaly and infiltrations of the bone marrow, liver and spleen. Over the last few years, several new immunological drugs, particularly immunotoxins, BRAF inhibitors and B-cell receptor (BCR) pathway inhibitors have been developed and investigated as potential treatment options. Areas covered: This article summarizes recent investigational therapies of HCL, looking at their: mechanism of action, pharmacological properties, clinical activity and toxicity, as well as their emerging role in its treatment. The authors conducted a literature review of the MEDLINE database for articles in English concerning immunotoxins, BRAF inhibitors and BCR pathway inhibitors via PubMed. Publications from 2000 through to June 2015 were scrutinized. The search terms used were: BRAF, vemurafenib, dabrafenib, ibrutinib, monoclonal antibodies, immunotoxins, moxetumomab pasudotox, and rituximab in conjunction with HCL. The authors also searched manually the conference proceedings from the previous 5 years of the American Society of Hematology, European Hematology Association, American Society of Clinical Oncology, and ACR/ARHP Annual Scientific Meetings were searched manually. Additional relevant publications were obtained by reviewing the references from the chosen articles. Expert opinion: The use of vemurafenib and moxetumomab pasudotox is a promising new strategy for the treatment of HCL. Data from ongoing and future clinical trials will aid in better defining the status of new drugs in the treatment of HCL.
    Expert Opinion on Investigational Drugs 08/2015; 24(11). DOI:10.1517/13543784.2015.1081895 · 5.53 Impact Factor
  • Tadeusz Robak · Piotr Smolewski ·
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    ABSTRACT: In this issue of Blood, Dietrich et al make the first observation of the presence of deleterious CDKN1B mutation in 16% of patients with hairy cell leukemia (HCL).1 Furthermore, in the majority of patients, the CDKN1B mutation was clonal, suggesting that this mutation plays a role in the pathogenesis of HCL.
    Blood 08/2015; 126(8):930-1. DOI:10.1182/blood-2015-06-652065 · 10.45 Impact Factor
  • Anna Korycka-Wołowiec · Dariusz Wołowiec · Tadeusz Robak ·
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    ABSTRACT: Introduction: Small molecule inhibitors are currently in various stages of preclinical and clinical trials and are expected to revolutionize the treatment of many neoplastic diseases, including B-cell lymphoid malignancies. Areas covered: This article reviews the chemical structure, mechanisms of action, pharmacodynamic and pharmacokinetic properties, as well as clinical applications of small molecules in the treatment of elderly patients with B-cell hematological malignancies. Bibliographic research covering mainly the period from 2010 until February 2015 was conducted on the MEDLINE database for articles in English. Proceedings of the American Society of Hematology, European Hematology Association and American Society of Clinical Oncology conferences held during the last 5 years were also included. Expert opinion: In the last few years, several preclinical and clinical trials have evaluated many small weight organic molecules which downregulate B-cell receptor (BCR) signaling and act via inhibition of either BCR-associated kinases or cyclin-dependent kinases, or which are antagonists of members of the B-cell lymphoma 2 protein family. Pharmacokinetic profiles of these agents as well as dosage used and adverse events in patients with lymphoid malignancies have been established. Some of these inhibitors satisfy therapeutic modalities as suitable for the elderly patients, including those with chronic lymphocytic leukemia and non-Hodgkin's lymphoma.
    Expert Opinion on Drug Metabolism &amp Toxicology 07/2015; 11(9). DOI:10.1517/17425255.2015.1055246 · 2.83 Impact Factor
  • Pawel Robak · Piotr Smolewski · Tadeusz Robak ·
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    ABSTRACT: Introduction: Over the last few years, several new immunological drugs, particularly monoclonal antibodies (mAbs), immunomodulatory drugs and B-cell receptor (BCR) pathway inhibitors have been developed and investigated in chronic lymphocytic leukemia (CLL). This article summarizes recent discoveries regarding their mechanism of action, pharmacological properties, clinical activity and toxicity, as well as the emerging role of these agents in CLL. Areas covered: A literature review of mAbs, BCR pathway inhibitors and immunomodulating drugs was conducted of the MEDLINE database via PubMed for articles in English. Publications from 2000 through February 2015 were scrutinized. The search terms used were alemtuzumab, BI 836826, duvelisib ibrutinib, idelalisib, lenalidomide, monoclonal antibodies, MEDI-551, MOR208, obinutuzumab, ocaratuzumab, ofatumumab, ONO-4059, otlertuzumab, spebrutinib, veltuzumab and XmAb5574 in conjunction with CLL. Conference proceedings from the previous 5 years of the American Society of Hematology, European Hematology Association, American Society of Clinical Oncology, and ACR/ARHP Annual Scientific Meetings were searched manually. Additional relevant publications were obtained by reviewing the references from the chosen articles. Expert opinion: The use of mAbs, BCR inhibitors and immunomodulating drugs is a promising new strategy for chemotherapy-free treatment of CLL. However, definitive data from ongoing and future clinical trials will aid in better defining the status of immunological drugs in the treatment of this disease.
    Expert Opinion on Emerging Drugs 07/2015; 20(3). DOI:10.1517/14728214.2015.1046432 · 3.06 Impact Factor
  • Piotr Smolewski · Tadeusz Robak ·
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    ABSTRACT: Introduction: Monoclonal antibodies (MoAbs) were developed in the 1980s in order to treat malignancies. An important target for MoAbs was the CD20 B-cell lineage antigen. Rituximab (RTX) is a chimeric mouse anti-human MoAb that targets the CD20 antigen on the surface of malignant and normal B lymphocytes, and has rapidly become the widest used immunotherapeutic drug. RTX has had a significant impact on how B-cell non-Hodgkin's lymphomas (NHLs) and chronic lymphocytic leukemia is now treated. Areas covered: In this review, the authors demonstrate the mechanisms of action of RTX, and the preclinical data that have led to clinical trials and its final approval for the treatment of B-cell NHLs. Expert opinion: The discovery of RTX opened a new era for treatment of B-cell malignancies and became the starting point for the development of new, more active classes of anti-CD20 agents. Furthermore, it has contributed to the construction of a number of MoAbs specific for other antigens that target different types of neoplastic cells.
    Expert Opinion on Drug Discovery 06/2015; 10(7):1-18. DOI:10.1517/17460441.2015.1045295 · 3.54 Impact Factor
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    ABSTRACT: New drugs introduced in recent years to the therapy of multiple myeloma patients resulted in better responses and prolongation of overall survival. Therapeutic regimens based on bortezomib, thalidomide and lenalidomide are recommended to most patients in first line therapy. Induction therapy should be accompanied with prolonged treatment composed of consolidation and maintenance. Besides the concept of longer treatment, it is recommended to start therapy in some patients earlier, taking into consideration biomarkers of active disease as well as transplantation procedure offered to older, fit patients. In this article we also described therapeutic recommendation for Waldenström macroglobulinemia and other plasmocytic dyscrasias. © 2015 Polskie Towarzystwo Hematologów i Transfuzjologów, Instytut Hematologii i Transfuzjologii.
    Acta haematologica Polonica 05/2015; 46(3):159-211. DOI:10.1016/j.achaem.2015.04.004
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    ABSTRACT: Treatment for patients with chronic lymphocytic leukaemia who are elderly or who have comorbidities is challenging because fludarabine-based chemoimmunotherapies are mostly not suitable. Chlorambucil remains the standard of care in many countries. We aimed to investigate whether the addition of ofatumumab to chlorambucil could lead to better clinical outcomes than does treatment with chlorambucil alone, while also being tolerable for patients who have few treatment options. We carried out a randomised, open-label, phase 3 trial for treatment-naive patients with chronic lymphocytic leukaemia in 109 centres in 16 countries. We included patients who had active disease needing treatment, but in whom fludarabine-based treatment was not possible. We randomly assigned patients (1:1) to receive oral chlorambucil (10 mg/m(2)) on days 1-7 of a 28 day treatment course or to receive chlorambucil by this schedule plus intravenous ofatumumab (cycle 1: 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1) for three to 12 cycles. Assignment was done with a randomisation list that was computer generated at GlaxoSmithKline, and was stratified, in a block size of two, by age, disease stage, and performance status. The primary endpoint was progression-free survival in the intention-to-treat population and assessment was done by an independent review committee that was masked to group assignment. The study is registered with ClinicalTrials.gov, number NCT00748189. We enrolled 447 patients, median age 69 years (range 35-92). Between Dec 22, 2008, and May 26, 2011, we randomly assigned 221 patients to chlorambucil plus ofatumumab and 226 patients to chlorambucil alone. Median progression-free survival was 22·4 months (95% CI 19·0-25·2) in the group assigned to chlorambucil plus ofatumumab compared with 13·1 months (10·6-13·8) in the group assigned to chlorambucil only (hazard ratio 0·57, 95% CI 0·45-0·72; p<0·0001). Grade 3 or greater adverse events were more common in the chlorambucil plus ofatumumab group (109 [50%] patients; vs 98 [43%] given chlorambucil alone), with neutropenia being the most common event (56 [26%] vs 32 [14%]). Grade 3 or greater infections had similar frequency in both groups. Grade 3 or greater infusion-related adverse events were reported in 22 (10%) patients given chlorambucil plus ofatumumab. Five (2%) patients died during treatment in each group. Addition of ofatumumab to chlorambucil led to clinically important improvements with a manageable side-effect profile in treatment-naive patients with chronic lymphocytic leukaemia who were elderly or had comorbidities. Chlorambucil plus ofatumumab is therefore an important treatment option for these patients who cannot tolerate more intensive therapy. GlaxoSmithKline, Genmab A/S. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet 04/2015; 385(9980). DOI:10.1016/S0140-6736(15)60027-7 · 45.22 Impact Factor
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    ABSTRACT: Cutaneous T-cell lymphoma (CTCL) is a rare heterogeneous group of non-Hodgkin lymphomas that arises in the skin but can progress to systemic disease (lymph nodes, blood, viscera). Historically, in CTCL clinical trials there has been little consistency in how responses were defined in each disease "compartment"-some studies only assessed responses in the skin. The histone deacetylase inhibitor romidepsin is approved by the US FDA for the treatment of CTCL in patients who have received at least 1 prior systemic therapy. Phase II studies that led to approval used rigorous composite end points that incorporated disease assessments in all compartments. The objective of this analysis was to thoroughly examine the activity of romidepsin within each disease compartment in patients with CTCL. Romidepsin was shown to have clinical activity across disease compartments and is suitable for use in patients with CTCL having skin involvement only, erythroderma, lymphadenopathy, and/or blood involvement. NCT00106431.
    Leukemia & lymphoma 03/2015; 56(10):1-22. DOI:10.3109/10428194.2015.1014360 · 2.89 Impact Factor
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    Haematologica 03/2015; 100(8). DOI:10.3324/haematol.2014.121459 · 5.81 Impact Factor
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    ABSTRACT: The proteasome inhibitor bortezomib was initially approved for the treatment of relapsed mantle-cell lymphoma. We investigated whether substituting bortezomib for vincristine in frontline therapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) could improve outcomes in patients with newly diagnosed mantle-cell lymphoma. In this phase 3 trial, we randomly assigned 487 adults with newly diagnosed mantle-cell lymphoma who were ineligible or not considered for stem-cell transplantation to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 (with prednisone administered orally on days 1 to 5) or VR-CAP (R-CHOP regimen, but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1, 4, 8, and 11). The primary end point was progression-free survival. After a median follow-up of 40 months, median progression-free survival (according to independent radiologic review) was 14.4 months in the R-CHOP group versus 24.7 months in the VR-CAP group (hazard ratio favoring the VR-CAP group, 0.63; P<0.001), a relative improvement of 59%. On the basis of investigator assessment, the median durations of progression-free survival were 16.1 months and 30.7 months, respectively (hazard ratio, 0.51; P<0.001), a relative improvement of 96%. Secondary end points were consistently improved in the VR-CAP group, including the complete response rate (42% vs. 53%), the median duration of complete response (18.0 months vs. 42.1 months), the median treatment-free interval (20.5 months vs. 40.6 months), and the 4-year overall survival rate (54% vs. 64%). Rates of neutropenia and thrombocytopenia were higher in the VR-CAP group. VR-CAP was more effective than R-CHOP in patients with newly diagnosed mantle-cell lymphoma but at the cost of increased hematologic toxicity. (Funded by Janssen Research and Development and Millennium Pharmaceuticals; LYM-3002 ClinicalTrials.gov number, NCT00722137.).
    New England Journal of Medicine 03/2015; 372(10):944-53. DOI:10.1056/NEJMoa1412096 · 55.87 Impact Factor
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    ABSTRACT: The role of HLA-G is extensively studied in cancer due to its inhibition of the immune response. Several polymorphisms in the HLA-G gene have been reported to significantly affect its expression. We, therefore, investigated whether functionally relevant HLA-G polymorphisms, HLA-G-725C/G/T, and HLA-G 14-base pair, have any influence on the susceptibility to diffuse large B-cell lymphoma (DLBCL) and its clinical course. The polymorphisms were genotyped in 207 previously untreated patients with DLBCL and 150 unrelated controls. A significant difference in genotype distribution of HLA-G polymorphic genotypes between the patients and controls was found. The frequencies of the HLA-G−725GG or the HLA-G−725GC genotype were lower, and those of the HLA-G ins/ins genotype were higher in the patients compared with the controls. Patients carrying the HLA-G-725CC genotype presented a higher probability of overall survival (OS) than subjects with other genotype combinations of HLA-G-725C/G/T (P = 0.003). The homozygous HLA-G del/del had a lower probability of OS than subjects carrying the HLA-G deletion/insertion (del/ins) or the HLA-G ins/ins genotype (P = 0.009). Two HLA-G genotype-based risk groups were defined according to the genotype distribution. The high-risk (HR) group presented a shorter OS than low-risk (LR) patients (P = 0.001). In a multivariate analysis adjusted for International Prognostic Index (IPI) factors, both the intermediate high/high IPI-risk group (P < 0.0001) and the HR genotype group (P = 0.004) independently increased the risk of death. This is the first study indicating an important role of HLA-G polymorphisms for the clinical course of DLBCL. The potential influence of HLA-G polymorphisms on the susceptibility to DLBCL thus deserves further study. © 2015 Wiley Periodicals, Inc.
    Genes Chromosomes and Cancer 03/2015; 54(3). DOI:10.1002/gcc.22235 · 4.04 Impact Factor

Publication Stats

9k Citations
1,637.53 Total Impact Points


  • 1996-2015
    • University of Lodz
      • Department of Cytobiochemistry
      Łódź, Łódź Voivodeship, Poland
  • 1994-2015
    • Medical University of Łódź
      Łódź, Łódź Voivodeship, Poland
  • 2005-2007
    • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
      Łódź, Łódź Voivodeship, Poland
  • 2004
    • Medical University of Gdansk
      Danzig, Pomeranian Voivodeship, Poland
  • 2002
    • Centre Hospitalier Lyon Sud
      Lyons, Rhône-Alpes, France
  • 2001
    • Medical University of Warsaw
      • Katedra i Klinika Pediatrii, Hematologii i Onkologii
      Warsaw, Masovian Voivodeship, Poland
  • 1997
    • Medical University of Lublin
      Lyublin, Lublin Voivodeship, Poland