Meletios A Dimopoulos

National and Kapodistrian University of Athens, Athínai, Attica, Greece

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Publications (367)2394.86 Total impact

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    Meletios A Dimopoulos · Evangelos Terpos

    Preview · Article · Jul 2015 · Journal of Clinical Oncology
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    ABSTRACT: Pomalidomide is a distinct oral IMiD immunomodulatory agent with direct antimyeloma, stromal-support inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and lenalidomide treatment. Initial results demonstrated significantly longer progression-free survival and overall survival with an acceptable tolerability profile for pomalidomide + low-dose dexamethasone vs high-dose dexamethasone. This secondary analysis describes patient outcomes by treatment history and depth of response. Pomalidomide + low-dose dexamethasone significantly prolonged progression-free survival and favored overall survival vs high-dose dexamethasone for all subgroups analyzed, regardless of prior treatments or refractory status. Both univariate and multivariate analyses showed that no variable relating to either the number (≤ or > 3) or type of prior treatment was a significant predictor of progression-free survival or overall survival. No cross-resistance with prior lenalidomide or thalidomide treatment was observed. Patients achieving a minimal response or better to pomalidomide + low-dose dexamethasone treatment experienced a survival benefit, which was even higher in those achieving at least a partial response (17.2 and 19.9 months, respectively, as compared with 7.5 months for patients with less than minimal response). These data suggest that pomalidomide + low-dose dexamethasone should be considered a standard of care in patients with refractory or relapsed and refractory multiple myeloma regardless of prior treatment. ClinicalTrials.gov: NCT01311687; EudraCT: 2010-019820-30. Copyright © 2015, Ferrata Storti Foundation.
    Full-text · Article · Jul 2015 · Haematologica
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    ABSTRACT: The epidemiology of multiple myeloma (MM) is an increasingly investigated field, with many controversies. This systematic review aims to synthesize meta-analyses examining risk factors for MM so as to provide a comprehensive, parsimonious summary of the current evidence. Eligible meta-analyses were sought in PubMed adopting a predefined algorithm, without any restriction of publication language; end-of-search date was October 10, 2014. The selection of eligible studies and data extraction were performed by working in pairs, independently and blindly to each other; in case of disagreement, consensus with the whole team was reached. Among the 22 ultimately included meta-analyses, 9 examined occupational factors, 4 assessed aspects of lifestyle (smoking, alcohol, body mass index), 5 evaluated the presence of other diseases, and 4 addressed genetic factors as potential risk factors of MM. A vast compendium of significant associations arose, including farming, occupation as a firefighter, occupation as a hairdresser, exposures to chemicals or pesticides, overweight and obesity, patterns of alcohol intake, pernicious anemia, ankylosing spondylitis, gene promoter methylation, and polymorphisms. In conclusion, MM is a multifactorial disease, encompassing a wide variety of risk factors that span numerous life aspects. Further accumulation of evidence through meta-analyses is anticipated in this rapidly growing field. Copyright © 2015 Elsevier Inc. All rights reserved.
    No preview · Article · Jun 2015 · Clinical lymphoma, myeloma & leukemia
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    ABSTRACT: Outcomes for patients with multiple myeloma (MM) have improved significantly over the past decade. Despite these advances, MM remains incurable and an unmet medical need remains for patients who are relapsed and/or refractory. Panobinostat is a potent, oral pan-deacetylase inhibitor that elicits anti-myeloma activity through epigenetic modulation of gene expression and disruption of protein metabolism. Preclinical data demonstrated that panobinostat has synergistic effects on myeloma cells when combined with bortezomib and dexamethasone. In a Phase III clinical trial evaluating bortezomib and dexamethasone in combination with panobinostat or placebo in patients with relapsed or relapsed and refractory MM (PANORAMA 1), panobinostat led to a significant increase in median progression-free survival. Panobinostat is currently under regulatory review with a recent accelerated approval granted for the treatment of relapsed disease, in which both bortezomib and immunomodulatory drugs have failed. Here, we summarize the preclinical, pharmacokinetic and clinical data for panobinostat in MM.
    No preview · Article · Jun 2015 · Expert Review of Anti-infective Therapy
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    Preview · Article · Apr 2015 · Haematologica
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    Ajay K Nooka · Esftathios Kastritis · Meletios A Dimopoulos · Sagar Lonial
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    ABSTRACT: Over the last few decades, significant improvement in outcomes have been observed for myeloma patients, mainly due to the use of currently available approved anti-myeloma agents along with combining autologous stem cell transplantation in the treatment of myeloma. With more targeted agents in development, the management of a myeloma patient at relapse has become complicated and as a consequence, results in vast heterogeneity in treatment patterns. While a consensus on the timing of initiation of treatment, the choice of the agents to be used, and the role of transplant is less clear, we describe an evidence-based approach and the factors to consider upon relapse. We describe additional newer agents and targets that are under development with the goal of achievement of durable remissions for myeloma patients. Copyright © 2015 American Society of Hematology.
    Full-text · Article · Apr 2015 · Blood
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    Full-text · Dataset · Feb 2015
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    ABSTRACT: This analysis, using data from the bortezomib-melphalan-prednisone (VMP) arm of the Phase III VISTA study, investigated whether increased cumulative bortezomib dose could improve overall survival (OS) in transplant-ineligible patients with previously untreated multiple myeloma. Median cumulative bortezomib dose received by the 340 patients was 39 mg/m(2) ; this was selected as the cut-off for defining the dose groups to be compared for OS. Patient characteristics were well balanced between dose groups except for age. OS was significantly longer in the higher (≥39 mg/m(2) ) versus lower (<39 mg/m(2) ) cumulative bortezomib dose group (median 66.3 vs. 46.2 months; hazard ratio [HR] 0.533, P < 0.0001; age-adjusted HR 0.561, P = 0.0002). To overcome confounding effects of early discontinuations/deaths, which were more common in the lower cumulative dose group (27% vs 4% of patients discontinued due to adverse events in the lower and higher cumulative dose groups, respectively), a landmark analysis was conducted at 180 days, eliminating patients who died or discontinued before this time from the analysis. OS from this landmark remained significantly longer in the higher dose group (median 60.4 vs. 50.3 months; HR 0.709, P = 0.0372). Thus, higher cumulative bortezomib dose, reflecting prolonged treatment duration and/or dose intensity, appears associated with improved OS. Approaches to achieve higher cumulative doses could include subcutaneous bortezomib administration, dose/schedule modifications, continuing therapy in responding patients, and proactive adverse event management. This article is protected by copyright. All rights reserved. © 2014 Wiley Periodicals, Inc., A Wiley Company.
    No preview · Article · Feb 2015 · American Journal of Hematology
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    ABSTRACT: International collaborative research is a mechanism for improving the development of disease-specific therapies and for improving health at the population level. However, limited data are available to assess the trends in research output related to orphan diseases. We used bibliometric mapping and clustering methods to illustrate the level of fragmentation in myeloma research and the development of collaborative efforts. Publication data from Thomson Reuters Web of Science were retrieved for 2005-2009 and followed until 2013. We created a database of multiple myeloma publications, and we analysed impact and co-authorship density to identify scientific collaborations, developments, and international key players over time. The global annual publication volume for studies on multiple myeloma increased from 1,144 in 2005 to 1,628 in 2009, which represents a 43% increase. This increase is high compared to the 24% and 14% increases observed for lymphoma and leukaemia. The major proportion (>90% of publications) was from the US and EU over the study period. The output and impact in terms of citations, identified several successful groups with a large number of intra-cluster collaborations in the US and EU. The US-based myeloma clusters clearly stand out as the most productive and highly cited, and the European Myeloma Network members exhibited a doubling of collaborative publications from 2005 to 2009, still increasing up to 2013. Multiple myeloma research output has increased substantially in the past decade. The fragmented European myeloma research activities based on national or regional groups are progressing, but they require a broad range of targeted research investments to improve multiple myeloma health care.
    Full-text · Article · Jan 2015 · PLoS ONE
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    ABSTRACT: We conducted a pooled analysis of 869 individual newly diagnosed elderly patient data from 3 prospective international trials. At diagnosis, a geriatric assessment had been performed to assess comorbidities, cognitive and physical status. An additive scoring system (range 0-5), based on age, comorbidities, cognitive and physical conditions, was developed to identify 3 groups: fit (score=0, 39%); intermediate-fitness (score=1, 31%), and frail (score≥2, 30%). The 3-year overall survival was 84% in fit patients, 76% in intermediate-fitness patients (HR 1.61, 95%CI 1.02-2.56, p=0.042) and 57% in frail patients (HR 3.57 CI 95% 2.37-5.39, p<0.001). The cumulative incidence of grade ≥3 non-hematologic adverse events at 12 months was 22.2% in fit, 26.4% in intermediate-fitness (HR 1.23, 95%CI 0.89-1.71; p 0.217) and 34.0% (HR 1.74, 95%CI 1.28-2.38; p<0.001) in frail patients. The cumulative incidence of treatment discontinuation at 12 months was 16.5% in fit, 20.8% in intermediate-fitness (HR 1.41, 95%CI 1.00-2.01, p=0.052) and 31.2% (HR 2.21, 95%CI 1.57-3.09; p<0.001) in frail patients. Our frailty score predicts mortality and the risk of toxicity in elderly myeloma patients. The International Myeloma Working group proposes this score for the measurement of frailty in designing future clinical trials. These trials are registered to www.clinicaltrials.gov as NCT01093136 (EMN01), NCT01190787 (26866138MMY2069), and NCT01346787 (IST-CAR-506). Copyright © 2015 American Society of Hematology.
    Full-text · Article · Jan 2015 · Blood
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    ABSTRACT: The aim of International Myeloma Working Group was to develop practical recommendations for the use of magnetic resonance imaging (MRI) in multiple myeloma (MM). An interdisciplinary panel of clinical experts on MM and myeloma bone disease developed recommendations for the value of MRI based on data published through March 2014. MRI has high sensitivity for the early detection of marrow infiltration by myeloma cells compared with other radiographic methods. Thus, MRI detects bone involvement in patients with myeloma much earlier than the myeloma-related bone destruction, with no radiation exposure. It is the gold standard for the imaging of axial skeleton, for the evaluation of painful lesions, and for distinguishing benign versus malignant osteoporotic vertebral fractures. MRI has the ability to detect spinal cord or nerve compression and presence of soft tissue masses, and it is recommended for the workup of solitary bone plasmacytoma. Regarding smoldering or asymptomatic myeloma, all patients should undergo whole-body MRI (WB-MRI; or spine and pelvic MRI if WB-MRI is not available), and if they have > one focal lesion of a diameter > 5 mm, they should be considered to have symptomatic disease that requires therapy. In cases of equivocal small lesions, a second MRI should be performed after 3 to 6 months, and if there is progression on MRI, the patient should be treated as having symptomatic myeloma. MRI at diagnosis of symptomatic patients and after treatment (mainly after autologous stem-cell transplantation) provides prognostic information; however, to date, this does not change treatment selection. © 2015 by American Society of Clinical Oncology.
    Full-text · Article · Jan 2015 · Journal of Clinical Oncology
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    ABSTRACT: Bortezomib and lenalidomide are increasingly used in patients with AL amyloidosis, but long term data on their use as primary therapy in AL amyloidosis are lacking while early mortality remains significant. Thus, we analyzed the long term outcomes of 85 consecutive unselected patients, which received primary therapy with bortezomib or lenalidomide and we prospectively evaluated a risk adapted strategy based on bortezomib/dexamethasone in order to reduce early mortality.Twenty-six patients received full-dose bortezomib/dexamethasone, 36 patients lenalidomide with oral cyclophosphamide & low-dose dexamethasone and 23 patients received bortezomib/dexamethasone at a dose and schedule adjusted to the risk of early death. On intent to treat, 67% of patients achieved a hematologic response (24% hemCRs) and 34% an organ response; both were more frequent with bortezomib. An early death occurred in 20%: in 36% of those treated with full-dose bortezomib/dexamethasone, in 22% of lenalidomide-treated patients but only in 4.5% of patients treated with risk-adapted bortezomib/dexamethasone. Activity of full vs adjusted dose bortezomib/dexamethasone was similar; twice weekly vs weekly administration of bortezomib also had similar activity. After a median follow up of 57 months, median survival is 47 months and is similar for patients treated with bortezomib vs lenalidomide-based regimens. However, risk adjusted-bortezomib/dexamethasone was associated with improved 1-year survival vs full-dose bortezomib/dexamethasone or lenalidomide-based therapy (81% vs 56% vs 53% respectively).In conclusion, risk-adapted bortezomib/dexamethasone may reduce early mortality and preserve activity while long term follow up indicates that remissions obtained with lenalidomide or bortezomib may be durable, even without consolidation with alkylators. This article is protected by copyright. All rights reserved.
    Full-text · Article · Jan 2015 · American Journal of Hematology
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    ABSTRACT: We compared the safety and efficacy of siltuximab (S), an anti-interleukin-6 chimeric monoclonal antibody, plus bortezomib (B) with placebo (plc)+B in patients with relapsed/refractory multiple myeloma in a randomized phase II study. Siltuximab was given by 6 mg/kg IV every 2 weeks. On progression, B was discontinued and high-dose dexamethasone could be added to S/plc. Response and progression-free survival (PFS) were analyzed pre-dexamethasone by EBMT criteria. For the 281 randomized patients, median PFS for S+B and plc+B was 8.0 and 7.6 months (HR 0.869, p=0.345), overall response rate was 55% vs. 47% (p=0.213), complete response rate was 11% vs. 7%, and median overall survival (OS) was 30.8 vs. 36.8 months (HR 1.353, p=0.103). Sustained suppression of C-reactive protein, a marker reflective of inhibition of interleukin-6 activity, was seen with S+B. Siltuximab did not affect B pharmacokinetics. S/plc discontinuation (75% vs. 66%), grade ≥3 neutropenia (49% vs. 29%), thrombocytopenia (48% vs. 34%), and all-grade infections (62% vs. 49%) occurred more frequently with S+B. The addition of siltuximab to bortezomib did not appear to improve PFS or OS despite a numerical increase in response rate in patients with relapsed or refractory multiple myeloma.
    Full-text · Article · Jan 2015 · American Journal of Hematology
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    ABSTRACT: Pomalidomide is a distinct immunomodulatory agent with significant activity in relapsed/refractory multiple myeloma (RRMM). The optimal treatment schedule in patients with RRMM who have received multiple lines of treatment, including bortezomib and lenalidomide, is 4 mg/day on days 1–21 of a 28-day cycle in combination with weekly low-dose dexamethasone. Improved responses and outcomes relative to traditional therapies continue to be confirmed in recently completed and ongoing trials. Pomalidomide exhibits direct tumoricidal, immunomodulatory, anti-angiogenic and anti-inflammatory activities, which facilitate combination therapy with agents with complementary mechanisms of action, resulting in greater anti-myeloma effects than single-agent therapy or previous combination therapies. For example, in combination with proteasome inhibitors and traditional chemotherapeutic agents in doublet or triplet regimens, pomalidomide provides high rates of durable response, and represents an important new treatment option for patients with RRMM requiring effective new therapies. Additionally, pomalidomide maintains its efficacy and tolerability profile in difficult-to-treat patients, including the elderly, patients with poor cytogenetics and those with renal impairment. This review summarises the clinical development of pomalidomide and discusses this effective agent for the treatment of patients with RRMM in the context of current myeloma treatment options, as well as potential future directions to further improve patient outcomes.
    No preview · Article · Jan 2015 · European Oncology and Haematology
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    ABSTRACT: The aim of this study was to compare the effectiveness of prophylactic single fixed dose of pegfilgrastim and daily administration of filgrastim on febrile neutropenia (FN), severe neutropenia, treatment delay, and dose reduction in patients with breast cancer receiving dose-dense adjuvant chemotherapy. A retrospective cohort study with 1058 breast cancer patients matched by age and chemotherapy was conducted. The primary endpoints were FN, severe (grade 3, 4) neutropenia, dose reduction (>10 % reduction of the dose planned), and treatment delay (dose given more than 2 days later). Eighteen episodes of FN (3.4 %) in the filgrastim group and 23 (4.3 %) in the pegfilgrastim group (p = 0.500) were recorded. More than half of the total episodes (27/41) occurred during the first 4 cycles of treatment. Patients who received filgrastim were almost three times more likely to experience a severe neutropenia episode and were significantly more likely to experience a dose reduction (18.5 %) compared to those who received pegfilgrastim (10.8 %) (p < 0.001). The percentage of patients, who received their planned dose on time, was significantly lower in patients receiving filgrastim (58 %) compared to those receiving pegfilgrastim (72.4 %, p < 0.001). No significant difference was detected on FN rate between daily administration of filgrastim and single administration of pegfilgrastim. However, patients receiving pegfilgrastim had a significantly lower rate of severe neutropenia, as well as dose reduction and treatment delay, thus, achieving a higher dose density.
    No preview · Article · Dec 2014 · Supportive Care Cancer
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    ABSTRACT: Background: Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. Methods: We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group). The primary end point was progression-free survival. Results: Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P=0.0001). The median overall survival was not reached in either group at the interim analysis. The Kaplan-Meier 24-month overall survival rates were 73.3% and 65.0% in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P=0.04). The rates of overall response (partial response or better) were 87.1% and 66.7% in the carfilzomib and control groups, respectively (P<0.001; 31.8% and 9.3% of patients in the respective groups had a complete response or better; 14.1% and 4.3% had a stringent complete response). Adverse events of grade 3 or higher were reported in 83.7% and 80.7% of patients in the carfilzomib and control groups, respectively; 15.3% and 17.7% of patients discontinued treatment owing to adverse events. Patients in the carfilzomib group reported superior health-related quality of life. Conclusions: In patients with relapsed multiple myeloma, the addition of carfilzomib to lenalidomide and dexamethasone resulted in significantly improved progression-free survival at the interim analysis and had a favorable risk-benefit profile. (Funded by Onyx Pharmaceuticals; ClinicalTrials.gov number, NCT01080391.).
    Full-text · Article · Dec 2014 · New England Journal of Medicine
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    ABSTRACT: - Copyright © 2014, Ferrata Storti Foundation.
    Full-text · Article · Nov 2014 · Haematologica
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    Meletios A Dimopoulos · Paul G Richardson · Philippe Moreau · Kenneth C Anderson
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    ABSTRACT: Recent developments in the treatment of multiple myeloma have led to improvements in response rates and to increased survival; however, relapse is inevitable in almost all patients. Recurrence of myeloma is typically more aggressive with each relapse, leading to the development of treatment-refractory disease, which is associated with a shorter survival. Several phase II and III trials have demonstrated the efficacy of recently approved agents in the setting of relapsed and/or refractory multiple myeloma, including immunomodulatory agents, such as lenalidomide and pomalidomide, and proteasome inhibitors, such as bortezomib and carfilzomib. Currently, however, there is no standard treatment for patients with relapsed and/or refractory disease. This Review discusses the current treatment landscape for patients with relapsed and/or refractory multiple myeloma and highlights disease-related and patient-related factors-such as pre-existing comorbidities or toxicities-that are important considerations for clinicians when selecting an appropriate treatment regimen.
    Preview · Article · Nov 2014 · Nature Reviews Clinical Oncology
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    ABSTRACT: Ovarian Cancer represents the most fatal type of gynaecological malignancies. The tumor microenvironment consists the region where a number of processes contributing to the pathogenesis of this deadly disease occur. Except the cell proliferation process itself, processes such as angiogenesis can be held accountable for the progress of disease. More specifically, angiogenesis represents a hallmark phenomenon in cancer and a number of studies have shown that it is responsible for the spread of tumor and metastasis in most types of cancer including ovarian cancer. The process leads to new blood vessel formation and stabilization of the tumor vasculature. In recent years angiogenesis has been given considerable attention in order to identify novel targets for developing effective antitumor therapies. Among other families of molecules, growth factors have been identified to play important roles in driving the process of angiogenesis and thus the formation of new blood vessels that play the key role in supplying cancer with appropriate nutrients, hence allowing its spread and metastasis. Such molecules include the vascular endothelial growth factor (VEGF), the platelet derived growth factor (PDGF), the fibroblast growth factor (FGF) and the angiopoietin (Ang)/Tie 2 receptor complex. These proteins are key players in molecular pathways located within the tumor cell and they have been recently under heavy research being in the spotlight of the development of anti angiogenic molecules that may act as stand-alone therapeutics (monotherapy) or in combination with current treatment regimes such as standard chemotherapy. Such molecules include Bevacizumab, Sorafenib, Imatinib mesylate, Sunitinib, Trebananib, Aflibercept, Intedanib, Pazopanib, and Cediranib. There is also a special reference to the possible angio-agenic effect that paclitaxel may confer either in monotherapy or in combination with other agents. The roles of these molecules that have been developed in order to combat angiogenesis are described in this paper.
    Full-text · Article · Nov 2014 · Journal of Cancer Science and Therapy
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    ABSTRACT: This International Myeloma Working Group consensus updates the disease definition of multiple myeloma to include validated biomarkers in addition to existing requirements of attributable CRAB features (hypercalcaemia, renal failure, anaemia, and bone lesions). These changes are based on the identification of biomarkers associated with near inevitable development of CRAB features in patients who would otherwise be regarded as having smouldering multiple myeloma. A delay in application of the label of multiple myeloma and postponement of therapy could be detrimental to these patients. In addition to this change, we clarify and update the underlying laboratory and radiographic variables that fulfil the criteria for the presence of myeloma-defining CRAB features, and the histological and monoclonal protein requirements for the disease diagnosis. Finally, we provide specific metrics that new biomarkers should meet for inclusion in the disease definition. The International Myeloma Working Group recommends the implementation of these criteria in routine practice and in future clinical trials, and recommends that future studies analyse any differences in outcome that might occur as a result of the new disease definition. Copyright © 2014 Elsevier Ltd. All rights reserved.
    Full-text · Article · Nov 2014 · The Lancet Oncology

Publication Stats

12k Citations
2,394.86 Total Impact Points

Institutions

  • 2000-2016
    • National and Kapodistrian University of Athens
      • Division of Clinical Therapeutics
      Athínai, Attica, Greece
  • 2015
    • Princess Alexandra Hospital (Queensland Health)
      Brisbane, Queensland, Australia
  • 2006-2015
    • Harokopion University of Athens
      Athínai, Attica, Greece
    • Yale University
      New Haven, Connecticut, United States
    • Ευρωκλινική
      Athínai, Attica, Greece
  • 1996-2015
    • Alexandra Regional General Hospital
      Athínai, Attica, Greece
  • 2010
    • Sapienza University of Rome
      Roma, Latium, Italy
  • 2004-2009
    • Κωνσταντοπούλειο νοσοκομείο Νέας Ιωνίας (Η Αγία Όλγα)
      Athínai, Attica, Greece
  • 2003-2009
    • Harvard University
      Cambridge, Massachusetts, United States
  • 2008
    • University of Maryland, Baltimore
      • Greenebaum Cancer Center
      Baltimore, MD, United States
  • 2007
    • University of Ioannina
      Yannina, Epirus, Greece
    • University Hospital of Heraklion
      Irákleio, Attica, Greece
  • 2005
    • Henry Dunant Hospital
      Athínai, Attica, Greece
  • 1999-2004
    • University of Houston
      Houston, Texas, United States
  • 1991-2003
    • University of Texas MD Anderson Cancer Center
      • • Department of Lymphoma and Myeloma
      • • Department of Medical Oncology
      Houston, TX, United States