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• W2136060045 abstract "Diffuse large B-cell lymphoma (DLBCL) constitutes 30%–58% of non-Hodgkin's lymphoma series. The crude incidence in Europe is 3.8/100 000/year [1.Sant M. Allemani C. Tereanu C. et al.Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project.Blood. 2010; 116: 3724-3734Crossref PubMed Scopus (614) Google Scholar]. The incidence increases with age and varies considerably across Europe. A family history of lymphoma, autoimmune disease, human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) seropositivity, a high body mass as a young adult and some occupational exposures have been identified as risk factors of DLBCL [2.Morton L.M. Slager S.L. Cerhan J.R. et al.Etiologic heterogeneity among non-Hodgkin lymphoma subtypes: the InterLymph Non-Hodgkin Lymphoma Subtypes Project.J Natl Cancer Inst Monogr. 2014; : 130-144Crossref Scopus (225) Google Scholar]. In recent years, there have been important survival improvements for DLBCL in all European regions [3.Sant M. Minicozzi P. Mounier M. et al.Survival for haematological malignancies in Europe between 1997 and 2008 by region and age: results of EUROCARE-5, a population-based study.Lancet Oncol. 2014; 15: 931-942Abstract Full Text Full Text PDF PubMed Scopus (206) Google Scholar]. The diagnosis of DLBCL should be carried out in a reference haematopathology laboratory with expertise in morphological interpretation and the facilities to carry out the full range of phenotypic and molecular investigations [V, A]. A surgical excision biopsy remains the optimal method of diagnosis [V, A]. This allows assessment of nodal architecture and provides adequate material for phenotypic and molecular studies. Ideally, the biopsy should be sent unfixed to the laboratory to allow flow cytometric studies to be carried out and high-quality DNA and RNA to be extracted. Needle-core and endoscopic biopsies should be reserved for patients for whom a surgical approach is impractical or would entail excessive risk [IV, B]. A fine-needle aspirate should not be used as the sole basis for a diagnosis of DLBCL [V, E]. A morphological diagnosis of DLBCL should be confirmed in all cases by immunophenotypic investigations, either immunohistochemistry (IHC) or flow cytometry or a combination of both techniques [V, A]. Panels used must be designed to confirm B-cell lineage, and must be comprehensive enough to highlight possible variant forms such as immunoblastic lymphoma [4.Ott G. Ziepert M. Klapper W. et al.Immunoblastic morphology but not the immunohistochemical GCB/non-GCB classifier predicts outcome in diffuse large B-cell lymphoma in the RICOVER-60 trial of the DSHNHL.Blood. 2010; 116: 4916-4925Crossref PubMed Scopus (157) Google Scholar], primary mediastinal B cell lymphoma (PMBCL), T-cell/histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL leg-type or EBV-positive DLBCL of the elderly. They must also distinguish alternative diagnoses that may be difficult to make on the basis of morphology alone, and which have important clinical consequences as plasmablastic lymphoma or soft tissue involvement by myeloma, Burkitt lymphoma, unclassifiable B-cell lymphoma with features intermediate between diffuse large cell lymphoma and Burkitt lymphoma, blastic mantle cell lymphoma and some cases of Hodgkin's lymphoma. A suggested immunohistochemical panel would include CD20, CD79a, BCL6, CD10, MYC, BCL2, Ki67, IRF4, CyclinD1, CD5 and CD23. EBER-1 staining may be used to identify the Epstein–Barr virus-positive DLBCL subtype of the elderly population. The histological report should give the diagnosis according to the current World Health Organization classification [5.Swerdlow S.H. Campo E. Harris N.L. et al.World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues.4th edition. IARC, Lyon, France2008Google Scholar]. Where the level of confidence in the diagnosis is reduced, for example, because only a small biopsy specimen is available or where the putatively neoplastic population has a normal phenotype by IHC, demonstration of B-cell monoclonality by a polymerase chain reaction-based method should be considered [IV, C] [6.Langerak A.W. Groenen P.J. Brüggemann M. et al.EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations.Leukemia. 2012; 26: 2159-2171Crossref PubMed Scopus (319) Google Scholar]. The cell of origin phenotype determined by gene expression profiling is also a major prognostic factor in DLBCL [7.Wright G. Tan B. Rosenwald A. et al.A gene expression-based method to diagnose clinically distinct subgroups of diffuse large B cell lymphoma.Proc Natl Acad Sci USA. 2003; 100: 9991-9996Crossref PubMed Scopus (827) Google Scholar, 8.Lenz G. Wright G.W. Emre N.C. et al.Molecular subtypes of diffuse large B-cell lymphoma arise by distinct genetic pathways.Proc Natl Acad Sci USA. 2008; 105: 13520-13525Crossref PubMed Scopus (771) Google Scholar, 9.Scott D.W. Wright G.W. Williams P.M. et al.Determining cell-of-origin subtypes of diffuse large B-cell lymphoma using gene expression in formalin-fixed paraffin-embedded tissue.Blood. 2014; 123: 1214-1217Crossref PubMed Scopus (426) Google Scholar]. Tumours with a germinal centre phenotype have a significantly better clinical outcome that those with an activated B-cell phenotype. The nature of type 3 or unclassified subgroups requires further clarification. Newer methods, based on evaluation of a limited set of genes, have been validated in comparison with standard gene expression, and are now used in the setting of clinical trials [9.Scott D.W. Wright G.W. Williams P.M. et al.Determining cell-of-origin subtypes of diffuse large B-cell lymphoma using gene expression in formalin-fixed paraffin-embedded tissue.Blood. 2014; 123: 1214-1217Crossref PubMed Scopus (426) Google Scholar, 10.Mareschal S. Ruminy P. Bagacean C. et al.Accurate classification of germinal center b-cell-like/activated b-cell-like diffuse large b-cell lymphoma using a simple and rapid reverse transcriptase-multiplex ligation-dependent probe amplification assay: a CALYM study.Mol Diagn. 2015; ([Epub ahead of print])Abstract Full Text Full Text PDF Scopus (44) Google Scholar]. Cell of origin can also be determined by IHC but published data on the prognostic effect of immunohistochemical techniques are contradictory, and it is not recommended to routinely base clinical decisions on these results [11.Hans C.P. Weisenburger D.D. Greiner T.C. et al.Confirmation of the molecular classification of diffuse large B-cell lymphoma by immunohistochemistry using a tissue microarray.Blood. 2004; 103: 275-282Crossref PubMed Scopus (3178) Google Scholar, 12.Choi W.W. Weisenburger D.D. Greiner T.C. et al.A new immunostain algorithm classifies diffuse large B-cell lymphoma into molecular subtypes with high accuracy.Clin Cancer Res. 2009; 15: 5494-5502Crossref PubMed Scopus (534) Google Scholar]. General issues of reproducibility may also limit the value of IHC as a prognostic biomarker [13.de Jong D. Rosenwald A. Chhanabhai M. et al.Immunohistochemical prognostic markers in diffuse large B-cell lymphoma: validation of tissue microarray as a prerequisite for broad clinical applications—a study from the Lunenburg Lymphoma Biomarker Consortium.J Clin Oncol. 2007; 25: 805-812Crossref PubMed Scopus (260) Google Scholar]. The presence of an MYC rearrangement in combination with BCL2 rearrangement, and possibly other genetic abnormalities, has been described as a special entity (‘double-hit’ or ‘triple-hit’ lymphoma). However, the prognostic significance of these rearrangements remains controversial and optimal clinical management is not established [14.Savage K.J. Johnson N.A. Ben-Neriah S. et al.MYC gene rearrangements are associated with a poor prognosis in diffuse large B-cell lymphoma patients treated with R-CHOP chemotherapy.Blood. 2009; 114: 3533-3537Crossref PubMed Scopus (502) Google Scholar, 15.Barrans S. Crouch S. Smith A. et al.Rearrangement of MYC is associated with poor prognosis in patients with diffuse large B-cell lymphoma treated in the era of rituximab.J Clin Oncol. 2010; 28: 3360-3365Crossref PubMed Scopus (470) Google Scholar, 16.Lin P. Dickason T.J. Fayad L.E. et al.Prognostic value of MYC rearrangement in cases of B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma.Cancer. 2012; 118: 1566-1573Crossref PubMed Scopus (58) Google Scholar]. This assessment is recommended, wherever technically possible, in newly diagnosed and relapsed patients being treated with curative intent, using interphase fluorescence in situ hybridisation [IV, B]. The immunohistochemical expression of MYC and/or BCL2 or both (double expressors) is only partly correlated with genetic abnormalities, but the concurrent expression of MYC and BCL2 is usually associated with a poor outcome [17.Green T.M. Young K.H. Visco C. et al.Immunohistochemical double-hit score is a strong predictor of outcome in patients with diffuse large B-cell lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone.J Clin Oncol. 2012; 30: 3460-3467Crossref PubMed Scopus (527) Google Scholar, 18.Johnson N.A. Slack G.W. Savage K.J. et al.Concurrent expression of MYC and BCL2 in diffuse large B-cell lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone.J Clin Oncol. 2012; 30: 3452-3459Crossref PubMed Scopus (705) Google Scholar, 19.Horn H. Ziepert M. Becher C. et al.MYC status in concert with BCL2 and BCL6 expression predicts outcome in diffuse large B-cell lymphoma.Blood. 2013; 121: 2253-2263Crossref PubMed Scopus (417) Google Scholar]. Physical examination, performance status (PS) and assessment of B symptoms are necessary [V, A]. A complete blood count, routine blood chemistry including lactate dehydrogenase (LDH) and uric acid, as well as screening tests for HIV, hepatitis B virus (HBV) (HBs antigen, anti-HBs and anti-HBc antibodies) and HCV are required [V, A]. Protein electrophoresis is recommended [IV, B]. Based on recent consensus recommendations for staging and restaging of lymphoma developed by the clinical and imaging working groups of the international conference of malignant lymphomas (Lugano classification), fluorodeoxyglucose positron emission tomography (FDG-PET)/computed tomography (CT) scan is now recommended as the gold standard for staging DLBCL patients [V, A] [20.Cheson B.D. Fisher R.I. Barrington S.F. et al.Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification.J Clin Oncol. 2014; 32: 3059-3068Crossref PubMed Scopus (2776) Google Scholar, 21.Barrington S.F. Mikhaeel N.G. Kostakoglu L. et al.Role of imaging in the staging and response assessment of lymphoma: consensus of the International Conference on Malignant Lymphomas Imaging Working Group.J Clin Oncol. 2014; 32: 3048-3058Crossref PubMed Scopus (1025) Google Scholar]. PET/CT is more accurate than contrast-enhanced CT (CeCT), with increased sensitivity for nodal and extranodal sites; in practice, CeCT is often carried out before PET/CT. Should this not be the case, a full diagnostic high-dose CeCT should be carried out when necessary, in combination with PET/CT and after the PET scan [V, B]. Indeed, CeCT may be necessary for a better delineation of lymphadenopathy from the bowel; the detection of compression/thrombosis of central/mediastinal vessels, radiation planning or a more accurate measurement of nodal sites in the context of a trial. The findings of CeCT when carried out at baseline determine whether the low-dose non-enhanced CT part of the PET/CT scan will be sufficient for restaging. Focal bone marrow FDG uptake with or without increased diffuse uptake is more sensitive than bone marrow biopsy (BMB) for infiltration in DLBCL and is highly specific [22.Khan A.B. Barrington S.F. Mikhaeel N.G. et al.PET-CT staging of DLBCL accurately identifies and provides new insight into the clinical significance of bone marrow involvement.Blood. 2013; 122: 61-67Crossref PubMed Scopus (168) Google Scholar]. Low-volume involvement (<10%–20%) and discordant lymphoma may be missed by PET/CT imaging but these positive BMB/negative PET/CT findings are <10% [23.Pelosi E. Penna D. Douroukas A. et al.Bone marrow disease detection with FDG-PET/CT and bone marrow biopsy during the staging of malignant lymphoma: results from a large multicentre study.Q J Nucl Med Mol Imaging. 2011; 55: 469-475PubMed Google Scholar]. Thus, biopsy is no longer required when a PET/CT scan demonstrates bone or marrow involvement indicating advanced-stage disease but is appropriate in case of negative PET, when its results would change prognosis and treatment, especially when a shortened number of immunochemotherapy cycles is proposed [V, C]. For suspected central nervous system (CNS) lymphoma, magnetic resonance imaging is the modality of choice [III, A]. A diagnostic lumbar puncture should be considered in high-risk patients as described above [V, A]. Flow cytometry, when available, enhances the detection of lymphoma cells in the cerebrospinal fluid [24.Benevolo G. Stacchini A. Spina M. et al.Final results of a multicenter trial addressing role of CSF flow cytometric analysis in NHL patients at high risk for CNS dissemination.Blood. 2012; 120: 3222-3228Crossref PubMed Scopus (63) Google Scholar]. Cardiac function (left ventricular ejection fraction) should be assessed before treatment [V, A]. The risks of infertility and possibilities of fertility preservation should be discussed, depending on the type of treatment being proposed. The staging is established according to the Ann Arbor classification system [I, A] (Table 1). A new staging system that has not been prospectively validated has been recently proposed [20.Cheson B.D. Fisher R.I. Barrington S.F. et al.Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification.J Clin Oncol. 2014; 32: 3059-3068Crossref PubMed Scopus (2776) Google Scholar]. For prognostic purposes, the International Prognostic Index (IPI) and age-adjusted IPI (aaIPI) should be calculated [I, A] [25.A predictive model for aggressive non-Hodgkin's lymphoma. The International Non-Hodgkin's Lymphoma Prognostic Factors Project.N Engl J Med. 1993; 329: 987-994Crossref PubMed Scopus (4993) Google Scholar] (Table 2). Other factors that may affect prognosis and treatment strategies, including the maximum bulk of the disease, should be assessed [30.Pfreundschuh M. Ho A.D. Cavallin-Stahl E. et al.Prognostic significance of maximum tumour (bulk) diameter in young patients with good-prognosis diffuse large-B-cell lymphoma treated with CHOP-like chemotherapy with or without rituximab: an exploratory analysis of the MabThera International Trial Group (MInT) study.Lancet Oncol. 2008; 9: 435-444Abstract Full Text Full Text PDF PubMed Scopus (155) Google Scholar].Table 1Ann Arbor staging classificationStageIInvolvement of a single lymphatic region (I) or localized involvement of single extralymphatic organ or site (IE)IIInvolvement of two or more lymphatic regions on the same side of the diaphragm (II) or localized involvement of a single extralymphatic organ or site and of one or more lymphatic regions on the same side of the diaphragm (IIE)IIIInvolvement of lymphatic regions on both sides of the diaphragmIVDiffuse or disseminated involvement of one or more extralymphatic organs with or without lymphatic involvement Open table in a new tab Table 2International prognostic index (IPI)International prognostic index (IPI)Estimated 3-year overall survival [26.Récher C. Coiffier B. Haioun C. et al.Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial.Lancet. 2011; 378: 1858-1867Abstract Full Text Full Text PDF PubMed Scopus (270) Google Scholar, 27.Fitoussi O. Belhadj K. Mounier N. et al.Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA.Haematologica. 2011; 96: 1136-1143Crossref PubMed Scopus (74) Google Scholar, 28.Ziepert M. Hasenclever D. Kuhnt E. et al.Standard international prognostic index remains a valid predictor of outcome for patients with aggressive CD20+ B-cell lymphoma in the rituximab era.J Clin Oncol. 2010; 28: 2373-2380Crossref PubMed Scopus (441) Google Scholar, 29.Ketterer N. Coiffier B. Thieblemont C. et al.Phase III study of ACVBP versus ACVBP plus rituximab for patients with localized low-risk diffuse large B-cell lymphoma (LNH03–1B).Ann Oncol. 2013; 24: 1032-1037Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar] (95% CI)Risk factorsAge >60 yearsSerum LDH > normalStage III–IVPerformance status 2–4Extranodal sites >1Risk categoriesLow0–191 (89–94)Low intermediate281 (73–86)High intermediate365 (58–73)High4–559 (49–69)Age-adjusted international prognostic index (aaIPI) in patients ≤60 yearsRisk factorsSerum LDH > normalStage III–IVPerformance status 2–4Risk categoriesLow098 (96–100)Low intermediate192 (87–95)High intermediate2}75 (66–82)High3LDH, lactate dehydrogenase; CI, confidence interval. Open table in a new tab LDH, lactate dehydrogenase; CI, confidence interval. Treatment strategies should be stratified according to age, IPI and feasibility of dose-intensified approaches (Table 3). Whenever available, the inclusion in a clinical trial is recommended.Table 3Recommended treatment strategies in diffuse large B-cell lymphomaPatients ≤60 yearsIPI low risk (aaIPI = 0) and no bulkIPI low risk (aaIPI = 0) with bulk or IPI low-intermediate risk (aaIPI = 1)IPI intermediate-high risk or IPI high risk (aaIPI = 2, 3)R-CHOP21 × 6R-ACVBP and sequential consolidationorR-CHOP21 × 6 + IF-RT on bulkR-CHOP21 × 6–8orR-CHOP14 × 6 with 8 RConsider more intensive regimens in selected patients:R-CHOEP14 × 6orR-CHOP or R-ACVBP plus HDCT with ASCTConsider CNS prophylaxis in patients at risk for CNS progressionElderly >60 yearsFit, 60–80 years>80 years without cardiac dysfunctionUnfit or frail or >60 years with cardiac dysfunctionR-CHOP21 × 6–8(R-CHOP21 × 6 for IPI low risk)orR-CHOP14 × 6 with 8 RAttenuated regimens:R-miniCHOP21 × 6Doxorubicin substitution with gemcitabine, etoposide or liposomal doxorubicin or others:R-C(X)OP21 × 6orpalliative careConsider CNS prophylaxis in patients at riskFirst relapse/progressEligible for transplantNot eligible for transplantPlatinum-based chemotherapy regimens (i.e. R-DHAP, R-ICE, R-GDP) as salvage treatmentFor chemosensitive patients: R-HDCT with ASCT as remission consolidationConsider allogeneic transplantation in patients relapsed after R-HDCT with ASCT or in patients with poor-risk factors at relapsePlatinum- and/or gemcitabine-based regimensClinical trials with novel drugs>2 relapse/progressEligible for transplantNot eligible for transplantAllogeneic transplantationClinical trials with novel drugsClinical trials with novel drugsPalliative careIPI, International Prognostic Index; aaIPI, age-adjusted IPI; R, rituximab; CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; ACVBP, doxorubicin, vindesine, cyclophosphamide, bleomycin and prednisolone; IF-RT, involved-field radiotherapy; HDCT, high-dose chemotherapy; ASCT, autologous stem-cell transplantation; DHAP, cisplatin, cytarabine, dexamethasone; ICE, ifosfamide, carboplatin, etoposide; GDP, cisplatin, gemcitabine, dexamethasone; CNS, central nervous system; CHOEP, cyclophosphamide, doxorubicin, vincristine, etoposide, prednisolone; R-C(X)OP, R-CHOP with substitution of doxorubicin. Open table in a new tab IPI, International Prognostic Index; aaIPI, age-adjusted IPI; R, rituximab; CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; ACVBP, doxorubicin, vindesine, cyclophosphamide, bleomycin and prednisolone; IF-RT, involved-field radiotherapy; HDCT, high-dose chemotherapy; ASCT, autologous stem-cell transplantation; DHAP, cisplatin, cytarabine, dexamethasone; ICE, ifosfamide, carboplatin, etoposide; GDP, cisplatin, gemcitabine, dexamethasone; CNS, central nervous system; CHOEP, cyclophosphamide, doxorubicin, vincristine, etoposide, prednisolone; R-C(X)OP, R-CHOP with substitution of doxorubicin. In cases with high tumour load, precautions such as the administration of prednisone (p.o.) several days as ‘prephase’ treatment are advised to avoid tumour lysis syndrome [I, A]. Dose reductions due to haematological toxicity should be avoided [I, A]. Febrile neutropaenia justifies prophylactic use of haematopoietic growth factors in patients treated with curative intent and in patients older than 60 years of age [I, A]. Six cycles of combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) treatment combined with six doses of rituximab given every 21 days is the current standard [I, A] [31.Pfreundschuh M. Kuhnt E. Trumper L. et al.CHOP-like chemotherapy with or without rituximab in young patients with good-prognosis diffuse large-B-cell lymphoma: 6-year results of an open-label randomised study of the MabThera International Trial (MInT) Group.Lancet Oncol. 2011; 12: 1013-1022Abstract Full Text Full Text PDF PubMed Scopus (527) Google Scholar]. Consolidation by radiotherapy to initial non-bulky sites has no proven benefit in patients treated with rituximab or not [I, A] [32.Reyes F. Lepage E. Ganem G. et al.ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma.N Engl J Med. 2005; 352: 1197-1205Crossref PubMed Scopus (284) Google Scholar, 33.TLamy, GDamaj, EGyanet al. R-CHOP with or without radiotherapy in non-bulky limited-stage diffuse large B cell lymphoma (DLBCL): preliminary results of the prospective randomized phase III 02-03 trial from the Lysa/Goelams Group. In: 2014 ASH Annual Meeting, Orlando, Florida. Abstract 393.Google Scholar]. Rituximab (R)-CHOP 21 × 6 with radiotherapy to the sites of previous bulky disease was shown to be effective in this group of patients, based on the results of the MINT study [II, B] [31.Pfreundschuh M. Kuhnt E. Trumper L. et al.CHOP-like chemotherapy with or without rituximab in young patients with good-prognosis diffuse large-B-cell lymphoma: 6-year results of an open-label randomised study of the MabThera International Trial (MInT) Group.Lancet Oncol. 2011; 12: 1013-1022Abstract Full Text Full Text PDF PubMed Scopus (527) Google Scholar]. Alternatively, an intensification of chemotherapy with R-ACVBP (rituximab, doxorubicin, vindesine, cyclophosphamide, bleomycin and prednisolone), given every 2 weeks followed by sequential consolidation, has been shown to improve survival compared with eight cycles of R-CHOP in this category, but radiotherapy was omitted in both arms of this trial [I, A] [26.Récher C. Coiffier B. Haioun C. et al.Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial.Lancet. 2011; 378: 1858-1867Abstract Full Text Full Text PDF PubMed Scopus (270) Google Scholar]. In this group of patients, either R-CHOP21 × 6 with radiotherapy to the sites of previous bulky disease or the intensified regimen R-ACVBP is recommended [II, B]. There is no current standard in this subgroup, and in this group especially, enrolment in clinical trials should be a priority. Six to eight cycles of chemotherapy with CHOP combined with eight doses of rituximab given every 21 days are most frequently applied [III, B]. Dose dense treatment with R-CHOP given every 14 days has not demonstrated a survival advantage over standard R-CHOP given every 21 days [I, C] [34.Cunningham D. Hawkes E.A. Jack A. et al.Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles.Lancet. 2013; 381: 1817-1826Abstract Full Text Full Text PDF PubMed Scopus (379) Google Scholar]. In this trial, R-CHOP 14 failed to show a better outcome in any DLBCL subset, including young poor-risk patients, although the trial was not powered to compare multiple clinical subgroups. Intensive treatment with R-ACVBP or R-CHOEP (rituximab, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisolone) is frequently used but these regimens have not been directly compared with R-CHOP in this category [II, B] [27.Fitoussi O. Belhadj K. Mounier N. et al.Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA.Haematologica. 2011; 96: 1136-1143Crossref PubMed Scopus (74) Google Scholar, 35.Schmitz N. Nickelsen M. Ziepert M. et al.Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002–1).Lancet Oncol. 2012; 13: 1250-1259Abstract Full Text Full Text PDF PubMed Scopus (182) Google Scholar]. Four randomised trials comparing rituximab chemotherapy (R-chemotherapy) followed by high-dose chemotherapy (HDC) and autologous stem-cell transplantation (ASCT) versus R-chemotherapy alone have been presented. Two trials showed a progression-free survival (PFS) benefit for HDC with ASCT but no impact, at present, on overall survival (OS) [36.Vitolo U. Chiappella A. Brusamolino E. et al.Rituximab dose-dense chemotherapy followed by intensified high-dose chemotherapy and autologous stem cell transplantation (HDC+ASCT) significantly reduces the risk of progression compared to standard rituximab dose-dense chemotherapy as first line treatment in young patients with high-risk (aa-IPI 2-3) diffuse large B-cell lymphoma (DLBCL): final results of phase III randomized trial DLCL04 of the Fondazione Italiana Linfomi (FIL).Blood. 2012; 120 (ASH Annual Meeting Abstracts): 688Google Scholar, 37.Stiff P.J. Unger J.M. Cook J.R. et al.Autologous transplantation as consolidation for aggressive non-Hodgkin's lymphoma.N Engl J Med. 2013; 369: 1681-1690Crossref PubMed Scopus (245) Google Scholar], while two trials failed to demonstrate an improvement for the HDC arm [35.Schmitz N. Nickelsen M. Ziepert M. et al.Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002–1).Lancet Oncol. 2012; 13: 1250-1259Abstract Full Text Full Text PDF PubMed Scopus (182) Google Scholar, 38.Le Gouill S. Milpied N.J. Lamy T. et al.First-line rituximab (R) high-dose therapy (R-HDT) versus R-CHOP14 for young adults with diffuse large B-cell lymphoma: preliminary results of the GOELAMS 075 prospective multicenter randomized trial.J Clin Oncol. 2011; 29 (ASCO Annual Meeting Abstracts Part 1): 8003Crossref Google Scholar]. Therefore, HDC with ASCT in first line remains experimental or may be proposed for selected high-risk patients [II, C]. The role of consolidation by radiotherapy to initial sites of bulky disease is unknown. The role of interim PET to select patients who could benefit from consolidative ASCT [39.Casasnovas R.O. Ysebaert L. Thieblemont C. et al.Final results of a randomized phase II GELA/LYSA study of rituximab plus ACVBP or CHOP, using a PET-driven consolidation strategy, in patients with high-risk diffuse large B-cell lymphoma (DLBCL).J Clin Oncol. 2014; 32 (ASCO Annual Meeting Abstracts): 8503Crossref Google Scholar] or from radiotherapy [40.Sehn L.H. Hardy E.L.G. Gill K.K. et al.Phase 2 trial of interim PET scan-tailored therapy in patients with advanced stage diffuse large B-cell lymphoma (DLBCL) in British Columbia (BC).Blood. 2014; 124 (ASH Annual Meeting Abstracts): 392Crossref Google Scholar] is under evaluation [I, C]. Six to eight cycles of combination chemotherapy with CHOP plus eight doses of rituximab given every 21 days is the current standard [I, A] [41.Coiffier B. Thieblemont C. Van Den Neste E. et al.Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte.Blood. 2010; 116: 2040-2045Crossref PubMed Scopus (1003) Google Scholar]. R-CHOP given every 14 days did not demonstrate a survival advantage over R-CHOP 21 [I, C] [34.Cunningham D. Hawkes E.A. Jack A. et al.Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles.Lancet. 2013; 381: 1817-1826Abstract Full Text Full Text PDF PubMed Scopus (379) Google Scholar, 42.Delarue R. Tilly H. Mounier N. et al.Dose-dense rituximab-CHOP compared with standard rituximab-CHOP in elderly patients with diffuse large B-cell lymphoma (the LNH03-6B study): a randomised phase 3 trial.Lancet Oncol. 2013; 14: 525-533Abstract Full Text Full Text PDF PubMed Scopus (218) Google Scholar]. If R-CHOP is given every 14 days, six cycles of CHOP with eight cycles of rituximab are sufficient [I, A] [43.Pfreundschuh M. Schubert J. Ziepert M. et al.Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60).Lancet Oncol. 2008; 9: 105-116Abstract Full Text Full Text PDF PubM" @default.
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• W2136060045 title "Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up" @default.
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