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Spa therapy is considered an add-on treatment for psoriasis, but without any objective evaluation in the absence of randomized trials. This multicenter, open-label, randomized trial compared immediate spa therapy versus a control group having usual treatments until study assessments at 4.5 months. Spa therapy was proposed in five French spa resorts with standardized programs. Inclusion criteria were adults with plaque psoriasis, Dermatology Life Quality Index (DLQI) > 10, and stable medical treatment in the last 6 months. The main objective was DLQI ≤ 10 at 4.5 months after inclusion. VQ-Dermato and EQ5D-3L also assessed quality of life (QoL), Perceived Stress Scale (PSS) stress, and visual analogue scales (VAS) pain and pruritus. Between January 2015 and November 2018, 128 patients were randomized to either immediate spa therapy (64) (within 34 days, median) or usual treatments (61) until assessment at 4.5 months. Most were first-time spa users (71.2%). Mean DLQI and Psoriasis Area and Severity Index at inclusion were 16.7 and 10.5, respectively. Immediate spa therapy patients achieved the primary objective for 66.1% [95% CI 52.6% > 77.9%] vs 41.4% [95% CI 28.6% > 55.1%] control group patients (p = 0.007). VQ-Dermato scores and pruritus VAS significantly improved. Outcomes at 12-month follow-up of the immediate spa therapy group showed persistent improvement of DLQI, VQ-Dermato, and pruritus. This randomized controlled trial demonstrated that a cure of spa therapy improves QoL and alleviates certain symptoms of psoriasis, in short and long terms. This justifies its integration in the therapeutic strategies for psoriasis. Trial registration number: ClinicalTrials.gov Identifier: NCT02098213.

Introduction Ivacaftor is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has demonstrated clinical benefits in phase 3 trials. We report results from a real-world study (BRIO) to assess the effectiveness of ivacaftor in people with cystic fibrosis (pwCF) in France. Methods BRIO was an observational study conducted at 35 centers in France. Both pwCF initiating ivacaftor treatment and those already taking ivacaftor were included and prospectively followed for 24 months. The primary objective was to evaluate the effect of ivacaftor on percent predicted forced expiratory volume in 1 s (ppFEV1); secondary objectives were evaluating the effect of ivacaftor on clinical effectiveness, healthcare resource utilization (HCRU), and safety. Results A total of 129 pwCF were enrolled; 58.9% were aged

International audience; BackgroundHigh-dose chemotherapy plus autologous stem-cell transplantation has been the standard treatment for newly diagnosed multiple myeloma in adults up to 65 years of age. However, promising data on the use of combination therapy with lenalidomide, bortezomib, and dexamethasone (RVD) in this population have raised questions about the role and timing of transplantation.MethodsWe randomly assigned 700 patients with multiple myeloma to receive induction therapy with three cycles of RVD and then consolidation therapy with either five additional cycles of RVD (350 patients) or high-dose melphalan plus stem-cell transplantation followed by two additional cycles of RVD (350 patients). Patients in both groups received maintenance therapy with lenalidomide for 1 year. The primary end point was progression-free survival.ResultsMedian progression-free survival was significantly longer in the group that underwent transplantation than in the group that received RVD alone (50 months vs. 36 months; adjusted hazard ratio for disease progression or death, 0.65; P

En France, les cooperations entre les laboratoires de biologie medicale des etablissements de sante s’intensifient apres celles realisees dans les laboratoires prives. Les biologistes sont dans ce cas confrontes a differentes hypotheses d’organisation qui sont souvent complexes car elles doivent permettre de conserver la qualite des soins et leur continuite tout en realisant des economies financieres. Ces economies sont le plus souvent basees sur la baisse globale du personnel et des equipements en mutualisant les examens biologiques a des degres divers. Dans cet article, nous decrivons les differents elements a prendre en compte (personnel, activites, budget, qualite, transports, materiels) et proposons differents scenarios de cooperation, de la plateforme centrale unique au transfert d’examens tres specialises, avec leurs avantages et leurs inconvenients. La gestion des aspects humains de ces cooperations est determinante pour faciliter leur reussite ainsi qu’un etat des lieux prealable fiable.

Resume Rappel On connait peu de choses sur les facteurs de risque des douleurs provoquees au cours des injections articulaires et rachidiennes. Methodes Dans cette etude nationale prospective multicentrique, la douleur liee au geste etait evaluee par les rhumatologues chez quatre patients consecutifs qui ont eu une ponction articulaire et des infiltrations du genou (G), et chez quatre patients consecutifs qui ont recu des injections rachidiennes (R). L’evaluation de la douleur etait faite juste avant l’injection, pendant et 48 heures apres. Resultats Un total de 249 rhumatologues ont inclus 1350 patients (720 G et 630 R ; 64 ± 14 ans, 64,6 % de femmes). La douleur postinjection, decrite dans 76,1 % des cas, etait generalement legere (moyenne 2,6 ± 2,5 1 sur 10) et n’etait pas differente en fonction du site d’injection. La frequence de cette douleur augmentait significativement avec la douleur liee a la maladie sous-jacente et le niveau d’anxiete avant le geste. Les patients se souvenaient de leur douleur 48 heures apres l’injection dans 66,2 % des cas, avec une intensite de 2,4 ± 2,6. Les patients qui avaient une douleur liee a une maladie sous-jacente, un niveau eleve de douleur immediate postinjection, un niveau d’anxiete eleve se « souvenaient » plus de leur douleur postinjection. En revanche, cette « memoire » etait moins frequente lorsque l’injection etait realisee pour la premiere fois. Les evaluations de la douleur liee a l’acte par les patients et les praticiens etaient peu concordantes (coefficient Kappa 0,45). Les praticiens surestimaient la frequence de la douleur mais sous-estimaient son intensite. Conclusion La douleur liee au geste est frequente mais faible chez les patients qui ont recu des injections musculosquelettiques. La douleur immediate apres le geste et son souvenir 48 heures apres, depend principalement du niveau de la douleur sous-jacente et de l’anxiete, quels que soit le site de l’injection et le traitement antalgique donne.

Background Little is known about the risk factors for procedural pain during spinal and joint injections. Methods In this prospective national multicentre study, procedural pain was investigated by rheumatologists who visited four consecutive patients undergoing synovial aspiration and infiltrations of the knee (K), and four consecutive patients undergoing spinal (S) injections. Pain assessments were carried out just before, during, and 48 hours after the procedure. Results The 249 rheumatologists enrolled 1350 patients (720 K and 630 S; 64 ± 14 years, 64.6% female). Instantaneous procedure-induced pain was reported in 76.1% of cases, was generally mild (mean 2.6 ± 2.5 on 10) and not different between the two sites. The frequency of procedure-induced pain increased significantly with pain related to the underlying disease and level of anxiety before the procedure. Procedure-induced pain was recalled after 48 hours later by 66.2% of the patients, with an intensity of 2.4 ± 2.6. The recall of procedure-induced pain increased with pain due to the underlying condition, with the intensity of instantaneous procedure-induced pain, with the level of anxiety, but was less frequent if the patient underwent the procedure for the first time. Patients’ and physicians’ estimates of procedural pain were poorly concordant (kappa coefficient 0.45), physicians tended to overestimate the frequency of pain but to underestimate its intensity. Conclusion Procedural pain is common, but mild, in patients undergoing musculoskeletal injections. Instantaneous procedural pain and its recall 48 hours later depend principally on the level of underlying pain and anxiety, regardless of the injection site and the analgesic procedure performed.

In many parts of the world, overweight and obesity have become increasingly prevalent in children in the past 2 decades. These states are associated with cardiovascular risk factors, and the risk increases with the development of complications such as impaired glucose tolerance, insulin resistance (IR), dyslipidemia, and hypertension. This study was planed to estimate the frequency of the IR syndrome (IRS) and metabolic syndrome (MS) in 65 overweight and 243 obese children and adolescents 7 to 17 years of age. MS was diagnosed using the National Cholesterol Education Program Adult Treatment Panel III criteria and IRS using the World Health Organization criteria. MS was diagnosed in 15.9% of the study group and IRS in 42.5%. More than half the children studied, 54.2%, did not have either IRS or MS. All but 3.6% of children with MS also presented with IRS. Body mass index (BMI) was a significant factor in MS after adjusting for age and gender. Other risk factors for MS included the homeostatic model assessment (HOMA) index and acanthosis nigricans. Children with IRS had significantly higher BMI values, and IRS became more frequent as the waist-to-hip ratio increased. Pubertal children were approximately 1.7-fold more likely than those who were prepubertal to develop IRS. The mother's BMI, but not the father's, significantly influenced the frequency of IRS. On multiple regression analysis, both the HOMA index and waist-to-hip ratio were significant and independent risk factors for MS. Both adiposity (personal and maternal) and puberty correlated positively and significantly with IRS. These findings show that metabolic abnormalities and insulin resistance are frequent in overweight and obese children and adolescents. In this study of obese European children, IRS appeared to be a relevant marker for cardiovascular complications.

We compared an acetaminophen (paracetamol) 1 g (n = 51) formulation for infusion with propacetamol 2 g (n = 51) and placebo (n = 50) in a randomized, controlled, double-blind, parallel group trial in patients with moderate-to-severe pain after third molar surgery. Treatment efficacy was assessed in house for 6 h after starting the 15-min infusion. Significant effects versus placebo (P < 0.01) were obtained with both active treatments on pain relief, pain intensity difference on a 100-mm visual analog scale, and on a categorical scale (except for propacetamol at 6 h). No significant differences were noted between active groups except at 1 h. Six-hour weighted sums of primary assessments showed significantly better efficacy than placebo (P < 0.0001) and no difference between active treatments. Median stopwatch time to onset of pain relief for active treatment was 6-8 min after infusion start. Active treatments showed comparable efficacy with a significantly longer duration of analgesia and better patients' global evaluation compared with placebo. The incidence of patients reporting local pain at the infusion site was significantly less frequent after IV acetaminophen or placebo (0%) in comparison with propacetamol (49%). In conclusion, acetaminophen 1 g and propacetamol 2 g were superior to placebo regarding analgesic efficacy, with a more frequent incidence of local pain at the infusion site for propacetamol.

Background Intravenous acetaminophen injection (paracetamol) is marketed in Europe for the management of acute pain. A repeated-dose, randomized, double-blind, placebo-controlled, three-parallel group study was performed to evaluate the analgesic efficacy and safety of intravenous acetaminophen as compared with its prodrug (propacetamol) and placebo. Propacetamol has been available in many European countries for more than 20 yr. Methods After orthopedic surgery, patients reporting moderate to severe pain received either 1 g intravenous acetaminophen, 2 g propacetamol, or placebo at 6-h intervals over 24 h. Patients were allowed "rescue" intravenous patient-controlled analgesia morphine. Pain intensity, pain relief, and morphine use were measured at selected intervals. Safety was monitored through adverse event reporting, clinical examination, and laboratory testing. Results One hundred fifty-one patients (intravenous acetaminophen: 49; propacetamol: 50; placebo: 52) received at least one dose of study medication. The intravenous acetaminophen and propacetamol groups differed significantly from the placebo group regarding pain relief from 15 min to 6 h (P < 0.05) and median time to morphine rescue (intravenous acetaminophen: 3 h; propacetamol: 2.6 h; placebo: 0.8 h). Intravenous acetaminophen and propacetamol significantly reduced morphine consumption over the 24-h period: The total morphine doses received over 24 h were 38.3 +/- 35.1 mg for intravenous acetaminophen, 40.8 +/- 30.2 mg for propacetamol, and 57. 4 +/- 52.3 mg for placebo, corresponding to decreases of -33% (19 mg) and -29% (17 mg) for intravenous acetaminophen and propacetamol, respectively. Drug-related adverse events were reported in 8.2%, 50% (most of them local), and 17.3% of patients treated with intravenous acetaminophen, propacetamol, and placebo, respectively. Conclusion Intravenous acetaminophen, 1 g, administered over a 24-h period in patients with moderate to severe pain after orthopedic surgery provided rapid and effective analgesia and was well tolerated.

Introduction: Recently, a report has suggested the eAcacy and safety of thalidomide in refractory multiple myeloma. In an attempt to assess the eAcacy and tolerance of thalidomide in advanced multiple myeloma (on behalf of the Intergroupe Franchophone dy Myelome (IFM)), we report the preliminary experience of the IFM with this drug. Materials and methods: Patients with advanced multiple myeloma (n=27) were treated with an oral dose of thalidomide (median 400 mg/day). At the start of treatment, all patients had active disease and 20 patients had received at least one autologous transplantion. Results: Median follow-up was 105 days from the first administration. The serum and/or urine levels of the M-component were reduced by at least 75% in four patients including one patient with a 490% reduction, by at least 50% in five patients and by at least 25% in three patients, giving a total response rate of 45% (12 out of 27 patients). Nine patients had stable disease and six patients had progressed disease. Short-term side-eAects of thalidomide were generally moderate. Conclusion: This study confirms that thalidomide is an eAective agent in patients with advanced myeloma. The Hematology Journal (2000) 1, 186‐189

Background The median survival of patients with myeloma after conventional chemotherapy is three years or less. Promising results have been reported with high-dose therapy supported by autologous bone marrow transplantation. We conducted a randomized study comparing conventional chemotherapy and high-dose therapy. Methods Two hundred previously untreated patients under the age of 65 years who had myeloma were randomly assigned at the time of diagnosis to receive either conventional chemotherapy or high-dose therapy and autologous bone marrow transplantation. Results The response rate among the patients who received high-dose therapy was 81 percent (including complete responses in 22 percent and very good partial responses in 16 percent), whereas it was 57 percent (complete responses in 5 percent and very good partial responses in 9 percent) in the group treated with conventional chemotherapy (P

A prospective, randomized trial was initiated in adult acute lymphoblastic leukemia (ALL) to compare (1) disease-free survival (DFS) after allogeneic or autologous bone marrow transplantation (BMT) and (2) the relapse rate of patients treated with or without interleukin-2 (IL-2) after autologous BMT. A total of 135 previously untreated patients, aged under 55 years, received the Berlin-Frankfurt-Muster (BFM) induction regimen: 126 patients (93%), of which 120 were HLA- typed, achieved complete remission (CR). According to this genetic randomization, patients with (n = 43) or without an HLA-identical sibling (n = 77) were to receive allogeneic or autologous BMT, respectively. The 3-year post-CR probability of DFS was significantly higher in the HLA-identical sibling group than in the non-HLA-identical sibling group (68% v 26%; P < .001). Eligible patients were randomized to receive (n = 30) or not to receive (n = 30) IL-2 after autologous BMT: the 3-year post-BMT probability of continuous CR was similar in both groups (29% v 27%, respectively). We conclude that, in ALL, early allogeneic BMT after the BFM induction regimen is an effective consolidation treatment and that IL-2 does not decrease the high relapse rate observed after autologous BMT.

To determine whether activation of Epstein-Barr virus (EBV) replication in tumour cells of AIDS-related non-Hodgkin's lymphoma (ARNHL) is correlated with CD4+ cell counts and influences antibody response to EBV [anti-Z Epstein-Barr replicative activator (ZEBRA), anti-early antigen (EA), anti-viral capsid antigen (VCA)].Retrospective study based on immunohistochemistry and in situ hybridization to detect EBV replicative gene products in tissue samples from patients affected by ARNHL and correlation with CD4+ cell counts and results of EBV serology (including anti-ZEBRA activity) in sera from the same patients.Seventeen out of 22 cases of ARNHL were selected for the presence of EBV [Epstein-Barr early region (EBER) RNA-positive]. Immunohistochemistry was performed with anti-ZEBRA, anti-EA-restricted, anti-VCA antibodies and in situ hybridization with BHLF1/NotI oligoprobes on tumour samples. Results were statistically correlated with those of CD4+ cell counts (17 out of 17) and with anti-EBV antibody titres (13 out of 17) assessed using standard immunofluorescence method and enzyme-linked immunosorbent assay procedure using recombinant ZEBRA protein and synthetic peptides as antigens.BZLF1 (ZEBRA) or early gene products (EA-R and EA-D/BHLF1/NotI) were detected in a small proportion (0.01-5%) of tumour cells in eight of these 17 cases by immunohistochemistry and in situ hybridization. Demonstration of replicative gene expression did not correlate with either low CD4+ cell counts (P0.05) or anti-EBV antibody titres (P0.05). Anti-ZEBRA activity was not significantly increased in patients affected with ARNHL, the cells of which expressed replicative gene products (P0.05).The degree of immunodeficiency does not clearly enhance replicative gene expression in tumour cells of ARNHL. EBV serology, including anti-ZEBRA activity, is not a reliable tool for predicting the occurrence of such proliferations.

A trial was initiated to determine the feasibility and efficacy of a three-phase treatment including: (1) induction chemotherapy (IC); (2) high-dose melphalan with total body irradiation supported by unpurged autologous bone marrow transplantation (ABMT); and (3) interferon (IFN) alpha maintenance treatment, in previously untreated aggressive myeloma. Thirty-five consecutive patients, ages under 65 years, were enrolled. Initial induction therapy was randomized between the VAD regimen (vincristine, doxorubicin, dexamethasone) or the VMCP regimen (vincristine, melphalan, cyclophosphamide, prednisone) that were found to give similar results as IC. Thirty-one of 35 (89%) patients, with good performance status and normal renal function after IC, received ABMT. IFN alpha was started soon after ABMT and was well tolerated. Fifteen of 35 (43%) patients achieved complete response (CR) and 14 of 35 (40%) achieved partial response (PR). Low pretreatment beta 2 microglobulin was the only predictive factor for accomplishing CR. The duration of response was significantly affected by the magnitude of response. The 33-month, post-ABMT probability of progression-free survival was 85% for patients in CR versus 24% for patients in PR. The 42-month, post-diagnosis probability of survival was 81%. This overall strategy may represent an advance in the management of multiple myeloma. Furthermore, the high rate and long duration of CR that we observed in patients with low beta 2 microglobulin suggest that such patients may preferentially benefit from this strategy.

Microscopic intracellular detection of Epstein-Barr virus (EBV) messenger RNA in Reed-Sternberg cells of Hodgkin's disease (HD) was possible by in situ hybridization, in tissue sections prepared by a method termed modified acetone methyl benzoate xylene (ModAMeX). The ModAMeX method was initially developed for simultaneous optimal preservation of leucocyte differentiation antigens and morphology. Two biotinylated DNA probes, corresponding to the same BamHI-W (internal repeat) of the EBV genome were used. EBV mRNA was detected in neoplastic cells in 16 of 54 (30%) lymph node biopsy specimens from usual subtypes of HD (lymphocyte predominance, 0/5; nodular sclerosis, 4/22; mixed cellularity, 12/26; unclassified, 0/1). EBV mRNA was also detected in the lymph node biopsy of 1 additional human immunodeficiency virus (HIV)-related case of HD (mixed cellularity) and in 2 of 4 cases of B-cell lymphomas occurring in patients with acquired immunodeficiency syndrome (AIDS). In other non-Hodgkin's lymphomas, EBV mRNA was detected in only 1 of 41 cases. Cases of HD positive for EBV mRNA were immunostained by CD30 and CD15 antibodies. The hybridization signals were exclusively restricted to Reed-Sternberg cells and variants. When analyzed retrospectively, no statistically significant correlation emerged between hybridization findings, EBV serology, or disease outcome over the 3 years of the availability of ModAMeX technique. The findings support the contention of a direct role of EBV in the pathogenesis of HD, at least in some cases.

Introduction Depuis quatre ans, des entretiens pharmaceutiques (EP) sont realises avant chaque cure de chimiotherapie a hopital de jour de medecine, en pneumologie et en hepato gastro-enterologie afin de lutter aux mieux contre les nausees et vomissements chimio-induits (NVCI). L’objectif de notre travail est tout d’abord d’evaluer l’interet et l’impact des EP par le patient et la pratique professionnelle des EP par le pharmacien. Materiels et methode Un questionnaire d’evaluation a ete distribue aux patients recevant une chimiotherapie en hopital de jour de medecine, en pneumologie, en hepato-gastroenterologie en decembre 2013 puis en mai 2014. Les principaux aspects evalues etaient : la satisfaction du premier EP, la pertinence d’avoir un EP avant chaque cure de chimiotherapie et leur avis sur le moment le plus approprie pour y proceder. Les dossiers de 30 patients ayant recu une cure de chimiotherapie en 2013 ont ensuite ete analyses par un pharmacien. Les differents criteres analyses etaient : le delai de stabilisation des NVCI et le bon ajustement du traitement antiemetique lors d’un changement de protocole (niveau emetisant). Resultats et discussion Au total, 63 questionnaires patients ont ete recueillis. Ils ont revele que les patients etaient tres satisfaits (62 %) ou satisfaits (38 %) de ces EP. La plupart des patients (63 %) trouvent que les consultations ont ete utiles avant chaque cure, tandis que 27 % pensent que seule une consultation pour la premiere cure est suffisante. Par ailleurs, 10 % des patients estiment que les EP ont ete utiles avant un changement de protocole de chimiotherapie et lorsque la cure ne s’est pas bien passee (recrudescence NVCI). Enfin, 90 % des patients estiment que les EP sont complementaires par rapport a la consultation medicale. Par ailleurs, 64 dossiers patients ont ete analyses. Pour 69 % des patients, les NVCI se stabilisent avant la troisieme cure. Le traitement antiemetique n’est pas adapte au nouveau niveau de chimiotherapie emetisante dans 55 % des cas. Les patients ont exprime un reel interet envers ces EP et les avantages qu’ils peuvent en tirer. De plus, les NVCI des patients sont stabilises plus rapidement grâce aux EP. En fait, il semble que ces consultations sont surtout necessaires pour la premiere cure (jusqu’a stabilisation du patient) ou lorsqu’il y a un changement de protocole de chimiotherapie. Le faible pourcentage d’adaptation de la prise en charge s’explique par le caractere repetitif des EP, le manque de temps et principalement le refus du patient a modifier son traitement. Conclusion Ces evaluations montrent qu’il est indispensable de maintenir ces EP mais de les reorganiser en les situant a des moments strategiques (debut et changement de cure) afin d’optimiser la prise en charge des NVCI et ameliorer la proportion d’adaptation du traitement contre les NVCI.

Bone marrow involvement by anaplastic large cell anaplastic large cell (ALC) lymphoma can be difficult to detect on routine morphologic examination alone. In a series of 42 patients with ALC lymphoma, the authors analyzed: (1) the usefulness of a limited panel of monoclonal antibodies directed against CD30 (Ber-H2, HRS4) and epithelial marrow involvement on routinely processed biopsy specimens; and (2) the prognostic significance of bone marrow involvement as detected on both morphologic and immunohistochemical grounds. On conventional examination, 17% of the patients were found to have bone marrow involvement at diagnosis. However, after immunohistochemical analysis, occult malignant cells were detected in 23% of the patients with negative bone marrow biopsy on routine histology. The low percentage of positive cases on routine morphologic examination compared to immunohistochemical examination was related to: (1) the scarcity of neoplastic cells which were scattered among hematopoietic cells; (2) the difficulty of distinguishing malignant cells from immature hematopoietic elements; and (3) the absence of alteration of the reticulin network. The authors observed a significant association between marrow infiltration and the presence of hematologic abnormalities (mostly anemia or cytopenias) at diagnosis, both in children and adult patients. More importantly, a significant lower survival was seen in patients with bone marrow involvement compared to those without bone marrow involvement. Immunohistochemistry with anti-CD30 and anti-EMA antibodies should be performed systematically in bone marrow biopsies from patients with ALC lymphoma to reliably identify the presence of bone marrow involvement that appears to carry a poor prognosis.

Abstract 310 High dose therapy with autologous stem cell transplantation (ASCT) is a standard treatment for young patients with myeloma. Some residual disease responsible for relapse is always present after ASCT. Effective maintenance treatment would be required to prevent relapse. However, such treatment is still to be defined. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide (LEN) for maintenance after transplantation. Patients, under 65 years of age, with non-progressive disease after a first line ASCT (performed within the last 6 months) were randomized to receive consolidation with LEN (25 mg/d, 21 days/month, for 2 months) followed by maintenance with either placebo (Arm A) or LEN (10 to 15 mg/d) until relapse (Arm B). From July 2006 to August 2008, 614 patients were randomized. Patient's characteristics of each group were similar with regard to age (57 years), ISS stage, FISH analysis, induction regimen (VAD / bortezomib-dex / others = 49%/44%/7%), diagnosis-randomization interval (10 months), and response at time of randomization. The first pre-planned interim analysis was performed on the 4th of September 2009 with a median follow up of 24 months from randomization (ASCO 2010, abstract 8018). The independent data and safety monitoring committee recommended to unblind the trial due to the PFS superiority of arm B (primary end point). On the 6th of July 2010, the trial was unblinded and the final analysis was performed with a median follow up of 34 months from randomization and 44 months from diagnosis. Consolidation with LEN improved the very good partial response rate (VGPR) (p 3 mg/l) cytogenetic profile (del 13, + or -), and response after transplantation (CR/VGPR or not). In multivariate analysis, PFS was related to maintenance with LEN (p The IFM 2005-02 trial demonstrates that lenalidomide is an effective and well tolerated maintenance treatment after transplantation for multiple myeloma patients. Disclosures: Attal: celgene: Consultancy, Research Funding; johnson and johnson: Consultancy, Research Funding. Off Label Use: maintenance treatment with Revlimid. Facon:celgene: Consultancy, Research Funding; johnson and johnson: Consultancy. Roussel:celgene: Consultancy; johnson and johnson: Consultancy. Avet-Loiseau:celgene: Consultancy, Research Funding; johnson and johnson: Consultancy, Research Funding. Harousseau:celgene: Consultancy; johnson and johnson: Consultancy.

Background Joint, spinal and soft tissue injections are commonly performed by rheumatologists in their daily practice. Contrary to other procedures, e.g. performed in pediatric care, little is known about the frequency, the intensity and the management of procedural pain observed in osteo-articular injections in daily practice. Methods This observational, prospective, national study was carried out among a French national representative database of primary rheumatologists to evaluate the prevalence and intensity of pain caused by intra-and peri-articular injections, synovial fluid aspirations, soft tissue injections, and spinal injections. For each physician, data were collected over 1 month, for up to 40 consecutive patients (>18-years-old) for whom a synovial fluid aspiration, an intra or peri-articular injection or a spinal injection were carried out during consultations. Statistical analysis was carried out in order to compare patients who had suffered from pain whilst undergoing the procedure to those who had not. Explanatory analyses were conducted by stepwise logistic regression with the characteristics of the patients to explain the existence of pain. Results Data were analysed for 8446 patients (64% female, mean age 62 ± 14 years) recruited by 240 physicians. The predominant sites injected were the knee (45.5%) and spine (19.1%). Over 80% of patients experienced procedural pain which was most common in the small joints (42%) and spine (32%) Pain was severe in 5.3% of patients, moderate in 26.6%, mild in 49.8%, and absent in 18.3%. Pain was significantly more intense in patients with severe pain linked to their underlying pathology and for procedures performed in small joints. Preventative or post-procedure analgesia was rarely given, only to 5.7% and 36.3% of patients, respectively. Preventative analgesia was more frequently prescribed in patients with more severe procedural pain. Conclusion Most patients undergoing intra-or peri-articular injections, synovial fluid aspirations and spine injections suffer from procedural pain. Most patients experience usually mild procedural pain and procedural pain management is uncommonly provided by physicians. Specific research and guidelines for the management of procedural pain related to rheumatologic care should be established to improve the quality of care provided by physicians.

We report a follow-up of 49 children with acute lymphoblastic leukemia (ALL) diagnosed between 1972 and 1978 (follow-up 12–18 years). This series allowed us to analyze the predictive value of karyotype in a long-term follow-up. Karyotypes were abnormal in 33 cases (67.3%): pseudodiploidy in 11 (22.4%), hyperdiploidy > 50 chromosomes in 8 (16.3%), hyperdiploidy 47–50 chromosomes in 11 (22.4%), and hypodiploidy in 3 cases (6.1%). Event-free survival (EFS) and survival studies showed that the outcome of patients was determined only by treatment and karyotype. Eleven patients have survived, nine in first remission (6 years 5 months to 15 years 2 months), and two are in second remission (3 years 8 months and 8 years 2 months). All ploidy groups are represented in these patients. Late relapses can occur in the hyperdiploid > 50 group, thus accounting for shorter EFS than expected, but because of the unusually long second remission of one patient, the rate of surviving patients was higher for this ploidy group than for all other ploidy groups together. Conversely, patients with only numerical abnormalities (no matter which ploidy group they belonged to), had a better outcome than did patients with structural changes or normal karyotypes and no discrepancy between EFS and survival curves was observed in this chromosomal group. Thus, our results suggest that numerical changes only should be considered an indicator of low risk factor, but our results, based on partially banded karyotypes, need to be verified by a current method and therapy.

Background Lenalidomide is an effective agent for the treatment of multiple myeloma (MM). The IFM Group conducted a randomized double-blind placebo controlled trial investigating the efficacy of lenalidomide maintenance treatment after autologous transplantation (IFM 2005-02 trial). The results showed that lenalidomide maintenance therapy significantly prolonged progression-free survival (PFS). Methods The aim of the present study was to identify prognostic factors affecting PFS in the 614 patients enrolled in this study. Analysis was performed using an extended Cox model, complete response (CR) was entered into the model as a time varying covariate. Results With a median follow-up of 60.6 months (54.5-68) PFS since randomization was shorter in the placebo arm (23.8 months, 95% CI 21-27.3) than in the lenalidomide arm (45.6 months, 95% CI: 40-55.1) (p Conclusion These results confirm that obtention of CR at any time during treatment is a major factor for improving PFS in MM patients receiving first-line treatment including autologous transplantation. In this setting our data and those of other studies seems to support that lenalidomide maintenance treatment could be an intereresting option for delaying progression. At this time the gain in PFS did not translate into an OS improvement Disclosures: Marit: janssen-cilag: Honoraria, upport for travel to meeting, meeting expenses, upport for travel to meeting, meeting expenses Other; celgene: support for travel to meeting, meeting expenses Other. Off Label Use: lenalidomide maintenance treatment after autologous transplantation in myeloma patients. Facon:Amgen: Membership on an entity’s Board of Directors or advisory committees; Britsol-Myers Squibb: Membership on an entity’s Board of Directors or advisory committees; Onyx: Membership on an entity’s Board of Directors or advisory committees; Millennium: The Takeda Oncology Company: Membership on an entity’s Board of Directors or advisory committees; Celgene: Membership on an entity’s Board of Directors or advisory committees; Janssen: Membership on an entity’s Board of Directors or advisory committees; Novartis: Membership on an entity’s Board of Directors or advisory committees. Hulin:JANSSEN: Honoraria; CELGENE: Honoraria. Moreau:JANSSEN: Honoraria, Speakers Bureau; CELGENE: Honoraria, Speakers Bureau. Roussel:JANSSEN: Honoraria; CELGENE: Honoraria. Avet-Loiseau:JANSSEN: Honoraria, Speakers Bureau; CELGENE: Honoraria, Speakers Bureau. Attal:CELGENE: Honoraria, Speakers Bureau; JANSSEN: Honoraria, Speakers Bureau.

Methods and Patients This randomized, placebo-controlled, phase 3 trial investigated the efficacy of lenalidomide (LEN) maintenance after transplantation for multiple myeloma. Patients, under 65 years of age, with non-progressive disease after a first-line autologous stem-cell transplant (ASCT) were randomized to receive maintenance with placebo or LEN (10 to 15 mg/d) until disease progression or unacceptable toxic effects. From July 2006 to August 2008, 614 patients were randomized. In January 2011, the DSMB recommended to stop LEN due to the increased incidence of second primary malignancies (SPMs). The median duration of maintenance treatment with LEN was 2 years (IQ range= 1-3). We previously reported this trial with a median follow-up of 45 months (Attal et al, N Engl J Med 2012). Results As of May 2013, median follow-up was 70 months from diagnosis and 60 months from randomization. LEN maintenance improved the 5-year progression-free survival (PFS) post randomization: 42%, versus 18% with placebo (p Conclusion This new analysis confirms that lenalidomide is an effective treatment to prolong PFS after transplantation for multiple myeloma patients. However, this impressive benefit is not currently associated with an improved overall survival, due to a shorter survival after the first progression. Disclosures: Attal: CELGENE: Honoraria, Speakers Bureau; JANSSEN: Honoraria, Speakers Bureau. Off Label Use: FRONTLINE THERAPY WITH CARFILZOMIB IN MULTIPLE MYELOMA. Facon:JANSSEN: Honoraria, Speakers Bureau; CELGENE: Honoraria, Speakers Bureau. Hulin:JANSSEN: Honoraria; CELGENE: Honoraria. Moreau:JANSSEN: Honoraria, Speakers Bureau; CELGENE: Honoraria, Speakers Bureau. Roussel:JANSSEN: Honoraria; CELGENE: Honoraria. Avet-Loiseau:JANSSEN: Honoraria, Speakers Bureau; CELGENE: Honoraria, Speakers Bureau.