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Summary Background Patients with COVID-19 pneumonia can have increased inflammation and elevated cytokines, including interleukin (IL)-6, which might be deleterious. Thus, sarilumab, a high-affinity anti-IL-6 receptor antibody, might improve the outcome of patients with moderate-to-severe COVID-19 pneumonia. Methods We did a multicentric, open-label, Bayesian randomised, adaptive, phase 2/3 clinical trial, nested within the CORIMUNO-19 cohort, to test a superiority hypothesis. Patients 18 years or older hospitalised with COVID-19 in six French centres, requiring at least 3L/min of oxygen but without ventilation assistance and a WHO Clinical Progression Scale [CPS] score of 5 were enrolled. Patients were randomly assigned (1:1) via a web-based system, according to a randomisation list stratified on centre and with blocks randomly selected among 2 and 4, to receive usual care plus 400 mg of sarilumab intravenously on day 1 and on day 3 if clinically indicated (sarilumab group) or usual care alone (usual care group). Primary outcomes were the proportion of patients with WHO-CPS scores greater than 5 on the 10-point scale on day 4 and survival without invasive or non-invasive ventilation at day 14. This completed trial is closed to new participants and is registered with ClinicalTrials.gov , NCT04324073 . Findings 165 patients were recruited from March 27 to April 6, 2020, and 148 patients were randomised (68 patients to the sarilumab group and 80 to the usual care group) and followed up for 90 days. Median age was 61·7 years [IQR 53·0–71·1] in the sarilumab group and 62·8 years [56·0–71·7] in the usual care group. In the sarilumab group 49 (72%) of 68 were men and in the usual care group 59 (78%) of 76 were men. Four patients in the usual care group withdrew consent and were not analysed. 18 (26%) of 68 patients in the sarilumab group had a WHO-CPS score greater than 5 at day 4 versus 20 (26%) of 76 in the usual care group (median posterior absolute risk difference 0·2%; 90% credible interval [CrI] −11·7 to 12·2), with a posterior probability of absolute risk difference greater than 0 of 48·9%. At day 14, 25 (37%) patients in the sarilumab and 26 (34%) patients in the usual care group needed ventilation or died, (median posterior hazard ratio [HR] 1·10; 90% CrI 0·69–1·74) with a posterior probability HR greater than 1 of 37·4%. Serious adverse events occurred in 27 (40%) patients in the sarilumab group and 28 (37%) patients in the usual care group (p=0·73). Interpretation Sarilumab treatment did not improve early outcomes in patients with moderate-to-severe COVID-19 pneumonia. Further studies are warranted to evaluate the effect of sarilumab on long-term survival. Funding Assistance publique—Hopitaux de Paris

International audience; Background: Patients with COVID-19 pneumonia have an excess of inflammation and increased concentrations of cytokines including interleukin-1 (IL-1). We aimed to determine whether anakinra, a recombinant human IL-1 receptor antagonist, could improve outcomes in patients in hospital with mild-to-moderate COVID-19 pneumonia.Methods: In this multicentre, open-label, Bayesian randomised clinical trial (CORIMUNO-ANA-1), nested within the CORIMUNO-19 cohort, we recruited patients from 16 University hospitals in France with mild-to-moderate COVID-19 pneumonia, severe acute respiratory syndrome coronavirus 2 infection confirmed by real-time RT-PCR, requiring at least 3 L/min of oxygen by mask or nasal cannula but without ventilation assistance, a score of 5 on the WHO Clinical Progression Scale (WHO-CPS), and a C-reactive protein serum concentration of more than 25 mg/L not requiring admission to the intensive care unit at admission to hospital. Eligible patients were randomly assigned (1:1) using a web-based secure centralised system, stratified by centre and blocked with varying block sizes (randomly of size two or four), to either usual care plus anakinra (200 mg twice a day on days 1-3, 100 mg twice on day 4, 100 mg once on day 5) or usual care alone. Usual care was provided at the discretion of the site clinicians. The two coprimary outcomes were the proportion of patients who had died or needed non-invasive or mechanical ventilation by day 4 (ie, a score of >5 on the WHO-CPS) and survival without need for mechanical or non-invasive ventilation (including high-flow oxygen) at day 14. All analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT04341584, and is now closed to accrual.Findings: Between April 8 and April 26, 2020, we screened 153 patients. The study was stopped early following the recommendation of the data and safety monitoring board, after the recruitment of 116 patients: 59 were assigned to the anakinra group, and 57 were assigned to the usual care group. Two patients in the usual care group withdrew consent and were not analysed. In the analysable population, the median age was 66 years (IQR 59 to 76) and 80 (70%) participants were men. In the anakinra group, 21 (36%) of 59 patients had a WHO-CPS score of more than 5 at day 4 versus 21 (38%) of 55 in the usual care group (median posterior absolute risk difference [ARD] -2·5%, 90% credible interval [CrI] -17·1 to 12·0), with a posterior probability of ARD of less than 0 (ie, anakinra better than usual care) of 61·2%. At day 14, 28 (47%; 95% CI 33 to 59) patients in the anakinra group and 28 (51%; 95% CI 36 to 62) in the usual care group needed ventilation or died, with a posterior probability of any efficacy of anakinra (hazard ratio [HR] being less than 1) of 54·5% (median posterior HR 0·97; 90% CrI 0·62 to 1·52). At day 90, 16 (27%) patients in the anakinra group and 15 (27%) in the usual care group had died. Serious adverse events occurred in 27 (46%) patients in the anakinra group and 21 (38%) in the usual care group (p=0·45).Interpretation: Anakinra did not improve outcomes in patients with mild-to-moderate COVID-19 pneumonia. Further studies are needed to assess the efficacy of anakinra in other selected groups of patients with more severe COVID-19.Funding: The Ministry of Health, Programme Hospitalier de Recherche Clinique, Foundation for Medical Research, and AP-HP Foundation.

Purpose Daratumumab is the first anti-CD38 monoclonal antibody of the class approved for recurrent and refractory multiple myeloma. Grade 3 and 4 Infusion-Related Reactions (IRRs) are frequent during the first and second infusions. Due to the risks associated with severe IRRs, daratumumab is systematically administered over a period of 3.5 hours. The main objective of this study was to evaluate the safety of a 90-minute daratumumab infusion from the third infusion. Patients and methods All patients who had received two or more doses of daratumumab in monotherapy or in combination with standard infusion rates were included. We excluded patients enrolled in clinical trials. For the rapid infusion protocol, 20% of the dose was administered over 30 minutes and the remaining 80% over 60 minutes. Results From April 1 to May 31, 2019, 25 patients received 53 90-minute infusions of daratumumab. Premedication included corticosteroids, antipyretics, antihistamines, and if necessary a leukotriene receptor antagonist. No grade 3 or grade 4 IRRs were observed. Conclusion From the third infusion, we found that a rapid administration of daratumumab (90 vs 210 minutes) was well tolerated and safe. It would be interesting to test this regimen from the second infusion.

Resume Introduction Les essais cliniques (EC) sont indispensables pour evaluer l’efficacite et l’innocuite de nouveaux traitements. Ils peuvent representer une mesure d’economie grâce a la fourniture des medicaments par le promoteur. Objectif L’objectif de cette etude est d’evaluer les couts evites en medicament hors-GHS ou sous Autorisation Temporaire d’Utilisation (ATU) par l’inclusion d’un patient dans un EC d’Hematologie. Materiels et methodes C’est une etude de cout, retrospective, monocentrique, observationnelle. La perspective de l’etude est elargie du point de vue de l’assurance maladie obligatoire. Nous avons inclus les EC d’Hematologie ayant eu au moins une dispensation entre 2007 et 2017 d’un medicament hors-GHS ou sous ATU, qui soit dans le protocole experimental ou standard. Dans le cadre d’un protocole experimental, nous avons inclus les medicaments experimentaux fournis par le promoteur. Les medicaments per os n’ont pas ete pris en compte. Les couts evites sont representes par l’economie realisee par la fourniture de ces medicaments dans l’EC et par le prix des medicaments consommes si le patient n’avait pas ete inclus dans l’EC. Resultats Quarante et un EC (289 patients) ont ete inclus dans cette etude, dont 51,2 % EC de phase III et 78 % de promotion institutionnelle. Ces EC ont engendre des couts evites d’une valeur de 4 244 255 € (environ 386 000 €/an) soit un cout evite moyen de 14 686 € par patient. Les substances actives ayant permis le plus de couts evites sont le rituximab (1 801 502 €) puis le bortezomib (1 574 571 €). Conclusion Tout en permettant le progres dans la recherche clinique, les EC contribuent a de reelles economies pour notre systeme de sante.

Background According to the Code of Public Health, the pharmacist advises and informs the patient to ensure the right use and high drug adherence. In clinical trials (CT), investigational medicinal products (IMP) are dispensed by the pharmacy department. A copy of the prescription is given to the patients in ambulatory: it is a support to information for the patient available at any time at home. In our hospital, prescriptions for CT are usually provided by the sponsor. Purpose The purpose of this work was to evaluate information about IMP on the prescriptions provided by the sponsors and to propose areas for improvement. Material and methods All the CTs with at least one IMP was taken at home and opened in the pharmacy department of a university hospital on 1 January 2018 were included in this retrospective study. A checklist of eight criteria deemed essential to inform the patient regarding his treatment was created in accordance with the regulations. Results A total of 93 CTs were evaluated, 35% were institutional CTs. Eleven per cent (n=10) of the prescriptions contained none of the listed criteria. For each criterion, the proportion of prescriptions including the information was 83% for dosage, 69% for product’s conditioning, 43% for treatment’s duration, 25% for time of taking, 19% for intake, 5% for storage temperature, 2% for adverse reactions and 0% for drug interactions. Eighty-eight per cent (n=82) of the evaluated CTs were oral IMP and 30% (n=25) were chemotherapies. Conclusion The most frequent information on prescriptions is the dosage and the packaging of the IMP. At the other end, information on what to do in case of adverse events and drug interactions are rare or non-existent. The pharmacist has an important and essential role in dispensing pharmaceutical advice for CT.1 A collaboration between services and pharmacy is planned in order to establish a standard prescription for CTs with specific information. Improving the quality of prescription information will optimise the safety of IMP taking. Reference and/or acknowledgements Schoenenberger JA, et al. Assessment of the information on investigational oral treatment provided to patients in clinical trials. Euro J Hospl Pharm 2012;(19):230–1. No conflict of interest.

Background Hypersensitivity reactions to platinum salts (PS) (cisplatin [CI], carboplatin [CA], and oxaliplatin [OX]) can be severe and their incidence is increasing due to their widespread use in cancer treatment. Objective To determine the rate of cross-reactivity between PS and whether CI can be administered without prior allergy testing in patients with a history of CA or OX hypersensitivity. Methods From September 2002 to April 2016, patients with suspected immediate PS hypersensitivity were tested and cross-reactivity between the 3 PS was evaluated. We then studied patients who were given CI without desensitization after immediate hypersensitivity to other PS. Results A total of 155 patients were included. Skin tests were positive in 97 patients (OX: 51, CA: 43, and CI: 3). Cross-reactivity to CA in OX-allergic patients was 45% (23 of 51) (95% confidence interval [CI]: 36% to 66%) and cross-reactivity to OX in CA-allergic patients was 37% (16 of 43) (95% CI: 23% to 53%). In contrast, cross-reactivity to CI was 0% (0 of 51) (95% CI: 0% to 7%) in OX-allergic patients and 7% (3 of 43) (95% CI: 2% to 17%) in CA-allergic patients. All these 3 patients had previously been exposed to CI in previous courses of chemotherapy. CI was initiated in 24 patients with proven hypersensitivity to CA or OX and had no hypersensitivity reactions. Conclusion Initiating CI in patients with proven immediate hypersensitivity to CA or OX appeared to be safe in our study.

International audience; Introduction : L’incidence des réactions d’hypersensibilité immédiate aux sels de platine (cisplatine, carboplatine et oxaliplatine) augmente avec leur large utilisation en cancérologie. Les objectifs de cette étude étaient d’établir la fréquence des sensibilités croisées entre les sels de platine, de déterminer si le cisplatine peut être utilisé sans test allergologique préalable en cas d’allergie immédiate au carboplatine ou à l’oxaliplatine et enfin de proposer une prise en charge simple pour retraiter rapidement les malades.Méthodes : Notre étude rétrospective a porté sur 155 malades ayant présenté une réaction d’hypersensibilité immédiate à un sel de platine. Des intradermoréactions aux trois sels de platine ont été effectuées puis une réintroduction à dose d’emblée thérapeutique a ensuite été proposée en fonction du résultat des tests.Résultats : Les tests étaient positifs chez 97 des 155 patients avec le sel de platine suspecté. La fréquence de la sensibilité croisée entre carboplatine et oxaliplatine était très élevée (40 %) alors qu’elle était rare (3 %) entre le cisplatine et les autres sels. Dans les trois cas d’hypersensibilité croisée entre le cisplatine et les 2 autres ; le cisplatine avait déjà était utilisé lors de précédentes chimiothérapies. Une réintroduction du cisplatine a été réalisée chez 24 patients ayant une hypersensibilité prouvée au carboplatine ou à l’oxaliplatine sans aucun effet secondaire.Discussion : Cette étude montre sur une grande série l’intérêt diagnostique des intradermoréactions aux sels de platine et leur utilité pour guider les réintroductions, confirmant ainsi les données préalablement publiées par notre service puis d’autres travaux de la littérature. La structure chimique des trois molécules pourrait expliquer l’absence de réaction croisée entre cisplatine et oxaliplatine/carboplatine, une chaîne est commune à l’oxaliplatine et au carboplatine mais pas au cisplatine.Conclusion : Les allergies au cisplatine sont très rares et les données des tests suggèrent qu’il est possible d’utiliser cette molécule sans risque d’allergie après un accident anaphylactique au carboplatine ou à l’oxaliplatine.

Background Thalidomide, lenalidomide and pomalidomide belong to the immunomodulatory drug family (IMIDs). Data on IMID adherence are lacking. Purpose The purpose of the study was to evaluate adherence to IMIDs in patients with multiple myeloma. Material and methods All patients managed in our teaching hospital for a multiple myeloma who had at least two successive dispensations of IMIDs were included in a prospective study between 1 March 2016 and 15 May 2016. We used a cancer specific questionnaire to measure patient adherence to IMIDs 1 (10 questions; 10 points). Non-adherence was defined as a score 1 Clinical and dispensation data were obtained from medical and pharmaceutical software in our hospital. Results 63 adult patients were included. Mean patient age was 68.2±10.4 years; 67% were men. Patients received lenalidomide (54%), pomalidomide (25%) or thalidomide (21%). Median time since diagnosis was 2.8 years (range 0.2–17.1). More than half of the patients used tools to help them with their medication. The mean questionnaire score was 8.2±1.2 (range 4–10). Mean time to fulfil the questionnaire was 9.2±4.7 min. 41% of the patients had ever taken their medicine too late in comparison with usual time. 57% of patients thought they took too many medicines. 43% of patients did not know the name of their medicines. We observed a mean MPR of 0.95±0.10 (range 0.67–1.20). A total of 76% of patients were considered as adherent using the questionnaire and 72% using the MPR. Conclusion Adherence to IMIDs was not optimal in our population. The use of adherence questionnaire and/or MPR may help the pharmacist to detect non-adherent patients. In these patients, pharmaceutical interventions may be of major interest. References and/or acknowledgements 1. Daouphars M, Ouvry M, Lenain P, et al. Preliminary validation of self-assessment tool to measure imatinib adherence in patients with chronic myeloid leukaemia. Pharmacotherapy2013;33:152–6. No conflict of interest

Background Patients with relapsed and refractory multiple myeloma (RRMM) have a median survival of about 3–6 months. 1 Purpose The aim of the study was to analyse efficacy, safety and cost of pomalidomide in patients with RRMM. Material and methods All patients in whom a treatment by pomalidomide was initiated between August 2013 and October 2015 for a RRMM in our hospital were included. Outcomes were predictive factors of early pomalidomide discontinuation (before the third month), overall response rate (ORR, using International Multiple Myeloma Working Group criteria 2 ), overall survival (OS), safety and treatment cost. Results 63 patients (mean age 61 years) were included. All patients received pomalidomide with dexamethasone. Pomalidomide was discontinued early in 17 (27%) patients. Time from diagnosis to pomalidomide initiation -3 ) and a haemoglobin level below 11g/dL (hazard ratio 2.7 vs ≥11 g/dL; 95% CI 1.0–7.0; p=0.04). The most common grade ≥3 adverse events were neutropenia (14%) and infections (25%). The mean pomalidomide cost per patient was €79 717±46 296 (range €17 850–214 200). Conclusion Compared with the MM-003 phase III trial, 3 we reported similar safety data but a higher ORR (51% vs 21%). We demonstrated the long term favourable safety and efficacy profile of pomalidomide in RRMM patients, even in those with stable disease. References and/or acknowledgements Kumar SK, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with ImiDs and bortezomib. Leukaemia2001;226:149–57. Rajkumar SV, et al. Consensus recommendations for the uniform reporting of clinical trials. Blood2011;117:4691–5. Miguel JS, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003). Lancet Oncol2013;14:1055–66. No conflict of interest

Background Thalidomide, a potent member of the immunomodulatory drug family, induces both direct myeloma cell death and indirect antimyeloma response through its impact on the microenvironment. The drug is approved in multiple myeloma, and also in other rare diseases, such as severe recurrent aphthous stomatitis. Thalidomide is considered an effective drug in all of its indications; it is also an expensive drug. In an area of limited resources, studies for assessing thalidomide adherence are needed for healthcare professionals and payers alike. Purpose The purpose of the study was to evaluate adherence to thalidomide. Material and methods Patients who had at least two successive dispensations of thalidomide, whatever the indication, between 12 July 2015 and 12 July 2016 in our teaching hospital were included in a retrospective study. The medication possession ratio (MPR) was used to evaluate thalidomide adherence. MPR was calculated according to the following formula: MPR=number of days of medication supplied within the refill interval/number of days in refill interval. 1 Clinical and dispensation data were obtained from medical and pharmaceutical software in our hospital. Based on the literature, the threshold of 90% was used to define two patient categories: MPR Results 51 adult patients were included: 40 with multiple myeloma (78%), 6 with cutaneous lupus erythematosus/Jessner–Kanof disease, 4 with serious aphthous/Behcet’s disease and 1 with Miescher’s granuloma. Mean patient age was 63.7±13.9 years; 51% were women. We observed a mean MPR of 0.90±0.16 (range 0.37–1.20). The mean MPR was 0.94±0.13 (range 0.61–1.20) in patients with multiple myeloma and 0.77±0.21 (range 0.37–0.99) in patients with other diseases. A total of 61% of patients were considered as adherents. The percentage of adherent patients was significantly higher in patients with multiple myeloma than in patients with other diseases (70% vs 27%, respectively; p=0.015). Conclusion Data are lacking concerning thalidomide adherence. Optimising thalidomide adherence may increase the efficacy of thalidomide based regimens. Considering the high cost of thalidomide, efforts to increase thalidomide adherence may also reduce wasted money in dispensing pills that are not taken by patients. References and/or acknowledgements 1. Peterson AM, et al. A checklist for medication compliance and persistence studies using retrospective databases. Value Health2007;10:3–12. No conflict of interest

Introduction Les reactions d’hypersensibilite immediate (HSI) surviennent dans 3,5 % a 5 % des traitements anti-tuberculeux. Les tests cutanes ne sont pas toujours performants et l’obligation de traiter rapidement le malade impose une reintroduction sequentielle de chaque anti-tuberculeux. Nous proposons un protocole d’induction de tolerance rapide pour le RIFATER® (rifampicine 120 mg, isoniazide 50 mg et pyrazilamide 300 mg). Methodes Un traitement par RIFATER® (6 cp) et DEXAMBUTOL® (ethambutol 500 mg) (2 cp) a ete debute chez un homme de 49 ans. Dans l’heure suivant la premiere prise, il presentait un erytheme generalise a predominance flexurale, prurigineux avec flushes. L’eruption a dure 24 h et le traitement etait interrompu. Les prick-tests pour le RIFATER, ses 3 composants separes et le DEXAMBUTOL® et les intradermoreactions etaient negatifs. La reintroduction du DEXAMBUTOL® etait sans effet secondaire. L’induction de tolerance du RIFATER etait effectuee selon ce protocole avec succes ( Tableau 1 ). Ainsi le traitement anti-tuberculeux a pu ainsi etre poursuivi. Discussion L’induction de tolerance « groupee » au RIFATER contenant 3 antituberculeux majeurs est une solution rapide et efficace chez un malade ayant presente une HSI. Nous avons choisi un schema en 12 etapes toutes les 30 min selon les recommandations de M. Castells. Des protocoles d’induction de tolerance sont deja decrits pour la rifampicine ou le pirazinamide. Buhari GK et al propose une induction de tolerance des 4 antituberculeux administres separement chaque jour durant 5 jours en 6 paliers. Cette procedure nous semble plus a risque et plus lourde, avec 5 jours d’hospitalisation. Conclusion Nous proposons un protocole d’induction de tolerance simple et efficace au RIFATER® permettant la reprise rapide du traitement antituberculeux en cas d’HSI.

Resume La chimioembolisation est le traitement de premiere ligne pour les patients atteints d’un carcinome hepatocellulaire (CHC) non resecable, non metastatique. Les microspheres chargees d’anticancereux recemment commercialisees ont pour objectif d’augmenter l’efficacite de la chimioembolisation en permettant un relargage controle et prolonge de l’anticancereux au plus proche de la tumeur. Notre etude monocentrique compare selon deux methodes de valorisation, les couts medicaux hospitaliers directs d’une premiere cure de chimioembolisation conventionnelle et d’une premiere cure de chimioembolisation avec microspheres chez 30 patients atteints de CHC. Le cout moyen valorise par la comptabilite analytique de notre etablissement s’eleve a 4 332 € pour une premiere chimioembolisation conventionnelle et a 3 577 € pour une premiere chimioembolisation avec microspheres. Le cout moyen valorise par les tarifs nationaux s’eleve a 4 507 € (+ 175 €) pour une premiere chimioembolisation conventionnelle et a 2 852 € (− 725 €) pour une premiere chimioembolisation avec microspheres. En conclusion, une premiere cure de chimioembolisation avec microspheres, valorisee d’apres les tarifs d’hospitalisation des GHS, est significativement ( p = 0,006) moins couteuse qu’une chimioembolisation conventionnelle.

Resume - Contexte Peu de donnees sont disponibles sur l’efficacite et la tolerance du palifermin dans le traitement preventif de la mucite buccale chez les patients autogreffes et traites avec les protocoles de conditionnement habituellement utilises en France. Methodes Notre etude retrospective porte sur les 5 premiers patients candidats pour une autogreffe et ayant beneficie d’une prophylaxie par palifermin (60 μg/kg/jour) entre decembre 2005 et mars 2006. Resultats Malgre le traitement prophylactique, 3 patients ont developpe une mucite buccale severe. De plus, pour 3 patients, l’imputabilite du palifermin a ete retenue dans la survenue d’une toxidermie severe ayant necessite, dans 2 cas, l’arret premature du traitement. Conclusion Ces resultats demandent a etre confirmes par une etude de plus grande envergure qui permettrait de mieux evaluer l’impact populationnel attendu du palifermin sur la morbi-mortalite des patients autogreffes en France et le profil de securite de ce medicament.

Transarterial chemoembolization (TACE) is the standard treatment in patients with unresectable non-metastatic hepatocellular carcinoma (HCC). New drug eluting beads aim at improving efficacy of TACE in retaining as long as possible the anticancer drug within the tumor. Our monocentric study compares direct hospital medical costs, according to two different methods, for a first course of conventional TACE and for a first course of TACE using drug eluting beads in 30 patients with HCC. The average cost of a first course of conventional TACE valued by the analytic accounting system is 4 332 € versus 3 577 € for a first course of TACE using drug eluting beads. The average cost of a first course of conventional TACE valued by the official tariffs from the new French Diagnosis Related Group prospective payment system is 4 507 € (+175 €) versus 2 852 € (-725 €) for a first course of TACE using drug eluting beads. Our study shows that a first TACE using drug eluting beads, valued by the official tariffs from the new French Diagnosis Related Group prospective payment system, is significantly (p = 0.006) less expensive than a first conventional TACE.

Few data are available on the efficacy of and tolerance to palifermin in the preventive treatment of oral mucositis in autograft patients treated with conditioning protocols usually used in France.Our retrospective study bears on the first five candidates for autograft who benefited from prophylactic treatment with palifermin (60 microg/kg/day) between December 2005 and March 2006.Despite the prophylactic treatment, 3 patients developed severe oral mucositis. Moreover, in 3 patients, palifermin was found to be responsible for the onset of severe toxidermia, which required, in 2 cases, interruption of the treatment.These results need to be confirmed by a larger study that would also make it possible to evaluate the impact of palifermin on morbi-mortality in autograft patients in France, and to determine the safety profile of this drug.