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Strategies that individualize the care of cancer patients receiving oral anticancer agents offer opportunities to improve treatment adherence and patient care. However, the impact of digital remote monitoring systems in this setting has not been evaluated. Here, we report the results of a phase 3 trial (CAPRI, NCT02828462) to assess the impact of a nurse navigator-led program on treatment delivery for patients with metastatic cancer. Patients receiving approved oral anticancer agents were randomized (1:1) to an intervention combining a nurse navigator-led follow-up system and a web portal-smartphone application on top of usual care, or to usual symptom monitoring at the discretion of the treating oncologist, for a duration of 6 months. The primary objective included optimization of the treatment dose. Secondary objectives were grade ≥3 toxicities, patient experience, rates and duration of hospitalization, response and survival, and quality of life. In 559 evaluable patients the relative dose intensity was higher in the experimental arm (93.4% versus 89.4%, P = 0.04). The intervention improved the patient experience (Patient Assessment of Chronic Illness Care score, 2.94 versus 2.67, P = 0.01), reduced the days of hospitalization (2.82 versus 4.44 days, P = 0.02), and decreased treatment-related grade ≥3 toxicities (27.6% versus 36.9%, P = 0.02). These findings show that patient-centered care through remote monitoring of symptoms and treatment may improve patient outcomes and experience.

Background High-dose cyclophosphamide to treat solid refractory tumors demonstrated meaningful activity, while data to treat lymphoma remain scarce. This study aims to assess high-dose cyclophosphamide to treat relapsed or refractory lymphoma. Methods A phase II study included adult patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, previously treated by ≥2 prior lines with no other available option of therapy. High-dose cyclophosphamide was given intravenously 3 g/m2 over two consecutive days and repeated once at 28 days in responding patients. Rituximab 375 mg/m2 intravenously was added in patients not refractory to anti-CD20 antibody. Results Forty-two patients with median age 65 [56-70] years were included. Patients had previously received a median of four lines of therapies. Tumor types were diffuse large B-cell lymphoma (n = 26; 62%), indolent B-cell non-Hodgkin lymphoma (n = 10; 24%), or mantle lymphoma (n = 6; 14%). Hematologic and non-hematologic grade 3-5 toxicities occurred in 42 (100%) and 18 (43%) of patients, respectively. The overall response rate was 45%. Conclusion One to two cycles of high-dose cyclophosphamide in hard-to-treat patients with relapsed or refractory B-cell non-Hodgkin lymphoma demonstrated a favorable safety and efficacy profile. This regimen could serve as a bridge to modern cellular therapy with CAR-T cell.

Objective The development of oncology day-hospital activities contributes to increase quality of life of patients and consequently have changed their perception about waiting. The extemporaneous preparation of antineoplastic has become difficult to achieve given the increasing activity, and hospital pharmacists have taken up the challenge by the implementation of the antineoplastic preparation in anticipation. Because anticipation can lead to an important number of preparations to be discarded, we also develop a recycled process for other patients to limit these waste extra costs. We aim to demonstrate the positive balance of anticipated preparation in this 4-year study report. Data sources: This prospective study was conducted in a major European oncology day-hospital from January, 2012 to December, 2015. The data were extracted from our software WinSimbad™ and updated as needed. The number and cost-associated of preparation ungiven chemotherapy doses (recycled or discarded) were compared to the global drug budget of our hospital in order to not exceed 2%. Data summary: 303,100 antineoplastic have been prepared. Approximately 35% of them were anticipated with an average of 5,431±984 that were finally ungiven. Two-third was recycled and the cost of the ungiven preparations finally discarded represents 1.7±0.15% of the global drug budget. Conclusions This study assesses the drug wastage and its associated cost of this concept through a prospective study and discusses the cost of ungiven antineoplastic preparations. With prior consideration of the need to define the acceptable rate of discarded ungiven preparation, the hospitals with an high oncology day-hospital activity should implement this approach.

Many drugs used in pediatric oncology are not labeled and adapted for pediatric use, such as caps of procarbazine to treat gliomas in children under 6 years old. Indeed, pediatric patients present difficulties to swallow these caps and it can lead to major observance problems. To provide a solution to this situation, we propose the development of an oral procarbazine suspension. Suspension was produced from the commercial capsules powder of procarbazine 50 mg, mixed with excipients, specifically selected for children. The physical and chemical stability of this presentation was assessing with a specific RP-HPLC method and degradation products were study in forced degradation conditions according to the French and the European recommendations. A 10 mg/mL suspension was formulated and divided into single-dose syringes, in order to secure administration. We formulated a new dosage form of procarbazine to ensure an accurate and safe dose for children administration.

Resume Thrombose veineuse et embolie pulmonaire sont frequentes et graves chez les personnes atteintes d’un cancer. Les heparines de bas poids moleculaire sont recommandees dans le cadre d’un traitement prolonge de cette maladie. Une enquete a ete realisee en Ile-de-France afin de decrire l’organisation, les pratiques et les connaissances des pharmaciens d’officine en termes de prise en charge de la maladie thromboembolique veineuse chez les patients cancereux.

Background The role of olanzapine in the treatment of chemotherapy-induced nausea and vomiting (CINV) in addition to the antiemetic therapeutic combination with aprepitant, setrons, and corticosteroids has not been well defined. Objective To investigate the effectiveness of the addition of olanzapine to a standard triplet therapy for the prevention of CINV in patients who experienced CINV during their first chemotherapy course, despite receiving a well-managed prevention protocol. Setting One comprehensive cancer centre in France. Method In a retrospective study with comparator, patients with a high risk of emesis were assigned to two groups during two different 6-month periods, before and after the introduction of olanzapine in clinical practice, respectively. In the olanzapine group, the antiemetic protocol for the second course of chemotherapy was reinforced by the addition of olanzapine at 5 mg/day from day 1 to 5 in contrast with the control group. Main outcome measure The proportion of patients who experienced neither nausea nor emesis during the delayed phase (24-120 h). Results The 25 patients in each group exhibited comparable characteristics and emetic chemotherapy level. During the first course, no significant difference was observed. During the second course, nausea and vomiting were ameliorated in 12 patients in the olanzapine group and 4 patients in the control group (p

Resume Objectifs Analyser la relation et les attentes des patients atteints de cancer vis-a-vis du pharmacien d’officine dans un projet de coordination des soins pharmaceutiques. Methode En novembre 2014, un questionnaire a ete distribue aux patients ambulatoires d’un hopital universitaire specialise en cancerologie. Treize questions exploraient les habitudes de consommation (typologie des consommateurs, usage des biens et prestations consommees) de la pharmacie et recueillaient leurs attentes en prestations pharmaceutiques dans le cadre de la prise en charge de leur cancer. Resultats Mille deux cent soixante douze ont ete inclus pour un taux de reponse final de 78 %. Caracteristiques des repondants : 64 % etaient des femmes, 63 % residaient en Ile-de-France et 49 % prenant des traitements relatifs a leur cancer (anticancereux, medicaments de soins de support). Plus de 84 % des repondants se rendaient au moins une fois par mois en officine et 95 % declaraient avoir recours a une unique pharmacie d’officine. 36 % a etre prets a partager leur compte rendu de sortie d’hospitalisation avec leur pharmacien et 61 % a ce que leur ordonnance de sortie d’hospitalisation soit transmise a leur officine « referente » pour anticiper les traitements. Discussion Les pharmaciens d’officine etaient percus positivement par les repondants. Les patients etaient disposes a echanger des informations et a etre accompagnes par ce professionnel de sante dans leur prise en charge du cancer. Leurs attentes etaient en premier lieu du management de l’iatrogenie medicamenteuse avec une remontee d’effets indesirables vers l’hopital et solutions validees pour leur prise en charge.

Background Serious neurological adverse events (NAE) have occurred during treatment with high-dose thiotepa regimens of children with high-risk solid tumours. The objective was to assess the incidence of NAE related to high-dose thiotepa and to identify potential contributing factors that could exacerbate the occurrence of this neurotoxicity. Methods From May 1987 to March 2011, children with solid tumours treated with high-dose thiotepa were retrospectively identified. Each NAE detected led to an independent case analysis. Potential contributing factors were pre-specified and univariate/multivariable analyses were performed. Results Three hundred seven courses of thiotepa (251 patients) were identified. The total dose per treatment ranged from 600 to 900 mg/m2. 81 NAE (26%) were identified. 46 NAE were related to high-dose thiotepa during the first course (18.3%) and 11 during the second course (19.6%). The symptoms appeared in a median time of 2 days after the introduction of thiotepa. Central and peripheral symptoms were headaches, tremors, confusion, seizures, cerebellar syndrome, and coma. High-dose thiotepa was reintroduced in 18 cases and symptoms reappeared in 5 children. For 3 patients who had seizures during the first course, premedication with clonazepam for the second course has prevented recurrence of NAE. As contributing factors, brain tumour and tramadol treatment increased the risk of thiotepa-related neurotoxicity by 2 to 6 times respectively. Conclusions The incidence of neurotoxicity was 18.3%. Brain tumours and tramadol treatment are risk factors to consider when using high-dose thiotepa. The outcome of patients was favourable without sequelae in all cases and rechallenge with thiotepa was possible.

Resume Introduction Le montage de perfusion, assemblage de multiples dispositifs medicaux steriles, permet l’administration de medicaments par voie intraveineuse. Les risques associes aux pratiques de perfusion sont divers : erreurs medicamenteuses, incompatibilites physico-chimiques (IPC) notamment. Un groupe de travail multidisciplinaire, d’un centre de lutte contre le cancer a diffuse un schema type en 2013. De plus, nous souhaitons ameliorer la prevention des IPC. Materiels et methode Une evaluation de pratiques professionnelles sur les montages de perfusion, en oncologie pediatrique a ete realisee en 2016. Les connaissances des infirmiers et des medecins sur les IPC ont ete apprecies via un questionnaire. Resultats Quarante-sept montages ont ete evalues, revelant 22 ecarts consideres mineurs (47 %) et 3 majeurs (6 %). Pour le questionnaire, 16 infirmiers (53 %) et 8 medecins (47 %) ont repondu. Les infirmiers connaissent davantage de situations a risques, mais les savoirs sont tres disparates. Un outil de prevention repertoriant la compatibilite de 44 medicaments administres 2 a 2, soit 946 situations, a ete propose et accepte. Discussion et conclusion Quatre cent dix-neuf situations (44,3 %) ne sont pas recensees dans la litterature, 414 (43,8 %) sont compatibles, 113 (11,9 %) sont incompatibles. Ces travaux ont ete realises en partenariat avec les services cliniques, la pharmacie et la direction des soins, dans le but de securiser la prise en charge des patients.

Background Peritoneal metastases (PM), corresponding to tumor implants into the peritoneal cavity, are associated with impaired prognosis and low responsiveness to systemic chemotherapy. A new therapeutic approach has dramatically changed the prognosis of patients with PM from colorectal cancer (CRC), consisting in the association of a complete cytoreductive surgery followed by intraperitoneal chemotherapy associated to hyperthermia (HIPEC). Many drugs have been administered intraperitoneally, but no clear consensus has been approved. Therefore, relevant preclinical models are essentials for the efficient translation of treatments option into affected patients. Method Organoids, the last generation of preclinical models, were used to rationalize and improve intraperitoneal chemotherapy. We tested several cytotoxics, combination, effect of hyperthermia, exposure duration and frequency. Results Organoids were a representative model of response to chemotherapies used for the treatment of PM from CRC; 460 mg/m 2 of oxaliplatin being the most efficient cytotoxic treatment. Repeated incubations with oxaliplatin; mimicking cycles of intraperitoneal treatment, resulted in an increased efficacy. Conclusion & discussion Organoids are relevant models to study the chemosensitivity of peritoneal metastases from CRCs. These models could be used for large scale drug screening strategies or personalized medicine, for colorectal carcinoma but also for PM from other origins.

There is increasing use of molecular technologies to guide cancer treatments, but few cost data are available. Our objective was to assess the costs of molecular-guided therapy for patients with advanced solid tumors alongside the Molecular Screening for Cancer Treatment and Optimization (MOSCATO) trial.The study population consisted of 529 patients. The molecular diagnosis included seven steps from tumor biopsy to the multidisciplinary molecular tumor board. The cost of a complete molecular diagnosis was assessed by micro-costing. Direct costs incurred from enrollment until progression were assessed from the French National Health Insurance perspective.The patients' mean age was 54 years (range: 3-82) and the mean follow-up period was 145 days (range: 1-707 days). A complete molecular diagnosis cost [euro ]2,396. There were 220 patients with an actionable target (42%), among whom 105 (20%) actually received a targeted therapy. The cost of molecular-guided therapy per patient was [euro ]31,269. The main cost drivers were anticancer drugs (54%) and hospitalizations (35%).This prospective cost analysis showed that molecular diagnosis accounts for only 6% of the cost of molecular-guided therapy per patient. The costs of drugs and hospitalizations are the main cost drivers.Genet Med advance online publication 01 December 2016.

2000 Background: Various interventions aiming to improve a safe use of oral anti-cancer agents have previously been reported. These retrospective studies involved nurse-led follow-up and use of health technologies. However, the potential impact of these combined strategies is limited by a lack of rigorous methodology. Methods: We performed a randomized phase 3 trial comparing an intervention combining NNs and a mobile application vs. SOC in cancer pts treated with OAA (excluding hormonal therapy) in our tertiary cancer center. Pts initiating OAA (all types of cancer, PS < 3, life expectancy > 6 months), were randomized in a 1:1 basis. The intervention combined a nursing-led follow-up and a mobile application for patients. NNs provided regular phone follow-ups to manage symptoms and assess toxicities, adherence and supportive care needs. Pts had access to a mobile application to record tracking data, contact NNs via secure messaging or a dedicated phone line. The intervention lasted 6 months. The primary endpoint was the Relative Dose Intensity (RDI). Secondary endpoints included adherence, toxicity, response and survival, quality of life, pts experience (PACIC Score), end-of-life support, and economic estimation of the use of healthcare resources. Results: From October 2016 to May 2019, 609 pts (median age: 62 years, 20-92; PS2: 11.8%) were included. 39% were receiving oral chemotherapy, and 61% other OAA. The RDI was significantly higher in the CAPRI arm (93.4% ±0.26 vs. 89.4% ±0.19, p = 0.04). The CAPRI intervention also improved PACIC scores (mean: 2.94±0.83 vs. 2.67±0.89, p = 0.01), the number of unplanned hospitalizations (15.1% vs. 22.0%, p = 0.04), hospitalization duration (mean: 2.82±6.96 days vs. 4.44±9.60, p = 0.02), and treatment-related grade≥3 toxicities (27.6% vs. 36.9%, p = 0.02). Conclusions: Compared to SOC, the CAPRI intervention improved RDI, pts experience, hospitalizations and their duration, as well as the rate of treatment-related grade≥3 toxicities. This type of intervention should represent a new standard in pts receiving OAA. Clinical trial information: NCT02828462.

Introduction The biocompatibility of the polysiloxane breast implant has been studied moderately. The aging of these implants due to lipid penetration and the release of polymerization impurities, such as Platine or octamethylcyclotetrasiloxane (named D4), has already been documented. Since these studies, manufacturing procedures have been improved; thus, the security of breast implants has also improved. Although polymerization and the choice of monomer influence the shell properties, few studies have compared these together in breast implants. Our study compares the permeability and mechanical resistance of 3 breast expander shells after in vivo and in vitro aging. Results In vitro, all tested shells quickly sorbed linear molecules, such as fatty acids, and released siloxane impurities. The penetration of a molecule with steric hindrance, such as cholesterol, is slower. Allergan shells have the highest rates of molecule sorption and siloxane release. In vivo, after implantation, Allergan shells lost their initial mechanical properties over time. This observation was not found for mentor shells. For all brands, many biological molecules penetrate the shells, among which cholesterol and fatty acids are always present. Discussion The aging of polysiloxane shells depends on the sorption of many biological molecules and the release of siloxane impurities. The siloxanes are impurities and / or degradation products that are due to aging. Moreover, according to our results, the shells act as matrices that separate molecules according to their chemical and physical properties. Conclusion Not all polysiloxane expander shells have the same properties during aging. The manufacturing procedures and the choice of siloxane monomers are the two most probative factors that explain the observed differences.

Analyze the relationship and expectations of cancer patients towards the community pharmacist in a pharmaceutical care coordination project.In November 2014, a questionnaire was distributed to ambulatory patients of a university hospital specialized in oncology. Thirteen questions explored the consumption habits and the usage of the pharmacy (typology of consumers, use of goods and benefits consumed), and collected their expectations for pharmaceutical benefits in the context of the management of their cancer.One thousand two hundred and seventy two patients were included for a final response rate of 78%. Characteristics of the respondents: 64% were women, 63% lived in Île-de-France and 49% took cancer-related treatments (anticancer drugs, supportive care medications). More than 84% of respondents went to pharmacies at least once a month and 95% reported resorting to a single pharmacy. 36% to be ready to share their hospital discharge report with their pharmacist and 61% to have their hospitalization order sent to their "referral" pharmacy to anticipate treatments. Discussion Community pharmacists were perceived positively by the respondents. Patients were willing to share information and be accompanied by this health professional in their cancer care. Their expectations were first and foremost the management of drug-related iatrogenic effects with a report of adverse effects to the hospital, and validated solutions for their management.

BACKGROUND Systematic prescription analyses by clinical pharmacists result in pharmacist interventions (PIs) to reduce prescription errors and improve medication safety. PIs are particularly critical in oncology, because antineoplastic drugs are highly toxic with low therapeutic indexes especially in a pediatric population. The aim of this study is to describe PIs in a pediatric oncology department and to identify potential risk factors associated with prescription errors. PROCEDURE We conducted a 20-month observational study in a pediatric oncology department concerning electronic prescription of injectable chemotherapies was conducted. PIs were analyzed for drug-related problems (DRPs), type of intervention, population characteristics, involved drugs, and the potential risk factors. RESULTS Clinical pharmacists made 90 PIs for 10,214 antineoplastic prescriptions for a rate of 88 PIs per 10,000 prescriptions. The majority of DRPs were dosage errors (61.8%), imputable to measurements (weight and/or height) in 47.4% or unreported dose reduction. The most common patient ages were in the range 1-10 years and the most common time for medical double checks was 2-9 pm. There were statistically more prescription errors in standardized protocols (P

Background Adverse drug events (ADEs) occur frequently in oncology and justify continuous assessment and monitoring. There are several methods for detecting them, but the trigger tool method seems the most appropriate. Although a generic tool exists, its use for ADEs in oncology has not been convincing. The development of a focused version is therefore necessary. Objective To provide an oncology-focused trigger tool that evaluates the prevalence, harm, and preventability in a standardised method for pragmatic use in ADE surveillance. Setting Hospitals with cancer care in France. Method The tool has been constructed in two steps: (1) constitution of an oncology-centred list of ADEs; 30 pharmacists/practitioners in cancer care from nine hospitals selected a list of ADEs using a method of agreement adapted from the RAND/UCLA Appropriateness Method; and (2) construction of three standardised dimensions for the characterisation of each ADE (including causality, severity, and preventability). Main outcome measure The main outcome measure was validation of the tool, including preventability criteria. Results The tool is composed of a final list of 15 ADEs. For each ADE, a ‘reviewer form’ has been designed and validated by the panel. It comprises (1) the trigger(s), (2) flowcharts to guide the reviewer, (3) criteria for grading harm, and (4) a standardised assessment of preventability with 6–14 closed sentences for each ADE in terms of therapeutic management and/or prevention of side-effects. Conclusion A complete ‘ready-to-use’ tool for ADE monitoring in oncology has been developed that allows the assessment of three standardised dimensions.

Background Patients diagnosed with therapy-related myeloid neoplasms (TRMN) with concomitant active neoplastic disorder (CAND) are usually proposed for best supportive care (BSC). We evaluated the feasibility of using 5-azacytidine (AZA) in this setting. Methods All patients referred to Gustave Roussy between 2010 and 2015 for TRMN diagnosis (less than 30% blast) and eligible for AZA treatment were included. Patients with CAND proposed for BSC were also described. Patient's outcomes were analyzed based on the presence or not of a CAND. Results Fifty-two patients with TRMN were analyzed, including 19 patients with CAND (14 eligible for AZA) and 33 without CAND eligible for AZA. The 5 patients with CAND ineligible for AZA had a worst performance status (p = 0.016) at diagnosis and a shorter overall survival (OS) (0.62 months). Baseline characteristics of patients eligible for AZA were similar in the 2 groups except a trend for best performance status in patients with CAND (p = 0.06). Overall response rate (71.4% vs 60.3%), transfusion independence (50.0% vs 45.5%) and OS (12.7 months vs 10.8 months) were similar between patients with and without CAND respectively (p = ns). Conclusion Here we report the feasibility and efficacy of AZA for selected patients with TRMN and a CAND.

Use of complementary and alternative medicine (CAM) has been reported to be more and more frequent among cancer patients in USA. The aim of this study was to analyze among French cancer patients the prevalence of CAM use, focusing on antioxidants (AO) that could interfere with antitumor agents. Seventy-nine patients, treated by antitumor chemotherapy in oncology day care unit, participated to an interview (medium age = 60 years old). CAM use was reported by 42% of patients: mostly AO (24%) (selenium, green tea and vitamins ACE, more specifically), but also relaxation, acupuncture, hypnosis (19%) and homeopathy (15%). Among patients using CAM, 66% of them indicated that their physicians were not aware of this use and 47% of them thought that CAM use was safe. Nevertheless, for seven patients who have taken AO, previous in vitro and preclinical studies suggested interactions with antitumor chemotherapy. Therefore, CAM use and, more specifically, AO use is common among cancer patients treated by antitumor chemotherapy in France. Nevertheless, AO could generate interactions with conventional treatment. Clinical studies are warranted to evaluate these interactions, and adequate communication with patients is needed.

Introduction Les patients hospitalises en oncologie sont a risque de developper des escarres. En 2001, la Haute autorite de sante (HAS) a classe les escarres en 5 stades allant de la rougeur a l’infection. Chaque stade necessite une prise en charge specifique. L’objectif de cette etude a ete d’evaluer la frequence des escarres dans les services de medecine et de chirurgie oncologique puis de verifier l’adequation entre la prise en charge des escarres et les recommandations du groupe local « Plaies et cicatrisation » basees sur des recommandations nationales. Materiels et methode Il s’agit d’une etude prospective monocentrique observationnelle realisee par l’interne en pharmacie sur 2 mois (2 juillet au 31 aout 2018) dans 2 services de medecine et 2 services de chirurgie d’un centre de lutte contre le cancer de 444 lits. L’âge, le sexe, le score de Braden et la presence ou non d’escarre ont ete reportes sur un tableur Excel lors de chaque entree d’un patient. Les donnees ont ete recoltees a partir des transmissions infirmieres sur le dossier patient informatise. Puis, pour chaque patient atteint d’une escarre, le stade de l’escarre, les soins realises et les pansements utilises ont ete recueillis et compares aux recommandations. Resultats et discussion Pendant l’etude, 304 patients ont ete hospitalises (1,2 H :F). Leur moyenne d’âge etait de 58,3 ± 14,1 ans avec un score de Braden a l’entree de 20,5 ± 2,8. Les populations etudiees sont comparables : les criteres etudies ne different pas significativement sur le sexe (p = 0,79), l’âge (p = 0,93) et le score de Braden (p = 0,99). Au total, 32 patients (10,5 %, 0,5 H :F) ont presente au moins une escarre au cours de leur hospitalisation : 9 (28 %) avaient une escarre a l’entree et 23 (72 %) l’ont developpe au cours du sejour. Parmi les patients sans escarre a l’entree, 5 (22 %) avaient un score de Braden ≤ 16–score en-dessous duquel une prevention « escarre » doit etre mise en place pendant l’hospitalisation. 47 escarres ont ete recensees soit 1,5 escarre par patient : 15 (32 %) escarres de stade 0, 19 de stade 1 (40 %), 3 de stade 2 (6,5 %), 6 de stade 3 (13 %), 1 de stade 4 (2 %) et 3 patients n’ont pas pu etre classes (6,5 %). Le taux d’adequation entre les soins recommandes et l’audit etait de 47 % (16/34) pour les stades primitifs (0 et 1) et de 80 % (8/10) pour les stades evolues (2 a 4). Le traitement de l’escarre du patient de stade 4 etait conforme aux recommandations. Le faible taux d’adequation pour les stades primitifs reflete a la fois d’une sous declaration des soins realises dans le dossier patient et d’une confusion de traitement entre les stades 0 et 1 (18 %, 6/34). Cette confusion peut etre liee a une meconnaissance de la procedure interne mais aussi des signes cliniques et traitements des escarres aux stades primitifs. Conclusion La frequence des escarres est dans la fourchette haute des valeurs de la litterature (5,3 a 11,8 %). Cet audit a revele un faible taux d’adequation aux stades primitifs de l’escarre. Une nouvelle enquete sera realisee pour identifier precisement les raisons de la meconnaissance des soignants sur ces stades precoces.

INTRODUCTION The phase 1 selection for clinical trials of patients with relapsed or refractory Diffuse Large-B cell lymphoma (R/R DLBCL) with a potentially rapid tumor growth is a challenge. Prognostics' factors identification could help to better orient patients in appropriate clinical trials. This study is focused on DLBCL to evaluate their outcomes in phase I clinical trials. Our main objectives were to identify prognostic factors, attest the investigational drugs' safety and perform a preliminary assessment of drugs' efficacy. METHOD All consecutive patients with R/R DLBCL included in phase I clinical trial at a single cancer center in France between 2008 and 2017. If a given patient had participated in several phase I clinical trial, only the data from his first trial were examined. The patients' and DLBCL characteristics, the safety data and the efficacy outcomes were recorded. Reponses were assessed according to the International Harmonization Project in Lymphoma Cheson 2007 criteria. Overall responses rates (ORR) included partial responses (PR) and complete response (CR) and tumor control rates included overall responses and stable disease (SD). RESULTS A total of 101 patients (males: 63,4%) with R/R DLBCL were included in a panel of 21 clinical trials. The median age was 64 (range 21-86). Before their inclusion in a phase I trial, patients had received a median of 3 (1-7) lines of treatment and 25,7% of patients had undergone an autologous stem cell transplantation. At the cute-off date, 5 of the 101 patients (4,95%) were still taking the investigational drug. The median progression-free survival and overall survival (OS) were 1,8 and 9,7 months. High-grade toxicity (grade 3 or higher) occurred in 47 of the 101 patients (46,5%), and was related to the investigational drug in 29 of these cases (61,7%). The most important drugs-related toxicity was a hematological toxicity (neutropenia and thrombocytopenia) for 79,3% of patients, other toxicities were digestive toxicity (5,9%), cutaneous toxicity (2,9%), hepatotoxicity (2,9%) and pneumopathy (2,9%). Dose-limiting toxicity (DLT) was experienced by 7 (6,9%) of the 101 patients. The time from D1C1 (day 1, cycle 1) to the occurrence of high-grade toxicity was 1,2 months (range 0,2-9,5). High-grade toxicity occurred during the DLT period (< 6 weeks) for 27 of the 46 patients (58,7%) and after the DLT period in the remaining 19 (41,3%) patients. Factors associated with poor overall survival (overall survival inferior to the median OS) were Ann Arbor staging (73.6% of poor OS patients (< 9.7 months) with a performance status at 4), serum albumin (30.2% of poor OS patients with a low rate of serum albumin ≤ 35 g/L), serum LDH (79.2% of poor OS patients with a high rate of serum LDH > 250 U/L) and progressive disease (90.6% of poor OS patients had a trial withdrawal because of progression). The overall objective response and disease control rates were 25% and 43%. The median trial duration was 1.9 months and were respectively 12,1 and 5,5 months for responders (PR and CR) and controlled patients (PR and CR and SD). 36.6% of patients were prematurely withdrawing of study (before weeks 6). Factors associated with premature withdrew were performance status at baseline (67.6% of early withdrawal patients at performance status 1); Ann Arbor staging (67.6% of early withdrawal patients at Ann Arbor stage 4); serum LDH (73% of early withdrawal patients with a high rate of serum LDH > 250 U/L) and serum albumin (35,1% of early withdrawal patients with a low rate of serum albumin ≤ 35 g/L). CONCLUSION High-grade toxicity occurred after the DLT period in 41.3% of patients with R/R DLBCL, suggesting that the conventional concept of dose-limiting toxicity should be redefined in the era of modern cancer therapies. Besides, even if the phase 1 selection for clinical trials is very selective, it's necessary to better orient patients in hematology. In fact, 36.6% of patients were prematurely withdrawing of study which could be anticipated thanks to the identification of prognostics' factors. Although the objective response is only a secondary endpoint in phase I clinical trials, the median duration of participation in trials (almost one year for responders and 5.5 months for controlled patients) are relevant for some new possibilities of therapeutics in the field of early drugs clinical trials. Disclosures Ribrag: NanoString Technologies: Consultancy, Honoraria; epizyme: Consultancy, Honoraria; Incyte Corporation: Consultancy; MSD: Honoraria; Roche: Honoraria, Other: travel; Infinity: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Other: travel; Amgen: Research Funding; Servier: Consultancy, Honoraria; pharmamar: Other: travel; Gilead: Consultancy, Honoraria; argenX: Research Funding.

Background Cetuximab is crucial in the management of squamous cell carcinoma of the head and neck of patients. Grade 3–4 cetuximab-induced infusion reactions (CI-IRs) occur in 2% of patients with colorectal cancer. Despite the 2.7% CI-IR rate in the EXTREME trial, higher rates were reported in small series of patients with head and neck squamous cell carcinoma (HNSCC) (6%–18%). There is an urgent need to better appraise the natural history and the predictive factors for CI-IRs in patients with HNSCC exposed to cetuximab. Methods The medical records from patients with HNSCC (n=428) treated by cetuximab at Gustave Roussy from January 2013 to December 2015 were reviewed. The impact of potential risk factors was analysed. Results Out of 428 patients, 24 patients (5.4%) presented CI-IR, including grade 3–4 (95.7%); about 21% (5/24) requiring intensive care unit referral and quasi all occurred within the first cycle (21/24). In a multivariate analysis, the occurrence of grade 3–4 CI-IR was associated with tobacco and alcohol history (p=8.5e–3) and with prior allergy history (p=2.9e–3). CI-IRs tended to be associated with poor overall survival in patients with recurrent and metastatic HNSCC and with a higher number of further lines of chemotherapy. Conclusion In real life, CI-IRs appear far more common in patients with HNSCC (5.4%) than reported in prospective trials. This is the largest series of patients ever focusing on the risk of CI-IR in patients with HNSCC. Prior allergy history and tobacco history are associated with CI-IR and could be used to better allocate treatment. Further prospective data are required to confirm these findings.

International audience; Abstract Background: Drug-related iatrogenic effects are common in oncology because chemotherapy is toxic. The evaluation of the application of the guidelines may be a way to understand the occurrence of adverse drug-related event (ADE). There is no specific method for identifying ADEs and measuring harm to patients in oncology. Objective: Our objective was to develop and test an Oncology Trigger Tool (OTT) for ADEs and to describe ADE characteristics and incidence. Methods: A clinical advisory panel identified situations at high risk of ADE occurrence and built 22 triggers with, in each case, an analysis flowchart to confirm or refute occurrence. The OTT was used to review 288 random admissions (Oct. 2010–Sept. 2011) and measure ADE incidence and severity (CTCAE 4.03 – Common Terminology Criteria for Adverse Events). Tool feasibility (time required), inter-rater (IR) reproducibility and positive predictive value (PPV) were measured. Results: Overall, 884 triggers were detected and 122 ADEs, with 42.4 ADEs/100 admissions or 46.0 ADEs/1000 patient-days, and a 31.1% rate of severe ADEs. The most common ADEs were hyperglycaemia (14.5%), unplanned drug-related admission within 30 days (13.7%) and opiate-induced constipation (12.1%). Unplanned drug-related admission was the most serious (82.4% incidence of severe harm). Mean time for OTT implementation was 21.8 min; IR reproducibility was high (j = 0.965 (trigger); j = 0.935 (ADE); j = 0.853 (harm)); PPV 22- trigger version was 20.7%. Conclusions: ADE analysis flowcharts coupled with standardised grading of harm consider- ably reduced IR variability, thus providing a robust oncology-focused trigger tool for use in ADE audits and hospital comparisons. The involvement of a clinical advisory panel in tool development should help drive changes for improving practice. Further research on the OTT is warranted.

Introduction Les magasiniers et les preparateurs en pharmacie hospitaliere (PPH) de l’unite des dispositifs medicaux (DM) sont en relation au quotidien avec les services de soin. Pour repondre efficacement aux besoins des services, leur formation est indispensable. Celle-ci inclus une formation initiale sur les bases theoriques et une formation continue pour maintenir et adapter leurs competences. L’objectif de ce travail a ete le developpement d’un outil de formation en ligne sur les DM et la sterilisation, a destination des PPH et des magasiniers. Materiels et methode Un cahier des charges a ete concu par l’equipe pharmaceutique (EP) : un externe, un interne et le pharmacien responsable des DM. L’outil de formation prevoyait un sommaire identifiant les cours, un dictionnaire et un module de quiz. Il devait etre accessible en ligne, sans identification. Les cours ont ete elabores par l’externe et l’interne a partir de la bibliographie scientifique et des observations faites en immersion dans les services de soins. Ils sont concus pour etre visionnes en moins de 20 minutes. Les supports de cours incluent des textes, images et videos. Resultats et discussion L’outil de formation est un blog en ligne, d’acces et de conception gratuits : il utilise Wordpress® pour la structure du blog, Vimeo® pour les videos et Google Forms® pour le module de quiz. L’integralite de la structure a ete concue par l’externe en pharmacie. Le blog s’ouvre sur une page d’accueil, presentant l’outil et donnant acces au sommaire. Ce sommaire comporte 11 themes, subdivises en plusieurs cours chacun. Dans chaque cours, les termes techniques renvoient a leur definition dans le dictionnaire. Un espace de commentaires est disponible pour poser des questions. Apres chaque cours, une evaluation des connaissances est possible grâce a un quiz, realisable en 10 minutes maximum. La note obtenue et les reponses attendues sont immediatement accessibles a la fin du quiz. L’analyse des resultats est possible sur Google forms. Le cahier des charges a ete respecte. Le blog permet un acces simple, depuis chaque poste informatique, a des formations courtes adaptees aux disponibilites de chacun. Les quiz permettent aux apprenants d’evaluer leurs connaissances et a l’EP d’evaluer les besoins de formation. L’incrementation reguliere de nouveaux cours et l’actualisation des contenus pour l’adapter aux innovations, seront necessaires. L’elaboration des cours est assuree par les externes et les internes, mais pourra etre ouverte a l’ensemble de l’equipe (magasiniers, PPH, EP) pour favoriser l’implication et la transmission des savoirs. Conclusion Ce blog repond a un besoin de formation exprime par les magasiniers et PPH pour interagir avec les services de soins. En acces libre et gratuit, il presente un contenu cible et interactif, en s’adaptant aux besoins et a la disponibilite de chacun. Les pistes d’evolution incluent son actualisation reguliere et l’ajout de theme sur la securite et la prevention au travail.

Aim: The goal of this study was to identify which patient characteristics had a significant impact on the patient-perceived usefulness of information technologies (IT) in health care and the current utilization by patients. Methods: A questionnaire-based survey was conducted in 2013, over seven non-consecutive days within seven outpatient departments of a comprehensive cancer center. We computed descriptive statistics based on survey responses and performed correlation analysis (Spearman test) to investigate characteristics of patients' IT usage and attitudes in relation to age, gender, socioeconomic status, social isolation, and place of living (urban/rural). We then performed multinomial logistic regression models for which likelihood ratio tests were used. Results: The participation level was 85% (n = 1371). 70% of respondents were females, and the median age was 53.4 years. 84% of patients reported feeling comfortable with the use of computers, tablets and smartphones. 71% of them used a mobile phone every day and 68% were daily Internet users. Age and socioeconomic status were negatively associated with the use of IT (p Study findings indicate that age and socioeconomic status were negatively associated with the perceived ease of use of IT (p IT applications useful/very useful neutral not useful/rather not useful n/a Schedule an appointment 71% 6% 22% 1% Communicate via emails with your physician 75% 5% 18% 2% Get help with medication monitoring (reminders, side effects) 61% 12% 26% 1% Get information about disease/support 69% 12% 18% 1% Get access to external contacts (psychologist, nurses,..) 66% 13% 20% 1% Conclusions: Most patients were connected to the Internet and used information technologies on a daily basis. Overall, they expressed an interest in using these tools in health care. Differences in perceived ease of use of IT according to age and socioeconomic status have to be addressed. Disclosure: All authors have declared no conflicts of interest.

International audience; Intrathecal (IT) chemotherapy has been the mainstay treatment for patients with meningeal carcinomatosis (MC) but the prognosis of MC remains disastrous and most patients expire before 6 months [1]. Recently IT administration of trastuzumab, an IgG1 anti-HER2 monoclonal antibody (mAbs), has been tested with signs of efficacy in HER2 positive breast cancer patients [2–5]. We report here the first case of IT panitumumab, a human recombinant IgG2 kappa mAbs that binds specifically to EGFR, for a patient with MC derived from an EGFR exon 19 mutant lung adenocarcinoma.

International audience; BACKGROUND AND OBJECTIVES: Busulfan is used as part of a conditioning regimen prior to hematopoietic stem cell transplantation for the treatment of certain cancers and immune deficiency syndromes. Due to its instability in aqueous preparations, busulfan for infusion is prepared from a concentrate and has a relatively short shelf life once prepared. The purpose of this study was to identify the most suitable storage container and temperature to maximize the shelf life of busulfan therapeutic infusions prepared from Busilvex(®).METHODS: Busilvex(®) 6 mg/mL was diluted to 0.55 mg/mL with 0.9 % NaCl and aliquots dispensed into polypropylene syringes, polyvinyl chloride bags, and glass bottles. Three storage temperatures were evaluated: 2-8 °C, 13-15 °C (thermostatically controlled chamber), and room temperature (20 ± 5 °C). At set time points, samples were analysed for busulfan content, using a high-performance liquid chromatography (HPLC) system with ultraviolet detection. The change in pH and osmolarity on storage was also determined, and solutions were inspected visually for formation of a precipitate or colour change. To determine the contribution of precipitation to loss of busulfan content on storage, samples from one time series were treated with the solvent dimethylacetamide prior to HPLC separation and quantitation of busulfan.RESULTS: The results of the active substance content monitoring study over a 48-h period demonstrate that busulfan solution is stable at a 5 % threshold, at 2-8 °C for 16 h in syringes, 14 h in glass bottles, and 6 h in bags. In addition, the period of stability decreases as the temperature increases (4 h at 20 ± 5 °C). The solution is considered to be stable, subject to precipitation liable to be observed regardless of the temperature.CONCLUSION: The best stability was observed for busulfan solutions placed at 2-8 °C in syringes. This study demonstrated that precipitation, in addition to hydrolysis, has a significant influence on the busulfan content.

Immunotherapy is a promising antitumor strategy that can successfully be combined with current anticancer treatment. In this study, arsenic trioxide (As2O3) was shown to increase the antitumor immune response in CT26 colon tumor-bearing mice through the modulation of regulatory T cell (Treg) numbers. As2O3 induced Treg-selective depletion in vitro. In vivo, tumor-bearing mice injected with 1 mg/kg As2O3 showed a significant decrease in the Treg/CD4 cell ratio and in absolute Treg count versus controls. As2O3 exerted antitumor effects only in immunocompetent mice and enhanced adoptive immunotherapy effects. Inhibition of As2O3-induced Treg depletion by the NO synthase inhibitor NG-nitro-l-arginine methyl ester and the superoxide dismutase mimic manganese [III] tetrakis-(5, 10, 15, 20)-benzoic acid porphyrin suggested that it was mediated by oxidative and nitrosative stress. The differential effect of As2O3 on Treg versus other CD4 cells may be related to differences in the cells’ redox status, as indicated by significant differences in 2′7′dichlorodihydrofluorescein diacetate and 4,5-diaminofluorescein diacetate fluorescence levels. In conclusion, these results show for the first time, to our knowledge, that low doses As2O3 can delay solid tumor growth by depleting Tregs through oxidative and nitrosative bursts, and suggest that As2O3 could be used to enhance the antitumor activity of adoptive immunotherapy strategies in human cancer.

Oxidative stress plays a role in the regulation of cancer cell metastasis which involves cell invasion and adhesion that could be supported by ADAM proteins through the activities of their metalloprotease and disintegrin domains. We hypothesized that oxidative stress could act through the induction of ADAM9 protein in some cancer cells. Indeed, Western blot analysis for ADAM9 performed on A549 cells exposed to H(2) O(2) reveals a dose-dependent induction of two proteins (80 and 68 kDa) correlated with a sharp increase of the ADAM protease activity measured in supernatant while the activity measured on the cell layer was slightly affected. The 80kDa protein corresponds to the mature form of ADAM9. Immunoprecipitation analysis performed on concentrated supernatants revealed that the 68 kDa protein is a secreted form of ADAM9. When exposed to H(2) O(2) , A549 cells cocultured with confluent endothelial vascular cells resulted in a 5.5 fold (p < 0.001) increase in the number of adherent cells. Similarly, matrigel assay revealed a 3.25 fold (p < 0.01) increase in the number of invasive cells. The suppression of ADAM9 expression by specific small interfering RNA reduced oxidative stress-induced invasiveness and adhesiveness. These functions could be mediated by an interaction between ADAM9 and β1 integrin because each of them were inhibited when the experiment is performed in presence of mAbs targeting ADAM9 ectodomain or β1-integrin. These results emphasize the importance of oxidative stress in the regulation of cancer cell metastasis and suggest that ADAM9 and its secreted isoform can be important determinants in the ability of cancer cells to disseminate.

e20652 Background: The patient-perceived usefulness of IT in oncology and the current utilization by patients could be strong predictors for the success of a coordinated care pathway (patients, can...

e18029 Background: 5-azacytidine (AZA) is recognized as a standard of care for patients with high risk myelodysplastic syndrome (MDS) and secondary acute myeloid leukemia (AML) to MDS with less tha...

Cancer patients receiving chemotherapy are at increased risk of venous thromboembolism (VTE). The presence of cancer and anticoagulant use are risk factors for bleeding, yet data on bleeding risk are limited in these patients. This analysis evaluated the risk of major bleeding in cancer patients receiving chemotherapy using a US claims database. This retrospective cohort study used the MarketScan® databases, a nationwide database containing data from about 100 payers and covering > 30 million patients annually. Adult cancer patients receiving chemotherapy within 6 months of cancer diagnosis between January 2004 and December 2010 were included. Cancers of interest were: lung, colon/rectum, pancreas, bladder, stomach, and ovary. The index date was the first date of chemotherapy. Patients were followed until the earliest of: 1) first diagnosis of major bleeding; 2) termination of enrolment in the health plan; 3) end of study. The primary outcome was the first occurrence of major bleeding, based on selected ICD-9-CM/CPT codes, following chemotherapy initiation. Of 74,575 patients identified, exclusion of those with prior history of bleeding at baseline (∼5%) resulted in 70,822 patients included in the analysis. Mean age was 62 years, 37% were ≥ 65 years, and 52% were male. Average time of follow up and chemotherapy were 14.3 and 8.6 months, respectively; 6% had a history of VTE within 6 months prior to the index date. Major bleeding occurred in 5.8% of patients and the incidence rate for all cancers combined was 4.9 per 100 person-year (PY) and 10.5, 9.3, 6.2, 4.3, 3.6, and 3.3/100 PY for pancreatic, stomach, lung, bladder, colon/rectum, and ovarian cancer, respectively. Approximately 14% of patients (N = 10,456) developed VTE after chemotherapy initiation (> half in the first 3 months of chemotherapy treatment). Of these, 7.8% experienced major bleeding with incidence rates ranging from 5.9-17.7/100 PY after VTE. Major bleeding incidence in cancer patients receiving chemotherapy varies by cancer type with the highest rates in patients with upper gastrointestinal cancer. Compared to the overall cohort, major bleeding risk was higher in cancer patients who developed VTE. Disclosure J.H. Zong: Employee of Sanofi. L. Eckert: Employee of Sanofi. L. Zhang: Employee of Sanofi. W.S. Dai: Employee of Sanofi. A.T. Cohen: Consult: Astellas, AZ, Bayer, BI, BMS, Daiichi, GSK, JJ ResFund: AZ, Bayer, BI, BMS, Daiichi, GSK, JJ BoardSpeakerAdvis comm: Bayer, BI, BMS, Daiichi, GSK, J&J, Mitsubishi, Pfizer, Sanofi. All other authors have declared no conflicts of interest.

Objective Adverse events related to drugs occur frequently and many of them are preventable. Despite cancer treatment are known to involve hazardous drugs, there are few practical methods to identify adverse drug events (ADEs) and measure harm to the patient. The purpose of this work was to develop a tool for adverse event detection in oncology patients. Methods The Trigger Tool approach has been developed and tested in oncology. First, 27 triggers were identified and flowcharts were constructed, based on international, national or local recommendations. Second, 11 clinical experts have validated the content of each trigger on three criteria: the criticality of the adverse event, the educational value of feedback, and the clinical relevance of the analysis. For each trigger, severity has been graded according to the NCI CTCAE 4.03. Third, the feasibility of the analysis based on a random sample of 130 patient records has been assessed through the time of analysis for each patient record, and the number of trigger and ADE observed. Results Experts evaluated the criticality of the 27 triggers from 5.1 to 10.9/25 and their educational value from 4.5 to 7.7/10. Regarding the feasibility analysis, 1157 hospital-bed days were reviewed from October 2010 to March 2011.It revealed 387 positive triggers, 80 of which are adverse events and 46 were drug related (ADE). The study counted 0.6 ADE/patient, including 1 grade 3 or more ADE for 11.8 patients. The most frequently observed ADE were constipation (7 ADE), fall (5 ADE), hypo/hyperglycemia (4 ADE), hypo/hyperkaliemia (3 ADE). The average time of analysis was established at 26min35s by patient record. Based on these results, 22 triggers have been preserved, composing the Iatrigger tool. Conclusion ADE detection is an important priority in patient safety research. The use of a ADE detection method requires some resource commitments. However, a validated tool like the Iatrigger tool can be applied in different hospital settings, allowing a precise follow-up of this particularly frail population. Disclosure All authors have declared no conflicts of interest.

9572 Background: Thiotepa (TTP) is a cytotoxic agent used in children with solid tumors at high doses followed by autologous stem cell transplantation (ASCT). During these treatments, neurological adverse events (NAE) were observed. Causal relationships and risk factors were investigated. Methods: Patients with solid tumors treated with high-dose thiotepa with ASCT between May 1987 and March 2011 were retrospectively identified. Clinico-biological data were collected and NAE were identified from medical and nursing records. Toxicity was graded according to the NCI CTCAE v4.03 classification. Imputability of thiotepa was assessed according to Begaud et al. method. Analysis of risk factors was assessed with Fisher's exact test (alpha 0.05) and relative risk was estimated by calculating odds ratios with their 95% confidence interval. Results: 251 patients received 307 courses (56 patients received twice) of high-dose thiotepa (600 mg/m²: 82 courses; 720 mg/m²: 76 courses; 900 mg/m²: 149 courses) with ASCT. The median age was 8.33 years (range, 1 - 31.2 years). 81 NAE (26.4%) were described. NAE were considered “possibly” related to TTP in 9 courses, “likely” related to TTP in 35 courses and “very likely” related to TTP in 13 courses. Other NAE were assessed “doubtful” or “incompatible”. In these 57 NAE, neurological symptoms appeared at a median time of 2 days (range, 0 - 4 days) after the introduction of TTP. Symptoms were headache, tremor, dizziness and confusion, blurred vision, seizure, pyramidal tract syndrome, cerebellar syndrome, opsoclonus-myoclonus syndrome and coma. These events disappeared without sequelea in a median time of 3 days (range, 1 - 8 days). TTP was reintroduced in 21 cases. NAE reappeared in 12 cases. For 3 patients with seizure during the first course, premedication with clonazepam prevented NAE during the second course. The use of analgesic for moderate to severe pain, such as tramadol or codeine, increased the probabiblity to have NAE (OR 5.6467; 95CI [1.5523-21.2786]; p 0.037). Conclusions: In our study, the incidence of NAE related to TTP was 18.6%. The outcome was favorable without sequelea in all cases. TTP could be reintroduced after NAE. The association of TTP with tramadol increases the risk of neurotoxicity.

9560 Background: Using the [51Cr]-ethylenediamine tetra acetic acid ([51Cr]-EDTA) method provides an accurate measure of glomerular filtration rate (GFR) for each patient. However, this method is not always feasible in routine. Thus, several mathematical equations have been developed to predict creatinine clearance. The most widely used in pediatric patients is the Schwartz formula, based on patient height and serum creatinine. However, this method has not been validated in pediatric cancer patients. The aim of the present study was to compare GFR measured with the 51Cr-EDTA method to GFR estimated with the Schwartz formula in patients younger than 18 years of age and treated for solid tumors. Methods: Data have been retrospectively collected on consecutive children treated between 2001 and 2011 at Institut Gustave Roussy. All of the patients had undergone assessment of GFR via 51Cr-EDTA clearance and estimation of renal function by the Schwartz formula. Exclusion criteria were serum creatinine under 25µmol/L or no recent dosage available. GFR analysis was realized using the slope intercept method after a single injection of 51Cr-EDTA solution.. Values of the GFR were calculated by multiplying the volume of dilution by the slope of the single exponential fit to the three data points and then expressed in ml/min/1.73m². Student paired t-test (alpha = 0.05) was used to compare results obtained for each patient with the two methods. Results: 196 patients (120 males, 76 females), treated with various types of cancer (neuroblastoma, osteosarcoma, Ewing sarcoma, lymphoma…) Mean age was 6.7 years. Mean GFR was 127.5 ml/min/1.73m² with the 51Cr-EDTA method versus 148.1 ml/min/1.73m² with the Schwartz formula. Mean of difference was 20.7 ml/min/1.73m² with a confidence interval [-25.7 ; -15.6] (p < 0.0001). Conclusions: GFR estimated with the Schwartz formula is statistically different from the isotopic method. In most cases, GFR estimated with the Schwartz formula is overestimated. This study highlights the lack of accuracy of this equation in pediatric population with cancer. The 51Cr-EDTA method must be preferred when a reliable and accurate evaluation of renal function is needed.