Le traçage anonyme, dangereux oxymore: Analyse de risques à destination des non-spécialistes

Dans le but affiché de ralentir la progression de l'épidémie COVID-19, la France envisage de mettre en place un système de traçage des contacts des maladesà l'aide d'une application mobile. Les concepteurs de ce type d'applications assurent qu'elles sont respectueuses de la vie privée. Cependant cette notion reste vague. Nous souhaitons donc contribuer au débat public en apportant unéclairage sur ce que pourrait et ne pourrait pas garantir une application de traçage, afin que chacun puisse se forger une opinion sur l'opportunité de son déploiement

Cancer de l’ovaire : la rechute précoce

National audienceLa rechute précoce est définie par une récidive qui survient moins de 6 mois après la dernière injection de chimiothérapie à base de platine. Elle peut être primaire ou secondaire, et après une ou plusieurs lignes de traitements avec un sel de platine. Il n’y a pas d’indication à une chirurgie carcinologique. Il est recommandé une monochimiothérapie sans platine (doxorubicine liposomale pégylée [DLP], paclitaxel hebdomadaire, topotécan ou gemcitabine) en association avec du bévacizumab si la patiente n’en a pas reçu antérieurement (niveau de preuve 1, grade A). Early relapse (primary or secondary) is defined by relapse of disease less than 6 months before the last infusion of chemotherapy (with a platinum compound). There is no carcinological surgical indication. Disease should be treated with a non-platinum single agent (pegylated liposomal doxorubicin, weekly paclitaxel, gemcitabine or topotecan). Bevacizumab can be added if patients have not already received it (level of proof 1, grade A)

Psychometric validation of the French version of the Supportive Care Needs Survey for Partners and Caregivers of cancer patients

International audienceThe objective of this study was to assess the psychometric properties of the French version of the Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C-F). The SCNS-P&C-F, the Hospital Anxiety and Depression Scale (HADS) and the CareGiver Oncology Quality of Life questionnaire (CarGOQoL) were completed by 327 caregivers at the baseline. The SCNS-P&C-F was completed a second time by 121 participants within 30 days. Four factors were retained with a good explanation of variance (82.65%) and acceptable internal consistencies (α: 0.70 to 0.94): 1) Health Care Service and Information Needs, 2) Emotional and Psychological Needs, 3) Work and Social Security Needs and 4) Communication and Family Support Needs. Overall, convergent and divergent validities were confirmed. The caregiver's gender, age, professional status and level of anxiety and depression, as well as the type of relationship with the patient and cancer, showed an effect on some caregivers’ unmet supportive care needs. Lastly, the test–retest reliability was acceptable (> 0.70), except for the communication and family support dimension. The scale is appropriate for clinical and research use (e.g. good reliability and validity)

Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial.

International audienceBACKGROUND: The end of life for cancer patients is the ultimate stage of the disease, and care in this setting is important as it can improve the wellbeing not only of patients, but also the patients' family and close friends. As it is a matter of profoundly personal concerns, patients' perception of this phase of the disease is difficult to assess and has thus been insufficiently studied. Nonetheless, caregivers are required to provide specific care to help patients and to treat them in order to improve their wellbeing during this period.While tools to assess health-related quality of life (QoL) in cancer patients at the end of life exist in English, to our knowledge, no validated tools are available in French. METHODS/DESIGN: This randomized multicenter cohort study will be carried out to cross-culturally adapt and validate a French version of the English QUAL-E and the Missoula Vitas Quality Of Life Index (MVQOLI) questionnaires for advanced cancer patients in a palliative setting. A randomized clinical trial component in addition to a cohort study is implemented in order to test psychometric hypotheses: order effect and improvement of sensibility to change.The validation procedure will ensure that the psychometric properties are maintained.The main criterion to assess the reliability of the questionnaires will be reproducibility (test-retest method) using intraclass correlation coefficients. It will be necessary to include 372 patients. The sensitivity to change, discriminant capability as well as convergent validity will be also investigated. DISCUSSION: If the cross-cultural validation of the MVQOLI and QUAL-E questionnaires for advanced cancer patients in a palliative setting have satisfactory psychometric properties, it will allow us to assess the specific dimensions of QoL at the end of life. TRIAL REGISTRATION: Current Controlled Trials NCT01545921

Distribution- and anchor-based methods to determine the minimally important difference on patient-reported outcome questionnaires in oncology: a structured review

Abstract Background Interpretation of differences or changes in patient-reported outcome scores should not only consider statistical significance, but also clinical relevance. Accordingly, accurate determination of the minimally important difference (MID) is crucial to assess the effectiveness of health care interventions, as well as for sample size calculation. Several methods have been proposed to determine the MID. Our aim was to review the statistical methods used to determine MID in patient-reported outcome (PRO) questionnaires in cancer patients, focusing on the distribution- and anchor-based approaches and to present the variability of criteria used as well as possible limitations. Methods We performed a systematic search using PubMed. We searched for all cancer studies related to MID determination on a PRO questionnaire. Two reviewers independently screened titles and abstracts to identify relevant articles. Data were extracted from eligible articles using a predefined data collection form. Discrepancies were resolved by discussion and the involvement of a third reviewer. Results Sixty-three articles were identified, of which 46 were retained for final analysis. Both distribution- and anchor-based approaches were used to assess the MID in 37 studies (80.4%). Different time points were used to apply the distribution-based method and the most frequently reported distribution was the 0.5 standard deviation at baseline. A change in a PRO external scale (N = 13, 30.2%) and performance status (N = 15, 34.9%) were the most frequently used anchors. The stability of the MID over time was rarely investigated and only 28.2% of studies used at least 3 assessment timepoints. The robustness of anchor-based MID was questionable in 37.2% of the studies where the minimal number of patients by anchor category was less than 20. Conclusion Efforts are needed to improve the quality of the methodology used for MID determination in PRO questionnaires used in oncology. In particular, increased attention to the sample size should be paid to guarantee reliable results. This could increase the use of these specific thresholds in future studies

Patients’ perceived tolerance of side effects in phase I cancer clinical trials: A qualitative study

International audienceThis qualitative study aimed to explore cancer patients’ perceived tolerance of side effects in phase I drug trials. Patients with solid tumours receiving molecularly targeted agents with/without chemotherapy were eligible for inclusion. In-depth semi-structured interviews were carried out with 17 patients with a median [range] age of 63 [41–72] years. Treatment was discontinued in seven patients. Verbatim transcripts of the audio-taped interviews were analysed using a constructivist grounded theory approach. Four conceptual categories emerged from data analysis, labelled “suffering from side effects” comprising a range of symptoms, psychosocial or role disturbances; “striving to cope with side effects” reflecting psychological strategies for managing side effects; “hoping” reflecting expectations about treatment efficacy and relief from side effects; and “appraisal of care.” Among patients remaining in the trial, treatment was currently perceived as fairly tolerable. For most respondents, whether still in a trial or not, treatment discontinuation could not be justified by the non-tolerance of treatment side effects. These results question the adequacy of patient-perceived tolerance reports to determine an optimal drug dose for phase II trials. Confronted with patients’ hopes and inappropriate beliefs, communication is challenging in phase I trials and could benefit from facilitating psychosocial interventions

An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial : idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma

IF 2.562International audienceOBJECTIVES : The objective of this study was to explore the association between health-related quality of life (HRQoL) and the recommended phase 2 dose in a phase I clinical trial according to the Time to HRQoL deterioration approach (TTD).SETTING : This is a phase I dose-escalation trial of transarterial chemoembolisation (TACE) with idarubicin-loaded beads performed in cirrhotic patients with hepatocellular carcinoma. Patients had to complete the EORTC QLQ-C30 HRQoL questionnaire at baseline and at days 15, 30 and 60 after TACE.PARTICIPANTS: Patients aged ≥18 years with HCC unsuitable for curative treatments were evaluated for the study (N=21).PRIMARY AND SECONDARY OUTCOME MEASUREMENTS : The primary objective was to determine the maximum tolerated dose (MTD) of idarubicin loaded after a single TACE session. MTD was defined as the dose level closest to that causing dose-limiting toxicity in 20% of patients. HRQoL was the secondary end point.RESULTS : Between March 2010 and March 2011, 9, 6 and 6 patients were included at idarubicin dose levels of 5, 10 and 15 mg, respectively. Calculated MTD of idarubicin was 10 mg. At the 10 mg idarubicin dose, patients presented a longer TTD than at 5 mg, for global health status (HR=0.91 (95% CI 0.18 to 4.72)), physical functioning (HR=0.38 (0.04 to 3.22)), fatigue (HR=0.67 (0.18 to 2.56)) and pain (HR=0.47 (0.05 to 4.24)).CONCLUSIONS: These HRQoL results were consistent with the estimated MTD, with a median TTD for global health status of 41 days (21 to NA) at 5 mg, 23 days (20 to NA) at 10 mg and 25 days (17 to NA) at 15 mg. These results show the importance of studying HRQoL in phase I trials

Intra-arterial Idarubicin_lipiodol without embolization in hepatocellular carcinoma: the LIDA-B phase I trial

International audienceBACKGROUND & AIMS:Idarubicin has high cytotoxicity on hepatocellular carcinoma (HCC) cells, high hepatic extraction ratio and high lipophilicity leading to stable emulsions with lipiodol. A dose-escalation phase I trial of idarubicin_lipiodol (without embolization) was conducted in cirrhotic patients with HCC to estimate the maximum-tolerated dose (MTD) and to assess safety, efficacy, pharmacokinetics, and health-related quality of life.METHODS:Patients underwent two sessions of treatment with a transarterial idarubicin_lipiodol emulsion without embolization. The idarubicin dose was escalated according to a modified continuous reassessment method. The MTD was defined as the dose closest to that causing dose-limiting toxicity (DLT) in 20% of patients.RESULTS:Fifteen patients were enrolled, including one patient at 10 mg, four patients at 15 mg, seven patients at 20 mg, and three patients at 25 mg. Two patients experienced DLT: oedematous ascitic decompensation and abdominal pain at 20, and 25 mg, respectively. The calculated MTD of idarubicin was 20 mg. The most frequent grade ≥3 adverse events were biological. One month after the second session, the objective response rate was 29% (complete response, 0%; partial response, 29%) by modified Response Evaluation Criteria In Solid Tumours. The median time to progression was 5.4 months (95%CI 3.0-14.6 months) and median overall survival was 20.6 months (95%CI 3.7-28.7 months). Pharmacokinetic analysis of idarubicin showed an interesting profile. Health-related quality of life results confirmed the good safety results.CONCLUSIONS:The MTD of idarubicin was 20 mg after two chemolipiodolization sessions. Encouraging safety, responses and survival were observed. A phase II trial has been scheduled.LAY SUMMARY:There is a need for transarterial regimens that improve responses and survival in unresectable HCC patients. In this phase I trial, we showed that two sessions of treatment with a transarterial idarubicin_lipiodol emulsion without embolization was well-tolerated and gave promising efficacy in terms of tumour control and survival.Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved