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2,373 results on '"Chevret Sylvie"'

1. Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis (RECORDS): study protocol for a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial

Author

Shidasp Siami, Charlène Le Moal, Thomas DAIX, Sylvie Chevret, Yonatan Perez, Constance Vuillard, Damien Roux, Jonathan Messika, Stephan Ehrmann, Jean-Pierre Quenot, Dalila Benzekri, Gwenhaël Colin, Thierry Boulain, Julie Mankikian, Laura Federici, Jean Reignier, Jean-Paul Mira, Marie-Ange Azais, Djillali Annane, Jean-Claude Lacherade, Grégoire Muller, Christine Lebert, Nicholas Heming, Arthur Bailly, Emmanuelle Mercier, Jean-Baptiste Lascarrou, Julio Badie, Louis-Marie Dumont, Gaetan Plantefeve, Francis Schneider, Patrice Tirot, Isabelle Vinatier, Mickael Landais, Michel Djibré, Bruno Francois, Alexandra Monnier, Francois Barbier, Ferhat Meziani, Hamid Merdji, Pascal Andreu, Julie Helms, Laetitia Bodet-Contentin, Nicolas Pichon, Noémie Zucman, Mehran Monchi, Xavier Monnet, Marie Labruyère, Denis Garot, Hassène Rahmani, Jérôme Fleuriet, Pierre-Louis Declerq, Adrien Robine, Fabrice Uhel, Charles Cerf, Gilles Troché, Alexandrou Antigoni, Annane Djillali, Arlt Birte, Badie Julio, Benghanem Sarah, Berdaguer Ferrari Fernando, Cerf Charles, Chelly Dagdia Zaineb, Chevret Sylvie, Colin Gwenhaël, Daniel Christel, Declercq Pierre-Louis, Delbove Agathe, Devillier Philippe, Fleuriet Jérome, François Bruno, Garchon Henri-Jean, Godot Véronique, Grassin-Delyle Stanislas, Grisolia Mathieu, Guitton Christophe, Helms Julie, Heming Nicholas, Herzog Marielle, Kamel Toufik, Kedad Zoubida, Lassalle Philippe, Lhermite Guillaume, Megarbane Bruno, Mekontso Dessap Armand, Mercier Emmanuelle, Meziani Ferhat, Mira Jean-Paul, Monchi Mehran, Monnet Xavier, Muller Grégoire, Quenot Jean-Pierre, Reignier Jean, Robine Adrien, Rottman Martin, Roux Anne-Laure, Schneider Francis, Siami Shidasp, Tissieres Pierre, Troché Gilles, Uhel Fabrice, Zeitouni Karine, Plantefève Gaëtan, Walid Darwiche, Antoine Guillon, Youenn Jouan, Annick Legras, Marlene Morisseau, Emmanuelle Rouve, Charlotte Salmon-Gandonniere, Raphael Clere-Jehl, Laure Stiel, Antoine Studer, Jean-Baptiste Roudaut, Marine Jacquier, Sophie Jacquier, Armelle Mathonnet, Mai-Anh Nai, Isabelle Runge, Sophie Tollec, Marc Amouretti, Pierre Moine, Paris Meng, Rania Bounab, Muriel-Sarah Fartoukh, Alexandre Elabbadi, Konstantinos Bachoumas, Remi Bernardon, Gauthier Blonz, Luc Desmedt, Brian Emonet, Maud Fiancette, Matthieu Henry, Julien Lorber, Laurent Martin-Lefevre, Caroline Pouplet, Aihem Yehia, Sarah Benghanem, Julien Charpentier, Clara Vigneron, Anne-Laure Fedou, Claire Mancia, Emmanuelle Begot, Philippe Vignon, Antoine Galy, Celine Gonzalez, Marine Goudelin, Bruno Evrard, Arnaud Desachy, Julien Vaidie, Guillaume Gilbert, Cedric Darreau, Benoit Derrien, Marjorie Saint-Martin, Nicolas Chudeau, Jean Christophe Callahan, Dominique Vivier, Pierre-Yves Olivier, Remy Marnai, Nicolas Sedillot, Xavier Tchenio, Yves Poncelin, Remi Bruyere, Grimaldi Lamiae, and Derridj Nawal

Subjects
Medicine
Abstract

Introduction Corticosteroids affect variably survival in sepsis trials, suggesting heterogeneity in patients’ response to corticosteroids. The RECORDS (Rapid rEcognition of COrticosteRoiD resistant or sensitive Sepsis) trial aimed at defining endotypes associated with adults with sepsis responsiveness to corticosteroids.Methods and analysis RECORDS, a multicentre, placebo-controlled, biomarker-guided, adaptive Bayesian design basket trial, will randomly assign to a biomarker stratum 1800 adults with community-acquired pneumonia, vasopressor-dependent sepsis, septic shock or acute respiratory distress syndrome. In each stratum, patients will be randomly assigned to receive a 7-day course of hydrocortisone and fludrocortisone or their placebos. Patients with COVID-19 will be treated with a 10-day standard course of dexamethasone and randomised to fludrocortisone or its placebo. Primary outcome will be 90-day death or persistent organ dysfunction. Large simulation study will be performed across a range of plausible scenarios to foresee power to detect a 5%–10% absolute difference with corticosteroids. We will assess subset-by-treatment interaction by estimating in a Bayesian framework two quantities: (1) measure of influence, relying on the value of the estimation of corticosteroids’ effect in each subset, and (2) measure of interaction.Ethics and dissemination The protocol was approved by the Ethics Committee (Comité de Protection des Personnes, Dijon, France), on 6 April 2020. Trial results will be disseminated at scientific conferences and results will be published in peer-reviewed journals.Trial registration number ClinicalTrials.gov Registry (NCT04280497).

Published
2023
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2. Transplantation for myelofibrosis patients in the ruxolitinib era: a registry study from the Société Francophone de Greffe de Moelle et de Thérapie Cellulaire

Author

Villar, Sara, Chevret, Sylvie, Poire, Xavier, Joris, Magalie, Chevallier, Patrice, Bourhis, Jean-Henri, Forcade, Edouard, Chantepie, Sylvain, Beauvais, David, Raus, Nicole, Bay, Jacques-Olivier, Loschi, Michael, Devillier, Raynier, Duléry, Remy, Ceballos, Patrice, Rubio, Marie Thérèse, Servais, Sophie, Nguyen, Stephanie, and Robin, Marie

Published
2024
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3. Clinical impact of genetic alterations including germline DDX41 mutations in MDS/low-blast count AML patients treated with azacitidine-based regimens

Author

Sébert, Marie, Freiman, Lucie, Chaffaut, Cendrine, Guerci, Agnès, Peterlin, Pierre, Thépot, Sylvain, Beyne-Rauzy, Odile, Park, Sophie, Cluzeau, Thomas, Chermat, Fatiha, Fenaux, Pierre, Preudhomme, Claude, Clappier, Emmanuelle, Chevret, Sylvie, Adès, Lionel, Duployez, Nicolas, and Duchmann, Matthieu

Published
2024
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4. Low cabotegravir trough concentrations without oral lead-in in patients with HIV-1 switching to long-acting cabotegravir and rilpivirine

Author

Rubenstein, Emma, Diemer, Myriam, Goldwirt, Lauriane, Lascoux-Combe, Caroline, Chaix, Marie-Laure, Rami, Agathe, Ponscarme, Diane, Lafaurie, Matthieu, Denis, Blandine, De Castro, Nathalie, Gras, Julien, Liegeon, Geoffroy, Sellier, Pierre-Olivier, Deville, Laure, Chevret, Sylvie, Delaugerre, Constance, and Molina, Jean-Michel

Published
2024
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5. Magnesium sulphate in patients with thrombotic thrombocytopenic purpura (MAGMAT): a randomised, double-blind, superiority trial

Author

Zafrani, Lara, Canet, Emmanuel, Walter-Petrich, Anouk, Joly-Laffargue, Bérangère, Veyradier, Agnès, Faguer, Stanislas, Bigé, Naïke, Calvet, Laure, Mayaux, Julien, Grangé, Steven, Rafat, Cédric, Poulain, Coralie, Klouche, Kada, Perez, Pierre, Pène, Frédéric, Pichereau, Claire, Duceau, Baptiste, Mariotte, Eric, Chevret, Sylvie, and Azoulay, Elie

Published
2023
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7. How to improve the quality of comparisons using external control cohorts in single-arm clinical trials?

Author

Lambert, Jérôme, Lengline, Etienne, Porcher, Raphaël, Thiébaut, Rodolphe, Zohar, Sarah, and Chevret, Sylvie

Subjects
Statistics - Applications, Statistics - Methodology
Abstract

PURPOSE Providing rapid answers and early acces to patients to innovative treatments without randomized clinical trial (RCT) is growing, with benefit estimated from single-arm trials. This has become common in oncology, impacting the approval pathway of health technology assessment agencies. We aimed to provide some guidance for indirect comparison to external controls to improve the level of evidence following such uncontrolled designs. METHODS We used the illustrative example of blinatumomab, a bispecific antibody for the treatment of B-cell ALL in complete remission (CR) with persistent minimal residual disease (MRD). Its approval relied on a single-arm trial conducted in 86 adults with B-cell ALL in CR, with undetectable MRD after one cycle as the main endpoint. To maximize the validity of indirect comparisons, a 3-step process for incorporating external control data to such single-arm trial data is proposed and detailed, with emphasis on the example. RESULTS The first step includes the definition of estimand, i.e. the treatment effect reflecting the clinical question. The second step relies on the adequate selection of external controls, from previous RCT or real-world data (RWD) obtained from patient cohort, registries, or electronic patient files. The third step consists in chosing the statistical approach targeting the treatment effect of interest, either in the whole population or restricted to the single-arm trial or the external controls, and depending on the available individual-level or aggregrated external data. CONCLUSION Validity of treatment effect derived from indirect comparisons heavily depends on carefull methodological considerations that are included in the proposed 3-step procedure. Because the level of evidence of a well conducted RCT cannot be guaranteed, post-market authorization evaluation is even more important than in standard settings., Comment: 12 pages;1 table; 2figures

Published
2022

8. Nilotinib with or without cytarabine for Philadelphia-positive acute lymphoblastic leukemia

Author

Chalandon, Yves, Rousselot, Philippe, Chevret, Sylvie, Cayuela, Jean-Michel, Kim, Rathana, Huguet, Françoise, Chevallier, Patrice, Graux, Carlos, Thiebaut-Bertrand, Anne, Chantepie, Sylvain, Thomas, Xavier, Vincent, Laure, Berthon, Céline, Hicheri, Yosr, Raffoux, Emmanuel, Escoffre-Barbe, Martine, Plantier, Isabelle, Joris, Magalie, Turlure, Pascal, Pasquier, Florence, Belhabri, Amine, Guepin, Gabrielle Roth, Blum, Sabine, Gregor, Michael, Lafage-Pochitaloff, Marina, Quessada, Julie, Lhéritier, Véronique, Clappier, Emmanuelle, Boissel, Nicolas, and Dombret, Hervé

Published
2024
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18. Bayesian model for early dose-finding in phase I trials with multiple treatment courses

Author

Ursino, Moreno, Biard, Lucie, and Chevret, Sylvie

Subjects
Statistics - Methodology
Abstract

Dose-finding clinical trials in oncology aim to determine the maximum tolerated dose (MTD) of a new drug, generally defined by the proportion of patients with short-term dose-limiting toxicities (DLTs). Model-based approaches for such phase I oncology trials have been widely designed and are mostly restricted to the DLTs occurring during the first cycle of treatment, although patients continue to receive treatment for multiple cycles. We aim to estimate the probability of DLTs over sequences of treatment cycles via a Bayesian cumulative modeling approach, where the probability of DLT is modeled taking into account the cumulative effect of the administered drug and the DLT cycle of occurrence. We propose a design, called DICE (Dose-fInding CumulativE), for dose escalation and de-escalation according to previously observed toxicities, which aims at finding the MTD sequence (MTS). We performed an extensive simulation study comparing this approach to the time-to-event continual reassessment method (TITE-CRM) and to a benchmark. In general, our approach achieved a better or comparable percentage of correct MTS selection. Moreover, we investigated the DICE prediction ability.

Published
2020

21. Hepatocyte-derived biomarkers predict liver-related events at 2 years in Child-Pugh class A alcohol-related cirrhosis

Author

Elkrief, Laure, Ganne-Carrié, Nathalie, Manceau, Hana, Tanguy, Marion, Valainathan, Shantha Ram, Riescher-Tuczkiewicz, Alix, Biquard, Louise, Barget, Nathalie, Chaffaut, Cendrine, Louvet, Alexandre, Paradis, Valérie, Ziol, Marianne, Bæk, Rikke, Jørgensen, Malene Møller, Van Niel, Guillaume, Coly, Pierre-Michael, Hammoutène, Adel, Dujardin, Fanny, Peoc’h, Katell, Poynard, Thierry, Chevret, Sylvie, and Rautou, Pierre-Emmanuel

Published
2023
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22. Evaluation of the Propensity score methods for estimating marginal odds ratios in case of small sample size

Author

Pirracchio Romain, Resche-Rigon Matthieu, and Chevret Sylvie

Subjects
Propensity scores, Propensity score matching, Inverse probability weighting, Small sample size, Simulation, Medicine (General), R5-920
Abstract

Abstract Background Propensity score (PS) methods are increasingly used, even when sample sizes are small or treatments are seldom used. However, the relative performance of the two mainly recommended PS methods, namely PS-matching or inverse probability of treatment weighting (IPTW), have not been studied in the context of small sample sizes. Methods We conducted a series of Monte Carlo simulations to evaluate the influence of sample size, prevalence of treatment exposure, and strength of the association between the variables and the outcome and/or the treatment exposure, on the performance of these two methods. Results Decreasing the sample size from 1,000 to 40 subjects did not substantially alter the Type I error rate, and led to relative biases below 10%. The IPTW method performed better than the PS-matching down to 60 subjects. When N was set at 40, the PS matching estimators were either similarly or even less biased than the IPTW estimators. Including variables unrelated to the exposure but related to the outcome in the PS model decreased the bias and the variance as compared to models omitting such variables. Excluding the true confounder from the PS model resulted, whatever the method used, in a significantly biased estimation of treatment effect. These results were illustrated in a real dataset. Conclusion Even in case of small study samples or low prevalence of treatment, PS-matching and IPTW can yield correct estimations of treatment effect unless the true confounders and the variables related only to the outcome are not included in the PS model.

Published
2012
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23. Benefits of ICU admission in critically ill patients: Whether instrumental variable methods or propensity scores should be used

Author

Payen Didier, Sprung Charles, Pirracchio Romain, and Chevret Sylvie

Subjects
Causal inference, Instrumental variables, Dichotomous outcome, Mortality, ICU, Medicine (General), R5-920
Abstract

Abstract Background The assessment of the causal effect of Intensive Care Unit (ICU) admission generally involves usual observational designs and thus requires controlling for confounding variables. Instrumental variable analysis is an econometric technique that allows causal inferences of the effectiveness of some treatments during situations to be made when a randomized trial has not been or cannot be conducted. This technique relies on the existence of one variable or "instrument" that is supposed to achieve similar observations with a different treatment for "arbitrary" reasons, thus inducing substantial variation in the treatment decision with no direct effect on the outcome. The objective of the study was to assess the benefit in terms of hospital mortality of ICU admission in a cohort of patients proposed for ICU admission (ELDICUS cohort). Methods Using this cohort of 8,201 patients triaged for ICU (including 6,752 (82.3%) patients admitted), the benefit of ICU admission was evaluated using 3 different approaches: instrumental variables, standard regression and propensity score matched analyses. We further evaluated the results obtained using different instrumental variable methods that have been proposed for dichotomous outcomes. Results The physician's main specialization was found to be the best instrument. All instrumental variable models adequately reduced baseline imbalances, but failed to show a significant effect of ICU admission on hospital mortality, with confidence intervals far higher than those obtained in standard or propensity-based analyses. Conclusions Instrumental variable methods offer an appealing alternative to handle the selection bias related to nonrandomized designs, especially when the presence of significant unmeasured confounding is suspected. Applied to the ELDICUS database, this analysis failed to show any significant beneficial effect of ICU admission on hospital mortality. This result could be due to the lack of statistical power of these methods.

Published
2011
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24. Joint modeling of multivariate longitudinal data and the dropout process in a competing risk setting: application to ICU data

Author

Deslandes Emmanuelle and Chevret Sylvie

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Joint modeling of longitudinal and survival data has been increasingly considered in clinical trials, notably in cancer and AIDS. In critically ill patients admitted to an intensive care unit (ICU), such models also appear to be of interest in the investigation of the effect of treatment on severity scores due to the likely association between the longitudinal score and the dropout process, either caused by deaths or live discharges from the ICU. However, in this competing risk setting, only cause-specific hazard sub-models for the multiple failure types data have been used. Methods We propose a joint model that consists of a linear mixed effects submodel for the longitudinal outcome, and a proportional subdistribution hazards submodel for the competing risks survival data, linked together by latent random effects. We use Markov chain Monte Carlo technique of Gibbs sampling to estimate the joint posterior distribution of the unknown parameters of the model. The proposed method is studied and compared to joint model with cause-specific hazards submodel in simulations and applied to a data set that consisted of repeated measurements of severity score and time of discharge and death for 1,401 ICU patients. Results Time by treatment interaction was observed on the evolution of the mean SOFA score when ignoring potentially informative dropouts due to ICU deaths and live discharges from the ICU. In contrast, this was no longer significant when modeling the cause-specific hazards of informative dropouts. Such a time by treatment interaction persisted together with an evidence of treatment effect on the hazard of death when modeling dropout processes through the use of the Fine and Gray model for sub-distribution hazards. Conclusions In the joint modeling of competing risks with longitudinal response, differences in the handling of competing risk outcomes appear to translate into the estimated difference in treatment effect on the longitudinal outcome. Such a modeling strategy should be carefully defined prior to analysis.

Published
2010
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25. Impact of age, leukocyte count and day 21-bone marrow response to chemotherapy on the long-term outcome of children with philadelphia chromosome-positive acute lymphoblastic leukemia in the pre-imatinib era: results of the FRALLE 93 study

Author

Debre Marianne, Lejars Odile, Stephan Jean-Louis, Piguet Christophe, Schmitt Claudine, Demeocq Francois, Le Gall Edouard, Vannier Jean-Pierre, Perel Yves, Auclerc Marie-Francoise, Gandemer Virginie, Jonveaux Philippe, Cayuela Jean-Michel, Chevret Sylvie, Leverger Guy, and Baruchel Andre

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background We explored the heterogeneity of philadelphia chromosome-positive acute lymphoblastic leukemia (Ph1-ALL) in a study of the effect of early features on prognosis in children. Here we report the long-term results of the FRALLE 93 study conducted in the era before the use of tyrosine kinase inhibitors. Methods Between 1993 and 1999, 36 children with Ph1-ALL were enrolled into the FRALLE 93 protocol. After conventional four-drug induction, children were stratified by availability of an HLA-matched sibling. Results Complete remission (CR) was observed in 26 children (72%), of which 13 underwent allogeneic bone marrow transplantation (BMT). Thirty-one children were good responders to prednisone, defined on day 8, and 21 were good responders to chemotherapy, defined by day-21 bone marrow (M1). Overall five-year disease-free survival (DFS) was 42 ± 9.7%. Based on multivariate analysis, two groups showed marked differences in five-year outcome: children with age3 and day-21 M1 marrow had a more favorable prognosis (14 pts: 100% CR, event free survival [EFS]: 57%, overall survival [OS]: 79%), than the high-risk group (22 patients: 55% CR, EFS: 18%, OS: 27%) (p < 0.005). We also observed a non statistically significant difference (p = 0.14) in outcome between these groups for transplanted patients (5-year DFS: 83 ± 14% and 33 ± 15%, respectively). Conclusion Age, leukocyte count and early response to treatment defined by the D21 bone marrow response provide an accurate model for outcome prediction. The combination of available tools such as minimal residual disease assessment with determination of these simple factors could be useful for refining indications for BMT in the current era of tyrosine-kinase inhibitor-based therapy.

Published
2009
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26. Pembrolizumab in patients with rare and ultra-rare sarcomas (AcSé Pembrolizumab): analysis of a subgroup from a non-randomised, open-label, phase 2, basket trial

Author

Blay, Jean-Yves, Chevret, Sylvie, Le Cesne, Axel, Brahmi, Mehdi, Penel, Nicolas, Cousin, Sophie, Bertucci, Francois, Bompas, Emmanuelle, Ryckewaert, Thomas, Soibinet, Pauline, Boudou-Rouquette, Pascaline, Saada Bouzid, Esma, Soulie, Patrick, Valentin, Thibaud, Lotz, Jean-Pierre, Tosi, Diego, Neviere, Zoé, Cancel, Mathilde, Ray-Coquard, Isabelle, Gambotti, Laetitia, Legrand, Frédéric, Lamrani-Ghaouti, Assia, Simon, Clotilde, Even, Caroline, and Massard, Christophe

Published
2023
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28. CPX-351 in higher risk myelodysplastic syndrome and chronic myelomonocytic leukaemia: a multicentre, single-arm, phase 2 study

Author

Peterlin, Pierre, Le Bris, Yannick, Turlure, Pascal, Chevallier, Patrice, Ménard, Audrey, Gourin, Marie-Pierre, Dumas, Pierre-Yves, Thepot, Sylvain, Berceanu, Ana, Park, Sophie, Hospital, Marie-Anne, Cluzeau, Thomas, Bouzy, Simon, Torregrosa-Diaz, Jose-Miguel, Drevon, Louis, Sapena, Rosa, Chermat, Fatiha, Ades, Lionel, Dimicoli-Salazar, Sophie, Chevret, Sylvie, Béné, Marie-Christine, and Fenaux, Pierre

Published
2023
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29. Anticoagulation improves survival in patients with cirrhosis and portal vein thrombosis: The IMPORTAL competing-risk meta-analysis

Author

Valla, Dominique, Durand, Francois, Artaza, Tomás, García-Pagán, Juan Carlos, Magaz, Marta, La Mura, Vincenzo, Primignani, Massimo, Luca, Angelo, Stanciu, Carol, Senzolo, Marco, Amitrano, Lucio, Stefanescu, Horia, Nery, Filipe, Chevret, Sylvie, Girleanu, Irina, Guerrero, Antonio, Campo, Laura del, Piscaglia, Fabio, Scheiner, Bernhard, Han, Guohong, Violi, Francesco, Ferreira, Carlos-Noronha, Téllez, Luis, Reiberger, Thomas, Basili, Stefania, Zamora, Javier, and Albillos, Agustín

Published
2023
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30. Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant data.

Author

Annane, Djillali, Pirracchio, Romain, Billot, Laurent, Waschka, Andre, Chevret, Sylvie, Cohen, Jeremy, Finfer, Simon, Gordon, Anthony, Hammond, Naomi, Myburgh, John, Venkatesh, Balasubramanian, Delaney, Anthony, and ULYSSES IPDMA Collaborators

Subjects
ULYSSES IPDMA Collaborators, Humans, Shock, Septic, Hydrocortisone, Fludrocortisone, Adult, Caribbean Region, Meta-Analysis as Topic, adult intensive & critical care, clinical pharmacology, clinical trials, adult intensive &amp, critical care, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

IntroductionThe benefits and risks of low-dose hydrocortisone in patients with septic shock have been investigated in numerous randomised controlled trials and trial-level meta-analyses. Yet, the routine use of this treatment remains controversial. To overcome the limitations of previous meta-analyses inherent to the use of aggregate data, we will perform an individual patient data meta-analysis (IPDMA) on the effect of hydrocortisone with or without fludrocortisone compared with placebo or usual care on 90-day mortality and other outcomes in patients with septic shock.Methods and analysisTo assess the benefits and risks of hydrocortisone, with or without fludrocortisone for adults with septic shock, we will search major electronic databases from inception to September 2020 (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and Latin American Caribbean Health Sciences Literature), complimented by a search for unpublished trials. The primary analysis will compare hydrocortisone with or without fludrocortisone to placebo or no treatment in adult patients with septic shock. Secondary analyses will compare hydrocortisone to placebo (or usual care), hydrocortisone plus fludrocortisone to placebo (or usual care), and hydrocortisone versus hydrocortisone plus fludrocortisone. The primary outcome will be all cause mortality at 90 days. We will conduct both one-stage IPDMA using mixed-effect models and machine learning with targeted maximum likelihood analyses. We will assess the risk of bias related to unshared data and related to the quality of individual trial.Ethics and disseminationThis IPDMA will use existing data from completed randomised clinical trials and will comply with the ethical and regulatory requirements regarding data sharing for each of the component trials. The findings of this study will be submitted for publication in a peer-review journal with straightforward policy for open access.Prospero registration numberCRD42017062198.

Published
2020

31. A Phase II prospective trial of azacitidine in steroid-dependent or refractory systemic autoimmune/inflammatory disorders and VEXAS syndrome associated with MDS and CMML

Author

Mekinian, Arsene, Zhao, Lin Pierre, Chevret, Sylvie, Desseaux, Kristell, Pascal, Laurent, Comont, Thibaut, Maria, Alexandre, Peterlin, Pierre, Terriou, Louis, D’Aveni Piney, Maud, Gourin, Marie-Pierre, Vey, Norbert, Rauzy, Odile Beyne, Grobost, Vincent, Bezanahary, Holy, Dimicoli-Salazar, Sophie, Banos, Anne, Wickenhauser, Stefan, De Renzis, Benoit, Durot, Eric, Natarajan-Amé, Shanti, Voillat, Laurent, Chermat, Fatiha, Lemaire, Karine, Jachiet, Vincent, Himberlin, Chantal, Thépot, Sylvain, Diaz, Jose Miguel Torregrosa, Frenzel, Laurent, Gyan, Emmanuel, Denis, Guillaume, Hirsch, Pierre, Kosmider, Olivier, Ades, Lionel, Fain, Olivier, and Fenaux, Pierre

Published
2022
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32. Bayesian models for survival data of clinical trials: Comparison of implementations using R software

Author

Biard, Lucie, Bergeron, Anne, and Chevret, Sylvie

Subjects
Statistics - Computation, Statistics - Applications
Abstract

Objective: To provide guidance for the use of the main functions available in R for performing post hoc Bayesian analysis of a randomized clinical trial with a survival endpoint using proportional hazard models. Study Design and Setting: Data derived from the ALLOZITHRO trial, conducted with 465 patients after allograft to prevent pulmonary complications and allocated between azithromycin and placebo; airflow decline-free survival at 2 years after randomization was the main endpoint. Results: Despite heterogeneity in modeling assumptions, in particular for the baseline hazard (parametric or nonparametric), and in estimation methods, Bayesian posterior mean hazard ratio (HR) estimates of azithromycin effect were close to those obtained by the maximum likelihood approach. Conclusion: Bayesian models can be implemented using various R packages, providing results in close agreement with the maximum likelihood estimates. These models provide probabilistic statements that could not be obtained otherwise., Comment: 21 pages, 8 figures (5 as supplementary material), 5 tables (4 as supplementary material); Corrected typos in arXiv abstract

Published
2019

33. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study

Author

de Masson, Adèle, Beylot-Barry, Marie, Ram-Wolff, Caroline, Mear, Jean-Baptiste, Dalle, Stéphane, d'Incan, Michel, Ingen-Housz-Oro, Saskia, Orvain, Corentin, Abraham, Julie, Dereure, Olivier, Charbonnier, Amandine, Cornillon, Jérôme, Longvert, Christine, Barete, Stéphane, Boulinguez, Serge, Wierzbicka-Hainaut, Ewa, Aubin, François, Rubio, Marie-Thérèse, Bernard, Marc, Schmidt-Tanguy, Aline, Houot, Roch, Pham-Ledard, Anne, Michonneau, David, Brice, Pauline, Labussière-Wallet, Hélène, Bouaziz, Jean-David, Grange, Florent, Moins-Teisserenc, Hélène, Jondeau, Katayoun, Michel, Laurence, Mourah, Samia, Battistella, Maxime, Daguindau, Etienne, Loschi, Michael, Picard, Alexandra, Franck, Nathalie, Maillard, Natacha, Huynh, Anne, Nguyen, Stéphanie, Marçais, Ambroise, Chaby, Guillaume, Ceballos, Patrice, Le Corre, Yannick, Maury, Sébastien, Bay, Jacques-Olivier, Adamski, Henri, Bachy, Emmanuel, Forcade, Edouard, Socié, Gérard, Bagot, Martine, Chevret, Sylvie, Peffault de Latour, Régis, and de Latour, Régis Peffault

Published
2023
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35. Integrating genetic variants into clinical models for hepatocellular carcinoma risk stratification in cirrhosis

Author

Nahon, Pierre, Asselah, Tarik, Guyader, Dominique, Pol, Stanislas, Fontaine, Hélène, Pageaux, Georges-Philippe, De Lédinghen, Victor, Ouzan, Denis, Zoulim, Fabien, Roulot, Dominique, Tran, Albert, Bronowicki, Jean-Pierre, Decaensi, Thomas, Riachi, Ghassan, Calès, Paul, Péron, Jean-Marie, Alric, Laurent, Bourlière, Marc, Mathurin, Philippe, Dharancy, Sebastien, Blanc, Jean-Frédéric, Abergel, Armand, Chazouillères, Olivier, Mallat, Ariane, Grangé, Jean-Didier, Attali, Pierre, Louis d’Alteroche, Wartelle, Claire, Dao, Thông, Thabut, Dominique, Pilette, Christophe, Silvain, Christine, Christidis, Christos, Nguyen-Khac, Eric, Bernard-Chabert, Brigitte, Hillaire, Sophie, Di Martino, Vincent, Ganne-Carrié, Nathalie, Chaffaut, Cendrine, Archambeaud, Isabelle, d’Alteroche, Louis, Oberti, Frédéric, Moreno, Christophe, Louvet, Alexandre, Moirand, Romain, Goria, Odile, Carbonell, Nicolas, Duclos-Vallée, Jean-Charles, de Ledinghen, Victor, Ozenne, Violaine, Henrion, Jean, Perlemuter, Gabriel, Amiot, Xavier, Zarski, Jean-Pierre, Chevret, Sylvie, Bamba-Funck, Jessica, Layese, Richard, Trépo, Eric, Zucman-Rossi, Jessica, Cagnot, Carole, Guyot, Erwan, Ziol, Marianne, Sutton, Angela, and Audureau, Etienne

Published
2023
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36. Low alcohol consumption influences outcomes in individuals with alcohol-related compensated cirrhosis in a French multicenter cohort

Author

Ganne-Carrié, Nathalie, Bourcier, Valérie, Chaffaut, Cendrine, Chevret, Sylvie, Archambeaud, Isabelle, Gournay, Jérôme, Louis d’Alteroche, Elkrief, Laure, Oberti, Frédéric, Fouchard-Hubert, Isabelle, Roulot, Dominique, Moreno, Christophe, Louvet, Alexandre, Dao, Thông, Moirand, Romain, Duclos-Vallée, Jean-Charles, Goria, Odile, Nguyen-Khac, Eric, Pol, Stanislas, Carbonell, Nicolas, Péron, Jean-Marie, de Lédinghen, Victor, Ozenne, Violaine, Henrion, Jean, Tran, Albert, Perlemuter, Gabriel, Amiot, Xavier, Zarski, Jean-Pierre, and d’Alteroche, Louis

Published
2023
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39. Impact of in vivo T-cell depletion in patients with myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplant: a registry study from the Chronic Malignancies Working Party of the EBMT

Author

Forcade, Edouard, Chevret, Sylvie, Finke, Jürgen, Ehninger, Gerhard, Ayuk, Francis, Beelen, Dietrich, Koster, Linda, Ganser, Arnold, Volin, Liisa, Sengeloev, Henrik, Michallet, Mauricette, Tischer, Johanna, Jindra, Pavel, Cascon, Maria Jesús Pascual, Koc, Yener, Arat, Mutlu, Tomaszewska, Agnieszka, Hayden, Patrick, de Witte, Theo, Yakoub-Agha, Ibrahim, Kröger, Nicolaus, and Robin, Marie

Published
2022
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40. Safety and efficacy of nivolumab, an anti-PD1 immunotherapy, in patients with advanced basal cell carcinoma, after failure or intolerance to sonic Hedgehog inhibitors: UNICANCER AcSé NIVOLUMAB trial

Author

Véron, Marie, Chevret, Sylvie, Grob, Jean-Jacques, Beylot-Barry, Marie, Saiag, Philippe, Fléchon, Aude, You, Benoit, Maubec, Eve, Jouary, Thomas, Toulemonde, Elise, Jamme, Philippe, Gambotti, Laëtitia, Lamrani-Ghaouti, Assia, Dupuy, Alain, Lebbe, Céleste, Seguin, Nicole Basset, Houede, Nadine, Leccia, Marie-Thérèse, Le Du, Fanny, de Pontville, Michel, Gaudy-Marquestre, Caroline, Guillot, Bernard, Simon, Clotilde, Marabelle, Aurélien, and Mortier, Laurent

Published
2022
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42. Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma versus standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI)

Author

Song, Alice T.W., Rocha, Vanderson, Mendrone-Júnior, Alfredo, Calado, Rodrigo T., De Santis, Gil C., Benites, Bruno D., Costa-Lima, Carolina, Vargas, Taiani, Marques, Leonardo S., Fernandes, Juliana C., Breda, Felipe C., Wendel, Silvano, Fachini, Roberta, Rizzo, Luiz V., Kutner, José Mauro, Avelino-Silva, Vivian I., Machado, Rafael R.G., Durigon, Edison L., Chevret, Sylvie, and Kallas, Esper G.

Published
2022
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43. Effect of early granulocyte-colony-stimulating factor administration in the prevention of febrile neutropenia and impact on toxicity and efficacy of anti-CD19 CAR-T in patients with relapsed/refractory B-cell lymphoma

Author

Liévin, Raphaël, Di Blasi, Roberta, Morin, Florence, Galli, Eugenio, Allain, Vincent, De Jorna, Romain, Vercellino, Laetitia, Parquet, Nathalie, Mebarki, Miryam, Larghero, Jerome, de Kerviler, Eric, Madelaine, Isabelle, Caillat-Zucman, Sophie, Chevret, Sylvie, and Thieblemont, Catherine

Published
2022
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48. A three-step support strategy for relatives of patients dying in the intensive care unit: a cluster randomised trial

Author

Kentish-Barnes, Nancy, Chevret, Sylvie, Valade, Sandrine, Jaber, Samir, Kerhuel, Lionel, Guisset, Olivier, Martin, Maëlle, Mazaud, Amélie, Papazian, Laurent, Argaud, Laurent, Demoule, Alexandre, Schnell, David, Lebas, Eddy, Ethuin, Frédéric, Hammad, Emmanuelle, Merceron, Sybille, Audibert, Juliette, Blayau, Clarisse, Delannoy, Pierre-Yves, Lautrette, Alexandre, Lesieur, Olivier, Renault, Anne, Reuter, Danielle, Terzi, Nicolas, Philippon-Jouve, Bénédicte, Fiancette, Maud, Ramakers, Michel, Rigaud, Jean-Philippe, Souppart, Virginie, Asehnoune, Karim, Champigneulle, Benoît, Goldgran-Toledano, Dany, Dubost, Jean-Louis, Bollaert, Pierre-Edouard, Chouquer, Renaud, Pochard, Frédéric, Cariou, Alain, and Azoulay, Elie

Published
2022
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49. Early hepatocellular carcinoma detection using magnetic resonance imaging is cost-effective in high-risk patients with cirrhosis

Author

Nahon, Pierre, Asselah, Tarik, Guyader, Dominique, Pol, Stanislas, Fontaine, Hélène, Pageaux, Georges-Philippe, De Lédinghen, Victor, Ouzan, Denis, Zoulim, Fabien, Roulot, Dominique, Tran, Albert, Bronowicki, Jean-Pierre, Decaensi, Thomas, Riachi, Ghassan, Calès, Paul, Péron, Jean-Marie, Alric, Laurent, Bourlière, Marc, Mathurin, Philippe, Dharancy, Sebastien, Blanc, Jean-Frédéric, Abergel, Armand, Chazouillères, Olivier, Mallat, Ariane, Grangé, Jean-Didier, Attali, Pierre, d’Alteroche, Louis, Wartelle, Claire, Dao, Thông, Thabut, Dominique, Pilette, Christophe, Silvain, Christine, Christidis, Christos, Nguyen-Khac, Eric, Bernard-Chabert, Brigitte, Hillaire, Sophie, Di Martino, Vincent, Bonnet, Delphine, Payssan-Sicart, Virginie, Pomes, Chloe, Bailly, François, Beaudoin, Marjolaine, Giboz, Dominique, Hartig-Lavie, Kerstin, Maynard, Marianne, Billaud, Eric, Boutoille, David, Cavellec, Morane, Cheraud-Carpentier, Marjorie, Hubert, Isabelle, Benhida, Jaouad, Lannes, Adrien, Lunel, Françoise, Oberti, Frédéric, Boyer, Nathalie, Giuily, Nathalie, Castelnau, Corinne, Scoazec, Giovanna, Chibah, Aziza, Keser, Sylvie, Bonardi, Karim, Vallet-Pichard, Anaïs, Sogni, Philippe, Foucher, Juliette, Hiriart, Jean-Baptiste, Wilson, Amy, Shili, Sarah, Chermak, Faiza, Ansaldi, Christelle, Ben Amara, Nisserine, Chouquet, Laëtitia, De Luca, Emilie, Oules, Valérie, Anty, Rodolphe, Gelsi, Eve, Truchi, Régine, Luckina, Elena, Messaoudi, Nadia, Moussali, Joseph, De Dieuleveult, Barbara, Labarriere, Damien, Poter, Pascal, Si Ahmed, Si Nafa, Grando-Lemaire, Véronique, Bourcier, Valérie, Brulé, Séverine, Stalhberger, Thomas, Jezequel, Caroline, Brener, Audrey, Laligant, Anne, Rabot, Aline, Renard, Isabelle, Baumert, Thomas F., Dofföel, Michel, Mutter, Catherine, Simo-Noumbissie, Pauline, Razi, Esma, Barraud, Hélène, Bensenane, Mouni, Nani, Abdelbasset, Hassani-Nani, Sarah, Bernard, Marie-Albertine, Bismuth, Michael, Caillo, Ludovic, Faure, Stéphanie, Ripault, Marie Pierre, Bureau, Christophe, Peron, Jean Marie, Robic, Marie Angèle, Tarallo, Léa, Faure, Marine, Froissart, Bruno, Hilleret, Marie-Noelle, Zarski, Jean-Pierre, Goria, Odile, Grard, Victorien, Montialoux, Hélène, François, Muriel, Ouedraogo, Christian, Pauleau, Christelle, Varault, Anne, Andreani, Tony, Angoulevant, Bénédicte, Chevance, Azeline, Serfaty, Lawrence, Antonini, Teresa, Coilly, Audrey, Duclos Vallée, Jean-Charles, Tateo, Mariagrazia, Bonny, Corinne, Brigitte, Chanteranne, Lamblin, Géraldine, Muti, Léon, Babouri, Abdenour, Filipe, Virginie, Barrault, Camille, Costes, Laurent, Hagège, Hervé, Merbah, Soraya, Carrier, Paul, Debette-Gratien, Maryline, Jacques, Jérémie, Lassailly, Guillaume, Artu, Florent, Canva, Valérie, Dharancy, Sébastien, Louvet, Alexandre, Latournerie, Marianne, Bardou, Marc, Mouillot, Thomas, Bacq, Yannick, Barbereau, Didier, Nicolas, Charlotte, Chevalier, Caroline, Archambeaud, Isabelle, Habes, Sarah, Botta-Fridlund, Danièle, Saillard, Eric, Lafrance, Marie-Josée, Cacoub, Patrice, Carrat, Fabrice, Carrieri, Patrizia, Delarocque-Astagneau, Elisabeth, De Ledinghen, Victor, Dorival, Céline, Dubuisson, Jean, Housset, Chantal, Larrey, Dominique, Marcellin, Patrick, Pawlotsky, Jean-Michel, Petrov-Sanchez, Ventzislava, Vaux, Sophie, Wittkop, Linda, Yazdanpanah, Yazdan, Zucman-Rossi, Jessica, Ganne-Carrié, Nathalie, Chaffaut, Cendrine, Moreno, Christophe, Moirand, Romain, Carbonell, Nicolas, Duclos-Vallée, Jean-Charles, de Ledinghen, Victor, Ozenne, Violaine, Henrion, Jean, Perlemuter, Gabriel, Amiot, Xavier, Chevret, Sylvie, Najean, Marie, Layese, Richard, Zarca, Kevin, Segar, Laeticia Blampain, Cagnot, Carole, N’Kontchou, Gisèle, Ronot, Maxime, Audureau, Etienne, and Durand-Zaleski, Isabelle

Published
2022
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50. Two‐stage randomized clinical trials with a right‐censored endpoint: Comparison of frequentist and Bayesian adaptive designs.

Author

Boumendil, Luana, Chevret, Sylvie, Lévy, Vincent, and Biard, Lucie

Subjects
*CLINICAL trials, *CHRONIC lymphocytic leukemia, *FALSE positive error, *OLDER patients, *ERROR rates, *ELECTRICAL impedance tomography
Abstract

Adaptive randomized clinical trials are of major interest when dealing with a time‐to‐event outcome in a prolonged observation window. No consensus exists either to define stopping boundaries or to combine p$$ p $$ values or test statistics in the terminal analysis in the case of a frequentist design and sample size adaptation. In a one‐sided setting, we compared three frequentist approaches using stopping boundaries relying on α$$ \alpha $$‐spending functions and a Bayesian monitoring setting with boundaries based on the posterior distribution of the log‐hazard ratio. All designs comprised a single interim analysis with an efficacy stopping rule and the possibility of sample size adaptation at this interim step. Three frequentist approaches were defined based on the terminal analysis: combination of stagewise statistics (Wassmer) or of p$$ p $$ values (Desseaux), or on patientwise splitting (Jörgens), and we compared the results with those of the Bayesian monitoring approach (Freedman). These different approaches were evaluated in a simulation study and then illustrated on a real dataset from a randomized clinical trial conducted in elderly patients with chronic lymphocytic leukemia. All approaches controlled for the type I error rate, except for the Bayesian monitoring approach, and yielded satisfactory power. It appears that the frequentist approaches are the best in underpowered trials. The power of all the approaches was affected by the violation of the proportional hazards (PH) assumption. For adaptive designs with a survival endpoint and a one‐sided alternative hypothesis, the Wassmer and Jörgens approaches after sample size adaptation should be preferred, unless violation of PH is suspected. [ABSTRACT FROM AUTHOR]

Published
2024
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