10 results on '"Sophie Dalac‐Rat"'
Search Results
2. Cutaneous vasculitis associated with mycosis fungoides
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Charlée Nardin, Candice Lesage, Eléonore Goubeau, Marie‐Helene Aubriot‐Lorton, Vanessa Lacheretz‐Szablewski, Nicolas Ortonne, Ines Saizonou, François Aubin, Olivier Dereure, and Sophie Dalac‐Rat
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Infectious Diseases ,Dermatology - Published
- 2022
3. An open label, non-randomised, phase IIIb study of trametinib in combination with dabrafenib in patients with unresectable (stage III) or distant metastatic (stage IV) BRAF V600-mutant melanoma: A subgroup analysis of patients with brain metastases
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Caroline Dutriaux, Caroline Robert, Jean-Jacques Grob, Laurent Mortier, Olivier Dereure, Céleste Lebbe, Sandrine Mansard, Florent Grange, Eve-Marie Neidhardt, Thierry Lesimple, Laurent Machet, Christophe Bedane, Hervé Maillard, Sophie Dalac-Rat, Charlée Nardin, Alexandra Szenik, Amine Denden, and Philippe Saiag
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Male ,Mitogen-Activated Protein Kinase Kinases ,Proto-Oncogene Proteins B-raf ,Cancer Research ,Brain Neoplasms ,Pyridones ,Imidazoles ,Pyrimidinones ,Oncology ,Antineoplastic Combined Chemotherapy Protocols ,Mutation ,Oximes ,Humans ,Lactate Dehydrogenases ,Melanoma - Abstract
Despite the poor prognosis associated with melanoma brain metastases (BM), data concerning these patients and their inclusion in clinical trials remains scarce. We report here the efficacy results of a subgroup analysis in patients with BRAFV600-mutant melanoma and BM treated with BRAF and MEK inhibitors dabrafenib (D) and trametinib (T).This phase IIIb single-arm, open-label, multicenter, French study included patients with unresectable stage IIIc or IV BRAFV600-mutant melanoma with or without BM. The present analysis focuses on patients with BM. Response rates were determined clinically and/or radiologically as per standard clinical practice. Progression-free survival (PFS) was estimated using the Kaplan Meier analysis and modelled with multivariate Cox regression model. Risk subgroups were identified using an exponential regression tree analysis. Significance was set at plt; 0.05.Between March 2015 and November 2016, 856 patients were included and 275 (32%) patients had BM. Median PFS was 5.68 months (95% confidence interval [CI], 5.29-6.87). Significant independent factors associated with shorter PFS were ECOG ≥1, elevated serum lactate dehydrogenase (LDH), ≥3 metastatic sites, and non-naïve status. The binary-split classification and regression tree modelling identified baseline LDH and ECOG status as major prognostic factors.This is to date the largest, close to real-world, study in advanced BRAFV600-mutant melanoma patients with BM treated with D+T. ECOGgt;1, ≥3 metastatic sites and elevated LDH were associated with shorter PFS, a finding previously demonstrated only in patients without BM. Further studies are warranted to determine the optimal treatment sequence in this population.
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- 2022
4. Effets indésirables tardifs des anti-PD1 : étude nationale française multicentrique prospective (MELBASE)
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Florence Brunet-Possenti, Clara Allayous, M.-T. Leccia, S. Dalle, Florence Granel-Brocard, Wendy Lefevre, Clémentine Carlet, C. Lebbé, Julie Charles, M. Le Bouar, L. Mortier, Sophie Dalac-Rat, J. De Quatrebarbes, C. Dutriaux, Olivier Dereure, D. Legoupil, H. Montaudié, Charlée Nardin, and B. Dréno
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Dermatology - Abstract
Introduction Les anti-PD1 sont associes a la survenue d’effets indesirables (EI) specifiques, en partie medies par l’immunite. Les patients atteints de melanomes avances inclus dans des essais cliniques ont ete traites par anti-PD1 pour une duree de deux ans ou moins et il n’existe pas de recommandation concernant la duree optimale de traitement. Il y a peu de donnees concernant les EIs tardifs des anti-PD1 (apres deux ans de traitement). L’objectif de cette etude etait de decrire les EIs (incluant les EIs tardifs) des anti-PD1 chez des patients atteints de melanomes avances traites en vie reelle pendant au moins deux ans. Materiel et methodes Les patients de la cohorte MELBASE (cohorte francaise multicentrique de suivi prospectif de patients atteints de melanomes de stades III non resecable ou IV de l’AJCC) traites par anti-PD1 pendant deux ans ou plus, entre janvier 2013 et novembre 2019, etaient inclus. Tous les EIs (dont les EIs tardifs, definis comme survenant au-dela de 2 ans de traitement) etaient colliges. Les facteurs potentiellement associes a la survenue d’EI etaient recherches. Resultats Parmi les 1849 patients atteints de melanomes avances inclus dans Melbase, 119 patients traites par anti-PD1 pendant au moins deux ans etaient inclus. La mediane de suivi de ces patients etait de 41,7 mois (25,2–57,5). Les principales caracteristiques initiales des patients etaient: sexe masculin (61 %), âge moyen 63 ans, antecedent de maladie auto-immune (11 %), mutation BRAF V600 (25 %), stade IV de l’AJCC (84 %), metastases cerebrales (22 %), ECOG 0-1 (88 %), et LDH eleves (18 %). Les patients avaient ete traites par nivolumab (n = 53, 45 %) ou pembrolizumab (n = 66, 55 %), et la maladie etait controlee par le traitement (reponse complete, partielle ou maladie stable dans 59 %, 34 % et 7 % des cas respectivement). La duree mediane de traitement etait de 35 mois (28,7–40,5). Des EIs etaient survenus chez 99 patients (83 %) apres une duree mediane de traitement de 13,3 mois (0–53,9) dont au moins un EI severe (grade 3–4) chez 30 patients (30 %). Les EIs tardifs, survenus au-dela de 2 ans de traitement par anti-PD1, etaient observes chez 51 patients (43 %). Ils etaient principalement de grade 1–2 mais severes chez 4 patients (3 %) et avaient conduit a l’hospitalisation de 5 patients (4 %). Parmi les patients ayant presente ces EIs tardifs, 45 (87 %) avaient deja presente un EI au cours des deux premieres annees de traitement et 29 (56 %) en avaient presente plusieurs. Les facteurs associes a la survenue d’EIs tardifs etaient les toxicites multiples avant 2 ans et la duree de traitement (p Discussion La poursuite du traitement par anti-PD1 au-dela de 2 ans s’accompagne frequemment d’EIs tardifs, le plus souvent benins. La survenue de plusieurs EIs au cours des 2 premieres annees etait un facteur de risque independant de survenue d’EIs tardifs.
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- 2020
5. A multicenter retrospective analysis of nivolumab in advanced melanoma during the French Temporary Authorization Use
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E. Hainaut, Jean-Philippe Lacour, Sandrine Monestier, Sandrine Mansard, Marie Thérèse Leccia, Brigitte Dréno, Stéphane Dalle, Patrick Combemale, E. Varey, Bernard Guillot, Philippe Saiag, Nicolas Meyer, Pascal Joly, Laurent Mortier, Caroline Dutriaux, Nathalie Beneton, Amir Khammari, Nabahet Ameur, François Skowron, and Sophie Dalac-Rat
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Melanoma ,Authorization ,medicine.disease ,Internal medicine ,medicine ,Retrospective analysis ,Nivolumab ,business ,Advanced melanoma - Abstract
e21598Background: Nivolumab was the first anti-PD1 therapy to receive a European marketed authorization for the treatment of advanced (unresectable or metastatic) melanoma. To collect and evaluate ...
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- 2018
6. Vismodegib in neoadjuvant treatment of locally advanced basal cell carcinoma: First results of a multicenter, open-label, phase 2 trial (VISMONEO study)
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Alain Dupuy, E. Desmedt, C. Templier, Sophie Dalac-Rat, Bernard Guillot, Philippe Saiag, Laurent Mortier, Alain Duhamel, Nicole Basset-Seguin, Nicolas Bertrand, and Pierre Guerreschi
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Locally advanced ,Vismodegib ,medicine.disease ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Neoadjuvant treatment ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,Basal cell carcinoma ,Open label ,business ,medicine.drug - Abstract
9509Background: Surgery is the main treatment of basal cell carcinoma. In locally advanced basal cell carcinoma (laBCC), surgery may cause functional or aesthetic damages. Neoadjuvant administratio...
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- 2018
7. Epidemiological study of unknown primary melanoma patients from the French national melanoma database RIC-Mel
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Céleste Lebbé, E. Varey, Stéphane Dalle, Patrick Combemale, Amir Khammari, Béatrice Crickx, Sophie Dalac-Rat, Alain Dupuy, Brigitte Dréno, Jean-Michel Nguyen, Bernard Guillot, Laurent Mortier, P. Celerier, François Skowron, Nicolas Meyer, Eve Maubec, Jean-Philippe Lacour, Caroline Dutriaux, and Marie Thérèse Leccia
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Melanoma ,macromolecular substances ,Disease ,medicine.disease ,Internal medicine ,Epidemiology ,Unknown primary ,Medicine ,business - Abstract
e21571Background: Melanomas of unknown primary (MUP) are considered as metastatic disease. Epidemiologic features of MUP patients have been described in several studies, but never yet from the Fren...
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- 2018
8. Micro- and macro-metastatic disease kinetics: Results from the French cohort Melbase
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Thierry Lesimple, Jean-Philippe Lacour, Bastien Oriano, D. Legoupil, Caroline Dutriaux, Sophie Dalac-Rat, Florence Granel Brocard, François Aubin, Laurent Mortier, Stéphane Dalle, Julie De Quatrebarbes, Eve Maubec, Jean-Philippe Arnault, Pierre-Emmanuel Stoebner, Bernard Guillot, Philippe Saiag, Marie Thérèse Leccia, Vincent Descamps, Céleste Lebbé, and Anais Vallet
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Oncology ,Cancer Research ,medicine.medical_specialty ,Immune system ,business.industry ,Internal medicine ,Cohort ,medicine ,Disease ,business ,Advanced melanoma - Abstract
9538 Background: In the past decade, the prognosis of advanced melanoma has been greatly improved by new therapeutic agents such as immune and targeted therapies, which are now being evaluated as adjuvant therapies. Although the kinetic of metastatic disease is correlated to patient survival, the unfolding of the dormant disease remains hardly predictable and data from the literature on the topic is controversial (Karakousis, Francken). We hypothesized that the course of the advanced disease could be predicted from time to distant recurrence. Methods: Melbase is a French multicentric cohort dedicated to the prospective follow-up of adults with unresectable stage III or IV melanoma. Date of primary excision, time to recurrence, progression free survival (PFS) and overall survival (OS) of 298 patients treated in first line by immune therapies (IT, n = 148), targeted therapies (TT, n = 68) or within clinical trials (n = 73) were collected on September 5th, 2016. Patients with unknown primary or de novo metastatic melanoma were not included. Time to distant recurrence was analyzed as a continuous variable and as a categorical variable ( < 12 months; 12 to 24 months; ≥ 24 months). Results: Patients’ characteristics at baseline are: mean age 62 years, PS 0-1 84%, elevated LDH 32%, BRAF mutated 39%, brain metastases 18%. Time to recurrence studied as a continuous variable was not correlated to PFS (HR = 0.96; 95%CI: 0.85-1.07) or OS (HR = 0.89; 95%CI: 0.77-1.03). These results remained insignificant after stratification upon treatment or even when time to recurrence was analyzed as a categorized variable. Conclusions: Our data showed no correlation between the time from primary to distant recurrence and PFS or OS in patients treated with TT or IT. Therefore, kinetics of advanced disease cannot be predicted by the history of dormant disease. Dormancy and metastasis proliferation are thus probably driven by different molecular and cellular mechanisms.
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- 2017
9. Role of time to switch from ipilimumab to anti-PD1 in anti-PD1 efficacy within the French national cohort, MelBase
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Pierre-Emmanuel Stoebner, Marie Beylot-Barry, Céleste Lebbé, Stéphane Dalle, Raphaël Porcher, Julie De Quatrebarbes, Laurent Mortier, Vincent Descamps, Jean-Philippe Lacour, A. Ballon, Jean-Philippe Arnault, Thierry Lesimple, Bernard Guillot, Philippe Saiag, Marie Thérèse Leccia, Eve Maubec, Clara Allayous, Bastien Oriano, Sophie Dalac-Rat, and François Aubin
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Internal medicine ,medicine ,Ipilimumab ,business ,Anti pd1 ,Advanced melanoma ,medicine.drug ,National cohort - Abstract
9551 Background: With increasing armamentarium in advanced melanoma management, the impact of various strategies remains to be determined including the importance of time to switch from one treatment to another. We report the impact of time to IPI/APD non-planned switch on APD efficacy in real life patients within MelBase (MB). Methods: MB is a French multicentric biobank dedicated to the prospective follow-up (FU) of unresectable stage III or IV melanoma with 1102 patients included since March 2013. Data were collected (Sept.2016) and analyzed (demography, overall survival (OS), progression-free survival (PFS), response rate, multivariate analysis, safety). Results: 71 patients were treated with IPI/APD sequence. 72% received 4 IPI injections. The median time to switch was 1.7 months (0.36-3). The characteristics at the initiation of APD are: mean age 64 yrs, PS 0-1 80%, elevated LDH 34%, BRAF WT 90%, brain metastasis 25%, ≥ 3 metastatic organ sites (MOS) 49%, median FU 11.9 months, OS 20 months (95%CI:12.6-NR), PFS 3.5 months (95%CI:2.9-6.2). The best overall response was 25%, disease control rate was 54% with a low toxicity profile (17% grade 3/4). In a multivariable analysis, longer time to switch was significantly associated with better OS (adjusted HR 0.38 per 1 more month, 95%CI:0.14-0.93), as well as ECOG 0-1 (aHR 3.11, 95%CI:0.99-9.72) and LDH < ULN (aHR 3.32, 95%CI:1.26-8.75). In addition, the association of time to switch with OS vary significantly according to the number of MOS ( < 3 MOS aHR 0.25, 95%CI:0.10-0.62; ≥3 MOS aHR 0.99 95%CI:0.41-2.39) and AJCC stage (M0/1a/1b aHR 0.06, 95%CI:0.01-0.43 ; M1c aHR 0.77, 95%CI:0.39-1.54). Conclusions: In patients who failed IPI treatment, longer survival after APD was associated to time to switch only in patients with favorable baseline factors. Such results are probably more related to the slow kinetics of the disease than to the delay itself. Our results are different from Blank et al.(ESMO 2016) who tested a planned switch, immediately after 2 IPI perfusions, and showed overall response rate close to IPI+APD association. We are currently conducting a similar study on the reverse sequence (APD/IPI) and the role on IPI efficacy.
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- 2017
10. VISMONEO : étude de phase II du vismodegib en traitement néoadjuvant du carcinome basocellulaire localement avancé : caractéristiques des patients
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Nicole Basset-Seguin, I. Benbouta, A. Mahmoudi, P. Saiag, D.-R. Sophie Dalac-Rat, D. Meddour, L. Mirakovska, M.-T. Leccia, Alain Duhamel, M. Dib, Bernard Guillot, Emilie Routier, P. Guerreschi, Xavier Mirabel, A. Dupuy, and L. Mortier
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Gynecology ,medicine.medical_specialty ,business.industry ,medicine ,Vismodegib ,Dermatology ,business ,medicine.drug - Abstract
Introduction L’utilisation de vismodegib dans le traitement neoadjuvant du carcinome basocellulaire localement avance (laBCC) non resecable pourrait reduire la taille de la tumeur, en faciliter la resection et potentiellement preserver la fonctionnalite et l’esthetique de la zone affectee. L’etude VISMONEO est realisee afin d’evaluer l’efficacite et la tolerance du vismodegib dans ce contexte. Materiel et methodes VISMONEO est une etude ouverte, non comparative, multicentrique, de phase II. Des patients presentant au moins une lesion de laBCC confirmee a l’histologie et une lesion d’un diametre ≥ 3 cm dans des zones ou le risque de recidive tumorale est intermediaire et un BCC d’un diametre ≥ 2 cm dans des zones ou le risque de recidive tumorale est plus eleve sont inclus. Le vismodegib etait administre par voie orale a une dose de 150 mg une fois par jour pendant 10 mois au maximum. Au total, 55 patients devraient etre suivis pendant 3 ans. Le critere d’evaluation principal est le pourcentage de patients atteints de BCC avec reduction du stade tumoral (down-staging) apres resection chirurgicale a l’issue d’un traitement par vismodegib durant au moins 4 mois. Les criteres d’evaluation principaux etaient les benefices cliniques evalues par un panel independant d’experts, l’impact medico-economique de cette strategie neoadjuvante, la tolerance (criteres NCI-CTCAE, v4.0) et la qualite de vie (questionnaire Skindex-16). Resultats Entre novembre 2014 et juin 2015, 55 patients ont ete inclus dans 17 centres en France. La moitie des patients etaient des hommes (51 %), l’âge moyen de 72 ans (± 12) et 73 % des patients (n = 40) avaient plus de 65 ans ; 58 % (n = 32) presentaient un indice de performance ECOG egal a 0, 35 % (n = 19) un ECOG de 1 et 7 % (n = 4) et un ECOG ≥ 2. La tumeur etait mesurable chez tous les patients et 3 (5,5 %) avaient un syndrome de Gorlin. Les sites affectes etaient principalement l’œil (35 %, n = 19), l’oreille (14 %, n = 8), la region temporale (14 %, n = 8), le nez (13 %, n = 7), le front (11 %, n = 6), la joue (5 %, n = 3), le cuir chevelu (4 %, n = 2) et d’autres sites (levres, region parietale : 4 %, n = 2). Pas de radiotherapie anterieure pour la plupart des patients, 98 % (n = 54). En decembre 2015, 8 patients etaient toujours sous traitement et 47 avaient termine le protocole (y compris patients toujours suivis et patients ayant beneficie d’une resection par une chirurgie moins lourde que prevue et avec reponse complete). Conclusion Les caracteristiques des patients atteints d’un laBCC traites par vismodegib en neoadjuvant et resection chirurgicale correspondent a celles des quelques patients avec laBCC resecable inclus dans les essais cliniques. Cette etude de phase II est en cours.
- Published
- 2016
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