7 results on '"Mabro M"'
Search Results
2. FOLFIRI Plus Durvalumab With or Without Tremelimumab in Second-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: The PRODIGE 59-FFCD 1707-DURIGAST Randomized Clinical Trial.
- Author
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Tougeron D, Dahan L, Evesque L, Le Malicot K, El Hajbi F, Aparicio T, Bouché O, Bonichon Lamichhane N, Chibaudel B, Angelergues A, Bodere A, Phelip JM, Mabro M, Kaluzinski L, Petorin C, Breysacher G, Rinaldi Y, Zaanan A, Smith D, Gouttebel MC, Perret C, Etchepare N, Emile JF, Sanfourche I, Di Fiore F, Lepage C, Artru P, and Louvet C
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Camptothecin analogs & derivatives, Camptothecin therapeutic use, Camptothecin administration & dosage, Camptothecin adverse effects, Adult, Esophageal Neoplasms drug therapy, Esophageal Neoplasms pathology, Progression-Free Survival, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Stomach Neoplasms drug therapy, Stomach Neoplasms pathology, Leucovorin therapeutic use, Leucovorin administration & dosage, Leucovorin adverse effects, Adenocarcinoma drug therapy, Fluorouracil therapeutic use, Fluorouracil administration & dosage, Esophagogastric Junction pathology, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal administration & dosage
- Abstract
Importance: Efficacy of second-line chemotherapy in advanced gastric or gastrooesphageal junction (GEJ) adenocarcinoma remains limited., Ojectives: To determine the efficacy of 1 or 2 immune checkpoint inhibitors combined with FOLFIRI (leucovorin [folinic acid], fluorouracil, and irinotecan) in the treatment of advanced gastric/GEJ adenocarcinoma., Design, Setting, and Participants: The PRODIGE 59-FFCD 1707-DURIGAST trial is a randomized, multicenter, noncomparative, phase 2 trial, conducted from August 27, 2020, and June 4, 2021, at 37 centers in France that included patients with advanced gastric/GEJ adenocarcinoma who had disease progression after platinum-based first-line chemotherapy., Intervention: Patients were randomized to receive FOLFIRI plus durvalumab (anti-programmed cell death 1 [PD-L1]) (FD arm) or FOLFIRI plus durvalumab and tremelimumab (anti-cytotoxic T-lymphocyte associated protein 4 [CTLA-4]) (FDT arm). The efficacy analyses used a clinical cutoff date of January 9, 2023., Main Outcome and Measures: The primary end point was progression-free survival (PFS) at 4 months according to RECIST 1.1 criteria evaluated by investigators., Results: Overall, between August 27, 2020, and June 4, 2021, 96 patients were randomized (48 in each arm). The median age was 59.7 years, 28 patients (30.4%) were women and 49 (53.3%) had GEJ tumors. Four month PFS was 44.7% (90% CI, 32.3-57.7) and 55.6% (90% CI, 42.3-68.3) in the FD and FDT arms, respectively. The primary end point was not met. Median PFS was 3.8 and 5.4 months, objective response rates were 34.7% and 37.7%, and median overall survival was 13.2 and 9.5 months in the FD and FDT arms, respectively. Disease control beyond 1 year was 14.9% in the FD arm and 24.4% in the FDT arm. Grade 3 to 4 treatment-related adverse events were observed in 22 (47.8%) patients in each arm. A combined positive score (CPS) PD-L1 of 5 or higher was observed in 18 tumors (34.0%) and a tumor proportion score (TPS) PD-L1 of 1% or higher in 13 tumors (24.5%). Median PFS according to CPS PD-L1 was similar (3.6 months for PD-L1 CPS ≥5 vs 5.4 months for PD-L1 CPS <5) by contrast for TPS PD-L1 (6.0 months for PD-L1 TPS ≥1% vs 3.8 months for PD-L1 TPS <1%)., Conclusions and Relevance: Combination of immune checkpoint inhibitors with FOLFIRI in second-line treatment for advanced gastric/GEJ adenocarcinoma showed an acceptable safety profile but antitumor activity only in a subgroup of patients., Trial Registration: ClinicalTrials.gov Identifier: NCT03959293.
- Published
- 2024
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3. Effect of Adapted Physical Activity in Patients With Advanced Pancreatic Cancer: The APACaP GERCOR Randomized Trial.
- Author
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Neuzillet C, Bouché O, Tournigand C, Chibaudel B, Bauguion L, Bengrine-Lefevre L, Lopez-Trabada Ataz D, Mabro M, Metges JP, Péré-Vergé D, Conroy T, Lièvre A, Andre M, Desseigne F, Goldwasser F, Henriques J, Anota A, and Hammel P
- Subjects
- Humans, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Fatigue etiology, Health Status, Research Design, Pancreatic Neoplasms drug therapy, Quality of Life, Exercise
- Abstract
Background: The impact of adapted physical activity (APA) on health-related quality of life (HRQoL) in patients with advanced pancreatic ductal adenocarcinoma (aPDAC) is unknown. This study evaluated whether APA in addition to standard care improved HRQoL in patients who have aPDAC who are receiving first-line chemotherapy., Patients and Methods: Patients with locally advanced/metastatic PDAC and an ECOG performance status of 0 to 2 were randomized (1:1) to receive standard care (standard arm) or standard care plus a home-based 16-week APA program (APA arm). The primary objective was the effect of the APA program on 3 dimensions of the EORTC QLQ-C30: global health status, physical function, and fatigue at week 16 (W16), with a one-sided type I error of 0.017 for each dimension. The primary HRQoL analysis was performed in patients with available baseline and W16 scores for the dimensions (ie, the modified intention-to-treat population 1 [mITT1]), and secondary longitudinal HRQoL analyses using the mixed model for repeated measures (MMRM) and time until definitive deterioration (TUDD) methods were performed in the mITT1 population and in patients with baseline and at least one follow-up questionnaire (mITT2 population). A difference of ≥5 points was considered to be clinically relevant., Results: Of 326 included patients, 313 were randomized to the standard (n=157) or APA (n=156) arms. In the mITT1 population (n=172), the mean differences in global health status, physical function, and fatigue at W16 adjusted from baseline were -0.98 (SD, 23.9; P=.39), -2.08 (SD, 21.3; P=.26), and 4.16 (SD, 29.2; P=.17), respectively, showing a non-statistically significant benefit with APA. In the mITT2 population (n=259), APA was associated with statistically significant and clinically relevant improvement in 5 and 8 dimensions of the HRQoL in the longitudinal MMRM and TUDD analyses, respectively., Conclusions: APA improved several dimensions of HRQoL in patients with aPDAC receiving first-line chemotherapy and standard care.
- Published
- 2023
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4. Optimal treatment strategy after first-line induction therapy in advanced HER2-positive oeso-gastric adenocarcinoma-a retrospective, international, multicentric AGEO study.
- Author
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Bergen ES, Pilla L, Auclin E, Ilhan-Mutlu A, Prager GW, Pietrantonio F, Antista M, Ghelardi F, Basile D, Aprile G, Longarini R, Hautefeuille V, Tougeron D, Artru P, Mabro M, Drouillard A, Roth G, Ben Abdelghani M, Clement I, Toullec C, Mineur L, Guimbaud R, Taieb J, and Zaanan A
- Subjects
- Humans, Retrospective Studies, Induction Chemotherapy, Receptor, ErbB-2, Antineoplastic Combined Chemotherapy Protocols, Trastuzumab therapeutic use, Stomach Neoplasms pathology, Adenocarcinoma
- Abstract
Background: The optimal treatment strategy after first-line induction therapy in advanced HER2-positive oeso-gastric adenocarcinoma (OGA) remains challenging., Methods: Patients treated with trastuzumab (T) plus platinum salts and fluoropyrimidine (F) as first-line chemotherapy between 2010 and 2020 for HER2-positive advanced OGA at 17 academic care centers in France, Italy, and Austria were included. The primary objective was the comparison of F + T vs T alone as maintenance regimen in terms of progression-free survival (PFS) and overall survival (OS) after a platinum-based chemotherapy induction + T. As secondary objective, PFS and OS between patients treated with reintroduction of initial chemotherapy or standard second-line chemotherapy at progression were assessed., Results: Among the 157 patients included, 86 (55%) received F + T and 71 (45%) T alone as a maintenance regimen after a median of 4 months of induction chemotherapy. Median PFS from start of maintenance therapy was 5.1 months in both groups (95% CI 4.2-7.7 for F + T and 95% CI 3.7-7.5 for T alone; p = 0.60) and median OS was 15.2 (95% CI 10.9-19.1) and 17.0 months (95% CI 15.5-21.6) for F + T and T alone, respectively (p = 0.40). Of 112/157 patients (71%) receiving systemic therapy after progression under maintenance, 26/112 (23%) were treated with a reintroduction of initial chemotherapy + T and 86/112 (77%) with a standard second-line regimen. Here, median OS was significantly longer with the reintroduction (13.8 (95% CI 12.1-19.9) vs 9.0 months (95% CI 7.1-11.9); p = 0.007) as confirmed by multivariate analysis (HR 0.49; 95% CI 0.28-0.85; p = 0.01)., Conclusion: No additional benefit of adding F to T monotherapy as a maintenance treatment could be observed. Reintroduction of initial therapy at first progression may be a feasible approach to preserve later treatment lines., (© 2023. The Author(s) under exclusive licence to The International Gastric Cancer Association and The Japanese Gastric Cancer Association.)
- Published
- 2023
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5. From a voluntary vaccination policy to mandatory vaccination against COVID-19 in cancer patients: an empirical and interdisciplinary study in bioethics.
- Author
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Stoeklé HC, Sekkate S, Angellier E, Kennel T, Benmaziane A, Mabro M, Geay JF, Beuzeboc P, and Hervé C
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- Humans, Interdisciplinary Studies, Policy, Quality of Life, Vaccination, Bioethics, COVID-19, Neoplasms
- Abstract
Background: At the start of 2021, oncologists lacked the necessary scientific knowledge to adapt their clinical practices optimally when faced with cancer patients refusing or reluctant to be vaccinated against COVID-19, despite the marked vulnerability of these patients to severe, and even fatal forms of this new viral infectious disease. Oncologists at Foch Hospital were confronted with this phenomenon, which was observed worldwide, in both the general population and the population of cancer patients., Methods: Between April and November 2021, the Ethics and Oncology Departments of Foch Hospital decided to investigate this subject, through an empirical and interdisciplinary study in bioethics. Our scientific objective was to try to identify and resolve the principal bio-ethical issues, with a view to improving clinical practices in oncology during future major pandemics of this kind, from a highly specific bio-ethical standpoint (= quality of life/survival). We used a mainly qualitative methodological approach based on questionnaires and interviews., Results: In April 2021, 29 cancer patients refused or were reluctant to be vaccinated (5.6%; 29/522). Seventeen of these patients said that making vaccination mandatory would have helped them to accept vaccination. In October 2021, only 10 cancer patients continued to maintain their refusal (1.9%; 10/522). One of the main reasons for the decrease in refusals was probably the introduction of the "pass sanitaire" (health pass) in July 2021, which rendered vaccination indispensable for many activities. However, even this was not sufficient to convince these 10 cancer patients., Conclusion: We identified a key bio-ethical issue, which we then tried to resolve: vaccination policy. We characterized a major tension between "the recommendation of anti-COVID-19 vaccination" (a new clinical practice) and "free will" (a moral value), and the duty to "protect each other" (a moral standard). Mandatory vaccination, at least in France, could resolve this tension, with positive effects on quality of life (i.e. happiness), or survival, in cancer patients initially refusing or reluctant to be vaccinated, but only if collective and individual scales are clearly distinguished., (© 2022. The Author(s).)
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- 2022
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6. Letter comments on: Efficacy and safety of BNT162b2 vaccination in solid cancer patients receiving anti-cancer therapy - A single-centre prospective study: Interaction between lymphopenia and anti-SARS-CoV-2 antibodies after two injections of the Pfizer-BioNTech vaccine in patients with cancers treated by chemotherapy or immunotherapy.
- Author
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Sekkate S, Stoeklé HC, Mabro M, Billard D, Kennel T, Vasse M, Hervé C, and Beuzeboc P
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- BNT162 Vaccine, Humans, SARS-CoV-2, Vaccination, COVID-19, Lymphopenia, Neoplasms drug therapy, Vaccines
- Abstract
Competing Interests: Conflict of interest statement None declared.
- Published
- 2022
- Full Text
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7. Prognostic Value and Relation with Adjuvant Treatment Duration of ctDNA in Stage III Colon Cancer: a Post Hoc Analysis of the PRODIGE-GERCOR IDEA-France Trial.
- Author
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Taieb J, Taly V, Henriques J, Bourreau C, Mineur L, Bennouna J, Desrame J, Louvet C, Lepere C, Mabro M, Egreteau J, Bouche O, Mulot C, Hormigos K, Chaba K, Mazard T, de Gramont A, Vernerey D, André T, and Laurent-Puig P
- Subjects
- Aged, Chemotherapy, Adjuvant, Colonic Neoplasms pathology, Disease-Free Survival, Duration of Therapy, Female, Humans, Male, Neoplasm Staging, Prognosis, Prospective Studies, Circulating Tumor DNA blood, Colonic Neoplasms blood, Colonic Neoplasms drug therapy
- Abstract
Purpose: Circulating tumor DNA (ctDNA) has been suggested as a major prognostic factor in resected stage-III colon cancer. We analyzed ctDNA of patients randomized in the phase III IDEA-France trial., Experimental Design: ctDNA was tested for WIF1 and NPY by droplet digital PCR with method developed and validated for colorectal cancer. Disease-free survival (DFS) and overall survival (OS) were analyzed via multivariable analysis in patients with ctDNA samples and in sub-groups according to treatment duration (3/6 months) and disease stage (high/low-risk stage III)., Results: Of 2,010 randomized patients, 1,345 had available ctDNA samples (1,017 collected both post-surgery and pre-chemotherapy). More Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 (78% versus 69%) and T4 and/or N2 (40% versus 36%) were observed in patients studied ( n = 1017) versus not analyzed ( n = 993). There were 877 ctDNA-negative (86.2%) and 140 ctDNA-positive (13.8%) patients; their baseline characteristics were similar. With a median follow-up of 6.6 years, the 3-year DFS rate was 66.39% for ctDNA-positive patients and 76.71% for ctDNA-negative patients ( P = 0.015). ctDNA was confirmed as an independent prognostic marker for DFS (adjusted HR = 1.55, 95% CI 1.13-2.12, P = 0.006) and OS (HR = 1.65, 95% CI 1.12-2.43, P = 0.011). ctDNA was prognostic in patients treated for 3 months and with T4 and/or N2 tumors, but not in those treated for 6 months and with T1-3/N1 tumors., Conclusions: In this first ctDNA assessment of a large series of patients with stage III colon cancer enrolled in phase III trial, post-surgery ctDNA was found in 13.8% of them and was confirmed as an independent prognostic marker. See related commentary by Bent and Kopetz, p. 5449 ., (©2021 American Association for Cancer Research.)
- Published
- 2021
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