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1. Permanent stoma after sphincter preservation for rectal cancer. A situation that occurs more often than you might think

Author

Flavie Thomas, Benjamin Menahem, Gil Lebreton, Karine Bouhier-Leporrier, Olivier Dejardin, and Arnaud Alves

Subjects
rectal cancer, permanent stoma, sphincter preserving surgery, anastomotic leakage, local recurrence, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

ObjectivesThis study aimed: (i) to assess the cumulative incidence of permanent stoma (PS) after sphincter-preserving surgery (SPS) for rectal cancer (RC): (ii) to analyze associated risk factors for primary and secondary PS; and (iii) to compare the long-term survival of patients according to the stoma state.MethodsWe conducted a retrospective single-center cohort study based on a prospectively maintained database of SRC patients undergoing SPS from January 2007 to December 2017. Incidence of both primary (no reversal of defunctioning stoma) and secondary (created after closure of defunctioning stoma) PS were investigated. Associations between potential risk factors and PS were analyzed using a logistic regression model. Cumulative survival curve was drawn by Kaplan-Meier method.ResultsOf the 257 eligible patients, 43 patients (16.7%) had a PS (16 primary PS and 27 secondary PS) after a median follow-up of 4.8 years. In multivariate analysis, the independent risk factors for primary PS were severe post-operative complications (OR 3.66; 95% CI, 1.19-11.20, p=0.022), and old age (OR 1.11; 95% CI 1.04-1.18, p=0.001) and those for secondary PS were local recurrence (OR 38.07; 95% CI 11.07-130.9, p

Published
2023
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2. Multidisciplinary team meetings: are all patients presented and does it impact quality of care and survival – a registry-based study

Author

Quentin Rollet, Véronique Bouvier, Grégoire Moutel, Ludivine Launay, Anne-Laure Bignon, Karine Bouhier-Leporrier, Guy Launoy, and Astrid Lièvre

Subjects
Disease management, Quality of health care, Health services accessibility, Health care ethics, Multidisciplinary team meeting, Public aspects of medicine, RA1-1270
Abstract

Abstract Background Multidisciplinary team meetings (MDTMs) are part of the standard cancer care process in many European countries. In France, they are a mandatory condition in the authorization system for cancer care administration, with the goal to ensure that all new patients diagnosed with cancer are presented in MDTMs. Aim Identify the factors associated with non-presentation or unknown presentation in MDTMs, and study the impact of presentation in MDTMs on quality of care and survival in patients diagnosed with colorectal cancer (CRC). Methods 3999 CRC patients diagnosed between 2005 and 2014 in the area covered by the “Calvados Registry of Digestive Tumours” were included. Multivariate multinomial logistic regression was used to assess the factors associated with presentation in MDTMs. Univariate analyses were performed to study the impact of MDTMs on quality of care. Multivariate Cox model and the Log-Rank test were used to assess the impact of MDTMs on survival. Results Non-presentation or unknown presentation in MDTMs were associated with higher age at diagnosis, dying within 3 months after diagnosis, unknown metastatic status, non-metastatic cancer and colon cancer. Non-presentation was associated with a diagnosis after 2010. Unknown presentation was associated with a diagnosis before 2007 and a longer travel time to the reference care centres. Presentation in MDTMs was associated with more chemotherapy administration for patients with metastatic cancer and more adjuvant chemotherapy for patients with stage III colon cancer. After excluding poor prognosis patients, lower survival was significantly associated with higher age at diagnosis, unknown metastatic status or metastatic cancer, presence of comorbidities, rectal cancer and non-presentation in MDTMs (HR = 1.5 [1.1–2.0], p

Published
2021
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3. CEA, CA19-9, circulating DNA and circulating tumour cell kinetics in patients treated for metastatic colorectal cancer (mCRC)

Author

David Sefrioui, Ludivine Beaussire, André Gillibert, France Blanchard, Emmanuel Toure, Céline Bazille, Anne Perdrix, Frédéric Ziegler, Alice Gangloff, Mélanie Hassine, Caroline Elie, Anne-Laure Bignon, Aurélie Parzy, Philippe Gomez, Caroline Thill, Florian Clatot, Jean-Christophe Sabourin, Thierry Frebourg, Jacques Benichou, Karine Bouhier-Leporrier, Marie-Pierre Gallais, Nasrin Sarafan-Vasseur, Pierre Michel, Frédéric Di Fiore, Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Normandie Université (NU), Unité de biostatistiques [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Département de Pathologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Laboratoire de biochimie générale [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Centre hospitalier universitaire de Rouen, Hepatogastroenterologie, chu Elbeuf Les Feugrais, Hepatogastroenterology, Caen University Hospital, Caen., Department of Hepatogastroenterology, Caen University Hospital, Departement Hepatogastroenterologie, Centre Francois Baclesse, Caen, Medical Oncology, centre Frédéric Joliot, Département de génétique [CHU Rouen] (Centre Normandie de Génomique et de Médecine Personnalisée), Service d'Hépato-Gastroentérologie [CHU Rouen], and Hôpital Charles Nicolle [Rouen]-Université de Rouen Normandie (UNIROUEN)

Subjects
Adult, Male, Cell kinetics, Oncology, Cancer Research, medicine.medical_specialty, Scoring system, endocrine system diseases, Colorectal cancer, medicine.medical_treatment, Article, Circulating Tumor DNA, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], medicine, Humans, Antigens, Tumor-Associated, Carbohydrate, In patient, Prospective Studies, Neoplasm Metastasis, ComputingMilieux_MISCELLANEOUS, Aged, Aged, 80 and over, Chemotherapy, business.industry, Middle Aged, Neoplastic Cells, Circulating, medicine.disease, Survival Analysis, digestive system diseases, Carcinoembryonic Antigen, Up-Regulation, 3. Good health, Gene Expression Regulation, Neoplastic, 030220 oncology & carcinogenesis, Circulating DNA, Female, CA19-9, Colorectal Neoplasms, business, Progressive disease
Abstract

BACKGROUND: We previously reported that CEA kinetics are a marker of progressive disease (PD) in metastatic colorectal cancer (mCRC). This study was specifically designed to confirm CEA kinetics for predicting PD and to evaluate CA19-9, cell-free DNA (cfDNA), circulating tumour DNA (ctDNA) and circulating tumour cell (CTC) kinetics. METHODS: Patients starting a chemotherapy (CT) with pre-treatment CEA > 5 ng/mL and/or CA19.9 > 30 UI/mL were prospectively included. Samples were collected from baseline to cycle 4 for CEA and CA19-9 and at baseline and the sixth week for other markers. CEA kinetics were calculated from the first to the third or fourth CT cycle. RESULTS: A total of 192 mCRC patients were included. CEA kinetics based on the previously identified >0.05 threshold was significantly associated with PD (p

Published
2021
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4. Perception, knowledge, and handling practice regarding the risk of exposure to antineoplastic drugs in oncology day hospitalization units and compounding unit staff

Author

Hubert Benoist, Amandine Busson, Audrey Faveyrial, Karine Bouhier-Leporrier, Fabienne Divanon, Cécile Breuil, Sophie Roger-Leenaert, Agnès Palix, Pascal Odou, Nicolas Simon, Guillaume Saint-Lorant, Service de Pharmacie [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Unité de recherche interdisciplinaire pour la prévention et le traitement des cancers (ANTICIPE), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-UNICANCER-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), and Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)

Subjects
practice healthcare worker antineoplastic, Oncology, Occupational exposure antineoplastic, [SDV]Life Sciences [q-bio], Pharmacology (medical), perception healthcare worker
Abstract

Background Antineoplastic drug exposure is a major problem in regard to caregivers’ health. The aim of the present study was to assess the perception, knowledge, and handling practices of all occupation level categories of two oncology day hospitalization units and two compounding units regarding the risk of exposure to antineoplastic drugs. Methods This descriptive study, performed through face-to-face interviews, concurrently assessed the perception, knowledge, and handling practices of antineoplastic drugs in five different job categories in four different settings. This work was part of a larger comprehensive project examining surface and blood contamination. Different scores were assigned to evaluate responses to a questionnaire about the perception, knowledge, and handling practices of healthcare workers, a risk global score including a risk perception score, and education/knowledge and handling practices scores. Results In the survey, continuous training was associated with the global risk score ( p = 0.03), particularly with the handling practices risk score ( p = 0.01). Job category was also significantly associated with the global risk score ( p Conclusions This study identified significant differences among healthcare workers depending on job categories in the antineoplastic drug handling practices and in the knowledge of the risks associated with occupational exposure to antineoplastic drugs. These differences were particularly important between trained and untrained participants, revealing the importance of implementing a continuous training program.

Published
2022
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5. Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancérologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX)

Author

David Malka, Benoît Dupont, Alain Gratet, Pamela Biondiani, Marion Chauvenet, Dany Gargot, Pierre-Emmanuel Henneresse, Hortense Laharie, Johann Dreanic, Valérie Lebrun Lyat, Catherine Brezault-Bonnet, Morgan Andre, Géraldine Perkins, Philippe Houyau, Yves Rinaldi, Etienne Suc, Dominique Besson, Valérie Boige, Cécile Julien, Julien Taieb, Simon Pernot, Benoît Avisse, Pauline Regnault, Ahmed Bedjaoui, Marie-Pierre Galais, Côme Lepage, Céline Lepère, Mme E. Barbier, Antoine Holllebecque, Anne Escande, Julie Vincent, Sandrine Lavau denes, Marie-Claude Gouttebel, Leila Bengrine Lefevre, Anne Thirot Bidault, Anne-Laure Pointet, Julie Gigout, Faiza Khemissa Akouz, Louis-Marie Dourthe, Frederick Moryoussef, Maxime Lesouef, Vincent Bourgeois, François Ghiringhelli, Patrick Texereau, Samy Louafi, Gildas Phelip, Yann Berge, Jean-François Codoul, Jérôme Chamois, Eric Terrebonne, Karine Bouhier Leporrier, Bidaut Wahiba, X. Artignan, Pr Pierre Michel, Iulia Pripon, David Sefrioui, Pierre-Luc Etienne, Romain Coriat, Aurélie Parzy, Mustapha Atlassi, Aziz Zaanan, Jean-Baptiste Bachet, Philippe Dominici, Jean Martin, Mathilde Martinez, Dominique Genet, Raymond Despax, Karine Le Malicot, Laurent Miglianico, Salvatore Caruso, Bruno Valenza, Nicolas Barriere, and Oana Zveltlana Cojocarasu

Subjects
Adult, Male, 0301 basic medicine, Cancer Research, medicine.medical_specialty, Paclitaxel, Population, Leucovorin, Phases of clinical research, Adenocarcinoma, Neutropenia, Irinotecan, Deoxycytidine, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Albumins, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Neoplasm Metastasis, education, Aged, education.field_of_study, Drug Substitution, business.industry, Middle Aged, medicine.disease, Gemcitabine, Neoadjuvant Therapy, Progression-Free Survival, Pancreatic Neoplasms, Treatment Outcome, 030104 developmental biology, Oncology, Tolerability, 030220 oncology & carcinogenesis, Disease Progression, FOLFIRI, Camptothecin, Female, Fluorouracil, France, business, Febrile neutropenia, medicine.drug
Abstract

Background Chemotherapy is effective in metastatic pancreatic adenocarcinoma (mPA), but new approaches are still needed to improve patients' survival and quality of life. We have previously published good efficacy and tolerability results on a sequential treatment strategy of gemcitabine followed by an intensified FOLFIRI (5FU+irinotecan) regimen. In the present study, we evaluated the same sequence but replaced gemcitabine by the new gemcitabine + nab-paclitaxel standard first-line combination. Patients and methods We randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit of normal values and performance status 0–2 to alternately receive gemcitabine + nab-paclitaxel for 2 months then FOLFIRI.3 for 2 months in arm A, or gemcitabine + nab-paclitaxel alone until progression in arm B. The primary objective was to increase the 6-month progression-free survival (PFS) rate from 40% (H0) to 60% (H1); using the binomial exact method, 124 patients were required. Analyses were carried out in preplanned modified intention-to-treat (mITT) and per-protocol (PP) populations. Results Between November 2015 and November 2016, 127 patients were enrolled. Main grade III–IV toxicities (% in arm A/B) were: diarrhoea (12.5/1.7), neutropenia (46.9/31, including febrile neutropenia: 1.6/0), skin toxicity (6.3/13.8), and peripheral neuropathy (6.3/8.6). No toxic deaths occurred. The objective response rate was 40.3% (95% confidence interval [CI]: 28.1–53.6) in arm A and 26.7% (95% CI: 16.1–39.7) in arm B. The primary end-point (6-month PFS rate) was 45.2% [one-sided 95% CI: 34.3–56.4] in arm A and 23.3% in arm B [one-sided 95% CI: 14.3–32.3] in the mITT population. In the PP population, median PFS and OS were 7.6 months and 6 months and 14.5 months and 12.2 months in arm A and B, respectively. Conclusions The FIRGEMAX strategy with gemcitabine + nab-paclitaxel alternating with FOLFIRI.3 every 2 months, appears feasible and effective, with manageable toxicities, in patients able to reach >2mo of treatment. Trial registration information EudraCT: 2014-004449-28: NCT: 0282701.

Published
2020
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6. MiR-31-3p do not predict anti-EGFR efficacy in first-line therapy of RAS wild-type metastatic right-sided colon cancer

Author

Emeric Boisteau, Alexandra Lespagnol, Marie De Tayrac, Sébastien Corre, Anthony Perrot, Nathalie Rioux-Leclercq, Séverine Martin-Lannerée, Pascal Artru, Philippe Chalabreysse, Pierre-Guillaume Poureau, Laurent Doucet, Dahna Coupez, Jaafar Bennouna, Céline Bossard, Romain Coriat, Frédéric Beuvon, Lucile Bauguion, François Leclair, Romain Chautard, Thierry Lecomte, Serge Guyetant, Romain Desgrippes, Denis Grasset, Hélène Lhostis, Karine Bouhier-Leporrier, Frédéric Bibeau, Julien Edeline, Marie-Dominique Galibert, Astrid Lièvre, CHU Pontchaillou [Rennes], Institut de Génétique et Développement de Rennes (IGDR), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Centre National de la Recherche Scientifique (CNRS)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), IntegraGen, Hôpital privé Jean Mermoz [Lyon], Cypath : siège social [Villeurbanne], University Hospital Gasthuisberg, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Institut des Maladies de l'Appareil Digestif, Université de Nantes (UN), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Départemental Vendée (CHDV), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Groupe innovation et ciblage cellulaire (GICC), EA 7501 [2018-...] (GICC EA 7501), Université de Tours (UT), Infectiologie et Santé Publique (UMR ISP), Université de Tours (UT)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CH de Saint-Malo [Broussais], Centre hospitalier Bretagne Atlantique (Morbihan) (CHBA), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Universitaire [Rennes], CRLCC Eugène Marquis (CRLCC), Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Oncogenesis, Stress, Signaling (OSS), This research received no external funding. We thank the Rennes University Hospital and the Centre d'Etude des Maladies Digestives de Rennes (CEMDR) for their financial support. Anthony Perrot was financially supported by the Rennes University Hospital., Université de Rennes (UR)-Centre National de la Recherche Scientifique (CNRS)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), University Hospital Gasthuisberg [Leuven], and Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Hepatology, [SDV]Life Sciences [q-bio], Gastroenterology, colorectal cancer, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, [SDV.CAN]Life Sciences [q-bio]/Cancer, miR-31-3p, anti-EGFR mAb, Bevacizumab, ErbB Receptors, MicroRNAs, Antineoplastic Combined Chemotherapy Protocols, Colonic Neoplasms, biomarker, metastasis, Humans, Colorectal Neoplasms, Retrospective Studies
Abstract

International audience; BACKGROUND: Low miR-31-3p expression was identified as predictive of anti-EGFR efficacy in RAS-wt mCRC. Primary tumor side was also proposed as a predictive factor of anti-EGFR benefit. This retrospective multicentric study evaluated the predictive role of miR-31-3p in right-sided RAS-wt mCRC patients treated with first-line CT+anti-EGFR or CT+bevacizumab (Beva). METHODS: Seventy-two right-sided RAS-wt mCRC patients treated in first-line with CT+anti-EGFR (n=43) or Beva (n=29) were included. Overall survival (OS), progression-free survival (PFS) and response rate (RR) were analyzed and stratified according to tumor miR-31-3p expression level and targeted therapy (TT). RESULTS: BRAF V600E mutation was more frequent in high vs low miR-31-3p expressers (60.6% vs 15.4%, P < 0.001). PFS was significantly longer with CT+Beva than with CT+anti-EGFR (13 vs 7 months; P = 0.024). Among low miR-31-3p expressers, PFS, OS and RR were not significantly different between the two groups, while in high miR-31-3p expressers, only PFS was longer in the CT+Beva group (11 vs 6 months; P = 0.03). In patients treated with CT+anti-EGFR, low miR-31-3p expressers had a significantly longer OS (20 vs 13 months; P = 0.02) than high miR-31-3p expressers. ORR was not significantly different between the two groups of treatment, in both low and high miR-31-3p expressers. MiR-31-3p expression status was statistically correlated between primary tumors and corresponding metastases. CONCLUSION: In this study, miR-31-3p couldn’t identify a subgroup of patients with right-sided RAS-wt mCRC who might benefit from anti-EGFR and suggest that Beva is the TT of choice in first-line treatment of these patients.

Published
2021
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7. CA19.9 decrease >15% is a predictor of favourable outcome in patients treated for advanced pancreatic carcinoma: analysis of two independent cohorts

Author

Anne-Laure Bignon, A. Parzy, Alice Gangloff, Karine Bouhier-Leporrier, Sabrina Sidali, Frédéric Di Fiore, David Sefrioui, M. Hassine, Marie-Pierre Galais, Pierre Michel, Lucie Laurent, Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen]-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Hépato-Gastro-Enterologie et Nutrition [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), and UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)

Subjects
Adult, Male, medicine.medical_specialty, CA-19-9 Antigen, endocrine system diseases, [SDV]Life Sciences [q-bio], Locally advanced, Adenocarcinoma, Sensitivity and Specificity, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Biomarkers, Tumor, medicine, Humans, In patient, Pancreatic carcinoma, Aged, Retrospective Studies, Aged, 80 and over, Training set, Hepatology, business.industry, Bilirubin, Retrospective cohort study, Middle Aged, medicine.disease, digestive system diseases, Pancreatic Neoplasms, 030220 oncology & carcinogenesis, Disease Progression, Female, 030211 gastroenterology & hepatology, CA19-9, France, business, Progressive disease
Abstract

Background Although carbohydrate antigen 19.9 (CA19.9) is widely used in pancreatic adenocarcinoma (PA), no consensual cut-off value of CA19.9 decrease has been established for treatment monitoring. Methods This was a retrospective study including patients with a baseline CA19.9 ≥ 37 UI/ml and with locally advanced or metastatic PA from two French centers. CA19.9 measurements were performed at baseline and first CT-scan evaluation. The aim was to use a training set to determine the best cut-off of CA19.9 decrease for predicting progressive disease (PD) and to analyze its performance in an independent validation cohort. Results A total of 95 and 93 patients were included in the training and validation sets, respectively. A ≤15% CA19.9 decrease was the best cut-off for predicting PD with a sensitivity (Se) = 68% and a specificity (Sp) = 90%. In the validation set, this threshold was associated with Se = 76% and Sp = 83%. A >15% CA19.9 decrease was significantly associated with improved PFS (median 8.3 versus 3.1 months, p 15% CA19.9 decrease was also identified as a factor independently associated with OS (HRa = 0.25, 95% CI:0.14–0.44). Conclusions A CA 19.9 decrease >15% is a favourable predictor of outcome in patients treated for advanced PA.

Published
2019
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8. Prevention of 5-fluorouracil-induced early severe toxicity by pre-therapeutic dihydropyrimidine dehydrogenase deficiency screening: Assessment of a multiparametric approach

Author

Ludovic Rosenfeld, Virginie Berger, Erick Gamelin, Karine Bouhier-Leporrier, Claire Stampfli, Isabelle Baumgaertner, Thierry Lecompte, Mehdi Kaassis, Eric Francois, Christophe Borg, Alain Morel, Celia Roemer-Becuwe, Veronique Guerin-Meyer, Roger Faroux, Michèle Boisdron-Celle, Oana Cojocarasu, Jean Philippe Metges, Olivier Capitain, Marie Pierre Galais, and Jaafar Bennouna

Subjects
0301 basic medicine, Chemotherapy, medicine.medical_specialty, business.industry, Colorectal cancer, medicine.medical_treatment, Incidence (epidemiology), Hematology, medicine.disease, Gastroenterology, Surgery, 03 medical and health sciences, Dihydropyrimidine dehydrogenase deficiency, 030104 developmental biology, 0302 clinical medicine, Oncology, Fluorouracil, 030220 oncology & carcinogenesis, Internal medicine, Toxicity, medicine, Dihydropyrimidine dehydrogenase, Prospective cohort study, business, medicine.drug
Abstract

5-Fluorouracil (5-FU)–based treatments can lead to early-onset severe (4%–5%) even fatal (0.3%) toxicities in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. This multicenter prospective cohort study aimed to assess the clinical benefit of pretherapeutic screening for DPD deficiency using a multiparametric approach. Two parallel cohorts of patients treated with 5-FU–based chemotherapy for colorectal carcinoma were compared in a prospective nonrandomized study. In arm A, patients had DPD deficiency screening before treatment, whereas in arm B no pretherapy screening was performed. Dosing was based on 5-FU administration guidelines of each institution. DPD deficiency screening was performed using a combined multiparametric approach (5-FUODPM Tox). The frequency of early grade 4–5 toxic events potentially induced by 5-FU was compared in the two groups. At total of 1,142 patients (n = 1,116 evaluable) were enrolled. In arm A, out of 718 evaluable patients, nine grade 4 early toxicities potentially related to 5-FU were reported in nine patients (1.2%) with no toxic death despite one complete DPD deficiency and 24 partial deficiencies. The 24 patients with partial deficiency had safe pharmacokinetics (PK)-monitored 5-FU. In arm B, among 398 evaluable patients, 17 grade 4–5 toxic early events potentially related to 5-FU were reported in 12 patients (4.2%). The incidence of early severe toxicity was significantly higher in arm B (P = .0019), confirming the positive impact of pretherapeutic DPD assessment. The percent of patients with a toxicity grade 3 or higher observed in arm A was 10.8% (n = 78) compared to 17.55% (n = 69) in arm B (P = .0497). The percentage of death was reduced from 2.5/1,000 in arm B to 0 in arm A. The time to occurrence of all grade ≥3 toxicities was determined in both arms and the difference between the two arms was significant (P = .047). Overall, one patient with complete DPD deficiency confirmed retrospectively died within 13 days from grade 5 multivisceral toxicity. Enrollment was prematurely closed after external experts’ decision. In conclusion, multiparametric pretherapeutic DPD deficiency screening significantly lowered the risk of early severe toxicity and avoided an early toxic death. This approach should be used for safe administration of 5-FU–based treatments.

Published
2017
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9. Utility of serum anti-cetuximab immunoglobulin E levels to identify patients at a high risk of severe hypersensitivity reaction to cetuximab

Author

Audrey Mailliez, Bénédicte Clarisse, Audrey Emmanuelle Dugué, Delphine Mariotte, Sylvie Zanetta, Annie Peytier, Cristian Moldovan, Stéphanie Dakpé, Pascal Do, Bruno Chauffert, Jean-Marie Reimund, Roland Schott, M.P. Galais, Emmanuel Babin, Benoît Dupont, Radj Gervais, Frédéric Di Fiore, Brigitte Le Mauff, Jean-Michel Grellard, Carmen Florescu, and Karine Bouhier-Leporrier

Subjects
medicine.medical_specialty, Colorectal cancer, Immunoglobulin E, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Medicine, Pharmacology (medical), 030212 general & internal medicine, Prospective cohort study, neoplasms, Pharmacology, Cetuximab, biology, business.industry, Head and neck cancer, Cancer, Odds ratio, medicine.disease, digestive system diseases, Confidence interval, 030220 oncology & carcinogenesis, Immunology, biology.protein, business, medicine.drug
Abstract

Aim Cetuximab is an anti-epidermal growth factor receptor antibody used for the treatment of metastatic colorectal cancer and head and neck cancer. Hypersensitivity reactions (HSRs) are associated with cetuximab use. The aim of the study was to evaluate the utility of anti-cetuximab immunoglobulin E (IgE) detection in order to identify patients at risk of HSR to cetuximab. Methods We included patients ready to receive a first cetuximab infusion in a prospective cohort carried out at nine French centres. Pretreatment anti-cetuximab IgE levels were measured. We compared the proportion of severe HSRs in the low anti-cetuximab IgE levels (≤29 IgE arbitrary units) subgroup with that in a historical cohort of 213 patients extracted from a previous study. Results Of the 301 assessable patients (mean age: 60.9 ± 9.3 years, head-and-neck cancer: 77%), 66 patients (22%) had high anti-cetuximab IgE levels, and 247 patients received cetuximab (including 38 with high anti-cetuximab levels). Severe HSRs occurred in eight patients (five grade 3 and three grade 4). The proportion of severe HSRs was lower in the low anti-cetuximab IgE levels subgroup vs. the historical cohort (3/209 [1.4%] vs. 11/213 [5.2%], odds ratio, 0.27, 95% confidence interval, 0.07–0.97), and higher in high vs. low anti-cetuximab IgE levels subgroup (5/38 [13.2%] vs. 3/209 [1.4%]; odds ratio, 10.4, 95% confidence interval, 2.4–45.6). Patients with severe HSRs had higher anti-cetuximab IgE levels than patients without reaction (median, 45 vs. 2 IgE arbitrary units, P = 0.006). Conclusions Detection of pretreatment anti-cetuximab IgE is feasible and helpful to identify patients at risk of severe cetuximab-induced HSRs.

Published
2016
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10. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study

Author

Jean-Paul Joly, Eric Assenat, Veronique Guerin-Meyer, Aurélie Bertaut, Jean-Louis Jouve, Jérôme Watelet, Christelle De La Fouchardiere, Catherine Lombard-Bohas, Trevor Stanbury, Karim Boudjema, Eveline Boucher, Laetitia Fartoux, Jean-Marc Phelip, Pascal Hammel, Jean-François Seitz, Karine Bouhier-Leporrier, Jean-Emmanuel Kurtz, M. Benabdelghani, Isabelle Baumgaertner, David Malka, David Tougeron, Roger Faroux, Julien Edeline, Christophe Louvet, Centre Eugène Marquis (CRLCC), Centre Paul Strauss, CRLCC Paul Strauss, Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER, Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Amiens-Picardie, CHU Pontchaillou [Rennes], Service d'Oncologie Médicale [CHU Saint -Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital du Bocage, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU Strasbourg, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service d'oncologie digestive et hépato-gastro-entérologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Service d'Oncologie médicale [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Henri Mondor, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Léon Bérard [Lyon], Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), UNICANCER [Paris], Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Institut Mutualiste de Montsouris (IMM), Institut Gustave Roussy (IGR), Département de médecine oncologique [Gustave Roussy], Service de gastroentérologie [CHU Saint-Etienne], and Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Time Factors, medicine.medical_treatment, [SDV.CAN]Life Sciences [q-bio]/Cancer, Gastroenterology, MESH: Antineoplastic Combinated Chemotherapy Protocol / therapeutic uses, Biliary Tract Neoplasms / drug therapy, Biliary Tract Neoplasms / surgery, Deoxycytidine / analogs & derivatives, Oxaliplatin / administration & dosage, Watchful waiting, Deoxycytidine, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Watchful Waiting, Aged, Aged, 80 and over, Chemotherapy, Biliary tract cancer, business.industry, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, Middle Aged, Gemcitabine, Progression-Free Survival, 3. Good health, Oxaliplatin, Clinical trial, Biliary Tract Surgical Procedures, Biliary Tract Neoplasms, Oncology, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Quality of Life, 030211 gastroenterology & hepatology, Female, France, business, Adjuvant, medicine.drug
Abstract

PURPOSE No standard adjuvant treatment currently is recommended in localized biliary tract cancer (BTC) after surgical resection. We aimed to assess whether gemcitabine and oxaliplatin chemotherapy (GEMOX) would increase relapse-free survival (RFS) while maintaining health-related quality of life (HRQOL) in patients who undergo resection. PATIENTS AND METHODS We performed a multicenter, open-label, randomized phase III trial in 33 centers. Patients were randomly assigned (1:1) within 3 months after R0 or R1 resection of a localized BTC to receive either GEMOX (gemcitabine 1,000 mg/m2 on day 1 and oxaliplatin 85 mg/m2 infused on day 2 of a 2-week cycle) for 12 cycles (experimental arm A) or surveillance (standard arm B). Primary end points were RFS and HRQOL. RESULTS Between July 2009 and February 2014, 196 patients were included. Baseline characteristics were balanced between the two arms. After a median follow-up of 46.5 months (95% CI, 42.6 to 49.3 months), 126 RFS events and 82 deaths were recorded. There was no significant difference in RFS between the two arms (median, 30.4 months in arm A v 18.5 months in arm B; hazard ratio [HR], 0.88; 95% CI, 0.62 to 1.25; P = .48). There was no difference in time to definitive deterioration of global HRQOL (median, 31.8 months in arm A v 32.1 months in arm B; HR, 1.28; 95% CI, 0.73 to 2.26; log-rank P = .39). Overall survival was not different (median, 75.8 months in arm A v 50.8 months in arm B; HR, 1.08; 95% CI, 0.70 to 1.66; log-rank P = .74). Maximal adverse events were grade 3 in 62% (arm A) versus 18% (arm B) and grade 4 in 11% versus 3% ( P < .001). CONCLUSION There was no benefit of adjuvant GEMOX in resected BTC despite adequate tolerance and delivery of the regimen.

Published
2019
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11. Digestive and genitourinary sequelae in rectal cancer survivors and their impact on health-related quality of life: Outcome of a high-resolution population-based study

Author

Guy Samama, Frédéric Genuist, Karine Bouhier-Leporrier, Jaroslaw Chomontovski, Laurent Mosquet, Denis Mauger, Marine Renier, Michel Cojocaru, Denis No Mura, Lakhdar Saadi, Jacques Soufron, Demetrios Koutsomanis, Cécile Bonnamy, Stéphane Corbinais, Antoine Granveau, Morgane Finochi, Yannick Le Roux, Claudine Lepoittevin, Daniel Cohen, Véronique Bouvier, Jean-Pierre Toudic, Emmanuel Polycarpe, Sylvain Auvray, Christelle Lartigau, Richard Barthélémy, Cyprien Rodriguez, Patrice Marchand, Jean-Marc Guilloit, Gil Lebreton, Joséphine Gardy, André L’Hirondel, Didier Reijasse, Eric Kalinski, Romain Gloro, Marie-Pierre Galais, Bernard Apoil, Guy Launoy, Dominique Arsène, Nathan Dolet, Florence Polycarpe, Olivier Dejardin, Eric Borotto, Jean-Pierre Desfachelles, Thierry Collet, Rémy Morello, Laurent Lagriffoul, Eric Degoutte, Yoann Marion, Jacques Jacob, Farouk Sleman, Franck Siriser, Catherine Renet, Barbara Alkofer, Aurélie Parzy, Benoit Dupont, Philippe Armand, Jean-Louis Brefort, Ammar Makki, Anne Laure Bignon, Arnaud Alves, Alexandre Thobie, Jean Michel Ollivier, Patrick Congard, Sophie Hervé, Laurent Lechevallier, Laurent-Eric Tiengou, Denis Lefrançois, Mehdi Hessissen, Marc Couque, Julien Leporrier, Nicolas Girard, Anne-Charlotte Lefebvre, Yves Teste, Laurent Lion, Céline Bazille, Louis Paul Argouarch, Amar Abdelli, Christian L’Hirondel, Y. Eid, Benjamin Menahem, Samouh Elfadel, Mihaela Saplacan, Marie-Vincent Ahkong, Service de Chirurgie Viscérale et Digestive [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Unité de recherche interdisciplinaire pour la prévention et le traitement des cancers (ANTICIPE), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité de Biostatistique et de Recherche Clinique (UBRC), and Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)

Subjects
Male, medicine.medical_specialty, Cross-sectional study, Colorectal cancer, [SDV]Life Sciences [q-bio], Digestive System Diseases, Population, 030230 surgery, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Cancer Survivors, Male Urogenital Diseases, Internal medicine, Surveys and Questionnaires, medicine, Humans, Registries, education, Aged, education.field_of_study, Genitourinary system, business.industry, Rectal Neoplasms, Middle Aged, medicine.disease, Combined Modality Therapy, Female Urogenital Diseases, 3. Good health, Cross-Sectional Studies, 030220 oncology & carcinogenesis, Population Surveillance, Cohort, Quality of Life, Surgery, International Prostate Symptom Score, Female, Sexual function, business, Follow-Up Studies
Abstract

Background With the rising number of rectal cancer survivors, more patients with sphincter-preserving surgery are having to live with a potentially impaired quality of life. The survey aimed to assess bowel and genitourinary sequelae and their impact on quality of life in an unselected registry-based population of rectal cancer survivors. Methods This cross-sectional cohort survey (registered at ClinicalTrials.gov ; ID: NCT03459235 ) included patients with rectal cancer who underwent curative surgery with sphincter-preserving surgery from January 1, 2007 to January 31, 2015. Patients with recurrent disease, intestinal stoma, or cognitive disorders were excluded. Validated scoring system included the Urinary Symptom Profile in women and the International Prostate Symptom Score in men for urinary function, International Index for Erectile Function 5 in men and Female Sexual Function Index in women for sexual function, and Core 30/ Colo Rectal 29 questionnaires for quality of life and Low Anterior Resection Syndrome score for bowel function. The impact of functional sequelae on global quality of life was evaluated by multiple linear regression. Results Responders (45.3%, 92/203 patients) and nonresponders were comparable according to sex, age, tumor stage, and neoadjuvant chemoradiation. With a mean follow-up of 6.5 years, 65.2% of the rectal cancer survivors had bowel dysfunction, of whom 41.3% experienced major Low Anterior Resection Syndrome and 80% of rectal cancer survivors experienced genitourinary dysfunction. In multiple linear regression, poor bowel function was a significant predictor of global quality of life in men (P = .04) and women (P = .0003). Conclusion This survey highlights the importance of sexual and bowel dysfunction in rectal cancer survivors and the strong correlation between high Low Anterior Resection Syndrome score and inferior quality of life. Further studies are needed to improve knowledge on how to predict bowel dysfunction and how to best support patients with bowel dysfunction.

Published
2019
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12. Overweight is associated to a better prognosis in metastatic colorectal cancer: A pooled analysis of FFCD trials

Author

Mireille Mousseau, Eric Francois, A. Fatisse, A. Bedjaoui, Abakar Mahamat, C. Lombard-Bohas, J. Ezenfis, Marc Porneuf, F. Subtil, M. Tissot, Emilie Maillard, M. Fayolle, J.F. Dor, A. Votte, P. Chiappa, P. Prost, Denis Cléau, P. Bergerault, J.C. Souquet, K. Beerblock, P. Chatrenet, J.M. Sabate, M. Carreiro, S. Beorchia, Vincent Hautefeuille, Jessika Moreau, N. Delas, C. Vilain, Christian Borel, Franck Audemar, M. Duluc, Touraj Mansourbakht, Bernard Denis, Gael Deplanque, Jean-Marc Phelip, C. Brezault, Anne Thirot-Bidault, L. Gasnault, Jean-Louis Jouve, Y. Rinaldi, B. Leduc, Y. Courouble, A. Alessio, Matthieu Schnee, P. Cassan, Antoine Adenis, Jocelyne Provencal, A. Botton, Laurent Cany, Françoise Desseigne, Marie-Christine Kaminsky, Mohamed Ramdani, B. Lafforgue, L. Rob, J.C. Barbare, S. Jacquot, A. Zaanan, J.-Y. Douillard, C. Cornila, B. Rhein, Benjamin Linot, Z. Ladhib, D. Zylberait, Cedric Lecaille, N. Hess-Laurens, H. Brixi-Benmansour, C. Rebischung, C. Giraud, L. Stefani, D. Pillon, J.P. Lafargue, J. Forestier, P. Laplaige, C. Paoletti, S. Lavau Denes, Etienne Suc, A. Patenotte, E. Echinard, François-Xavier Caroli-Bosc, D. Goldfain, V. Quentin, Hervé Perrier, J.D. Grangé, A. Marre, M. Baconnier, Bruno Coudert, Thomas Walter, R. Benoit, A. Blanchi, A.C. Dupont-Gossart, Emilie Barbier, X. Coulaud, D. Besson, Isabelle Trouilloud, D. Sevin-Robiche, M Giovannini, O. Boulat, C. Lobry, H. Castanie, Y. Molin, Thomas Aparicio, Valérie Boige, P. Lehair, J.P. Robin, J.P. Latrive, J. Goineau, Clément Belletier, G. Medinger, C. Lepere, Philippe Rougier, N. Bouaria, E. Carola, V. Derias, Bernard Paillot, Yves Becouarn, F. Kikolski, Martin Combe, Julie Vincent, C. Briac-Levaché, C. Becht, François Ghiringhelli, J. Charneau, Dany Gargot, Julien Vergniol, Denis Péré-Vergé, P. Pienkowski, Patrick Texereau, I. Baumgaertner, J.P. Ramain, Pierre-Luc Etienne, P. Claudé, Jean Francois Paitel, J.P. Plachot, M.-C. Clavero-Fabri, P. Geoffroy, A. Cadier-Lagnes, Y. Le Bricquir, S. Fratte, O. Favre, Aimery de Gramont, J. Butel, David Tougeron, B. Winkfield, E. Janssen, J. Meunier, Julien Volet, N. Gérardin, D. Soubrane, Vincent Bourgeois, Xavier Adhoute, Y.H. Lam, P.A. Haineaux, A. Rotenberg, J-B. Bachet, C. Berger, F. Almaric, J. Tuaillon, G. Gatineau-Saillant, F. Zerouala-Boussaha, E. Cuillerier, R. Lamy, D. Luet, D. Baudet-Klepping, E.A. Pariente, M. Gignoux, J. Martin, M. Blasquez, Romain Coriat, C. Bineau, J. Boutin, A. Aouakli, F. Dewaele, A.M. Queuniet, V. Sebbagh, P. Couzigou, N. Barrière, Faiza Khemissa, P. Follana, Laurence Chone, F. Petit-Laurent, N. Abdelli, Olivier Capitain, D. Bechade, Corinne Sarda, J.P. Herr, P. Pouderoux, Julien Taieb, M. Pauwels, E. Zrihen, L. Wander, Gael Goujon, G. Boilleau-Jolimoy, Anne Thirot Bidault, B. Landi, V. Jestin Le Tallec, Jaafar Bennouna, O. Berthelet, M. Glikmanas, H. Salloum, Côme Lepage, Thierry Lecomte, P. Amoyal, C. Platini, Veronique Guerin-Meyer, B. Garcia, Laetitia Dahan, Pascal Burtin, J. Villand, S. Nguyen, A. Roussel, F. Di Fiore, S. Oddou-Lagraniere, J.P. Aucouturier, Veronique Lorgis, Gerard Cavaglione, J.P. Lagasse, Dominique Auby, Pierre Michel, F. Bonnetain, Gilles Breysacher, R. Mackiewicz, Philippe Ruszniewski, T. Morin, J. Thaury, Clara Locher, J.M. Vantelon, S. Nasca, J.P. Barbieux, H. Maechel, Y. Coscas, May Mabro, S. Montembault, P. Novello, M. Charbit, J. Deguiral, A. Gagnaire, D. Festin, A. Gueye, Hélène Senellart, Achim Weber, Nadia Bouarioua, Jérôme Dauba, Michel Ducreux, Jean-Luc Raoul, G. Coulanjon, J.N. Vaillant, S. Chaussade, A. Gilbert, Anne-Laure Villing, Dominique Genet, P. Martin, M. Ben Abdelghani, M.P. Galais, A. Azzedine, A. Lemaire, C. Barberis, C. Buffet, J. Egreteau, G. Roquin, M. Mornet, Isabelle Cumin, M. Pelletier, P. Feydy, J. Lacourt, T. Chatellier, Jean-Louis Legoux, M. Benchalal, I. Graber, S. Nahon, P. Pantioni, A. Hollebecque, M. Zawadi, Pascal Hammel, M. Mignot, Roger Faroux, J. Lafon, Mohamed Gasmi, Jean-Philippe Spano, S. Pesque-Penaud, C. de la Fouchardiere, J. Cretin, Olivier Bouché, D. Smith, E. Norguet-Monnereau, G. Bordes, Sylvain Manfredi, Thévenet P, Herve Lacroix, E. Dorval Danquechin, Eric Terrebonne, Laurent Bedenne, P. Godeau, David Malka, V. Veuillez, Emmanuel Mitry, F. Riot, Sandrine Hiret, François Morvan, M.C. Gouttebel, Jean-François Seitz, Karine Bouhier-Leporrier, N. Stremsdoerfer, P. Souillac, M. Mozer, C. Couffon, F. Husseini, J.M. Cheula, J.-M. Gornet, K. Slimane Fawzi, Service d'hépato-gastro-entérologie [Hôpital Saint-Louis], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Sorbonne Paris Cité (USPC), Université Paris-Saclay, Oncologie digestive, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Service de gastroentérologie (CHD Vendee - Hopital Les Oudairies, La Roche Sur Yon), CHD Vendee (La Roche Sur Yon), Fédération Francophone de la Cancérologie Digestive, FFCD, Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Université Bourgogne Franche-Comté [COMUE] (UBFC), Service d'Hépato-Gastro-Entérologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Département d'hépato-gastro-entérologie [Hôpital Trousseau : CHRU Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Privé des Côtes d'Armor (HPCA), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Service de gastroentérologie [CHU Saint-Etienne], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Institut de Cancérologie de la Loire [Saint-Priest en Jarez], Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen]-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Service d'hépato-gastro-entérologie et oncologie digestive [CHR Orléans], Centre Hospitalier Régional d'Orléans (CHRO), Service De Gastroenterologie, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, Hôpital Louis Pasteur [Colmar] (CH Colmar), Département d'hépato-gastro-entérologie [CHU Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes)-Institut des Maladies de l’Appareil Digestif [CHU Nantes], Service d'oncologie [Institut Hospitalier Franco-Britannique : Levallois-Perret], Institut hospitalier Franco-Britannique [Levallois-Perret], Département d'oncologie médicale (CHU Robert Debré, Reims), Centre Hospitalier Universitaire de Reims (CHU Reims), Service d'oncologie digestive et hépato-gastro-entérologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-CHU Trousseau [APHP], Hôpital Charles Nicolle [Rouen]-CHU Rouen, and Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN)

Subjects
Male, 0301 basic medicine, Cancer Research, medicine.medical_specialty, Bevacizumab, Colorectal cancer, Angiogenesis Inhibitors, [SDV.CAN]Life Sciences [q-bio]/Cancer, Kaplan-Meier Estimate, Overweight, Gastroenterology, Pooled analysis, Body Mass Index, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Outcome Assessment, Health Care, Individual data, medicine, Overall survival, Humans, Neoplasm Metastasis, Objective response, Aged, 2. Zero hunger, Clinical Trials as Topic, Prognostic factor, business.industry, nutritional and metabolic diseases, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Prognosis, medicine.disease, 3. Good health, 030104 developmental biology, Oncology, Normal weight, 030220 oncology & carcinogenesis, Female, medicine.symptom, Colorectal Neoplasms, business, medicine.drug
Abstract

IF 7.191 (2017); International audience; BACKGROUND:Previous studies showed that high and low body mass index (BMI) was associated with worse prognosis in early-stage colorectal cancer (CRC), and low BMI was associated with worse prognosis in metastatic CRC (mCRC). We aimed to assess efficacy outcomes according to BMI.PATIENTS AND METHODS:A pooled analysis of individual data from 2085 patients enrolled in eight FFCD first-line mCRC trials from 1991 to 2013 was performed. Comparisons were made according to the BMI cut-off: Obese (BMI ≥30), overweight patients (BMI ≥ 25), normal BMI patients (BMI: 18.5-24) and thin patients (BMI

Published
2018
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13. Poorly differentiated gastro-entero-pancreatic neuroendocrine carcinomas: Are they really heterogeneous? Insights from the FFCD-GTE national cohort

Author

Sylvain Manfredi, Eric Terrebonne, Gael Deplanque, Jean-Yves Scoazec, Anne-Laure Ran-Royo, Marc Ferec, Guillaume Cadiot, Eric Maringe, C. Desauw, Philippe Rougier, Thomas Aparicio, Castex, Guillaume Geslin, Jean-François Seitz, François Dewaele, Karine Bouhier-Leporrier, Vincent Hautefeuille, Anne Thirot-Bidault, Olivia Hentic, G. Roquin, David Tougeron, Olivier Dubreuil, C. Rebischung, Laetitia Dahan, Ivan Borbath, Jean-Louis Legoux, Laurent Bedenne, Sandrine Lavau denes, Catherine Ligeza, Mathieu Baconnier, K. Le Malicot, Laurent Cany, Côme Lepage, Thierry Lecomte, Céline Lepère, I. Bonnet, Valérie Rossi, Isabelle Wanicki Caron, Laetitia Stephanie, Cedric Lecaille, Eric Baudin, Thomas Walter, David Malka, Patricia Niccoli, Vincent Bourgeois, Etienne Suc, Joël Guigay, Romain Coriat, Rosine Guimbaud, Catherine Lombard-Bohas, Caroline Petorin, Hospices Civils de Lyon (HCL), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Institut Gustave Roussy (IGR), Fédération Francophone de la Cancérologie Digestive, FFCD, CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Pontchaillou [Rennes], CHU Valenciennes, CHU Toulouse [Toulouse], Hôpital Cochin [AP-HP], Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), CHU de Lille, Hôpital Bicêtre, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service de Gastro-entérologie [Avicenne], Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Avicenne [AP-HP], Hôpital de la source, CHU Lyon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Robert Debré, Service d'Hépato-gastroentérologie, 51092 Reims, France, affiliation inconnue, CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Hôpital Haut-Lévêque, Université Sciences et Technologies - Bordeaux 1-CHU Bordeaux [Bordeaux], Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Clinique Saint-Jean Languedoc [Toulouse] (CSJL), CHU Amiens-Picardie, Hôpital Duchenne, CH Boulogne sur Mer, Polyclinique Francheville, Centre Catherine-de-Sienne [Nantes] (CCS), Polyclinique Bordeaux Nord Aquitaine, Hôpital Michallon, CH du Haut Anjou (Château-Gontier), CH Annecy Genevois, CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier du pays de Morlaix, Hôpital Saint-Joseph, Assistance Publique-Hôpitaux de Paris, Cabinet privé des Dr Geslin Provost (Vannes), CHU Rouen, Normandie Université (NU), CHU Dupuytren, CHU Dijon, Clinique Mutualiste de l'Estuaire (Saint Nazaire), Hospices Civils de Beaune [Centre hospitalier de Beaune], Centre de radiothérapie et d'oncologie médicale privée (Béziers), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Université Côte d'Azur (UCA)-UNICANCER

Subjects
Oncology, Male, Cancer Research, medicine.medical_specialty, 030209 endocrinology & metabolism, [SDV.CAN]Life Sciences [q-bio]/Cancer, Carboplatin, Cohort Studies, 03 medical and health sciences, Gastrointestinal cancer, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, FOLFIRI Regimen, Humans, Neoplasm Metastasis, Prospective cohort study, Aged, Etoposide, Gastrointestinal Neoplasms, Univariate analysis, Performance status, business.industry, Large cell, Hazard ratio, Ki67 index, medicine.disease, Prognosis, 3. Good health, Carcinoma, Neuroendocrine, Pancreatic Neoplasms, Treatment, Cell Transformation, Neoplastic, 030220 oncology & carcinogenesis, Neuroendocrine carcinoma, Female, Cisplatin, business, Cohort study
Abstract

IF 6.029; International audience; BackgroundDiagnosis and management of poorly differentiated gastro-entero-pancreatic (GEP) neuroendocrine carcinomas (NECs) remain challenging. Recent studies suggest prognostic heterogeneity. We designed within the French Group of Endocrine Tumours a prospective cohort to gain insight in the prognostic stratification and treatment of GEP-NEC.Patients and methodsAll patients with a diagnosis of GEP-NEC between 1st January 2010 and 31st December 2013 could be included in this national cohort. Adenoneuroendocrine tumours were excluded.Results253 patients from 49 centres were included. Median age was 66 years. Main primary locations were pancreas (21%), colorectal (27%), oesophagus-stomach (18%); primary location was unknown in 20%. Tumours were metastatic at diagnosis in 78% of cases. Performance status (PS) at diagnosis was 0–1 in 79% of patients. Among the 147 (58%) cases reviewed by an expert pathological network, 39% were classified as small cell NEC and 61% as large cell NEC. Median Ki67 index was 75% (range, 20–100). Median overall survival was 15.6 (13.6–17.0) months. Significant adverse prognostic factors in univariate analysis were PS > 1 (hazard ratio [HR] = 2.5), metastatic disease (HR = 1.6), NSE > 2 upper limit of normal [ULN]; HR = 3.2), CgA > 2 ULN (HR = 1.7) and lactate dehydrogenase >2 ULN (HR = 2.1). After first-line palliative chemotherapy (CT1) with platinum-etoposide (n = 152), objective response, progression-free survival and overall survival were 50%, 6.2 and 11.6 months; they were 24%, 2.9 and 5.9, respectively, after post-CT1 FOLFIRI regimen (n = 72).ConclusionsWe report a large prospective series of GEP-NEC which show the predominance of large cell type and advanced stage at diagnosis. Prognosis was found more homogeneous than previously reported, mainly impacted by PS and tumour burden.

Published
2017
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14. Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours

Author

Marianne Pavel, Denis Smith, M. Ducreux, Astrid Lièvre, Karine Bouhier-Leporrier, Karine Le Malicot, Jean-Louis Legoux, Anja Rinke, Olivia Hentic, Juan W. Valle, Nadia Bouarioua, Christos Toumpanakis, Guillaume Cadiot, David Tougeron, Thomas Walter, Rosine Guimbaud, Laetitia Dahan, Frédéric Di Fiore, Côme Lepage, Ivan Borbath, Roger Faroux, Jean-Yves Scoazec, Service d'hépato-gastroentérologie et cancérologie digestive (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Fédération Francophone de la Cancérologie Digestive, FFCD, Equipe EPICAD (LNC - U1231), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Hôpital de la Timone [CHU - APHM] (TIMONE), Neuroendocrine Tumour Unit, Centre for Gastroenterology, Royal Free Hospital, Regional Hospital of Orleans, Service de Biostatistique, Gastro - Entérologie et Nutrition, CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen]-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Bases moléculaires de la réponse aux xénobiotiques (U775 (IFR95)), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Robert Debré, Service d'Hépato-gastroentérologie, 51092 Reims, France, affiliation inconnue, Service d'Oncologie Médicale, Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Centre Hospitalier Départemental Les Oudairies, Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département d'Oncologie Médicale, Service d'Oncologie Médicale [Centre hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Service d'Hépato-Gastroentérologie [Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Centre de Recherche en Cancérologie de Lyon (CRCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Lipides - Nutrition - Cancer [Dijon - U1231] ( LNC ), Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Hôpital de la Timone [CHU - APHM] ( TIMONE ), Hôpital Charles Nicolle [Rouen]-CHU Rouen-Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ), Bases moléculaires de la réponse aux xénobiotiques ( U775 (IFR95) ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen ( CLCC Henri Becquerel ), Centre de Recherche en Cancérologie de Lyon ( CRCL ), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Centre Hospitalier Lyon Sud [CHU - HCL] ( CHLS ), Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ), Fédération Francophone de Cancérologie Digestive (FFCD), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Claude Bernard Lyon 1 ( UCBL ), and Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon]-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS )

Subjects
Oncology, Male, Duodenopancreatic neuroendocrine tumours, medicine.medical_treatment, Lanreotide, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, chemistry.chemical_compound, 0302 clinical medicine, Quality of life, Maintenance therapy, Clinical Protocols, Duodenal Neoplasms, Prospective Studies, Prospective cohort study, Gastroenterology, Middle Aged, 3. Good health, Europe, Clinical trial, Neuroendocrine Tumors, Treatment Outcome, 030220 oncology & carcinogenesis, Female, Somatostatin, Adult, medicine.medical_specialty, Randomization, Adolescent, Maintenance, 030209 endocrinology & metabolism, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, Placebo, Peptides, Cyclic, Disease-Free Survival, 03 medical and health sciences, Young Adult, Double-Blind Method, Internal medicine, medicine, Humans, Aged, Chemotherapy, Hepatology, business.industry, Surgery, Pancreatic Neoplasms, First line, chemistry, Quality of Life, business
Abstract

Introduction Patients with metastatic or locally advanced, non-resectable, grade 1 or 2 well-differentiated duodeno-pancreatic (WDDP) NETs are treated following European guidelines. Patients (Pts) with aggressive disease, i.e. progressive and/or symptomatic metastases and/or with significant hepatic invasion (>30–50%), and/or bone metastases, anti-tumour therapy should receive systemic combination of chemotherapy once disease control is obtained. Aim(s) The aim is to stop chemotherapy until progression. REMINET is an academic randomized, double-blind, placebo-controlled, phase II/III study designed to evaluate lanreotide (LAN) as maintenance treatment after L1 chemotherapy in G1-G2 WDDP NET. Materials and methods Main eligibility criteria: adults pts with a metastatic (synchronous or metachronous) or locally advanced, non-resectable, grade 1 or 2 WDDP NETs and documented control disease after L1 therapy at least 4 weeks prior to randomization. Results 222 patients will be randomly assigned in a 1:1 ratio to receive 120 mg LAN or placebo, every 28 days, until disease progression or unacceptable toxicity. The aim of the phase II part is to demonstrate a 6-months PFS >45% in LAN arm. Secondary endpoints are PFS according to central review, overall survival, safety and quality of life. A bio-bank of frozen blood will be constituted. Conclusion The study is currently open in France, Germany, Belgium, United Kingdom and Ireland. A total of 25 patients are randomized (NCT02288377).

Published
2017
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15. Risk factors associated with hypersensitivity reactions to cetuximab: anti-cetuximab IgE detection as screening test

Author

Bénédicte Clarisse, Karine Bouhier-Leporrier, Brigitte Le Mauff, Benoît Dupont, Radj Gervais, Marie-Pierre Galais, Jean-Marie Reimund, Jean-Michel Grellard, and Delphine Mariotte

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Allergy, Screening test, Cetuximab, Enzyme-Linked Immunosorbent Assay, Antibodies, Monoclonal, Humanized, Immunoglobulin E, Severity of Illness Index, Drug Hypersensitivity, Risk Factors, Internal medicine, medicine, Humans, neoplasms, Retrospective Studies, biology, business.industry, General Medicine, Odds ratio, medicine.disease, digestive system diseases, Hypersensitivity reaction, Immunology, Cohort, biology.protein, France, business, Anaphylaxis, medicine.drug
Abstract

ABSTRACT Aim: To describe the factors associated with a high risk of a hypersensitivity reaction to cetuximab. Patients & methods: We retrospectively studied a cohort of patients living in Normandy (France) treated with cetuximab. Results: Among the 229 treated patients, 24 (10.5%) had a hypersensitivity reaction to cetuximab, including 11 grade 3–5 reactions. Detection of anti-cetuximab IgE could be performed in 108 patients. Anti-cetuximab IgE was found in 13 of 17 patients (76.5%) who had a hypersensitivity reaction to cetuximab compared with 17 of 91 control patients (18.7%; adjusted odds ratio: 14.99; 95% CI: 3.59–62.63). No clinical criteria predicted the risk of allergy to cetuximab. Conclusion: Anti-cetuximab IgE may help physicians identify patients at risk of a hypersensitivity reaction to cetuximab.

Published
2014
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16. Evaluation of current practice

Author

Sara Grossi, Gérard Zalcman, Karine Bouhier-Leporrier, Dominique Maron, Corinne Delcambre-Lair, Brice Dubois, Minh-Dung Ngo, Katharina Gunzer, Bénédicte Clarisse, Vincent Launay-Vacher, Laure Kaluzinski, Stephanie Lheureux, and Florence Joly

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Renal function, Antineoplastic Agents, Young Adult, chemistry.chemical_compound, Breast cancer, Risk Factors, Neoplasms, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Pharmacology (medical), Prospective Studies, Adverse effect, Prospective cohort study, Aged, Aged, 80 and over, Pharmacology, Proteinuria, business.industry, Middle Aged, medicine.disease, Carboplatin, Discontinuation, Clinical trial, Oncology, chemistry, Female, medicine.symptom, business
Abstract

Adverse effects induced by cytotoxic chemotherapy (CT) have been mostly evaluated in clinical trials. The aim of this study was to assess in a nonselected patients group the incidence of CT-related toxicities and to identify risk factors in daily practice. Patients treated with CT (except cisplatin-based or carboplatin-based CT), for a solid tumour, were included in a prospective multicentre observational study. Clinical parameters, renal function and albumin level were assessed at baseline. Multivariate logistic regression was used to identify risk factors of CT-related toxicities. A total of 502 patients were recruited in different types of oncology departments. During CT, 62% of patients experienced grade 2-4 toxicities. Haematological toxicities affected 34% of patients and 20% of patients developed an infection requiring antibiotics. For 55% of patients, toxicities induced dose reduction (59% of cases), CT delay (25%) or discontinuation (16%) according to the management habits in the investigating centre. Performance status≥1, breast cancer, lymphopenia, hypoalbuminaemia and clearance creatinine

Published
2011
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17. Anti-cetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis

Author

Brigitte Le Mauff, Delphine Mariotte, Benoît Dupont, Aurore Tranchant, Radj Gervais, Jean-Marie Reimund, D. Laroche, M.P. Galais, Karine Bouhier-Leporrier, and Elisabeth Comby

Subjects
Adult, Hypersensitivity, Immediate, Male, Risk, medicine.medical_specialty, Colorectal cancer, medicine.drug_class, Immunology, Cetuximab, Enzyme-Linked Immunosorbent Assay, Antibodies, Monoclonal, Humanized, Immunoglobulin E, Monoclonal antibody, Sensitivity and Specificity, Gastroenterology, Mice, Predictive Value of Tests, Neoplasms, Report, Internal medicine, medicine, Animals, Humans, Immunology and Allergy, Epidermal growth factor receptor, Anaphylaxis, neoplasms, Aged, Aged, 80 and over, biology, business.industry, Incidence (epidemiology), Antibodies, Monoclonal, Cancer, Middle Aged, medicine.disease, digestive system diseases, Antibodies, Anti-Idiotypic, biology.protein, Female, business, medicine.drug
Abstract

Cetuximab, a chimeric mouse-human IgG1 monoclonal antibody against the epidermal growth factor receptor, has proven effective in the treatment of metastatic colorectal cancer and squamous cell carcinoma of the head and neck. However, a high incidence of immediate hypersensitivity reactions (HSR) to cetuximab after the first infusion has been observed. We have developed a test for identification of patients likely to show treatment-related HSR to cetuximab. An enzyme-linked immunosorbent assay (ELISA) for detecting anti-cetuximab IgEs was developed and tested on serum samples collected from cancer patients before start of cetuximab treatment, and from healthy blood donors. Similar levels of anti-cetuximab IgE were detected in pre-treatment patient sera (24/92, 26.1%) and sera from healthy blood donors (33/117, 28.2%). HSR were observed in 14 out of the 92 patients (15.2%), and 8 of these (57.1%) were grade 3–4. Anti-cetuximab IgEs were detected in 7/8 of the patients (87.5%) with severe HSRs as compared with 14/78 patients (17.9%) with no HSR (p = 0.0002). Predictive value of the anti-cetuximab IgE test for HSR events of grades 3–4 was calculated using Receiver Operating Characteristics analysis. With a cut-off value of 29 arbitrary units for the anti-cetuximab IgE, the ELISA test showed a sensitivity of 87.5%, specificity of 82.1%, positive predictive value of 33.3% and negative predictive value of 98.5%. Anti-cetuximab IgE ELISA detection could be a valuable tool to help the physician anticipate an anaphylaxis episode following cetuximab infusion and opt for a suitable alternative treatment.

Published
2011
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18. Gemcitabine plus nab-paclitaxel until progression or given sequentially with 5-fluorouracile plus irinotecan (FOLFIRI.3) for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC): A randomized phase II study (PRODIGE 37-FIRGEMAX)

Author

Hortense Laharie-Mineur, Emilie Barbier, Anne Thirot Bidault, Côme Lepage, Romain Coriat, Eric Terrebonne, Marie-Claude Gouttebel, Jean-Baptiste Bachet, Yves Rinaldi, Patrick Texereau, Anne-Laure Pointet, David Malka, Faiza Khemissa, Alain Gratet, Julien Taieb, F. Ghiringhelli, Karine Bouhier-Leporrier, and Laurent Miglianico

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Chemotherapy, Pancreatic ductal adenocarcinoma, business.industry, medicine.medical_treatment, Phases of clinical research, Gemcitabine, First line treatment, Irinotecan, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, medicine, FOLFIRI, business, medicine.drug, Nab-paclitaxel
Abstract

4107Background: Chemotherapy is effective in mPDAC but new approaches are still needed to improve patients (pts) survival and quality of life. We have previously published successful results of a s...

Published
2018
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19. Recent developments in colorectal cancer treatment by monoclonal antibodies

Author

M.P. Galais, Karine Bouhier-Leporrier, Dominique Arsène, and Jean-Marie Reimund

Subjects
Oncology, medicine.medical_specialty, Bevacizumab, medicine.drug_class, Colorectal cancer, Clinical Biochemistry, Edrecolomab, Monoclonal antibody, chemistry.chemical_compound, Internal medicine, Drug Discovery, Animals, Humans, Medicine, Epidermal growth factor receptor, Pharmacology, biology, Cetuximab, business.industry, Immunization, Passive, Antibodies, Monoclonal, medicine.disease, Vascular endothelial growth factor, chemistry, Monoclonal, biology.protein, Colorectal Neoplasms, business, medicine.drug
Abstract

A growing understanding of the molecular mechanisms involved in cancer biology and continuous refinement of available technologies for drug discovery have prompted the development of new therapeutic tools targeting specific cancer-associated molecular pathways. Among these so-called biological therapies, monoclonal antibodies have now reached the time of clinical application. Besides initial development of the murine antibody edrecolomab, the impact of monoclonal antibodies on cancer therapy has recently been clearly demonstrated in colorectal cancer by targeting two major pathways critical to tumourigenesis: the epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) signalling pathways. These antibodies showed significant clinical activity in advanced colorectal cancer, especially when combined with chemotherapy. This paper reviews the status of the monoclonal chimeric antibody cetuximab (Erbitux) and other anti-EGFR antibodies, and of bevacizumab (Avastin; an anti-VEGF humanised monoclonal antibody), in colorectal cancer treatment.

Published
2006
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20. Adjuvant GEMOX for biliary tract cancer: Updated relapse-free survival and first overall survival results of the randomized PRODIGE 12-ACCORD 18 (UNICANCER GI) phase III trial

Author

C. Louvet, E. Boucher, F. Bonnetain, M. Benabdelghani, J.F. Seitz, Laetitia Fartoux, Roger Faroux, Julien Edeline, Beata Juzyna, J-L. Jouve, Jérôme Watelet, Eric Assenat, David Malka, Aurélie Bertaut, Pascal Hammel, Karine Bouhier-Leporrier, J.M. Phelip, Trevor Stanbury, J-P. Joly, and Veronique Guerin-Meyer

Subjects
medicine.medical_specialty, Biliary tract cancer, business.industry, 05 social sciences, Hematology, GemOx, Relapse free survival, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Pharmaceutical Adjuvants, Oncology, 030220 oncology & carcinogenesis, Internal medicine, 0502 economics and business, medicine, Overall survival, 050211 marketing, business
Published
2017
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21. In reply

Author

Michele Boisdron-Celle, Olivier Capitain, Roger Faroux, Christophe Borg, Jean Philippe Metges, Marie Pierre Galais, Mehdi Kaassis, Jaafar Bennouna, Karine Bouhier-Leporrier, Eric Francois, Isabelle Baumgaertner, Véronique Guerin-Meyer, Oana Cojocarasu, Celia Roemer-Becuwe, Claire Stampfli, Ludovic Rosenfeld, Thierry Lecompte, Virginie Berger, Alain Morel, and Erick Gamelin

Subjects
Dihydropyrimidine Dehydrogenase Deficiency, Oncology, Humans, Fluorouracil, Hematology
Published
2017
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22. Gemox versus surveillance following surgery of localized biliary tract cancer: Results of the PRODIGE 12-ACCORD 18 (UNICANCER GI) phase III trial

Author

Jérôme Watelet, Jean Francois Seitz, Jean-Louis Jouve, Jean-Marc Phelip, Véronique Guérin Meyer, Trevor Stanbury, Julien Edeline, Aurelie Bertaut, Karine Bouhier-Leporrier, Jean-Paul Joly, Meher Ben Abdelghani, Olivier Rosmorduc, Beata Juzyna, Christophe Louvet, David Malka, Eric Assenat, Franck Bonnetain, Eveline Boucher, Roger Faroux, and Pascal Hammel

Subjects
Cancer Research, medicine.medical_specialty, Chemotherapy, Biliary tract cancer, business.industry, medicine.medical_treatment, GemOx, medicine.disease, Gemcitabine, Surgery, law.invention, 03 medical and health sciences, 0302 clinical medicine, Oncology, Randomized controlled trial, Quality of life, law, 030220 oncology & carcinogenesis, medicine, 030211 gastroenterology & hepatology, Gallbladder cancer, business, Adjuvant, medicine.drug
Abstract

225 Background: No standard post-surgery adjuvant treatment is currently recommended in localized biliary tract cancer (BTC). Gemcitabine combined with platinum is the standard chemotherapy for advanced BTC. The aim of this phase III randomized trial was to assess whether GEMOX would increase relapse-free survival (RFS) while maintaining health-related quality of life (HrQoL). Methods: We performed a multicenter randomized phase III trial. Patients were randomized, within 3 months of R0 or R1 resection of a localized BTC (intra-hepatic, perihilar, extra-hepatic cholangiocarcinoma or gallbladder cancer), to receive either GEMOX 85 for 12 cycles (Experimental Arm A) or surveillance (Standard Arm B). Co-primary objectives were RFS and HrQoL. 190 patients and 126 RFS events were required to show an increase of median RFS from 18 to 30 months. Results: Between July 2009 and February 2014, 196 patients were included in 33 French centers. Baseline characteristics were balanced, with similar primary sites, R0 resection rates were 86.2% (Arm A) vs 87.9% (Arm B), lymph node invasion present in 37.2% vs 36.4%. In Arm A, a median of 12 cycles was delivered (mean: 9.3, range: 0-12). Maximal grade of adverse events were grade 3 in 57.5% vs 22.2%, and grade 4 in 17.0% vs 9.1%. During treatment one patient died in each arm. The main grade ≥ 3 adverse events in the year following inclusion were peripheral neuropathy (50.0% vs 1.1%), and neutropenia (22.3% vs 0%). Median follow-up was 44.3 months, with 54 and 64 RFS events in arms A vs B. There was no significant difference in RFS between the arms (log-rank p = 0.31), with a hazard ratio of 0.83 [95% CI: 0.58-1.19], p = 0.31 (futility boundaries were crossed). Median RFS was 30.4 [95% CI: 15.4-45.8] vs 22.0 months [95%CI: 13.6-38.3] in arms A & B respectively, and 4-years RFS was 39.3% [95%CI: 28.4%-50.0%] vs 33.2% [95%CI: 23.1-43.7%]. Global Health HrQoL scores were not different at 12 months (70.8 vs 83.3, p = 0.18) and at 24 months (75.0 vs 83.3, p = 0.50). Conclusions: Adjuvant chemotherapy in BTC with GEMOX was feasible and associated with expected toxicities and no deterioration of HrQoL. There was no significant difference in RFS between GEMOX and surveillance. Clinical trial information: NCT01313377.

Published
2017
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23. Prospective analysis of CEA, CA19.9, circulating DNA (cDNA) and circulating tumor cells (CTC) in patients (pts) treated for a metastatic colorectal cancer (mCRC)_Results of COCA-COLON study

Author

Emmanuel Toure, F. Di Fiore, N. Vasseur, Thierry Frebourg, Frédéric Ziegler, Caroline Thill, F. Blanchard, David Sefrioui, J.-C. Sabourin, Pierre Michel, M.-P. Gallais, Anne Perdrix, A. Parzy, Ludivine Beaussire, Florian Clatot, Karine Bouhier-Leporrier, Alice Gangloff, André Gillibert, J. Delacour, and A.-C. Lefebvre

Subjects
Oncology, medicine.medical_specialty, biology, business.industry, Colorectal cancer, Hematology, medicine.disease, biology.organism_classification, Coca, Prospective analysis, Circulating tumor cell, Internal medicine, Complementary DNA, medicine, Circulating DNA, CA19-9, In patient, business
Published
2016
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24. REMINET: A European, multicentre, PHASE II/III randomized double-blind, placebo-controlled study evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours

Author

Jean-Louis Legoux, Olivia Hentic, Ivan Borbath, Frédéric Di Fiore, David Tougeron, Anja Rinke, Karine Bouhier Leporrier, Astrid Lièvre, Nadia Bouarioua, Guillaume Cadiot, Laetitia Dahan, Rosine Guimbaud, Juan W. Valle, Denis Smith, Côme Lepage, Thomas Walter, Karine Le Malicot, Michel Ducreux, Marianne Pavel, and Roger Faroux

Subjects
Cancer Research, medicine.medical_specialty, business.industry, Locally advanced, Placebo-controlled study, macromolecular substances, Lanreotide, Gastroenterology, carbohydrates (lipids), First line treatment, Double blind, stomatognathic diseases, chemistry.chemical_compound, Oncology, chemistry, Maintenance therapy, Internal medicine, otorhinolaryngologic diseases, bacteria, Medicine, In patient, business
Abstract

TPS4148Background: Patients (pts) with metastatic or locally advanced, non-resectable, Well-Differentiated Duodeno-Pancreatic (WDDP) NETs are treated following European guidelines. Pts with more ag...

Published
2016
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25. Prospective analysis of CEA, circulating DNA (cDNA) and circulating tumor cells (CTC) kinetics in patients (pts) treated for a metastatic colorectal cancer (mCRC)

Author

David Sefrioui, Nasrin Sarafan-Vasseur, Emmanuel Toure, Julien Delacour, Frederic Ziegler, Caroline Thill, Alice Gangloff, France Blanchard, Ludivine Beaussire, Karine Bouhier Leporrier, Marie-Pierre Galais, Anne Perdrix, Florian Clatot, Fabrice Jardin, Jean-Christophe Sabourin, Thierry Frébourg, Pierre Michel, and Frédéric Di Fiore

Subjects
Cancer Research, Chemotherapy, endocrine system diseases, Colorectal cancer, business.industry, medicine.medical_treatment, medicine.disease, digestive system diseases, Regimen, Prospective analysis, Circulating tumor cell, Oncology, Complementary DNA, medicine, Cancer research, Circulating DNA, In patient, business, neoplasms
Abstract

3560Background: CEA, cDNA and CTC have been reported as useful markers in mCRC pts treated with chemotherapy (CT)-based regimen. We previously reported that CEA kinetic (threshold 0.05) was associa...

Published
2016
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26. Prevention of 5-FU-induced health-threatening toxicity by pretherapeutic DPD deficiency screening: Medical and economic assessment of a multiparametric approach

Author

Roger Faroux, Jean-Philippe Metges, Ludovic Rosenfeld, Karine Bouhier Leporrier, Erick Gamelin, Oana Cojocarasu, Jaafar Bennouna, Christophe Borg, Claire Stampfli, Veronique Guerin-Meyer, Mehdi Kaassis, Michèle Boisdron-Celle, Eric Francois, Marie-Pierre Galais, Alain Morel, Celia Roemer-Becuwe, Olivier Capitain, Thierry Lecomte, Virginie Berger, and Isabelle Baumgaertner

Subjects
Cancer Research, medicine.medical_specialty, Oncology, Economic assessment, business.industry, Toxicity, medicine, Intensive care medicine, business, Surgery
Abstract

3601 Background: While 5-FU is the foundation of many in GI oncology treatments, pts with DPD deficiency can experience early-onset severe (5%) even fatal (0.3%) toxicities. This study aimed to confirm the pharmaco-economic benefits of pre-therapeutic screening for DPD deficiency using a multiparametric approach in a multicenter prospective cohort study (NCT01547923). Methods: Two parallel cohorts of pts treated with 5-FU-based chemotherapy for colorectal carcinoma were compared: Group A: initial DPD deficiency screening; Group B: no evaluation. Enrollment was based on 5-FU administration guidelines of each institution. DPD deficiency screening combined genotyping and phenotyping (ODPM Tox) (1,2,3). The 2 groups were to be compared in terms of early 5-FU-induced toxicity grade, toxicity cost and DPD screening cost. The enrollment was to be immediately closed in the case of proven 5-FU-related toxic death. Results: 1,130 pts were included from 06/01/2008 to 07/31/2012. Group A: no severe toxicity despite 1 pt with complete deficiency (pt not treated with 5-FU), 20 pts with partial deficiency had safe PK-monitored 5-FU (ODPM Protocol) with only one hospitalization due to toxicity. Group B: One death due to complete DPD deficiency, confirmed retrospectively. Enrollment prematurely closed after experts’ unanimous decision citing ethical concerns. 21 pts with partial DPD deficiency. 5 reported toxicity-related hospitalizations. Data treatment is ongoing. Conclusions: One complete deficiency occurred in both groups: Group A pt had safe treatment whereas Group B pt died due to 5-FU toxicity. Pre-therapeutic DPD deficiency screening using this multi-parametric approach should be performed before 5-FU-based treatment and PK-guided dose adaptation allows for safe treatment of even partially DPD deficient patients. Clinical trial information: NCT01547923. [Table: see text]

Published
2013
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27. Prevention of 5-FU-induced toxicities using pretherapeutic DPD deficiency screening: Medical and economic assessment of a multiparametric approach

Author

Erick Gamelin, Marie-Pierre Galais, Alain Morel, Jaafar Bennouna, Jean-Philippe Metges, Christophe Borg, Virginie Berger, Karine Bouhier Leporrier, Claire Stampfli, Ludovic Rosenfeld, Isabelle Baumgaertner, Olivier Capitain, Roger Faroux, Thierry Lecomte, Oana Cojocarasu, Celia Roemer-Becuwe, Eric Francois, Mehdi Kaassis, Veronique Guerin-Meyer, and Michèle Boisdron-Celle

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Chemotherapy, Colorectal cancer, business.industry, medicine.medical_treatment, Patient characteristics, medicine.disease, Group B, Surgery, Economic assessment, Internal medicine, Toxicity, medicine, Prospective cohort study, business, Genotyping
Abstract

351 Background: 5-FU is the backbone of most chemotherapy regimens in GI oncology. Patients with DPD deficiency can experience early onset severe (5%) even fatal (0.3%) toxic side-effects. We decided to confirm the medical and economic interest of pre-therapeutic screening of DPD deficiency using a multiparametric approach in a multicenter prospective cohort study (Eudract n°2008-000026-39). Methods: Two parallel cohorts of patients treated with 5-FU-based chemotherapy for colorectal carcinoma were compared: Group A: initial DPD activity evaluation; Group B: no evaluation. Enrollment in either group was based on 5-FU administration guidelines at each institution. DPD deficiency screening combined genotyping and phenotyping (ODPM Tox) as well as other patient characteristics (1,2,3). The 2 groups were compared in terms of early 5-FU-induced toxicity grade, toxicity cost and DPD screening cost. The enrollment was to be immediately closed if 5-FU-induced toxic death occurred. Results: 1,130 patients were included from to 16/06/2008 to 07/31/2012. Group A: no severe toxicity despite 1 patient with complete deficiency (5-FU replaced by another TS inhibitor), 17 patients with partial deficiency safely received PK-monitored 5-FU (ODPM Protocol). Group B: 1 death: 65 y.o. patient, adjuvant FOLFOX 4, 5-FU-induced SAE at day 6: grade 4 febrile neutropenia, septicemia, diarrhoea, mucositis and secondary dehydration, renal failure, then death. 5-FU imputable Grade 5 SAE declared by investigator. Complete DPD deficiency retrospectively confirmed. The enrollment was prematurely closed after unanimous experts’ decision for ethical reasons. Data treatment is ongoing. Conclusions: One complete deficiency occurred in both groups: Group A patient had safe treatment whereas Group B patient died due to 5-FU grade 5 toxicity. DPD deficiency screening by a multiparametric approach (ODPM Tox) should be performed before 5-FU treatments. Clinical trial information: 2008-000026-39. [Table: see text]

Published
2013
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