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7 results on '"Département d'Oncologie Médicale [Centre René-Huguenin, Saint-Cloud]"'

1. Prolonged in‐hospital stay and higher mortality after Covid‐19 among patients with <scp>non‐Hodgkin</scp> lymphoma treated with B‐cell depleting immunotherapy

Author

Roberta Di Blasi, Laure Philippe, Thomas Hueso, Catherine Thieblemont, Karine Lacombe, Bénédicte Deau Fischer, Serge Bologna, Caroline Besson, Guillemette Fouquet, Sylvain Choquet, Milena Kohn, Rémy Duléry, Carole Soussain, Bernard Drenou, Pierre Feugier, Etienne Daguindau, Marc Delord, Nicolas Noel, Adrien Chauchet, Sylvain Lamure, Sandra Malak, Cédric Rossi, Bertrand Joly, Guillaume Cartron, Yassine Taoufik, Service d'hématologie clinique et de thérapie cellulaire [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), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Département d’Hématologie Clinique [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier de Versailles André Mignot (CHV), Service d'hématologie-oncologie adultes, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP), Service d'hématologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut Gustave Roussy (IGR), Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Groupe hospitalier de la région de Mulhouse Sud-Alsace (GHRMSA), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Curie [Saint-Cloud], Service d'Hématologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Service d'Hématologie clinique [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre d'Oncologie de Gentilly, Centre Hospitalier Sud Francilien, CH Evry-Corbeil, Service d'Hématologie [CH Annecy], CH Annecy, Hôpital Bicêtre, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Roche, Takeda Pharmaceutical Company, TPC, We thank all the clinicians and patients in the participating centers for their contributions to this multicenter study. We are grateful to the Centre Hospitalier de Versailles, in particular Philippe Rousselot and Laure Morisset for promoting the research and for supporting the editing. We thank France Lymphome Espoir for reviewing the study material, LYSA for discussions on the design of this study, and Sophie Rigaudeau and C?cile Laur?ana for their contribution to the collection of the cases., Rémy Duléry reports personal fees from Takeda, Novartis, and Biotest and non‐financial support from Gilead outside the submitted work. Roberta Di Blasi reports personal fees from Gilead and Novartis outside the submitted work. Serge Bologna reports personal fees from Janssen and Roche outside the submitted work. Guillaume Cartron reports personal fees from Roche, Celgene, Sanofi, Gilead, Janssen, and Abbvie outside the submitted work. Karine Lacombe reports personal fees and non‐financial support from Gilead, MSD, Abbvie, ViiV Healthcare, and Janssen outside the submitted work. Caroline Besson reports research funding from Roche and non‐financial support from Takeda and Roche outside the submitted work., HAL UVSQ, Équipe, Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Département d'Oncologie Médicale [Centre René-Huguenin, Saint-Cloud], Hôpital René HUGUENIN (Saint-Cloud), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], and Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)

Subjects
[SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology, Male, [SDV]Life Sciences [q-bio], MESH: COVID-19 / complications, Comorbidity, MESH: Lymphoma, Non-Hodgkin / complications, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Risk Factors, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, MESH: Age Factors, Young adult, Research Articles, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Aged, 80 and over, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, B-Lymphocytes, education.field_of_study, Lymphoma, Non-Hodgkin, MESH: SARS-CoV-2, Hazard ratio, Age Factors, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, Middle Aged, Combined Modality Therapy, MESH: Antigens, CD20 / immunology, 3. Good health, 030220 oncology & carcinogenesis, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Female, Rituximab, B-cell depleting immunotherapy, Immunotherapy, [SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy, Research Article, medicine.drug, Adult, medicine.medical_specialty, Population, lymphoma, [SDV.CAN]Life Sciences [q-bio]/Cancer, anti-CD20 therapy, Young Adult, MESH: Rituximab / administration & dosage, 03 medical and health sciences, [SDV.CAN] Life Sciences [q-bio]/Cancer, MESH: COVID-19 / mortality, Internal medicine, medicine, Humans, education, MESH: B-Lymphocytes / drug effects, Survival analysis, Aged, Proportional Hazards Models, Retrospective Studies, MESH: Aged, 80 and over, SARS-CoV-2, Proportional hazards model, business.industry, COVID-19, Retrospective cohort study, [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy, MESH: Combined Modality Therapy, Length of Stay, vaccination, Antigens, CD20, medicine.disease, Survival Analysis, Lymphoma, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Drug Resistance, Neoplasm, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, 030215 immunology
Abstract

International audience; Prolonged Covid-19 is an emerging issue for patients with lymphoma or immune deficiency. We aimed to examine prolonged length of in-hospital stay (LOS) due to Covid-19 among patients with lymphoma and assess its determinants and outcomes. Adult patients with lymphoma admitted for Covid-19 to 16 French hospitals in March and April, 2020 were included. Length of in-hospital stay was analyzed as a competitor vs death. The study included 111 patients. The median age was 65 years (range, 19–92). Ninety-four patients (85%) had B-cell non-Hodgkin lymphoma. Within the 12 months prior to hospitalization for Covid-19, 79 patients (71%) were treated for their lymphoma. Among them, 63 (57%) received an anti-CD20 therapy. Fourteen patients (12%) had relapsed/refractory disease. The median LOS was 14 days (range, 1–235). After a median follow-up of 191 days (3–260), the 6-month overall survival was 69%. In multivariable analyses, recent administration of anti-CD20 therapy was associated with prolonged LOS (subdistribution hazard ratio 2.26, 95% confidence interval 1.42–3.6, p < 0.001) and higher risk of death (hazard ratio 2.17, 95% confidence interval 1.04–4.52, p = 0.039). An age ≥ 70 years and relapsed/refractory lymphoma were also associated with prolonged LOS and decreased overall survival. In conclusion, an age ≥ 70 years, a relapsed/refractory lymphoma and recent administration of anti-CD20 therapy are risk factors for prolonged LOS and death for lymphoma patients hospitalized for Covid-19. These findings may contribute to guide the management of lymphoma during the pandemic, support evaluating specific therapeutic approaches, and raise questions on the efficacy and timing of vaccination of this particular population.

Published
2021
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2. Clinical Interest of Combining Transcriptomic and Genomic Signatures in High-Grade Serous Ovarian Cancer

Author

Roman Rouzier, Tatiana Popova, Marc-Henri Stern, Fatima Mechta-Grigoriou, Yann Kieffer, Claire Bonneau, Département d'Oncologie Médicale [Centre René-Huguenin, Saint-Cloud], Hôpital René HUGUENIN (Saint-Cloud), Unité de génétique et biologie des cancers (U830), Université Paris Descartes - Paris 5 (UPD5)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), and Institut Curie [Paris]

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, lcsh:QH426-470, endocrine system diseases, [SDV]Life Sciences [q-bio], [SDV.CAN]Life Sciences [q-bio]/Cancer, mesenchymal, Transcriptome, 03 medical and health sciences, 0302 clinical medicine, BRCA1/2, Internal medicine, medicine, Serous ovarian cancer, Genetics, HGSOC, Genetics (clinical), ComputingMilieux_MISCELLANEOUS, Original Research, business.industry, fibrosis, Genomic signature, Patient survival, medicine.disease, 3. Good health, Serous fluid, lcsh:Genetics, 030104 developmental biology, homologous recombination deficiency, 030220 oncology & carcinogenesis, Molecular Medicine, prognosis, Homologous Recombination Deficiency, business, Ovarian cancer, Patient stratification
Abstract

High-grade serous ovarian cancer is one of the deadliest gynecological malignancies and remains a clinical challenge. There is a critical need to effectively define patient stratification in a clinical setting. In this study, we address this question and determine the optimal number of molecular subgroups for ovarian cancer patients. By studying several independent patient cohorts, we observed that classifying high-grade serous ovarian tumors into four molecular subgroups using a transcriptomic-based approach did not reproducibly predict patient survival. In contrast, classifying these tumors into only two molecular subgroups, fibrosis and non-fibrosis, could reliably inform on patient survival. In addition, we found complementarity between transcriptomic data and the genomic signature for homologous recombination deficiency (HRD) that helped in defining prognosis of ovarian cancer patients. We also established that the transcriptomic and genomic signatures underlined independent biological processes and defined four different risk populations. Thus, combining genomic and transcriptomic information appears as the most appropriate stratification method to reliably subgroup high-grade serous ovarian cancer patients. This method can easily be transferred into the clinical setting.

Published
2020
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3. Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials

Author

B Sigal, Christel Breton-Callu, Emmanuelle Fourme, Laurence Venat-Bouvet, Jérôme Lemonnier, N Quenel-Tueux, Thibault De La Motte Rouge, Jean-Yves Pierga, Marie-Ange Mouret-Reynier, Simone Mathoulin-Pélissier, Thomas Bachelot, Florence Lerebours, Hervé Bonnefoi, Véronique Becette, Gaëtan MacGrogan, Sofia Rivera, Marina Pulido, Christine Tunon de Lara, Marc Debled, Florence Dalenc, Département d'Oncologie Médicale [Centre René-Huguenin, Saint-Cloud], Hôpital René HUGUENIN (Saint-Cloud), CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de Veille Sanitaire, Institut national de veille sanitaire, Service d'Oncologie Médicale, Institut Bergonié [Bordeaux], UNICANCER-UNICANCER, Validation et identification de nouvelles cibles en oncologie (VINCO), UNICANCER-UNICANCER-Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Radiothérapie Moléculaire et Innovation Thérapeutique (RaMo-IT), Institut Gustave Roussy (IGR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Service de Chirurgie, Institut Curie [Paris], Service d'Oncologie médicale [CHU Limoges], CHU Limoges, Plateforme de génétique moléculaire des cancers d'Aquitaine, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Eugène Marquis (CRLCC), Institut Claudius Regaud, Oncogénèse et progression tumorale, 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), UNICANCER [Paris], and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Time Factors, Multivariate analysis, [SDV]Life Sciences [q-bio], education, Phases of clinical research, Anastrozole, [SDV.CAN]Life Sciences [q-bio]/Cancer, Breast Neoplasms, Article, 03 medical and health sciences, Breast cancer, 0302 clinical medicine, Internal medicine, medicine, Humans, Endocrine system, 030212 general & internal medicine, Pathological, Aged, Univariate analysis, Fulvestrant, business.industry, EPICENE, Prognosis, medicine.disease, Survival Analysis, Neoadjuvant Therapy, 3. Good health, Risk factors, 030220 oncology & carcinogenesis, Female, business, medicine.drug
Abstract

Background Few data are available on survival and predictive factors in early breast cancer (BC) patients treated with neoadjuvant endocrine therapy (NET). Methods This is a pooled analysis of two multicentre, randomised non-comparative phase 2 clinical trials evaluating neoadjuvant anastrozole and fulvestrant efficacy for postmenopausal HR+/HER2- breast cancer patients: HORGEN (NCT00871858) and CARMINA02 (NCT00629616) studies. Results In total, 236 patients were included in CARMINA02 and HORGEN trials. Modified intention-to-treat analysis was available for 217 patients. Median follow-up was 65.2 months. Relapse-free survival (RFS) and overall survival (OS) at 5 years were 83.7% (95% CI: 77.9–88) and 92.7% (95% CI: 88.2–95.6), respectively, with no difference between treatment arms. On univariate analysis, tumour staging (T2 vs T3–4; p = 0.0001), Ki-67 at surgery (≤10% vs >10%; p = 0.0093), pathological tumour size (pT1–2 vs pT3–4; p = 0.0012) and node status (pN negative vs positive; p = 0.007), adjuvant chemotherapy (p = 0.0167) and PEPI score (PEPI group I + II vs III; p = 0.0004) were associated with RFS. No events were observed in patients with pathological response according to the Sataloff classification. Multivariate analysis showed that preoperative endocrine prognostic index (PEPI) group III was associated with significantly worse RFS (p = 0.0069, hazard ratio = 3.33 (95% CI: 1.39–7.98)). Conclusions Postmenopausal HR+/HER2- breast cancer patients receiving NET generally have a favourable outcome. The PEPI score identifies a subset of patients of poorer prognosis who are candidates for further additional treatment.

Published
2020
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4. Association with pregnancy increases the risk of local recurrence but does not impact overall survival in breast cancer: A case–control study of 87 cases

Author

Roman Rouzier, A. Langer, Florence Lerebours, A.S. Genin, Y. De Rycke, Anne Donnadieu, D. Stevens, Département d'Oncologie Médicale [Centre René-Huguenin, Saint-Cloud], Hôpital René HUGUENIN (Saint-Cloud), Institut Curie [Paris], Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), and Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)

Subjects
Oncology, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Kaplan-Meier Estimate, Mastectomy, Segmental, Breast cancer, 0302 clinical medicine, Pregnancy, Overall survival, 030212 general & internal medicine, Mastectomy, Neoadjuvant therapy, Univariate analysis, Carcinoma, Ductal, Breast, Local relapse, General Medicine, Prognosis, Neoadjuvant Therapy, Tumor Burden, 3. Good health, Survival Rate, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Pregnancy Complications, Neoplastic, Adult, medicine.medical_specialty, Antineoplastic Agents, Breast Neoplasms, Disease-Free Survival, 03 medical and health sciences, Internal medicine, medicine, Humans, Radical surgery, Survival rate, Neoplasm Staging, Proportional Hazards Models, Gynecology, Proportional hazards model, business.industry, medicine.disease, Carcinoma, Lobular, Carcinoma, Intraductal, Noninfiltrating, Case-Control Studies, Multivariate Analysis, Lymph Node Excision, Surgery, Neoplasm Recurrence, Local, business
Abstract

International audience; Pregnancy-associated breast cancer (PABC) constitutes 7% of all BCs in young women. The prognosis of PABC remains controversial. In this study, we evaluated the impact of the association of pregnancy with BC on the rates of overall survival (OS), disease free survival (DFS), and distant and local recurrence-free survival. We conducted a retrospective unicenter case–control study. We enrolled PABC patients treated at our institution between 1992 and 2009. For each case, 2 BC controls were matched for age and year of diagnosis. Univariate and multivariate analyses were performed to assess the parameters associated with prognosis. Eighty-seven PABC patients were enrolled and matched with 174 controls. The univariate analysis did not reveal any significant differences in OS, DFS or distant recurrence rates between the 2 groups. Pregnancy associated status, a tumor larger than T2 and neoadjuvant chemotherapy as the primary treatment were significantly associated with an increased risk of local relapse. The multivariate analysis showed that the pregnancy associated status and the tumor size were strong prognostic factors of local recurrence. Pregnancy associated status negates the prognostic value of tumor size, as both T0–T2 and T3–T4 PABC patients have the same poor prognosis as control BC patients with T3–T4 tumors. Interestingly, although PABC patients have more locally advanced tumors, they did not have a higher rate of radical surgery than the control BC patients. Pregnancy associated status is a strong prognostic factor of local relapse in BC. In PABC patients, when possible, radical surgery should be the preferred first treatment step.

Published
2016
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5. Serum CA125 and HE4 levels as predictors for optimal interval surgery and platinum sensitivity after neoadjuvant platinum-based chemotherapy in patients with advanced epithelial ovarian cancer

Author

Béatrice Guéry, Dominique Bellet, Claire Bonneau, Aurélie Roulot, Roman Rouzier, Aurélie Pelissier, Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Département d'Oncologie Médicale [Centre René-Huguenin, Saint-Cloud], and Hôpital René HUGUENIN (Saint-Cloud)

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, endocrine system diseases, Optimal cytoreduction, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Predictive value, HE4, Neoadjuvant chemotherapy, 03 medical and health sciences, CA125, 0302 clinical medicine, Internal medicine, Obstetrics and Gynaecology, Medicine, Epithelial ovarian cancer, In patient, Advanced ovarian cancer, Chemotherapy, Receiver operating characteristic, business.industry, Platinum sensitivity, Research, Obstetrics and Gynecology, 030104 developmental biology, 030220 oncology & carcinogenesis, Serum ca125, business
Abstract

International audience; Background: The aim of this study is to evaluate a new tumour marker, HE4, and to compare it with CA125 in predicting optimal cytoreduction and response to chemotherapy. Thirty patients with advanced epithelial ovarian cancer and multiple sera harvested during neoadjuvant chemotherapy (NAC) were included. Results: Based on ROC curves analysis, CA125 ≤ 75 UI/ml and HE4 ≤ 252 pmol/L after the 3rd cycles of NAC, with a sensitivity of 93.7 % and a specificity of 92.3 % (PPV = 93.7 % and NPV = 92.3 %), offered the best combination for predicting optimal cytoreduction. In addition, the HE4 value of 115 pmol/L is the best cut-off level for identifying platinum-sensitive patients. Conclusions: The introduction of HE4 as a new tool for predicting platinum-sensitivity and interval optimal cytoreduction is promising.

Published
2016
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6. Delivery room management of extremely preterm infants: The EPIPAGE-2 study

Author

Mélanie Durox, Monique Kaminski, Micheline Garel, Laurence Foix-l'Hélias, Babak Khoshnood, Pierre-Yves Ancel, Pascal Boileau, Julie Perlbarg, Françcois O. Goffinet, Département d'Oncologie Médicale [Centre René-Huguenin, Saint-Cloud], Hôpital René HUGUENIN (Saint-Cloud), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Fondation de France, and This study was supported by a grant from the Fondation de France (http:// www.fondationdefrance.org), which had no role in the design and conduct of the study, the collection, analysis or interpretation of data or writing of the report.

Subjects
medicine.medical_specialty, Pediatrics, Birth weight, [SDV]Life Sciences [q-bio], Population, Clinical Decision-Making, Gestational Age, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, Intensive care, Infant Mortality, Medicine, Humans, 030212 general & internal medicine, Neonatology, education, education.field_of_study, Pregnancy, Withholding Treatment, business.industry, Obstetrics, Delivery Rooms, Obstetrics and Gynecology, Gestational age, Infant, General Medicine, medicine.disease, Survival Rate, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Intensive Care, Neonatal, France, business, Cohort study
Abstract

International audience; Objective To analyse the delivery room management of babies born between 22 and 26 weeks of completed gestational age and to identify the factors associated with the withholding or withdrawal of intensive care. Study design Population-based cohort study. Patients and methods Our study population comprised 2145 births between 22 and 26 completed weeks enrolled in the EPIPAGE-2 study, a French cohort of very preterm infants born in 2011. The primary outcome measure was withholding or withdrawal of intensive care in the delivery room. Results Among infants born alive at 22-23 weeks, intensive care was withheld or withdrawn for >90%. At 24 weeks, resuscitative measures were withheld or withdrawn for 38%, at 25 weeks for 8% and at 26 weeks for 3%. Other factors besides gestational age at birth associated with this withholding or withdrawal for infants born at 24-26 weeks were birth weight

Published
2016
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7. Cost-Effectiveness Analysis of Trastuzumab (Herceptin) in HER2-Overexpressed Metastatic Breast Cancer

Author

Patrice Viens, Anne-Gaëlle Le Corroller-Soriano, Michel Marty, Henri Roché, Veronique Girre, Jocelyne Jacquemier, Jean-Paul Moatti, Etienne Brain, Anthony Gonçalves, Carole Perez-Ellis, Dupuis, Christine, Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U912 INSERM - Aix Marseille Univ - IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d’Oncologie Médicale [IPC, Marseille], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Université de la Méditerranée - Aix-Marseille 2, Département de Biopathologie [Marseille], Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Département d'Oncologie Médicale [Institut Curie, Paris], Institut Curie [Paris], Département d'oncologie médicale, Institut Claudius Regaud, Institut Curie - Saint Cloud (ICSC), Département d'Oncologie Médicale [Centre René-Huguenin, Saint-Cloud], Hôpital René HUGUENIN (Saint-Cloud), Supported by a grant from the French Ministry of Health STIC 2002 and a fellowship grant from the 'French League against Cancer.', Institut de Recherche pour le Développement (IRD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), and Institut Curie [Saint-Cloud]

Subjects
Oncology, Cancer Research, Receptor, ErbB-2, Cost-Benefit Analysis, 0302 clinical medicine, Trastuzumab, Medicine, 030212 general & internal medicine, Neoplasm Metastasis, skin and connective tissue diseases, health care economics and organizations, education.field_of_study, biology, Cost-effectiveness analysis, Middle Aged, Metastatic breast cancer, 3. Good health, 030220 oncology & carcinogenesis, Female, France, medicine.drug, Adult, medicine.medical_specialty, Population, Antineoplastic Agents, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, Humans, education, neoplasms, Survival analysis, Aged, Retrospective Studies, Gynecology, business.industry, Euros, Retrospective cohort study, Genes, erbB-2, biology.organism_classification, medicine.disease, Survival Analysis, Confidence interval, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business
Abstract

Objective: In women with Human Epidermal growth Receptor 2 (HER2)-positive metastatic breast cancer (MBC), Trastuzumab has become the standard of care but previous studies have raised doubts about its economic acceptability. We carried out the first cost-effectiveness study for Trastuzumab in MBC patients, in France, that is based on observed resource use and outcomes in clinical practice. Methods: We retrospectively analyzed 47 HER2-positive MBC patients in a before-and-after design study. Nineteen patients did not receive Trastuzumab ("before" Trastuzumab introduction in clinical practice) and 28 patients received Trastuzumab (the "after" population). Direct medical costs were estimated on the basis of the physical quantities reported in the patient medical records, for the period from first metastatic progression until death or date of patient last news. Monetary values (2002 French francs) were attributed to these quantities on the basis of unit costs and incremental cost-effectiveness ratios were calculated. Results: In the Trastuzumab group, median overall survival was significantly higher (37 months vs. 19 months in the non-Ttrastuzumab group, P = 0.001) but total treatment costs were 3 times higher (39,608 Euros vs. 12,795 Euros). The cost per additional life-year saved by Trastuzumab treatment was estimated to be 27,492 Euros (95% confidence interval: *20,964 Euros-34,020 Euros/year of life [bootstrapped estimation]). Conclusions: Our data suggest that despite its high unit price, Trastuzumab should be considered cost-effective in MBC patients to the extent that its incremental cost per life-year saved remains lower than gross domestic product per capita in countries like France.

Published
2009
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