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2. Validation of the European Oncology Quality of Life Toolkit

Author

Gustave Roussy, Cancer Campus, Grand Paris, German Cancer Research Center, Oslo universitetssykehus HF, The Netherlands Cancer Institute, Hospital del Mar Research Institute, Istituto Europeo di Oncologia, European Organisation for Research and Treatment of Cancer - EORTC, UNICANCER, EAPC, Institut Curie, EUROPEAN CANCER ORGANISATION, DIGICORE/IFO, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Alleanza Contro il Cancro, Istituti Fisioterapici Ospitalieri, STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG, University of Milan, SporeData OÜ, ORGANISATION OF EUROPEAN CANCER INSTITUTES, FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA, Medical University Innsbruck, SDRUZHENIE ASOTSIATSIA NA PATSIENTITE SONKOLOGICHNI ZABOLYAVANIA I PRIYATELI, FEDERATIA ASOCIATIILOR BOLNAVILOR DE CANCER, University of Leeds, The Leeds Teaching Hospitals NHS Trust, and Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet)

Published
2024

16. Implementation, Effectiveness and Impact of a Value Based Intervention for Patients With Breast or Lung Cancer (VOICE)

Author

Hospital de Cruces, Hospital Donostia, Hospital Universitario 12 de Octubre, Complejo Hospitalario de Especialidades Juan Ramón Jimenez, Institut Català d'Oncologia, Hospital Universitari de Bellvitge, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori, Instituto Portugues de Oncologia, Francisco Gentil, Porto, Onze Lieve Vrouwziekenhuis Aalst, and UNICANCER

Published
2024

24. Prospective Cohort of Patients With Hepatocellular Carcinoma in France (CHIEF)

Author

Biobanque de Picardie, Société Nationale Française de Gastroentérologie, Association Française pour l'Etude du Foie (AFEF), Federation Francophone de Cancerologie Digestive, Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH), UNICANCER, Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR), Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG), Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT), Société Française de Pathologie (SFP), Société Française de Radiologie (SFR), and Societe Francaise de Radiotherapie Oncologique

Published
2023

43. Plasma Uracil as a DPD Phenotyping Test: Pre-Analytical Handling Matters!

Author

Thomas, Fabienne, Launay, Manon, Guitton, Jérôme, Loriot, Marie-Anne, Boyer, Jean-Christophe, Haufroid, Vincent, Etienne-Grimaldi, Marie-Christine, Royer, Bernard, GPCO-UNICANCER Group, UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, and UCL - (SLuc) Service de biochimie médicale

Subjects
Pharmacology, Dihydropyrimidine Dehydrogenase Deficiency, Humans, Pharmacology (medical), Fluorouracil, Uracil, Dihydrouracil Dehydrogenase (NADP)
Abstract

To the Editor: We read with interest the article by de With et al. reporting the results of a prospective multicenter study where pretreatment uracil blood samples were collected and handled in 17 Dutch hospitals but analyzed in the reference hospital. [...]

Published
2022

44. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer.

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre de génétique médicale UCL, Delaloge, Suzette, Dureau, Sylvain, D'Hondt, Véronique, Desmoulins, Isabelle, Heudel, Pierre-Etienne, Duhoux, Francois P, Levy, Christelle, Lerebours, Florence, Mouret-Reynier, Marie A, Dalenc, Florence, Frenel, Jean-Sébastien, Jouannaud, Christelle, Venat-Bouvet, Laurence, Nguyen, Suzanne, Callens, Cécile, Gentien, David, Rapinat, Audrey, Manduzio, Helene, Vincent-Salomon, Anne, Lemonnier, Jérôme, Cottu, Paul, French Breast cancer Intergroup Unicancer-UCBG, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre de génétique médicale UCL, Delaloge, Suzette, Dureau, Sylvain, D'Hondt, Véronique, Desmoulins, Isabelle, Heudel, Pierre-Etienne, Duhoux, Francois P, Levy, Christelle, Lerebours, Florence, Mouret-Reynier, Marie A, Dalenc, Florence, Frenel, Jean-Sébastien, Jouannaud, Christelle, Venat-Bouvet, Laurence, Nguyen, Suzanne, Callens, Cécile, Gentien, David, Rapinat, Audrey, Manduzio, Helene, Vincent-Salomon, Anne, Lemonnier, Jérôme, Cottu, Paul, and French Breast cancer Intergroup Unicancer-UCBG

Abstract

Besides their development as additional adjuvant treatments, CDK4/6 inhibitors combined with endocrine therapy could represent less toxic alternatives to chemotherapy in postmenopausal women with high-risk oestrogen receptor-positive, HER2-negative breast cancer currently a candidate for chemotherapy. The multicentre, international, randomised phase 2 NEOPAL trial showed that the letrozole-palbociclib combination led to clinical and pathological responses equivalent to sequential anthracycline-taxanes chemotherapy. Secondary objectives included survival outcomes. Secondary end-points of NEOPAL included progression-free survival (PFS) and invasive-disease free survival (iDFS) in the intent-to-treat population. Exploratory end-points were overall survival (OS) and breast cancer specific survival (BCSS) in the intent-to-treat population, as well as iDFS, OS and BCSS according to the administration of chemotherapy. Hundred and six patients were randomised. Pathological complete response rates were 3.8% and 5.9%. Twenty-three of the 53 patients in the letrozole-palbociclib arm received postoperative adjuvant chemotherapy. At a median follow-up of 40.4 months [0-56.6], 11 progressions have been observed, of which three were in the letrozole-palbociclib and 8 in the control arm. PFS (HR = 1.01; [95%CI 0.36-2.90], p = 0.98) and iDFS (HR = 0.83; [95%CI 0.31-2.23], p = 0.71) did not differ between both arms. The 40 months PFS rate was 86.7% [95%CI 78.0-96.4] and 89.9% [95%CI 81.8-98.7] in letrozole-palbociclib and control arms, respectively. Outcomes of patients who did not receive chemotherapy were not statistically different from those who received it. NEOPAL suggests that a neoadjuvant letrozole-palbociclib strategy may allow sparing chemotherapy in some patients with luminal breast cancer while allowing good long-term outcomes. Larger confirmatory studies are needed.

Published
2022

45. Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer

Author

Delaloge, Suzette, Dureau, Sylvain, D'Hondt, Véronique, Desmoulins, Isabelle, Heudel, Pierre-Etienne, Duhoux, François, Levy, Christelle, Lerebours, Florence, Mouret-Reynier, Marie A, Dalenc, Florence, Frenel, Jean-Sébastien, Jouannaud, Christelle, Venat-Bouvet, Laurence, Nguyen, Suzanne, Callens, Cécile, Gentien, David, Rapinat, Audrey, Manduzio, Helene, Vincent-Salomon, Anne, Lemonnier, Jérôme, Cottu, Paul, French Breast cancer Intergroup Unicancer-UCBG, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)

Subjects
Cancer Research, Survival, Pyridines, Receptor, ErbB-2, [SDV]Life Sciences [q-bio], Breast Neoplasms, Survival Analysis, Neoadjuvant Therapy, Piperazines, CDK4/6 inhibitor, Oncology, Receptors, Estrogen, Luminal breast cancer, Antineoplastic Combined Chemotherapy Protocols, Letrozole, Humans, Chemotherapy, Female, Neoadjuvant
Abstract

Besides their development as additional adjuvant treatments, CDK4/6 inhibitors combined with endocrine therapy could represent less toxic alternatives to chemotherapy in postmenopausal women with high-risk oestrogen receptor-positive, HER2-negative breast cancer currently a candidate for chemotherapy. The multicentre, international, randomised phase 2 NEOPAL trial showed that the letrozole-palbociclib combination led to clinical and pathological responses equivalent to sequential anthracycline-taxanes chemotherapy. Secondary objectives included survival outcomes. Secondary end-points of NEOPAL included progression-free survival (PFS) and invasive-disease free survival (iDFS) in the intent-to-treat population. Exploratory end-points were overall survival (OS) and breast cancer specific survival (BCSS) in the intent-to-treat population, as well as iDFS, OS and BCSS according to the administration of chemotherapy. Hundred and six patients were randomised. Pathological complete response rates were 3.8% and 5.9%. Twenty-three of the 53 patients in the letrozole-palbociclib arm received postoperative adjuvant chemotherapy. At a median follow-up of 40.4 months [0-56.6], 11 progressions have been observed, of which three were in the letrozole-palbociclib and 8 in the control arm. PFS (HR = 1.01; [95%CI 0.36-2.90], p = 0.98) and iDFS (HR = 0.83; [95%CI 0.31-2.23], p = 0.71) did not differ between both arms. The 40 months PFS rate was 86.7% [95%CI 78.0-96.4] and 89.9% [95%CI 81.8-98.7] in letrozole-palbociclib and control arms, respectively. Outcomes of patients who did not receive chemotherapy were not statistically different from those who received it. NEOPAL suggests that a neoadjuvant letrozole-palbociclib strategy may allow sparing chemotherapy in some patients with luminal breast cancer while allowing good long-term outcomes. Larger confirmatory studies are needed.

Published
2022

46. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer

Author

Conroy, Thierry, Hammel, Pascal, Hebbar, Mohamed, Ben Abdelghani, Meher, Wei, Alice, Raoul, Jean-Luc, Choné, Laurence, Francois, Eric, Artru, Pascal, Biagi, James, Lecomte, Thierry, Assenat, Eric, Faroux, Roger, Ychou, Marc, Volet, Julien, Sauvanet, Alain, Breysacher, Gilles, Di Fiore, Frédéric, Cripps, Christine, Kavan, Petr, Texereau, Patrick, Bouhier-Leporrier, Karine, Khemissa-Akouz, Faiza, Legoux, Jean-Louis, Juzyna, Beata, Gourgou, Sophie, O'Callaghan, Christopher, Jouffroy-Zeller, Claire, Rat, Patrick, Malka, David, Castan, Florence, Bachet, Jean-Baptiste, Trials Group, Canadian Cancer, Group, Unicancer-GI–PRODIGE, Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, 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), Hôpital Claude Huriez [Lille], CHU Lille, CRLCC Paul Strauss, Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Hôpital privé Jean Mermoz, CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre Hospitalier Universitaire de Reims (CHU Reims), Service de chirurgie hepato-pancreato-biliaire, 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), Hôpital Louis Pasteur [Colmar] (CH Colmar), CHU Rouen, Normandie Université (NU), CHU Mont de Marsan, 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), Centre Hospitalier Saint Jean de Perpignan, Centre Hospitalier Régional d'Orléans (CHRO), R&D UNICANCER, Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCL/UNICANCER), UNICANCER-UNICANCER, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Oncologie digestive, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut de Cancérologie de Lorraine - Alexis Vautrin (ICL), Hôpital Beaujon-Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Hôpital Claude Huriez, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CRLCC Antoine Lacassagne, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon, Centre Hospitalier Régional d'Orléans (CHR), Service de Gastroentérologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
Adult, Male, medicine.medical_specialty, FOLFIRINOX, Leucovorin, [SDV.CAN]Life Sciences [q-bio]/Cancer, Irinotecan, Deoxycytidine, Gastroenterology, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Pancreatic cancer, Antineoplastic Combined Chemotherapy Protocols, Organometallic Compounds, medicine, Adjuvant therapy, Humans, Prospective Studies, Survival rate, Aged, Proportional Hazards Models, Aged, 80 and over, business.industry, Combination chemotherapy, General Medicine, Middle Aged, medicine.disease, Gemcitabine, 3. Good health, Oxaliplatin, Pancreatic Neoplasms, Drug Combinations, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, 030211 gastroenterology & hepatology, Fluorouracil, Folfirinox Regimen, Lung Diseases, Interstitial, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, medicine.drug
Abstract

International audience; BACKGROUND:Among patients with metastatic pancreatic cancer, combination chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) leads to longer overall survival than gemcitabine therapy. We compared the efficacy and safety of a modified FOLFIRINOX regimen with gemcitabine as adjuvant therapy in patients with resected pancreatic cancer.METHODS:We randomly assigned 493 patients with resected pancreatic ductal adenocarcinoma to receive a modified FOLFIRINOX regimen (oxaliplatin [85 mg per square meter of body-surface area], irinotecan [180 mg per square meter, reduced to 150 mg per square meter after a protocol-specified safety analysis], leucovorin [400 mg per square meter], and fluorouracil [2400 mg per square meter] every 2 weeks) or gemcitabine (1000 mg per square meter on days 1, 8, and 15 every 4 weeks) for 24 weeks. The primary end point was disease-free survival. Secondary end points included overall survival and safety.RESULTS:At a median follow-up of 33.6 months, the median disease-free survival was 21.6 months in the modified-FOLFIRINOX group and 12.8 months in the gemcitabine group (stratified hazard ratio for cancer-related event, second cancer, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.73; P

Published
2018

47. Artificial increase of uracilemia during fluoropyrimidine treatment can lead to DPD deficiency misinterpretation.

Author

UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, UCL - (SLuc) Service de biochimie médicale, UCL - (SLuc) Centre de toxicologie clinique, UCL - (SLuc) Centre de génétique médicale UCL, Thomas, F, Maillard, M, Launay, M, Tron, C, Etienne-Grimaldi, M-C, Gautier-Veyret, E, Haufroid, V, Pallet, N, Royer, B, Narjoz, C, Schmitt, A, Groupe de Pharmacologie Clinique Oncologique (GPCO-UNICANCER), UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, UCL - (SLuc) Service de biochimie médicale, UCL - (SLuc) Centre de toxicologie clinique, UCL - (SLuc) Centre de génétique médicale UCL, Thomas, F, Maillard, M, Launay, M, Tron, C, Etienne-Grimaldi, M-C, Gautier-Veyret, E, Haufroid, V, Pallet, N, Royer, B, Narjoz, C, Schmitt, A, and Groupe de Pharmacologie Clinique Oncologique (GPCO-UNICANCER)

Abstract

No abstract available

Published
2021

48. Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX.

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (MGD) Service d'oncologie médicale, UCL - (SLuc) Unité d'oncologie médicale, Emile, Jean-François, Julié, Catherine, Le Malicot, Karine, Lepage, Come, Tabernero, Josep, Mini, Enrico, Folprecht, Gunnar, Van Laethem, Jean-Luc, Dimet, Stéphanie, Boulagnon-Rombi, Camille, Allard, Marc-Antoine, Penault-Llorca, Frédérique, Bennouna, Jaafar, Laurent-Puig, Pierre, Taieb, Julien, PETACC8 Study Investigators, Austrian Breast and Colorectal cancer Study Group (ABCSG), Belgian Group of Digestive Oncology (BGDO), Lone Nørgård Petersen, Fédération Francophone de Cancérologie Digestive (FFCD), Fédération Nationale des Centres de Lutte Contre le Cancer (UNICANCER), Fédération Nationale des Centres de Lutte Contre le Cancer Association Européenne de Recherche en Oncologie (AERO), Arbeitsgemeinschaft Internistische Onkologie (AIO), Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD), Gruppo Oncologico dell'Italia Meridionale (GOIM), Istituto Oncologico Romagnolo (IOR), Gruppo Cooperativo Chirurgico Italiano (GOCCI), Gruppo Oncologico Nord Ovest (GONO), Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Gruppo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação Oncológica (GCCD, APIO), Grupo Español para el Tratamiento de los Tumores Digestivos (TTD), John Allen Bridgewater, Kerger, Joseph, Humblet, Yves, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (MGD) Service d'oncologie médicale, UCL - (SLuc) Unité d'oncologie médicale, Emile, Jean-François, Julié, Catherine, Le Malicot, Karine, Lepage, Come, Tabernero, Josep, Mini, Enrico, Folprecht, Gunnar, Van Laethem, Jean-Luc, Dimet, Stéphanie, Boulagnon-Rombi, Camille, Allard, Marc-Antoine, Penault-Llorca, Frédérique, Bennouna, Jaafar, Laurent-Puig, Pierre, Taieb, Julien, PETACC8 Study Investigators, Austrian Breast and Colorectal cancer Study Group (ABCSG), Belgian Group of Digestive Oncology (BGDO), Lone Nørgård Petersen, Fédération Francophone de Cancérologie Digestive (FFCD), Fédération Nationale des Centres de Lutte Contre le Cancer (UNICANCER), Fédération Nationale des Centres de Lutte Contre le Cancer Association Européenne de Recherche en Oncologie (AERO), Arbeitsgemeinschaft Internistische Onkologie (AIO), Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD), Gruppo Oncologico dell'Italia Meridionale (GOIM), Istituto Oncologico Romagnolo (IOR), Gruppo Cooperativo Chirurgico Italiano (GOCCI), Gruppo Oncologico Nord Ovest (GONO), Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Gruppo Cooperativo do Cancro Digestivo da Associação Portuguesa de Investigação Oncológica (GCCD, APIO), Grupo Español para el Tratamiento de los Tumores Digestivos (TTD), John Allen Bridgewater, Kerger, Joseph, and Humblet, Yves

Abstract

BACKGROUND: The prognostic value of lymphocyte infiltration (LI) of colorectal carcinoma (CC) has been demonstrated by several groups. However, no validated test is currently available for clinical practice. We previously described an automated and reproducible method for testing LI and aimed to validate it for clinical use. PATIENTS AND METHODS: According to National Institutes of Health criteria, we designed a prospective validation of this biomarker in patients included in the PETACC8 phase III study. Primary objective was to compare percentage of patients alive and without recurrence at 2 years in patients with high versus low LI (#NCT02364024). Associations of LI with patient recurrence and survival were analysed, and multivariable models were adjusted for treatment and relevant factors. Automated testing of LI was performed on virtual slides without access to clinical data. RESULTS: Among the 1220 CC patients enrolled, LI was high, low and not evaluable in 241 (19.8%), 790 (64.8%) and 189 (15.5%), respectively. Primary objective was met with a 2-year recurrence rate of 14.4% versus 21.1% in patients with high and low LI, respectively (p = 0.02). Patients with high LI also had better disease free survival (DFS) and overall survival (OS). Tumour stage, grade, RAS status and BRAF status were with LI the only prognostic markers in multivariable analysis for OS. Subgroup analyses revealed that high LI had better DFS and OS in mismatch repair (MMR) proficient patients, and in patients without RAS mutation, but not in MMR deficient and RAS mutated patients. CONCLUSION: Although this is the first validation with high level of evidence (IIB) of the prognostic value of a LI test in colon cancers, it still needs to be confirmed in independent series of colon cancer patients.

Published
2017

49. Extended benefit from sequential administration of docetaxel after standard fluorouracil, epirubicin, and cyclophosphamide regimen for node-positive breast cancer: the 8-year follow-up results of the UNICANCER-PACS01 trial

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Coudert, Bruno, Asselain, Bernard, Campone, Mario, Spielmann, Marc, Machiels, Jean-Pascal, Pénault-Llorca, Frédérique, Serin, Daniel, Lévy, Christelle, Romieu, Gilles, Canon, Jean-Luc, Orfeuvre, Hubert, Piot, Gilles, Petit, Thierry, Jerusalem, Guy, Audhuy, Bruno, Veyret, Corinne, Beauduin, Marc, Eymard, Jean-Christophe, Martin, Anne-Laure, Roché, Henri, the UNICANCER Breast Group, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Coudert, Bruno, Asselain, Bernard, Campone, Mario, Spielmann, Marc, Machiels, Jean-Pascal, Pénault-Llorca, Frédérique, Serin, Daniel, Lévy, Christelle, Romieu, Gilles, Canon, Jean-Luc, Orfeuvre, Hubert, Piot, Gilles, Petit, Thierry, Jerusalem, Guy, Audhuy, Bruno, Veyret, Corinne, Beauduin, Marc, Eymard, Jean-Christophe, Martin, Anne-Laure, Roché, Henri, and the UNICANCER Breast Group

Abstract

PURPOSE: The initial report from the Programme Action Concertée Sein (PACS) PACS01 trial demonstrated a benefit at 5 years for disease-free survival (DFS) and overall survival (OS) rates with the sequential administration of docetaxel after FEC100 (fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2)) for patients with node-positive, operable breast cancer. We evaluate here the impact of this regimen at 8 years. PATIENTS AND METHODS: Between June 1997 and March 2000, a total of 1,999 patients (age <65) with localized, resectable, non-pretreated, unilateral breast cancer were randomly assigned to receive either standard FEC100 for 6 cycles or 3 cycles of FEC100 followed by 3 cycles of 100 mg/m(2) docetaxel (FEC-D), both given every 21 days. Radiotherapy was mandatory after conservative surgery and tamoxifen was given for 5 years to hormone receptor (HR)-positive patients. Five-year DFS was the trial's main endpoint. Updated 8-year survival data are presented. RESULTS: With a median follow-up of 92.8 months, 639 patients experienced at least one event. A total number of 383 deaths were registered. Eight-year DFS rates were 65.8% with FEC alone and 70.2% with FEC-D. OS rates at 8 years were 78% with FEC alone and 83.2% with FEC-D. Cox regression analysis adjusted for age and number of positive nodes showed a 15% reduction in the relative risk of relapse and a 25% reduction in the relative risk of death in favor of FEC-D. Significant relative risk reductions were observed in the HR-positive, HER2-positive, and Ki67 ≥20% subpopulations. CONCLUSION: Benefits for DFS and OS rates with the sequential FEC-D regimen are fully confirmed at 8 years.

Published
2012

50. Long-term outcomes after severe acute kidney injury in critically ill patients: the SALTO study

Author

Khalil Chaïbi, Franck Ehooman, Bertrand Pons, Laurent Martin-Lefevre, Eric Boulet, Alexandre Boyer, Guillaume Chevrel, Nicolas Lerolle, Dorothée Carpentier, Nicolas de Prost, Alexandre Lautrette, Anne Bretagnol, Julien Mayaux, Saad Nseir, Bruno Megarbane, Marina Thirion, Jean-Marie Forel, Julien Maizel, Hodane Yonis, Philippe Markowicz, Guillaume Thiery, Frédérique Schortgen, Cécile Couchoud, Didier Dreyfuss, Stephane Gaudry, Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Maladies rénales fréquentes et rares : des mécanismes moléculaires à la médecine personnalisée (CoRaKID), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Centre Hospitalier René Dubos [Pontoise], Centre Hospitalier Sud Francilien, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU Rouen, Normandie Université (NU), CHU Henri Mondor [Créteil], Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Centre Hospitalier Régional d'Orléans (CHRO), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S_1144 / U1144)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Lariboisière-Fernand-Widal [APHP], Centre Hospitalier Victor Dupouy, Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS), Aix Marseille Université (AMU), Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517 (MP3CV), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, CHU Amiens-Picardie, and Hospices Civils de Lyon (HCL)

Subjects
Worsening renal failure, Renal replacement therapy, Long-term outcomes, Critical Care and Intensive Care Medicine, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Acute kidney injury
Abstract

Background The extent of the consequences of an episode of severe acute kidney injury (AKI) on long-term outcome of critically ill patients remain debated. We conducted a prospective follow-up of patients included in a large multicenter clinical trial of renal replacement therapy (RRT) initiation strategy during severe AKI (the Artificial Kidney Initiation in Kidney Injury, AKIKI) to investigate long-term survival, renal outcome and health related quality of life (HRQOL). We also assessed the influence of RRT initiation strategy on these outcomes. Results Follow-up of patients extended from 60 days to a median of 3.35 years [interquartile range (IQR), 1.89 to 4.09] after the end of initial study. Of the 619 patients included in the AKIKI trial, 316 survived after 60 days. The overall survival rate at 3 years from inclusion was 39.4% (95% CI 35.4 to 43.4). A total of 46 patients (on the 175 with available data on long-term kidney function) experienced worsening of renal function (WRF) at the time of follow-up [overall incidence of 26%, cumulative incidence at 4 years: 20.6% (CI 95% 13.0 to 28.3)]. Fifteen patients required chronic dialysis (5% of patients who survived after day 90). Among the 226 long-term survivors, 80 (35%) answered the EQ-5D questionnaire. The median index value reported was 0.67 (IQR 0.40 to 1.00) indicating a noticeable alteration of quality of life. Initiation strategy for RRT had no effect on any long-term outcome. Conclusion Severe AKI in critically ill patients was associated with a high proportion of death within the first 2 months but less so during long-term follow-up. A quarter of long-term survivors experienced a WRF and suffered from a noticeable impairment of quality of life. Renal replacement therapy initiation strategy was not associated with mortality outcome. Graphical Abstract

Published
2023

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