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1. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial

Author

François-Clément Bidard, Anne-Claire Hardy-Bessard, Florence Dalenc, Thomas Bachelot, Jean-Yves Pierga, Thibault de la Motte Rouge, Renaud Sabatier, Coraline Dubot, Jean-Sébastien Frenel, Jean Marc Ferrero, Sylvain Ladoire, Christelle Levy, Marie-Ange Mouret-Reynier, Alain Lortholary, Julien Grenier, Camille Chakiba, Laetitia Stefani, Jérôme Edouard Plaza, Florian Clatot, Luis Teixeira, Véronique D'Hondt, Hélène Vegas, Olfa Derbel, Claire Garnier-Tixidre, Jean-Luc Canon, Barbara Pistilli, Fabrice André, Laurent Arnould, Anne Pradines, Ivan Bièche, Céline Callens, Jérôme Lemonnier, Frédérique Berger, Suzette Delaloge, Francois-Clement BIDARD, Barbara PISTILLI, Florence DALENC, Thomas BACHELOT, Thibault DE LA MOTTE ROUGE, Renaud SABATIER, Coraline DUBOT, Jean-Sébastien FRENEL, Jean-Marc FERRERO, Sylvain LADOIRE, Christelle LEVY, Marie-Ange MOURET-REYNIER, Anne-Claire HARDY-BESSARD, Alain LORTHOLARY, Julien GRENIER, Camille CHAKIBA, Laetitia STEFANI, Patrick SOULIE, Jean-Philippe JACQUIN, Jérôme Edouard PLAZA, Florian CLATOT, Luis TEIXEIRA, Véronique D'HONDT, Hélène VEGAS, Olfa DERBEL, Claire GARNIER TIXIDRE, Catherine DELBALDO, Lionel MOREAU, Caroline CHENEAU, Jean-François PAITEL, Chantal BERNARD-MARTY, Dominique SPAETH, Dominique GENET, Isabelle MOULLET, Nathalie BONICHON-LAMICHHANE, Laura DEIANA, Charlotte GREILSAMER, Laurence VENAT-BOUVET, Valérie DELECROIX, Adrien MELIS, Hubert ORFEUVRE, Suzanne NGUYEN, Eric LEGOUFFE, Alain ZANNETTI, Romuald LE SCODAN, Nadine DOHOLLOU, Philippe DALIVOUST, Olivier ARSENE, Nathalie MARQUES, Thierry PETIT, Delphine MOLLON, Jérôme DAUBA, Nathalie BONNIN, François MORVAN, Miriam GARDNER, Adina MARTI, Charles-Briac LEVACHE, Emma LACHAIER, Mihaela ACHILLE, Christophe VALMAR, Ryan BOUAITA, Jacques MEDIONI, Cyril FOA, Francesco DEL PIANO, Michel GOZY, Anne ESCANDE, Nicolas LEDUC, Brigitte LUCAS, Dominique MILLE, Hanifa AMMARGUELLAT, Abeer NAJEM, Fanny TROUBOUL, Philippe BARTHELEMY, Hervé DESCLOS, Didier MAYEUR, Fabrice LORCHEL, François GUINET, Anne-Pascale LAURENTY, Axelle BOUDRANT, Olivier GISSEROT, Corinne ALLEAUME, Aimery DE GRAMONT, Institut Curie [Paris], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Centre Armoricain de Radiothérapie, d'Imagerie médicale et d'Oncologie [Plérin, Saint-Brieuc] (CARIO), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département cancer environnement (Centre Léon Bérard - Lyon), Centre Léon Bérard [Lyon], Centre Eugène Marquis (CRLCC), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Service d'oncogénétique [Centre georges-François Leclerc], Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, Radiothérapie [Centre François Baclesse], Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Hôpital privé du Confluent [Nantes], Institut Sainte Catherine [Avignon], Institut Bergonié [Bordeaux], Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut du Cancer de Montpellier (ICM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Hôpital privé Jean Mermoz [Lyon], Institut Gustave Roussy (IGR), Département de médecine oncologique [Gustave Roussy], Université Paris Dauphine-PSL, Université Paris sciences et lettres (PSL), and Pfizer

Subjects
Adult, Neutropenia, Adolescent, Aromatase Inhibitors, Receptor, ErbB-2, [SDV]Life Sciences [q-bio], Breast Neoplasms, Disease-Free Survival, Oncology, Receptors, Estrogen, Lymphopenia, Antineoplastic Combined Chemotherapy Protocols, Mutation, Humans, Female, Prospective Studies, Fulvestrant
Abstract

In advanced oestrogen receptor-positive, HER2-negative breast cancer, acquired resistance to aromatase inhibitors frequently stems from ESR1-mutated subclones, which might be sensitive to fulvestrant. The PADA-1 trial aimed to show the efficacy of an early change in therapy on the basis of a rising ESR1 mutation in blood (bESR1We did a randomised, open-label, phase 3 trial in 83 hospitals in France. Women aged at least 18 years with oestrogen receptor-positive, HER2-negative advanced breast cancer and an Eastern Cooperative Oncology Group performance status of 0-2 were recruited and monitored for rising bESR1From March 22, 2017, to Jan 31, 2019, 1017 patients were included, of whom 279 (27%) developed a rising bESR1PADA-1 is the first prospective randomised trial showing that the early therapeutic targeting of bESR1Pfizer.

Published
2022

2. Preliminary tolerance analysis of adjuvant chemotherapy in older patients after resection of stage III colon cancer from the PRODIGE 34-FFCD randomized trial

Author

Aparicio, T., Bouché, O., Etienne, P. L., Barbier, E., Mineur, L., Desgrippes, R., Guerin-Meyer, V., Hocine, F., Martin, J., Le Brun-Ly, V., Cretin, J., Desramé, J., Rinaldi, Y., Cany, L., Falandry, C., Lefevre, L. B., Marous, M., Terrebonne, E., Mosser, L., Turpin, J., Turpin, A., Bauguion, L., Reichling, C., Eynde, M., Carola, E., Hiret, S., UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'oncologie médicale, UCL - (SLuc) Service d'hépato-gastro-entérologie, CarMeN, laboratoire, Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Robert Debré, Hôpital Robert Debré-Centre Hospitalier Universitaire de Reims (CHU Reims), Hôpital Privé des Côtes d'Armor (HPCA), Lipides - Nutrition - Cancer (U866) (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-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA), Service Biostatistiques et Informatique Médicale (CHU de Dijon) (DIM), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Fédération Francophone de Cancérologie Digestive (FFCD), Institut Sainte Catherine [Avignon], CH de Saint-Malo [Broussais], Service d'Oncologie Médicale [Angers], Centre Paul Papin, Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Centre Hospitalier Simone Veil de Beauvais [Beauvais], Clinique François Chénieux, Hôpital Dupuytren [CHU Limoges], Institut de Cancérologie du GARD ICG - CHU Nîmes (Instit Cancéro - GARD), Hôpital privé Jean Mermoz [Lyon], Hôpital Européen [Fondation Ambroise Paré - Marseille], Clinique Francheville [Périgueux], Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Service d'oncogénétique [Centre georges-François Leclerc], Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, CHU de la Martinique [Fort de France], Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Hôpital Jacques Puel - Bourran [Rodez] (HJPB), Clinique Sainte Isabelle [Abbeville, France], Service d'oncologie médicale (CHRU Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), CH Colmar, Cliniques Universitaires Saint-Luc [Bruxelles], Groupe Hospitalier Public du Sud de l'Oise [Creil] (GHPSO), CRLCC René Gauducheau, and Département d'oncologie médicale [Saint Herblain]

Subjects
Geriatric evaluation, [SDV.AEN] Life Sciences [q-bio]/Food and Nutrition, Hepatology, Older, Gastroenterology, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Adjuvant chemotherapy, Colon cancer
Abstract

International audience; BACKGROUND: Colon adenocarcinoma mainly occurs in older patients. Oxaliplatin-based adjuvant chemotherapy improved disease-free survival after stage III colon cancer resection, but this improvement was not demonstrated in older patients. METHODS: The purpose of ADAGE-PRODIGE 34, randomized open phase III trial is to compare in patients over 70 years oxaliplatin plus fluoropyrimidine with fluoropyrimidine alone in fit patients (Group 1) and fluoropyrimidine with observation in frail patients (Group 2) after resection of stage III colon adenocarcinoma. We report a preliminary tolerance analysis on 50% of the first patients enrolled. RESULTS: The analysis was conducted on 491 patients (378 in Group 1 and 113 in Group 2). Patients in Group 2 were older and showed more frailty criteria than those in Group 1. Cumulative grade 3-5 toxicities were more frequent in patients treated with oxaliplatin in Group 1 or with fluoropyrimidine in Group 2 than in patients treated with fluoropyrimidine in Group 1. At least one course was deferred in more than half of the patients in all groups. Early treatment cessation was more frequent in Group 2. CONCLUSION: No safety concerns were raised for the continuation of accrual. The frailty criteria distribution suggests that the investigator's evaluation for group allocation was accurate.

Published
2022

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