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1. 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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2. A Phase II Multicenter Trial on High-Dose Vitamin D Supplementation for the Correction of Vitamin D Insufficiency in Patients with Breast Cancer Receiving Adjuvant Chemotherapy

Author

Elodie Chartron, Nelly Firmin, Célia Touraine, Angélique Chapelle, Eric Legouffe, Lobna Rifai, Stéphane Pouderoux, Lise Roca, Véronique D’Hondt, William Jacot, Département d'oncologie Médicale, CRLCC Val d'Aurelle - Paul Lamarque, Institut du Cancer de Montpellier (ICM), Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), ONCOGARD - NIMES, Institut de Cancérologie du GARD ICG - CHU Nîmes (Instit Cancéro - GARD), Service d'hématologie et oncologie médicale, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie-Université de Montpellier (UM), 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), and UNICANCER - Institut régional du Cancer Montpellier Val d'Aurelle (ICM)

Subjects
Adult, Nutrition and Dietetics, Nutrition. Foods and food supply, [SDV.CAN]Life Sciences [q-bio]/Cancer, Breast Neoplasms, Middle Aged, Vitamin D Deficiency, Article, adjuvant chemotherapy, Treatment Outcome, breast cancer, Chemotherapy, Adjuvant, Dietary Supplements, Humans, TX341-641, Female, Vitamin D, vitamin D insufficiency, Biomarkers, Food Science, hypercalciuria, Aged
Abstract

International audience; Breast cancer (BC) treatments induce vitamin D (VD) insufficiency and bone metabolism changes, resulting in osteoporosis and skeletal morbidity risk. We report the results of a bicentric phase II trial (ClinicalTrials.gov Identifier: NCT04091178) on the safety and efficacy of high-dose oral VD supplementation for VD deficiency correction in 44 patients with early BC treated with adjuvant chemotherapies. Patients received one dose of 100,000 IU 25-OH VD every 3 weeks from day 1 of cycle 1 to day 1 of cycle 5. The primary endpoint was the percentage of patients achieving serum 25-OH VD concentration normalization on day 1 of cycle 6 (D1C6). Secondary endpoints were safety, VD and calcium parameters at baseline and during chemotherapy, and identification of predictive biomarkers of VD normalization on D1C6. On D1C6, 21 patients (47.7%, 95% CI: 33.0–62.8) achieved VD normalization. No VD-related clinical toxicity was reported. However, 13 patients (29.5%) presented asymptomatic grade 1 hypercalciuria, leading to interruption of the high-dose oral VD supplementation in 10, followed by a rapid reduction in serum VD concentration. No baseline clinical factor was predictive of VD normalization on D1C6. This high-dose VD supplementation appears safe and efficient in patients with early BC receiving adjuvant chemotherapy.

Published
2021
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3. Clinical and molecular response to interferon-α therapy in essential thrombocythemia patients with CALR mutations

Author

Serge Carillo, Aurélie Chauveau, Stéphane Giraudier, Jean-Jacques Kiladjian, Emmanuelle Verger, Valérie Ugo, Mohammed A. Yassin, Bruno Cassinat, Christine Chomienne, Marie-Hélène Schlageter, Jean-Christophe Ianotto, Eric Legouffe, Nader Al-Dewik, Christine Dosquet, Unite de Biologie Cellulaire (Biol Cell - ST LOUIS - PARIS), 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), Laboratoire d'hématologie (Labo Hémato - BREST), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Unité de Formation de Recherche de Médecine (UFRM - BREST), Université de Brest (UBO), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Laboratoire d'hématologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Institut de cancérologie et d'hématologie, Hôpital Morvan [Brest]-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Department of Hematology and Bone Marrow Transplant (DHBMT - DOHA - QATAR), National Center for Cancer Care and Research (NCCCR - DOHA - QATAR), Qatar Medical Genetic Center (QMGC - DOHA - QATAR), Hamad medical corporation, Département de Cytologie Clinique (Dep Cyto Clin - NIMES), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Service d'hématologie et oncologie médicale, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie-Université de Montpellier (UM), ONCOGARD - NIMES, Institut de Cancérologie du GARD ICG - CHU Nîmes (Instit Cancéro - GARD), Université d'Angers - Faculté de médecine (UA UFR Médecine), Université d'Angers (UA)-Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Laboratoire d'Hématologie Biologique (Hémato - ANGERS), Centre Hospitalier Universitaire d'Angers (CHU Angers), Hématologie -Immunologie -Cibles thérapeutiques, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigations Cliniques, Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Lapeyronie-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Université de Montpellier (UM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Institut des Biomolécules Max Mousseron [Pôle Chimie Balard] (IBMM), and Ecole Nationale Supérieure de Chimie de Montpellier (ENSCM)-Institut de Chimie du CNRS (INC)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, Oncology, [SDV]Life Sciences [q-bio], DNA Mutational Analysis, Gene mutation, medicine.disease_cause, Biochemistry, Somatic evolution in cancer, Polyethylene Glycols, 0302 clinical medicine, Hydroxyurea, interferon-a therapy, 0303 health sciences, Mutation, essential thrombocythemia, biology, Remission Induction, Hematology, Middle Aged, Isocitrate Dehydrogenase, Recombinant Proteins, 3. Good health, DNA-Binding Proteins, 030220 oncology & carcinogenesis, Female, Thrombocythemia, Essential, CALR mutations, Adult, medicine.medical_specialty, Adolescent, Immunology, Alpha interferon, IDH2, Dioxygenases, Clonal Evolution, Young Adult, 03 medical and health sciences, Proto-Oncogene Proteins, Internal medicine, medicine, Humans, Allele, Alleles, 030304 developmental biology, Aspirin, Essential thrombocythemia, Interferon-alpha, Off-Label Use, Cell Biology, Genes, p53, medicine.disease, Clone Cells, Repressor Proteins, biology.protein, Calreticulin, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

International audience; Myeloproliferative neoplasms are clonal disorders characterized by the presence of several gene mutations associated with particular hematologic parameters, clinical evolution, and prognosis. Few therapeutic options are available, among which interferon α (IFNα) presents interesting properties like the ability to induce hematologic responses (HRs) and molecular responses (MRs) in patients with JAK2 mutation. We report on the response to IFNα therapy in a cohort of 31 essential thrombocythemia (ET) patients with CALR mutations (mean follow-up of 11.8 years). HR was achieved in all patients. Median CALR mutant allelic burden (%CALR) significantly decreased from 41% at baseline to 26% after treatment, and 2 patients even achieved complete MR. In contrast, %CALR was not significantly modified in ET patients treated with hydroxyurea or aspirin only. Next-generation sequencing identified additional mutations in 6 patients (affecting TET2, ASXL1, IDH2, and TP53 genes). The presence of additional mutations was associated with poorer MR on CALR mutant clones, with only minor or no MRs in this subset of patients. Analysis of the evolution of the different variant allele frequencies showed that the mutated clones had a differential sensitivity to IFNα in a given patient, but no new mutation emerged during treatment. In all, this study shows that IFNα induces high rates of HRs and MRs in CALR-mutated ET, and that the presence of additional nondriver mutations may influence the MR to therapy.

Published
2015
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4. Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial

Author

Nadine Houede, Claude Linassier, Philippe Beuzeboc, Paule Chinet-Charrot, Laura Faivre, Loic Mourey, Aude Flechon, Frank Priou, Gael Deplanque, Jean-Marc Ferrero, Jean-Louis Davin, Christine Theodore, Muriel Habibian, Brigitte Laguerre, Remy Delva, Anne-Laure Martin, Ivan Krakowski, Agnès Laplanche, Karim Fizazi, Frederic Rolland, Jean-Luc Labourey, Stéphane Culine, Jean-François Berdah, Gwenaelle Gravis, François Lesaunier, Isabelle Cojean-Zelek, Eric Legouffe, Alain Ravaud, Marjorie Baciuchka, Stéphane Oudard, Jean-Léon Lagrange, Institut Gustave Roussy (IGR), Centre Régional de Lutte contre le Cancer François Baclesse (CRLC François Baclesse ), Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Institut de cancérologie de l'Ouest - Paul Papin (ICO - Paul Papin), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Institut de cancérologie de l'Ouest - Nantes (ICO Nantes), CRLCC Paul Papin-CRLCC René Gauducheau, Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Centre Antoine Lacassagne, CRLCC Antoine Lacassagne, Centre Hospitalier Régional Universitaire de Nîmes (CHRU Nîmes), 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), Institut Claudius Regaud, CRLCC Institut Claudius Regaud, Hôpital Foch [Suresnes], Institut de Cancérologie de Lorraine - Alexis Vautrin (ICL), Hôpital privé Toulon Hyères : Sainte Marguerite, Hôpital de la Timone [CHU - APHM] (TIMONE), CRLCC Eugène Marquis (CRLCC), Centre Léon Bérard [Lyon], Hôpital Saint-André, Groupe Hospitalier Diaconesses Croix Saint-Simon, Hôpital Européen Georges Pompidou [APHP] (HEGP), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), CHU Limoges, CRLCC Henri Becquerel, ONCOGARD - NIMES, Institut de Cancérologie du GARD (Instit Cancéro - GARD), Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Hôpital Saint-Joseph, Institut Curie, Institut Sainte Catherine [Avignon], UNICANCER [Paris], Hôpital Saint-Louis, Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), 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), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Institut de Cancérologie du GARD ICG - CHU Nîmes (Instit Cancéro - GARD), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Institut Curie [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Université Côte d'Azur (UCA)-UNICANCER, Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée)

Subjects
Male, medicine.medical_specialty, Maximum Tolerated Dose, Population, 030232 urology & nephrology, Urology, [SDV.CAN]Life Sciences [q-bio]/Cancer, Docetaxel, Kaplan-Meier Estimate, Disease-Free Survival, Drug Administration Schedule, Androgen deprivation therapy, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Neoplasm Invasiveness, education, Aged, Neoplasm Staging, Proportional Hazards Models, education.field_of_study, Dose-Response Relationship, Drug, business.industry, Standard treatment, Goserelin, Prostatic Neoplasms, Cancer, Androgen Antagonists, Middle Aged, Prostate-Specific Antigen, medicine.disease, Survival Analysis, 3. Good health, Surgery, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Estramustine, Taxoids, France, Neoplasm Recurrence, Local, business, Follow-Up Studies, medicine.drug
Abstract

International audience; BACKGROUND:Early risk-stratified chemotherapy is a standard treatment for breast, colorectal, and lung cancers, but not for high-risk localised prostate cancer. Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer. We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer.METHODS:We did this randomised phase 3 trial at 26 hospitals in France. We enrolled patients with treatment-naive prostate cancer and at least one risk factor (ie, stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration >20 ng/mL, or pathological node-positive). All patients underwent a staging pelvic lymph node dissection. Patients were randomly assigned (1:1) to either androgen deprivation therapy (ADT; goserelin 10·8 mg every 3 months for 3 years) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m(2) and estramustine 10 mg/kg per day on days 1-5, every 3 weeks, or ADT only. The randomisation was done centrally by computer, stratified by risk factor. Local treatment was administered at 3 months. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing. This study is registered with ClinicalTrials.gov, number NCT00055731.FINDINGS:We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group. Median follow-up was 8·8 years (IQR 8·1-9·7). 88 (43%) of 207 patients in the ADT plus docetaxel and estramustine group had an event (relapse or death) versus 111 (54%) of 206 in the ADT only group. 8-year relapse-free survival was 62% (95% CI 55-69) in the ADT plus docetaxel and estramustine group versus 50% (44-57) in the ADT only group (adjusted hazard ratio [HR] 0·71, 95% CI 0·54-0·94, p=0·017). Of patients who were treated with radiotherapy and had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths.INTERPRETATION:Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival.FUNDING:Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer.

Published
2015
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