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Your search keyword '"MESH : Chemotherapy, Adjuvant"' showing total 24 results
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24 results on '"MESH : Chemotherapy, Adjuvant"'

1. PRODIGE 34-FFCD 1402-ADAGE: Adjuvant chemotherapy in elderly patients with resected stage III colon cancer: A randomized phase 3 trial

Author

Aparicio , Thomas, Francois , Eric, Cristol-Dalstein , Laurence, Carola , Elisabeth, Maillard , Emilie, Paillaud , Elena, Retornaz , Frédérique, Faroux , Roger, André , Thierry, Bedenne , Laurent, Seitz , Jean-François, Service de Gastro-entérologie [Avicenne], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Avicenne-Université Paris 13 ( UP13 ), Centre Antoine Lacassagne, CRLCC Antoine Lacassagne, UNICANCER - Institut régional du Cancer [Montpellier] ( ICM ), CRLCC Val d'Aurelle - Paul Lamarque, CH Creil/Senlis, Fédération Francophone de la Cancérologie Digestive, FFCD, 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 ), Unité de médecine gériatrique ( Gériatrie - Henri Mondor ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier, Centre Gérontologique Départemental de Marseille ( CGD 13 ), Service de chirurgie digestive (CH de La Roche-sur-Yon), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Service d'Oncologie Médicale [CHU Saint -Antoine], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Saint-Antoine [APHP], 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 ), Ligue Nationale Contre le Cancer, Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), UNICANCER - Institut régional du Cancer Montpellier Val d'Aurelle (ICM), Lipides - Nutrition - Cancer (U866) (LNC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bourgogne (UB)-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Unité de médecine gériatrique (Gériatrie - Henri Mondor), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Hôpital Albert Chenevier, Centre Gérontologique Départemental de Marseille (CGD 13), 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), and Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)

Subjects
Male, Organoplatinum Compounds, Oxaloacetates, MESH : Antineoplastic Combined Chemotherapy Protocols, Leucovorin, MESH : Aged, MESH : Leucovorin, Deoxycytidine, Activities of Daily Living, Antineoplastic Combined Chemotherapy Protocols, MESH : Neoplasm Staging, MESH : Female, Digestive System Surgical Procedures, MESH: Treatment Outcome, MESH: Digestive System Surgical Procedures, MESH: Aged, MESH: Organoplatinum Compounds, MESH : Chemotherapy, Adjuvant, MESH: Neoplasm Staging, MESH: Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, MESH : Colonic Neoplasms, MESH: Chemotherapy, Adjuvant, Chemotherapy, Adjuvant, Colonic Neoplasms, MESH : Fluorouracil, MESH : Disease-Free Survival, Female, [ SDV.MHEP.HEG ] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Fluorouracil, Efficacy, MESH : Male, MESH : Treatment Outcome, MESH : Organoplatinum Compounds, MESH : Capecitabine, Disease-Free Survival, MESH : Deoxycytidine, Humans, MESH : Digestive System Surgical Procedures, Capecitabine, Aged, Neoplasm Staging, MESH: Colonic Neoplasms, MESH: Humans, MESH: Activities of Daily Living, MESH: Deoxycytidine, MESH : Humans, MESH: Capecitabine, MESH: Quality of Life, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, MESH : Quality of Life, MESH: Male, MESH: Disease-Free Survival, Quality of Life, MESH: Leucovorin, MESH : Activities of Daily Living, MESH: Fluorouracil, MESH: Female
Abstract

IF 2.719; International audience

Published
2016

2. Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial

Author

Didier Debieuvre, Jean-Marc Limacher, Elisabeth Quoix, A. Madroszyk, Marc Buyse, Jean-Yves Bonnefoy, Z. Papai, Erich Stoelben, Gisèle Lacoste, Piotr Koralewski, Hervé Lena, Denis Braun, Alain Rivière, Marie-Pierre Chenard, Bérangère Bastien, Jean-Luc Breton, Annette Tavernaro, Rodryg Ramlau, Bruce Acres, Nadine Bizouarne, Virginie Westeel, Service de pneumologie, CHU Strasbourg-Hopital Civil, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ) -Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Laboratoire d'Ingénierie des Systèmes Mécaniques et des MAtériaux ( LISMMA ), Université Paris 8 Vincennes-Saint-Denis ( UP8 ) -SUPMECA - Institut supérieur de mécanique de Paris, Centre Hospitalier de Belfort-Montbéliard, Service de Pneumologie, CHI de la Haute-Saône, International Drug Development Institute ( IDDI ), Service d'Anatomie Pathologique Générale, CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Laboratoire d'Ingénierie des Systèmes Mécaniques et des MAtériaux (LISMMA), Université Paris 8 Vincennes-Saint-Denis (UP8)-SUPMECA - Institut supérieur de mécanique de Paris (SUPMECA), CH Belfort-Montbéliard, and International Drug Development Institute (IDDI)

Subjects
Male, Lung Neoplasms, MESH: Chi-Square Distribution, MESH : Antineoplastic Combined Chemotherapy Protocols, medicine.medical_treatment, MESH: Membrane Glycoproteins, MESH : Aged, MESH: Risk Assessment, Deoxycytidine, Gastroenterology, MESH: Cancer Vaccines, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, MESH: Vaccinia virus, Clinical endpoint, MESH : Neoplasm Staging, MESH: Treatment Outcome, Vaccines, Synthetic, 0303 health sciences, Membrane Glycoproteins, MESH: Middle Aged, MESH : Vaccinia virus, MESH : Antimetabolites, Antineoplastic, MESH : Chemotherapy, Adjuvant, 3. Good health, MESH: Antineoplastic Combined Chemotherapy Protocols, Oncology, 030220 oncology & carcinogenesis, Antimetabolites, Antineoplastic, medicine.medical_specialty, MESH: Vaccines, Synthetic, Risk Assessment, Disease-Free Survival, MESH : Cisplatin, 03 medical and health sciences, Humans, MESH : Middle Aged, MESH : Lung Neoplasms, MESH : Vaccines, Synthetic, Adverse effect, MESH: Kaplan-Meier Estimate, Aged, Chi-Square Distribution, MESH: Humans, MESH : Carcinoma, Non-Small-Cell Lung, MESH : Chi-Square Distribution, MESH: Deoxycytidine, MESH : Humans, MESH: Adult, MESH: Interleukin-2, MESH : Proportional Hazards Models, medicine.disease, MESH: Lung Neoplasms, MESH: Disease-Free Survival, Cisplatin, MESH: Female, MESH: Mucin-1, Time Factors, MESH : Membrane Glycoproteins, Kaplan-Meier Estimate, MESH: Proportional Hazards Models, Risk Factors, MESH: Risk Factors, Carcinoma, Non-Small-Cell Lung, MESH : Female, MESH : Risk Assessment, MESH: Aged, MESH: Antimetabolites, Antineoplastic, MESH : Cancer Vaccines, MESH: Neoplasm Staging, Middle Aged, MESH : Adult, MESH : Risk Factors, Europe, Treatment Outcome, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH : Mucin-1, MESH : Disease-Free Survival, Female, MESH : Time Factors, medicine.drug, Adult, Combination therapy, MESH : Male, MESH : Europe, Vaccinia virus, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Treatment Outcome, Neutropenia, Cancer Vaccines, MESH : Interleukin-2, MESH : Kaplan-Meier Estimate, MESH : Deoxycytidine, Internal medicine, medicine, Lung cancer, Neoplasm Staging, Proportional Hazards Models, 030304 developmental biology, Chemotherapy, Performance status, business.industry, Mucin-1, MESH: Time Factors, Gemcitabine, MESH: Male, Surgery, MESH: Cisplatin, Interleukin-2, MESH: Europe, business, MESH: Carcinoma, Non-Small-Cell Lung
Abstract

International audience; BACKGROUND: Chemotherapy is the standard of care for advanced stages of non-small-cell lung cancer (NSCLC). TG4010 is a targeted immunotherapy based on a poxvirus (modified vaccinia virus Ankara) that codes for MUC1 tumour-associated antigen and interleukin 2. This study assessed TG4010 in combination with first-line chemotherapy in advanced NSCLC. METHODS: 148 patients with advanced (stage IIIB [wet] or IV) NSCLC expressing MUC1 by immunohistochemistry, and with performance status 0 or 1, were enrolled in parallel groups in this open-label, phase 2B study. 74 patients were allocated to the combination therapy group, and received TG4010 (10(8) plaque forming units) plus cisplatin (75 mg/m(2) on day 1) and gemcitabine (1250 mg/m(2) on days 1 and 8) repeated every 3 weeks for up to six cycles. 74 patients allocated to the control group received the same chemotherapy alone. Patients were allocated using a dynamic minimisation procedure stratified by centre, performance status, and disease stage. The primary endpoint was 6-month progression-free survival (PFS), with a target rate of 40% or higher in the experimental group. Analyses were done on an intention-to-treat basis. This study is completed and is registered with ClinicalTrials.gov, number NCT00415818. FINDINGS: 6-month PFS was 43*2% (32 of 74; 95% CI 33*4-53*5) in the TG4010 plus chemotherapy group, and 35*1% (26 of 74; 25*9-45*3) in the chemotherapy alone group. Fever, abdominal pain, and injection-site pain of any grade according to National Cancer Institute Common Toxicity Criteria were more common in the TG4010 group than in the chemotherapy alone group: 17 of 73 patients (23*3%) versus six of 72 (8*3%), 12 (16*4%) versus two (2*8%), and four (5*5%) versus zero (0%), respectively. The most common grade 3-4 adverse events were neutropenia (33 [45*2%] of patients in the TG4010 plus chemotherapy group vs 31 [43*1%] in the chemotherapy alone group) and fatigue (18 [24*7%] vs 13 [18*1%]); the only grade 3-4 events that differed significantly between groups were anorexia (three [4*1%] vs 10 [13*9%]) and pleural effusion (none vs four [5*6%]). 38 of 73 patients (52*1%) in the TG4010 plus chemotherapy group and 34 of 72 (47*2%) in the chemotherapy alone group had at least one serious adverse event. INTERPRETATION: This phase 2B study suggests that TG4010 enhances the effect of chemotherapy in advanced NSCLC. A confirmatory phase 2B-3 trial has been initiated. FUNDING: Transgene SA, Advanced Diagnostics for New Therapeutic Approaches (ADNA)/OSEO.

Published
2011

3. Patients With Curative Resection of cT3-4 Rectal Cancer After Preoperative Radiotherapy or Radiochemotherapy: Does Anybody Benefit From Adjuvant Fluorouracil-Based Chemotherapy? A Trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group

Author

Collette, Laurence, Bosset, Jean-Francois, Den Dulk, Marcel, Nguyen, France, Mineur, Laurent, Maingon, Philippe, Radosevic-Jelic, Ljiljana, Piérart, Marianne, Calais, Gilles, Renseigné, Non, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut Sainte Catherine [Avignon], Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), and Institut Sainte Catherine

Subjects
Male, Cancer Research, Colorectal cancer, medicine.medical_treatment, MESH : Aged, MESH : Analysis of Variance, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Medicine, MESH : Female, MESH : Rectal Neoplasms, Neoadjuvant therapy, MESH: Aged, MESH: Middle Aged, MESH : Chemotherapy, Adjuvant, MESH : Adult, Middle Aged, Neoadjuvant Therapy, 3. Good health, MESH : Antineoplastic Agents, Oncology, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, Fluorouracil, MESH: Survival Analysis, 030220 oncology & carcinogenesis, MESH : Fluorouracil, Female, 030211 gastroenterology & hepatology, medicine.drug, Adult, medicine.medical_specialty, MESH : Male, MESH: Neoadjuvant Therapy, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, MESH: Analysis of Variance, Humans, MESH : Middle Aged, Aged, Analysis of Variance, MESH: Humans, Rectal Neoplasms, business.industry, MESH : Humans, MESH: Rectal Neoplasms, Cancer, MESH: Adult, medicine.disease, Survival Analysis, MESH: Male, Surgery, Radiation therapy, Clinical trial, MESH: Antineoplastic Agents, MESH : Survival Analysis, business, MESH : Neoadjuvant Therapy, MESH: Female, MESH: Fluorouracil, Chemoradiotherapy
Abstract

Purpose European Organisation for Research and Treatment of Cancer (EORTC) trial 22921 compared adjuvant fluorouracil-based chemotherapy (CT) to no adjuvant treatment in a 2 × 2 factorial trial with randomization for preoperative (chemo)radiotherapy in patients with resectable T3-4 rectal cancer. The results showed no significant impact of adjuvant CT on progression-free or overall survival, although a difference seemed to emerge at approximately, respectively, 2 and 5 years after the start of preoperative treatment. We further explored the data with the aim of refining our understanding of the long-term results. Patients and Methods Data of 785 of the 1,011 randomly assigned patients who whose disease was M0 at curative surgery were used. Using meta-analytic methods, we investigated the homogeneity of the effect of adjuvant CT on the time to relapse or death after surgery (disease-free survival [DFS]) and survival in patient subgroups. Results Although there was no statistically significant impact of adjuvant CT on DFS for the whole group (P > .5), the treatment effect differed significantly between the ypT0-2 and the ypT3-4 patients (heterogeneity P = .009): only the ypT0-2 patients seemed to benefit from adjuvant CT (P = .011). The same pattern was observed for overall survival. Conclusion Exploratory analyses suggest that only good-prognosis patients (ypT0-2) benefit from adjuvant CT. This could explain why, in the whole group, the progression-free and overall survival diverged only after the poor-prognosis patients (ypT3-4) had experienced treatment failure. Patients in whom no downstaging was achieved did not benefit. This also suggests that the same prognostic factors may drive both tumor sensitivity for the primary treatment and long-term clinical benefit from further adjuvant CT.

Published
2007

4. Clinical and economic impact of epoetin in adjuvant-chemotherapy for breast cancer

Author

Xavier Pivot, Bernard Schmitt, Yacine Merrouche, Philippe Fagnoni, Samuel Limat, Emmanuel Guardiola, Stéphanie Briaud, Loic Chaigneau, Marie-Christine Woronoff-Lemsi, Départment de pharmacie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Recherches épidémiologiques et cliniques en cancérologie digestive, Université de Bourgogne (UB)-IFR100 - Structure fédérative de recherche Santé-STIC-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Oncologie Médicale [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Caisse Régionale d'Assurance Maladie de Bourgogne et Franche Comté (CRAM BFC), Caisse primaire d'assurance maladie (CPAM), Service d'oncologie, Institut de Cancérologie de la Loire Lucien Neuwirth, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)-Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Institut National de la Santé et de la Recherche Médicale (INSERM), Saas, Philippe, Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Université de Bourgogne ( UB ) -IFR100 - Structure fédérative de recherche Santé-STIC-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service d'oncologie Médicale, Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Jean Minjoz, Caisse régionale d'assurance maladie, CPAM, Centre Hospitalier Universitaire de Saint-Etienne ( CHU de Saint-Etienne ) -Centre Hospitalier Universitaire de Saint-Etienne ( CHU de Saint-Etienne ), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC ( HOTE GREFFON ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Etablissement français du sang [Bourgogne-France-Comté] ( EFS [Bourgogne-France-Comté] ) -Université de Franche-Comté ( UFC ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])

Subjects
Oncology, MESH : Retrospective Studies, MESH : Antineoplastic Combined Chemotherapy Protocols, medicine.medical_treatment, MESH : Aged, MESH : Hemoglobins, MESH : Breast Neoplasms, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, [ SDV.IMM ] Life Sciences [q-bio]/Immunology, MESH: Treatment Outcome, MESH: Middle Aged, MESH : Hematinics, MESH : Infusions, Intravenous, MESH : Chemotherapy, Adjuvant, 3. Good health, MESH: Epoetin Alfa, MESH: Quality-Adjusted Life Years, MESH: Antineoplastic Combined Chemotherapy Protocols, MESH: Hemoglobins, 030220 oncology & carcinogenesis, Quality-Adjusted Life Years, MESH : Sensitivity and Specificity, 0305 other medical science, medicine.medical_specialty, [SDV.IMM] Life Sciences [q-bio]/Immunology, MESH : Anemia, Sensitivity and Specificity, MESH: Epirubicin, MESH: Doxorubicin, 03 medical and health sciences, Breast cancer, Humans, MESH : Middle Aged, Cyclophosphamide, Aged, Retrospective Studies, MESH: Humans, MESH : Humans, MESH: Cyclophosphamide, Epoetin alfa, MESH: Adult, MESH: Retrospective Studies, medicine.disease, MESH: Sensitivity and Specificity, Quality-adjusted life year, Epoetin Alfa, Erythropoietin, MESH: Female, MESH: Fluorouracil, Biomarkers, MESH: Cost-Benefit Analysis, MESH: Anemia, Cost-Benefit Analysis, MESH: Hematinics, Hemoglobins, hemic and lymphatic diseases, MESH : Female, Infusions, Intravenous, MESH : Cyclophosphamide, MESH: Aged, 030503 health policy & services, Anemia, Middle Aged, MESH : Adult, Recombinant Proteins, Treatment Outcome, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH : Fluorouracil, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, MESH : Cost-Benefit Analysis, Fluorouracil, France, MESH : Epirubicin, Adjuvant, medicine.drug, Adult, Breast Neoplasms, MESH : Treatment Outcome, Internal medicine, medicine, MESH : Doxorubicin, MESH : France, MESH: Infusions, Intravenous, Epirubicin, Chemotherapy, business.industry, MESH: Biological Markers, MESH: Quality of Life, Cancer, Retrospective cohort study, MESH : Quality of Life, MESH : Quality-Adjusted Life Years, MESH : Biological Markers, MESH: France, MESH : Epoetin Alfa, Doxorubicin, Hematinics, Quality of Life, business, MESH: Breast Neoplasms
Abstract

International audience; INTRODUCTION: Anaemia is a common toxicity in cancer patients and epoetins (EPOs) are now an established treatment. The economic profile of EPO treatment was assessed in patients with breast cancer treated by adjuvant-chemotherapy. MATERIALS AND METHODS: Two strategies were compared: without treatment by EPO and with the possible use of treatment by EPO (epoetin alfa) when required. The clinical effectiveness criterion was time adjusted to quality of life and economic data included only direct medical costs. MAIN RESULTS: One hundred ninety-two patients were included. In the group with the strategy containing the possible use of EPO, 45.5% of patients effectively received EPO. A significant difference in the haemoglobin level profile over time was observed which provided a significant overall benefit of 0.0052 (p

Published
2006

5. Intraperitoneal clearance as a potential biomarker of cisplatin after intraperitoneal perioperative chemotherapy: a population pharmacokinetic study

Author

Virginie Nerich, Sebastien Pili-Floury, Marielle Combe, Antoine Thiery-Vuillemin, Sylvain Onteniente, Damien Montange, Emmanuel Guardiola, Vincent Jullien, Bruno Chauffert, Patrice Muret, Xavier Pivot, Bernard Royer, Bruno Heyd, Delphine Delroeux, Jean-Pierre Kantelip, Sarah Piedoux, Elsa Kalbacher, Centre d'Investigation Clinique de Besançon (Inserm CIC 1431), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Laboratoire de Pharmacologie Clinique et Toxicologie [CHRU Besancon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Service d'Oncologie Médicale [CHRU Besançon], Service de pharmacologie, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Saint-Vincent de Paul-Université Paris Descartes - Paris 5 (UPD5), Epilepsies de l'Enfant et Plasticité Cérébrale (U1129), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'oncologie chirurgicale, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service d'anesthésie et soins intensifs [CHRU Besançon], Pôle pharmaceutique [CHRU Besançon], Service d'oncologie, CHU Amiens-Picardie, Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté]), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Centre d'Investigation Clinique de Besançon ( CICB ), Etablissement Français du Sang Bourgogne Franche-Comté-Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Franche-Comté ( UFC ), Université de Franche-Comté ( UFC ), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) ( HOTE GREFFON ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Etablissement français du sang [Bourgogne-France-Comté] ( EFS [Bourgogne-France-Comté] ) -Université de Franche-Comté ( UFC ), Laboratoire de Pharmacologie Clinique et Toxicologie [Besancon], Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Jean Minjoz-Université de Franche-Comté ( UFC ), Service d'oncologie Médicale, Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Jean Minjoz, CHU Cochin [AP-HP]-Hôpital Saint-Vincent de Paul-Université Paris Descartes - Paris 5 ( UPD5 ), Epilepsies de l'Enfant et Plasticité Cérébrale ( U1129 ), Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Service d'anesthésie et soins intensifs, Hôpital Jean Minjoz, Service de pharmacie, Saas, Philippe, and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Cancer Research, MESH : Aged, cisplatin, MESH : Models, Biological, Pharmacology, intraperitoneal perioperative chemotherapy, 030226 pharmacology & pharmacy, Intraoperative Period, MESH : Metabolic Clearance Rate, 0302 clinical medicine, population pharmacokinetics, Clinical Studies, [ SDV.IMM ] Life Sciences [q-bio]/Immunology, MESH : Female, Ovarian Neoplasms, Volume of distribution, MESH: Aged, education.field_of_study, MESH: Middle Aged, MESH: Peritoneum, MESH : Chemotherapy, Adjuvant, Middle Aged, MESH : Adult, 3. Good health, MESH : Antineoplastic Agents, MESH: Ovarian Neoplasms, Epinephrine, Oncology, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Toxicity, biomarker, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, MESH : Intraoperative Period, Peritoneum, Injections, Intraperitoneal, MESH: Injections, Intraperitoneal, medicine.drug, Adult, medicine.medical_specialty, [SDV.IMM] Life Sciences [q-bio]/Immunology, Metabolic Clearance Rate, MESH: Epinephrine, MESH : Drug Administration Schedule, Population, Urology, Antineoplastic Agents, MESH: Drug Administration Schedule, Models, Biological, Drug Administration Schedule, MESH : Cisplatin, 03 medical and health sciences, Pharmacokinetics, medicine, Humans, MESH : Middle Aged, education, MESH : Peritoneum, Aged, Cisplatin, MESH: Intraoperative Period, MESH: Metabolic Clearance Rate, MESH : Injections, Intraperitoneal, MESH: Humans, MESH : Ovarian Neoplasms, business.industry, MESH : Humans, MESH: Models, Biological, MESH: Biological Markers, MESH: Adult, medicine.disease, NONMEM, MESH : Biological Markers, MESH: Cisplatin, MESH : Epinephrine, MESH: Antineoplastic Agents, Ovarian cancer, business, MESH: Female, Biomarkers
Abstract

International audience; BACKGROUND: Intraperitoneal (IP) perioperative chemotherapy with cisplatin is an interesting option in ovarian cancer treatment. A combination of cisplatin with IP epinephrine (already shown to improve IP and decrease systemic platinum (Pt) exposure) was evaluated using a population pharmacokinetic analysis. METHODS: Data from 55 patients treated with cisplatin-based IP perioperative chemotherapy with (n=26) or without (n=29) epinephrine were analysed using NONMEM. RESULTS: Epinephrine halves clearance between peritoneum and serum (IPCL) and increases the Pt central volume of distribution, IP exposure and penetration in tissue. IPCL has a better predictive value than any other parameter with respect to renal toxicity. CONCLUSION: This confirms that IPCL could be useful in assessing renal toxicity. As IPCL is also linked to tissue penetration and IP exposure, it may be proposed as biomarker. In addition to a Bayesian estimation, we propose a single-sample calculation-way to assess it. Prospective studies are needed to validate IPCL as a biomarker in this context.

Published
2012

6. [Preoperative radiochemotherapy for rectal cancer: forecasting the next steps through ongoing and forthcoming studies]

Author

G, Créhange, J-F, Bosset, P, Maingon, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), and Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC )

Subjects
MESH: Radiation-Sensitizing Agents, Radiation-Sensitizing Agents, MESH: Combined Modality Therapy, Time Factors, Organoplatinum Compounds, MESH : Radiation-Sensitizing Agents, MESH : Antineoplastic Combined Chemotherapy Protocols, Leucovorin, Cetuximab, MESH : Camptothecin, MESH : Leucovorin, MESH : Randomized Controlled Trials as Topic, Deoxycytidine, MESH : Multicenter Studies as Topic, MESH : Radiotherapy, Conformal, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH: Antibodies, Monoclonal, MESH : Clinical Trials, Phase II as Topic, MESH : Adenocarcinoma, MESH: Clinical Trials, Phase III as Topic, Antineoplastic Combined Chemotherapy Protocols, Multicenter Studies as Topic, MESH : Rectal Neoplasms, Randomized Controlled Trials as Topic, MESH: Treatment Outcome, MESH: Antimetabolites, Antineoplastic, MESH : Antimetabolites, Antineoplastic, MESH: Organoplatinum Compounds, Antibodies, Monoclonal, MESH : Chemotherapy, Adjuvant, Combined Modality Therapy, Neoadjuvant Therapy, Oxaliplatin, MESH: Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH : Antibodies, Monoclonal, MESH: Radiotherapy, Conformal, MESH : Fluorouracil, MESH: Camptothecin, Fluorouracil, MESH: Clinical Trials, Phase II as Topic, MESH : Time Factors, MESH: Forecasting, Antimetabolites, Antineoplastic, MESH: Neoadjuvant Therapy, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Treatment Outcome, Adenocarcinoma, Antibodies, Monoclonal, Humanized, Irinotecan, MESH : Organoplatinum Compounds, Clinical Trials, Phase II as Topic, MESH : Deoxycytidine, Humans, MESH : Forecasting, MESH : Clinical Trials, Phase III as Topic, Capecitabine, MESH: Humans, Rectal Neoplasms, MESH : Humans, MESH: Adenocarcinoma, MESH: Time Factors, MESH: Deoxycytidine, MESH: Rectal Neoplasms, MESH: Randomized Controlled Trials as Topic, Clinical Trials, Phase III as Topic, MESH: Multicenter Studies as Topic, Camptothecin, Radiotherapy, Conformal, MESH : Combined Modality Therapy, MESH: Leucovorin, MESH : Neoadjuvant Therapy, MESH: Fluorouracil, Forecasting
Abstract

International audience; Protracted preoperative radiochemotherapy with a 5-FU-based scheme, or a short course of preoperative radiotherapy without chemotherapy, are the standard neoadjuvant treatments for resectable stage II-III rectal cancer. Local failure rates are low and reproducible, between 6 and 15% when followed with a "Total Mesorectal Excision". Nevertheless, the therapeutic strategy needs to be improved: distant metastatic recurrence rates remain stable around 30 to 35%, while both sphincter and sexual sequels are still significant. The aim of the present paper was to analyse the ongoing trials listed on the following search engines: the Institut National du Cancer in France, the National Cancer Institute and the National Institute of Health in the United States, and the major cooperative groups. Keywords for the search were: "rectal cancer", "preoperative radiotherapy", "phase II-III", "preoperative chemotherapy", "adjuvant chemotherapy" and "surgery". Twenty-three trials were selected and classified in different groups, each of them addressing a question of strategy: (1) place of adjuvant chemotherapy; (2) optimization of preoperative radiotherapy; (3) evaluation of new radiosensitization protocols and/or neoadjuvant chemotherapy; (4) optimization of techniques and timing of surgery; (5) place of radiotherapy for non resectable or metastatic tumors.

Published
2011

7. [Rectal cancer: The radiation basis of radiotherapy, target volume]

Author

Bosset, J.-F., Servagi-Vernat, S., Créhange, G., Azria, David, Gérard, J.-P., Hennequin, C., Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), CRLC Val d'Aurelle-Paul Lamarque, CRLCC Val d'Aurelle - Paul Lamarque, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)

Subjects
Organs at Risk, MESH: Combined Modality Therapy, Neoplasm, Residual, MESH: Radiotherapy, MESH: Organ Size, MESH: Lymphatic Metastasis, Anal Canal, MESH: Magnetic Resonance Imaging, MESH : Anal Canal, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH: Lymphatic Irradiation, MESH : Rectal Neoplasms, MESH: Radiotherapy Planning, Computer-Assisted, MESH: Organs at Risk, MESH : Neoplasm Recurrence, Local, MESH: Anal Canal, MESH : Chemotherapy, Adjuvant, MESH : Lymphatic Metastasis, Organ Size, Combined Modality Therapy, Magnetic Resonance Imaging, Neoadjuvant Therapy, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, Lymphatic Metastasis, MESH: Neoplasm Recurrence, Local, MESH: Radiotherapy, Adjuvant, MESH : Lymphatic Irradiation, MESH: Neoadjuvant Therapy, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Radiotherapy, Adjuvant, MESH : Magnetic Resonance Imaging, Humans, MESH : Neoplasm, Residual, MESH: Neoplasm, Residual, Lymphatic Irradiation, MESH: Humans, Radiotherapy, Rectal Neoplasms, MESH : Radiotherapy, Radiotherapy Planning, Computer-Assisted, MESH : Humans, MESH: Rectal Neoplasms, MESH : Organ Size, MESH : Radiotherapy Planning, Computer-Assisted, MESH : Organs at Risk, Radiotherapy, Adjuvant, Neoplasm Recurrence, Local, MESH : Combined Modality Therapy, MESH : Neoadjuvant Therapy
Abstract

International audience; Since the implementation of preoperative chemoradiotherapy and mesorectal excision, the 5-year rates of locoregional failures in T3-T4 N0-N1 M0 rectal cancer fell from 25-30% thirty years ago to 5-8% nowadays. A critical analysis of the locoregional failures sites and mechanisms, as well as the identification of nodal extension, helps the radiation oncologist to optimize the radiotherapy target definition. The upper limit of the clinical target volume is usually set at the top of the third sacral vertebra. The lateral pelvic nodes should be included when the tumor is located in the distal part of the rectum. The anal sphincter and the levator muscles should be spared when a conservative surgery is planned. In case of abdominoperineal excision, the ischiorectal fossa and the sphincters should be included in the clinical target volume. A confrontation with radiologist and surgeon is mandatory to improve the definition of the target volumes to be treated.

Published
2011

8. [Non-small cell lung cancer: Perioperative treatments]

Author

Westeel , Virginie, Schipman , Benjamin, Jacoulet , Pascale, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ) -Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), and Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon )

Subjects
MESH: Combined Modality Therapy, Lung Neoplasms, MESH: Radiotherapy, Adjuvant, MESH: Neoadjuvant Therapy, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Radiotherapy, Adjuvant, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH: Patient Care Team, Carcinoma, Non-Small-Cell Lung, MESH: Cooperative Behavior, Humans, MESH : Neoplasm Staging, MESH : Lung Neoplasms, Cooperative Behavior, Neoplasm Staging, Patient Care Team, MESH : Carcinoma, Non-Small-Cell Lung, MESH: Humans, MESH : Neoplasm Recurrence, Local, MESH : Patient Care Team, MESH : Humans, MESH : Chemotherapy, Adjuvant, MESH: Neoplasm Staging, MESH : Cooperative Behavior, Combined Modality Therapy, MESH : Interdisciplinary Communication, Neoadjuvant Therapy, MESH: Lung Neoplasms, MESH : Antineoplastic Agents, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH: Antineoplastic Agents, Interdisciplinary Communication, Radiotherapy, Adjuvant, MESH: Interdisciplinary Communication, Neoplasm Recurrence, Local, MESH : Combined Modality Therapy, MESH : Neoadjuvant Therapy, MESH: Neoplasm Recurrence, Local, MESH: Carcinoma, Non-Small-Cell Lung
Abstract

International audience; The objectives of perioperative treatments in non-small cell lung cancer (NSCLC) are to reduce the risk of recurrence, by the early destruction of micrometastases. Data from the literature have been used to precise their indications and modalities. However, for each patient, the decision of a perioperative treatment must result from a multidisciplinary discussion. Perioperative chemotherapy is indicated in stage II or III NSCLC. Adjuvant chemotherapy, which has a highest best level of evidence, is standard, with a 5% survival benefit at 5 years. Preoperative chemotherapy is an option. Postoperative mediastinal radiotherapy has to be discussed in pN2 disease. Ongoing studies in the perioperative setting evaluate the role of targeted agents, and the interest of personalized strategies based on biological markers.

Published
2011

9. Importance of pre-analytical steps for transcriptome and RT-qPCR analyses in the context of the phase II randomised multicentre trial REMAGUS02 of neoadjuvant chemotherapy in breast cancer patients

Author

Véronique Scott, Nicolas Servant, David Gentien, Michel Marty, Philippe Bertheau, Frédérique Spyratos, Patricia de Cremoux, Fabien Valet, Brigitte Sigal-Zafrani, Catherine Barbaroux, Jacqueline Lehmann-Che, Marie-Christine Mathieu, Sophie Vacher, Carine Tran-Perennou, Bernard Asselain, Jean-Marc Guinebretière, BMC, Ed., Département de Biologie des Tumeurs, Institut Curie [Paris], Cancer et génome: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, Mines Paris - PSL (École nationale supérieure des mines de Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de biostatistiques, Département de Recherche Translationnelle, Département de biochimie [Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire de recherche translationnelle, Direction de la recherche [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Service de Génétique Oncologique, Département de biologie et pathologie médicales [Gustave Roussy], Institut Gustave Roussy (IGR), Service d'anatomo-pathologie [Paris], Département de pathologie, Institut Curie [Paris]-Hôpital René HUGUENIN (Saint-Cloud), Centre des Innovations Thérapeutiques en Oncologie et Hématologie, This work was supported by academic grants (PHRC AOM/2OO2/02117) and industrial grants from Pfizer inc., Roche, Sanofi-Aventis.ISRCTN10059974., INSTITUT CURIE, Cancer et génôme: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, MINES ParisTech - École nationale supérieure des mines de Paris-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -INSTITUT CURIE, Département de recherche translationnelle, Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ) -Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Institut Gustave Roussy ( IGR ) -Institut Gustave Roussy ( IGR ), Institut Gustave Roussy ( IGR ), INSTITUT CURIE-Hôpital René HUGUENIN (Saint-Cloud), MINES ParisTech - École nationale supérieure des mines de Paris, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)

Subjects
Oncology, Cancer Research, medicine.medical_treatment, quality criteria, MESH : Breast Neoplasms, Bioinformatics, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, Transcriptome, 0302 clinical medicine, Reference genes, MESH: Reverse Transcriptase Polymerase Chain Reaction, Cluster Analysis, Medicine, MESH : Female, Neoadjuvant therapy, 0303 health sciences, neoadjuvant setting, Reverse Transcriptase Polymerase Chain Reaction, MESH: Research Design, MESH : Reverse Transcriptase Polymerase Chain Reaction, MESH : Chemotherapy, Adjuvant, MESH: Gene Expression Regulation, Neoplastic, MESH : Research Design, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Neoadjuvant Therapy, 3. Good health, Gene Expression Regulation, Neoplastic, MESH: Reproducibility of Results, MESH : Antineoplastic Agents, Chemotherapy, Adjuvant, Research Design, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Research Article, medicine.medical_specialty, MESH : Gene Expression Regulation, Neoplastic, MESH: Neoadjuvant Therapy, Antineoplastic Agents, Breast Neoplasms, Context (language use), [SDV.CAN]Life Sciences [q-bio]/Cancer, RNA integrity number, lcsh:RC254-282, 03 medical and health sciences, MESH: Gene Expression Profiling, Breast cancer, breast cancer, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, Genetics, Humans, MESH : Cluster Analysis, 030304 developmental biology, MESH: Humans, business.industry, Gene Expression Profiling, MESH : Gene Expression Profiling, MESH : Reproducibility of Results, MESH : Humans, RT-qPCR, Reproducibility of Results, RNA, medicine.disease, MESH: Cluster Analysis, Gene expression profiling, MESH: Antineoplastic Agents, business, MESH : Neoadjuvant Therapy, transcriptome, MESH: Female, MESH: Breast Neoplasms
Abstract

Background Identification of predictive markers of response to treatment is a major objective in breast cancer. A major problem in clinical sampling is the variability of RNA templates, requiring accurate management of tumour material and subsequent analyses for future translation in clinical practice. Our aim was to establish the feasibility and reliability of high throughput RNA analysis in a prospective trial. Methods This study was conducted on RNA from initial biopsies, in a prospective trial of neoadjuvant chemotherapy in 327 patients with inoperable breast cancer. Four independent centres included patients and samples. Human U133 GeneChips plus 2.0 arrays for transcriptome analysis and quantitative RT-qPCR of 45 target genes and 6 reference genes were analysed on total RNA. Results Thirty seven samples were excluded because i) they contained less than 30% malignant cells, or ii) they provided RNA Integrity Number (RIN) of poor quality. Among the 290 remaining cases, taking into account strict quality control criteria initially defined to ensure good quality of sampling, 78% and 82% samples were eligible for transcriptome and RT-qPCR analyses, respectively. For RT-qPCR, efficiency was corrected by using standard curves for each gene and each plate. It was greater than 90% for all genes. Clustering analysis highlighted relevant breast cancer phenotypes for both techniques (ER+, PR+, HER2+, triple negative). Interestingly, clustering on trancriptome data also demonstrated a "centre effect", probably due to the sampling or extraction methods used in on of the centres. Conversely, the calibration of RT-qPCR analysis led to the centre effect withdrawing, allowing multicentre analysis of gene transcripts with high accuracy. Conclusions Our data showed that strict quality criteria for RNA integrity assessment and well calibrated and standardized RT-qPCR allows multicentre analysis of genes transcripts with high accuracy in the clinical context. More stringent criteria are needed for transcriptome analysis for clinical applications.

Published
2011

10. Prognostic value of phosphorylated STAT3 in advanced rectal cancer: a study from 104 French patients included in the EORTC 22921 trial

Author

Bernadette Kantelip, Harouna Zaki, Francine Arbez-Gindre, Mariette Mercier, Franck Monnien, Christophe Borg, Christiane Mougin, Jean-François Bosset, Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC ( HOTE GREFFON ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Etablissement français du sang [Bourgogne-France-Comté] ( EFS [Bourgogne-France-Comté] ) -Université de Franche-Comté ( UFC ), Service d'oncologie Médicale, Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Jean Minjoz, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Laboratoire d'anatomie pathologique [Besancon], Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Jean Minjoz-Université de Franche-Comté ( UFC ), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Service d'Oncologie Médicale [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Service d'Anatomie pathologique [CHRU Besançon], and Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)

Subjects
Male, Oncology, MESH: Neoplasm Proteins, Pathology, MESH: Combined Modality Therapy, Colorectal cancer, medicine.medical_treatment, MESH : Aged, medicine.disease_cause, MESH: Epidemiologic Methods, law.invention, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH : Phosphorylation, 0302 clinical medicine, MESH: Aged, 80 and over, Randomized controlled trial, law, MESH : Tumor Markers, Biological, MESH : STAT3 Transcription Factor, MESH : Female, Phosphorylation, MESH : Rectal Neoplasms, MESH: Treatment Outcome, Aged, 80 and over, MESH: Aged, 0303 health sciences, MESH : Cell Nucleus, MESH: Middle Aged, MESH : Prognosis, MESH: STAT3 Transcription Factor, Anatomical pathology, MESH : Chemotherapy, Adjuvant, General Medicine, Middle Aged, MESH : Adult, Prognosis, Combined Modality Therapy, Neoplasm Proteins, 3. Good health, Treatment Outcome, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, France, Adult, STAT3 Transcription Factor, MESH: Cell Nucleus, medicine.medical_specialty, MESH : Male, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Treatment Outcome, MESH: Prognosis, MESH : Epidemiologic Methods, Pathology and Forensic Medicine, 03 medical and health sciences, MESH : Neoplasm Proteins, Internal medicine, Biomarkers, Tumor, medicine, Humans, MESH : Middle Aged, MESH : Aged, 80 and over, MESH : France, Aged, 030304 developmental biology, Cell Nucleus, Chemotherapy, MESH: Humans, Oncogene, MESH: Phosphorylation, Rectal Neoplasms, business.industry, MESH : Humans, Cancer, MESH: Rectal Neoplasms, MESH: Adult, medicine.disease, MESH: Male, Clinical trial, MESH: France, MESH: Tumor Markers, Biological, Epidemiologic Methods, Carcinogenesis, business, MESH : Combined Modality Therapy, MESH: Female
Abstract

International audience; BACKGROUND: Signal transducer and activator of transcription 3 (STAT3) has been implicated as an oncogene in several neoplastic diseases. However, the biological effects of STAT3 have not been extensively studied in rectal carcinogenesis. AIMS: To evaluate STAT3 activation in advanced rectal cancers and its association with clinicopathological variables and prognosis. METHODS: Nuclear immunohistochemical expression of phosphorylated STAT3 (p-STAT3) was studied in 104 advanced rectal cancers (T3-T4). All patients were participating in the EORTC 22921 trial to assess whether preoperative chemoradiotherapy followed by postoperative chemotherapy improved overall and progression-free survival. RESULTS: Nuclear p-STAT3 expression was detected in 37.5% of rectal cancer patients. No correlation was observed between p-STAT3 and any clinicopathological variables tested. However, patients with tumours positive for p-STAT3 had significantly improved overall survival. CONCLUSION: These results highlight an unexpected role for nuclear p-STAT3 expression in advanced rectal cancers and need further investigation to clarify this finding.

Published
2010

11. Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial

Author

M. Tiv, Gilles Calais, Etienne Bardet, Marc Puyraveau, P. Maingon, Mariette Mercier, Laurent Mineur, J.-F. Bosset, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), and Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC )

Subjects
Male, MESH: Combined Modality Therapy, MESH: Radiotherapy, Treatment outcome, MESH : Aged, MESH : Diarrhea, MESH : Interpersonal Relations, 030218 nuclear medicine & medical imaging, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH : Adenocarcinoma, 0302 clinical medicine, MESH : Cross-Sectional Studies, Medicine, MESH : Female, MESH : Rectal Neoplasms, MESH : Sexual Dysfunction, Physiological, MESH: Treatment Outcome, MESH: Aged, Chemo-radiotherapy, MESH: Middle Aged, MESH: Sexual Dysfunction, Physiological, Follow up studies, MESH : Chemotherapy, Adjuvant, MESH: Follow-Up Studies, MESH: Interpersonal Relations, Middle Aged, Combined Modality Therapy, humanities, Neoadjuvant Therapy, 3. Good health, MESH : Antineoplastic Agents, MESH: Diarrhea, Treatment Outcome, Oncology, MESH: Chemotherapy, Adjuvant, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Diarrhea, medicine.medical_specialty, Anorectal disease, MESH : Male, MESH: Neoadjuvant Therapy, MESH: Radiation Injuries, [SDV.CAN]Life Sciences [q-bio]/Cancer, Antineoplastic Agents, MESH : Treatment Outcome, Adenocarcinoma, 03 medical and health sciences, Combined treatment, MESH: Cross-Sectional Studies, Body Image, Humans, Radiology, Nuclear Medicine and imaging, In patient, MESH : Middle Aged, Interpersonal Relations, Radiation Injuries, MESH: Body Image, Aged, Gynecology, Preoperative chemoradiotherapy, MESH: Humans, Radiotherapy, business.industry, MESH : Radiotherapy, Rectal Neoplasms, MESH : Body Image, MESH : Humans, MESH : Radiation Injuries, MESH: Adenocarcinoma, MESH: Quality of Life, MESH: Rectal Neoplasms, MESH : Follow-Up Studies, MESH : Quality of Life, MESH: Male, Sexual Dysfunction, Physiological, Cross-Sectional Studies, Quality of Life, MESH: Antineoplastic Agents, business, MESH : Combined Modality Therapy, Rectal disease, MESH : Neoadjuvant Therapy, MESH: Female, Follow-Up Studies
Abstract

Resume Objectif de l’etude La qualite de vie a ete peu etudiee chez des patients atteints de cancer rectal. Cette etude concerne les patients francais traites dans l’essai 22921 de l’European Organization for Research and Treatment of Cancer (EORTC) qui a evalue le role et la place de la chimiotherapie par rapport a la radiotherapie preoperatoire. Patients et methodes Les questionnaires de qualite de vie QLQ-C30 et QLQ-CR38 de l’EORTC ont ete utilises chez des patients indemnes de maladie, avec un recul median de 4,6 ans depuis la randomisation. Resultats Tous les scores des dimensions du QLQ-C30 etaient eleves, entre 78 et 88, avec un score global de qualite de vie de 73. Les scores des symptomes etaient bas sauf pour la diarrhee. Avec le QLQ-CR38, les scores « image de soi » et « perspectives » etaient eleves a respectivement 79,6 et 69,7. Les scores « fonction » et « satisfaction » sexuelles etaient bas. Les hommes avaient plus de problemes sexuels que les femmes (62,5 contre 25, scores moyens respectifs). La chimiotherapie etait associee a des scores plus eleves de diarrhees, et des scores plus faibles de « role », « social », « fonction » et « sante globale ». Conclusion Avec un recul de 4,6 ans, depuis le debut du traitement, la qualite de vie des patients traites pour un cancer rectal etait assez bonne. L’ajout de la chimiotherapie a la radiotherapie preoperatoire augmente le risque de diarrhee et degrade certains items de qualite de vie.

Published
2010

12. Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925)

Author

Matzinger, O., Heimsoth, I., Poortmans, P., Collette, L., Struikmans, H., Bogaert, W. van den, Fourquet, A., Bartelink, H., Ataman, F., Gulyban, A., Pierart, M., Tienhoven, G. van, EORTC Radiation Oncology Grp, Breast Canc Grp, CCA -Cancer Center Amsterdam, Radiotherapy, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), and Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC )

Subjects
Oncology, MESH: Radiotherapy, MESH: Lymphatic Metastasis, MESH: Mastectomy, medicine.medical_treatment, MESH : Aged, MESH: Amino Acid Sequence, MESH : Breast Neoplasms, Severity of Illness Index, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH: Protein Conformation, 0302 clinical medicine, MESH : Neoplasm Staging, MESH: Animals, Mastectomy, MESH : Protein Conformation, health care economics and organizations, MESH: Middle Aged, MESH : Amino Acid Sequence, Heart, MESH : Chemotherapy, Adjuvant, MESH : Lymphatic Metastasis, General Medicine, 3. Good health, MESH : Diabetes Mellitus, Medial supraclavicular lymph node, 030220 oncology & carcinogenesis, MESH: Diabetes Mellitus, Type 2, medicine.medical_specialty, MESH: Diabetes Mellitus, MESH: Receptor, Insulin, 03 medical and health sciences, MESH : Amyloid, Breast cancer, MESH: Severity of Illness Index, Severity of illness, Humans, MESH : Middle Aged, MESH : Islets of Langerhans, Aged, Pneumonitis, MESH: Humans, MESH: Molecular Sequence Data, MESH : Glucose, MESH : Radiotherapy, MESH: Islets of Langerhans, MESH : Humans, MESH: Adult, medicine.disease, MESH: Heart, Radiation therapy, MESH: Female, MESH: Combined Modality Therapy, MESH : Molecular Sequence Data, Pulmonary Fibrosis, 030218 nuclear medicine & medical imaging, MESH : Diabetes Mellitus, Type 2, MESH : Female, quality-assurance cardiac toxicity randomized-trial high-risk postoperative radiotherapy adjuvant radiotherapy premenopausal women radiation chemotherapy management, MESH: Aged, MESH: Neoplasm Staging, Hematology, Middle Aged, MESH : Adult, Combined Modality Therapy, humanities, MESH: Glucose, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, Lymphatic Metastasis, MESH: Monosaccharide Transport Proteins, Toxicity, Female, MESH : Severity of Illness Index, MESH : Mastectomy, Adult, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Pulmonary Fibrosis, MESH: Sequence Homology, Nucleic Acid, MESH : Heart, Internal medicine, medicine, Radiology, Nuclear Medicine and imaging, MESH : Sequence Homology, Nucleic Acid, Neoplasm Staging, MESH : Monosaccharide Transport Proteins, MESH: Amyloid, Radiotherapy, MESH: Pulmonary Fibrosis, Performance status, business.industry, MESH : Receptor, Insulin, MESH : Animals, MESH : Combined Modality Therapy, business, MESH: Breast Neoplasms
Abstract

National audience; INTRODUCTION: The EORTC 22922/10925 trial investigated the potential survival benefit and toxicity of elective irradiation of the internal mammary and medial supraclavicular (IM-MS) nodes Accrual completed in January 2004 and first results are expected in 2012. We present the toxicity reported until year 3 after treatment. PATIENTS AND METHODS: At each visit, toxicity was reported but severity was not graded routinely. Toxicity rates and performance status (PS) changes at three years were compared by chi(2) tests and logistic regression models in all the 3,866 of 4,004 patients eligible to the trial who received the allocated treatment. RESULTS: Only lung (fibrosis; dyspnoea; pneumonitis; any lung toxicities) (4.3% vs. 1.3%; p < 0.0001) but not cardiac toxicity (0.3% vs. 0.4%; p = 0.55) significantly increased with IM-MS treatment. No significant worsening of the PS was observed (p = 0.79), suggesting that treatment-related toxicity does not impair patient's daily activities. CONCLUSIONS: IM-MS irradiation seems well tolerated and does not significantly impair WHO PS at three years. A follow-up period of at least 10 years is needed to determine whether cardiac toxicity is increased after radiotherapy.

Published
2010

13. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study

Author

Ph. Rougier, Thomas Aparicio, Christophe Mariette, F. Mornex, J.-F. Bosset, O. Bouche, Franck Bonnetain, Laurent Mineur, A. Azzedine, Pascal Hammel, Bruno Chauffert, N. Stremsdoerfer, J. Butel, Philippe Maingon, Laurent Bedenne, 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 ), Grand Accélérateur National d'Ions Lourds ( GANIL ), Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ) -Institut National de Physique Nucléaire et de Physique des Particules du CNRS ( IN2P3 ) -Centre National de la Recherche Scientifique ( CNRS ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), 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), Grand Accélérateur National d'Ions Lourds (GANIL), Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Matrice extracellulaire et dynamique cellulaire - UMR 7369 (MEDyC), Université de Reims Champagne-Ardenne (URCA)-SFR CAP Santé (Champagne-Ardenne Picardie Santé), and Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, MESH: Remission Induction, MESH : Antineoplastic Combined Chemotherapy Protocols, medicine.medical_treatment, MESH : Aged, MESH: Risk Assessment, Deoxycytidine, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, MESH : Neoplasm Staging, ComputingMilieux_MISCELLANEOUS, MESH: Treatment Outcome, MESH: Middle Aged, Biopsy, Needle, Remission Induction, MESH : Infusions, Intravenous, MESH : Chemotherapy, Adjuvant, MESH: Follow-Up Studies, Immunohistochemistry, 3. Good health, MESH: Antineoplastic Combined Chemotherapy Protocols, Oncology, Fluorouracil, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, medicine.medical_specialty, MESH: Radiotherapy, Adjuvant, MESH: Probability, MESH : Drug Administration Schedule, Urology, MESH: Drug Administration Schedule, Antimetabolite, Risk Assessment, Drug Administration Schedule, MESH : Radiotherapy, Adjuvant, MESH : Cisplatin, 03 medical and health sciences, Humans, MESH : Middle Aged, Aged, MESH: Humans, Dose-Response Relationship, Drug, MESH: Deoxycytidine, MESH : Humans, MESH: Adult, MESH : Follow-Up Studies, Survival Analysis, Pancreatic Neoplasms, Concomitant, Cisplatin, MESH: Female, MESH: Fluorouracil, MESH : Pancreatic Neoplasms, MESH: Combined Modality Therapy, MESH : Immunohistochemistry, MESH : Dose-Response Relationship, Drug, MESH : Biopsy, Needle, MESH : Neoplasm Invasiveness, MESH: Dose-Response Relationship, Drug, MESH : Female, MESH : Risk Assessment, MESH: Radiotherapy Dosage, Infusions, Intravenous, MESH: Aged, MESH : Radiotherapy Dosage, Radiotherapy Dosage, Hematology, MESH: Neoplasm Staging, Middle Aged, MESH : Adult, Chemotherapy regimen, Combined Modality Therapy, Treatment Outcome, MESH: Chemotherapy, Adjuvant, Chemotherapy, Adjuvant, MESH: Survival Analysis, MESH : Fluorouracil, Female, MESH: Pancreatic Neoplasms, medicine.drug, Adult, MESH: Biopsy, Needle, medicine.drug_class, MESH : Male, MESH : Probability, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Treatment Outcome, MESH : Deoxycytidine, medicine, Neoplasm Invasiveness, MESH: Infusions, Intravenous, Neoplasm Staging, Probability, Chemotherapy, MESH : Remission Induction, Performance status, business.industry, MESH: Immunohistochemistry, MESH: Neoplasm Invasiveness, Gemcitabine, MESH: Male, Surgery, MESH: Cisplatin, Radiotherapy, Adjuvant, MESH : Survival Analysis, business, MESH : Combined Modality Therapy, Chemoradiotherapy, Follow-Up Studies
Abstract

International audience; BACKGROUND: The role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer (LAPC) is uncertain. PATIENTS AND METHODS: One hundred and nineteen patients with LAPC, World Health Organization performance status of zero to two were randomly assigned to either the induction CHRT group (60 Gy, 2 Gy/fraction; concomitant 5-fluorouracil infusion, 300 mg/m(2)/day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2)/day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity. RESULTS: Overall survival was shorter in the CHRT than in GEM arm [median survival 8.6 (99% confidence interval 7.1-11.4) and 13 months (8.7-18.1), P = 0.03]. One-year survival was, respectively, 32% and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the CHRT arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). CONCLUSION: This intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone.

Published
2008

14. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial

Author

Eggermont , Alexander M M, Suciu , Stefan, Santinami , Mario, Testori , Alessandro, Kruit , Wim H J, Marsden , Jeremy, Punt , Cornelis J A, Salès , François, Gore , Martin, Mackie , Rona, Kusic , Zvonko, Dummer , Reinhard, Hauschild , Axel, Musat , Elena, Spatz , Alain, Keilholz , Ulrich, Renseigné , Non, Aubin , François, Département de biologie et pathologie médicales [Gustave Roussy], Institut Gustave Roussy ( IGR ), Department of Medicine III, Charité, Campus Benjamin Franklin, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Institut Gustave Roussy (IGR), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Other departments, Surgery, Medical Oncology, and University of Zurich

Subjects
Male, MESH: Observation, MESH : Aged, Observation, 2700 General Medicine, MESH : Observation, Gastroenterology, Polyethylene Glycols, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH: Proportional Hazards Models, 0302 clinical medicine, Immune Regulation [NCMLS 2], Pegylated interferon, Interferon, Medicine, MESH : Female, Neoplasm Metastasis, Melanoma, MESH: Aged, 0303 health sciences, MESH: Middle Aged, interferon alfa-2b, melanoma, EORTC 18991, Hazard ratio, MESH : Polyethylene Glycols, 10177 Dermatology Clinic, MESH : Chemotherapy, Adjuvant, General Medicine, Middle Aged, MESH : Adult, Recombinant Proteins, 3. Good health, MESH : Antiviral Agents, Tolerability, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, MESH : Neoplasm Metastasis, MESH : Disease-Free Survival, Female, medicine.drug, Adult, MESH: Antiviral Agents, MESH: Interferon Alfa-2b, medicine.medical_specialty, Adolescent, MESH: Melanoma, MESH : Male, MESH : Melanoma, Alpha interferon, 610 Medicine & health, [SDV.CAN]Life Sciences [q-bio]/Cancer, Interferon alpha-2, Antiviral Agents, Disease-Free Survival, 03 medical and health sciences, Translational research [ONCOL 3], Interventional oncology [UMCN 1.5], Internal medicine, MESH : Adolescent, Adjuvant therapy, Humans, MESH : Middle Aged, Interferon alfa, Aged, Proportional Hazards Models, 030304 developmental biology, MESH: Adolescent, MESH: Humans, Intention-to-treat analysis, Hereditary cancer and cancer-related syndromes [ONCOL 1], business.industry, MESH : Humans, Interferon-alpha, MESH: Adult, MESH : Proportional Hazards Models, MESH : Interferon Alfa-2b, MESH: Neoplasm Metastasis, MESH: Male, Surgery, MESH: Polyethylene Glycols, MESH: Disease-Free Survival, business, MESH: Female
Abstract

Contains fulltext : 69569.pdf (Publisher’s version ) (Closed access) BACKGROUND: Any benefit of adjuvant interferon alfa-2b for melanoma could depend on dose and duration of treatment. Our aim was to determine whether pegylated interferon alfa-2b can facilitate prolonged exposure while maintaining tolerability. METHODS: 1256 patients with resected stage III melanoma were randomly assigned to observation (n=629) or pegylated interferon alfa-2b (n=627) 6 mug/kg per week for 8 weeks (induction) then 3 mug/kg per week (maintenance) for an intended duration of 5 years. Randomisation was stratified for microscopic (N1) versus macroscopic (N2) nodal involvement, number of positive nodes, ulceration and tumour thickness, sex, and centre. Randomisation was done with a minimisation technique. The primary endpoint was recurrence-free survival. Analyses were done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00006249. FINDINGS: All randomised patients were included in the primary efficacy analysis. 608 patients in the interferon group and 613 patients in the observation group were included in safety analyses. The median length of treatment with pegylated interferon alfa-2b was 12 (IQR 3.8-33.4) months. At 3.8 (3.2-4.2) years median follow-up, 328 recurrence events had occurred in the interferon group compared with 368 in the observation group (hazard ratio 0.82, 95% CI 0.71-0.96; p=0.01); the 4-year rate of recurrence-free survival was 45.6% (SE 2.2) in the interferon group and 38.9% (2.2) in the observation group. There was no difference in overall survival between the groups. Grade 3 adverse events occurred in 246 (40%) patients in the interferon group and 60 (10%) in the observation group; grade 4 adverse events occurred in 32 (5%) patients in the interferon group and 14 (2%) in the observation group. In the interferon group, the most common grade 3 or 4 adverse events were fatigue (97 patients, 16%), hepatotoxicity (66, 11%), and depression (39, 6%). Treatment with pegylated interferon alfa-2b was discontinued because of toxicity in 191 (31%) patients. INTERPRETATION: Adjuvant pegylated interferon alfa-2b for stage III melanoma has a significant, sustained effect on recurrence-free survival.

Published
2008

15. Variations in management of stage I to stage III cutaneous melanoma: a population-based study of clinical practices in France

Author

G. Hedelin, Marie-Laure Batard, Jean-Michel Halna, Catherine Michel, Christian Delvincourt, G. Reuter, Florence Granel-Brocard, Sophie Dalac, Florent Grange, Arlette Danzon, François Truchetet, Jean Luc Schmutz, François Aubin, P. Bernard, Fabien Vitry, Béatrice Baury, Dan Lipsker, Stéphane Dalle, Unité de recherche clinique [Reims], Centre Hospitalier Universitaire de Reims ( CHU Reims ) -Hôpital Maison Blanche, Service de Dermatologie et Allergologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Département de dermatologie, Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Saint-Jacques-Université de Franche-Comté ( UFC ), Registre des cancers du Bas-Rhin, CRLCC Paul Strauss, Institut de Génomique Fonctionnelle ( IGF ), Centre National de la Recherche Scientifique ( CNRS ) -Université Montpellier 2 - Sciences et Techniques ( UM2 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Montpellier 1 ( UM1 ) -Université de Montpellier ( UM ), Matrice extracellulaire et dynamique cellulaire - UMR 7369 (MEDyC), Université de Reims Champagne-Ardenne (URCA)-SFR CAP Santé (Champagne-Ardenne Picardie Santé), Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Reims (CHU Reims)-Hôpital Maison Blanche, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Hôpital Saint-Jacques-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Hôpital de l'Hôtel Dieu [CHU-HCL], and Hospices Civils de Lyon (HCL)

Subjects
Male, Skin Neoplasms, Time Factors, MESH : Retrospective Studies, medicine.medical_treatment, MESH : Aged, MESH : Dose-Response Relationship, Drug, MESH: Dose-Response Relationship, Drug, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 030207 dermatology & venereal diseases, 0302 clinical medicine, MESH: Aged, 80 and over, MESH : Interferons, MESH : Population Surveillance, MESH: Interferons, MESH : Neoplasm Staging, MESH : Female, Stage (cooking), Melanoma, ComputingMilieux_MISCELLANEOUS, MESH : Sentinel Lymph Node Biopsy, Aged, 80 and over, MESH: Aged, education.field_of_study, MESH: Middle Aged, MESH : Chemotherapy, Adjuvant, General Medicine, MESH: Neoplasm Staging, Middle Aged, MESH : Adult, 3. Good health, MESH : Antineoplastic Agents, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Population Surveillance, MESH : Dermatology, Female, Radiology, France, MESH : Time Factors, Adult, medicine.medical_specialty, Adolescent, MESH: Melanoma, MESH: Sentinel Lymph Node Biopsy, MESH : Male, Population, Sentinel lymph node, MESH : Melanoma, Antineoplastic Agents, MESH: Dermatology, [SDV.CAN]Life Sciences [q-bio]/Cancer, Dermatology, MESH: Population Surveillance, Breslow Thickness, 03 medical and health sciences, MESH : Adolescent, Adjuvant therapy, medicine, Humans, MESH : Middle Aged, education, MESH : Aged, 80 and over, MESH : France, Cancer staging, Aged, Neoplasm Staging, Retrospective Studies, MESH: Adolescent, MESH: Humans, Dose-Response Relationship, Drug, business.industry, Sentinel Lymph Node Biopsy, MESH: Skin Neoplasms, MESH: Time Factors, MESH : Humans, MESH : Skin Neoplasms, MESH: Adult, MESH: Retrospective Studies, MESH: Male, Surgery, MESH: France, Regimen, MESH: Antineoplastic Agents, Lymphadenectomy, Interferons, business, MESH: Female
Abstract

International audience; OBJECTIVE: To describe current management of cutaneous melanoma (CM) and identify factors accounting for disparities. DESIGN: Retrospective population-based study using survey of cancer registries and pathology laboratories, and questionnaires to physicians. SETTING: Five regions covering 19.2% of the French territory and including 8.2 million inhabitants. PATIENTS: Incident cases of patients with stage I to stage II (hereinafter, stage I-II) tumors staged according to the American Joint Committee on Cancer Staging guidelines and nodal stage III CM in 2004. MAIN OUTCOME MEASURES: Modalities of diagnosis and excision, surgical margins, sentinel lymph node biopsy, adjuvant therapies and surveillance procedures, and their variations according to age, sex, residence, location of primary CM, Breslow thickness, type of physicians, modalities of decisions, and health care patterns. RESULTS: Clinical stage I-II CMs (n = 710 cases) slightly predominated in females (53%), with a lower mean Breslow thickness (1.4 mm) than in males (1.9 mm). Initial excisions were most often performed by private dermatologists and wide excisions by surgeons. Narrow margins (8%) were associated with advanced age, higher Breslow thickness, and head location. Sentinel lymph node biopsy was performed in 34% of CMs thicker than 1.0 mm, depending on geographical regions, distance from reference centers, and health care patterns. Adjuvant therapies (mainly low-dose interferon) were proposed in 53% of thick CMs (>1.5 mm), depending on the patient's age and geographical region. In contrast with French recommendations, surveillance procedures frequently included systematic medical imaging. Stage III nodal CMs (n = 89 cases) predominated in males (62%). After lymphadenectomy, adjuvant therapies (including high-dose interferon in 32% of cases and chemotherapies in 24% of cases) were proposed in 68% of cases, depending on the patient's age and geographical region. A complete 1-year high-dose interferon regimen was administered in less than 10% of cases. CONCLUSION: Large disparities still exist in the management of CM in France, depending to a greater extent on medical and geographical environment than on the characteristics of either patients or tumors.

Published
2008

16. Adjuvant corticosteroid therapy for chronic disseminated candidiasis

Author

Olivier Lortholary, Erianna Bellaton, Bertrand Dupont, Marc Lecuit, Faezeh Legrand, Pierre-Simon Rohrlich, Michel Huerre, Service d'hématologie et immunologie pédiatrique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 (UPD7), Service d'hématologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre d'infectiologie Necker-Pasteur [CHU Necker], Institut Pasteur [Paris] (IP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Microorganismes et Barrières de l'Hôte (Equipe avenir), Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Histotechnologie et Pathologie, Institut Pasteur [Paris] (IP), Service d'hémato-onco-pédiatrie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Hôpital Saint-Jacques, Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Mycologie moléculaire, Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS), Institut Pasteur [Paris]-CHU Necker - Enfants Malades [AP-HP], Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Pasteur [Paris], Institut Pasteur [Paris], Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Institut Pasteur [Paris]-Centre National de la Recherche Scientifique (CNRS), Saas, Philippe, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 ( UPD7 ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -hopital Jean Minjoz, Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Equipe avenir Microorganismes et Barrières de l'Hôte, Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Saint-Jacques, Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) ( HOTE GREFFON ), Université de Franche-Comté ( UFC ) -Etablissement français du sang [Bourgogne-France-Comté] ( EFS [Bourgogne-France-Comté] ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), and Institut Pasteur [Paris]-Centre National de la Recherche Scientifique ( CNRS )

Subjects
Male, Abdominal pain, MESH : Retrospective Studies, MESH: Spleen, medicine.medical_treatment, MESH : Aged, MESH : Immune Reconstitution Inflammatory Syndrome, MESH: Length of Stay, MESH : Child, Adrenal Cortex Hormones, MESH: Child, [ SDV.IMM ] Life Sciences [q-bio]/Immunology, Medicine, Child, 0303 health sciences, MESH: Middle Aged, Candidiasis, MESH : Chemotherapy, Adjuvant, 3. Good health, MESH : Length of Stay, C-Reactive Protein, Child, Preschool, MESH : Fever, Microbiology (medical), medicine.medical_specialty, [SDV.IMM] Life Sciences [q-bio]/Immunology, MESH : Abdominal Pain, Liver Abscess, MESH : Adrenal Cortex Hormones, MESH: Adrenal Cortex Hormones, 03 medical and health sciences, MESH : Adolescent, MESH: Fever, Humans, MESH : Middle Aged, Mycosis, Aged, Retrospective Studies, MESH: Adolescent, MESH: Humans, 030306 microbiology, MESH : Humans, MESH : Leukemia, MESH : Liver Abscess, MESH: Child, Preschool, MESH: Retrospective Studies, MESH: Adult, Length of Stay, medicine.disease, MESH: Antifungal Agents, MESH: Abdominal Pain, MESH: Fibrinogen, MESH: Female, Antifungal Agents, Time Factors, MESH : Fibrinogen, MESH : Child, Preschool, MESH : Candidiasis, Prednisone, Immune Reconstitution Inflammatory Syndrome, MESH : Female, MESH: Aged, Acute leukemia, Leukemia, MESH : Adult, Middle Aged, MESH: Candidiasis, Infectious Diseases, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH: Immune Reconstitution Inflammatory Syndrome, Corticosteroid, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, medicine.symptom, MESH : Time Factors, medicine.drug, MESH : Spleen, Adult, Adolescent, Fever, medicine.drug_class, MESH : Male, MESH : Antifungal Agents, MESH: Liver Abscess, Immune reconstitution inflammatory syndrome, Internal medicine, MESH: Leukemia, MESH: C-Reactive Protein, 030304 developmental biology, Chemotherapy, business.industry, MESH: Time Factors, Fibrinogen, Retrospective cohort study, MESH : C-Reactive Protein, MESH: Male, Surgery, Abdominal Pain, business, Spleen
Abstract

International audience; BACKGROUND: Chronic disseminated candidiasis (CDC) is typically observed during neutrophil recovery in patients with acute leukemia and requires protracted antifungal therapy. OBJECTIVE: Our objective was to document the efficacy and tolerance of corticosteroid therapy (CST) in patients with symptomatic CDC, including those who experienced fever and abdominal pain despite ongoing antifungal therapy. METHODS: We performed a retrospective, multicenter study involving 10 pediatric and adult patients who experienced ongoing symptomatic CDC despite receipt of appropriate antifungal therapy for whom adjuvant oral CST was initiated. RESULTS: All cases of CDC were proven or probable, as determined on the basis of the European Organization for Research and Treatment of Cancer-Mycosis Study Group definition criteria, and occurred in patients with leukemia. CDC-attributable clinical symptoms resolved with CST, which was started a mean of 33.8 days after antifungal therapy had been initiated. Fever and abdominal pain disappeared a median of 4-5 days, and serum fibrinogen and C-reactive protein levels returned to normal values within 14-30 days. The median duration of hospitalization after CST initiation was 8.8 days. Hepatosplenic microabscesses decreased or disappeared within a mean period of 107 days (range, 30-210 days). No relapses of CDC were observed during a median duration of follow-up of 6.5 years (range, 4-9 years). CONCLUSIONS: In children and adults who experience persistently symptomatic CDC despite ongoing receipt of antifungal therapy, CST involving a prednisone equivalent at a dosage of > or =0.5 mg/kg per day for at least 3 weeks is associated with a prompt resolution of symptoms and of inflammatory response. These findings support the pathophysiological hypothesis that CDC belongs to the spectrum of fungus-related immune reconstitution inflammatory syndrome.

Published
2008

17. The diagnosis and management of rectal cancer: expert discussion and recommendations derived from the 9th World Congress on Gastrointestinal Cancer, Barcelona, 2007

Author

Margaret A. Tempero, Rob Glynne-Jones, C.J.H. van de Velde, Malcolm A.S. Moore, H.-J. Schmoll, Josep Tabernero, David Cunningham, Michel Ducreux, Ph. Rougier, Bernard Nordlinger, David J. Kerr, A. de Gramont, Richard M. Goldberg, Y-K Kang, Karin Haustermans, N. Arber, Mario Dicato, Roberto Labianca, B. D. Minsky, John Zalcberg, J.-F. Bosset, Alberto Sobrero, Daniel G. Haller, E. Van Cutsem, Eduardo Díaz-Rubio, Werner Scheithauer, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Service des Maladies du Sang, the Service de Médecine Interne Oncologie-CHU Saint-Antoine [APHP], NASA Goddard Space Flight Center ( GSFC ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and NASA Goddard Space Flight Center (GSFC)

Subjects
MESH: Combined Modality Therapy, Palliative care, Colorectal cancer, medicine.medical_treatment, MESH: Quality Control, MESH : Randomized Controlled Trials as Topic, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 0302 clinical medicine, MESH: Practice Guidelines as Topic, Health care, Medicine, MESH : Neoplasm Staging, Neoplasm Metastasis, MESH : Rectal Neoplasms, Randomized Controlled Trials as Topic, Clinical Trials as Topic, MESH : Chemotherapy, Adjuvant, MESH : Quality Control, MESH: Neoplasm Staging, Hematology, Combined Modality Therapy, Total mesorectal excision, Neoadjuvant Therapy, 3. Good health, MESH : Practice Guidelines as Topic, Oncology, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Practice Guidelines as Topic, MESH : Neoplasm Metastasis, 030211 gastroenterology & hepatology, Quality Control, MESH: Preoperative Care, medicine.medical_specialty, MESH: Clinical Trials as Topic, MESH: Radiotherapy, Adjuvant, MESH: Neoadjuvant Therapy, [SDV.CAN]Life Sciences [q-bio]/Cancer, Preoperative care, MESH : Radiotherapy, Adjuvant, 03 medical and health sciences, Preoperative Care, Humans, Neoplasm Staging, MESH: Humans, Rectal Neoplasms, business.industry, General surgery, MESH : Humans, MESH: Rectal Neoplasms, medicine.disease, MESH: Neoplasm Metastasis, MESH : Clinical Trials as Topic, Clinical trial, Radiation therapy, MESH: Randomized Controlled Trials as Topic, MESH : Preoperative Care, Radiotherapy, Adjuvant, MESH : Combined Modality Therapy, business, MESH : Neoadjuvant Therapy, Chemoradiotherapy
Abstract

International audience; Knowledge of the biology and management of rectal cancer continues to improve. A multidisciplinary approach to a patient with rectal cancer by an experienced expert team is mandatory, to assure optimal diagnosis and staging, surgery, selection of the appropriate neo-adjuvant and adjuvant strategy and chemotherapeutic management. Moreover, optimal symptom management also requires a dedicated team of health care professionals. The introduction of total mesorectal excision has been associated with a decrease in the rate of local failure after surgery. High quality surgery and the achievement of pathological measures of quality are a prerequisite to adequate locoregional control. There are now randomized data in favour of chemoradiotherapy or short course radiotherapy in the preoperative setting. Preoperative chemoradiotherapy is more beneficial and has less toxicity for patients with resectable rectal cancer than postoperative chemoradiotherapy. Furthermore chemoradiotherapy leads also to downsizing of locally advanced rectal cancer. New strategies that decrease the likelihood of distant metastases after initial treatment need be developed with high priority. Those involved in the care for patients with rectal cancer should be encouraged to participate in well-designed clinical trials, to increase the evidence-based knowledge and to make further progress. Health care workers involved in the care of rectal cancer patients should be encouraged to adopt quality control processes leading to increased expertise.

Published
2008

18. Does concurrent radiochemotherapy affect cosmetic results in the adjuvant setting after breast-conserving surgery? Results of the ARCOSEIN multicenter, Phase III study: patients' and doctors' views

Author

A. Favre, Alain Fourquet, David Azria, Daniel Serin, Gilles Calais, Jean-François Bosset, Olivier LeFoch, Joseph Gligorov, A. Toledano, J. Miny-Buffet, Marc A. Bollet, Pascal Garaud, Institut de recherche en cancérologie de Montpellier ( IRCM ), Université Montpellier 1 ( UM1 ) -CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Montpellier ( UM ), CRLC Val d'Aurelle-Paul Lamarque, CRLCC Val d'Aurelle - Paul Lamarque, Unité de Psycho-Oncologie ( UPO ), INSTITUT CURIE, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ) -Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Institut de recherche en cancérologie de Montpellier (IRCM - U896 Inserm - UM1), CRLCC Val d'Aurelle - Paul Lamarque-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 1 (UM1), Unité de Psycho-Oncologie (UPO), Institut Curie [Paris], Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)

Subjects
MESH : Esthetics, Cancer Research, medicine.medical_treatment, MESH : Aged, MESH : Breast Neoplasms, Mastectomy, Segmental, MESH : Radiation Oncology, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 0302 clinical medicine, Breast-conserving surgery, MESH : Female, 030212 general & internal medicine, Stage (cooking), MESH: Aged, MESH: Middle Aged, Radiation, MESH : Chemotherapy, Adjuvant, Middle Aged, MESH : Adult, MESH: Radiation Oncology, 3. Good health, Oncology, MESH: Chemotherapy, Adjuvant, Chemotherapy, Adjuvant, Patient Satisfaction, 030220 oncology & carcinogenesis, MESH : Cholestyramine Resin, Female, MESH: Axilla, MESH: Esthetics, Adult, medicine.medical_specialty, MESH : Patient Satisfaction, Esthetics, Attitude of Health Personnel, MESH: Attitude of Health Personnel, Concordance, Cholestyramine Resin, [SDV.CAN]Life Sciences [q-bio]/Cancer, Breast Neoplasms, MESH : Lymph Node Excision, 03 medical and health sciences, Breast cancer, medicine, Humans, MESH : Axilla, Radiology, Nuclear Medicine and imaging, MESH : Middle Aged, MESH: Mastectomy, Segmental, MESH : Mastectomy, Segmental, Aged, MESH: Humans, MESH: Lymph Node Excision, business.industry, MESH : Humans, Cosmesis, MESH: Adult, medicine.disease, MESH: Patient Satisfaction, Surgery, Radiation therapy, Regimen, MESH: Cholestyramine Resin, Axilla, Radiation Oncology, Lymph Node Excision, business, MESH: Female, MESH: Breast Neoplasms, Chemoradiotherapy, MESH : Attitude of Health Personnel
Abstract

International audience; PURPOSE: To evaluate the cosmetic results of sequential vs. concurrent adjuvant chemotherapy with radiotherapy after breast-conserving surgery for breast cancer, and to compare ratings by patients and physicians. METHODS AND MATERIALS: From 1996 to 2000, 716 patients with Stage I-II breast cancers were included in a multicenter, Phase III trial (the ARCOSEIN study) comparing, after breast-conserving surgery with axillary dissection, sequential treatment with chemotherapy first followed by radiotherapy vs. chemotherapy administered concurrently with radiotherapy. Cosmetic results with regard to both the overall aspect of the breast and specific changes (color, scar) were evaluated in a total of 214 patients (107 in each arm) by means of questionnaires to both the patient and a physician whose rating was blinded to treatment allocation. RESULTS: Patients' overall satisfaction with cosmesis was not statistically different between the two arms, with approximately 92% with at least satisfactory results (p = 0.72), although differences between the treated and untreated breasts were greater after the concurrent regimen (29% vs. 14% with more than moderate differences; p = 0.0015). Physician assessment of overall cosmesis was less favorable, with lower rates of at least satisfactory results in the concurrent arm (60% vs. 85%; p = 0.001). Consequently, the concordance for overall satisfaction with cosmesis between patients and doctors was only fair (kappa = 0.62). CONCLUSION: After breast-conserving surgery, the concurrent use of chemotherapy with radiotherapy is significantly associated with greater differences between the breasts. These differences do not translate into patients' lessened satisfaction with cosmesis.

Published
2007

19. Satisfaction with care among patients with non-metastatic breast cancer: development and first steps of validation of the REPERES-60 questionnaire

Author

Virginie Migeot, Isabelle Gasquet, Simone Mathoulin-Pélissier, Roger Salamon, Isabelle Ingrand, Gautier Defossez, Lynda Sifer-Riviere, Pierre Ingrand, Institut Universitaire de Santé Publique [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), Plateforme de génétique moléculaire des cancers d'Aquitaine, Institut Bergonié [Bordeaux], UNICANCER-UNICANCER, Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), CERMES - Centre de recherche Médecine, Science, Santé Société (CERMES - UMR 8169 / U750), Université Paris-Sud - Paris 11 (UP11)-École des hautes études en sciences sociales (EHESS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Epidémiologie, santé publique et développement, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR99-ISPED, Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Mouillet, Evelyne, Centre hospitalier universitaire de Poitiers ( CHU Poitiers ), Institut Bergonié - CRLCC Bordeaux, Troubles du comportement alimentaire de l'adolescent ( UMR_S 669 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 ), Centre de recherche Médecine, Science, Santé et Société ( CERMES ), Université Paris-Sud - Paris 11 ( UP11 ) -École des hautes études en sciences sociales ( EHESS ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), and Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR99-ISPED

Subjects
MESH: Combined Modality Therapy, Cancer Research, MESH: Mastectomy, MESH : Aged, MESH: Logistic Models, MESH : Breast Neoplasms, MESH: Health Care Surveys, MESH: Risk Assessment, MESH : Neoplasm Invasiveness, Care provision, MESH: Patient Participation, 0302 clinical medicine, Surveys and Questionnaires, Medicine, MESH : Neoplasm Staging, MESH : Female, 030212 general & internal medicine, MESH : Risk Assessment, Mastectomy, MESH: Treatment Outcome, MESH: Aged, education.field_of_study, MESH: Middle Aged, MESH : Questionnaires, MESH : Chemotherapy, Adjuvant, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Neoplasm Staging, MESH : Adult, Focus Groups, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Combined Modality Therapy, 3. Good health, MESH: Reproducibility of Results, Treatment Outcome, Oncology, MESH: Chemotherapy, Adjuvant, Chemotherapy, Adjuvant, Patient Satisfaction, 030220 oncology & carcinogenesis, Female, France, MESH : Mastectomy, MESH : Focus Groups, Research Article, Adult, medicine.medical_specialty, MESH : Patient Satisfaction, MESH: Radiotherapy, Adjuvant, Population, Breast Neoplasms, MESH : Treatment Outcome, lcsh:RC254-282, Risk Assessment, MESH : Radiotherapy, Adjuvant, 03 medical and health sciences, Patient satisfaction, Quality of life (healthcare), Breast cancer, Genetics, Humans, MESH : Middle Aged, Neoplasm Invasiveness, MESH : Health Care Surveys, Patient participation, MESH : France, education, Aged, Neoplasm Staging, Gynecology, MESH: Humans, business.industry, MESH : Reproducibility of Results, MESH: Questionnaires, MESH : Humans, Discriminant validity, Reproducibility of Results, MESH: Adult, MESH: Neoplasm Invasiveness, medicine.disease, Focus group, MESH: Patient Satisfaction, MESH : Patient Participation, MESH: France, Logistic Models, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Family medicine, Health Care Surveys, MESH: Focus Groups, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Radiotherapy, Adjuvant, Patient Participation, MESH : Combined Modality Therapy, business, MESH: Female, MESH: Breast Neoplasms, MESH : Logistic Models
Abstract

Background The care itinerary for cancer involves difficulties that occur in several different areas, whether in the diagnostic procedures, in surgery, or in adjuvant treatment. The aim of this work was to obtain a valid instrument measuring satisfaction among patients with breast cancer and exploring their care itinerary overall. Methods Development phase: Patient focus groups were implemented in two French regions in order to identify areas of satisfaction in relation to the different phases of care provision in breast cancer. On the basis of the literature and the themes and wordings derived from the focus groups, the patients identified several areas of satisfaction, which they found to be partially covered in an American satisfaction measure that has been validated in the French general population (the Consumer Satisfaction Survey in its French version, CSS-VF, 39 items). The patient focus groups suggested adaptation of certain dimensions of this instrument to the potential care providers (37 items) and produced 45 new items in six areas. Validation phase: Using a large sample of patients (cohort of 820 women with invasive non-metastatic breast cancer) approached one month after treatment, this phase selected items that were comprehensible (non-response rate < 10%), non-redundant (r < 0.80) and reproducible (test-retest conducted on a sub-sample of 166 patients). The dimensions were identified by factor analysis on the selected items. Divergent and discriminant validity were assessed (relationships with quality of life questionnaire, comparisons between extreme groups). Results Results were in favour of not inserting additional broken-down items into the CSS-VF and retaining 21 new items. The factor analysis found the initial structure of the CSS-VF (39 items in 9 dimensions) and the 21 new items divide up into four dimensions (listening abilities and information provided by doctors, organisation and follow-up of medical care provision, psychological support, material environment). No redundancy was observed between new items and CSS-VF items. Internal consistency was high. Divergent and discriminant validity were satisfactory. Conclusion Adding four new dimensions to the CSS-VF yielded a valid 60-item instrument for assessment of care provided in breast cancer. These promising results now require further investigations of its responsiveness and its robustness in other linguistic, cultural and healthcare settings.

Published
2007

20. Phase III trial of concurrent or sequential adjuvant chemoradiotherapy after conservative surgery for early-stage breast cancer: final results of the ARCOSEIN trial

Author

A. Favre, Olivier Le Floch, Gilles Calais, Pascal Garaud, Alain Toledano, Alain Fourquet, David Azria, Jean-François Bosset, J. Miny-Buffet, Daniel Serin, Institut de recherche en cancérologie de Montpellier (IRCM - U896 Inserm - UM1), CRLCC Val d'Aurelle - Paul Lamarque-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 1 (UM1), CRLC Val d'Aurelle-Paul Lamarque, CRLCC Val d'Aurelle - Paul Lamarque, Institut St Catherine, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université de Franche-Comté (UFC), Hôpital Bretonneau, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Bretonneau, Imagerie fonctionnelle (IF), Institut National de la Recherche Agronomique (INRA)-EFS-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut Sainte Catherine [Avignon], Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bretonneau, Institut de recherche en cancérologie de Montpellier ( IRCM ), Université Montpellier 1 ( UM1 ) -CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Montpellier ( UM ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Bretonneau, Imagerie fonctionnelle ( IF ), and Institut National de la Recherche Agronomique ( INRA ) -EFS-CHRU Tours-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS )

Subjects
Cancer Research, MESH: Combined Modality Therapy, MESH : Antineoplastic Combined Chemotherapy Protocols, medicine.medical_treatment, Segmental, MESH : Breast Neoplasms, Mastectomy, Segmental, 030218 nuclear medicine & medical imaging, law.invention, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 0302 clinical medicine, Randomized controlled trial, law, Antineoplastic Combined Chemotherapy Protocols, MESH: Dose Fractionation, MESH : Female, Dose Fractionation, MESH : Cyclophosphamide, Mastectomy, Adjuvant, MESH: Treatment Outcome, MESH: Middle Aged, MESH : Neoplasm Recurrence, Local, MESH : Chemotherapy, Adjuvant, MESH : Adult, Middle Aged, Combined Modality Therapy, 3. Good health, MESH: Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, Oncology, Local, Fluorouracil, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, MESH : Fluorouracil, MESH : Disease-Free Survival, Female, MESH: Mitoxantrone, MESH: Neoplasm Recurrence, Local, medicine.drug, Adult, medicine.medical_specialty, MESH: Radiotherapy, Adjuvant, MESH : Drug Administration Schedule, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Treatment Outcome, MESH: Drug Administration Schedule, MESH : Radiotherapy, Adjuvant, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Breast cancer, medicine, Chemotherapy, Humans, MESH : Middle Aged, Cyclophosphamide, MESH: Mastectomy, Segmental, MESH : Mastectomy, Segmental, Mitoxantrone, MESH: Humans, Radiotherapy, business.industry, MESH : Dose Fractionation, MESH : Humans, MESH: Cyclophosphamide, MESH: Adult, medicine.disease, Surgery, Radiation therapy, Clinical trial, Regimen, Neoplasm Recurrence, MESH : Mitoxantrone, MESH: Disease-Free Survival, Radiotherapy, Adjuvant, Dose Fractionation, Radiation, Neoplasm Recurrence, Local, business, MESH : Combined Modality Therapy, MESH: Fluorouracil, MESH: Female, Chemoradiotherapy, MESH: Breast Neoplasms
Abstract

Purpose In 1996, we initiated the French multicenter phase III randomized trial to compare the effect on disease-free survival (DFS) of concurrent versus sequential chemotherapy (CT) and radiotherapy (RT) after breast-conserving surgery for stages I and II breast cancer. This report presents the clinical results with a median follow-up of 60 months. Patients and Methods Between February 1996 and April 2000, 716 patients were entered onto this trial. Adjuvant treatment began within 6 weeks after surgery. Sequential treatment of CT administered first followed by RT was compared with concurrent treatment of CT administered with RT. The CT regimen consisted of mitoxantrone (12 mg/m2), fluorouracil (500 mg/m2), and cyclophosphamide (500 mg/m2) on day 1, and it was repeated every 21 days for six courses. RT was delivered to the breast and, when indicated, to the regional lymphatics. Results There was no statistically significant difference in treatment in the 5-year DFS (80% in both groups; P = .83), locoregional recurrence-free survival (LRFS; 92% in sequential v 95% in concurrent; P = .76), metastasis-free survival (87% in sequential v 84% in concurrent; P = .55), or overall survival (90% in sequential v 91% in concurrent; P = .76). Nevertheless, in the node-positive subgroup, the 5-year LRFS was statistically better in the concurrent arm (97% in concurrent v 91% in sequential; P = .02), corresponding to a risk of locoregional recurrence decreased by 39% (hazard ratio, 0.61; 95% CI, 0.38 to 0.93). Conclusion This treatment protocol remains an appealing clinical option for many women with operable breast cancer at a high risk of recurrence. Combination treatments with new drugs for breast cancer are warranted.

Published
2007

21. Pulmonary and cutaneous sarcoidosis associated with interferon therapy for melanoma

Author

Pelletier, Fabien, Manzoni, Philippe, Jacoulet, Pascale, Humbert, Philippe, Aubin, François, Saas, Philippe, Département de dermatologie, Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Hôpital Saint-Jacques-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Saint-Jacques-Université de Franche-Comté ( UFC ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ) -Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC ( HOTE GREFFON ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Etablissement français du sang [Bourgogne-France-Comté] ( EFS [Bourgogne-France-Comté] ) -Université de Franche-Comté ( UFC ), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Hôpital Saint-Jacques-Université de Franche-Comté (UFC), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])

Subjects
Male, MESH: Sarcoidosis, Sarcoidosis, [SDV.IMM] Life Sciences [q-bio]/Immunology, MESH: Melanoma, MESH : Male, MESH: Sarcoidosis, Pulmonary, MESH : Melanoma, MESH : Sarcoidosis, Antineoplastic Agents, MESH: Skin Diseases, Skin Diseases, Sarcoidosis, Pulmonary, stomatognathic system, [ SDV.IMM ] Life Sciences [q-bio]/Immunology, Humans, MESH : Middle Aged, Melanoma, MESH : Sarcoidosis, Pulmonary, MESH: Humans, MESH: Middle Aged, MESH : Humans, Interferon-alpha, virus diseases, MESH : Chemotherapy, Adjuvant, Middle Aged, digestive system diseases, MESH: Male, MESH : Antineoplastic Agents, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH : Interferon-alpha, MESH: Antineoplastic Agents, [SDV.IMM]Life Sciences [q-bio]/Immunology, MESH : Skin Diseases, MESH: Interferon-alpha
Abstract

International audience; Interferon alfa is widely used as adjuvant therapy for melanoma. Numerous side effects have been attributed to interferon alfa. Interferon alfa-induced sarcoidosis is an uncommon event. We report the third case of pulmonary and cutaneous sarcoidosis in the course of interferon alfa treatment for melanoma. Most cases of sarcoidosis have been reported during treatment of chronic hepatitis C. The prognosis is good with discontinuation of treatment. Other than interferon therapy, sarcoidosis or granulomatosis reactions rarely have been reported in malignant melanoma. We discuss and review the literature on the physiopathology of sarcoidosis brought on by interferon therapy.

Published
2007

22. Concurrent administration of adjuvant chemotherapy and radiotherapy after breast-conserving surgery enhances late toxicities: long-term results of the ARCOSEIN multicenter randomized study

Author

Jean-François Bosset, Noel Breteau, Olivier Le Floch, Alain Fourquet, Gilles Body, Pascal Garaud, David Azria, Gilles Calais, Daniel Serin, Alain Toledano, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut de recherche en cancérologie de Montpellier (IRCM - U896 Inserm - UM1), CRLCC Val d'Aurelle - Paul Lamarque-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 1 (UM1), CRLC Val d'Aurelle-Paul Lamarque, CRLCC Val d'Aurelle - Paul Lamarque, Hôpital Bretonneau, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bretonneau, Imagerie fonctionnelle (IF), Institut National de la Recherche Agronomique (INRA)-EFS-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ) -Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Institut de recherche en cancérologie de Montpellier ( IRCM ), Université Montpellier 1 ( UM1 ) -CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Montpellier ( UM ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Bretonneau, Imagerie fonctionnelle ( IF ), Institut National de la Recherche Agronomique ( INRA ) -EFS-CHRU Tours-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Université de Franche-Comté (UFC), and Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Bretonneau

Subjects
Cancer Research, MESH: Combined Modality Therapy, MESH : Antineoplastic Combined Chemotherapy Protocols, medicine.medical_treatment, MESH : Aged, MESH : Prospective Studies, Skin Pigmentation, Segmental, MESH : Breast Neoplasms, Mastectomy, Segmental, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 030218 nuclear medicine & medical imaging, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Breast-conserving surgery, MESH : Female, Prospective Studies, MESH: Radiotherapy Dosage, MESH : Cyclophosphamide, Radiation oncologist, Mastectomy, Adjuvant, MESH: Aged, Radiation, MESH: Middle Aged, MESH : Neoplasm Recurrence, Local, MESH : Radiotherapy Dosage, MESH : Chemotherapy, Adjuvant, Radiotherapy Dosage, MESH : Adult, Middle Aged, Combined Modality Therapy, 3. Good health, MESH: Antineoplastic Combined Chemotherapy Protocols, Oncology, Local, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, MESH : Fluorouracil, Female, MESH: Skin Pigmentation, Fluorouracil, MESH: Mitoxantrone, MESH: Neoplasm Recurrence, Local, medicine.drug, Adult, medicine.medical_specialty, Cyclophosphamide, Urology, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Breast cancer, medicine, Chemotherapy, Humans, MESH : Middle Aged, Radiology, Nuclear Medicine and imaging, MESH: Mastectomy, Segmental, MESH : Mastectomy, Segmental, Subcutaneous fibrosis, Aged, MESH: Humans, business.industry, MESH : Humans, MESH: Cyclophosphamide, MESH: Adult, medicine.disease, MESH: Prospective Studies, Surgery, Radiation therapy, Regimen, Neoplasm Recurrence, MESH : Mitoxantrone, Neoplasm Recurrence, Local, MESH : Skin Pigmentation, Mitoxantrone, MESH : Combined Modality Therapy, business, MESH: Female, MESH: Fluorouracil, MESH: Breast Neoplasms
Abstract

International audience; PURPOSE: In 1996, a multicenter randomized study was initiated that compared sequential vs. concurrent adjuvant chemotherapy (CT) with radiation therapy (RT) after breast-conserving surgery (ARCOSEIN study). After a median follow-up of 6.7 years (range, 4.3-9 years), we decided to prospectively evaluate the late effects of these 2 strategies. METHODS AND MATERIALS: A total of 297 patients from the 5 larger participating institutions were asked to report for a follow-up examination. Seventy-two percent (214 patients) were eligible for evaluation of late toxicity. After breast-conserving surgery, patients were treated either with sequential treatment with CT first followed by RT (Arm A) or CT administered concurrently with RT (Arm B). In all patients, CT regimen consisted of mitoxantrone (12 mg/m2), 5-FU (500 mg/m2), and cyclophosphamide (500 mg/m2), 6 cycles (Day 1 to Day 21). Conventional RT was delivered to the whole breast by administration of a 2 Gy per fraction protocol to a total dose of 50 Gy (+/- boost to the primary tumor bed). The assessment of toxicity was blinded to treatment and was graded by the radiation oncologist, according to the LENT/SOMA scale. Skin pigmentation was also evaluated according to a personal 5-points scoring system (excellent, good, moderate, poor, very poor). RESULTS: Among the 214 evaluable patients, 107 were treated in each arm. The 2 populations were homogeneous for patient, tumor, and treatment characteristics. Subcutaneous fibrosis (SF), telangectasia (T), skin pigmentation (SP), and breast atrophy (BA) were significantly increased in Arm B. No statistical difference was observed between the 2 arms of the study concerning Grade 2 or higher pain, breast edema, or lymphedema. No deaths were caused by late toxicity. CONCLUSION: After breast-conserving surgery, the concurrent use of CT with RT is significantly associated with an increase incidence of Grade 2 or greater late side effects.

Published
2006

23. [What to do with a rising PSA after complete remission post-prostatectomy?]

Author

Bosset , M., Bosset , Jean-François, Maingon , P., Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)

Subjects
Male, MESH: Remission Induction, Antineoplastic Agents, Hormonal, MESH: Radiotherapy, Adjuvant, MESH : Prostatectomy, MESH : Male, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH : Radiotherapy, Adjuvant, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, MESH: Prostatectomy, Humans, MESH : Prostate-Specific Antigen, Prostatectomy, MESH : Remission Induction, MESH: Humans, Remission Induction, MESH : Humans, Prostatic Neoplasms, MESH : Chemotherapy, Adjuvant, Prostate-Specific Antigen, MESH: Antineoplastic Agents, Hormonal, MESH: Male, MESH: Prostate-Specific Antigen, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH: Prostatic Neoplasms, Radiotherapy, Adjuvant, MESH : Prostatic Neoplasms, MESH : Antineoplastic Agents, Hormonal
Abstract

International audience; Between twenty and to forty percent of patients will develop an isolated PSA failure after a radical prostatectomy. Pelvic irradiation is a therapeutic option with curative intention. It is the best therapeutic option for young people with good prognostic factors. Combined radiation with hormonal or chemotherapy should be evaluated in patients with poor prognostic factors. For patients with a short life expectancy, hormonotherapy or a watch and see policy are acceptable options.

Published
2006

24. [Concurrent administration of adjuvant chemotherapy and radiotherapy after breast-conservative surgery enhances late toxicities]

Author

Toledano, A., Garaud, P., Serin, D., Fourquet, A., Bosset, Jean-François, Miny-Buffet, J., Favre, A., Azria, David, Body, G., Le Floch, O., Calais, G., Department of Applied Mathematics and Statistics [Santa Cruz], University of California [Santa Cruz] ( UCSC ), Laboratoire du Service d'Oncologie Médicale, Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Institut Jacques Monod ( IJM ), Université Paris Diderot - Paris 7 ( UPD7 ) -Centre National de la Recherche Scientifique ( CNRS ), University of California [Santa Cruz] (UCSC), University of California-University of California, CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut Jacques Monod (IJM (UMR_7592)), Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), CHU Pitié-Salpêtrière [APHP], and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Université de Franche-Comté (UFC)

Subjects
MESH : Single-Blind Method, MESH : Antineoplastic Combined Chemotherapy Protocols, MESH : Aged, MESH : Prospective Studies, Skin Pigmentation, MESH: Antineoplastic Agents, Alkylating, MESH : Breast Neoplasms, Mastectomy, Segmental, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, Antineoplastic Combined Chemotherapy Protocols, MESH: Dose Fractionation, Single-Blind Method, MESH : Female, Breast, Prospective Studies, MESH : Atrophy, MESH: Breast, MESH : Cyclophosphamide, MESH: Telangiectasis, MESH: Aged, MESH: Middle Aged, MESH : Chemotherapy, Adjuvant, MESH: Follow-Up Studies, Middle Aged, MESH : Adult, MESH: Antineoplastic Combined Chemotherapy Protocols, MESH : Antineoplastic Agents, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH: Fibrosis, MESH : Fibrosis, Female, MESH: Skin Pigmentation, MESH: Mitoxantrone, Adult, MESH: Radiotherapy, Adjuvant, MESH : Antineoplastic Agents, Alkylating, Antineoplastic Agents, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH: Atrophy, MESH : Lymph Node Excision, MESH : Radiotherapy, Adjuvant, Humans, MESH : Middle Aged, Telangiectasis, Antineoplastic Agents, Alkylating, Cyclophosphamide, MESH: Mastectomy, Segmental, MESH : Mastectomy, Segmental, Aged, MESH: Humans, MESH : Telangiectasis, MESH: Lymph Node Excision, MESH : Dose Fractionation, MESH : Humans, MESH: Cyclophosphamide, MESH: Adult, MESH : Follow-Up Studies, MESH: Single-Blind Method, Fibrosis, MESH: Prospective Studies, MESH : Mitoxantrone, Lymph Node Excision, MESH: Antineoplastic Agents, MESH : Breast, Radiotherapy, Adjuvant, Dose Fractionation, Radiation, Atrophy, Mitoxantrone, MESH : Skin Pigmentation, MESH: Female, MESH: Breast Neoplasms, Follow-Up Studies
Abstract

International audience; PURPOSE: In 1996, a multicenter randomized study comparing after breast-conservative surgery, sequential vs concurrent adjuvant chemotherapy (CT) with radiation therapy (RT) was initiated (ARCOSEIN study). Seven hundred sixteen patients were included in this trial. After a median follow-up of 6.7 (4.3-9) years, we decided to prospectively evaluate the late effects of these two strategies. PATIENTS AND METHODS: A total of 297 patients were asked to follow-up from the five larger including institutions. Seventy-two percent (214 patients) were eligible for late toxicity. After breast-conserving surgery with axillary dissection, patients were treated either with sequential treatment with CT first followed by RT (arm A) or CT administered concurrently with RT (arm B). In all patients, CT regimen combined mitoxantrone (12 mg/m(2)), 5-FU (500 mg/m(2)), and cyclophosphamide (500 mg/m(2)), 6 cycles (day 1-day 21). In arm B, patients received concurrently the first 3 cycles of CT with RT. In arm A, RT started 3 to 5 weeks after the 6th cycle of CT. Conventional RT was delivered to the whole breast using a 2 Gy-fraction protocol to a total dose of 50 Gy (+/-boost to the primary tumour bed). The assessment of toxicity was blinded to treatment and was graded by the radiation oncologist according to the LENT-SOMA scale. Skin pigmentation was also evaluated using a personal 5-points scoring system (excellent, good, moderate, poor, very poor). RESULTS: Among the 214 evaluated patients, 107 were treated in each arm. The two populations were homogeneous for patients', tumors' and treatment characteristics. Subcutaneous fibrosis (SF), telengectasia (T), skin pigmentation (SP), and breast atrophy (BA) were significantly increased in arm B. Twenty patients experienced grade superior or equal to 2 (SF) in arm B vs five in arm A (P=0.003). Twenty-five and seven patients showed grade superior or equal to 2 (T) in arm B and A, respectively (P=0.001). Forty-four and twenty patients showed grade superior or equal to 2 (BA) in arm B and A, respectively (P=0.0006). Thirty patients experienced grade superior or equal to 3 (SP) in arm B vs fifteen in arm A (P=0.02). No statistical difference was observed between the two arms concerning grade superior or equal to 2 pain, breast oedema, and lymphoedema. No deaths were caused by late toxicity. CONCLUSION: Following breast conserving surgery, the concurrent use of CT with RT is significantly associated with an increase incidence of grade 2 or greater late side effects.

Published
2006

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