Search

Your search keyword '"F Dalenc"' showing total 262 results
Start Over Author "F Dalenc"
262 results on '"F Dalenc"'

1. Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1

Author

C Cheneau, S Barthier, J Lemonnier, Fabrice Andre, C Dubot, L Teixeira, A Escande, T De La Motte Rouge, T Petit, L Arnould, Laurent Arnould, Suzette Delaloge, Jerome Lemonnier, A Marti, L Stefani, F Berger, C Levy, P Barthelemy, S Nguyen, M Gardner, A Lortholary, François-Clément Bidard, J Plaza, L Joly, Thibault de la Motte Rouge, F Andre, I Bièche, C Alleaume, R Sabatier, B Lucas, Ivan Bieche, O Derbel, L Venat-Bouvet, F Del Piano, Florian Clatot, Anne-Claire Hardy-Bessard, Frédérique Berger, Margaux Marce, Thomas Bachelot, Anne Pradines, Jean-Luc Canon, Sandrine Marques, M Achille, H Ammarguellat, O Arsene, T Bachelot, C Bernard-Marty, F-C Bidard, N Bonichon-Lamichhane, N Bonnin, R Bouaita, A Boudrant, V-A Brunel, C Chakiba, F Clatot, F Dalenc, A De Gramont, L Deiana, C Delbaldo, V Delecroix, H Desclos, V D'Hondt, N Dohollou, J-M Ferrero, C Foa, J-S Frenel, C Garnier Tixidre, D Genet, O Gisserot, M Gozy, C Greilsamer, J Grenier, F Guinet, A-C Hardy-Bessard, J-P Jacquin, E Lachaier, S Ladoire, A-P Laurenty, R Le Scodan, N Leduc, E Legouffe, C Levache, F Lorchel, N Marques, J Medioni, A Melis, D Mille, D Mollon, L Moreau, I Moullet, M-A Mouret-Reynier, A Najem, H Orfeuvre, J-F Paitel, B Pistilli, C Riedl, P Soulie, D Spaeth, F Trouboul, C Valmar, H Vegas, A Zannetti, FC Bidard, S Delaloge, A Pradines, JL Canon, and S Marques

Subjects
Medicine
Abstract

Introduction The combination of a CDK4/6 inhibitor with an aromatase inhibitor (AI) has recently become the gold standard for AI-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2−) advanced breast cancer. However, most patients receiving this combination will ultimately progress and require further therapies.Several studies have demonstrated that the onset of a ESR1 gene mutation lead to AIs resistance in the advanced setting. ESR1 mutations can be detected in circulating tumour DNA (ctDNA) using a digital PCR assay. Our study aims to prove the clinical efficacy of periodic monitoring for emerging or rise of ESR1 mutations in ctDNA to trigger an early change from AI plus palbociclib to fulvestrant plus palbociclib treatment while assessing global safety.Methods PADA-1 is a randomised, open-label, multicentric, phase III trial conducted in patients receiving AI and palbociclib as first line therapy for metastatic ER +HER2- breast cancer. 1000 patients will be included and treated with palbociclib in combination with an AI. Patients will be screened for circulating blood ESR1 mutation detection at regular intervals. Patients for whom a rising circulating ESR1 mutation is detected without tumour progression (up to N=200) will be randomised (1:1) between (1) Arm A: no modification of therapy; and (2) Arm B: palbociclib in combination with fulvestrant, a selective ER down-regulator. At tumour progression, an optional crossover will be offered to patients randomised in arm A. The coprimary endpoints are (1) Grade ≥3 haematological toxicities and their associations with baseline characteristics and (2) progression-free survival in randomised patients.Ethics and dissemination The study has been approved by the French medicines agency (ANSM) and by an ethics committee (ref 01/17_1 CPP Ouest-IV Nantes) in January 2017. The trial results will be published in academic conference presentations and international peer-reviewed journals.Trial registration numbers EudraCT: 2016-004360-18; NCT03079011.

Published
2022
Full Text
View/download PDF

2. Compliance to genomic test recommendations to guide adjuvant chemotherapy decision‐making in the case of hormone receptor‐positive, human epidermal growth factor receptor 2‐negative breast cancer, in real‐life settings

Author

D. Hequet, N. Hajjaji, E. Charafe‐Jauffret, A. Boucrauta, F. Dalenc, V. Nicolai, J. Lopez, O. Tredan, E. Deluche, V. Fermeaux, L. Tixier, A. Cayre, E. Menet, F. Lerebours, and R. Rouzier

Subjects
breast cancer, deescalation, genomic tests, guidelines, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Genomic tests are a useful tool for adjuvant chemotherapy decision‐making in the case of hormone receptor‐positive (HR+), and human epidermal growth factor receptor 2‐negative (HER2−) breast cancer with intermediate prognostic factors. Real‐life data on the use of tests can help identify the target population for testing. Methods French multicentric study (8 centers) including patients, all candidates for adjuvant chemotherapy for HR‐positive, HER2‐negative early breast cancer. We describe the percentage of tests performed outside recommendations, according to the year of testing. We calculated a ratio defined as the number of tests required to avoid chemotherapy for one patient, and according to patient and cancer characteristics. We then performed a cost‐saving analysis using medical cost data over a period of 1 year from diagnosis, calculated from a previous study. Finally, we calculated the threshold of the ratio (number of tests required to avoid chemotherapy for one patient) below which the use of genomic tests was cost‐saving. Results A total of 2331 patients underwent a Prosigna test. The ratio (performed test/avoided chemotherapy) was 2.8 [95% CI: 2.7–2.9] in the whole population. In the group following recommendations for test indication, the ratio was 2.3 [95% CI: 2.2–2.4]. In the case of non‐abidance by recommendations, the ratio was 3 [95% CI: 2.8–3.2]. Chemotherapy was avoided in 841 patients (36%) following the results of the Prosigna test. The direct medical costs saved over 1 year of care were 3,878,798€ and 1,718,472€ in the group of patients following test recommendations. We calculated that the ratio (performed test/avoided chemotherapy) needed to be under 6.9 for testing to prove cost‐saving. Conclusion The use of genomic testing proved cost‐saving in this large multicentric real‐life analysis, even in certain cases when the test was performed outside recommendations.

Published
2023
Full Text
View/download PDF

3. CinéBreast-factors influencing the time to first metastatic recurrence in breast cancer: Analysis of real-life data from the French ESME MBC database

Author

P. Gougis, M. Carton, C. Tchokothe, M. Campone, F. Dalenc, A. Mailliez, C. Levy, W. Jacot, M. Debled, M. Leheurteur, T. Bachelot, A. Hennequin, C. Perrin, A. Gonçalves, L. Uwer, J.C. Eymard, T. Petit, M.A. Mouret-Reynier, E. Chamorey, G. Simon, M. Saghatchian, C. Cailliot, and C. Le Tourneau

Subjects
Breast cancer, Metastatic recurrence, Growth rate, Real-life data, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Purpose: The Time to First Metastatic Recurrence (TFMR) could be considered as an indirect reflection of the tumour growth kinetics which plays an important role in cancer. Molecular subtypes such as expression of estrogen receptor are known predictive factors of TFMR. The CinéBreast study aimed to identify predictive factors of the time to TFMR. Methods: The French Epidemiological Strategy and Medical Economics (ESME) Metastatic Breast Cancer (MBC) Database (NCT03275311) was used, which contains data from a cohort of metastatic breast cancer patients from 2008 to 2016 using retrospective data collection. It is a national multi-centre database. The impact of TFMR on overall survival (OS) since first metastasis was also evaluated. Results: Among 16 702 patients recorded in the ESME MBC database, 10 595 had an initially localised breast cancer with hormone receptor (HR) and HER2 status available, with a metastatic recurrence. Median follow up was 56 months. Median TFMR was 59 months (120: 24%). HER2+ and TNBC were respectively 4 times and 12 times (p

Published
2020
Full Text
View/download PDF

7. 189O A phase II study of patritumab deruxtecan (HER3-DXd), in patients (pts) with advanced breast cancer (ABC), with biomarker analysis to characterize response to therapy (ICARUS-BREAST01)

Author

B. Pistilli, N. Ibrahimi, M. Lacroix-Triki, V. D'Hondt, C. Vicier, J-S. Frenel, F. Dalenc, T. Bachelot, M-A. Benderra, D. Loirat, A. Ducoulombier, D. Mayeur, G.B. Nachabeh, K. Serhal, N. Corcos, D. Sellami, S. Michiels, F. André, M.F. Mosele, and G. Montagnac

Subjects
Cancer Research, Oncology
Published
2023

13. 1551O Factors associated with chemotherapy (CT)-related amenorrhea (CRA) and its relationship with quality of life (QOL) in premenopausal women with early breast cancer (BC): Results from the prospective CANTO cohort study

Author

R. Kabirian, J. Havas, M.A. Franzoi, C. Coutant, O. Tredan, C. Levy, P.H. Cottu, A. Dhaini Merimeche, S. Guillermet, J-M. Ferrero, S. Giacchetti, T. Petit, F. Dalenc, P. Rouanet, O. Querel, A-L. Martin, B. Pistilli, M. Lambertini, I.V. Luis, and A. Di Meglio

Subjects
Oncology, Hematology
Published
2022

16. 220P Elacestrant vs fulvestrant or aromatase inhibitor (AI) in phase III trial evaluating elacestrant, an oral selective estrogen receptor degrader (SERD), vs standard of care (SOC) endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC): Subgroup analysis from EMERALD

Author

P.G. Aftimos, J. Cortés, F.C. Bidard, null V. Kaklamani, A. Bardia, P. Neven, G. Streich, A. Montero, F. Forget, M.A. Mouret Reynier, J. Sohn, D. Taylor, K. Harnden, H. Khong, J. Kocsis, F. Dalenc, P. Dillon, G. Tonini, K.J. Grzegorzewski, and J. Lu

Subjects
Oncology, Hematology
Published
2022

17. 213MO Primary endpoint analysis of a randomized phase II of darolutamide or capecitabine in patients with triple-negative androgen receptor-positive advanced breast cancer (UCBG3-06 START trial)

Author

M. Arnedos, A. Goncalves, M. Pulido, F. Lerebours, O. Tredan, F. Dalenc, S. Guiu, D. Mollon Grange, L. Teixeira, C. Levy, B. Verret, H.A.S. Dawood, P. Augereau, L. Deiana, S. Ladoire, E. Carola, M.A. Mouret Reynier, C. Guyonneau, G. MacGrogan, and H. Bonnefoi

Subjects
Oncology, Hematology
Published
2022

18. Corrigendum to 'De novo metastatic breast cancer in patients with a small locoregional tumour (T1-T2/N0): characteristics and prognosis' [Eur J Cancer 158 (2021) 181–188]

Author

T. Gaillard, M. Carton, A. Mailliez, I. Desmoulins, M.A. Mouret-Reynier, T. Petit, M. Leheurteur, V. Dieras, J.M. Ferrero, L. Uwer, S. Guiu, A. Gonc¸alves, C. Levy, M. Debled, F. Dalenc, A. Patsouris, T. Bachelot, J.C. Eymard, M. Chevrot, A. Conversano, M. Robain, and D. Hequet

Subjects
Cancer Research, Oncology
Published
2022

21. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Author

D. Miles, J. Gligorov, F. André, D. Cameron, A. Schneeweiss, C. Barrios, B. Xu, A. Wardley, D. Kaen, L. Andrade, V. Semiglazov, M. Reinisch, S. Patel, M. Patre, L. Morales, S.L. Patel, M. Kaul, T. Barata, J. O’Shaughnessy, Q. Zhang, Z. Shao, X. Wang, C. Geng, X. Yan, Z. Tong, K. Shen, Y. Yin, T. Sun, J. Yang, J. Feng, M. Yan, Y. Wang, Q. Liu, S. Zhang, M. De Laurentiis, A. Santoro, V. Guarneri, M. Colleoni, C. Natoli, L. Cortesi, S. Placido, L. Gianni, F. Ferrau, L. Livi, A. Zambelli, L. Del Mastro, G. Tonini, F. Montemurro, G. Bianchi, R. Pedersini, S. Prete, G. Allegrini, G. Naso, P. Vici, D. Loirat, A. Mailliez, F. Priou, O. Tredan, F. Dalenc, C. Perrin, M. Timar David, N. Dohollou, L. Teixeira, F. Brocard, A. Arnaud, S. Delaloge, J.-P. Spano, L. Mansi, F. Damian, J. Pedrini, S. Aleixo, R. Hegg, R. Junior, M. Schmidt, C. Wenzel, E.-M. Grischke, M. Just, N. Harbeck, C. Schumacher, U. Peters, D. Fischer, H. Forstbauer, R. Liersch, E. Warner, N. Bouganim, C. Doyle, J. Price Hiller, T. Vandenberg, M. Pavic, A. Robinson, G. Roldan Urgoiti, N. Califaretti, A. Alacacioglu, M. Gumus, B. Yalcin, I. Cicin, F. Kose, K. Uygun, M. Kaplan, E. Cubukcu, M. Harries, D. Doval, S. Gupta, P. Mohapatra, S. Chatterjee, N. Ghadyalpatil, M. Singhal, S. Nag, A. Agarwal, I. Wolf, E. Gal Yam, R. Yerushalmi, T. Peretz, G. Fried, N. Ben Baruch, D. Katz, E. Hamilton, F. Kayali, A. Brufsky, M. Telli, G. Wright, R. Oyola, T. Rakowski, S. Graff, S. Tjulandin, A. Aparicio, M. Ruiz Borrego, L. Merino, J. Guerra Martinez, E. Lopez, T. Yamashita, S. Ohtani, K. Inoue, Y. Ito, N. Niikura, T. Nakayama, Y. Sagara, Y. Yanagita, Y. Kamada, K. Kaneko, A. Nervo, A. Eniu, M. Schenker, P. Priester, B. Melichar, M. Zimovjanova, P. Sormova, J. Sufliarsky, M. Kakalejcik, R. Belbaraka, H. Errihani, D. Le Than, D. Pham, G. Aravantinos, C. Papadimitriou, G. Koumakis, C. Papandreou, P. Podolski, and K. Tabane

Subjects
0301 basic medicine, Oncology, PD-L1, atezolizumab, medicine.medical_specialty, advanced breast cancer, immune checkpoint inhibitor, paclitaxel, triple-negative breast cancer, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Humans, Paclitaxel, Progression-Free Survival, Triple Negative Breast Neoplasms, medicine.medical_treatment, Population, Antibodies, 03 medical and health sciences, 0302 clinical medicine, Atezolizumab, Internal medicine, Monoclonal, Clinical endpoint, Medicine, Progression-free survival, education, Humanized, Triple-negative breast cancer, education.field_of_study, Chemotherapy, Taxane, business.industry, Hazard ratio, Hematology, 030104 developmental biology, 030220 oncology & carcinogenesis, business
Abstract

Background In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-bound-paclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed death-ligand 1 (PD-L1)-positive populations, and a clinically meaningful overall survival (OS) effect in PD-L1-positive aTNBC. The phase III KEYNOTE-355 trial adding pembrolizumab to chemotherapy for aTNBC showed similar PFS effects. IMpassion131 evaluated first-line atezolizumab–paclitaxel in aTNBC. Patients and methods Eligible patients [no prior systemic therapy or ≥12 months since (neo)adjuvant chemotherapy] were randomised 2:1 to atezolizumab 840 mg or placebo (days 1, 15), both with paclitaxel 90 mg/m2 (days 1, 8, 15), every 28 days until disease progression or unacceptable toxicity. Stratification factors were tumour PD-L1 status, prior taxane, liver metastases and geographical region. The primary endpoint was investigator-assessed PFS, tested hierarchically first in the PD-L1-positive [immune cell expression ≥1%, VENTANA PD-L1 (SP142) assay] population, and then in the ITT population. OS was a secondary endpoint. Results Of 651 randomised patients, 45% had PD-L1-positive aTNBC. At the primary PFS analysis, adding atezolizumab to paclitaxel did not improve investigator-assessed PFS in the PD-L1-positive population [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.60-1.12; P = 0.20; median PFS 6.0 months with atezolizumab–paclitaxel versus 5.7 months with placebo–paclitaxel]. In the PD-L1-positive population, atezolizumab–paclitaxel was associated with more favourable unconfirmed best overall response rate (63% versus 55% with placebo–paclitaxel) and median duration of response (7.2 versus 5.5 months, respectively). Final OS results showed no difference between arms (HR 1.11, 95% CI 0.76-1.64; median 22.1 months with atezolizumab–paclitaxel versus 28.3 months with placebo–paclitaxel in the PD-L1-positive population). Results in the ITT population were consistent with the PD-L1-positive population. The safety profile was consistent with known effects of each study drug. Conclusion Combining atezolizumab with paclitaxel did not improve PFS or OS versus paclitaxel alone. ClinicalTrials.gov NCT03125902.

Published
2021

22. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

D. Miles, E. Ciruelos, A. Schneeweiss, F. Puglisi, T. Peretz-Yablonski, M. Campone, I. Bondarenko, Z. Nowecki, H. Errihani, S. Paluch-Shimon, A. Wardley, J.-L. Merot, P. Trask, Y. du Toit, C. Pena-Murillo, V. Revelant, D. Klingbiel, T. Bachelot, K. Bouzid, I. Desmoulins, B. Coudert, I. Glogowska, E. Ciruelos Gil, F. Dalenc, F. Ricci, V. Dieras, B. Kaufman, A. Ferreira, M. Mano, H. Kalofonos, C. Andreetta, F. Montemurro, S. Barrett, Q. Zhang, D. Mavroudis, J. Matus, C. Villarreal Garza, C. Beato, G. Ismael, X. Hu, H. Abdel Azeem, R. Gaafar, C. Perrin, P. Kerbrat, J. Ettl, S. Paepke, E. Hitre, I. Lang, M. Trudeau, S. Verma, H. Li, O. Hoffmann, B. Aktas, A. Cariello, G. Cruciani, A. Tienghi, C. Tondini, T. Al-Twegieri, N. Loman, R. Laing, E. Brain, P. Fasching, M. Lux, A. Frassoldati, Z. Aziz, J. Salas, J. Streb, K. Krzemieniecki, A. Wronski, J. Garcia Garcia, S. Menjon Beltran, I. Cicin, P. Schmid, C. Gallagher, N. Turner, Z. Tong, K. Boer, B. Juhász, Z. Horvath, G. Bianchini, L. Gianni, G. Curigliano, A. Juarez Ramiro, S. Susnjar, E. Matos, E. Sevillano, L. Garcia Estevez, E. Gokmen, R. Uslu, H. Wildiers, F. Schutz, M. Cruz, H. Bourgeois, R. von Schumann, S. Stemmer, A. Dominguez, F. Morales-Vásques, M. Wojtukiewicz, J. Trifunovic, M.J. Echarri Gonzalez, J. Illarramendi Mañas, E. Martinez De Dueñas, N. Voitko, J. Hicks, S. Waters, P. Barrett-Lee, D. Wheatley, R. De Boer, V. Cocquyt, G. Jerusalem, C. Barrios, L. Panasci, J. Mattson, M. Tanner, M. Gozy, G. Vasilopoulos, C. Papandreou, J. Revesz, N. Battelli, G. Benedetti, L. Latini, C. Gridelli, J. Lazaro Leon, J. Alarcón Company, A. Arance Fernandez, A. Barnadas Molins, I. Calvo Plaza, R. Bratos, A. Gonzalez Martin, Y. Izarzugaza Peron, L. Klint, A. Kovalev, N. McCarthy, B. Yeo, D. Kee, J. Thomson, S. White, R. Greil, S. Wang, X. Artignan, I. Juhasz-Böess, A. Rody, R. Ngan, F. Dourleshter, H. Goldberg, L. Doni, F. Di Costanzo, F. Ferraù, M. Drobniene, E. Aleknavicius, K. Rashid, L. Costa, L. de la Cruz Merino, J. Garcia Saenz, R. López, O. Del Val Munoz, O. Ozyilkan, F. Azribi, H. Jaafar, R. Baird, M. Verrill, J. Beith, A. Petzer, J. Moreira de Andrade, V. Bernstein, N. Macpherson, D. Rayson, I. Saad Eldin, M. Achille, P. Augereau, V. Müller, A. Rasco, E. Evron, D. Katz, R. Berardi, S. Cascinu, A. De Censi, A. Gennari, N. El-Saghir, M. Ghosn, H.M. Oosterkamp, J. Van den Bosch, M. Kukulska, E. Kalinka, J. Alonso, E. Dalmau Portulas, M. Del Mar Gordon Santiago, I. Pelaez Fernandez, S. Aksoy, K. Altundag, H. Senol Coskun, H. Bozcuk, Y. Shparyk, L. Barraclough, N. Levitt, U. Panwar, S. Kelly, A. Rigg, M. Varughese, C. Castillo, L. Fein, L. Malik, R. Stuart-Harris, C. Singer, H. Stoeger, H. Samonigg, J. Feng, M. Cedeño, J. Ruohola, J.-F. Berdah, A. Goncalves, H. Orfeuvre, E.-M. Grischke, E. Simon, S. Wagner, G. Koumakis, K. Papazisis, N. Ben Baruch, G. Fried, D. Geffen, N. Karminsky, T. Peretz, L. Cavanna, P. Pedrazzioli, D. Grasso, E. Ruggeri, G. D’Auria, L. Moscetti, E. Juozaityte, J. Rodriguez Cid, H. Roerdink, N. Siddiqi, J. Passos Coelho, A. Arcediano Del Amo, E. Garcia Garre, M. García Gonzalez, A. Garcia-Palomo Perez, C. Herenandez Perez, P. Lopez Alvarez, M.H. Lopez De Ceballos, N. Martínez Jañez, M. Mele Olive, K. McAdam, T. Perren, G. Dunn, A. Humphreys, W. Taylor, R. Vera, L. Kaen, J. Andel, G. Steger, J. De Grève, M. Huizing, R. Hegg, A. Joy, P. Kuruvilla, S. Sehdev, S. Smiljanic, R. Kütner, J. Alexandre, J. Grosjean, P. Laplaige, R. Largillier, P. Maes, P. Martin, V. Pottier, B. Christensen, F. Khandan, H.-J. Lück, D.-M. Zahm, G. Fountzilas, V. Karavasilis, T. Safra, M. Inbar, L. Ryvo, A. Bonetti, E. Seles, A. Giacobino, Y. Chavarri Guerra, F. de Jongh, A. van der Velden, L. van Warmerdam, S. Vrijaldenhoven, C.H. Smorenburg, M. Cavero, R. Andres Conejero, A. Oltra Ferrando, A. Redondo Sanchez, N. Ribelles Entrena, S. Saura Grau, G. Viñas Vilaro, K. Bachmeier, M. Beresford, M. Butt, J. Joffe, C. Poole, P. Woodings, P. Chakraborti, G. Yordi, N. Woodward, A. Nobre, G. Luiz Amorim, N. Califaretti, S. Fox, A. Robidoux, E. Li, N. Li, J. Jiang, T. Soria, P. Padrik, O. Lahdenpera, H. Barletta, N. Dohollou, D. Genet, K. Prulhiere, D. Coeffic, T. Facchini, S. Vieillot, S. Catala, L. Teixeira, T. Hesse, T. Kühn, A. Ober, R. Repp, W. Schröder, D. Pectasides, G. Bodoky, Z. Kahan, I. Jiveliouk, O. Rosengarten, V. Rossi, O. Alabiso, M. Pérez Martínez, A.J. van de Wouw, J. Smok-Kalwat, M. Damasecno, I. Augusto, G. Sousa, A. Saadein, N. Abdelhafiez, O. Abulkhair, A. Antón Torres, M. Corbellas Aparicio, R. Llorente Domenech, J. Florián Jerico, J. Garcia Mata, M. Gil Raga, A. Galan Brotons, A. Llombart Cussac, C. Llorca Ferrandiz, P. Martinez Del Prado, C. Olier Garate, C. Rodriguez Sanchez, R. Sanchez Gomez, M. Santisteban Eslava, J. Soberino, M. Vidal Losada Garcia, D. Soto de Prado, J. Torrego Garcia, E. Vicente Rubio, M. Garcia, A. Murias Rosales, H. Granstam Björneklett, U. Narbe, M. Jafri, D. Rea, J. Newby, A. Jones, S. Westwell, A. Ring, I. Alonso, R. Rodríguez, Miles, D., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Campone, M., Bondarenko, I., Nowecki, Z., Errihani, H., Paluch-Shimon, S., Wardley, A., Merot, J. -L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., Klingbiel, D., Bachelot, T., Bouzid, K., Desmoulins, I., Coudert, B., Glogowska, I., Ciruelos Gil, E., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhasz, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vasques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M. J., Illarramendi Manas, J., Martinez De Duenas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcon Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., Mccarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Boess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferrau, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., Lopez, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Muller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H. M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeno, M., Ruohola, J., Berdah, J. -F., Goncalves, A., Orfeuvre, H., Grischke, E. -M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D'Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., Garcia Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M. H., Martinez Janez, N., Mele Olive, M., Mcadam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Greve, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kutner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Luck, H. -J., Zahm, D. -M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C. H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Vinas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kuhn, T., Ober, A., Repp, R., Schroder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Perez Martinez, M., van de Wouw, A. J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Anton Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florian Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Bjorneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodriguez, R., Apollo - University of Cambridge Repository, Medical Genetics, Clinical sciences, and Laboratory for Medical and Molecular Oncology

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, medicine.medical_treatment, chemistry.chemical_compound, paclitaxel, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, skin and connective tissue diseases, HER2 positive, hormone receptor, metastatic breast cancer, overall survival, pertuzumab, Hematology, Metastatic breast cancer, Receptor, ErbB-2/genetics, Neoplasm Recurrence, Local/drug therapy, Treatment Outcome, Docetaxel, Paclitaxel, 030220 oncology & carcinogenesis, Female, Taxoids, Pertuzumab, medicine.drug, medicine.medical_specialty, Taxoids/therapeutic use, Breast Neoplasms, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Breast Neoplasms/drug therapy, Internal medicine, medicine, Humans, Trastuzumab/adverse effects, neoplasms, Chemotherapy, Taxane, business.industry, Antineoplastic Combined Chemotherapy Protocols/adverse effects, medicine.disease, 030104 developmental biology, chemistry, Neoplasm Recurrence, Local, business
Abstract

Background The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. Patients and methods Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. Results Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade ≥3 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). Conclusions Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design.

Published
2021

23. 167MO Association between ER, PR and HER2 levels and outcome under palbociclib (Pal) + aromatase inhibitors (AIs) as first-line therapy for ER+ HER2- metastatic breast cancer (MBC): An exploratory analysis of the PADA-1 trial

Author

T. De La Motte Rouge, J-S. Frenel, A-C. Hardy-Bessard, T. Bachelot, B. Pistilli, S. Delaloge, L. Deiana, F. Del Piano, D. Genet, M. Gardner, E. Legouffe, C.B. Levache, H. Orfeuvre, C. Valmar, L. Venat, A. Zannetti, R. Le Scodan, F. Dalenc, D. Berger, and F.C. Bidard

Subjects
Oncology, Hematology
Published
2022

24. Alternative methodological approach to randomized trial for surgical procedures routinely used

Author

G. Ferron, Alejandra Martinez, H. Roche, Thomas Filleron, F. Dalenc, Eva Jouve, and Amélie Lusque

Subjects
Adult, medicine.medical_specialty, Mammaplasty, Breast Neoplasms, CUSUM, Medical Oncology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Randomized controlled trial, Surgical oncology, law, medicine, Humans, Pharmacology (medical), Medical history, Medical physics, 030212 general & internal medicine, Intersectoral Collaboration, Mastectomy, Randomized Controlled Trials as Topic, Surgeons, business.industry, General Medicine, medicine.disease, Quality Improvement, Research Personnel, Observational Studies as Topic, Research Design, Nipples, 030220 oncology & carcinogenesis, Propensity score matching, Female, France, Breast reconstruction, business, Organ Sparing Treatments, Medical literature
Abstract

Background In medical oncology, changes in practices are almost always based on randomized trials but medical history shows that it is different in surgical oncology. In the past, many surgical procedures were routinely performed without a rigorous evaluation of the risk-benefit. To highlight the complexity of developing randomized surgical trials, disquisitions on methodology presented in the medical literature. This is particularly true when we consider breast reconstruction after surgical treatment for breast cancer. It is illusory to perform and conduct a randomized clinical trial (RCT) when a surgical procedure is routinely used by most surgeons. Methods As a case study, we present the scientific rationale and the design of the MAPAM01 trial which evaluates the security of the nipple sparing mastectomy. Other alternative approaches, such as propensity score and CUSUM, are presented. Results In this situation, to design surgical trials using alternative methodological approaches present a particularly important challenge both for surgeons and methodologists. Alternative approach to randomized trials can be useful to evaluate surgical procedures routinely used. Conclusion Close collaboration between surgeons and methodologists is needed to propose appropriate and well-designed surgical trials.

Published
2018

25. [Regional state-of-the-art of the access to oncofertility consultation for young women with breast cancer]

Author

A, Gosset, C, Cohade, P, Grosclaude, E, Oumsack, F, Dalenc, M, Montagut, J, Parinaud, and C, Vaysse

Subjects
Adult, Health Knowledge, Attitudes, Practice, Ovulation Induction, Physicians, Surveys and Questionnaires, Fertility Preservation, Humans, Antineoplastic Agents, Breast Neoplasms, Female, Infertility, Female, Referral and Consultation, Health Services Accessibility
Abstract

According to the 2004 Bioethics Act, oncofertility counselling must be systematically offered to all women of childbearing age before they are exposed to potentially gonadotoxic treatment. The main objective of this study was to evaluate the proportion of women under 40 years of age treated with chemotherapy for breast cancer in Midi-Pyrénées who have received an oncofertility consultation. A secondary objective was to assess practitioners' knowledge on the subject.A cross-reference was made between the databases of the oncology network in Midi-Pyrénées and the two approved centres for the preservation of fertility in the region. A computerized practitioner questionnaire was sent to all surgeons and oncologists who could manage these patients.From 2012 and 2017, 667 women aged≤40 years received (neo)adjuvant chemotherapy treatment: only 156 (23.4%) had access to an oncofertility consultation and 58 (8.7%) received preservation. This rate (23.4%) varied according to the age of the patients, ranging from 56.9% for those aged 25-29 to 13.4% for those aged 35-39 and the managing institution. Of the 85 practitioners surveyed, 45 (55%) responded to the questionnaire, and of these 20 (44%) knew that ovarian stimulation treatment could be used even in hormone-dependent breast cancer situations and 13 (29%) of practitioners believed that the time required to preserve fertility was more than 1 month.Our study revealed a significant disparity in access to oncofertility consultation. It is essential to set up information and awareness-raising actions on the subject.

Published
2019

26. 6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, open-label, phase 3 randomised trial

Author

Xavier Pivot, Gilles Romieu, Marc Debled, Jean-Yves Pierga, Pierre Kerbrat, Thomas Bachelot, Alain Lortholary, Marc Espié, Pierre Fumoleau, Daniel Serin, Jean-Philippe Jacquin, Christelle Jouannaud, Maria Rios, Sophie Abadie-Lacourtoisie, Laurence Venat-Bouvet, Laurent Cany, Stéphanie Catala, David Khayat, Laetitia Gambotti, Iris Pauporté, Celine Faure-Mercier, Sophie Paget-Bailly, Julie Henriques, Jean Marie Grouin, C Piprot, L Cals, L Chaigneau, F Demarchi, T N'Guyen, U Stein, C Villanueva, JL Bréau, AK Chouahnia, P Saintigny, F Boué, P deSaint-Hilaire, I Guimont, N Grossat, B Valenza, E Lévy, J Médioni, C Delbaldo, J Grenier, D Pouessel, S Lavau-Denès, C Falandry, C Fournel-Fédérico, G Freyer, S Tartas, V Trillet-Lenoir, F Bons, G Auclerc, S Chièze, N Raban, C Tournigand, S Trager-Maury, G Bousquet, C Cuvier, S Giacchetti, A Hocini, C LeMaignan, JL Misset, D Avenin, C Beerblock, J Gligorov, P Rivera, H Roché, P Bougnoux, N Hajjaji, O Capitain, R Delva, P Maillart, P Soulié, H Bonnefoi, M Durand, N Madranges, L Mauriac, P Chollet, AF Dillies, X Durando, JP Ferrière, C Mouret-Reynier, JM Nabholtz, I Van Praagh, P Cottu, V Diéras, A Durieux, M Galotte, V Girre, S Henry, I Iurisci, M Jouve, V Laurence, L Mignot, S Piperno-Neumann, P Tresca, B Coudert, E Ferrant, F Mayer, AC Vanneuville, J Bonneterre, V Servent, L Vanlemmens, P Vennin, JP Guastalla, P Biron, L Dupuy-Brousseau, L Lancry, I Ray-Coquard, P Rebattu, O Trédan, JM Extra, F Rousseau, C Tarpin, M Fabbro, E Luporsi, L Uwer, B Weber, D Berton-Rigaud, E Bourbouloux, M Campone, JM Ferrero, P Follana, R Largillier, V Mari, B Costa, H Curé, JC Eymard, N Jovenin, D Lebrun, J Meunier, G Yazbek, D Gedoin, B Laguerre, C Lefeuvre, E Vauléon, A Chevrier, C Guillemet, M Leheurteur, O Rigal, I Tennevet, C Veyret, E Brain, M Guiterrez, F Mefti-Lacheraf, T Petit, F Dalenc, L Gladieff, F André, S Delaloge, J Domont, J Ezenfis, M Spielmann, P Guillet, V Boulanger, J Provençal, L Stefani, C Alliot, D Ré, C Bellaiche-Miccio, G Boutan-Laroze, R Vanica, P Dion, G Sadki-Benaoudia, A Marti, AL Villing, B Slama, JL Dutel, S Nguyen, R Saad, O Arsène, Z Merad-Boudia, H Orfeuvre, J Egreteau, MJ Goudier, R Lamy, B Leduc, C Sarda, B Salles, C Agostini, I Cauvin, A Dufresne, M Mangold, S Lebouvier-Sadot, B Audhuy, JC Barats, S Cluet-Dennetière, D Zylberait, G Netter, L Gautier-Felizot, I Cojean-Zelek, A Plantade, S Vignot, E Guardiola, P Marti, I deHartingh, R Diab, A Dietmann, S Ruck, C Portois, S Oddou-Lagranière, F Campos-Gazeau, A Bourcier, F Priou, JF Geay, D Mayeur, P Gabez, R ElAmarti, M Combe, P Raichon-Patru, P Amsalhem, J Dauba, D Paraiso, F Guinet, B Duvert, M Litor, F Kara-Slimane, A Bichoffe, N Denizon, P Soyer, F Morvan, S Van-Hulst, L Vincent, C Alleaume, P Ibanez-Martin, A Youssef, Z Tadrist, E Carola, C Pourny, JF Toccanier, N Al-Aukla, K Mahour-Bacha, J Salvat, P Nouyrigat, S Clippe, MC Gouttebel, L Vedrine, G Clavreul, O Collard, D Mille, Y Goubely, R Hervé, S Kirscher, F Plat, V Delecroix, V Ligeza-Poisson, D Coeffic, D Fric, C Garnier, C Leyronnas, T Kreitman, E Teissier, P Martin, S Rohart deCordoue, C ElKouri, JF Ramée, C Laporte, O Bernard, T Altwegg, A Darut-Jouve, JP Dujols, F Darloy, C Giraud, V Pottier-Kyndt, N Achour, S Drony, M Moriceau, C Sarrazin, JC Legueul, J Mandet, D Besson, AC Hardy-Bessard, J Cretin, P Houyau, E Achille, D Genêt, H Thévenot, A Moran-Ribon, JM Pavlovitch, P Ardisson, I Moullet, B Couderc, V Fichet, F Burki, A Auliard, CB Levaché, P Cailleux, F Schaeffer, N Albin, D Sévin-Robiche, J Domas, S Ellis, P Montcuquet, GA Baumont, M Bégue, S Gréget, JL Ratoanina, A Vanoli, C Bielsa, M Bonichon-Lamichhane, D Jaubert, H Laharie-Mineur, L Alcaraz, E Legouffe, H Bourgeois, G Cartron, F Denis, O Dupuis, G Ganem, S Roche-Forestier, L Delzenne, E Chirat, JL Baticle, E Béguier, S Jacquot, E Janssen, H Lauché, A LeRol, JP Chantelard, GA L'Helgoualc'h, EC Antoine, A Kanoui, JF Llory, JM Vannetzel, J Vignoud, C Bruna, T Facchini, K Moutel-Corviole, A Voloch, A Ghoul, D Loiseau, N Barbet, N Dohollou, and K Yakendji

Subjects
Adult, medicine.medical_specialty, Receptor, ErbB-2, Population, Breast Neoplasms, 030204 cardiovascular system & hematology, Drug Administration Schedule, law.invention, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Breast cancer, Antineoplastic Agents, Immunological, Randomized controlled trial, Trastuzumab, law, Internal medicine, medicine, Adjuvant therapy, Humans, 030212 general & internal medicine, skin and connective tissue diseases, education, Infusions, Intravenous, Aged, education.field_of_study, business.industry, Hazard ratio, General Medicine, Middle Aged, Interim analysis, medicine.disease, Survival Analysis, Treatment Outcome, Chemotherapy, Adjuvant, Concomitant, Female, France, business, medicine.drug
Abstract

Summary Background In 2013, the interim analysis of the Protocol for Herceptin as Adjuvant therapy with Reduced Exposure (PHARE) trial could not show that 6 months of adjuvant trastuzumab was non-inferior to 12 months. Here, we report the planned final analysis based on the prespecified number of occurring events. Methods PHARE is an open-label, phase 3, non-inferiority randomised trial of patients with HER2-positive early breast cancer comparing 6 months versus 12 months of trastuzumab treatment concomitant with or following standard neoadjuvant or adjuvant chemotherapy. The study was undertaken in 156 centres in France. Eligible patients were women aged 18 years or older with non-metastatic, operable, histologically confirmed adenocarcinoma of the breast and either positive axillary nodes or negative axillary nodes but a tumour of at least 10 mm. Participants must have received at least four cycles of a chemotherapy for this breast cancer and have started receiving adjuvant trastuzumab-treatment. Eligible patients were randomly assigned to either 6 months or 12 months of trastuzumab therapy duration between the third and sixth months of adjuvant trastuzumab. The randomisation was stratified by concomitant or sequential treatment with chemotherapy, oestrogen receptor status, and centre. The primary objective was non-inferiority in the intention-to-treat population in the 6-month group in terms of disease-free survival with a prespecified hazard margin of 1·15. This trial is registered with ClinicalTrials.gov, number NCT00381901. Findings 3384 patients were enrolled and randomly assigned to either 12 months (n=1691) or 6 months (n=1693) of adjuvant trastuzumab. One patient in the 12-month group and three patients in the 6-month group were excluded, so 1690 patients in each group were included in the intention-to-treat analysis. At a median follow-up of 7·5 years (IQR 5·3–8·8), 704 events relevant to disease-free survival were observed (345 [20·4%] in the 12-month group and 359 [21·2%] in the 6-month group). The adjusted hazard ratio for disease-free survival in the 12-month group versus the 6-month group was 1·08 (95% CI 0·93–1·25; p=0·39). The non-inferiority margin was included in the 95% CI. No differences in effects pertaining to trastuzumab duration were found in any of the subgroups. After the completion of trastuzumab treatment, rare adverse events occurred over time and the safety analysis remained similar to the previously published report. In particular, we found no change in the cardiac safety comparison, and only three additional cases in which the left ventricular ejection fraction decreased to less than 50% have been reported in the 12-month group. Interpretation The PHARE study did not show the non-inferiority of 6 months versus 12 months of adjuvant trastuzumab. Hence, adjuvant trastuzumab standard duration should remain 12 months. Funding The French National Cancer Institute.

Published
2019

27. Is there a role for locoregional treatment of the primary tumor in de novo metastatic breast cancer in the era of tailored therapies?

Author

Charlotte Vaysse, E. Alouani, Youlia M. Kirova, E. Pons-Tostivint, and F. Dalenc

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Tumor biology, business.industry, medicine.medical_treatment, Hematology, medicine.disease, Metastatic breast cancer, Primary tumor, 3. Good health, Radiation therapy, Clinical trial, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, medicine, Practical algorithm, business, Survival rate, Therapeutic strategy
Abstract

Improvements in systemic therapies have changed the face of de novo metastatic breast cancer (dnMBC), with a 5-year survival rate exceeding 25 %. Increasing evidence suggests that a subset of patients could benefit from a locoregional treatment (LRT) with prolonged survival, although the diversity of publications on the subject make it difficult to draw any conclusions. In this review, we summarize the available data on retrospective, prospective and current ongoing clinical trials. Since factors such as tumor biology, pattern of metastatic dissemination and the timing of the treatment are closely linked to the therapeutic strategy, we focus on papers which include these aspects. We discuss recent studies indicating that exclusive radiotherapy provides results comparable with those obtained by surgery. We will then discuss the biological rationale for LRT. Finally, we propose a decision-tree to select the optimal candidates for LRT in dnMBC patients.

Published
2021

28. Survivorship patient care plan: Justification and set up

Author

A. Lesur, A. Gangler, and F. Dalenc

Subjects
Pediatrics, medicine.medical_specialty, business.industry, Specialty, Cancer, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Health promotion, Quality of life (healthcare), Breast cancer, Oncology, Nursing, Multidisciplinary approach, 030220 oncology & carcinogenesis, Health care, Medicine, 030212 general & internal medicine, business, Psychosocial
Abstract

The growing number of breast cancer survivors challenges healthcare organizations, particularly oncology specialty and primary care providers. Currently, in France, the follow-up care is based on detection of recurrences, of second primary contralateral breast cancer, of long-term treatment sequelae, in addition to psychosocial consequences of cancer and its treatment. This review will discuss the evidence base and intents of breast cancer survivorship care plans (CSCPs) as a wellness model for cancer survivors in clinical setting, mainly providing health promotion recommendations such as regular exercise. The CPCPs involve multidisciplinary approach and patient–physician communication. Therefore, this comprehensive care will improve their quality of life, treatment compliance, and general health care maintenance. This article offers innovative guidance to implement the post-cancer patient care and includes the relevant templates to be submitted to the patients.

Published
2016

29. Les traitements adjuvants des cancers du sein : dernières avancées et perspectives pour des cancers très différents

Author

F. Dalenc and S. Guiu

Subjects
Gynecology, medicine.medical_specialty, Medical treatment, business.industry, medicine.medical_treatment, Significant part, Disease, medicine.disease, Natural history, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Oncology, 030220 oncology & carcinogenesis, medicine, 030212 general & internal medicine, Stage (cooking), skin and connective tissue diseases, business, Adjuvant
Abstract

The most significant part of breast cancers is the localised stage diagnosis, which are widely curable through a combination of topical and adjuvant systemic treatments. The specific choice of these adjuvant treatments (type, duration and route of administration), as well as the decision whether or not to give them, taking into account the heterogeneity of breast cancer tumours and the improvement in the understanding of the natural history of this disease, plus discussion with the woman, results in increasingly personalised medical treatment. In this article, we are going to review the recent changes, the questions that have arisen and the outlook for adjuvant systemic breast cancer treatments.

Published
2016

30. 5-year overall survival after early breast cancer diagnosed during pregnancy: A retrospective case-control multicentre French study

Author

Florence Lerebours, A. Vinceneux, Marc Debled, François Morvan, Thomas Bachelot, Magali Provansal, J-M Ferrero, D. Allouache, Pierre Kerbrat, A. Lesur, L. Vanlemmens, Barbara Pistilli, A Ploquin, E. Tresch, F. Coussy, C Loustalot, Séverine Guiu, Jean-Sebastien Frenel, Roman Rouzier, F. Dalenc, Service d'oncologie médicale (CHRU Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, CRLCC René Huguenin, Institut Curie [Paris], Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), Département d'oncologie médicale [Centre Georges-François Leclerc], Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, Centre Léon Bérard [Lyon], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Hôpital Saint-Louis, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Institut Bergonié [Bordeaux], Centre Eugène Marquis (CRLCC), Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Centre Hospitalier René Dubos [Pontoise], Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Claudius Regaud, Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Center Oscar Lambret, CRLCC Oscar Lambret, Institut de cancérologie de l'Ouest - Nantes (ICO Nantes), CRLCC Paul Papin-CRLCC René Gauducheau, Institut Curie, Institut de Cancérologie de Lorraine - Alexis Vautrin (ICL), Centre Régional de Lutte contre le cancer - Centre Georges-François Leclerc (CRLCC - CGFL), CRLCC Antoine Lacassagne, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7), Institut Bergonié - CRLCC Bordeaux, Centre Régional de Lutte contre le Cancer François Baclesse (CRLC François Baclesse ), Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), CRLCC Institut Claudius Regaud, Université de Lille-UNICANCER, Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), and Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Adult, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Pregnancy, Internal medicine, medicine, Overall survival, Humans, 030212 general & internal medicine, Pathological, Neoplasm Staging, Retrospective Studies, Early breast cancer, Chemotherapy, Taxane, business.industry, medicine.disease, Prognosis, 3. Good health, Management, Survival Rate, Oncology, Case-Control Studies, 030220 oncology & carcinogenesis, T-stage, Female, France, business, Pregnancy Complications, Neoplastic, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Background Breast cancer diagnosed during pregnancy (BCP) is rare, but the prevalence is expected to rise. Long-term follow-up data regarding this clinically challenging condition are scarce. The main objective of this multicentre case-control French study was to compare the survival between pregnant patients and matched controls. Methods Patients from 27 centres diagnosed between 2000 and 2009 with histologically proven invasive breast cancer occurring during pregnancy were retrospectively included. Controls were matched to BCP patients on age, clinical T stage, hormone receptor, HER2, administration of neo-adjuvant chemotherapy and pathological node involvement in the absence of neo-adjuvant chemotherapy. Five-year overall survival (OS), disease-free survival (DFS) and metastasis-free survival (MFS) rates were estimated using the Kaplan–Meier method. Results One hundred and eleven BCP patients and 253 controls were included. Median age was 33 and 35 years, respectively. Both populations were managed similarly, except for less frequent sentinel node dissection (p = 0.026) and taxane administration (p = 0.03) among BCP patients. Median follow-up was 7.5 years. Survival rates were similar between both BCP and control patients: 5-year OS rates were 83.1% (95% CI: 74.5–89.0) vs 85.5% (95% CI: 80.4–89.4), respectively, p = 0.31; 5-year DFS rates 60.0% (95% CI: 50.1–68.6) vs 68.5% (95% CI: 62.3–73.9), respectively, p = 0.12 and 5-year MFS rates 71.0% (95% CI: 61.3–78.6) and 74.5% (95% CI: 68.6–79.5), respectively, p = 0.21. Conclusion Our study showed that the survival outcomes of patients diagnosed with BCP were not significantly different as compared to those of matched non-pregnant controls. A proper management of women diagnosed with BCP is crucial.

Published
2018

31. Lésion cutanée axillaire atypique : penser au sein ectopique

Author

F. Deilhes, F. Dalenc, M. Masson Regnault, C. Richet, and F. Giordano-Labadie

Subjects
Dermatology
Abstract

Introduction Une involution incomplete de la ligne lactifere au cours de l’embryogenese se produit dans 0,2 a 6 % de la population, generant la presence de tissu mammaire ectopique. Le developpement de neoplasie sur ces glandes est tres rare. Nous rapportons le cas d’un authentique carcinome mammaire developpe sur glande ectopique axillaire, se presentant sous la forme d’un nodule cutane axillaire. Observation Une femme de 55 ans consultait en dermatologie pour un nodule de la region axillaire gauche. Cette lesion ancienne etait restee stable pendant au moins 15 ans mais s’etait etendue recemment. A l’examen clinique, on notait une lesion nodule discretement inflammatoire, mesurant environ 30 × 40 mm, polylobe, avec un aspect fibreux et retractile par endroits et de consistance pierreuse a la palpation. Les bilans mammographiques et echographiques des seins realises regulierement etaient sans anomalie. La biopsie cutanee concluait a un adenocarcinome mammaire de type lobulaire, recepteurs hormonaux positifs, HER2 negatifs. Un traitement neoadjuvant par hormonotherapie fut propose devant la negativite du bilan d’extension et la resecabilite premiere trop delabrante de la lesion. A trois mois de l’introduction, une nette reduction tumorale permettait d’envisager prochainement la chirurgie ( Fig. 1 ). Discussion Le developpement de neoplasies mammaires sur glandes ectopiques est rare et peu decrit dans la litterature. L’agressivite tumorale serait plus importante que sur glande non ectopique. Le sein ectopique correspond a un diverticule mammaire sans connexion avec le sein « visible ». Il ne comporte ni areole ni mamelon. La localisation axillaire represente 70 % des tissus mammaires ectopiques et est souvent confondue avec un lipome, un kyste ou une adenopathie. Le sein ectopique presente les memes pathologies que le sein anatomique. Sa degenerescence est a l’origine de 0,3 a 0,6 % des cancers mammaires et est plus frequente en zone axillaire (94 % des cas), ou ils se presentent comme des tumeurs inflammatoires survenant parfois sur un nodule ancien, augmentant en taille soudainement comme dans notre cas. Le traitement s’effectue au cas par cas, et obeit aux consensus etablis pour les carcinomes mammaires. Conclusion Devant un nodule axillaire atypique, meme ancien, et malgre la normalite du bilan echo-mammographique des seins, il faut savoir penser au carcinome mammaire sur sein ectopique.

Published
2018

32. Cancers du sein T1a,b N0 M0 (RPC 2013)

Author

P. Cottu, M. Lacroix-Triki, W. Jacot, Y. Belkacemi, F. Dalenc, M. Rodrigues, and D. Coeffic

Subjects
Oncology, medicine.medical_specialty, business.industry, Internal medicine, Medicine, business
Published
2013

33. [Uncommon dermatologic disorders triggered by radiation therapy of breast cancer: A case-series]

Author

C, Dalmasso, É, Tournier, B, de Lafontan, A, Modesto, F, Dalenc, É, Chantalat, L, Gladieff, E, Jouve, C, Livideanu, F, Izar, and V, Sibaud

Subjects
Adult, Aged, 80 and over, Humans, Breast Neoplasms, Female, Radiation Injuries, Skin Diseases, Aged
Abstract

Radiotherapy's main skin toxicities are now well-separated, acute (acute radiation dermatitis) or chronic complications (chronic radiation dermatitis, induced cutaneous carcinoma, aesthetic sequelae). Exceptionally, radiotherapy may induce, by isomorphic reaction or Koebner's phenomenon, some specific dermatosis. In this article, we report five new observations of these unusual complications of radiation therapy, occurring in very variable time after breast irradiation and remaining strictly localized in the irradiated field (cutaneous mastocytosis, Sweet syndrome, lichen planus, vitiligo). These cases emphasize the need to realize a systematic histological exam if any atypical skin lesion appears after radiotherapy, even long after.

Published
2016

36. Helical Tomotherapy (HT) for Postmastectomy Radiation Therapy (PMRT) Treatment after Implant Breast Reconstruction

Author

B. De Lafontan, Elizabeth Cohen-Jonathan Moyal, R. Dejean, D. Gangloff, C.I. Chira, E. Jouve, G. Hangard, Léonor Chaltiel, F. Dalenc, C. Massabeau, and F. Izar

Subjects
Cancer Research, medicine.medical_specialty, Radiation, business.industry, medicine.medical_treatment, Postmastectomy radiation, Tomotherapy, Oncology, Medicine, Radiology, Nuclear Medicine and imaging, Radiology, Implant, business, Breast reconstruction
Published
2018

37. Phase I study of irinotecan and cisplatin in combination with pelvic radiotherapy in the treatment of locally advanced cervical cancer: A GINECO trial

Author

C. Kerr, Jean-Emmanuel Kurtz, F. Dalenc, M. El Demery, Martine Delannes, Michel Fabbro, D. Paraiso, Laurence Gladieff, F. Guichard, and Eric Pujade-Lauraine

Subjects
Adult, Oncology, medicine.medical_specialty, Abdominal pain, Brachytherapy, Urology, Uterine Cervical Neoplasms, Phases of clinical research, Irinotecan, Drug Administration Schedule, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Cervix, Aged, Neoplasm Staging, Cisplatin, Cervical cancer, Dose-Response Relationship, Drug, Radiotherapy, business.industry, Obstetrics and Gynecology, Cancer, Middle Aged, medicine.disease, Combined Modality Therapy, female genital diseases and pregnancy complications, medicine.anatomical_structure, Camptothecin, Female, medicine.symptom, business, Febrile neutropenia, medicine.drug
Abstract

Purpose To define the recommended dose of the association of weekly irinotecan (Iri) and cisplatin (CP) with pelvic radiotherapy in Locally Advanced Cervical Cancer. Patients and methods Stage IB2-IV cervix cancer patients were treated with escalating doses of Iri starting from 30 mg/m 2 and a fixed dose of CP at 20 mg/m 2 , both weekly concomitantly with a 45-Gy pelvic irradiation. Results Fifteen patients entered the study, 6 at level 1 (Iri 30 mg/m 2 ), 3 at level 2 (Iri 40 mg/m 2 ) and 6 at intermediate dose (Iri 35 mg/m 2 ). Median age was 47 years (34-72), FIGO stage IB ( n =1), IIB ( n =7), III ( n =6), IVA ( n =1). The recommended dose was weekly Iri 35 mg/m 2 and CP 20 mg/m 2 . Dose limiting toxicities (grades 3–4) were diarrhea, abdominal pain, febrile neutropenia and fatigue. Conclusion In cervix cancer patients, radiosensitization with weekly cisplatin and irinotecan is feasible, and the recommended doses are cisplatin 20 mg/m 2 /week and irinotecan 35 mg/m 2 /week for future phase II studies.

Published
2010

38. Efficacy of a global supportive skin care programme with hydrotherapy after non-metastatic breast cancer treatment: A randomised, controlled study

Author

A.‐L. Ranc Royo, B. De Lafontan, D. Guerrero, P. Dulguerova, V. Sibaud, N. Levasseur, C. Bernard‐Marty, J.‐M. Levecq, C. Massabeau, J. Guyonnaud, S. Salas, Virginie Ribet, C. Sarda, A.B. Rossi, and F. Dalenc

Subjects
medicine.medical_treatment, Docetaxel, Gonadotropin-Releasing Hormone, 030207 dermatology & venereal diseases, 0302 clinical medicine, Hyperpigmentation, Antineoplastic Combined Chemotherapy Protocols, Lymphedema, Mastectomy, Neoadjuvant therapy, Massage, Aromatase Inhibitors, Middle Aged, Skin Care, Neoadjuvant Therapy, humanities, Manual Lymphatic Drainage, Oncology, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Hand-Foot Syndrome, Taxoids, Fluorouracil, Radiodermatitis, Epirubicin, medicine.drug, Adult, medicine.medical_specialty, Antineoplastic Agents, Breast Neoplasms, Skin Diseases, 03 medical and health sciences, Breast cancer, Internal medicine, medicine, Adjuvant therapy, Humans, Adverse effect, Hydrotherapy, Cyclophosphamide, Emollients, business.industry, Pruritus, Carcinoma, medicine.disease, Surgery, Radiation therapy, Tamoxifen, Quality of Life, Radiotherapy, Adjuvant, business
Abstract

This study investigated the efficacy of post-treatment hydrotherapy as supportive care for management of persistent/long-lasting dermatologic adverse events (dAEs) induced in breast cancer survivors by adjuvant therapy, and its impact on quality of life (QoL). Patients in complete remission after standardised (neo)adjuvant chemotherapy, surgery and radiotherapy combination treatment for infiltrating HR+/HER2-breast carcinoma were enrolled in this randomised, multicentre controlled study 1-5 weeks after completing radiotherapy. The control group (CG, n = 33) received best supportive care and the treatment group (HG, n = 35) received 3-weeks of specific hydrotherapy. The primary criterion was change in QoL (QLQ-BR23) after hydrotherapy. Clinical grading of dAEs, cancer-related QoL (QLQ-C30), dermatologic QoL (DLQI) and general psychological well-being (PGWBI) were assessed. Significant dAEs were found at inclusion in both groups (n = 261). Most items showed significantly greater improvement in the HG versus CG group: QLQ-BR23 (breast [p = .0001] and arm symptoms [p = .0015], systemic therapy side effects [p = .0044], body image [p = .0139]), some dAE grading, DLQI (p = .0002) and PGWBI (p = .0028). Xerosis (88% of patients at inclusion) completely healed in all HG patients. Specific hydrotherapy is an effective supportive care for highly prevalent and long-lasting dAEs occurring after early breast cancer treatment, including chemotherapy, and leads to improved QoL and dermatologic toxicities.

Published
2017

39. Champ de tomothérapie : un site révélateur de la mastocytose systémique

Author

F. Izar, Eric Espinosa, Camille Laurent, Vincent Sibaud, P.A. Apoil, F. Dalenc, C. Bulai-Livideanu, Carle Paul, Emilie Tournier, and Patrice Dubreuil

Subjects
Dermatology
Abstract

Introduction L’atteinte cutanee de la mastocytose systemique (MS) est classiquement diffuse et symetrique. La tomotherapie (TT) ou « radiotherapie guidee par l’image » permet de reduire les risques pour les organes sains adjacents. Nous rapportons le premier cas de MS avec atteinte cutanee limitee de type urticaire pigmentaire (UP) localisee sur le champ de TT pour un cancer mammaire. Observations Une femme de 37 ans avait dans ses antecedents un GIST (KIT negatif) opere en 2013 et un cancer mammaire droit opere et traite par chimiotherapie jusque fin 2014. Apres pose de prothese, immediatement, soit du 2 janvier au 10 fevrier 2015, elle a recu de la TT 50 Gray. Il n’a pas eu de signe radiodermite. En juin 2015, elle remarquait l’apparition de lesions sur le champ de TT. Elle consultait fin 2015 pour ces lesions qui persistaient dans le temps. Le signe de Darier etait discretement positif, elle ne se plaignait d’aucun symptome et la tryptase serique etait normale. La biopsie cutanee confirmait l’UP. Le bilan complementaire confirmait le caractere systemique de cette mastocytose. La peau et la moelle etaient D816 V positives. Discussion Ce cas est original par le caractere localise de l’UP bien que cela survienne dans un contexte d’une MS. Dans la litterature n’ont ete rapportes que 4 cas de mastocytose cutanee localisee sur le champ de la radiotherapie classique. Il s’agit de 3 cas d’UP et un cas de telangiectasia macularis eruptiva perstans. Tous ces cas relevaient de mastocytose cutanee isolee et le statut du KIT n’etait pas precise. Les delais de survenue apres le debut de la radiotherapie varient entre 1 et 14 mois. Bien que ce type de radiotherapie soit utilise aussi pour d’autres cancers, il est interessant de souligner que tous les cas de mastocytose sur le champ de radiotherapie sont survenus apres le traitement d’un cancer mammaire. Il semble que le microenvironnement inflammatoire du cancer mammaire, la chirurgie et la radiotherapie aient favorise l’activation, le recrutement de precurseurs mastocytaires et/ou la proliferation des mastocytes dans la peau. L’apparition de lesions 5 mois apres le debut de la TT dans notre cas suggere un recrutement cutane de precurseurs mastocytaires tumoraux sanguins associes eventuellement a une proliferation de mastocytes cutanes residents possiblement tumoraux. Une autre hypothese pour cette atteinte localisee serait que les mastocytes tumoraux etaient deja localises en nombre augmente et regroupes en amas dans la peau et que les modifications entrainees par la TT ont favorise une activation de ces mastocytes avec l’apparition de la pigmentation caracteristique de l’UP. Dans ce second cas de figure, on s’attendrait cependant a ce que les lesions surviennent plus vite et pas 5 mois apres le debut de la TT. Conclusion L’UP peut etre localisee meme quand elle est associee a l’atteinte systemique.

Published
2016

40. Comment augmenter la performance des médicaments anti-HER?

Author

Yann Berge, H. Roché, and F. Dalenc

Abstract

Les cancers du sein sont ceux qui ont les premiers beneficie des traitements anti-HER, et ce des le debut des annees 2000. Les molecules developpees a ce jour n’ont certes pas permis la guerison des formes metastatiques des cancers du sein qui surexpriment HER2, mais en ont modifie l’histoire naturelle et donc le pronostic. De plus, la demonstration en 2005 de l’activite importante du trastuzumab en situation adjuvante a permis de positionner pour la premiere fois, un traitement anti-HER en situation curative potentielle. Par ailleurs, le developpement de cette therapie anti-HER2 est exemplaire car il est le resultat d’une parfaite collaboration entre le laboratoire et la clinique. On ne peut prescrire ce medicament qu’aux patientes ayant une tumeur ou la voie HER2 est la voie oncogenique dominante. La selection des patientes par un ou des biomarqueurs, suivie de la prescription d’une therapie adaptee, est ce dont on reve pour chacune des situations cliniques rencontrees. Aujourd’hui, comprenant mieux la tumorigenese, le mode d’action ainsi que les mecanismes de resistance des traitements anti-HER et possedant un large eventail de therapies ciblees, nous pouvons reflechir a la facon d’augmenter la performance des traitements anti-HER.

Published
2012

41. [Pharmacological bases of intraperitoneal chemotherapy]

Author

L, Gladieff, E, Chatelut, F, Dalenc, and G, Ferron

Subjects
Ovarian Neoplasms, Neoplasm, Residual, Paclitaxel, Antineoplastic Agents, Carboplatin, Mice, Area Under Curve, Models, Animal, Animals, Humans, Female, Infusions, Parenteral, Cisplatin, Peritoneum
Abstract

Intraperitoneal chemotherapy is a very attractive therapeutic alternative in the treatment of advanced ovarian carcinoma, due to its intraperitoneal spreading. Pharmacokinetic rational was described 30 years ago: a drug administered within the peritoneal cavity diffuse through the peritoneum towards the plasmatic compartment, depending on both its molecular weight and its lipid solubility. A slow output of the drug from the peritoneal cavity and a high plasma clearance are associated with a great pharmacokinetic advantage, illustrated by the area under the concentration time curve ratio. Then it is possible to increase the amount of drug directly delivered at the tumor site, while controlling the systemic toxicity. The agent administered in a large fluid volume come into direct contact with the tumor nodules, into which it penetrates from the free surface while it also reaches them by blood flow. The peripheral penetration being however limited to the first cellular layers, this way of delivery is interesting only for small residual disease. The most active drugs in the treatment of ovarian cancer, paclitaxel and platinum agents, are particularly convenient for this way of administration. The most optimal administration modality still remains to be defined and the development of the targeted therapies still opens new perspectives.

Published
2009

42. Altérations de l’expression, et implications pronostique et thérapeutique, des protéines régulatrices de l’épissage des ARNm dans les cancers du sein

Author

Stéphan Vagner, F. Dalenc, S. Dejean, P. Besse, Magali Lacroix-Triki, H. Roché, and J. F. Dupuy

Abstract

Les proteines SR (« arginine-Serine-Rich splicing regulator ») et hnRNP (« heterogeneous nuclear ribonucleoprotein ») sont des proteines de liaison aux ARNm qui regulent plusieurs aspects du metabolisme des ARNm associe a l’expression des genes. La plupart de ces proteines agissent a differents niveaux, allant des etapes nucleaires d’epissage des pre-ARNm jusqu’a l’etape de traduction des ARNm dans le cytoplasme (1, 5, 6). Plusieurs etudes ont notamment prouve l’existence d’un lien entre cancer et epissage alternatif d’oncogenes et/ou suppresseurs de tumeurs (2)–(4), (7)–(9). Dans ce contexte, nous avons etudie le profil d’expression de ces proteines dans les cancers du sein.

Published
2007

46. PPAC (programme personnalisé de l'après-cancer) : rationnel et mise en place.

Author

Gangler, A., Lesur, A., and Dalenc, F. Dalenc

Subjects
BREAST cancer, CANCER patients, MEDICAL care, PRIMARY care, ONCOLOGY, FOLLOW-up studies (Medicine), QUALITY of life
Abstract

Copyright of Oncologie (Tech Science Press) is the property of Tech Science Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2016
Full Text
View/download PDF

47. Association Between Tumor Egfr and Kras Mutation Status and Clinical Outcomes in Nsclc Patients Randomized to Sorafenib Plus Best Supportive Care (BSC) or Bsc Alone: Subanalysis of the Phase III Mission Trial

Author

Chris Twelves, J. Thompson, C. Fernández, H. Bonnefoi, Robert Jones, R. de Wit, Yves Humblet, C. Boni, T. Seto, P. Rougier, I.T. Rubio, S. McMahon, V. Patel, David Gentien, A. Santoro, José Baselga, M. Barrié, E. Ciruelos, R.A. Madan, U. Jungnelius, E. Esteban, H. Abbas, C. Robert, J. Martin, F. Selle, Dong Wook Kim, H. Singh-Jasuja, Arthur L. Klatsky, Harald A. Weber, A. Bonetti, Florence Lerebours, A. Hamed, Georgina V. Long, Véronique Diéras, A. Savarese, E.M. Guerra, Richard Bell, Nick Thatcher, M.S.L. Teng, Toni K. Choueiri, M. Untch, Nicole M. Kuderer, H-J. Lenz, D. Serin, A. Fandi, Frédéric Commo, Y-L. Wu, A.S. Daud, Kazuhiko Nakagawa, Debora Barton, D. Brewer, G. Folprecht, Frank Cihon, Michael Thomas, M. Fleischer, T. Nakajima, Mary Anne Armstrong, Jonathan Cebon, M. Rios, L. Gissmann, P. Preux, A. Loundou, Lluis M. Mir, F. Lordick, Lynn M. Schuchter, B. Vasseur, Ulrika Harmenberg, B. Massuti Sureda, M. Matta, X. Durando, C. Costa, J-P. Guastalla, Brigitte Sigal-Zafrani, S. Falk, Nicolas Servant, M. Campone, Richard M. Goldberg, Petronella O. Witteveen, A. Grothey, T. Olive, Andrea Wagner, L. Crinò, R. Rosell, T. De Pas, P. Attali, Mitchell Dowsett, M. Lacroix, Y. Xu, F. Hilpert, Benjamin Solomon, Enriqueta Felip, A. Pasic, D. Genet, A. Falcone, A. Niethammer, K. Tauer, D. Berton-Rigaud, L. Bedenne, Enrico Mini, J-P. Jacquin, J.-L. Van Laethem, Egbert F. Smit, R.J. Jones, David Cella, K. Pittman, W. Hwu, D. Bollag, Yan Li, Roma Parikh, P.J. Wiechno, C. Jouannaud, Masahiro Takeuchi, P. Slaouti, Eric Pujade-Lauraine, A. Sobrero, C. Campello, H. Y. Lim, Ellie Guardino, L.S. Schwartzberg, Margarita Majem, F. Dalenc, Bruno R. Bastos, P. Senico, J.S. de Bono, Olivier Rosmorduc, Bernard Asselain, J. Atkins, C. Centeno, F. Subtil, H.J.M. Groen, F. Bonnetain, Benjamin Besse, Sarah Pearson, N. Vogelzang, J.T. Hartmann, Susan J Dutton, B. Zaric, G.A. Bjarnason, S. Olsen, L. Jia, Jun Guo, L. Venat-Bouvet, R. D. Gelber, Silvia Novello, Etienne Brain, Carlo Barone, S. Lavau-Denes, S. Zhu, C.N. Sternberg, Roman Perez-Soler, V. Tassell, D. Frappaz, C. Cremolini, J. Clancy, D. Wan, G. Masi, M. Jensen, Richard F. Kefford, Michael Baum, D. Lu, A. Gonzalez Martin, Alain Algazi, C. Valsuani, A. Maubon, C. Heery, L. Cupit, R.J. Motzer, P. Kerbrat, N. Gadea, A. P. Dei Tos, C.S. Cooper, Ricardo J. Gonzalez, A. Vuorela, A. Gonçalves, H. Tan, Thomas E. Hutson, G. Goss, M. Frenay, M. Munill, R. Kudchakar, J. Schlom, L. Mineur, Max Bulsara, J. Wei, Y. Wang, T.J. Ong, Wasaburou Koizumi, Michael Staehler, F. Ghiringhelli, F. Barlesi, C. Mermel, M. Provansal, David R. Spigel, Bernard Escudier, C. Granetto, Trever G. Bivona, Gerold Meinhardt, Jaime R. Merchan, A. Chatterjee, L. Salvatore, Suzette Delaloge, D. Laurent, J. Clark, Fabrice Andre, I. Ray-Coquard, P. Salman, Peng Sun, S. Hodge, M. Schneider, Petr Kavan, B. Biesma, Paul Ross, A. Gimenez-Capitan, T. Schmelter, J. Ritchie, Jean-Yves Pierga, W. Mansoor, R. Hubner, C. Girault, S. Di Cosimo, D.W. Fyfe, G. Allegrini, Yang Sun, S. Burgers, J. Reeves, P. Mulholland, B. Chauffert, S.M. Steinberg, David R. Ferry, H.C. Chung, N. Budnik, Sang Cheul Oh, R. Gervais, M.A. Molina, Iben Spanggaard, X. Pivot, Anna C. Pavlick, Jeffrey Crawford, M. Schirripa, K. Fife, M. Davoudianfar, Alexander Reuss, C. Sonaglio, Elena Castro, Nicholas Choong, A. Kramar, I. Chan, J. Ferrero, M. Snoj, L. Peachey, Jaap Verweij, I. El-Hariry, H.A. Azim, E. Tabouret, P. Arlen, Ian Judson, M. Praet, J.C-H. Yang, D.G. Power, R. Schott, N. Karachaliou, R. Midgely, Lei Zhang, L. Paz-Ares, W.T.A. van der Graaf, J. Labourey, Andrew X. Zhu, H. Wang, A.D. Vincent, Chris Parker, Masashi Fujii, Hirotsugu Uemura, M-J. Ahn, J. Mehta, Lauren McCann, Samar Alsafadi, A.M. Poveda, Y. Lou, S. Peoples, K. Sivarajan, S. Chiara, P. Fumoleau, O. Aren, G. McArthur, J. Zhu, Julie Gehl, P. Laurent-Puig, Martine Piccart, J. Evans, Laurence Collette, K. B. Kim, Jeffrey S Tobias, J. A. Sosman, Carol Peña, Frederik Wenz, A. Goldhirsch, F. Teofilovici, J. Thaler, Jose Leal, P. Giannikopoulos, Mark A. Socinski, Patrick Julier, L. Boni, L. Cany, C. Boucard, Ludovic Lacroix, A. Dahle-Smith, Y-K. Kang, Yi-Long Wu, Ian E. Krop, C. Heredia, O. Ishibashi, M. Santarpia, Aoife M. Ryan, B. Leyland-Jones, Paul Nathan, A-M.C. Dingemans, F.H. Blackhall, Anna Polli, C. Lepage, L. Antonuzzo, S. Cushen, D-Y. Oh, C. Dalban, A. Mori, M. Espié, V. Semiglazov, MA LeBerre, J. Adelaide, Natalia Udaltsova, Nuhad K. Ibrahim, Richard Sullivan, D.A. Fennell, J. Skrzypski, G. Romieu, H. Eidtmann, J. Bosch-Barrera, Taofeek K. Owonikoko, M. DeSilvio, C. Jackisch, Robert J. Motzer, G. Sersa, F. Boudouresque, Russell D. Petty, S. Jefferies, T. Moran Bueno, M.O. Palumbo, M. Ouafik, J. Balmana, D. Valcárcel, S. Cupini, G. Bodoky, S. Szyldergemajn, A. Fabi, M. Cardoso, R. Allerton, U. Kenny, O. Chinot, Daniel J. Sargent, U. De Giorgi, Mark D. Pegram, J. M. Del Campo, J. Surralles, H. Oltean, A. Garcia-Alonso, Kensaku Yoshida, E. Juhasz, Howard I. Scher, H. Goette, David Baer, L. Fornaro, D. Cameron, Nicholas D. James, Thomas F. Gajewski, P. Lacroix, M. Harrison, G.D. Friedman, A. Enke, C. Bouquet, I. Bradbury, S. Halford, M. Jimenez, A. Chang, J-Y Pierga, P. Pultar, T. Bachelot, Daniel C. Danila, L. Eckert, J. Douillard, L. Burns, F. De Marinis, David Miles, Q. Wang, A. Vergnenegre, D. Khayat, F.J. Carrilho, H. Codrington, K. Wang, D. Moro-Sibilot, N. Bosch, J.L. Quesada, M.D. Dibonaventura, E. de Azambuja, S. Abadie-Lacourtoisie, Christophe Massard, L. Fang, I. Pauporte, L. Feuvret, C. Manegold, Ramon Luengo-Fernandez, M. Banzi, J.S. Guillamo, B. Żurawski, Suresh S. Ramalingam, J.L. Gulley, M. Liu, M. Ychou, O. Al-Salihi, T. Hutson, S. Santillana, Alice T. Shaw, I.E. Smith, S. Culine, H. Tailla, Kiran Patel, Patrick Schöffski, Adil Daud, Luca Gianni, R. Camidge, A. Lortholary, M. Lu, L. Taillandier, A. James, M. Procter, Carmen Criscitiello, Mika Mustonen, R. Rampling, Jayant S. Vaidya, D. Agbor-Tarh, T. Gamble, Subramanian Hariharan, Andrea Cavalcanti, R. Malik, Ignace Vergote, Sandrine Marreaud, Heather A. Wakelee, Shonda M Little, Hans Gelderblom, M. Arnedos Ballester, J. Tabernero, J. Honnorat, S. Li, O. Bouché, Isabelle Gilloteau, A. Goren, J.G. Aerts, J. Blay, W. Eiermann, D. Joseph, Jie Jin, J.F. Emile, Gerhardt Attard, Markus Moehler, Yang Hyun Kim, S. Verma, Nicole Tubiana-Mathieu, J. Taieb, G. Giaccone, Shahneen Sandhu, Kenneth J. O'Byrne, E. Van Cutsem, T. Yoshino, Saskia Litière, Keith T. Flaherty, J. R. Infante, Chetan Lathia, V. Vukovic, E. Giommoni, Alison Reid, S. Siena, Keith C. Deen, Tony Mok, J. Wang, J.S. Weber, Corey J. Langer, E. Fea, P. de Souza, C. Levy, K. Kumari, A. Casado, M. Welslau, Karl D. Lewis, O. Dalesio, R. Swaby, M. Fabbro, Brian I. Rini, Janusz Jankowski, Daniel P. Petrylak, Robert E. Hawkins, M. Mohebtash, A. Adenis, A. Ribas, Igor Puzanov, I. Tennevet, H. Kim, Karim Fizazi, O. Hamid, D. Olmos Hidalgo, J.A. Bridgewater, S. Catala, H. Melezinkova, G. Kurteva, Aristotle Bamias, F. Loupakis, Vera Hirsh, Pasi A. Jänne, Kimberly L. Blackwell, M.R. Garcia-Campelo, C. Kahatt, J. Bellmunt, and J. Alexandre

Subjects
Oncology, Sorafenib, medicine.medical_specialty, Proportional hazards model, business.industry, Hematology, medicine.disease_cause, Placebo, medicine.disease, Breast cancer, Egfr mutation, Internal medicine, Medicine, Biomarker (medicine), KRAS, Stage (cooking), business, medicine.drug
Abstract

Background Tumor EGFR and KRas mutations are both predictive and prognostic biomarkers in patients with advanced NSCLC. We analyzed the correlation between these biomarkers and treatment outcomes in a phase III trial of 3rd/4th line sorafenib in patients with NSCLC. Methods The global, randomized, placebo-controlled MISSION trial enrolled 703 patients with advanced relapsed/refractory NSCLC of predominantly non-squamous histology. The primary study endpoint was overall survival (OS). EGFR and KRas mutations were analyzed in archival tumor samples and in circulating tumor DNA isolated from plasma. Results Tumor and/or plasma mutation data were available from 347 patients (49%). EGFR and KRas mutations were detected in 89 (26%) and 68 (20%) patients, respectively, and were well balanced between treatment arms. Analysis of the interaction between EGFR mutation status and treatment effect on survival suggested that patients with EGFR mutations (mEGFR) benefitted from sorafenib, while those with wild-type EGFR (wtEGFR) did not (p = 0.023). Median OS was two-fold longer in mEGFR patients receiving sorafenib versus placebo (423 vs 197 days, HR 0.48, p = 0.002). There was no significant difference in OS between patients with wtEGFR receiving sorafenib or placebo (253 vs 256 days, HR 0.92, p = 0.559). An interaction was also seen between EGFR mutation status and the sorafenib effect on PFS (p = 0.015). Patients with mEGFR treated with sorafenib had better outcomes compared to placebo based on Cox regression analysis (HR 0.27, p Conclusion Post-hoc analyses of efficacy outcomes in MISSION suggest that advanced NSCLC patients with EGFR mutations may derive a survival benefit from receiving 3rd/4th line sorafenib. These results must be interpreted with caution due to the small, non-representative nature of the genetic biomarker subpopulation analyzed in this trial. Further prospective investigation may be warranted. Disclosure T.S.K. Mok: Honoraria: AstraZeneca, Roche, Eli Lilly, Merck Serono, Eisai, BMS, BeiGene, AVEO, Pfizer, Taiho, Boehringer Ingelheim, and GSK Biologicals Speaker: Astrazeneca, Roche, Eli Lilly, Boehringer Ingelheim, and Merck Serono Research funding: Astrazeneca. L. Paz-Ares: Dr. Paz-Ares has received honoraria from Bayer HealthCare Pharmaceuticals, Lilly, Roche and Pfizer. Y. Wu: Dr. Wu has received lecture fees from Roche, AstraZeneca, Eli Lilly, and Pfizer. V. Hirsh: Member of the steering committee for the MISSION trial. C. Lathia: Dr. Lathia is an employee of Bayer HealthCare. T.J. Ong: Dr. Ong is an employee of, and owns shares in, Bayer HealthCare. C. Pena: Dr. Pena is an employee of Bayer HealthCare. All other authors have declared no conflicts of interest.

Published
2012

48. Multivariate analysis (MVA) of progression-free survival (PFS) in two phase IIb, multinational, double-blind, randomized, placebo (PL)-controlled trials evaluating sorafenib (SOR) plus standard chemotherapy in patients (pts) with HER2-negative locally advanced or metastatic breast cancer (BC)

Author

T. P. Sahoo, William J. Gradishar, Virginia G. Kaklamani, D. Lokanatha, Fernando Ferreira Costa, J. Baselga, J.G.M. Segalla, F. Dalenc, Vinod Raina, and Hélio Pinczowski

Subjects
Sorafenib, Cancer Research, medicine.medical_specialty, Randomization, business.industry, Proportional hazards model, Hazard ratio, medicine.disease, Gastroenterology, Metastatic breast cancer, Surgery, Capecitabine, Regimen, Oncology, Internal medicine, medicine, Progression-free survival, business, medicine.drug
Abstract

1073 Background: Two phase IIb trials in pts with advanced BC demonstrated activity for SOR plus standard chemotherapy for the primary endpoint of PFS. In Study A, median PFS for SOR + capecitabine (CAP) versus PL+CAP was 6.4 versus 4.1 mo (hazard ratio [HR] 0.58; 1-sided p=0.0006). In Study B, median PFS for SOR + paclitaxel (PAC) versus PL+PAC was 6.9 versus 5.6 mo (HR 0.79; 1-sided p=0.09). In both studies, randomization was stratified by visceral status with slight imbalances in some covariates. We performed MVA to assess the impact of imbalances and prognostic factors on PFS. Methods: Study A: Pts (N=229) with ≤1 prior chemo regimen for advanced BC were randomized to CAP (1,000 mg/m2 po, twice daily [BID], 14 of 21 days) + SOR (400 mg po, BID) or PL. Study B: Pts (N=237) with no prior chemo for advanced BC were randomized to PAC (90 mg/m2/wk IV, 3 wk on/1 wk off) + SOR (400 mg po, BID) or PL. MVA: Cox proportional hazards models of PFS stratified by visceral status were used for each study. Additiona...

Published
2010

50. 580 POSTER RhoA and RhoB inversly modulate estrogen receptor alpha expression and transcriptional activities in breast cancer cell lines

Author

George C. Prendergast, Y. Bergé, P. Balaguer, Gilles Favre, F. Dalenc, E. Meunier, S. Doisneau-Sixou, E. Malissein, and E. Bouliong-Pillai

Subjects
Cancer Research, Estrogen-related receptor alpha, RHOA, Oncology, Breast cancer cell line, biology, RHOB, Cancer research, biology.protein, Estrogen receptor, Estrogen receptor alpha, Estrogen receptor beta
Published
2008

Catalog

Books, media, physical & digital resources
See catalog results