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2. 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
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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
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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.
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- 2021
3. Long-term fatigue and quality of life among epithelial ovarian cancer survivors: a GINECO case/control VIVROVAIRE I study
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A. Lesoin, Alain Zannetti, A.M. Savoye, G. De Rauglaudre, Jean-Michel Grellard, Michel Fabbro, S N’guyen, Jérôme Alexandre, Patricia Pautier, Anne Floquet, N. Dohollou, Alain Lortholary, Anne Gompel, Dominique Berton-Rigaud, Bénédicte Clarisse, Catherine Lhommé, S Abadie Lacourtoisie, L. Chauvenet, Florence Joly, Olivier Tredan, K Prulhiere, François Gernier, Djihane Ahmed-Lecheheb, C. Roemer-Becuwe, Philippe Follana, Valérie Delecroix, S Trager-Maury, Natacha Heutte, Elsa Kalbacher, Jean-Emmanuel Kurtz, Centre Régional de Lutte contre le Cancer François Baclesse (CRLC François Baclesse ), Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Centre d’études des transformations des activités physiques et sportives (CETAPS), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut de Recherche Interdisciplinaire Homme et Société (IRIHS), Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Centre de Recherche en Cancérologie de Lyon (CRCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département de Radio-Oncologie [Nantes] (Centre Catherine de Sienne), Centre Catherine-de-Sienne [Nantes] (CCS), Service de Gynécologie et Obstétrique [Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Laboratoire de Psychologie Cognitive (LABACOLIL), Université de Lille, Sciences Humaines et Sociales, Université de Lyon, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
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Adult ,0301 basic medicine ,medicine.medical_specialty ,endocrine system diseases ,medicine.medical_treatment ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Anxiety ,Carcinoma, Ovarian Epithelial ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Cancer Survivors ,Quality of life ,Surveys and Questionnaires ,Internal medicine ,Humans ,Medicine ,Fatigue ,Depression (differential diagnoses) ,ComputingMilieux_MISCELLANEOUS ,Aged ,Aged, 80 and over ,Ovarian Neoplasms ,Chemotherapy ,Sleep disorder ,Taxane ,Depression ,business.industry ,Chronic fatigue ,Hematology ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Chemotherapy regimen ,humanities ,female genital diseases and pregnancy complications ,3. Good health ,Cross-Sectional Studies ,030104 developmental biology ,Oncology ,Case-Control Studies ,030220 oncology & carcinogenesis ,Quality of Life ,Female ,France ,medicine.symptom ,business - Abstract
Few data are available on long-term fatigue (LTF) and quality of life (QoL) among epithelial ovarian cancer survivors (EOCS). In this case-control study, we compared LTF, symptoms and several QoL domains in EOCS relapse-free ≥3 years after first-line treatment and age-matched healthy women.EOCS were recruited from 25 cooperative GINECO centers in France. Controls were randomly selected from the electoral rolls. All participants completed validated self-reported questionnaires: fatigue (FACIT-F), QoL (FACT-G/O), neurotoxicity (FACT-Ntx), anxiety/depression (HADS), sleep disturbance (ISI), and physical activity (IPAQ). Severe LTF (SLTF) was defined as a FACIT-F score37/52. Univariate and multivariate logistic regressions were conducted to analyze SLTF and its influencing factors in EOCS.A total of 318 EOCS and 318 controls were included. EOCS were 63-year-old on average, with FIGO stage I/II (50%), III/IV (48%); 99% had received platinum and taxane chemotherapy, with an average 6-year follow-up. There were no differences between the two groups in socio-demographic characteristics and global QoL. EOCS had poorer FACIT-F scores (40 versus 45, P 0.0001), lower functional well-being scores (18 versus 20, P = 0.0002), poorer FACT-O scores (31 versus 34 P 0.0001), and poorer FACT-Ntx scores (35 versus 39, P 0.0001). They also reported more SLTF (26% versus 13%, P = 0.0004), poorer sleep quality (63% versus 47%, P = 0.0003), and more depression (22% versus 13%, P = 0.01). Fewer than 20% of EOCS and controls exercised regularly. In multivariate analyses, EOCS with high levels of depression, neurotoxicity, and sleep disturbance had an increased risk of developing SLTF (P 0.01).Compared with controls, EOCS presented similar QoL but persistent LTF, EOC-related symptoms, neurotoxicity, depression, and sleep disturbance. Depression, neuropathy, and sleep disturbance are the main conditions associated with severe LTF.
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- 2019
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4. Abstract P3-09-07: Construction of two quality of life questionnaires from young breast cancer patients and their partner
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L Chossiere, Anne Congard, J-M Ferrero, Christine Levy, C Giraud, H. Simon, S Tiberghien, J Grosjean, K Prulhiere, Christelle Duprez, D. Nierges, V Christophe, Emmanuelle Fournier, S De Cordoue, A. Lesur, C Loustalot, M. Leclercq, Laurence Vanlemmens, Pascal Antoine, C. Lefeuvre-Plesse, C. Guillemet, J-S. Frenel, Tanguy Leroy, and C Becuwe
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Cancer Research ,Construct validity ,Context (language use) ,medicine.disease ,Negative affectivity ,Breast cancer ,Oncology ,Convergent validity ,Quality of life ,Scale (social sciences) ,medicine ,Everyday life ,Psychology ,Clinical psychology - Abstract
Background : The quality of life of couples which one of the members is affected by a cancerous pathology at a relatively young age is important to evaluate in global care. No questionnaire specifically addresses some thematic proper to young women (ex education, desire for a child(s), couple relationship), problems which are yet important for young women suffering from breast cancer. Besides, no questionnaire evaluates the partner's quality of life in this particular context, even if he is frequently the first source of support for the woman (Vanlemmens et al., 2012). Objectives : The main objective was to create a particular and specific tool for measuring the impact of breast cancer on the quality of life of young women (< 45 years of age) with non-metastatic disease and the quality of life of their partners. This work presents the psychometric validation of two questionnaires for patient and partner consisted of items comparable to the semantic level. Methods: We followed the different steps to construct a quality of life tool. After preliminary non-directive interviews and identification of relevant items, we administered the questionnaires on a wide sample of 546 young breast cancer patients and 497 partners. Psychometric testing assessed the hypothesized scale structure based on an examination of item-scale correlation, scale reliability by testing for internal consistency using Cronbach's alpha coefficient, construct validity with inter-scale correlations. Results : Items analyses indicate a good internal consistency of both questionnaires (superior to .75). This questionnaire includes 37 items. The factorial structure highlights 8 factors : 1) management of children and of everyday life, 2) negative affectivity and apprehension about future, 3) feeling of couple cohesion, 4) financial difficulties, 5) body image and sexual life, 6) deterioration with close relations, 7) sharing and support of close relations, and 8) management of the professional life..This structure explains respectively 56% for the patients and 58% for the partners of the total variance. As expected, convergent validity showed strong correlations with Kalicou scales and quality of life measures (QLQC-30 and QLQBR-23). Conclusions: Overall psychometric results for the 2 Kalicou questionnaires confirmed them as valid questionnaires for breast cancer patients and partners. This study will allow the clinicians to have a measurement tool for subjective real-life experience of young breast cancer women and their partner. These questionnaires will also allow comparisons according to the stage and study the interactions of couple. This tool should help to identify modifications of the subjective quality of life. The objective is to improve the medical, psychological and social care for patients and their partner, with a systemic, dynamic approach. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-09-07.
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- 2013
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5. PARP inhibitors (PARPi) prolongation after local therapy for oligo-metastatic progression in relapsed ovarian cancer patients.
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Gauduchon T, Kfoury M, Lorusso D, Floquet A, Ventriglia J, Salaun H, Moubarak M, Rivoirard R, Polastro L, Favier L, You B, Berton D, de la Motte Rouge T, Mansi L, Abdeddaim C, Prulhiere K, Lancry Lecomte L, Provansal M, Dalban C, and Ray-Coquard I
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- Humans, Female, Carcinoma, Ovarian Epithelial drug therapy, Retrospective Studies, Neoplasm Recurrence, Local drug therapy, Poly(ADP-ribose) Polymerase Inhibitors, Ovarian Neoplasms drug therapy
- Abstract
Background: PARP inhibitors (PARPi) have revolutionized the management of high-grade epithelial ovarian cancer (HGOC) treatment. However, a significant number of patients relapse or progress under PARPi, leading to the introduction of a new line of systemic therapy such as chemotherapy. In patients with a limited number of metastatic sites at progression, -referred to as an oligometastatic progression- a potential indication for local therapy followed by re-introduction or continuation of PARPi treatment rather than initiating a new line of chemotherapy could be proposed. However, the impact of such strategies on progression free survival (PFS) in these patients remains unknown., Methods: This international multicenter retrospective study evaluated the efficacy of PARPi continuation or re-introduction in patients with HGOC after local treatment for oligometastatic progression. The main objective was to assess PFS under PARPi after local therapy (PFS post-LT). Secondary objectives included safety and overall survival (OS)., Results: 74 patients were identified in 20 centers between April 2020 and November 2021. 65% of patients were BRCA mutated and 92% had received ≥2 lines of prior systemic chemotherapy before the initial introduction of PARPi. Main progression sites were lymph nodes (42%), peritoneum (27%), liver (16%), other visceral (16%) and abdominal wall (4%). Local therapies included radiotherapy (45%), surgery (43%), both (7%), percutaneous thermal ablation (4%) or chemoembolization (1%). Median PFS post-LT was 11.5 months [95% CI 7.4; 17.2]. After a median follow up of 14.8 months, 6 patients (8.1%) discontinued PARPi due to toxicity. The 1-year overall survival rate was 90.7% [95% CI 79.1; 96.0]., Conclusions: With close to one year without progression or introduction of a new line of systemic therapy, this study reports the feasibility and potential benefit of this original strategy in patients with oligometastatic progression under PARPi., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2023
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6. [Nice-Saint-Paul de Vence 2020 recommendations for clinical practice: Management of metastatic and/or relapsing endometrial cancer].
- Author
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Alexandre J, Le Frere-Belda MA, Prulhiere K, Treilleux I, Leary A, Pomel C, Chargari C, Ducassou A, and Joly F
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- Decision Trees, Endometrial Neoplasms secondary, Female, Humans, Endometrial Neoplasms diagnosis, Endometrial Neoplasms therapy, Neoplasm Recurrence, Local diagnosis, Neoplasm Recurrence, Local therapy
- Abstract
Endometrial cancer is a common cancer in older women and is often associated with comorbidities. Management of metastatic disease and/or relapse requires a multidisciplinary approach. Recent advances in the understanding of oncogenesis and molecular classification of endometrial cancers offer new therapeutic perspectives. These first recommendations, established following the methodology of Nice-Saint-Paul recommendations for clinical practice (RPC), aims to integrate molecular advances in diagnostic and therapeutic management. In 2020, the histological diagnosis of endometrial cancer is based on morphology and immunohistochemistry, including at least p53, oestrogen and progesterone receptors. Deficiency in the DNA mismatch repair system (MMR) must be assessed in all advanced endometrial tumors for oncogenetic and theranostic purposes. It can be sought initially by an analysis in immunohistochemistry with the 4 markers (MLH1, MSH2, MSH6, PMS2). Medical treatment depends on histological type, presence of hormone receptors and patient's profile to refer to chemotherapy (carboplatin-paclitaxel) or hormone therapy (for example of the progestogen type); in the event of MMR-deficiency, immunotherapy trial is the best option. As part of overall management of advanced endometrial cancer, radiotherapy (and surgery in rare cases) must be discussed, in particular in the event of loco-regional only relapse or oligometastatic disease., (Copyright © 2020 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)
- Published
- 2020
- Full Text
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7. Long-term fatigue and quality of life among epithelial ovarian cancer survivors: a GINECO case/control VIVROVAIRE I study.
- Author
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Joly F, Ahmed-Lecheheb D, Kalbacher E, Heutte N, Clarisse B, Grellard JM, Gernier F, Berton-Rigaud D, Tredan O, Fabbro M, Savoye AM, Kurtz JE, Alexandre J, Follana P, Delecroix V, Dohollou N, Roemer-Becuwe C, De Rauglaudre G, Lortholary A, Prulhiere K, Lesoin A, Zannetti A, N'Guyen S, Trager-Maury S, Chauvenet L, Abadie Lacourtoisie S, Gompel A, Lhommé C, Floquet A, and Pautier P
- Subjects
- Adult, Aged, Aged, 80 and over, Anxiety epidemiology, Anxiety etiology, Carcinoma, Ovarian Epithelial physiopathology, Carcinoma, Ovarian Epithelial psychology, Carcinoma, Ovarian Epithelial therapy, Case-Control Studies, Combined Modality Therapy, Cross-Sectional Studies, Depression epidemiology, Depression etiology, Fatigue etiology, Female, France epidemiology, Humans, Middle Aged, Ovarian Neoplasms physiopathology, Ovarian Neoplasms psychology, Ovarian Neoplasms therapy, Surveys and Questionnaires, Young Adult, Cancer Survivors statistics & numerical data, Carcinoma, Ovarian Epithelial epidemiology, Fatigue epidemiology, Ovarian Neoplasms epidemiology, Quality of Life psychology
- Abstract
Background: Few data are available on long-term fatigue (LTF) and quality of life (QoL) among epithelial ovarian cancer survivors (EOCS). In this case-control study, we compared LTF, symptoms and several QoL domains in EOCS relapse-free ≥3 years after first-line treatment and age-matched healthy women., Patients and Methods: EOCS were recruited from 25 cooperative GINECO centers in France. Controls were randomly selected from the electoral rolls. All participants completed validated self-reported questionnaires: fatigue (FACIT-F), QoL (FACT-G/O), neurotoxicity (FACT-Ntx), anxiety/depression (HADS), sleep disturbance (ISI), and physical activity (IPAQ). Severe LTF (SLTF) was defined as a FACIT-F score <37/52. Univariate and multivariate logistic regressions were conducted to analyze SLTF and its influencing factors in EOCS., Results: A total of 318 EOCS and 318 controls were included. EOCS were 63-year-old on average, with FIGO stage I/II (50%), III/IV (48%); 99% had received platinum and taxane chemotherapy, with an average 6-year follow-up. There were no differences between the two groups in socio-demographic characteristics and global QoL. EOCS had poorer FACIT-F scores (40 versus 45, P < 0.0001), lower functional well-being scores (18 versus 20, P = 0.0002), poorer FACT-O scores (31 versus 34 P < 0.0001), and poorer FACT-Ntx scores (35 versus 39, P < 0.0001). They also reported more SLTF (26% versus 13%, P = 0.0004), poorer sleep quality (63% versus 47%, P = 0.0003), and more depression (22% versus 13%, P = 0.01). Fewer than 20% of EOCS and controls exercised regularly. In multivariate analyses, EOCS with high levels of depression, neurotoxicity, and sleep disturbance had an increased risk of developing SLTF (P < 0.01)., Conclusion: Compared with controls, EOCS presented similar QoL but persistent LTF, EOC-related symptoms, neurotoxicity, depression, and sleep disturbance. Depression, neuropathy, and sleep disturbance are the main conditions associated with severe LTF., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2019
- Full Text
- View/download PDF
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