Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study
BackgroundIn triple negative breast cancer patients treated with neoadjuvant chemotherapy, residual disease at surgery is the most relevant unfavorable prognostic factor. Current guidelines consider the use of adjuvant capecitabine, based on the results of the randomized CREATE-X study, carried out...
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Frontiers Media S.A.
2023-05-01
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Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2023.1152123/full |
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author | Francesca Sofia Di Lisa Eriseld Krasniqi Laura Pizzuti Maddalena Barba Katia Cannita Ugo De Giorgi Fulvio Borella Jennifer Foglietta Anna Cariello Antonella Ferro Elisa Picardo Marco Mitidieri Valentina Sini Simonetta Stani Giuseppe Tonini Daniele Santini Nicla La Verde Anna Rita Gambaro Antonino Grassadonia Nicola Tinari Ornella Garrone Giuseppina Sarobba Lorenzo Livi Lorenzo Livi Icro Meattini Icro Meattini Giuliana D’Auria Matteo Vergati Teresa Gamucci Mirco Pistelli Rossana Berardi Emanuela Risi Francesco Giotta Vito Lorusso Lucia Rinaldi Salvatore Artale Marina Elena Cazzaniga Marina Elena Cazzaniga Fable Zustovich Federico Cappuzzo Lorenza Landi Rosalba Torrisi Simone Scagnoli Andrea Botticelli Andrea Michelotti Beatrice Fratini Rosa Saltarelli Ida Paris Margherita Muratore Alessandra Cassano Lorenzo Gianni Valeria Gaspari Enzo Maria Veltri Federica Zoratto Elena Fiorio Maria Agnese Fabbri Marco Mazzotta Enzo Maria Ruggeri Rebecca Pedersini Maria Rosaria Valerio Lorena Filomeno Mauro Minelli Paola Scavina Mimma Raffaele Antonio Astone Roy De Vita Marcello Pozzi Ferdinando Riccardi Filippo Greco Luca Moscetti Monica Giordano Marcello Maugeri-Saccà Marcello Maugeri-Saccà Alessandro Zennaro Claudio Botti Fabio Pelle Sonia Cappelli Flavia Cavicchi Enrico Vizza Giuseppe Sanguineti Federica Tomao Enrico Cortesi Paolo Marchetti Silverio Tomao Iolanda Speranza Isabella Sperduti Gennaro Ciliberto Patrizia Vici |
author_facet | Francesca Sofia Di Lisa Eriseld Krasniqi Laura Pizzuti Maddalena Barba Katia Cannita Ugo De Giorgi Fulvio Borella Jennifer Foglietta Anna Cariello Antonella Ferro Elisa Picardo Marco Mitidieri Valentina Sini Simonetta Stani Giuseppe Tonini Daniele Santini Nicla La Verde Anna Rita Gambaro Antonino Grassadonia Nicola Tinari Ornella Garrone Giuseppina Sarobba Lorenzo Livi Lorenzo Livi Icro Meattini Icro Meattini Giuliana D’Auria Matteo Vergati Teresa Gamucci Mirco Pistelli Rossana Berardi Emanuela Risi Francesco Giotta Vito Lorusso Lucia Rinaldi Salvatore Artale Marina Elena Cazzaniga Marina Elena Cazzaniga Fable Zustovich Federico Cappuzzo Lorenza Landi Rosalba Torrisi Simone Scagnoli Andrea Botticelli Andrea Michelotti Beatrice Fratini Rosa Saltarelli Ida Paris Margherita Muratore Alessandra Cassano Lorenzo Gianni Valeria Gaspari Enzo Maria Veltri Federica Zoratto Elena Fiorio Maria Agnese Fabbri Marco Mazzotta Enzo Maria Ruggeri Rebecca Pedersini Maria Rosaria Valerio Lorena Filomeno Mauro Minelli Paola Scavina Mimma Raffaele Antonio Astone Roy De Vita Marcello Pozzi Ferdinando Riccardi Filippo Greco Luca Moscetti Monica Giordano Marcello Maugeri-Saccà Marcello Maugeri-Saccà Alessandro Zennaro Claudio Botti Fabio Pelle Sonia Cappelli Flavia Cavicchi Enrico Vizza Giuseppe Sanguineti Federica Tomao Enrico Cortesi Paolo Marchetti Silverio Tomao Iolanda Speranza Isabella Sperduti Gennaro Ciliberto Patrizia Vici |
author_sort | Francesca Sofia Di Lisa |
collection | DOAJ |
description | BackgroundIn triple negative breast cancer patients treated with neoadjuvant chemotherapy, residual disease at surgery is the most relevant unfavorable prognostic factor. Current guidelines consider the use of adjuvant capecitabine, based on the results of the randomized CREATE-X study, carried out in Asian patients and including a small subset of triple negative tumors. Thus far, evidence on Caucasian patients is limited, and no real-world data are available.MethodsWe carried out a multicenter, observational study, involving 44 oncologic centres. Triple negative breast cancer patients with residual disease, treated with adjuvant capecitabine from January 2017 through June 2021, were recruited. We primarily focused on treatment tolerability, with toxicity being reported as potential cause of treatment discontinuation. Secondarily, we assessed effectiveness in the overall study population and in a subset having a minimum follow-up of 2 years.ResultsOverall, 270 patients were retrospectively identified. The 50.4% of the patients had residual node positive disease, 7.8% and 81.9% had large or G3 residual tumor, respectively, and 80.4% a Ki-67 >20%. Toxicity-related treatment discontinuation was observed only in 10.4% of the patients. In the whole population, at a median follow-up of 15 months, 2-year disease-free survival was 62%, 2 and 3-year overall survival 84.0% and 76.2%, respectively. In 129 patients with a median follow-up of 25 months, 2-year disease-free survival was 43.4%, 2 and 3-year overall survival 78.0% and 70.8%, respectively. Six or more cycles of capecitabine were associated with more favourable outcomes compared with less than six cycles.ConclusionThe CaRe study shows an unexpectedly good tolerance of adjuvant capecitabine in a real-world setting, although effectiveness appears to be lower than that observed in the CREATE-X study. Methodological differences between the two studies impose significant limits to comparability concerning effectiveness, and strongly invite further research. |
first_indexed | 2024-03-13T11:06:39Z |
format | Article |
id | doaj.art-9054ef5212d94639a5488c4656e59bc0 |
institution | Directory Open Access Journal |
issn | 2234-943X |
language | English |
last_indexed | 2024-03-13T11:06:39Z |
publishDate | 2023-05-01 |
publisher | Frontiers Media S.A. |
record_format | Article |
series | Frontiers in Oncology |
spelling | doaj.art-9054ef5212d94639a5488c4656e59bc02023-05-16T05:45:21ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2023-05-011310.3389/fonc.2023.11521231152123Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational studyFrancesca Sofia Di Lisa0Eriseld Krasniqi1Laura Pizzuti2Maddalena Barba3Katia Cannita4Ugo De Giorgi5Fulvio Borella6Jennifer Foglietta7Anna Cariello8Antonella Ferro9Elisa Picardo10Marco Mitidieri11Valentina Sini12Simonetta Stani13Giuseppe Tonini14Daniele Santini15Nicla La Verde16Anna Rita Gambaro17Antonino Grassadonia18Nicola Tinari19Ornella Garrone20Giuseppina Sarobba21Lorenzo Livi22Lorenzo Livi23Icro Meattini24Icro Meattini25Giuliana D’Auria26Matteo Vergati27Teresa Gamucci28Mirco Pistelli29Rossana Berardi30Emanuela Risi31Francesco Giotta32Vito Lorusso33Lucia Rinaldi34Salvatore Artale35Marina Elena Cazzaniga36Marina Elena Cazzaniga37Fable Zustovich38Federico Cappuzzo39Lorenza Landi40Rosalba Torrisi41Simone Scagnoli42Andrea Botticelli43Andrea Michelotti44Beatrice Fratini45Rosa Saltarelli46Ida Paris47Margherita Muratore48Alessandra Cassano49Lorenzo Gianni50Valeria Gaspari51Enzo Maria Veltri52Federica Zoratto53Elena Fiorio54Maria Agnese Fabbri55Marco Mazzotta56Enzo Maria Ruggeri57Rebecca Pedersini58Maria Rosaria Valerio59Lorena Filomeno60Mauro Minelli61Paola Scavina62Mimma Raffaele63Antonio Astone64Roy De Vita65Marcello Pozzi66Ferdinando Riccardi67Filippo Greco68Luca Moscetti69Monica Giordano70Marcello Maugeri-Saccà71Marcello Maugeri-Saccà72Alessandro Zennaro73Claudio Botti74Fabio Pelle75Sonia Cappelli76Flavia Cavicchi77Enrico Vizza78Giuseppe Sanguineti79Federica Tomao80Enrico Cortesi81Paolo Marchetti82Silverio Tomao83Iolanda Speranza84Isabella Sperduti85Gennaro Ciliberto86Patrizia Vici87Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, ItalyDivision of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, ItalyDivision of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, ItalyDivision of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, ItalyOncology Division, Mazzini Hospital, ASL Teramo, Teramo, ItalyDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, ItalyGynecology and Obstetrics 1, Department of Surgical Sciences, City of Health and Science, Sant' Anna Hospital, University of Turin, Turin, ItalyMedical Oncology, P.O. Narni-Amelia, Terni, ItalyOncology Department, AUSL Romagna, Ravenna, ItalyBreast Center, Santa Chiara Hospital, Trento, ItalyGynecology and Obstetrics 4, Department of Surgical Sciences, City of Health and Science, Sant' Anna Hospital, University of Turin, Turin, ItalyGynecology and Obstetrics 4, Department of Surgical Sciences, City of Health and Science, Sant' Anna Hospital, University of Turin, Turin, Italy0Medical Oncology, Santo Spirito Hospital, Rome, Italy0Medical Oncology, Santo Spirito Hospital, Rome, Italy1Department of Medical Oncology, Fondazione Policlinico Universitario Campus Biomedico, Rome, Italy2Medical Oncology A, Policlinico Umberto I, Department of Radiological, Oncological and Anatomo-Pathological Sciences, “Sapienza” University of Rome, Rome, Italy3Department of Oncology, Ospedale Luigi Sacco, ASST Fatebenefratelli Sacco, Milan, Italy3Department of Oncology, Ospedale Luigi Sacco, ASST Fatebenefratelli Sacco, Milan, Italy4Department of Innovative Technologies in Medicine and Dentistry and Centre for Advanced Studies and Technology (CAST), G. D’Annunzio University, Chieti, Italy5Department of Medical, Oral and Biotechnological Sciences and Center for Advanced Studies and Technology (CAST), G. D’Annunzio University, Chieti, Italy6Medical Oncology, Fondazione IRCCS Ca’Granda Ospedale Maggiore Policlinico Milano, Milan, Italy7Department of Medical Oncology, ASL Nuoro, Nuoro, Italy8Department of Biomedical, Experimental and Clinical Sciences “M. Serio”, University of Florence, Florence, Italy9Radiotherapy Unit, Oncology Department, Azienda Ospedaliera Universitaria Careggi, Florence, Italy8Department of Biomedical, Experimental and Clinical Sciences “M. Serio”, University of Florence, Florence, Italy9Radiotherapy Unit, Oncology Department, Azienda Ospedaliera Universitaria Careggi, Florence, Italy0UOC of Medical Oncology, Sandro Pertini Hospital, Rome, Italy0UOC of Medical Oncology, Sandro Pertini Hospital, Rome, Italy0UOC of Medical Oncology, Sandro Pertini Hospital, Rome, Italy1Oncology Clinic, Università Politecnica delle Marche, Ospedali Riuniti Hospital, Ancona, Italy1Oncology Clinic, Università Politecnica delle Marche, Ospedali Riuniti Hospital, Ancona, Italy2Sandro Pitigliani Medical Oncology Department, Hospital of Prato, Prato, Italy3Department of Medical Oncology, IRCCS Giovanni Paolo II Institute, Bari, Italy3Department of Medical Oncology, IRCCS Giovanni Paolo II Institute, Bari, Italy4“Don Tonino Bello” Oncology Unit, IRCCS Istituto Tumori “Giovanni Paolo II”, Bari, Italy5Oncology Department, Ospedale di Gallarate, ASST Valle Olona, Gallarate, Italy6Phase 1 Research Centre and Oncology Unit, Department of Medicine and Surgery, University of Milano-Bicocca, ASST Monza, Monza, Italy7Oncology Unit, ASST Monza, Monza, Italy8Oncology Division, AULSS 1 Dolomiti, San Martino Medical Hospital, Belluno, ItalyDivision of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy9Phase I Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy0Department of Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Milan, Italy1Department of Medical and Surgical Sciences and Translational Medicine, “Sapienza” University of Rome, Rome, Italy2Medical Oncology A, Policlinico Umberto I, Department of Radiological, Oncological and Anatomo-Pathological Sciences, “Sapienza” University of Rome, Rome, Italy2UO Medical Oncology I, S. Chiara Hospital, Pisa University Hospital, Pisa, Italy2UO Medical Oncology I, S. Chiara Hospital, Pisa University Hospital, Pisa, Italy3Oncology Division, San Giovanni Evangelista Hospital, ASL RM5, Rome, Italy4Division of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy4Division of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy5Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy6Oncology Unit Rimini, Azienda USL Romagna, Rimini, Italy6Oncology Unit Rimini, Azienda USL Romagna, Rimini, Italy7Medical Oncology Unit, Santa Maria Goretti Hospital, Latina, Italy7Medical Oncology Unit, Santa Maria Goretti Hospital, Latina, Italy8Pathology Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy9Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy9Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy9Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy0Breast Unit-Oncologia, ASST-Spedali Civili, Brescia, Italy1Medical Oncology, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, ItalyPhase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy2Division of Oncology, San Giovanni Hospital, Rome, Italy2Division of Oncology, San Giovanni Hospital, Rome, Italy3Presidio Oncologico Cassia – S. Andrea, ASL Roma 1, Rome, Italy4Oncology Division, San Pietro Fatebenefratelli Hospital, Rome, Italy5Department of Plastic and Reconstructive Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy5Department of Plastic and Reconstructive Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy6Oncology Unit, Antonio Cardarelli Hospital, Naples, Italy7Medical Oncology Unit, AULSS 9 Regione Veneto, Scaligera - Ospedale Generale Mater Salutis, Legnago, Italy8Division of Medical Oncology, Department of Oncology-Hematology, University Hospital of Modena, Modena, Italy9Medical Oncology Division, ASST-Lariana, Como, ItalyDivision of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy0Clinical Trial Center, Biostatistics and Bioinformatics, IRCCS Regina Elena National Cancer Institute, Rome, Italy0Clinical Trial Center, Biostatistics and Bioinformatics, IRCCS Regina Elena National Cancer Institute, Rome, Italy1Department of Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy1Department of Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy1Department of Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy1Department of Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy2Gynecologic Oncology Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy3Department of Radiation Oncology, IRCCS Regina Elena National Cancer Institute, Rome, Italy4Department of Maternal and Child Health and Urological Sciences, “Sapienza” University of Rome, Policlinico Umberto I, Rome, Italy5Medical Oncology B, Policlinico Umberto I, Department of Radiological, Oncological and Pathological Sciences, “Sapienza” University of Rome, Rome, Italy6Scientific Direction, IRCCS IDI, Istituto Dermopatico dell'Immacolata, Rome, Italy7Department of Radiological, Oncological and Pathological Sciences, “Sapienza” University of Rome, Rome, Italy2Medical Oncology A, Policlinico Umberto I, Department of Radiological, Oncological and Anatomo-Pathological Sciences, “Sapienza” University of Rome, Rome, Italy0Clinical Trial Center, Biostatistics and Bioinformatics, IRCCS Regina Elena National Cancer Institute, Rome, Italy8Scientific Direction, IRCCS Regina Elena National Cancer Institute, Rome, ItalyPhase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, ItalyBackgroundIn triple negative breast cancer patients treated with neoadjuvant chemotherapy, residual disease at surgery is the most relevant unfavorable prognostic factor. Current guidelines consider the use of adjuvant capecitabine, based on the results of the randomized CREATE-X study, carried out in Asian patients and including a small subset of triple negative tumors. Thus far, evidence on Caucasian patients is limited, and no real-world data are available.MethodsWe carried out a multicenter, observational study, involving 44 oncologic centres. Triple negative breast cancer patients with residual disease, treated with adjuvant capecitabine from January 2017 through June 2021, were recruited. We primarily focused on treatment tolerability, with toxicity being reported as potential cause of treatment discontinuation. Secondarily, we assessed effectiveness in the overall study population and in a subset having a minimum follow-up of 2 years.ResultsOverall, 270 patients were retrospectively identified. The 50.4% of the patients had residual node positive disease, 7.8% and 81.9% had large or G3 residual tumor, respectively, and 80.4% a Ki-67 >20%. Toxicity-related treatment discontinuation was observed only in 10.4% of the patients. In the whole population, at a median follow-up of 15 months, 2-year disease-free survival was 62%, 2 and 3-year overall survival 84.0% and 76.2%, respectively. In 129 patients with a median follow-up of 25 months, 2-year disease-free survival was 43.4%, 2 and 3-year overall survival 78.0% and 70.8%, respectively. Six or more cycles of capecitabine were associated with more favourable outcomes compared with less than six cycles.ConclusionThe CaRe study shows an unexpectedly good tolerance of adjuvant capecitabine in a real-world setting, although effectiveness appears to be lower than that observed in the CREATE-X study. Methodological differences between the two studies impose significant limits to comparability concerning effectiveness, and strongly invite further research.https://www.frontiersin.org/articles/10.3389/fonc.2023.1152123/fulltriple negative breast cancerneoadjuvant treatmentresidual tumorsadjuvant capecitabinetreatment discontinuation |
spellingShingle | Francesca Sofia Di Lisa Eriseld Krasniqi Laura Pizzuti Maddalena Barba Katia Cannita Ugo De Giorgi Fulvio Borella Jennifer Foglietta Anna Cariello Antonella Ferro Elisa Picardo Marco Mitidieri Valentina Sini Simonetta Stani Giuseppe Tonini Daniele Santini Nicla La Verde Anna Rita Gambaro Antonino Grassadonia Nicola Tinari Ornella Garrone Giuseppina Sarobba Lorenzo Livi Lorenzo Livi Icro Meattini Icro Meattini Giuliana D’Auria Matteo Vergati Teresa Gamucci Mirco Pistelli Rossana Berardi Emanuela Risi Francesco Giotta Vito Lorusso Lucia Rinaldi Salvatore Artale Marina Elena Cazzaniga Marina Elena Cazzaniga Fable Zustovich Federico Cappuzzo Lorenza Landi Rosalba Torrisi Simone Scagnoli Andrea Botticelli Andrea Michelotti Beatrice Fratini Rosa Saltarelli Ida Paris Margherita Muratore Alessandra Cassano Lorenzo Gianni Valeria Gaspari Enzo Maria Veltri Federica Zoratto Elena Fiorio Maria Agnese Fabbri Marco Mazzotta Enzo Maria Ruggeri Rebecca Pedersini Maria Rosaria Valerio Lorena Filomeno Mauro Minelli Paola Scavina Mimma Raffaele Antonio Astone Roy De Vita Marcello Pozzi Ferdinando Riccardi Filippo Greco Luca Moscetti Monica Giordano Marcello Maugeri-Saccà Marcello Maugeri-Saccà Alessandro Zennaro Claudio Botti Fabio Pelle Sonia Cappelli Flavia Cavicchi Enrico Vizza Giuseppe Sanguineti Federica Tomao Enrico Cortesi Paolo Marchetti Silverio Tomao Iolanda Speranza Isabella Sperduti Gennaro Ciliberto Patrizia Vici Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study Frontiers in Oncology triple negative breast cancer neoadjuvant treatment residual tumors adjuvant capecitabine treatment discontinuation |
title | Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study |
title_full | Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study |
title_fullStr | Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study |
title_full_unstemmed | Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study |
title_short | Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study |
title_sort | adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment real world evidence from care a multicentric observational study |
topic | triple negative breast cancer neoadjuvant treatment residual tumors adjuvant capecitabine treatment discontinuation |
url | https://www.frontiersin.org/articles/10.3389/fonc.2023.1152123/full |
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