Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from

adjuvant capecitabine neoadjuvant treatment residual tumors treatment discontinuation triple negative breast cancer

Journal

Frontiers in oncology
ISSN: 2234-943X
Titre abrégé: Front Oncol
Pays: Switzerland
ID NLM: 101568867

Informations de publication

Date de publication:
2023
Historique:
received: 27 01 2023
accepted: 26 04 2023
medline: 1 6 2023
pubmed: 1 6 2023
entrez: 1 6 2023
Statut: epublish

Résumé

In 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 We 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. Overall, 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. The

Sections du résumé

Background UNASSIGNED
In 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
Methods UNASSIGNED
We 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.
Results UNASSIGNED
Overall, 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.
Conclusion UNASSIGNED
The

Identifiants

pubmed: 37260975
doi: 10.3389/fonc.2023.1152123
pmc: PMC10227592
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1152123

Informations de copyright

Copyright © 2023 Di Lisa, Krasniqi, Pizzuti, Barba, Cannita, De Giorgi, Borella, Foglietta, Cariello, Ferro, Picardo, Mitidieri, Sini, Stani, Tonini, Santini, La Verde, Gambaro, Grassadonia, Tinari, Garrone, Sarobba, Livi, Meattini, D’Auria, Vergati, Gamucci, Pistelli, Berardi, Risi, Giotta, Lorusso, Rinaldi, Artale, Cazzaniga, Zustovich, Cappuzzo, Landi, Torrisi, Scagnoli, Botticelli, Michelotti, Fratini, Saltarelli, Paris, Muratore, Cassano, Gianni, Gaspari, Veltri, Zoratto, Fiorio, Fabbri, Mazzotta, Ruggeri, Pedersini, Valerio, Filomeno, Minelli, Scavina, Raffaele, Astone, De Vita, Pozzi, Riccardi, Greco, Moscetti, Giordano, Maugeri-Saccà, Zennaro, Botti, Pelle, Cappelli, Cavicchi, Vizza, Sanguineti, Tomao, Cortesi, Marchetti, Tomao, Speranza, Sperduti, Ciliberto and Vici.

Déclaration de conflit d'intérêts

LP received speaker fees from Novartis, outside the submitted work. UDG: Pfizer, BMS, MSD, PharmaMAR, AStellas, Bayer, Ipsen, Novartis; Invited speaker Roche, BMS, SAnofi, AstraZeneca; received research grants from AstraZeneca, SAnofi, Roche, outside the submitted work. AF received honoraria as a speaker from Eli Lilly, Novartis, Pierre-Fabre, outside the submitted work. GT: advisory boards from Novartis, Pfizer, Eisai, Roche, and Eli Lilly, outside the submitted work. DS: advisory boards from Novartis, Pfizer, Eisai, Roche, and Eli Lilly, outside the submitted work. NLV: Roche, MSD, Eisai, Novartis, AstraZeneca, GSK, Pfizer, Gentili, Daiichi Sankyo, Dephaforum, outside the submitted work. OG: Eisai, MSD, Gilead, Seagen, Novartis, Eli Lilly, outside the submitted work. IM: advisory boards from Eli Lilly, Novartis, Gentili, Roche, Pfizer, Ipsen, and Pierre-Fabre, outside the submitted work. GD’A: Novartis, Amgen, Eli Lilly outside the submitted work. TG received travel grants from Eisai, Roche, Pfizer, and Novartis; speaker fees/advisory boards from Roche, Pfizer, Novartis, Gentili, and Eli Lilly, outside the submitted work. MPi Consultant/advisory boards from Gilead, Eli Lilly, Pfizer, Novartis, Gentili, MSD, outside the submitted work. RB received research grant/advisory boards from AstraZeneca, Boehringer Ingelheim, Novartis, MSD, Otsuka, Eli Lilly, Roche, Amgen, GSK, Eisai, outside the submitted work. FGi: advisory boards from Gilead, Daiichi Sankyo, Seagen, outside the submitted work. MEC consultant/advisory role for Pierre-Fabre, Roche, Novartis, Eli Lilly, Celgene, outside the submitted work. RT: AstraZeneca, Eisai, Pfizer, Eli Lilly, MSD, Exact Science, outside the submitted work. AB: MSD, BMS, Pfizer, Novartis, Roche outside the submitted work. AM received travel grants from Eisai, Celgene, and Novartis Ipsen; personal fees/advisory boards from Eisai, Novartis, AstraZeneca, Teva, Pfizer, and Celgene, outside the submitted work. IP received personal fees/advisory boards from Roche, Pfizer, Novartis, Italfarmaco, Gentili, and Pierre-Fabre. LG received congress travel accomodation from Roche, Daiichi Sankyo, AstraZeneca, Pfizer, Novartis; advisory role for Astra Zeneca outside the submitted work. MMin: Novartis, MSD, Eli Lilly, outside the submitted work. LM received personal fees/advisory board from Roche, Novartis, Eisai, and Pfizer, outside the submitted work. EC: Astellas, Roche, BMS, Jansen, MSD, Sirtex, Merck, Bayer, Servier, Novartis, outside the submitted work. PM has/had a consultant/advisory role for BMS, Roche, Genentech, MSD, Novartis, Amgen, Merck Serono, Pierre-Fabre and Incyte, outside the submitted work. PV received speaker fees/advisory boards from Roche, Pfizer, Novartis and Eli Lilly, outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Références

J Clin Oncol. 2021 Aug 20;39(24):2720-2731
pubmed: 34003702
Clin Cancer Res. 2007 Apr 15;13(8):2329-34
pubmed: 17438091
J Clin Oncol. 2018 Jul 10;36(20):2105-2122
pubmed: 29846122
NPJ Breast Cancer. 2021 Mar 22;7(1):29
pubmed: 33753748
Lancet. 2020 Oct 10;396(10257):1090-1100
pubmed: 32966830
Eur J Cancer. 2009 Sep;45 Suppl 1:27-40
pubmed: 19775602
Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34
pubmed: 17671126
Breast Cancer Res Treat. 2009 May;115(2):423-8
pubmed: 18543098
J Clin Oncol. 2021 Aug 10;39(23):2539-2551
pubmed: 34092112
Cancer Treat Rev. 2019 Jan;72:7-14
pubmed: 30414986
J Clin Oncol. 2020 Apr 20;38(12):1346-1366
pubmed: 31928404
J Clin Oncol. 2020 Jan 20;38(3):203-213
pubmed: 31804894
J Clin Oncol. 2008 May 1;26(13):2118-23
pubmed: 18445840
N Engl J Med. 2022 Feb 10;386(6):556-567
pubmed: 35139274
Lancet. 2014 Jul 12;384(9938):164-72
pubmed: 24529560
Nat Clin Pract Oncol. 2009 Jan;6(1):17-24
pubmed: 18936793
J Clin Oncol. 2017 Apr 1;35(10):1049-1060
pubmed: 28135148
N Engl J Med. 2017 Jun 1;376(22):2147-2159
pubmed: 28564564
J Oncol Pharm Pract. 2021 Dec;27(8):1883-1890
pubmed: 33153384
N Engl J Med. 2020 Feb 27;382(9):810-821
pubmed: 32101663
Cancer Chemother Pharmacol. 2003 Sep;52(3):193-201
pubmed: 12783206
N Engl J Med. 2021 Jun 24;384(25):2394-2405
pubmed: 34081848
J Clin Oncol. 2008 Mar 10;26(8):1275-81
pubmed: 18250347

Auteurs

Francesca Sofia Di Lisa (FS)

Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Eriseld Krasniqi (E)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Laura Pizzuti (L)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Maddalena Barba (M)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Katia Cannita (K)

Oncology Division, Mazzini Hospital, ASL Teramo, Teramo, Italy.

Ugo De Giorgi (U)

Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.

Fulvio Borella (F)

Gynecology and Obstetrics 1, Department of Surgical Sciences, City of Health and Science, Sant' Anna Hospital, University of Turin, Turin, Italy.

Jennifer Foglietta (J)

Medical Oncology, P.O. Narni-Amelia, Terni, Italy.

Anna Cariello (A)

Oncology Department, AUSL Romagna, Ravenna, Italy.

Antonella Ferro (A)

Breast Center, Santa Chiara Hospital, Trento, Italy.

Elisa Picardo (E)

Gynecology and Obstetrics 4, Department of Surgical Sciences, City of Health and Science, Sant' Anna Hospital, University of Turin, Turin, Italy.

Marco Mitidieri (M)

Gynecology and Obstetrics 4, Department of Surgical Sciences, City of Health and Science, Sant' Anna Hospital, University of Turin, Turin, Italy.

Valentina Sini (V)

Medical Oncology, Santo Spirito Hospital, Rome, Italy.

Simonetta Stani (S)

Medical Oncology, Santo Spirito Hospital, Rome, Italy.

Giuseppe Tonini (G)

Department of Medical Oncology, Fondazione Policlinico Universitario Campus Biomedico, Rome, Italy.

Daniele Santini (D)

Medical Oncology A, Policlinico Umberto I, Department of Radiological, Oncological and Anatomo-Pathological Sciences, "Sapienza" University of Rome, Rome, Italy.

Nicla La Verde (N)

Department of Oncology, Ospedale Luigi Sacco, ASST Fatebenefratelli Sacco, Milan, Italy.

Anna Rita Gambaro (AR)

Department of Oncology, Ospedale Luigi Sacco, ASST Fatebenefratelli Sacco, Milan, Italy.

Antonino Grassadonia (A)

Department of Innovative Technologies in Medicine and Dentistry and Centre for Advanced Studies and Technology (CAST), G. D'Annunzio University, Chieti, Italy.

Nicola Tinari (N)

Department of Medical, Oral and Biotechnological Sciences and Center for Advanced Studies and Technology (CAST), G. D'Annunzio University, Chieti, Italy.

Ornella Garrone (O)

Medical Oncology, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano, Milan, Italy.

Giuseppina Sarobba (G)

Department of Medical Oncology, ASL Nuoro, Nuoro, Italy.

Lorenzo Livi (L)

Department of Biomedical, Experimental and Clinical Sciences "M. Serio", University of Florence, Florence, Italy.
Radiotherapy Unit, Oncology Department, Azienda Ospedaliera Universitaria Careggi, Florence, Italy.

Icro Meattini (I)

Department of Biomedical, Experimental and Clinical Sciences "M. Serio", University of Florence, Florence, Italy.
Radiotherapy Unit, Oncology Department, Azienda Ospedaliera Universitaria Careggi, Florence, Italy.

Giuliana D'Auria (G)

UOC of Medical Oncology, Sandro Pertini Hospital, Rome, Italy.

Matteo Vergati (M)

UOC of Medical Oncology, Sandro Pertini Hospital, Rome, Italy.

Teresa Gamucci (T)

UOC of Medical Oncology, Sandro Pertini Hospital, Rome, Italy.

Mirco Pistelli (M)

Oncology Clinic, Università Politecnica delle Marche, Ospedali Riuniti Hospital, Ancona, Italy.

Rossana Berardi (R)

Oncology Clinic, Università Politecnica delle Marche, Ospedali Riuniti Hospital, Ancona, Italy.

Emanuela Risi (E)

Sandro Pitigliani Medical Oncology Department, Hospital of Prato, Prato, Italy.

Francesco Giotta (F)

Department of Medical Oncology, IRCCS Giovanni Paolo II Institute, Bari, Italy.

Vito Lorusso (V)

Department of Medical Oncology, IRCCS Giovanni Paolo II Institute, Bari, Italy.

Lucia Rinaldi (L)

"Don Tonino Bello" Oncology Unit, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.

Salvatore Artale (S)

Oncology Department, Ospedale di Gallarate, ASST Valle Olona, Gallarate, Italy.

Marina Elena Cazzaniga (ME)

Phase 1 Research Centre and Oncology Unit, Department of Medicine and Surgery, University of Milano-Bicocca, ASST Monza, Monza, Italy.
Oncology Unit, ASST Monza, Monza, Italy.

Fable Zustovich (F)

Oncology Division, AULSS 1 Dolomiti, San Martino Medical Hospital, Belluno, Italy.

Federico Cappuzzo (F)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Lorenza Landi (L)

Phase I Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Rosalba Torrisi (R)

Department of Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.

Simone Scagnoli (S)

Department of Medical and Surgical Sciences and Translational Medicine, "Sapienza" University of Rome, Rome, Italy.

Andrea Botticelli (A)

Medical Oncology A, Policlinico Umberto I, Department of Radiological, Oncological and Anatomo-Pathological Sciences, "Sapienza" University of Rome, Rome, Italy.

Andrea Michelotti (A)

UO Medical Oncology I, S. Chiara Hospital, Pisa University Hospital, Pisa, Italy.

Beatrice Fratini (B)

UO Medical Oncology I, S. Chiara Hospital, Pisa University Hospital, Pisa, Italy.

Rosa Saltarelli (R)

Oncology Division, San Giovanni Evangelista Hospital, ASL RM5, Rome, Italy.

Ida Paris (I)

Division of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

Margherita Muratore (M)

Division of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

Alessandra Cassano (A)

Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.

Lorenzo Gianni (L)

Oncology Unit Rimini, Azienda USL Romagna, Rimini, Italy.

Valeria Gaspari (V)

Oncology Unit Rimini, Azienda USL Romagna, Rimini, Italy.

Enzo Maria Veltri (EM)

Medical Oncology Unit, Santa Maria Goretti Hospital, Latina, Italy.

Federica Zoratto (F)

Medical Oncology Unit, Santa Maria Goretti Hospital, Latina, Italy.

Elena Fiorio (E)

Pathology Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.

Maria Agnese Fabbri (MA)

Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy.

Marco Mazzotta (M)

Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy.

Enzo Maria Ruggeri (EM)

Medical Oncology Unit, Belcolle Hospital, Viterbo, Italy.

Rebecca Pedersini (R)

Breast Unit-Oncologia, ASST-Spedali Civili, Brescia, Italy.

Maria Rosaria Valerio (MR)

Medical Oncology, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy.

Lorena Filomeno (L)

Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Mauro Minelli (M)

Division of Oncology, San Giovanni Hospital, Rome, Italy.

Paola Scavina (P)

Division of Oncology, San Giovanni Hospital, Rome, Italy.

Mimma Raffaele (M)

Presidio Oncologico Cassia - S. Andrea, ASL Roma 1, Rome, Italy.

Antonio Astone (A)

Oncology Division, San Pietro Fatebenefratelli Hospital, Rome, Italy.

Roy De Vita (R)

Department of Plastic and Reconstructive Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Marcello Pozzi (M)

Department of Plastic and Reconstructive Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Ferdinando Riccardi (F)

Oncology Unit, Antonio Cardarelli Hospital, Naples, Italy.

Filippo Greco (F)

Medical Oncology Unit, AULSS 9 Regione Veneto, Scaligera - Ospedale Generale Mater Salutis, Legnago, Italy.

Luca Moscetti (L)

Division of Medical Oncology, Department of Oncology-Hematology, University Hospital of Modena, Modena, Italy.

Monica Giordano (M)

Medical Oncology Division, ASST-Lariana, Como, Italy.

Marcello Maugeri-Saccà (M)

Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Clinical Trial Center, Biostatistics and Bioinformatics, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Alessandro Zennaro (A)

Clinical Trial Center, Biostatistics and Bioinformatics, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Claudio Botti (C)

Department of Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Fabio Pelle (F)

Department of Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Sonia Cappelli (S)

Department of Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Flavia Cavicchi (F)

Department of Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Enrico Vizza (E)

Gynecologic Oncology Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Giuseppe Sanguineti (G)

Department of Radiation Oncology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Federica Tomao (F)

Department of Maternal and Child Health and Urological Sciences, "Sapienza" University of Rome, Policlinico Umberto I, Rome, Italy.

Enrico Cortesi (E)

Medical Oncology B, Policlinico Umberto I, Department of Radiological, Oncological and Pathological Sciences, "Sapienza" University of Rome, Rome, Italy.

Paolo Marchetti (P)

Scientific Direction, IRCCS IDI, Istituto Dermopatico dell'Immacolata, Rome, Italy.

Silverio Tomao (S)

Department of Radiological, Oncological and Pathological Sciences, "Sapienza" University of Rome, Rome, Italy.

Iolanda Speranza (I)

Medical Oncology A, Policlinico Umberto I, Department of Radiological, Oncological and Anatomo-Pathological Sciences, "Sapienza" University of Rome, Rome, Italy.

Isabella Sperduti (I)

Clinical Trial Center, Biostatistics and Bioinformatics, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Gennaro Ciliberto (G)

Scientific Direction, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Patrizia Vici (P)

Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Classifications MeSH