Frontiers in Oncology (May 2023)

Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study

  • 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

DOI
https://doi.org/10.3389/fonc.2023.1152123
Journal volume & issue
Vol. 13

Abstract

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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.

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