Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study
Authors: Di Lisa Francesca Sofia , Krasniqi Eriseld , Pizzuti Laura , Barba Maddalena , Cannita Katia , De Giorgi Ugo , Borella Fulvio , Foglietta Jennifer , Cariello Anna , Ferro Antonella , Picardo Elisa , Mitidieri Marco , Sini Valentina , Stani Simonetta , Tonini Giuseppe , Santini Daniele , La Verde Nicla , Gambaro Anna Rita , Grassadonia Antonino , Tinari Nicola , Garrone Ornella , Sarobba Giuseppina , Livi Lorenzo , Meattini Icro , D’Auria Giuliana , Vergati Matteo , Gamucci Teresa , Pistelli Mirco , Berardi Rossana , Risi Emanuela , Giotta Francesco , Lorusso Vito , Rinaldi Lucia , Artale Salvatore , Cazzaniga Marina Elena , Zustovich Fable , Cappuzzo Federico , Landi Lorenza , Torrisi Rosalba , Scagnoli Simone , Botticelli Andrea , Michelotti Andrea , Fratini Beatrice , Saltarelli Rosa , Paris Ida , Muratore Margherita , Cassano Alessandra , Gianni Lorenzo , Gaspari Valeria , Veltri Enzo Maria , Zoratto Federica , Fiorio Elena , Fabbri Maria Agnese , Mazzotta Marco , Ruggeri Enzo Maria , Pedersini Rebecca , Valerio Maria Rosaria , Filomeno Lorena , Minelli Mauro , Scavina Paola , Raffaele Mimma , Astone Antonio , De Vita Roy , Pozzi Marcello , Riccardi Ferdinando , Greco Filippo , Moscetti Luca , Giordano Monica , Maugeri-Saccà Marcello , Zennaro Alessandro , Botti Claudio , Pelle Fabio , Cappelli Sonia , Cavicchi Flavia , Vizza Enrico , Sanguineti Giuseppe , Tomao Federica , Cortesi Enrico , Marchetti Paolo , Tomao Silverio , Speranza Iolanda , Sperduti Isabella , Ciliberto Gennaro , Vici Patrizia 
Published: May 2023

Background

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 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.

Methods

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

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 &gt;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

The 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.