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

被引：6

作者：

Di Lisa, Francesca Sofia ^{[1
]}

Krasniqi, Eriseld ^{[2
]}

Pizzuti, Laura ^{[2
]}

Barba, Maddalena ^{[2
]}

Cannita, Katia ^{[3
]}

De Giorgi, Ugo ^{[4
]}

Borella, Fulvio ^{[5
]}

Foglietta, Jennifer ^{[6
]}

Cariello, Anna ^{[7
]}

Ferro, Antonella ^{[8
]}

Picardo, Elisa ^{[9
]}

Mitidieri, Marco ^{[9
]}

Sini, Valentina ^{[10
]}

Stani, Simonetta ^{[10
]}

Tonini, Giuseppe ^{[11
]}

Santini, Daniele ^{[12
]}

La Verde, Nicla ^{[13
]}

Gambaro, Anna Rita ^{[13
]}

Grassadonia, Antonino ^{[14
,15
]}

Tinari, Nicola ^{[15
,16
]}

Garrone, Ornella ^{[17
]}

Sarobba, Giuseppina ^{[18
]}

Livi, Lorenzo ^{[19
,20
]}

Meattini, Icro ^{[19
,20
]}

D'Auria, Giuliana ^{[21
]}

Vergati, Matteo ^{[21
]}

Gamucci, Teresa ^{[21
]}

Pistelli, Mirco ^{[22
]}

Berardi, Rossana ^{[22
]}

Risi, Emanuela ^{[23
]}

Giotta, Francesco ^{[24
]}

Lorusso, Vito ^{[24
]}

Rinaldi, Lucia ^{[25
]}

Artale, Salvatore ^{[26
]}

Cazzaniga, Marina Elena ^{[27
,28
,29
]}

Zustovich, Fable ^{[30
]}

Cappuzzo, Federico ^{[2
]}

Landi, Lorenza ^{[31
]}

Torrisi, Rosalba ^{[32
,33
]}

Scagnoli, Simone ^{[34
]}

Botticelli, Andrea ^{[12
]}

Michelotti, Andrea ^{[35
]}

Fratini, Beatrice ^{[35
]}

Saltarelli, Rosa ^{[36
]}

Paris, Ida ^{[37
]}

Muratore, Margherita ^{[37
]}

Cassano, Alessandra ^{[38
]}

Gianni, Lorenzo ^{[39
]}

Gaspari, Valeria ^{[39
]}

Veltri, Enzo Maria ^{[40
]}

机构：

[1] IRCCS Regina Elena Natl Canc Inst, Phase 4 Clin Studies Unit, Rome, Italy

[2] IRCCS Regina Elena Natl Canc Inst, Div Med Oncol 2, Rome, Italy

[3] Mazzini Hosp, Oncol Div, ASL Teramo, Teramo, Italy

[4] IRCCS Ist Romagnolo Studio Tumori IRST Dino Amado, Dept Med Oncol, Meldola, Italy

[5] Univ Turin, St Anna Hosp, Dept Surg Sci, City Hlth & Sci,Gynecol & Obstet 1, Turin, Italy

[6] PO Narni Amelia, Med Oncol, Terni, Italy

[7] AUSL Romagna, Oncol Dept, Ravenna, Italy

[8] Santa Chiara Hosp, Breast Ctr, Trento, Italy

[9] Univ Turin, St Anna Hosp, Dept Surg Sci, City Hlth & Sci,Gynecol & Obstet 4, Turin, Italy

[10] Santo Spirito Hosp, Med Oncol, Rome, Italy

[11] Fdn Policlin Univ Campus Biomed, Dept Med Oncol, Rome, Italy

[12] Sapienza Univ Rome, Dept Radiol Oncol & Anatomopathol Sci, Policlin Umberto I, Med Oncol A, Rome, Italy

[13] Osped L Sacco, Dept Oncol, ASST Fatebenefratelli Sacco, Milan, Italy

[14] Univ G dAnnunzio, Dept Innovat Technol Med & Dent, Chieti, Italy

[15] Univ G dAnnunzio, Ctr Adv Studies & Technol CAST, Chieti, Italy

[16] Univ G dAnnunzio, Dept Med Oral & Biotechnol Sci, Chieti, Italy

[17] Fdn IRCCS Ca Granda Osped Maggiore Policlin Milan, Med Oncol, Milan, Italy

[18] ASL Nuoro, Dept Med Oncol, Nuoro, Italy

[19] Univ Florence, Dept Biomed Expt & Clin Sci M Serio, Florence, Italy

[20] Azienda Osped Univ Careggi, Oncol Dept, Radiotherapy Unit, Florence, Italy

[21] Sandro Pertini Hosp, UOC Med Oncol, Rome, Italy

[22] Univ Politecn Marche, Osped Riuniti Hosp, Oncol Clin, Ancona, Italy

[23] Hosp Prato, Sandro Pitigliani Med Oncol Dept, Prato, Italy

[24] IRCCS Giovanni Paolo II Inst, Dept Med Oncol, Bari, Italy

[25] IRCCS Ist Tumori Giovanni Paolo II, Don Tonino Bello Oncol Unit, Bari, Italy

[26] Osped Gallarate, ASST Valle Olona, Oncol Dept, Gallarate, Italy

[27] Univ Milano Bicocca, ASST Monza, Phase 1 Res Ctr, Monza, Italy

[28] Univ Milano Bicocca, Dept Med & Surg, ASST Monza, Oncol Unit, Monza, Italy

[29] ASST Monza, Oncol Unit, Monza, Italy

[30] San Martino Med Hosp, AULSS 1 Dolomiti, Oncol Div, Belluno, Italy

[31] IRCCS Regina Elena Natl Canc Inst, Phase 1 Clin Studies Unit, Rome, Italy

[32] IRCCS Humanitas Res Hosp, Dept Med Oncol, Milan, Italy

[33] IRCCS Humanitas Res Hosp, Hematol Unit, Milan, Italy

[34] Sapienza Univ Rome, Dept Med & Surg Sci & Translat Med, Rome, Italy

[35] Pisa Univ Hosp, S Chiara Hosp, UO Med Oncol 1, Pisa, Italy

[36] San Giovanni Evangelista Hosp, ASL RM5, Oncol Div, Rome, Italy

[37] Fdn Policlin Univ Agostino Gemelli IRCCS, Dept Woman & Child Hlth & Publ Hlth, Div Gynecol Oncol, Rome, Italy

[38] Univ Cattolica Sacro Cuore, Fdn Policlin Univ Agostino Gemelli IRCCS, Comprehens Canc Ctr, Med Oncol, Rome, Italy

[39] Azienda USL Romagna, Oncol Unit Rimini, Rimini, Italy

[40] Santa Maria Goretti Hosp, Med Oncol Unit, Latina, Italy

[41] Azienda Osped Univ Integrata, Pathol Unit, Verona, Italy

[42] Belcolle Hosp, Med Oncol Unit, Viterbo, Italy

[43] ASST Spedali Civili, Breast Unit Oncol, Brescia, Italy

[44] Azienda Osped Univ Policlin Paolo Giaccone, Med Oncol, Palermo, Italy

[45] San Giovanni Hosp, Div Oncol, Rome, Italy

[46] ASL Roma 1, Presidio Oncol Cassia S Andrea, Rome, Italy

[47] San Pietro Fatebenefratelli Hosp, Oncol Div, Rome, Italy

[48] IRCCS Regina Elena Natl Canc Inst, Dept Plast & Reconstruct Surg, Rome, Italy

[49] Antonio Cardarelli Hosp, Oncol Unit, Naples, Italy

[50] Scaligera Osped Gen Mater Salutis, AULSS 9 Reg Veneto, Med Oncol Unit, Legnago, Italy

来源：

FRONTIERS IN ONCOLOGY | 2023年 / 13卷

关键词：

triple negative breast cancer; neoadjuvant treatment; residual tumors; adjuvant capecitabine; treatment discontinuation; CHEMOTHERAPY; SURVIVAL; TRIAL; RISK;

D O I：

10.3389/fonc.2023.1152123

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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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