新辅助治疗后仍有残留病灶的三阴性乳腺癌患者辅助使用卡培他滨：一项多中心观察性研究的真实世界证据
Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from , a multicentric, observational study.
作者信息
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
机构信息
Phase IV Clinical Studies Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Division of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
出版信息
Front Oncol. 2023 May 16;13:1152123. doi: 10.3389/fonc.2023.1152123. eCollection 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 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 >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 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 study. Methodological differences between the two studies impose significant limits to comparability concerning effectiveness, and strongly invite further research.
背景
在接受新辅助化疗的三阴性乳腺癌患者中，手术时的残留病灶是最相关的不良预后因素。基于一项在亚洲患者中开展且纳入了一小部分三阴性肿瘤患者的随机研究结果，当前指南考虑使用辅助性卡培他滨。迄今为止，关于白种人患者的证据有限，且尚无真实世界数据。
方法
我们开展了一项多中心观察性研究，涉及44个肿瘤中心。招募了2017年1月至2021年6月期间接受辅助性卡培他滨治疗的伴有残留病灶的三阴性乳腺癌患者。我们主要关注治疗耐受性，将毒性反应报告为治疗中断的潜在原因。其次，我们评估了整个研究人群以及随访至少2年的亚组中的有效性。
结果
总体而言，共回顾性纳入270例患者。50.4%的患者有残留淋巴结阳性疾病，7.8%和81.9%的患者分别有大的或G3级残留肿瘤，80.4%的患者Ki-67>20%。仅10.4%的患者因毒性反应而中断治疗。在总体人群中，中位随访15个月时，2年无病生存率为62%，2年和3年总生存率分别为84.0%和76.2%。在129例中位随访25个月的患者中，2年无病生存率为43.4%，2年和3年总生存率分别为78.0%和70.8%。与少于6个周期相比，6个或更多周期的卡培他滨与更有利的结局相关。
结论
该研究表明，在真实世界中辅助性卡培他滨的耐受性出人意料地良好，尽管有效性似乎低于在[具体研究]中观察到的情况。两项研究之间的方法学差异对有效性的可比性造成了重大限制，并强烈呼吁进一步开展研究。
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