Docetaxel plus S-1 versus docetaxel plus capecitabine as first-line treatment for advanced breast cancer patients: a prospective randomized phase II study

Autor: Nilupai Abudureheiyimu, Yun Wu, Qing Li, Pin Zhang, Fei Ma, Peng Yuan, Yang Luo, Ying Fan, Shanshan Chen, Ruigang Cai, Qiao Li, Yiqun Han, Hangcheng Xu, Yan Wang, Jiayu Wang, Binghe Xu
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Journal of the National Cancer Center, Vol 3, Iss 2, Pp 115-120 (2023)
Druh dokumentu: article
ISSN: 2667-0054
DOI: 10.1016/j.jncc.2023.05.003
Popis: Background: This study was conducted to evaluate the efficacy and safety of docetaxel/S-1 (TS) compared with docetaxel/capecitabine (TX) as a first-line treatment for advanced breast cancer. Methods: Patients with advanced metastatic breast cancer were randomly divided into the TS group (n = 54) and the TX group (n = 57) for first-line chemotherapy from August 2015 to April 2019 (ClinicalTrials.org registration no. NCT02947061). Following the completion of combination therapy, patients without progression received S-1 or capecitabine maintenance treatment. The primary end point was progression-free survival (PFS). Results: Among 111 enrolled patients, the median PFS did not differ significantly between the TS group and the TX group (TS vs. TX, 9.0 vs. 7.4 months, P = 0.365, 95% confidence interval [CI]: 0.50–1.11, hazard ratio [HR]: 0.75). There was also no statistically significant difference in median overall survival (OS) between the two groups (TS vs. TX, 40.2 vs. 41.3 months, P = 0.976). In addition, visceral metastasis and metastasis sites, such as the liver or lung, did not lead to a significant effect on PFS and OS. The two regimens showed no significant difference in adverse events, except hand-foot syndrome, which predominated in the TX group (38.6% vs. 7.4%, P = 0.001), and diarrhea (24.1% vs. 3.6%, P = 0.003) and elevation of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels (14.8% vs. 3.5%, P = 0.049), which were more frequent in the TS group. Conclusions: The TS and TX regimens demonstrated similar efficacy and safety for the first-line treatment of advanced breast cancer. The TS regimen had fewer cases of severe hand-foot syndrome than the TX regimen, representing an effective alternative option to the TX regimen. Further studies are warranted to define the efficacy and safety of this strategy in real-world settings.
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