Department of Human Anatomy, School of Basic Medical Sciences, Hubei University of Medicine, Shiyan, PR China.
Department of Clinical Laboratory, Taihe Hospital, Affiliated Hospital of Hubei University of Medicine, Shiyan, PR China.
Clinics (Sao Paulo). 2023 Oct 28;78:100291. doi: 10.1016/j.clinsp.2023.100291. eCollection 2024.
This study aimed to compare progression-free survival, overall survival, clinical benefits, and adverse effects in postmenopausal women with hormone receptor-positive and HER2-negative breast cancer who received buparlisib plus fulvestrant against those of women who received dalpiciclib plus fulvestrant, considering ribociclib plus letrozole treatment as the reference standard.
Women received buparlisib plus fulvestrant (BF cohort, n = 108), dalpiciclib plus fulvestrant (DF cohort, n = 132), or ribociclib plus letrozole (RL cohort, n = 150) until unacceptable toxicity was observed.
A total of 117 (89 %), 80 (74 %), and 84 (56 %) women in the BF, DF, and RL cohorts, respectively, had clinical benefits. After treatment, the clinical benefits for women and after 42 months of follow-up progression-free survival and overall survival were higher in the DF cohort than in the BF and RL cohorts (p < 0.05 for all). Neutropenia, vomiting, constipation, nausea, diarrhea, and anorexia were reported higher in women of the DF and BF cohorts than in women of the RL cohort. Leukopenia and increased levels of alanine aminotransferase and aspartate aminotransferase were reported to be higher in women in the RL cohort than in women in the DF and BF cohorts. Depression, anxiety, and increased levels of alanine aminotransferase and aspartate aminotransferase were reported to be higher in women in the BF cohort than in women in the DF and RL cohorts.
Dalpiciclib plus fulvestrant is effective and comparatively safe in postmenopausal women with hormone receptor-positive and HER2-negative breast cancers. Dalpiciclib, buparlisib, fulvestrant, and ribociclib cause neutropenia, severe depression, adverse gastroenterological effects, and adverse hepatological effects, respectively.
本研究旨在比较接受玻玛西林联合氟维司群（BF 队列，n=108）、达尔西利联合氟维司群（DF 队列，n=132）或瑞波西利联合来曲唑（RL 队列，n=150）治疗的激素受体阳性、HER2 阴性绝经后乳腺癌患者的无进展生存期、总生存期、临床获益和不良反应，以瑞波西利联合来曲唑治疗为参考标准。
直至观察到不可接受的毒性，患者接受玻玛西林联合氟维司群（BF 队列）、达尔西利联合氟维司群（DF 队列）或瑞波西利联合来曲唑（RL 队列）治疗。
BF、DF 和 RL 队列中分别有 117（89%）、80（74%）和 84（56%）例患者有临床获益。治疗后，DF 队列的临床获益率和无进展生存期及总生存期均高于 BF 和 RL 队列（所有 P 值均<0.05）。DF 队列和 BF 队列的中性粒细胞减少症、呕吐、便秘、恶心、腹泻和厌食发生率高于 RL 队列。RL 队列的白细胞减少症、丙氨酸氨基转移酶和天冬氨酸氨基转移酶水平升高发生率高于 DF 队列和 BF 队列。BF 队列的抑郁、焦虑及丙氨酸氨基转移酶和天冬氨酸氨基转移酶水平升高发生率高于 DF 队列和 RL 队列。
达尔西利联合氟维司群治疗激素受体阳性、HER2 阴性绝经后乳腺癌患者有效且相对安全。达尔西利、玻玛西林、氟维司群和瑞波西利分别引起中性粒细胞减少症、严重抑郁、不良胃肠道反应和不良肝毒性。
