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Capivasertib plus fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer: phase 3 CAPItello-291 study extended Chinese cohort

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机构: [1]Fudan Univ, Fudan Univ Shanghai Canc Ctr, Dept Med Oncol, Shanghai, Peoples R China [2]Harbin Med Univ Canc Hosp, Harbin, Peoples R China [3]Liaoning Canc Hosp, Shenyang, Liaoning, Peoples R China [4]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan, Peoples R China [5]First Hosp Jilin Univ, Changchun, Peoples R China [6]First Hosp China Med Univ, Shenyang, Liaoning, Peoples R China [7]Natl Taiwan Univ Hosp, Taipei, Taiwan [8]Taipei Vet Gen Hosp, Taipei, Taiwan [9]Zhengzhou Univ, Affiliated Canc Hosp, Zhengzhou 450008, Peoples R China [10]Guangzhou Med Univ, Affiliated Tumor Hosp, Guangzhou, Peoples R China [11]First Peoples Hosp Foshan, Foshan, Peoples R China [12]Linkou Chang Gung Mem Hosp, Div Breast Surg, Taoyuan, Taiwan [13]Third Hosp Nanchang, Nanchang, Peoples R China [14]Second Peoples Hosp Neijiang, Neijiang, Peoples R China [15]Linyi Canc Hosp, Linyi, Peoples R China [16]Tongji Med Coll, Hubei Canc Hosp, Dept Breast Surg, Wuhan, Hubei, Peoples R China [17]Zhejiang Univ, Sch Med, Sir Run Run Shaw Hosp, Hangzhou, Peoples R China [18]Affiliated Hosp Hebei Univ, Baoding, Hebei, Peoples R China [19]Zhejiang Canc Hosp, Hangzhou, Peoples R China [20]AstraZeneca, Oncol R&D, Gaithersburg, MD USA [21]AstraZeneca, Oncol R&D, Shanghai, Peoples R China [22]Royal Marsden Hosp, Inst Canc Res, London, England
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In the global CAPItello-291 randomized phase 3 study (NCT04305496) in patients with hormone receptor-positive/HER2-negative advanced breast cancer and progression during/after aromatase inhibitor treatment, capivasertib-fulvestrant significantly improved progression-free survival (PFS) in the overall population and patients with PIK3CA/AKT1/PTEN-altered tumors versus placebo-fulvestrant. We assessed efficacy and safety of capivasertib-fulvestrant in a prespecified exploratory analysis of a Chinese cohort (n = 24) and extended study with the same protocol (n = 110). Clinically meaningful PFS benefit for capivasertib-fulvestrant was observed in the overall population (median PFS: 6.9 [capivasertib-fulvestrant] versus 2.8 [placebo-fulvestrant] months; hazard ratio 0.51, 95% CI 0.34-0.76), patients with PIK3CA/AKT1/PTEN-altered tumors (n = 46; 5.7 versus 1.9 months; hazard ratio 0.41, 95% CI 0.19-0.85) and PIK3CA/AKT1/PTEN-non-altered tumors (patients with confirmed next-generation sequencing results [n = 68]; 9.2 versus 2.7 months; hazard ratio 0.38; 95% CI 0.21-0.68). The most frequent adverse events (AEs) with capivasertib-fulvestrant were diarrhea (60.6% versus 11.3% with placebo-fulvestrant) and hyperglycemia (57.7% versus 17.7%). AEs leading to capivasertib-fulvestrant discontinuation were reported in 11.3% of patients versus 3.2% for placebo-fulvestrant. The benefit-risk profile of capivasertib-fulvestrant in the Chinese cohort was favorable; further exploration in patients with PIK3CA/AKT1/PTEN-non-altered tumors is warranted.

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大类 | 1 区 综合性期刊
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Q1 MULTIDISCIPLINARY SCIENCES

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第一作者机构: [1]Fudan Univ, Fudan Univ Shanghai Canc Ctr, Dept Med Oncol, Shanghai, Peoples R China
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