TY - JOUR
T1 - Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2)
T2 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial
AU - Li, Ning
AU - Zhang, Youzhong
AU - Wang, Jing
AU - Zhu, Jianqing
AU - Wang, Li
AU - Wu, Xiaohua
AU - Yao, Desheng
AU - Wu, Qiang
AU - Liu, Jihong
AU - Tang, Junying
AU - Yin, Rutie
AU - Lou, Ge
AU - An, Ruifang
AU - Zhang, Guonan
AU - Xia, Xiaoping
AU - Li, Qingshui
AU - Zhu, Yaping
AU - Zheng, Hong
AU - Yang, Xinfeng
AU - Hu, Yuanjing
AU - Zhang, Xin
AU - Hao, Min
AU - Huang, Yi
AU - Lin, Zhongqiu
AU - Wang, Dong
AU - Guo, Xiaoqing
AU - Yao, Shuzhong
AU - Wan, Xiaoyun
AU - Zhou, Huaijun
AU - Yao, Liangqing
AU - Yang, Xielan
AU - Cui, Heng
AU - Meng, Yuanguang
AU - Zhang, Songling
AU - Qu, Jing
AU - Zhang, Ben
AU - Zou, Jianjun
AU - Wu, Lingying
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - PURPOSEThis phase III trial aimed to explore the efficacy and safety of fuzuloparib (formerly fluzoparib) versus placebo as a maintenance treatment after response to second-or later-line platinum-based chemotherapy in patients with high-grade, platinum-sensitive, recurrent ovarian cancer.PATIENTS AND METHODSPatients with platinum-sensitive, recurrent ovarian cancer previously treated with at least two platinum-based regimens were assigned (2:1) to receive fuzuloparib (150 mg, twice daily) or matching placebo for 28-day cycles. The primary end points were progression-free survival (PFS) assessed by blinded independent review committee (BIRC) in the overall population and PFS by BIRC in the subpopulation with germline BRCA 1/2 mutation.RESULTSBetween April 30, 2019, and January 10, 2020, 252 patients were randomly assigned to the fuzuloparib (n = 167) or placebo (n = 85). As of July 1, 2020, the median PFS per BIRC assessment in the overall population was significantly improved with fuzuloparib treatment (hazard ratio [HR], 0.25; 95% CI, 0.17 to 0.36; one-sided P <.0001) compared with that with placebo. The HR derived from a prespecified subgroup analysis showed a consistent trend of benefit in patients with germline BRCA 1/2 mutations (HR, 0.14; 95% CI, 0.07 to 0.28) or in those without mutations (HR, 0.46; 95% CI, 0.29 to 0.74). The most common grade ≥ 3 treatment-emergent adverse events reported in the fuzuloparib group were anemia (25.1%), decreased platelet count (16.8%), and decreased neutrophil count (12.6%). Only one patient (0.6%) discontinued fuzuloparib because of treatment-related toxicity (concurrent decreased white blood cell count and neutrophil count).CONCLUSIONFuzuloparib as maintenance therapy achieved a statistically significant and clinically meaningful improvement in PFS for patients with platinum-sensitive, recurrent ovarian cancer versus placebo, regardless of germline BRCA 1/2 mutation, and showed a manageable safety profile.
AB - PURPOSEThis phase III trial aimed to explore the efficacy and safety of fuzuloparib (formerly fluzoparib) versus placebo as a maintenance treatment after response to second-or later-line platinum-based chemotherapy in patients with high-grade, platinum-sensitive, recurrent ovarian cancer.PATIENTS AND METHODSPatients with platinum-sensitive, recurrent ovarian cancer previously treated with at least two platinum-based regimens were assigned (2:1) to receive fuzuloparib (150 mg, twice daily) or matching placebo for 28-day cycles. The primary end points were progression-free survival (PFS) assessed by blinded independent review committee (BIRC) in the overall population and PFS by BIRC in the subpopulation with germline BRCA 1/2 mutation.RESULTSBetween April 30, 2019, and January 10, 2020, 252 patients were randomly assigned to the fuzuloparib (n = 167) or placebo (n = 85). As of July 1, 2020, the median PFS per BIRC assessment in the overall population was significantly improved with fuzuloparib treatment (hazard ratio [HR], 0.25; 95% CI, 0.17 to 0.36; one-sided P <.0001) compared with that with placebo. The HR derived from a prespecified subgroup analysis showed a consistent trend of benefit in patients with germline BRCA 1/2 mutations (HR, 0.14; 95% CI, 0.07 to 0.28) or in those without mutations (HR, 0.46; 95% CI, 0.29 to 0.74). The most common grade ≥ 3 treatment-emergent adverse events reported in the fuzuloparib group were anemia (25.1%), decreased platelet count (16.8%), and decreased neutrophil count (12.6%). Only one patient (0.6%) discontinued fuzuloparib because of treatment-related toxicity (concurrent decreased white blood cell count and neutrophil count).CONCLUSIONFuzuloparib as maintenance therapy achieved a statistically significant and clinically meaningful improvement in PFS for patients with platinum-sensitive, recurrent ovarian cancer versus placebo, regardless of germline BRCA 1/2 mutation, and showed a manageable safety profile.
UR - https://www.scopus.com/pages/publications/85130864706
U2 - 10.1200/JCO.21.01511
DO - 10.1200/JCO.21.01511
M3 - 文章
C2 - 35404684
AN - SCOPUS:85130864706
SN - 0732-183X
VL - 40
SP - 2436
EP - 2446
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 22
ER -
可持续发展目标 3 良好健康与福祉