China Oncology ›› 2021, Vol. 31 ›› Issue (7): 561-566.doi: 10.19401/j.cnki.1007-3639.2021.07.001

• Specialists’ Article • Previous Articles     Next Articles

Preliminary study on efficacy and safety of fluzoparib in patients with metastatic castration-resistant prostate cancer

WEI Yu 1 , ZHANG Tingwei 1 , HE Yi 2 , LI Jun 3 , BI Jianbin 4 , ZENG Yu 5 , WAN Lijun 6 , WU Gaoliang 7 , WANG Huansheng 8 , ZHANG Jun 9 , ZHU Wei 2 , QU Yuanyuan 1 , ZHU Yao 1 , YE Dingwei 1    

  1. 1. Department of Urology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; 2. Department of Urology, The First Hospital of Jiaxing, Jiaxing 314000, Zhejiang Province, China; 3. Department of Urology, Sichuan Provincial People’s Hospital, Chengdu 610000, Sichuan Province, China; 4. Department of Urology, The First Affiliated Hospital of China Medical University, Shenyang 110001, Liaoning Province, China; 5. Department of Urology, Liaoning Cancer Hospital, Shenyang 110042, Liaoning Province, China; 6. Department of Urology, Quzhou People’s Hospital, Quzhou 324000, Zhejiang Province, China; 7. Department of Urology, Jiangxi Cancer Hospital, Nanchang 330000, Jiangxi Province, China; 8. Department of Urology, Shandong Cancer Hospital, Jinan 250117, Shandong Province, China; 9. Department of Urology, Third Affiliated Hospital, Army Medical University, Chongqing 400030, China
  • Online:2021-07-30 Published:2021-08-03
  • Contact: YE Dingwei E-mail: dwyeli@163.com

Abstract: Background and purpose: Inhibitors of poly (ADP-ribose) polymerase (PARPi) has been shown in multiple clinical trials to benefit survival in patients with homologous recombination repair (HRR) gene mutations in metastatic castration-resistant prostate cancer (mCRPC). Fluzoparib has been approved for the treatment of ovarian, fallopian tube and peritoneal cancers, but no data have been reported for prostate cancer. The purpose of this study was to evaluate the efficacy and safety of fluzoparib in the treatment of patients with prostate cancer. Methods: The clinical data of 13 mCRPC patients treated with fluzoparib alone or fluzoparib combined with abiraterone or SHR3680 (androgen receptor antagonist) in 9 hospitals nationwide including Fudan University Shanghai Cancer Center from January 1, 2020 to February 1, 2021 were retrospectively analyzed. Genetic mutation data, survival data, adverse reactions and other data were obtained through outpatient cases or telephone follow-up. Results: Among the 13 patients, 3 patients were treated with fluzoparib alone, 8 patients were treated with fluzoparib combined with abiraterone, and 2 patients were treated with fluzoparib combined with SHR3680. All the 3 patients treated with monotherapy carried HRR gene mutations, and all had prostate-specific antigen (PSA); among those, 2 patients (66.7%) had PSA decrease of more than 50%. All the 8 patients treated with fluzoparib combined with abiraterone had been resistant to abiraterone at the earlier stage, and the genetic testing results showed that 2 patients did not carry HRR pathogenic mutation, and 1 patient did not receive genetic testing. Among the 8 patients, only 1 patient without HRR pathogenic mutation had an increase in PSA after receiving the combined treatment, while the remaining 7 patients (87.5%) had a decrease in PSA. PSA decreased by more than 50% in 3 patients (37.5%) and 90% in 2 patients (25.0%). The 2 patients treated with fluzoparib combined with SHR3680 had been resistant to abiraterone and docetaxel at the earlier stage, one patient had no genetic test and no PSA response, and the other patient had no DNA damage repair (DDR) gene mutation, however, decreased by more than 50%. At the same time, 61.5% (8/13) of the patients showed different degrees of adverse reactions, the main adverse reactions were anemia, joint pain, loss of appetite and fatigue; 23.1% (3/13) of the patients developed grade 3 anemia, of whom 1 patient terminated the treatment. Conclusion: Fluzoparib shows promising clinical prospects, and is well tolerated in both monotherapy and combination therapy. However, this conclusion needs to be further confirmed in prospective clinical studies with larger sample size.

Key words: Prostate cancer, Fluzoparib, Homologous recombination repair deficiency, Efficacy