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Proffered Paper - Gynaecological cancers 1

LBA29 - Individualized starting dose of niraparib in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC): A randomized, double-blind, placebo-controlled, phase III trial (NORA)

Date

19 Sep 2020

Session

Proffered Paper - Gynaecological cancers 1

Presenters

Xiaohua Wu

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

X. Wu1, J. Zhu2, R. Yin3, J. Yang4, J. Liu5, J. Wang6, L. Wu7, Z. Liu8, Y. Gao9, D. Wang10, G. Lou11, H. Yang12, Q. Zhou13, B. Kong14, Y. Huang15, L. Chen16, G. Li17, R. An18, K. Wang19, Y. Zhang20

Author affiliations

  • 1 Department Of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 2 Department Of Gynecologic Oncology, Cancer hospital of the University of Chinese Academy of Sciences, 310022 - Hangzhou/CN
  • 3 Department Of Gynecology And Obstetrics, West China Second University Hospital, Sichuan University; Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, 610066 - Chengdu/CN
  • 4 Department Of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100032 - Beijing/CN
  • 5 Department Of Gynecologic Oncology, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 6 Department Of Gynecologic Oncology, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, 410013 - Changsha/CN
  • 7 Department Of Gynecologic Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 8 Department Of Oncology, The First Hospital of Jilin University, 130021 - Changchun/CN
  • 9 Department Of Gynecological Oncology, Peking University Cancer Hospital & Institute, 100142 - Beijing/CN
  • 10 Department Of Gynecology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 110042 - Shenyang/CN
  • 11 Department Of Gynecology And Oncology, Harbin medical university cancer hospital, 150081 - Harbin/CN
  • 12 Department Of Gynecology, Yunnan Cancer Hospital/The Third Affiliated Hospital of Kunming Medical University, 650118 - Kunming/CN
  • 13 Department Of Gynecologic Oncology, Chongqing university cancer hospital, 400030 - Chongqing/CN
  • 14 Department Of Obstetrics And Gynecology, Qilu Hospital, Shandong University, 250012 - Ji'nan/CN
  • 15 Department Of Gynecologic Oncology, Hubei Cancer Hospital, 430079 - Wuhan/CN
  • 16 Department Of Gynecological Oncology, Affiliated Cancer Hospital of Guangzhou Medical University, 510095 - Guangzhou/CN
  • 17 Department Of Gynecologic Oncology, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan/CN
  • 18 Department Of Obstetrics And Gynecology, The First Affiliated Hospital of Xi’an Jiaotong University, 710061 - Xi'an/CN
  • 19 Department Of Gynecologic Oncology, Tianjin Medical University Cancer Insitute and Hospital, 300060 - Tianjin/CN
  • 20 Department Of Obstetrics & Gynecology, Xiangya Hospital, Central South University, 410008 - Changsha/CN
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Resources

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Abstract LBA29

Background

Post-hoc analysis of NOVA study suggested that patients with low body weight (< 77 kg) or low platelet count (< 150,000/μL) may benefit from an initial starting dose of niraparib 200 mg without compromising efficacy. We aimed to prospectively assess the efficacy and safety of niraparib with an individualized starting dose (ISD) in Chinese patients.

Methods

NORA trial was conducted in 32 hospitals in China. Eligible patients were women with PSROC who had either germline BRCA mutation or high-grade serious histologic features and who had a complete or partial response after completion of the last round of platinum therapy. Patients were randomly allocated (2:1) to receive oral niraparib or placebo once daily. The starting dose was individualized (ISD) per baseline body weight and platelet count (200 mg for patients with baseline body weight < 77 kg or platelet count < 150,000/μL; otherwise, 300 mg). The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review.

Results

From September 26 2017 to February 2 2019, 265 patients were randomized to niraparib (n=177) or placebo (n=88); 16 patients received fixed starting dose of 300 mg and 249 patients received an ISD (300 mg, n=14; 200 mg, n=235) under the amended protocol. The median PFS was significantly longer for patients on niraparib versus placebo; 18.3 (95% CI, 10.9, not evaluable) versus 5.4 (95% CI, 3.7, 5.7) months (HR=0.32; 95% CI, 0.23–0.45; p <0.0001). Grade ≥3 treatment emergent adverse events (TEAE) occurred in 50.8% and 19.3% of patients (niraparib vs placebo), especially for hematological TEAE reported in the Table. Table: LBA29

Hematology TEAE of Grade ≥ 3

TEAEs, n (%) Niraparib (n=177) Placebo (n=88)
Neutrophil count decreased 36 (20.3) 7 (8.0)
Platelet count decreased # 20 (11.3) 1 (1.1)
Anaemia 26 (14.7) 2 (2.3)

# Include PTs of platelet count decreased & thrombocytopenia.

Conclusions

This is the first study to demonstrate the efficacy and safety of niraparib in Chinese patients with PSROC. ISD of niraparib is effective and safe and should be considered a standard clinical practice in this patient population.

Clinical trial identification

NCT03705156.

Editorial acknowledgement

Legal entity responsible for the study

Zai Lab (Shanghai) Co., Ltd.

Funding

Zai Lab (Shanghai) Co., Ltd., Shanghai, China. National Major Scientific and Technological Special Project for “Significant New Drugs Development” in 2018 (No. 2018ZX09736019), China.

Disclosure

All authors have declared no conflicts of interest.

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