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  • O017/#15 Efficacy and safety of niraparib maintenance treatment in platinum-sensitive recurrent ovarian cancer after shorter or longer chemotherapy: a post hoc subgroup analysis

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Oral Abstracts
Plenary 6
O017/#15 Efficacy and safety of niraparib maintenance treatment in platinum-sensitive recurrent ovarian cancer after shorter or longer chemotherapy: a post hoc subgroup analysis
  1. Y Gao1,
  2. X Wu2,
  3. J Zhu3,
  4. R Yin4,
  5. J Yang5,
  6. J Liu6,
  7. J Wang7,
  8. L Wu8,
  9. Z Liu9,
  10. D Wang10,
  11. G Lou11,
  12. H Yang12,
  13. Q Zhou13,
  14. B Kong14,
  15. Y Huang15,
  16. L Chen16,
  17. G Li17,
  18. R An18,
  19. T Tan19 and
  20. J Dong19
  1. 1Peking University Cancer Hospital and Institute, Department of Gynecology, Beijing, China
  2. 2Fudan University Shanghai Cancer Center, Department of Gynecologic Oncology, Shanghai, China
  3. 3Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Department of Gynecologic Oncology, Hangzhou, China
  4. 4West China Second University Hospital, Sichuan University, Department of Obstetrics and Gynecology; Key Laboratory of Birth Defects and Related Diseases of Women and Children (sichuan University), Ministry of Education, Chengdu, China
  5. 5Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Department of Gynecologic Oncology, Beijing, China
  6. 6Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology, Guangzhou, China
  7. 7Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Department of Gynecologic Oncology, Changsha, China
  8. 8National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Department of Gynecologic Oncology, Beijing, China
  9. 9The First Hospital of Jilin University, Department of Oncology, Changchun, China
  10. 10Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Department of Gynecology, Shenyang, China
  11. 11Harbin Medical University Cancer Hospital, Department of Gynecology, Harbin, China
  12. 12The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Hospital, Department of Gynecologic Oncology, Kunming, China
  13. 13Chongqing University Cancer Hospital, Gynecological Oncology Center, Chongqing, China
  14. 14Qilu Hospital of Shandong University, Department of Obstetrics and Gynecology, Jinan, China
  15. 15Hubei Cancer Hospital, Department of Gynecologic Oncology, Wuhan, China
  16. 16Affiliated Cancer Hospital of Guangzhou Medical University, Department of Gynecological Oncology, Guangzhou, China
  17. 17Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Cancer Center, Wuhan, China
  18. 18The First Affiliated Hospital of Xi’an Jiaotong University, Department of Obstetrics and Gynecology, Xi’an, China
  19. 19Zai Lab (Shanghai) Co., Ltd, Randd Department, Shanghai, China

Abstract

Objectives Traditionally ≥6 cycles of platinum-containing chemotherapy (Pt-chemo) are recommended for platinum-sensitive recurrent ovarian cancer (PSROC). PARP inhibitor maintenance treatment (MT) can be initiated upon clinical complete/partial response (CR/PR) after ≥4 cycles of chemotherapy. Shorter chemotherapy may improve patient experience without compromising efficacy. This study aims to compare the efficacy and safety of niraparib to placebo as MT administered after ≤4 or >4 cycles of Pt-chemo.

Methods This is a post hoc analysis of the published NORA phase III study (NCT03705156). Adults with PSROC and CR/PR to most recent Pt-chemo were randomized 2:1 to niraparib or placebo. Primary endpoint was PFS by BICR. Subgroups comprised patients with ≤4 or >4 cycles of most recent Pt-chemo.

Results Table 1 summarizes key baseline characteristics which were overall balanced between groups. Median (95% CI) PFS was 18.37 months (8.54–not estimable [NE], ≤4-cycle/niraparib) versus 3.88 months (3.68–7.43, ≤4-cycle/placebo; HR=0.36 [p=0.0016]), and was 18.33 months (10.28–NE, >4-cycle/niraparib) versus 5.49 months (3.71–5.75, >4-cycle/placebo; HR=0.33 [p<0.0001]) (figure 1). Overall safety profiles were comparable between ≤4-cycle/niraparib and >4-cycle/niraparib, with similar percentages of patients experiencing neutrophil count decrease (60.4%; 58.1%), anemia (50.0%; 55.0%), and platelet count decrease (45.8%; 58.1%). Composition of grade ≥3 TEAEs was consistent with the overall NORA results.

View this table:
Abstract O017/#15 Table 1

Key baseline characteristics for subgroups with ≤4 or >4 treatment cycles of most recent PT-chemo

Abstract O017/#15 Figure 1
Abstract O017/#15 Figure 1

PFS by blinded independent central review (interaction-to-treat)

Conclusions Similar niraparib-versus-placebo PFS benefits were observed after ≤4-cycle or >4-cycle Pt-chemo in CR/PR patients. The efficacy and safety of niraparib MT after shorter Pt-chemo remain to be verified in larger samples.

https://doi.org/10.1136/ijgc-2021-IGCS.17

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