Niraparib treatment patterns and outcomes in first-line maintenance therapy for ovarian cancer: The RENI-1 study

Abstract

Background:

Prospective real-world data on poly(adenosine diphosphate-ribose [ADP]-ribose) polymerase inhibitors (PARPi) as first-line maintenance therapy (1LMT) for ovarian cancer are limited. This study was conducted to evaluate the treatment patterns, efficacy, and safety of niraparib as 1LMT in Chinese patients with ovarian cancer.

Methods:

This was a prospective, multicenter, noninterventional, real-world study evaluating niraparib as 1LMT in newly diagnosed ovarian cancer. The primary endpoint was treatment patterns. Secondary endpoints included progression-free survival (PFS), chemotherapy-free interval (CFI), time to first subsequent treatment (TFST), overall survival (OS), safety, and quality of life (QoL).

Results:

A total of 227 patients were enrolled. The median time to maintenance initiation was 7.4 weeks. Most patients (218/227, 96.0%) received niraparib monotherapy; 95.6% (n = 217) started at 200 mg daily, and 73.6% (n = 167) maintained a stable 200 mg dose. After a median follow-up of 41.5 months, the median PFS was 36.5 months in the intention-to-treat (ITT) population and 25.4 months in patients with The International Federation of Gynecology and Obstetrics (FIGO) stage III–IV disease. Median PFS was not reached (NR) in the BRCA1/2-mutated and homologous recombination deficiency (HRD) positive subgroups, and it was 25.4 and 22.2 months in the BRCA1/2 wild-type and HRD-proficient subgroups, respectively. PFS rates at 36 months were 67.5% in the BRCA1/2-mutated, 58.7% in the HRD-positive, and 50.1% in the ITT population. Median CFI, TFST, and OS were NR; OS rate at 36 months was 80.2%. Factors associated with longer PFS included R0 resection, primary debulking surgery, complete response after chemotherapy, BRCA1/2 mutation, and HRD positivity. No new safety concerns were identified, and QoL remained stable.

Conclusion:

As the prospective real-world study of niraparib 1LMT in China, it provides powerful complementary evidence to pivotal randomized controlled trials conducted in highly selective populations, further supporting niraparib as the first-line maintenance standard treatment.

Introduction

Ovarian cancer is one of the most lethal gynecologic malignancies.^[1] Over the past decade, poly(adenosine diphosphate-ribose [ADP]-ribose) polymerase inhibitors (PARPi) have significantly prolonged progression-free survival (PFS) as first-line maintenance therapy (1LMT), marking a major milestone in the management of epithelial ovarian cancer.^[2–6] Four PARP inhibitors are currently approved in China for this indication, with variations in their approved populations.^[2,7–9]

Niraparib, a highly selective inhibitor of PARP 1/2, was the first PARP inhibitor approved in China for 1LMT in a broad patient population, irrespective of biomarker status. Approval was supported by two pivotal phase III trials PRIMA and PRIME, which demonstrated significant PFS benefits over placebo across different risk groups. PRIMA enrolled high-risk patients, excluding those with stage III disease who achieved R0 resection after primary debulking surgery (PDS), whereas PRIME included a broader population irrespective of cytoreductive surgery outcomes. In the intention-to-treat (ITT) population, median PFS improved from 8.2 to 13.8 months (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.50–0.76; P <0.001) in PRIMA, and from 8.3 to 24.8 months (HR, 0.45; 95% CI, 0.34–0.60; P <0.001) in PRIME.^[3,4]

Despite robust evidence from randomized controlled trials (RCTs), the generalizability of their findings is often limited by strict eligibility criteria and highly controlled study settings. In real-world practice, treatment decisions are shaped by multiple factors, including comorbidities, treatment adherence, clinician experience, drug accessibility, reimbursement policies, and cost. Real-world data (RWD) are therefore essential for evaluating treatment effectiveness and safety in broader populations. However, most published RWD on PARP inhibitors are retrospective and limited by data quality and completeness.^[10,11]

To address these gaps and generate real-world evidence to inform clinical decision-making, we conducted RENI-1 (real-world study of niraparib as first-line maintenance treatment in patients with newly diagnosed ovarian cancer, NCT04986371), a prospective, noninterventional real-world study evaluating the treatment patterns, efficacy, and safety of niraparib as 1LMT in Chinese patients with ovarian cancer.

Methods

Study design and participants

This was a prospective, multicenter, noninterventional real-world study conducted across 22 hospitals in China [Supplementary Table 1, http://links.lww.com/CM9/C926]. The study was performed in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines for clinical drug trials, and applicable Chinese regulations and standards. The protocol was reviewed and approved by the Ethics Committee of the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College (Approval No. 21/251-2922). Ethical approval was also obtained at each participating center before patient enrollment. Written informed consent was obtained from all patients before inclusion. Eligible patients were aged ≥18 years with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients who achieved a complete or partial response (PR) following first-line platinum-based chemotherapy and were considered eligible for niraparib maintenance therapy by their treating physicians were included [Supplementary Table 2, http://links.lww.com/CM9/C926].

Procedures

Niraparib monotherapy or niraparib-based combination therapy was administered according to patient performance status. The starting dose was determined by baseline body weight and platelet count: patients weighing <77 kg or with a platelet count <150 × 10⁹/L received 200 mg once daily, whereas others received 300 mg once daily. A 100 mg once-daily starting dose could also be prescribed at the investigators’ discretion. Maintenance treatment was delivered in 28-day cycles until disease progression, death, unacceptable toxicity, patient withdrawal, loss to follow-up, or completion of 36 months. Efficacy and safety assessments were conducted at months 1, 3, and 6 after treatment initiation and every 6 months thereafter.

Homologous recombination deficiency (HRD) status was primarily assessed by central laboratory testing using HRDetect CDx (MEDx Translational Medicine Co., Ltd., Suzhou, China), with positivity defined as an HRD score ≥43 or the presence of deleterious or suspected deleterious BRCA1/2 mutations. In addition, patients could provide BRCA1/2 and/or HRD status results from other accredited local commercial laboratories.

Outcomes

The primary endpoints were the treatment patterns of niraparib, specifically the time from completion of the last chemotherapy to initiation of maintenance therapy, the treatment regimen, the starting dose, and the stable dose (defined as the maintained dose at cycle 4). Secondary endpoints included median PFS, 6-month PFS rate, chemotherapy-free interval (CFI), time to first subsequent treatment (TFST), overall survival (OS), safety, and quality of life (QoL). PFS was defined as the time from initiation of niraparib treatment to disease progression or death from any cause. CFI was defined as the time from completion of the last chemotherapy to initiation of the subsequent antitumor therapy. TFST was defined as the time from initiation of niraparib treatment to the start of the first subsequent antitumor therapy. OS was defined as the time from initiation of niraparib treatment to death from any cause. Efficacy assessments were performed by investigators according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).^[12] Adverse events (AEs) were classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v.5.0.^[13] QoL was assessed at each visit using the European Quality of Life Five Dimension–Five Level questionnaire (EQ-5D-5L) and the Functional Assessment of Cancer Therapy–Ovarian Symptoms Index (FOSI).^[14,15] Exploratory analyses evaluated treatment patterns and efficacy in biomarker-defined subgroups, as well as clinical factors associated with PFS.

Statistical analysis

Statistical analyses were performed using R v.4.3.3 (R Foundation, Vienna, Austria). Categorical variables were summarized as frequencies and percentages, while continuous variables were summarized as means ± standard deviations or medians and ranges. The chi-squared test or Fisher’s exact test was used to analyze categorical variables. Kaplan–Meier methods were used to estimate survival outcomes, and 95% CIs were calculated. “NR” indicated that the median was not reached and “NE” indicated that the CI was not estimable at the data cut-off due to insufficient events. The Cox proportional-hazards model was applied to evaluate associations between baseline candidate prognostic factors and PFS. Proportional-hazards assumptions were assessed using Schoenfeld residuals test, which confirmed that the assumption was satisfied, supporting the appropriateness of the model. Forest plots were generated to display HRs, 95% CIs, and corresponding P-values for each variable. Univariate and multivariate logistic regression models were used to explore factors associated with PFS ≥24 and ≥36 months. Statistical significance was set at P <0.05.

Results

Demographic and clinical characteristics

From September 7, 2021 to August 31, 2022, 251 patients were screened, and 227 were enrolled [Supplementary Figure 1, http://links.lww.com/CM9/C926]. The cut-off date for this analysis was September 19, 2025. As shown in Table 1, the median age was 57 years (range 32–78 years). Stage IV disease was observed in 66 patients (29.1%) and 97 (42.7%) received neoadjuvant therapy. Most patients (99.1%) underwent cytoreductive surgery, with macroscopic residual disease reported in 75 (33.0%). The median number of cycles of first-line chemotherapy was six. Among these patients, 39 (17.2%) received bevacizumab in combination with chemotherapy, and 67 (29.5%) achieved a PR after chemotherapy. Eleven (4.8%) had elevated cancer antigen 125 (CA-125) levels (>35 U/mL) before maintenance therapy. Additionally, 47 (20.7%) carried BRCA1/2 mutations, and 118 (52.0%) were HRD-positive. Comorbidities were present in 115 (50.7%), most commonly hypertension (49, 21.6%), diabetes (19, 8.4%), and phlebothrombosis (13, 5.7%). Comparison with the PRIMA and PRIME trials revealed significant differences in baseline characteristics [Supplementary Table 3, http://links.lww.com/CM9/C926].^[3,4]

Table 1.

Baseline characteristics of patients with newly diagnosed ovarian cancer.

Characteristics	Patients (N = 227)
Age	57 (32–78)
≤65 years	180 (79.3)
>65 years	47 (20.7)
ECOG performance status
0	134 (59.0)
1	90 (39.7)
2	3 (1.3)
FIGO stage
I	4 (1.8)
II	13 (5.7)
III	144 (63.4)
IV	66 (29.1)
Primary tumor location
Ovary	193 (85.0)
Fallopian tube	31 (13.7)
Peritoneum	3 (1.3)
Histologic subtype
Serous ovarian cancer	209 (92.0)
Endometrioid carcinoma	9 (4.0)
Other*	9 (4.0)
Neoadjuvant chemotherapy
Yes	97 (42.7)
No	130 (57.3)
Cytoreductive surgery outcome
No macroscopic residual disease (R0)	144 (63.4)
Macroscopic residual disease (R1/R2)	75 (33.0)
Missing	6 (2.7)
No surgery	2 (0.9)
Chemotherapy cycles	6 (2–15)†
Prior bevacizumab in chemotherapy
Yes	39 (17.2)
No	188 (82.8)
Response after chemotherapy
Complete response	160 (70.5)
Partial response	67 (29.5)
CA-125 levels before maintenance therapy
≤35 U/mL	216 (95.2)
>35 U/mL	11 (4.8)
BRCA1/2 status‡
Mutant	47 (20.7)
Wild type	163 (71.8)
Unknown	17 (7.5)
Homologous recombination status§
Deficiency (HRD)	118 (52.0)
Proficiency (HRP)	65 (28.6)
Unknown	44 (19.4)
Comorbidities
No	112 (49.3)
Yes‖	115 (50.7)
Hypertension	49 (21.6)
Diabetes	19 (8.4)
Phlebothrombosis	13 (5.7)
Hyperlipidemia	9 (4.0)
Coronary heart disease	9 (4.0)
Hepatitis B	2 (0.9)
Depression	2 (0.9)
Cerebral embolism	1 (0.4)
Others	46 (20.3)

Data are presented as n (%) or median (range). ^*Other histological subtypes included one mucinous carcinoma, three mucinous adenocarcinomas, and five clear cell carcinomas. ^†The maximum of 15 cycles was observed in one patient treated with a weekly chemotherapy regimen, which corresponds approximately to five cycles in a 3-weekly regimen. ^‡BRCA1/2 mutations referred to deleterious or suspected deleterious mutations in the BRCA1 or BRCA2 gene, either germline or somatic. ^§HRD was defined as the presence of BRCA mutations and/or a tumor HRD status ≥43 on the HRD assay, whereas HRP was defined as the absence of BRCA mutations with a tumor HRD status <43 on the HRD assay. ^‖Some patients had more than one comorbidity. CA-125: Cancer antigen 125; ECOG: Eastern Cooperative Oncology Group; FIGO: International Federation of Gynecology and Obstetrics; HRD: Homologous recombination deficiency; HRP: Homologous recombination proficiency.

Treatment patterns

Treatment patterns are summarized in Table 2. The median interval from completion of chemotherapy to initiation of niraparib was 7.4 weeks (range 0.9–40.0 weeks). A total of 192 patients (84.6%) began maintenance within 12 weeks of completing chemotherapy. Of the 227 patients, 218 (96.0%) received niraparib monotherapy, and 9 (4.0%) received niraparib combined with antiangiogenic agents (bevacizumab or anlotinib). Most patients (217, 95.6%) started niraparib at 200 mg daily. Ultimately, 167 (73.6%) maintained a stable dose of 200 mg, 29 (12.8%) remained on 100 mg daily, and 7 (3.0%) alternated between 100 and 200 mg daily. Treatment patterns did not differ significantly across BRCA1/2 mutation or HRD subgroups [Supplementary Table 4, http://links.lww.com/CM9/C926].

Table 2.

Treatment patterns of patients with newly diagnosed ovarian cancer.

Treatment patterns	Patients (N = 227)
Median time to maintenance initiation (weeks)*	7.4 (0.9–40.0)
Time to maintenance initiation
≤12 weeks	192 (84.6)
>12 weeks	35 (15.4)
Maintenance regimen
Niraparib monotherapy	218 (96.0)
Niraparib + bevacizumab	5 (2.2)
Niraparib + anlotinib	4 (1.8)
Starting daily dose of niraparib
100 mg	8 (3.5)
200 mg	217 (95.6)
100 mg/200 mg alternative	2 (0.9)
Stable daily dose of niraparib†
100 mg	29 (12.8)
200 mg	167 (73.6)
100 mg/200 mg alternative	7 (3.0)
Treatment interruption	17 (7.5)
Lost to follow-up	4 (1.8)
Patient withdrawal	3 (1.3)

Data are presented as n (%) or median (range). ^*Median initiation time was defined as the median interval from completion of chemotherapy to initiation of niraparib maintenance therapy. ^†Stable dose of niraparib was defined as the dose at the beginning of cycle 4.

At the data cut-off, 86 of 227 patients (37.9%) in the ITT population had received niraparib for ≥3 years. By BRCA status, the proportions were 55.3% (26/47) in the BRCA1/2-mutated subgroup, 33.1% (54/163) in the BRCA1/2 wild type, and 35.3% (6/17) in BRCA1/2-unknown patients. Similarly, by HRD status, 48.3% (57/118) of HRD patients had a treatment duration ≥3 years, compared with 29.2% (19/65) of HRP patients and 22.7% (10/44) of HRD-unknown patients [Supplementary Table 5, http://links.lww.com/CM9/C926].

Efficacy

At the data cut-off, the median follow-up was 41.5 months. Overall, 111 patients (48.9%) had experienced disease progression or death. In the ITT population, the 6-, 24-, and 36-month PFS rates were 85.5%, 54.1%, and 50.1%, respectively. The median PFS was 36.5 months (95% CI, 22.7–NE) in the ITT population and was 25.4 months (95% CI, 18.0–NE) in patients with International Federation of Gynecology and Obstetrics (FIGO) stage III–IV disease. Median CFI and TFST were not reached (NR) [Figure 1A, B and Supplementary Figure 2, http://links.lww.com/CM9/C926]. At the data cut-off, 42 patients (18.5%) had died, and the estimated 36-month OS rate was 80.2% [Supplementary Figure 3, http://links.lww.com/CM9/C926].

Figure 1.

Kaplan–Meier estimates of progression-free survival (PFS). (A) PFS in the intention-to-treat population. (B) PFS in the patients with FIGO stage III–IV. (C) PFS by BRCA1/2 mutation status. (D) PFS by homologous recombination status. Kaplan–Meier curves illustrate the rate of disease progression or death as evaluated by investigators. BRCA-m: BRCA-mutated; BRCA-wt: BRCA wild-type; BRCA-UNK: BRCA mutation status unknown; CI: Confidence interval; FIGO: International Federation of Gynecology and Obstetrics; HRD: Homologous recombination deficiency; HRP: Homologous recombination proficiency; HR-UNK: HRD status unknown; ITT: Intention-to-treat; NE: Not estimable; NR: Not reached.

By BRCA status, the median PFS was NR (95% CI, NE–NE) in the BRCA1/2-mutated subgroup, 25.4 months (95% CI, 17.5–NE) in the BRCA1/2-wild-type subgroup, and 12.2 months (95% CI, 9.4–NE) in the BRCA1/2-unknown subgroup. The corresponding 6-month PFS rates were 95.7%, 82.9%, and 81.2%, respectively. By HRD status, the median PFS was NR (95% CI, 37.5–NE) in the HRD-positive subgroup, 22.2 months (95% CI, 11.8–NE) in the HRP subgroup, and 17.2 months (95% CI, 11.1–NE) in the HRD–unknown subgroup, with 6-month PFS rates of 89.8%, 80.5%, and 80.7%, respectively [Figure 1C, D]. PFS outcomes in patients with FIGO stage III–IV stratified by biomarker subgroups are shown in Supplementary Figure 4, http://links.lww.com/CM9/C926.

Subgroup analyses based on baseline characteristics and treatment patterns are summarized in Supplementary Figure 5A, http://links.lww.com/CM9/C926. Patients with FIGO stage I–II disease, postoperative R0 status, PDS, complete response, BRCA1/2 mutation, HRD positivity, CA-125 ≤35 U/mL before maintenance initiation, and monotherapy demonstrated significantly longer PFS (P <0.05). The sample size was fewer than 20 patients in the stage I–II, CA-125 >35 U/mL, and combination therapy subgroups. No significant differences in PFS were observed by number of chemotherapy cycles, interval from chemotherapy completion and maintenance initiation, comorbidities, starting dose, or stable dose. PFS outcomes stratified by stable dose (200 mg vs. non–200 mg) and by prior chemotherapy ± bevacizumab are shown in Supplementary Figure 5B and C, http://links.lww.com/CM9/C926, respectively, with no significant differences observed.

Further exploratory analyses evaluated predictors of long-term benefit. In multivariate models, postoperative R0 status consistently emerged as independent predictors of PFS ≥24 months and ≥36 months [Supplementary Table 6, http://links.lww.com/CM9/C926].

Subsequent therapies regimen

Among the 111 patients who experienced disease progression, data on subsequent therapies were available for 90 (83.6%). Of these, 74 patients (82.2%) received platinum-based chemotherapy with or without bevacizumab, 9 (10.0%) received nonplatinum chemotherapy with or without bevacizumab, and 7 (7.8%) received targeted therapies. Details of the subsequent regimens are provided in Supplementary Table 7, http://links.lww.com/CM9/C926.

Safety

Treatment-related adverse events (TRAEs) occurred in 164 patients (72.2%), and grade ≥3 TRAEs were reported in 41 patients (18.1%) [Supplementary Table 8, http://links.lww.com/CM9/C926]. Serious TRAEs were observed in 13 patients (5.7%). At the data cut-off, 56 (24.7%) patients had treatment interruptions, 49 (21.6%) had dose reductions, and 13 (5.7%) discontinued treatment due to TRAEs.

The most common events were hematologic toxicities, including leukopenia (69/227, 30.4%), anemia (66/227, 29.1%), neutropenia (53/227, 23.3%), and thrombocytopenia (45/227, 19.8%). Most cases of thrombocytopenia (38/45, 84.4%), neutropenia (40/53, 75.5%), and leukopenia (52/69, 75.4%) occurred within the first 3 months of treatment. The most frequent grade ≥3 TRAEs were anemia (15/227, 6.6%), neutropenia (12/227, 5.3%), thrombocytopenia (12/227, 5.3%), and leukopenia (9/227, 4.0%). The majority of grade ≥3 AEs occurred within the first 3 months of maintenance [Supplementary Figure 6, http://links.lww.com/CM9/C926]. No cases of myelodysplastic syndrome (MDS)/acute myeloid leukemia or secondary primary malignancies were reported.

The effects of chemotherapy cycles and BRCA/HRD status on TRAEs incidence during maintenance therapy were also analyzed, with no significant correlations observed [Supplementary Table 9, http://links.lww.com/CM9/C926].

Patient-reported outcomes

Baseline and follow-up QoL questionnaire results are shown in Supplementary Figure 7, http://links.lww.com/CM9/C926. Both EQ-5D-5L and FOSI assessments indicated that niraparib did not adversely affect QoL throughout treatment. Patients maintained stable physical performance.

Discussion

The RENI-1 study is a prospective, multicenter, real-world investigation of niraparib as first-line maintenance therapy (1LMT) for epithelial ovarian cancer, and represents the largest dataset to date on niraparib 1LMT in China. Building on pivotal RCTs conducted in highly selective populations, RENI-1 further confirmed the benefit of niraparib in 1LMT and provided valuable real-world evidence in Chinese patients, including patients’ clinical characteristics, treatment patterns, long-term maintenance duration, predictors of PFS benefit, safety profile, patient-reported outcomes, and post-progression therapies.

Efficacy comparison with pivotal trials

Compared with the PRIME trial, RENI-1 included fewer patients with BRCA1/2 mutations (20.7% vs. 33.3%), HRD positivity (52.0% vs. 66.7%), and complete response after chemotherapy (70.5% vs. 83.1%). Despite these differences, the median PFS of stage III–IV patients in RENI-1 (25.4 months) was comparable to PRIME (24.8 months). Subgroups analyses further demonstrated clinical benefit regardless of BRCA1/2 mutation or HRD status. HRD testing was heterogeneous across centers and assays (37% from noncentral laboratories), yet outcomes remained beneficial in patients with both HRD and HRP, consistent with the PRIME trial. Importantly, the real-world study reported long-term niraparib treatment ≥3 years, with 37.9% of the overall population and more than half of BRCA1/2-mutated patients remaining on therapy, highlighting durable benefit and tolerability of niraparib in routine practice.

Clinical characteristics, treatment patterns, and clinical practice variability

More than half of the patients had comorbidities, a feature rarely reported in previous trials, yet PFS outcomes were comparable between patients with and without comorbidities. Niraparib’s unique carboxylesterase metabolism, which minimizes CYP-mediated drug–drug interactions, further supports its feasibility in patients receiving multiple medications.^[16,17]

With respect to treatment patterns, most patients (84.6%) initiated niraparib within 12 weeks after chemotherapy, while a smaller proportion (11.5%) started between 12 and 24 weeks due to delayed recovery or clinical considerations. Comparable outcomes across these groups suggest that later initiation may be feasible in selected patients, such as those with delayed hematologic or organ recovery. Nearly all patients (96%) received niraparib monotherapy, including 35 of 39 previously treated with chemotherapy plus bevacizumab. PFS outcomes were comparable regardless of earlier bevacizumab exposure. These findings support niraparib monotherapy as an effective 1LMT option even after chemotherapy plus bevacizumab, although larger studies are required for confirmation. Most patients (95.6%) started at 200 mg/day, consistent with PRIME, reflecting lower body weight and platelet counts in the Chinese population. By cycle 4, 73.6% remained on this dose, indicating good tolerability and adherence.

Predictors of long-term clinical benefit

Identifying predictors of long-term benefit is essential for treatment decisions. In RENI-1, exploratory analyses showed that postoperative R0 status, PDS, complete response, BRCA1/2 mutation, and HRD positivity were associated with prolonged PFS (P <0.05), consistent with previous reports.^{[10,11,18–22]} Results for stage I–II, CA-125 >35 U/mL, and combination therapy should be interpreted with caution given the small sample sizes (<20 patients in each subgroup). Specifically, R0 status remained significant predictor of long-term PFS (≥24 and ≥36 months). This is a real-world study to evaluate predictors of PFS ≥36 months in patients receiving niraparib as 1LMT. By contrast, a post-hoc PRIMA analysis identified BRCA1/2 mutation or HRD status, FIGO stage, and the number of baseline nontarget lesions as predictors of PFS ≥24 months.^[23] These findings may not be generalizable beyond high-risk populations.

Safety, quality of life, and subsequent therapies

The incidence and profile of TRAEs were comparable to the Expanded Access Program in Spain and generally lower than in the PRIMA and PRIME trials,^[24] likely due to supportive care practices, less systematic AE capture, and reduced follow-up during coronavirus disease-2019 (COVID-19). Most events (79.9%) occurred within the first 3 months, underscoring the need for close monitoring in early treatment. Treatment discontinuation due to TRAEs occurred in 5.7% of patients, consistent with the PRIME trial. No association between chemotherapy cycles or BRCA/HRD status and toxicity was observed, supporting the safe use of niraparib across diverse real-world populations. RENI-1 reported the long-term patient-reported outcomes of niraparib as a first-line treatment (1LMT) in Chinese patients with ovarian cancer. QoL assessments using EQ-5D-5L and FOSI showed no significant deterioration during treatment compared with baseline, supporting the tolerability of long-term maintenance.

There is currently no standard strategy after progression on PARP inhibitor maintenance, and the impact of earlier PARP inhibitors exposure on subsequent chemotherapy efficacy remains controversial.^[25–27] RENI-1 provides the first real-world evidence on postprogression treatments in Chinese patients receiving niraparib 1LMT, showing that the majority still received platinum-based regimens, while only a minority received nonplatinum or targeted therapies. The effectiveness of these subsequent treatments requires further investigation.

Limitations

This study has several limitations. First, although the median follow-up reached 41.5 months, OS maturity was only 18.5%, necessitating longer follow-up. Second, as an observational study, potential selection bias cannot be excluded, and a small proportion of patients with FIGO stage I–II were included. However, after excluding these early-stage patients, PFS outcomes in RENI-1 remained consistent with those of the PRIME trial.

Conclusions

The RENI-1 real-world study complements pivotal RCTs with strict enrollment criteria, reflecting more diverse treatment patterns. Efficacy outcomes were consistent with PRIME. No new safety signals were observed, and QoL remained stable.

Funding

This study was supported by the Beijing Xisike Clinical Oncology Research Foundation (No. Y-zai2021/ms-0255) and the National High Level Hospital Clinical Research Funding (No. 80102022510).

Conflicts of interest

This study was funded by Zai Lab (Shanghai) Co., Ltd. The funders had no role in the design or execution of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Supplementary Material

cm9-139-2968-s001.pdf ^{(1.8MB, pdf)}