Abstract 315P
Background
Based on PRIMA and PRIME, Niraparib is approved by FDA and NMPA for first-line maintenance of OC regardless of biomarker status. Niraparib is widely used in China, while its efficacy and safety in real world remains to be verified. The purpose of this study was to evaluate the efficacy and safety of niraparib as maintenance in newly diagnosed advanced OC.
Methods
We retrospectively collected patients with pathologically confirmed diagnosis of OC, who received niraparib as first-line maintenance therapy at the Department of Gynecology, Tianjin Cancer Hospital between January 2021 and December 2022. Demographics, baseline characteristics, clinical outcomes and adverse events were collected. The history of niraparib use, including the time from the end of chemotherapy to the start of maintenance therapy, the starting dose, and the stable dose used after 3 months, were also collected.
Results
102 patients were enrolled. The median age was 58 years and 84.3% were FIGO stage III/IV. 18.6% BRCAmut, 58.8% BRCAwt and 22.5% BRCAunkown, while 36.3% HRD deficient, 12.7% HRD proficient and 51% HRD unkown. 53.9% received NACT, 76.5% were R0 after surgery and 62.7% were CR after chemotherapy. Median follow-up was 10.5m. In the ITT population, the mPFS was not reached, with a 24-month PFS rate of 52.5%. The mPFS of BRCAmut, BRCAwt, and BRCAunknown was not reached, 14.4 and 14.6m, respectively. The 24-month PFS rates were 90%, 48.4% and 37.9%, respectively. The mPFS of HRD deficient and HRD proficient were both not reached. 84.3% of patients experienced any grade TEAEs, while 17.6% experienced TEAEs of grade ≥3. TEAEs leading to treatment interruption was 36.3%, leading to dose reduction was 29.4%, leading to discontinuation was 0.98%. The most common hematological TEAEs were platelet count decreased (28.4%) while grade ≥3 TEAEs was 5.9%, white blood cell count decreased (20.6%) and neutrophil count decreased (26.5%). Non-hematologic TEAEs were nausea (31.4%), fatigue (30.4%) and insomnia (21.6%).
Conclusions
In the real world, niraparib maintenance in newly diagnosed advanced OC is effective and safe, which was consistent with previous RCT. More clinical related factors affecting prognosis will be further explored.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Tianjin Medical University Cancer Institute & Hospital.
Funding
Committee of Gynecological Oncology, Tianjin anti-cancer association.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
227P - Proteomic analysis of urothelial lesions reveals novel diagnostic biomarkers to distinguish pathologic pitfalls and protein-protein interactions
Presenter: Changlim Hyun
Session: Poster Display
Resources:
Abstract
228P - Real-world data on dose adjustment of cabozantinib in advanced renal cell carcinoma
Presenter: Hemavathi Baskarane
Session: Poster Display
Resources:
Abstract
229P - The application of diffusion kurtosis imaging in predicting muscle invasion of bladder cancer: A comparison with conventional DWI
Presenter: Shuai Jiang
Session: Poster Display
Resources:
Abstract
230P - Oncological outcomes between partial cystectomy and radical cystectomy in solitary muscle invasive bladder cancer with downgraded T stage
Presenter: Ming Wei Hsu
Session: Poster Display
Resources:
Abstract
231P - BMI-predicted progression-free survival after pembrolizumab therapy for urothelial cancer: Asian version of BMI classification is suitable for Asian patients
Presenter: mirii harada
Session: Poster Display
Resources:
Abstract
232P - The immunosuppressive features of the 20S Proteasome β-subunit gene family in von Hippel-Lindau (VHL)-mutated clear cell renal cell carcinoma (ccRCC): A TCGA-based bioinformatics study
Presenter: Saja Alzghoul
Session: Poster Display
Resources:
Abstract
233P - The crosstalk between PBRM1 loss and tumor immune microenvironment (TIME) of clear cell renal cell carcinoma (ccRCC): A possible interconnection to immunotherapy response
Presenter: Ahmed Al Sharie
Session: Poster Display
Resources:
Abstract
235P - Do FGFR2 and 3 proteins have a role in the prognosis of urothelial bladder carcinoma?
Presenter: Alshimaa Al Hanafy
Session: Poster Display
Resources:
Abstract
236P - The effects of chemotherapy on body composition in patients with advanced urothelial carcinoma
Presenter: KOSUKE KITAMURA
Session: Poster Display
Resources:
Abstract
237P - Real-world analysis of adjuvant nivolumab in resected urothelial cancer: A single institute study in Taiwanese patients
Presenter: Mu-Hsin Chang
Session: Poster Display
Resources:
Abstract