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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | AiRuiYi (fluzoparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Fuzuloparib maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer: A multicenter, randomized, double-blind, placebo-controlled, phase III trial
Published date:
03/19/2021
Excerpt:
...patients were randomly assigned to the fuzuloparib (n = 167) or placebo (n = 85). The HR derived from prespecified subgroup analyses showed a consistent trend of benefit in patients with BRCA 1/2 mutation (HR, 0.14, 95% CI, 0.07-0.28)...
Source:
Title:
A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
Excerpt:
...- Confirmed documented BRCA1/2 mutation;...
Trial ID:
Source:
Title:
A Study of Fluzoparib Maintenance Treatment in Participants with HRD Positive Initially Treated Advanced Ovarian Cancer Following Response on Front-Line Short Cycle Platinum-Based Chemotherapy
Excerpt:
...Satisfactory primary debulking surgeryno visible residual tumor or residual tumor building technology and GIS algorithm were used to evaluate the status of homologous recombination defects in specimens, and to detect point mutations (SNV) and insertion deletion mutations (indel) in the coding region of the BRCA1 / BRCA2 gene and the exon-intron junction region (20bp). ...
Trial ID:
Less C2 evidence
Source:
Title:
An Open-label, Multicenter, Single-arm, Phase II Study of Fluzoparib in Patients with Germline BRCA1/2 Mutation and Platinum-sensitive Recurrent Ovarian Cancer
Published date:
03/09/2021
Excerpt:
Fluzoparib demonstrated promising antitumor activity and acceptable safety profile in germline BRCA1/2-mutated, platinum-sensitive relapsed ovarian cancer. Thus, fluzoparib might be a novel treatment option for this population
DOI:
10.1158/1078-0432.CCR-20-3546
Trial ID:
Source:
Title:
Phase I dose-escalation and expansion study of PARP inhibitor, fluzoparib (SHR3162), in patients with advanced solid tumors
Published date:
04/29/2020
Excerpt:
In patients with germline BC susceptibility gene mutation (gBRCA Mut) (11/43 OC; 2/16 BC), mPFS was 8.9 months for OC (range, 1.0-23.2; 95% CI, 1.0-16.8) and 14 and 28 months for BC (those two patients both also had somaticBRCA Mut)….Efficacy in patients with gBRCA1/2Mut gBRCA1/2Mut was tested in 43 patients with OC and 16 patients with BC; 11 in 43 OC (7 gBRCA1Mut, 2 gBRCA2Mut, 2 both gBRCA1/2Mut) and 2 in 16 BC (one gBRCA2Mut, one both gBRCA1/2Mut) had a gBRCAMut.
DOI:
10.21147/j.issn.1000-9604.2020.03.08
Source:
Title:
341 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and recurrent ovarian cancer
Published date:
03/29/2020
Excerpt:
This was an open-label, multicenter, phase 2 study of oral fluzoparib in Chinese patients with recurrent ovarian cancer. Adult patents (≥18 years) with germline BRCA1 or BRCA2 mutations...Median duration of response was 10.1 months (95% CI 7.23–NC)...Fluzoparib had demonstrated promising antitumor activity and an acceptable safety profile in patients with recurrent BRCA1- or BRCA2-mutated ovarian cancer.
Trial ID:
Source:
Title:
4168 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and platinum sensitive recurrent ovarian cancer
Published date:
09/29/2019
Excerpt:
The ORR and disease control rate (DCR) were 64.1% (66/103) and 95.1% (98/103), respectively…Fluzoparib demonstrated promising antitumor activity and acceptable safety in patients with advanced BRCA1/2-mutated ovarian cancer.
Trial ID:
