Neoadjuvant niraparib monotherapy for unresectable, homologous recombination deficiency-positive, high-grade serous ovarian cancer (NANT): a multicentre, single-arm, phase 2 trial.
Dan Liu, Zikun Peng, Wei Zhang et al.
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In 30 seconds
This multicentre, single-arm phase 2 trial evaluated two cycles of neoadjuvant niraparib monotherapy in treatment-naïve patients with HRD-positive, advanced high-grade serous or endometrioid ovarian cancer considered unlikely to undergo complete primary debulking. Among 48 response-evaluable patients, 30 responded (objective response rate 63%; 95% CI 47-76); among 40 patients who underwent surgery, 32 achieved R0 resection (80%; 95% CI 64-91). The findings indicate activity in this selected population, but the study did not compare niraparib with standard neoadjuvant chemotherapy.
Key findings
- Objective response occurred in 30 of 48 response-evaluable patients: 63% (95% CI 47-76).
- R0 resection was achieved in 32 of 40 operated patients: 80% (95% CI 64-91).
- Grade 3-4 treatment-related thrombocytopenia occurred in 32 (48%) of 67 patients; no treatment-related deaths occurred.
Why it matters
For selected patients with HRD-positive advanced ovarian cancer who are initially unsuitable for primary debulking, a chemotherapy-free neoadjuvant approach may have antitumour activity and permit complete resection. The response and surgical outcomes provide a rationale for further evaluation, while the observed haematological toxicities underscore the need to weigh treatment burden alongside potential surgical benefit.
What to keep in mind
The single-arm phase 2 design provides no direct comparison with standard platinum-taxane neoadjuvant chemotherapy. Participants were selected and all self-identified as Han Chinese, limiting generalisability.