Abstract 398P
Background
Maintenance PARPi post platinum response in stage III & IV results in OS benefit in high grade serous (HGS) ovarian cancers. We aimed to find the real-world data of clinical benefit and adverse events of maintenance PARPi in Indian patients.
Methods
This multicentre retrospective observational study was conducted across 6 participating centres from Network of Oncology Clinical Trials of India, a BIRAC funded network, from May 2019 to Dec 2022. We included AOC (stage III/IV) patients with BRCAmut or HRD+ and received PARPi (Olaparib or Rucaparib) as first-line maintenance therapy.
Results
46 patients were enrolled. Median age was 50.5 years. All had HGS histology. 32 (69.6%) had stage III cancer. 12(26.1%) had family history of cancer. The median turnaround time for gBRCA and HRD testing was 18 and 20.5 days respectively. BRCA1mut was seen in 30 (65.2%), BRCA2mut in 5 (10.9%), and Non BRCA HRD+ in 11 (23.9%). 27 (58.7%) & 19 (41.3%) received Olaparib and Rucaparib respectively. After a median follow up duration of 22.5 months (18–53 months). mPFS is not reached. PFS rate at 12 & 18 months are 97.8% & 86.9% respectively. No difference in mPFS between olaparib and rucaparib. No difference in mPFS between BRCAmut Vs BRCA wild HRD + patients (NR vs 29m, p=0.219). 4 (14.9%) and 14 (73.7%) on Olaparib and Rucaparib required dose modification to 150mg BD and 300mg BD respectively. There was no difference in PFS between standard dose and reduced dose. Most common grade ≥3 side effects included anaemia (13%), fatigue (6.5%), and thrombocytopenia (2.2%). The limitation of our study includes short follow up, retrospective design, and low numbers.
Conclusions
In one of the first multicenter real-world studies from LMIC, PARP inhibitors demonstrated efficacy and toxicity similar to trial settings. There was no statistically significant differences observed between Olaparib and Rucaparib, standard and reduced doses, or BRCAmut and HRD+ patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Biotechnology Industry Research Assistance Council (BIRAC).
Disclosure
All authors have declared no conflicts of interest.