Abstract 55P
Background
The GEICO-88R study evaluated the real-world use of niraparib (NIR) as maintenance treatment in patients (pts) with PSROC (Cueva et al, EJC 2023). A subanalysis of the LTR subgroup (NIR exposure ≥12 mo) was also communicated (Cueva et al, ESMO 2023,795-P).
Methods
In this study across 57 Spanish sites, pts received NIR at fixed 300 mg/day or individualized starting dose. Now, an extended follow-up (FU) analysis of LTR has been performed, focused on subsequent systemic lines.
Results
The characteristics of 107 LTR were previously reported describing a high-risk population, mostly BRCAwt (81.3%), with a median of 2 prior treatment lines and significant concomitant comorbidities (46.7%). Of note, 58.3% ORR was observed in the 48 pts with pre-NIR measurable disease. 61 pts (62.8%) had at least 1 post-NIR systemic line, with 53 pts (86.9%) having a platinum-based treatment (PBT). The proportion of pts receiving subsequent lines was: 1-2L, 55.7%; 3-4L, 24.6%; ≥5L, 19.7%. 31 (29%) pts remained on NIR therapy upon analysis. 61 pts (57%) had very long maintenance (>24 mo) and 68.9% of them remained alive. With a median FU of 49.1 mo, the median PFS, PFS2 and OS were 26.4 (95% CI 21.3-28.8), 33.5 (95% CI 28.5-NA) and 56.9 mo (95% CI 48.2-NA) respectively. Median PFS of first and second post-NIR lines were 8.2 (95% CI 6-12) and 7 mo (95% CI 4.7-10.4) respectively. The ORR with the first subsequent line was 34.9%. 2 pts had AML (1.8%) and 1 MDS (0.9%). Table: 55P
First and second lines after niraparib (NIR)
| LTR (N = 97) | N (%) | N (%) | |
| First-line after NIR | 61 (62.8) | Second-line after NIR | 45 (46.4) |
| PBT + bev | 12 (19.7) | PBT + bev | 1 (2.2) |
| PBT w/o bev | 31 (50.8) | PBT w/o bev | 11 (24.4) |
| Pac + bev | 1 (1.6) | Pac + bev | 4 (8.9) |
| PARPi | 2 (3.3) | Pac w/o bev | 6 (13.3) |
| Other | 15 (24.6) | PRS + bev | 1 (2.2) |
| None | 36 (37.1) | PRS w/o bev | 5 (11.1) |
| PARPi | 2 (4.4) | ||
| Other | 15 (33.3) | ||
| None | 52 (53.6) |
PBT: Platinum-based treatment. PRS: Platinum-resistant scheme (other than paclitaxel). Bev: Bevacizumab. Pac: Paclitaxel.
Conclusions
This subanalysis of LTR to NIR maintenance in real life focusing on post-NIR treatment shows a significant proportion of pts with NIR therapy >24 mo; that most pts received a PBT as next line; and a remarkable median OS (56.9 mo).
Clinical trial identification
NCT04546373 Sponsor Study Number: GEICO 88-R.
Legal entity responsible for the study
Grupo Español de Investigación en Cáncer Ginecológico (GEICO).
Funding
GSK.
Disclosure
J.F. Cueva Banuelos: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Novartis; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, GSK, Clovis, Pfizer, Novartis, Lilly, Roche, Pierre Fabre, Palex, PharmaMar; Financial Interests, Personal, Other, Attending and accommodation scientific meetings: AstraZeneca, Lilly, MSD. Y. Garcia Garcia: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca, Roche; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, Roche; Financial Interests, Personal, Other, Congress fees and travel expenses: MSD; Financial Interests, Personal, Other, Congress fees: GSK. A. Yubero Esteban: Financial Interests, Personal, Advisory Board: Clovis Oncology, AstraZeneca, GSK, PharmaMar; Financial Interests, Institutional, Invited Speaker: WntResearch AB. A. Gallego Martinez: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, GSK, Clovis; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Expert Testimony: MSD, Clovis, GSK; Other, Personal, Other, Travel/accommodation/expenses: MSD, GSK, AstraZeneca. A. Martinez Bueno: Financial Interests, Personal, Invited Speaker: Seagen, GSK, AstraZeneca; Financial Interests, Personal, Other, Travel expenses, Accommodation and registration fees: Roche, GSK; Financial Interests, Personal, Other, Travel expenses, accommodations and registration fees: MSD. S. Gonzalez: Financial Interests, Personal, Advisory Board: Lilly, Seagen, AstraZeneca; Financial Interests, Personal, Invited Speaker: Novartis, GSK, Roche; Financial Interests, Personal, Other, Travel and Accommodations: Pfizer, Clovis. L. Gaba Garcia: Financial Interests, Personal, Advisory Board: GSK, PharmaMar, AstraZeneca, MSD, Clovis Oncology; Financial Interests, Personal, Invited Speaker: GSK, MSD, Clovis Oncology; Financial Interests, Personal, Expert Testimony: AstraZeneca. C. Gomez Raposo: Financial Interests, Institutional, Advisory Board: GSK. S. Hernando Polo: Financial Interests, Personal, Advisory Board, Advisory board: GSK; Financial Interests, Personal, Advisory Board, Advisory Board: MSD-AstraZeneca, Pfizer; Non-Financial Interests, Personal, Principal Investigator, Principal Investigator: GSK. R. Marquez Vazquez: Financial Interests, Institutional, Invited Speaker: GSK, AstraZeneca. J. Fuentes Pradera: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, Takeda, Sanofi; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: Gilead, Roche, Daiichi Sankyo, Bioatla. A. Taus Garcia: Financial Interests, Personal, Invited Speaker: GSK, Takeda, Roche, AstraZeneca, Pfizer, Eisai; Financial Interests, Personal, Advisory Board: Sanofi, BMS, AstraZeneca. A. González-Martín: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Clovis, GSK, Genmab, Alkermes, Sutro, Roche, Sotio, PharmaMar, Oncoinvent, Novartis, Mersana, MSD, Macrogenics, Eisai, Immunogen, Regeneron, HederaDx, Illumina, Tubulis; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, Clovis, Roche, Novocure, MSD, Takeda, Zaylab; Financial Interests, Institutional, Invited Speaker, PI of ANITA trial: GSK, Roche; Financial Interests, Personal, Invited Speaker, Member of ENGOT ov43-SC: MSD; Financial Interests, Institutional, Invited Speaker, ENGOT PI of EPIK-O trial: Novartis; Financial Interests, Institutional, Invited Speaker, ENGOT PI of AVB-500 phase III trial: Aravive. All other authors have declared no conflicts of interest.