KEY TAKEAWAYS
- The C-PATROL observational study aimed to investigate survival outcomes in patients with PSROC undergoing surgery followed by PBC.
- Researchers observed improved PFS and OS, achieving complete tumor resection before PBC and olaparib maintenance.
Maintenance monotherapy with the poly-(ADP-ribose)-polymerase inhibitor olaparib has previously shown good effectiveness and tolerability in patients with platinum-sensitive relapsed ovarian cancer (PSROC) who are in response to platinum-based chemotherapy (PBC) in the C-PATROL study. Cytoreductive surgery followed by PBC has the potential to improve survival in PSROC if a complete resection can be achieved.
Frederik Marmé and the team aimed to assess the impact of cytoreductive surgery followed by PBC on survival outcomes in patients with PSROC eligible for olaparib maintenance therapy.
They conducted an inclusive analysis within the prospective German non-interventional study C-PATROL (NCT02503436) to examine routine clinical data of patients with BRCA-mutated PSROC. The study focused on patients treated with PBC and receiving olaparib maintenance therapy as per label.
This predefined subgroup analysis compared patients based on their surgical outcomes during the current relapse: those who achieved macroscopic tumor-free status (MTF) versus those who did not undergo surgery or did not achieve MTF. Descriptive statistics were used for data analysis.
About 277 patients were enrolled between October 2015 and October 2019 for the study. Within the intention-to-treat (ITT) set (N=267), 66 patients were in the MTF subgroup compared to 201 in the non-MTF subgroup (182 without surgery and 19 non-MTF). Median age was 59 years in the MTF group and 61 years in the non-MTF group. ECOG performance status of 0 was observed in 58% vs 60%, with 82% vs 63% being tumor-free after primary surgery. Patients with ≥2 relapses accounted for 27% (MTF) vs 34% (non-MTF), and those with a complete response to current PBC were 65% vs 20%.
Median follow-up was 42.8 months (range: 0.3–80.5) for MTF vs 20.3 months (0.0–79.4) for non-MTF. Median progression-free survival (PFS) was 43.2 months (95% CI 21.9–not reached [nr]) vs 12.1 months (10.7–14.1), and median overall survival (OS) was not reached (nr) (95% CI 60.8–nr) vs 27.4 months (24.4–33.6). Adverse events (AEs) were consistent with olaparib’s known tolerability profile (safety set: n=274). Any AE occurred in 96% (MTF) vs 95% (non-MTF), grade ≥3 AE in 34% vs 42%, olaparib discontinuation due to AE: 9% vs 12%).
The study concluded that PSROC patients achieving macroscopic complete tumor resection before receiving PBC and olaparib maintenance therapy experienced significantly improved PFS and OS.
The study was sponsored by AstraZeneca.
Source: https://cslide.ctimeetingtech.com/gynae24hybrid/attendee/confcal_1
Clinical Trial: https://clinicaltrials.gov/study/NCT02503436
Marmé F, Hilpert F, Welslau M.K., et al. (2024). “Real-world data of patients with recurrent BRCA-mutated platinum-sensitive ovarian cancer treated with olaparib maintenance: Surgical outcome subgroup analysis from the C-PATROL study.” Presented at ESMO-GC 2024 (Abstract 54P).
