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. The prospective German non-interventional study C-PATROL (NCT02503436) captured routine clinical data of patients with BRCA-mutated PSROC treated with PBC and receiving olaparib maintenance according to label. This predefined subgroup analysis compares patients based on surgery details for the current relapse and its outcome: patients who were macroscopic tumour-free (MTF) versus no surgery/non-MTF (non-MTF). Data were analysed by descriptive statistics. The study enrolled 277 patients between 10/2015 and 10/2019. Within the ITT set (study selection criteria fulfilled; N=267), 66 patients were included in the MTF vs 201 in the non-MTF subgroup (182 had no surgery and 19 were non-MTF). Median age was 59 vs 61 years, 58% vs 60% had an ECOG performance status of 0, 82% vs 63% were tumour-free after primary surgery, 27% vs 34% had ≥2 relapses, and 65% vs 20% had a complete response (CR) to the current PBC. Median follow-up was 42.8 (range: 0.3–80.5) vs 20.3 months (0.0–79.4). Median progression-free survival (PFS) was 43.2 (95% CI 21.9–nr) vs 12.1 months (10.7–14.1). 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 the known tolerability profile of olaparib (safety set: n=274; any AE: 96% vs 95%, AE of CTCAE grade ≥3: 34% vs 42%, olaparib discontinuation due to AE: 9% vs 12%). Patients with PSROC for whom in the real-world a macroscopic complete (recurrence)tumour-resection was achieved before receiving PBC and olaparib maintenance, have a beneficial prognosis concerning PFS and OS.

Maintenance treatment with olaparib has demonstrated significant improvements in median progression-free survival (PFS) compared with placebo in patients with platinum-sensitive relapsed ovarian cancer (PSROC) who are in response to platinum-based chemotherapy (PBC). Olaparib was the first-in-class poly (ADP-ribose) polymerase inhibitor (PARPi) approved as monotherapy in the EU in 12/2014 (hard capsules, HC, 400 mg twice daily) in BRCA-mutated (BRCAm) PSROC. In addition, film-coated tablets (FT, 300 mg, twice daily) were approved in 05/2018 in PSROC regardless of BRCA status. After entering routine clinical practice, real-world data on olaparib were limited and this non-interventional study (NIS) was initiated. Here, final survival results are reported. The prospective NIS C-PATROL (NCT02503436) was performed at 68 sites (50 hospitals, 18 office-based) in Germany. Routine clinical data were collected of BRCAm PSROC patients treated with olaparib according to label. Between 28 Oct 2015 and 30 Sep 2019, 282 patients were enrolled. Of these, 269 patients were included in the analysis (median age: 60 yrs; ECOG ≤1: 93%; ≥2 relapses: 32%; ≥3 prior PBC: 34%). 46 patients started with FT and 223 patients with HC; 70 patients switched from HC to FT. Median follow-up was 23.5 months (range 0.00 – 80.5) and median olaparib treatment duration was 13.6 months (0.1–80.9). 10% of patients received olaparib for ≥5 years. Median PFS was 14.3 months (95% CI 12.2–18.0). Median overall survival was 35.4 months (95% CI 29.2–47.1). 132 patients received at least one subsequent medication. Adverse events (AEs) were consistent with known tolerability profile of olaparib. 31 patients (11.3%, safety set: total n=274) discontinued olaparib treatment and 60 patients (21.9%) received reduced olaparib dose due to AEs. This real-word study supports efficacy and tolerability of olaparib maintenance therapy after PBC in patients with BRCAm PSROC. Long-term exposure to olaparib was observed with no new safety signals.

Einleitung Deutschlandweite Daten zur Therapiequalität und zum Krankheitsverlauf von Patientinnen mit Rezidiv eines Ovarialkarzinoms gibt es bisher nicht.

Zielsetzung Rolle der Rezidiv-OP bei Patientinnen aus der AGO-DESKTOP III-Studie, die in den Standard-Therapiearm (Chemotherapie alleine) randomisiert wurden und bei nachfolgendem Rezidiv operiert wurden.

Zielsetzung Die Komplettresektion verbessert das Überleben von Patientinnen mit platinsensiblem Ovarialkarzinom-Rezidiv mit positivem AGO-Score signifikant. Gibt es einen Zusammenhang zwischen der Höhe des CA125 zum Rezidivzeitpunkt mit dem operativen und onkologischen Outcome?

Zielsetzung QS-Ovar dokumentierte von 2004 bis 2016 alle im 3. Quartal erstdiagnostizierten Ovarialkarzinome (OC). Diese repräsentative Datenerhebung soll Umsetzung von Therapiestandards und Auswirkungen auf das Überleben für FIGO I Ovarialkarzinome evaluieren.

Zielsetzung Zentrale Aufgabe bei Patientinnen mit fortgeschrittenem Ovarialkarzinom ist die Aufrechterhaltung oder die Verbesserung der gesundheitsbezogenen Lebensqualität (quality of life, QoL). QoL wird sowohl von Krankheitssymptomen als auch therapieassoziierten Nebenwirkungen bestimmt und ist in klinischen Studien ein wichtiger patientenorientierter Endpunkt. Diese Analyse untersucht den Einfluss der Diagnose des Erstrezidivs auf QoL.

Zielsetzung Identifikation von Prognosefaktoren für Patientinnen, bei denen die Standard-Therapie des fortgeschrittenen Ovarialkarzinoms aus primärer zytoreduktiver Operation(PDS) und anschließender Chemotherapie eine frühe Progression nicht verhindert.