Geburtshilfe Frauenheilkd 2018; 78(10): 90
DOI: 10.1055/s-0038-1671019
Poster
Donnerstag, 01.11.2018
Gynäkologische Onkologie III
Georg Thieme Verlag KG Stuttgart · New York

Olaparib in German routine clinical practice – Updated interim results of the non-interventional study C-PATROL

JP Grabowski
1   Charité Medical University Berlin, Department of Gynecology and Center for Oncological Surgery and European Competence Center for Ovarian Cancer, Berlin, Deutschland
,
J Sehouli
1   Charité Medical University Berlin, Department of Gynecology and Center for Oncological Surgery and European Competence Center for Ovarian Cancer, Berlin, Deutschland
,
F Hilpert
2   Oncology Centre at Jerusalem Hospital Hamburg, Hamburg, Deutschland
,
M Welslau
3   Medical office for hemato-oncology, Aschaffenburg, Deutschland
,
T Schinköthe
4   CANKADO, Kirchheim, Deutschland
,
J Seitz
5   University Hospital Heidelberg, Department of Obstetrics & Gynecology, Heidelberg, Deutschland
,
A El-Balat
6   Goethe University Frankfurt, Department of Obstetrics and Gynecology, Frankfurt, Deutschland
,
EM Grischke
7   University Hospital of Tübingen, Center for Women's Health, Tübingen, Deutschland
,
R Glowik
8   AstraZeneca, Wedel, Deutschland
,
F Marmé
5   University Hospital Heidelberg, Department of Obstetrics & Gynecology, Heidelberg, Deutschland
› Author Affiliations
Further Information

Publication History

Publication Date:
20 September 2018 (online)

Also available at
 

Aim:

Only limited real-world evidence data are available for PARP inhibitors. C-PATROL assesses effectiveness and safety of BRCA-mutated platinum-sensitive relapsed ovarian cancer (PSR-OC) patients treated with olaparib capsules according to EU label under real-life conditions in Germany.

Methods:

C-PATROL (NCT02503436) is a German prospective, non-interventional study collecting data on olaparib maintenance in BRCA-mutated PSR-OC patients, with response to last platinum-based chemotherapy. This 2nd interim analysis (cut-off: 01FEB2018) covers patients who started olaparib treatment between OCT2015 and JAN2018. Data are analyzed by descriptive statistics.

Results:

165 BRCA-mutated PSR-OC patients with ≥3 months observation were analyzed (median age: 61 [36 to 85] years; ECOG ≤1: 92.7%; ≥2 relapses: 40.0%; ≥3 prior platinum chemotherapies: 40.0%). Data were stratified according to subgroups (age: < 70/≥70 years; comorbidities: yes/no).

Patients started with a median daily dose of 800 [100 to 800] mg olaparib (capsules). 40.0% had ≥1 dose reduction, 33.9% had ≥1 therapy interruption (median duration: 13 [0 to 430] days). 79 patients (47.9%) discontinued treatment, mainly due to progression (59 patients). 12 patients (7.3%) discontinued due to AEs. 89.7% of patients had AEs (any grade). Nausea (44.2%), fatigue (34.6%) and anemia (28.5%) occurred most frequently, with anemia being less frequent in patients ≥70 years and without comorbidities.

Summary:

This interim analysis indicates that treatment with olaparib capsules is initiated at the recommended daily dose of 800 mg and that olaparib is well tolerated under routine conditions. AEs are generally manageable and the toxicity profile is in line with results of olaparib clinical trials.

Funding:

AstraZeneca.