Article
C•PATROL: A German, non-interventional study of olaparib in patients with BRCA1/2-mutated, platinum-sensitive, relapsed ovarian cancer
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Authors
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Frederik Marmé
- University Hospital Heidelberg, Heidelberg, Germany, Heidelberg, Germany
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Felix Hilpert
- Jerusalem Hospital Hamburg, Hamburg, Germany, Hamburg, Germany
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Manfred Welslau
- Medical office for hemato-oncology, Aschaffenburg, Germany, Aschaffenburg, Germany
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Timo Schinköthe
- CANKADO, Kirchheim, Germany, Kirchheim, Germany
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Regina Glowik
- AstraZeneca GmbH, Wedel, Germany
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Jalid Sehouli
- Charité Medical University, Berlin, Germany, Berlin, Germany
| Published: | September 26, 2017 |
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Outline
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Background: Proteins encoded by BRCA1 and BRCA2 are involved in the repair of DNA double strand breaks by homologous recombination repair. Mutations in BRCA1/2 (BRCAm+) can result in defective repair of double-stranded DNA breaks and are a risk factor for ovarian cancer. The poly (ADP-ribose) polymerase (PARP) inhibitor olaparib can exploit homologous recombination repair deficiencies in BRCAm+ cells to induce synthetic lethality. Olaparib was approved in Europe in December 2014 for the maintenance treatment of patients with platinum-sensitive relapsed BRCAm+ (germline or somatic) ovarian cancer who are in response to platinum-based chemotherapy (400 mg taken twice daily, equivalent to a total daily dose of 800 mg, capsules formulation).
Research question: Within clinical trials (NCT00753545), olaparib leads to a statistically and clinically significant increase in progression-free survival (PFS) compared to placebo, improved survival and was shown to be well tolerated. So far, no systematic outcome research on olaparib treatment in daily routine practice has been initiated.
Method: The non-interventional study C•Patrol (NCT02503436 on ClinicalTrials.gov) analyses various outcome data (PFS, PFS2, overall survival (OS), time to first and time to second subsequent therapy (TFST, TSST)), the patient-reported health-related quality of life (assessed by FACT-O, FACIT-Fatigue, and FLIE questionnaires), and the safety and tolerability of ovarian cancer patients treated with olaparib under real-life medical conditions in Germany.
Results: Starting in October 2015, 121 patients are currently enrolled at 53 study sites (status March 2017).
Conclusion and Implications: An Amendment will introduce, in addition to the German version, patient-questionnaires in English, Turkish, and Arabic language. An interim analysis focusing on risk minimization activities with regard to olaparib treatment will start soon. The interim analysis will involve the first 75 patients with a documented observational period ≥ 3 months.
