GBG 82 - OlympiA

Name

Adjuvant olaparib in breast cancer patients with gBRCA mutations at high risk of recurrence

Allgemeines

PARP-IH in der adjuvanten Therapie des tripple - negativen Mammakarzinoms.

EudraCT Number 2013-002377-21

Allgemeines

randomized, open-label, phase 3 trial olaparib monotherapy compared with standard therapy germline BRCA mutation HER2– metastatic breast cancer two previous chemotherapy regimens for metastatic disease. random 2:1 ratio olaparib tablets 300 mg twice daily or standard therapy with single-agent chemotherapy of the physician’s choice (capecitabine, eribulin, vinorelbine in 21-day cycles). 302 patients 205 olaparib 97 standard therapy. PFS 7.0 months vs. 4.2 months HR 0.58; 95%-CI 0.43 to 0.80; P<0.001 response rate 59.9% in the olaparib group and 28.8% in the standard-therapy group. >2° adverse events 36.6% in the olaparib group and 50.5% standard-therapy group treatment discontinuation due to toxic effects was 4.9% and 7.7% HER2-negative metastatic breast cancer and a germline BRCA mutation, olaparib monotherapy provided a significant benefit over standard therapy; median progression-free survival was 2.8 months longer and the risk of disease progression or death was 42% lower with olaparib monotherapy than with standard therapy. ( Funded by AstraZeneca; OlympiAD ClinicalTrials.gov number, NCT02000622.)  PARP-IH in der adjuvanten Therapie des Mammakarzinoms.

EudraCT Number 2013-002377-21

Fragestellung

progressionsfreies Überleben

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Ergebnisse

Wirkmechanismus

Olaparib ist ein PARP-IH. PARP ist an der DNA-Einzelstrang - Reparatur beteiligt. PARP und PARP-IH bilden an der DNA einen Komplex, der bei einer Zellteilung zu Doppelstrangbrüchen führt.

Random

Olaparib versus Placebo

2 x 300 mg täglich, 12 Monate

Einschluss

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