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Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatinum in patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study)

Background - The efficacy and toxicity of olaparib as combination therapy in early breast cancer (BC) patients with homologous recombinant deficiency (HRD) [score high and/or germline (g) or tumour (t) BRCA1/2 mutation] is not well described. GeparOLA (ClinicalTrials.gov, NCT02789332) investigated o...

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Main Authors: Fasching, Peter Andreas (Author) , Link, T. (Author) , Hauke, J. (Author) , Seither, F. (Author) , Jackisch, C. (Author) , Klare, P. (Author) , Schmatloch, S. (Author) , Hanusch, C. (Author) , Huober, J. (Author) , Stefek, A. (Author) , Seiler, S. (Author) , Schmitt, W. D. (Author) , Uleer, C. (Author) , Doering, G. (Author) , Rhiem, K. (Author) , Schneeweiss, Andreas (Author) , Engels, K. (Author) , Denkert, C. (Author) , Schmutzler, R. K. (Author) , Hahnen, E. (Author) , Untch, M. (Author) , Burchardi, N. (Author) , Blohmer, J. -U. (Author) , Loibl, S. (Author)
Format: Article (Journal)
Language:English
Published: 2021
In: Annals of oncology
Year: 2020, Volume: 32, Issue: 1, Pages: 49-57
ISSN:1569-8041
DOI:10.1016/j.annonc.2020.10.471
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.annonc.2020.10.471
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753420429631
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Author Notes:P.A. Fasching, T. Link, J. Hauke, F. Seither, C. Jackisch, P. Klare, S. Schmatloch, C. Hanusch, J. Huober, A. Stefek, S. Seiler, W.D. Schmitt, C. Uleer, G. Doering, K. Rhiem, A. Schneeweiss, K. Engels, C. Denkert, R.K. Schmutzler, E. Hahnen, M. Untch, N. Burchardi, J.-U. Blohmer & S. Loibl
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Summary:Background - The efficacy and toxicity of olaparib as combination therapy in early breast cancer (BC) patients with homologous recombinant deficiency (HRD) [score high and/or germline (g) or tumour (t) BRCA1/2 mutation] is not well described. GeparOLA (ClinicalTrials.gov, NCT02789332) investigated olaparib in combination with paclitaxel in HER2-negative early BC with HRD. - Patients and methods - Patients with untreated primary HER2-negative cT2-cT4a-d or cT1c with either cN+ or pNSLN+ or cT1c and triple-negative breast cancer (TNBC) or cT1c and Ki-67>20% BC with HRD were randomised either to paclitaxel (P) 80 mg/m2 weekly plus olaparib (O) 100 mg twice daily for 12 weeks or P plus carboplatinum (Cb) area under the curve 2 weekly for 12 weeks, both followed by epirubicin/cyclophosphamide (EC). Stratification factors were hormone receptor (HR) status (HR+ versus HR−) and age (<40 versus ≥40 years). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). A two-sided one-group χ2-test was planned to exclude a pCR rate of ≤55% in the PO-EC arm. Secondary end points were other pCR definitions, breast conservation rate, clinical/imaging response, tolerability and safety. - Results - A total of 107 patients were randomised between September 2016 and July 2018; 106 (PO N = 69; PCb N = 37) started treatment. Median age was 47.0 years (range 25.0-71.0); 36.2% had cT1, 61.0% cT2, 2.9% cT3, and 31.8% cN-positive tumours; grade 3 tumours: 86.8%; Ki-67>20%: 89.6%; TNBC: 72.6%; confirmed gBRCA1/2 mutation: 56.2%. The pCR rate with PO was 55.1% [90% confidence interval (CI) 44.5% to 65.3%] versus PCb 48.6% (90% CI 34.3% to 63.2%). Analysis for the stratified subgroups showed higher pCR rates with PO in the cohorts of patients <40 years and HR+ patients. - Conclusion - GeparOLA could not exclude a pCR rate of ≤55% in the PO arm. PO was significantly better tolerated and the combination merits further evaluation.
Item Description:Available online: 21 October 2020
Gesehen am 15.02.2021
Physical Description:Online Resource
ISSN:1569-8041
DOI:10.1016/j.annonc.2020.10.471

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