Fasching, P. A., Link, T., Hauke, J., Seither, F., Jackisch, C., Klare, P., Schmatloch, S., Hanusch, C., Huober, J., Stefek, A., Seiler, S., Schmitt, W. D., Uleer, C., Doering, G., Rhiem, K., Schneeweiss, A., Engels, K., Denkert, C., Schmutzler, R. K., Hahnen, E., Untch, M., Burchardi, N., Blohmer, J-U and Loibl, S. (2021). Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatinum in patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study). Ann. Oncol., 32 (1). S. 49 - 58. AMSTERDAM: ELSEVIER. ISSN 1569-8041

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Abstract

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 (ClinicalTriais 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 pNSIN + 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/m(2) weekly plus olaparib (0) 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; ypTO/is ypNO). A two-sided one-group chi(2)-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 Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fasching, P. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Link, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hauke, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seither, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jackisch, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klare, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmatloch, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hanusch, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huober, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stefek, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seiler, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmitt, W. D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uleer, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doering, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rhiem, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneeweiss, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engels, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Denkert, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmutzler, R. K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hahnen, E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Untch, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burchardi, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blohmer, J-UUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loibl, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-604688
DOI: 10.1016/j.annonc.2020.10.471
Journal or Publication Title: Ann. Oncol.
Volume: 32
Number: 1
Page Range: S. 49 - 58
Date: 2021
Publisher: ELSEVIER
Place of Publication: AMSTERDAM
ISSN: 1569-8041
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PATHOLOGICAL COMPLETE RESPONSE; CHEMOTHERAPY; OLAPARIB; CARBOPLATIN; GEPARSIXTO; SURVIVAL; MUTATIONMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60468

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