Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatin in patients with HER2-negative breast cancer and HRD: long-term survival of the GeparOLA study
The GeparOLA study evaluated paclitaxel plus olaparib (PO) in neoadjuvant chemotherapy for patients with HER2-negative early breast cancer with homologous recombination deficiency (HRD). HRD was defined by high HRD score or germline (g)/tumor (t) BRCA1/2 mutations (g/tBRCA1/2mut). In this study, we...
Gespeichert in:
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
May 1, 2025
|
| In: |
Clinical cancer research
Year: 2025, Jahrgang: 31, Heft: 9, Pages: 1596-1604 |
| ISSN: | 1557-3265 |
| DOI: | 10.1158/1078-0432.CCR-24-2806 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1158/1078-0432.CCR-24-2806 Verlag, lizenzpflichtig, Volltext: https://aacrjournals.org/clincancerres/article/31/9/1596/761237/Neoadjuvant-Paclitaxel-Olaparib-in-Comparison-to 
|
| Verfasserangaben: | Peter A. Fasching, Sabine Schmatloch, Jan Hauke, Julia Rey, Christian Jackisch, Peter Klare, Theresa Link, Claus Hanusch, Jens Huober, Andrea Stefek, Johannes Holtschmidt, Andreas Schneeweiss, Christoph Uleer, Wolfgang D. Schmitt, Gabriele Doering, Kerstin Rhiem, Carsten Denkert, Rita K. Schmutzler, Christine Solbach, Eric Hahnen, Andreas Hartkopf, Michael Untch, Vesna Bjelic-Radisic, Valentina Nekljudova, Jens-Uwe Blohmer, and Sibylle Loibl, on behalf of GBG and AGO-B |
MARC
| LEADER | 00000naa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1941608337 | ||
| 003 | DE-627 | ||
| 005 | 20251119140714.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 251119s2025 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1158/1078-0432.CCR-24-2806 |2 doi | |
| 035 | |a (DE-627)1941608337 | ||
| 035 | |a (DE-599)KXP1941608337 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Fasching, Peter Andreas |d 1975- |e VerfasserIn |0 (DE-588)129068780 |0 (DE-627)388703040 |0 (DE-576)297477099 |4 aut | |
| 245 | 1 | 0 | |a Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatin in patients with HER2-negative breast cancer and HRD |b long-term survival of the GeparOLA study |c Peter A. Fasching, Sabine Schmatloch, Jan Hauke, Julia Rey, Christian Jackisch, Peter Klare, Theresa Link, Claus Hanusch, Jens Huober, Andrea Stefek, Johannes Holtschmidt, Andreas Schneeweiss, Christoph Uleer, Wolfgang D. Schmitt, Gabriele Doering, Kerstin Rhiem, Carsten Denkert, Rita K. Schmutzler, Christine Solbach, Eric Hahnen, Andreas Hartkopf, Michael Untch, Vesna Bjelic-Radisic, Valentina Nekljudova, Jens-Uwe Blohmer, and Sibylle Loibl, on behalf of GBG and AGO-B |
| 264 | 1 | |c May 1, 2025 | |
| 300 | |b Diagramme | ||
| 300 | |a 9 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Gesehen am 19.11.2025 | ||
| 520 | |a The GeparOLA study evaluated paclitaxel plus olaparib (PO) in neoadjuvant chemotherapy for patients with HER2-negative early breast cancer with homologous recombination deficiency (HRD). HRD was defined by high HRD score or germline (g)/tumor (t) BRCA1/2 mutations (g/tBRCA1/2mut). In this study, we report long-term outcome data.GeparOLA (NCT02789332) was a randomized, multicenter, prospective, open-label, phase II trial. Patients with HER2-negative early breast cancer with HRD with an indication for chemotherapy (cT2-cT4a-d or cT1c and cN+ or cT1c and pNSLN+ or cT1c and triple-negative breast cancer, or cT1c and Ki-67 >20%) were randomly assigned to PO or paclitaxel + carboplatin (PCb), both followed by epirubicin + cyclophosphamide. Long-term efficacy endpoints were secondary endpoints and included invasive disease-free survival (iDFS), distant disease-free survival (DDFS), and overall survival, with a planned median follow-up of >4 years.Between September 2016 and July 2018, 107 patients were randomized and 106 (PO N = 69 and PCb N = 37) started treatment. The median age was 47.0 years; of all patients, 35.8% had cT1 tumors, 31.4% were cN+, 86.8% had G3 tumors, 89.6% had Ki-67 >20%, and 72.6% were triple negative. After a median follow-up of 49.8 months, 18 (15 in PO and three in PCb) iDFS events and seven (six in PO and one in PCb) deaths were reported. The 4-year iDFS (76.0% PO vs. 88.5% PCb, hazard ratio = 2.86; 95% CI, 0.83-9.90; log-rank P = 0.081), DDFS (81.2% PO vs. 93.4% PCb, hazard ratio = 3.03; 95% CI, 0.67-13.67; log-rank P = 0.129), and overall survival (89.2% PO vs. 96.9% PCb, hazard ratio = 3.27; 95% CI, 0.39-27.20; log-rank P = 0.244) tended to be inferior with olaparib. Patients without g/tBRCA1/2mut benefited from Cb (seven of 30 patients had iDFS/DDFS events in PO vs. 0/16 in PCb; log-rank P = 0.037), whereas no difference for patients with g/tBRCA1/2mut was observed (hazard ratio = 1.16, log-rank P = 0.83).For HER2-negative early breast cancer with HRD, olaparib showed a tendency for inferior outcomes compared with Cb, particularly in patients without g/tBRCA1/2mut. In patients with g/tBRCA1/2mut, olaparib may replace Cb. | ||
| 700 | 1 | |a Schmatloch, Sabine |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hauke, Jan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Rey, Julia |e VerfasserIn |4 aut | |
| 700 | 1 | |a Jackisch, Christian |e VerfasserIn |4 aut | |
| 700 | 1 | |a Klare, Peter |e VerfasserIn |4 aut | |
| 700 | 1 | |a Link, Theresa |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hanusch, Claus |e VerfasserIn |4 aut | |
| 700 | 1 | |a Huober, Jens |e VerfasserIn |4 aut | |
| 700 | 1 | |a Stefek, Andrea |e VerfasserIn |4 aut | |
| 700 | 1 | |a Holtschmidt, Johannes |e VerfasserIn |4 aut | |
| 700 | 1 | |a Schneeweiss, Andreas |d 1961- |e VerfasserIn |0 (DE-588)109972554 |0 (DE-627)632849630 |0 (DE-576)327251859 |4 aut | |
| 700 | 1 | |a Uleer, Christoph |e VerfasserIn |4 aut | |
| 700 | 1 | |a Schmitt, Wolfgang D. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Doering, Gabriele |e VerfasserIn |4 aut | |
| 700 | 1 | |a Rhiem, Kerstin |e VerfasserIn |4 aut | |
| 700 | 1 | |a Denkert, Carsten |e VerfasserIn |4 aut | |
| 700 | 1 | |a Schmutzler, Rita K. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Solbach, Christine |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hahnen, Eric |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hartkopf, Andreas |e VerfasserIn |4 aut | |
| 700 | 1 | |a Untch, Michael |e VerfasserIn |4 aut | |
| 700 | 1 | |a Bjelic-Radisic, Vesna |e VerfasserIn |4 aut | |
| 700 | 1 | |a Nekljudova, Valentina |e VerfasserIn |4 aut | |
| 700 | 1 | |a Blohmer, Jens-Uwe |e VerfasserIn |4 aut | |
| 700 | 1 | |a Loibl, Sibylle |e VerfasserIn |0 (DE-588)12433024X |0 (DE-627)085790508 |0 (DE-576)294122753 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical cancer research |d Philadelphia, Pa. [u.a.] : AACR, 1995 |g 31(2025), 9, Seite 1596-1604 |h Online-Ressource |w (DE-627)325489971 |w (DE-600)2036787-9 |w (DE-576)094502234 |x 1557-3265 |7 nnas |a Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatin in patients with HER2-negative breast cancer and HRD long-term survival of the GeparOLA study |
| 773 | 1 | 8 | |g volume:31 |g year:2025 |g number:9 |g pages:1596-1604 |g extent:9 |a Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatin in patients with HER2-negative breast cancer and HRD long-term survival of the GeparOLA study |
| 856 | 4 | 0 | |u https://doi.org/10.1158/1078-0432.CCR-24-2806 |x Verlag |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u https://aacrjournals.org/clincancerres/article/31/9/1596/761237/Neoadjuvant-Paclitaxel-Olaparib-in-Comparison-to |x Verlag |z lizenzpflichtig |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20251119 | ||
| 993 | |a Article | ||
| 994 | |a 2025 | ||
| 998 | |g 109972554 |a Schneeweiss, Andreas |m 109972554:Schneeweiss, Andreas |d 910000 |d 910400 |d 50000 |e 910000PS109972554 |e 910400PS109972554 |e 50000PS109972554 |k 0/910000/ |k 1/910000/910400/ |k 0/50000/ |p 12 | ||
| 999 | |a KXP-PPN1941608337 |e 4808673258 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"id":{"doi":["10.1158/1078-0432.CCR-24-2806"],"eki":["1941608337"]},"physDesc":[{"extent":"9 S.","noteIll":"Diagramme"}],"title":[{"title":"Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatin in patients with HER2-negative breast cancer and HRD","subtitle":"long-term survival of the GeparOLA study","title_sort":"Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatin in patients with HER2-negative breast cancer and HRD"}],"type":{"bibl":"article-journal","media":"Online-Ressource"},"origin":[{"dateIssuedKey":"2025","dateIssuedDisp":"May 1, 2025"}],"relHost":[{"note":["Gesehen am 08.06.2023","Fortsetzung der Druck-Ausgabe"],"pubHistory":["1.1995 -"],"part":{"extent":"9","pages":"1596-1604","issue":"9","text":"31(2025), 9, Seite 1596-1604","year":"2025","volume":"31"},"language":["eng"],"disp":"Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatin in patients with HER2-negative breast cancer and HRD long-term survival of the GeparOLA studyClinical cancer research","type":{"media":"Online-Ressource","bibl":"periodical"},"corporate":[{"role":"isb","display":"American Association for Cancer Research"}],"recId":"325489971","name":{"displayForm":["American Association for Cancer Research"]},"origin":[{"publisher":"AACR","dateIssuedDisp":"1995-","dateIssuedKey":"1995","publisherPlace":"Philadelphia, Pa. [u.a.]"}],"physDesc":[{"extent":"Online-Ressource"}],"id":{"issn":["1557-3265"],"eki":["325489971"],"zdb":["2036787-9"]},"title":[{"title_sort":"Clinical cancer research","title":"Clinical cancer research"}]}],"language":["eng"],"name":{"displayForm":["Peter A. Fasching, Sabine Schmatloch, Jan Hauke, Julia Rey, Christian Jackisch, Peter Klare, Theresa Link, Claus Hanusch, Jens Huober, Andrea Stefek, Johannes Holtschmidt, Andreas Schneeweiss, Christoph Uleer, Wolfgang D. Schmitt, Gabriele Doering, Kerstin Rhiem, Carsten Denkert, Rita K. Schmutzler, Christine Solbach, Eric Hahnen, Andreas Hartkopf, Michael Untch, Vesna Bjelic-Radisic, Valentina Nekljudova, Jens-Uwe Blohmer, and Sibylle Loibl, on behalf of GBG and AGO-B"]},"note":["Gesehen am 19.11.2025"],"person":[{"given":"Peter Andreas","display":"Fasching, Peter Andreas","role":"aut","family":"Fasching"},{"role":"aut","family":"Schmatloch","given":"Sabine","display":"Schmatloch, Sabine"},{"display":"Hauke, Jan","given":"Jan","role":"aut","family":"Hauke"},{"given":"Julia","display":"Rey, Julia","role":"aut","family":"Rey"},{"family":"Jackisch","role":"aut","given":"Christian","display":"Jackisch, Christian"},{"display":"Klare, Peter","given":"Peter","role":"aut","family":"Klare"},{"display":"Link, Theresa","given":"Theresa","role":"aut","family":"Link"},{"display":"Hanusch, Claus","given":"Claus","family":"Hanusch","role":"aut"},{"display":"Huober, Jens","given":"Jens","role":"aut","family":"Huober"},{"given":"Andrea","display":"Stefek, Andrea","family":"Stefek","role":"aut"},{"role":"aut","family":"Holtschmidt","given":"Johannes","display":"Holtschmidt, Johannes"},{"display":"Schneeweiss, Andreas","given":"Andreas","family":"Schneeweiss","role":"aut"},{"family":"Uleer","role":"aut","display":"Uleer, Christoph","given":"Christoph"},{"display":"Schmitt, Wolfgang D.","given":"Wolfgang D.","family":"Schmitt","role":"aut"},{"display":"Doering, Gabriele","given":"Gabriele","family":"Doering","role":"aut"},{"family":"Rhiem","role":"aut","given":"Kerstin","display":"Rhiem, Kerstin"},{"display":"Denkert, Carsten","given":"Carsten","family":"Denkert","role":"aut"},{"given":"Rita K.","display":"Schmutzler, Rita K.","family":"Schmutzler","role":"aut"},{"display":"Solbach, Christine","given":"Christine","family":"Solbach","role":"aut"},{"role":"aut","family":"Hahnen","display":"Hahnen, Eric","given":"Eric"},{"display":"Hartkopf, Andreas","given":"Andreas","role":"aut","family":"Hartkopf"},{"role":"aut","family":"Untch","given":"Michael","display":"Untch, Michael"},{"role":"aut","family":"Bjelic-Radisic","given":"Vesna","display":"Bjelic-Radisic, Vesna"},{"role":"aut","family":"Nekljudova","display":"Nekljudova, Valentina","given":"Valentina"},{"role":"aut","family":"Blohmer","given":"Jens-Uwe","display":"Blohmer, Jens-Uwe"},{"given":"Sibylle","display":"Loibl, Sibylle","role":"aut","family":"Loibl"}],"recId":"1941608337"} | ||
| SRT | |a FASCHINGPENEOADJUVAN1202 | ||