Olaparib efficacy in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer : Subgroup analyses from the phase III OlympiAD trial
© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC..
In the primary analysis of the phase III OlympiAD trial, olaparib significantly prolonged progression-free survival (PFS) vs chemotherapy treatment of physician's choice (TPC) in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer (mBC). We report subgroup analyses for the final analysis at a median OS follow-up of 18.9 months (olaparib) and 15.5 months (TPC). Patients (N = 302) with gBRCAm, HER2-negative mBC and ≤2 previous lines of chemotherapy for mBC were randomized 2:1 to open-label olaparib (300 mg twice daily) or TPC. All subgroup analyses were prespecified except site of metastases. Investigator-assessed median PFS was 8.0 months (95% confidence interval [CI] 5.8-8.4; 176/205 events) for olaparib and 3.8 months (95% CI 2.8-4.2; 83/97 events) for TPC (hazard ratio 0.51, 95% CI 0.39-0.66). In subgroup analyses, median PFS hazard ratios (95% CI) favored olaparib: hormone receptor status (triple-negative: 0.47, 0.32-0.69; hormone receptor-positive: 0.52, 0.36-0.75); gBRCAm (BRCA1: 0.49, 0.35-0.71; BRCA2: 0.49, 0.33-0.74); site of metastases (visceral/CNS: 0.53, 0.40-0.71; non-visceral: 0.45, 0.23-0.98); prior chemotherapy for mBC (yes: 0.51, 0.38-0.70; no: 0.49, 0.30-0.82); prior platinum-based chemotherapy for BC (yes: 0.49, 0.30-0.83; no: 0.50, 0.37-0.69); progressive disease at randomization (yes: 0.48, 0.35-0.65; no: 0.61, 0.36-1.07). Investigator-assessed objective response rates were higher across all subgroups with olaparib (35-68%) vs TPC (5-40%). Global health status/health-related quality of life increased in all subgroups with olaparib vs decreased/no change with TPC. These data confirm the consistency of olaparib benefit across patient subgroups in OlympiAD.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:153 |
|---|---|
| Enthalten in: |
International journal of cancer - 153(2023), 4 vom: 15. Aug., Seite 803-814 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Senkus, Elżbieta [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 26.06.2023 Date Revised 26.06.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1002/ijc.34525 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM354761625 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM354761625 | ||
| 003 | DE-627 | ||
| 005 | 20231226062919.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1002/ijc.34525 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1182.xml |
| 035 | |a (DE-627)NLM354761625 | ||
| 035 | |a (NLM)36971103 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Senkus, Elżbieta |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Olaparib efficacy in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer |b Subgroup analyses from the phase III OlympiAD trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 26.06.2023 | ||
| 500 | |a Date Revised 26.06.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC. | ||
| 520 | |a In the primary analysis of the phase III OlympiAD trial, olaparib significantly prolonged progression-free survival (PFS) vs chemotherapy treatment of physician's choice (TPC) in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer (mBC). We report subgroup analyses for the final analysis at a median OS follow-up of 18.9 months (olaparib) and 15.5 months (TPC). Patients (N = 302) with gBRCAm, HER2-negative mBC and ≤2 previous lines of chemotherapy for mBC were randomized 2:1 to open-label olaparib (300 mg twice daily) or TPC. All subgroup analyses were prespecified except site of metastases. Investigator-assessed median PFS was 8.0 months (95% confidence interval [CI] 5.8-8.4; 176/205 events) for olaparib and 3.8 months (95% CI 2.8-4.2; 83/97 events) for TPC (hazard ratio 0.51, 95% CI 0.39-0.66). In subgroup analyses, median PFS hazard ratios (95% CI) favored olaparib: hormone receptor status (triple-negative: 0.47, 0.32-0.69; hormone receptor-positive: 0.52, 0.36-0.75); gBRCAm (BRCA1: 0.49, 0.35-0.71; BRCA2: 0.49, 0.33-0.74); site of metastases (visceral/CNS: 0.53, 0.40-0.71; non-visceral: 0.45, 0.23-0.98); prior chemotherapy for mBC (yes: 0.51, 0.38-0.70; no: 0.49, 0.30-0.82); prior platinum-based chemotherapy for BC (yes: 0.49, 0.30-0.83; no: 0.50, 0.37-0.69); progressive disease at randomization (yes: 0.48, 0.35-0.65; no: 0.61, 0.36-1.07). Investigator-assessed objective response rates were higher across all subgroups with olaparib (35-68%) vs TPC (5-40%). Global health status/health-related quality of life increased in all subgroups with olaparib vs decreased/no change with TPC. These data confirm the consistency of olaparib benefit across patient subgroups in OlympiAD | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a PARP inhibitor | |
| 650 | 4 | |a breast cancer | |
| 650 | 4 | |a germline BRCA mutation | |
| 650 | 4 | |a olaparib | |
| 650 | 4 | |a subgroups | |
| 650 | 7 | |a BRCA1 Protein |2 NLM | |
| 650 | 7 | |a olaparib |2 NLM | |
| 650 | 7 | |a WOH1JD9AR8 |2 NLM | |
| 650 | 7 | |a Phthalazines |2 NLM | |
| 700 | 1 | |a Delaloge, Suzette |e verfasserin |4 aut | |
| 700 | 1 | |a Domchek, Susan M |e verfasserin |4 aut | |
| 700 | 1 | |a Conte, Pierfranco |e verfasserin |4 aut | |
| 700 | 1 | |a Im, Seock-Ah |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Binghe |e verfasserin |4 aut | |
| 700 | 1 | |a Armstrong, Anne |e verfasserin |4 aut | |
| 700 | 1 | |a Masuda, Norikazu |e verfasserin |4 aut | |
| 700 | 1 | |a Fielding, Anitra |e verfasserin |4 aut | |
| 700 | 1 | |a Robson, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Tung, Nadine |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t International journal of cancer |d 1966 |g 153(2023), 4 vom: 15. Aug., Seite 803-814 |w (DE-627)NLM000004383 |x 1097-0215 |7 nnns |
| 773 | 1 | 8 | |g volume:153 |g year:2023 |g number:4 |g day:15 |g month:08 |g pages:803-814 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1002/ijc.34525 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 153 |j 2023 |e 4 |b 15 |c 08 |h 803-814 | ||