Breast Cancer Index and Prediction of Extended Aromatase Inhibitor Therapy Benefit in Hormone Receptor-positive Breast Cancer from the NRG Oncology/NSABP B-42 Trial
PURPOSE: BCI (H/I) has been shown to predict extended endocrine therapy (EET) benefit. We examined BCI (H/I) for EET benefit prediction in NSABP B-42, which evaluated extended letrozole therapy (ELT) in hormone receptor-positive breast cancer patients after 5 years of ET.
METHODS: Stratified Cox model was used to analyze RFI as primary endpoint, with DR, BCFI, and DFS, as secondary endpoints. Due to a non-proportional effect of ELT on DR, time-dependent analyses were performed.
RESULTS: The translational cohort included 2,178 patients (45% BCI (H/I)-High, 55% BCI (H/I)-Low). ELT showed an absolute 10-year RFI benefit of 1.6% (P=0.10), resulting in an underpowered primary analysis (50% power). ELT benefit and BCI (H/I) did not show a significant interaction for RFI (BCI [(H/I])-Low: 10y absolute benefit 1.1% [HR=0.70, 0.43-1.12, P=0.13]; BCI [(H/I])-High: 2.4% [HR=0.83, 0.55-1.26, p=0.38]; Pinteraction=0.56). Time-dependent DR analysis showed that after 4y, BCI (H/I)-High patients had significant ELT benefit (HR=0.29, 0.12-0.69, P<0.01), whereas BCI (H/I)-Low patients were less likely to benefit (HR=0.68, 0.33-1.39, P=0.29) (Pinteraction=0.14). Prediction of ELT benefit by BCI (H/I) was more apparent in the HER2- subset after 4y (ELT-by-BCI (H/I) Pinteraction=0.04).
CONCLUSIONS: BCI(H/I)-High vs -Low did not show a statistically significant difference in ELT benefit for the primary endpoint (RFI). However, in time-dependent DR analysis, BCI (H/I)-High patients experienced statistically significant benefit from ELT after 4y, whereas (H/I)-Low patients did not. Because BCI (H/I) has been validated as a predictive marker of EET benefit in other trials, additional follow-up may enable further characterization of BCI's predictive ability.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Clinical cancer research : an official journal of the American Association for Cancer Research - (2024) vom: 20. Feb. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mamounas, Eleftherios P [VerfasserIn] |
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| Anmerkungen: |
Date Revised 20.03.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1158/1078-0432.CCR-23-1977 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368669645 |
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| 100 | 1 | |a Mamounas, Eleftherios P |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Breast Cancer Index and Prediction of Extended Aromatase Inhibitor Therapy Benefit in Hormone Receptor-positive Breast Cancer from the NRG Oncology/NSABP B-42 Trial |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 20.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a PURPOSE: BCI (H/I) has been shown to predict extended endocrine therapy (EET) benefit. We examined BCI (H/I) for EET benefit prediction in NSABP B-42, which evaluated extended letrozole therapy (ELT) in hormone receptor-positive breast cancer patients after 5 years of ET | ||
| 520 | |a METHODS: Stratified Cox model was used to analyze RFI as primary endpoint, with DR, BCFI, and DFS, as secondary endpoints. Due to a non-proportional effect of ELT on DR, time-dependent analyses were performed | ||
| 520 | |a RESULTS: The translational cohort included 2,178 patients (45% BCI (H/I)-High, 55% BCI (H/I)-Low). ELT showed an absolute 10-year RFI benefit of 1.6% (P=0.10), resulting in an underpowered primary analysis (50% power). ELT benefit and BCI (H/I) did not show a significant interaction for RFI (BCI [(H/I])-Low: 10y absolute benefit 1.1% [HR=0.70, 0.43-1.12, P=0.13]; BCI [(H/I])-High: 2.4% [HR=0.83, 0.55-1.26, p=0.38]; Pinteraction=0.56). Time-dependent DR analysis showed that after 4y, BCI (H/I)-High patients had significant ELT benefit (HR=0.29, 0.12-0.69, P<0.01), whereas BCI (H/I)-Low patients were less likely to benefit (HR=0.68, 0.33-1.39, P=0.29) (Pinteraction=0.14). Prediction of ELT benefit by BCI (H/I) was more apparent in the HER2- subset after 4y (ELT-by-BCI (H/I) Pinteraction=0.04) | ||
| 520 | |a CONCLUSIONS: BCI(H/I)-High vs -Low did not show a statistically significant difference in ELT benefit for the primary endpoint (RFI). However, in time-dependent DR analysis, BCI (H/I)-High patients experienced statistically significant benefit from ELT after 4y, whereas (H/I)-Low patients did not. Because BCI (H/I) has been validated as a predictive marker of EET benefit in other trials, additional follow-up may enable further characterization of BCI's predictive ability | ||
| 650 | 4 | |a Journal Article | |
| 700 | 1 | |a Bandos, Hanna |e verfasserin |4 aut | |
| 700 | 1 | |a Rastogi, Priya |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Yi |e verfasserin |4 aut | |
| 700 | 1 | |a Treuner, Kai |e verfasserin |4 aut | |
| 700 | 1 | |a Lucas, Peter C |e verfasserin |4 aut | |
| 700 | 1 | |a Geyer, Charles E |e verfasserin |4 aut | |
| 700 | 1 | |a Fehrenbacher, Louis |e verfasserin |4 aut | |
| 700 | 1 | |a Chia, Stephen K |e verfasserin |4 aut | |
| 700 | 1 | |a Brufsky, Adam M |e verfasserin |4 aut | |
| 700 | 1 | |a Walshe, Janice M |e verfasserin |4 aut | |
| 700 | 1 | |a Soori, Gamini S |e verfasserin |4 aut | |
| 700 | 1 | |a Dakhil, Shaker |e verfasserin |4 aut | |
| 700 | 1 | |a Paik, Soonmyung |e verfasserin |4 aut | |
| 700 | 1 | |a Swain, Sandra M |e verfasserin |4 aut | |
| 700 | 1 | |a Sgroi, Dennis C |e verfasserin |4 aut | |
| 700 | 1 | |a Schnabel, Catherine A |e verfasserin |4 aut | |
| 700 | 1 | |a Wolmark, Norman |e verfasserin |4 aut | |
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