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

被引:8
作者
Mamounas, Eleftherios P. [1 ,17 ]
Bandos, Hanna [2 ,3 ]
Rastogi, Priya [4 ,5 ]
Zhang, Yi [6 ]
Treuner, Kai [6 ]
Lucas, Peter C. [4 ]
Geyer, Charles E. [4 ]
Fehrenbacher, Louis [7 ]
Chia, Stephen K. [8 ,9 ]
Brufsky, Adam M. [4 ,5 ]
Walshe, Janice M. [10 ]
Soori, Gamini S. [11 ]
Dakhil, Shaker [12 ]
Paik, Soonmyung [13 ,14 ]
Swain, Sandra M. [15 ]
Sgroi, Dennis C. [16 ]
Schnabel, Catherine A. [6 ]
Wolmark, Norman [4 ]
机构
[1] Orlando Hlth Canc Inst, Orlando, FL USA
[2] NRG Oncol SDMC, Pittsburgh, PA USA
[3] Univ Pittsburgh, Pittsburgh, PA USA
[4] UPMC Hillman Canc Ctr, Pittsburgh, PA USA
[5] Magee Womens Hosp, Pittsburgh, PA USA
[6] A Hologic Co, Biotheranost Inc, San Diego, CA USA
[7] Kaiser Permanente Oncol Clin Trials Northern CA, Novato, CA USA
[8] British Columbia Canc Agcy, Vancouver, BC, Canada
[9] Univ British Columbia, Vancouver, BC, Canada
[10] Irish Clin Oncol Res Grp ICORG, Canc Trials Ireland, Dublin, Ireland
[11] Florida Canc Specialists, Ft Myers, FL USA
[12] CCOP Wichita Canc Ctr Kansas, Wichita, KS USA
[13] Theragenbio Inc, Pankyo, South Korea
[14] Yonsei Univ, Coll Med, Severance Biomed Sci Inst, Seoul, South Korea
[15] Georgetown Univ, Med Ctr, Georgetown Lombardi Comprehens Canc Ctr, Washington, DC USA
[16] Massachusetts Gen Hosp, Boston, MA USA
[17] Orlando Hlth Canc Inst, Surg, 1400 S Orange Ave, Orlando, FL 32806 USA
关键词
LATE DISTANT RECURRENCE; SURGICAL ADJUVANT BREAST; ENDOCRINE THERAPY; POSTMENOPAUSAL WOMEN; TAMOXIFEN; SCORE; RISK; LETROZOLE;
D O I
10.1158/1078-0432.CCR-23-1977
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 patients with hormone receptor-positive breast cancer after 5 years of ET. Experimental design: A stratified Cox model was used to analyze RFI as the primary endpoint, with DR, BCFI, and DFS as secondary endpoints. Because of a nonproportional 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: 10 years absolute benefit 1.1% [HR, 0.70; 95% confidence interval (CI), 0.43-1.12; P = 0.13]; BCI (H/I)-High: 2.4% [HR, 0.83; 95% CI, 0.55-1.26; P = 0.38]; P-interaction = 0.56). Time-dependent DR analysis showed that after 4 years, BCI (H/I)-High patients had significant ELT benefit (HR = 0.29; 95% CI, 0.12-0.69; P < 0.01), whereas BCI (H/I)-Low patients were less likely to benefit (HR, 0.68; 95% CI, 0.33-1.39; P = 0.29; P-interaction = 0.14). Prediction of ELT benefit by BCI (H/I) was more apparent in the HER2- subset after 4 years (ELT-by-BCI (H/I) P-interaction = 0.04). Conclusions: BCI (H/I)-High versus BCI (H/I)-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 4 years, 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.
引用
收藏
页码:1984 / 1991
页数:8
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