Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial

Viale, Giuseppe; Regan, MM; Dell’Orto, Patrizia; Mastropasqua, Mauro G.; Maiorano, Eugenio; Rasmussen, Birgitte Buur; MacGrogan, Gaëtan; Forbes, JF; Paridaens, Robert; Colleoni, Marco; Láng, István; Thürlimann, Beat; Mouridsen, Henning T.; Mauriac, L.; Gelber, RD; Price, KN; Goldhirsch, Aron; Gusterson, B A; As, Coates

doi:10.1093/annonc/mdq738

Cited by 91 publications

(59 citation statements)

References 19 publications

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“…A number of studies have investigated tumor biomarkers that indicated differential benefit from aromatase inhibitors versus tamoxifen in patients with early breast cancer (4)(5)(6). Such biomarkers included the conventional factors, estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor type 2 (HER2) and Ki-67, and did not identify patients who derived a differential relative benefit from aromatase inhibitors over tamoxifen.…”

Section: Introductionmentioning

confidence: 99%

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Prognostic impact of progesterone receptor status combined with body mass index in breast cancer patients treated with adjuvant aromatase inhibitor

et al. 2015

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Abstract.Aromatase inhibitors have played a central role in endocrine therapy for the treatment of estrogen receptor (ER)-positive breast cancer in postmenopausal patients. However, prognostic factors for recurrence following such treatment have not been identified. The current study aimed to validate the prognostic value of endocrine-related progesterone receptor (PgR) status combined with body mass index (BMI). Among 659 consecutive patients with primary breast cancer who underwent curative surgery between 2002 and 2012, 184 postmenopausal patients with ER-positive (ER+) and human epidermal growth factor receptor type 2-negative (HER2-) breast cancer who were treated with adjuvant aromatase inhibitor therapy were assessed. The patients were assigned to groups based on BMI, according to the WHO cut-off value: ≥25 kg/m 2 (high, H) or <25 kg/m 2 (low, L). Positive nodal status, negative PgR status, BMI-H and a high Ki-67 labeling index (≥20%) were found to be significantly associated with a short recurrence-free interval (RFI) upon univariate analysis (P=0.048, 0.007, 0.027, and 0.012, respectively). The patients were further grouped based on their combined PgR/BMI status. The RFI was significantly shorter in the PgR-and/or BMI-H group compared with that of the PgR+/BMI-L group (P=0.012). Multivariate analysis revealed PgR-tumors and/or BMI-H and positive nodal status to be independent prognostic factors (P=0.012 and 0.020, respectively). The present findings indicate that PgR/BMI status may serve as a practical tool in the management of ER+ and HER2-breast cancer in patients treated with adjuvant aromatase inhibitors. IntroductionAromatase inhibitors have been widely administered as adjuvant treatment for hormone receptor-positive breast cancer in postmenopausal women. The results of recent clinical trials have demonstrated that third-generation aromatase inhibitors, including anastrozole, letrozole and exemestane, are more effective than tamoxifen in treating early stage or metastatic breast cancer in postmenopausal women (1). Thus, aromatase inhibitors are now considered to be the gold standard of endocrine therapy for such patients in adjuvant and metastatic settings (2,3). Characterization of the risk of recurrence for patients who receive aromatase inhibitors is important for selecting appropriate treatment. However, factors that can predict the outcomes of aromatase inhibitor treatment remain unknown.A number of studies have investigated tumor biomarkers that indicated differential benefit from aromatase inhibitors versus tamoxifen in patients with early breast cancer (4-6). Such biomarkers included the conventional factors, estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor type 2 (HER2) and Ki-67, and did not identify patients who derived a differential relative benefit from aromatase inhibitors over tamoxifen. Expression of the PgR gene is thought to largely depend on an intact ER signaling pathway, and the expression of PgR is associated with endocrine responsiv...

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Section: Introductionmentioning

confidence: 99%

“…Conversely, the selection criteria of adjuvant treatment in patients with the ER+/HER2-subtype is particularly difficult to define. Patients who are at high risk for recurrence need to be distinguished from those at low risk, for whom adjuvant aromatase inhibitors may be sufficient (4)(5)(6).…”

Section: Introductionmentioning

confidence: 99%

Prognostic impact of progesterone receptor status combined with body mass index in breast cancer patients treated with adjuvant aromatase inhibitor

et al. 2015

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“…[11] The predictive and prognostic value of PR expression in ER negative cancers is much less understood, mostly because of the rarity of this disease subset.…”

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confidence: 99%

Estrogen receptor (ER) mRNA expression and molecular subtype distribution in ER-negative/progesterone receptor-positive breast cancers

Itoh

Inomata

Matsuoka

et al. 2013

Breast Cancer Res Treat

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“…En el meta-análisis citado previamente el beneficio de la TE adyuvante fue similar en pacientes con RE+ versus aquellos con RE-y RP+ 8 . Tumores RE+/ RP-pueden reflejar la activación de vías de señales de crecimiento y los IA podrían ser más efectivos que el tamoxifeno en esta población 31 .…”

Section: Bio-marcadores Clásicos En CMunclassified

Terapia endocrina neoadyuvante en cáncer de mama, una alternativa de tratamiento e investigación

et al. 2013

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Neoadyuvant endocrine therapy in breast cancerE l cáncer de mama (CM) es la primera causa de muerte por neoplasias en mujeres chilenas 1 . El amplio uso de métodos de screening, con el consiguiente aumento en las tasas de diagnóstico precoz, ha mejorado su pronóstico 2 . Nuevos esquemas y drogas de quimioterapia (QT) citotóxica, además del uso de anticuerpos monoclonales en tumores que expresan el receptor del factor de crecimiento epidérmico tipo 2 (HER2+), han contribuido también a esta mejoría, especialmente en tumores RE negativos y HER2+ 3 . Sin embargo, la resistencia al tratamiento y recaídas de la enfermedad son frecuentes.La búsqueda de mejores terapias se basa finalmente en resultados obtenidos de estudios clínicos fase III, los que comparan distintos tipos de tratamiento adyuvante (postoperatorio), teniendo como objetivo primario la sobrevida global (SG). Otra alternativa es medir los efectos de la terapia sisté-mica en el ámbito preoperatorio (neoadyuvancia), evaluando cambios inducidos por el tratamiento en el corto plazo sobre bio-marcadores predefinidos que están relacionados con la SG. De estos, la respuesta patológica (PR) obtenida luego de terapia neoadyuvante ha sido utilizada para predecir la SG de pacientes con CM 4 . Varios estudios utilizando QT preoperatoria en pacientes con tumores localmente avanzados han demostrado que el tratamiento neoadyuvante aumenta la posibilidad de conservación de la mama y mejora los resultados quirúrgicos, sin detrimento en la sobrevida, en relación al tratamiento con QT posoperatoria [4][5][6] .Dado que más del 80% de los CM expresan el receptor estrogénico (RE), tratamientos destinados a modular su actividad son parte fundamental en su manejo. La terapia endocrina (TE) adyuvante logra disminuir la recurrencia de la enfermedad y mejorar la SG de tumores RE+; parece lógico, por tanto, que la TE orientada molecularmente al RE y que ha demostrado beneficio en adyuvancia, se utilice también en el escenario preoperatorio en tumores RE+ 7 .

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Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial

Abstract: A composite measure of risk informs treatment selection better than individual biomarkers and supports the choice of 5 years of letrozole for patients at highest risk for recurrence.

Cited by 91 publications

References 19 publications

Prognostic impact of progesterone receptor status combined with body mass index in breast cancer patients treated with adjuvant aromatase inhibitor

Prognostic impact of progesterone receptor status combined with body mass index in breast cancer patients treated with adjuvant aromatase inhibitor

Estrogen receptor (ER) mRNA expression and molecular subtype distribution in ER-negative/progesterone receptor-positive breast cancers

Terapia endocrina neoadyuvante en cáncer de mama, una alternativa de tratamiento e investigación

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