Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT

被引：101

作者：

Pagani, Olivia ^{[1
,2
]}

Francis, Prudence A. ^{[3
,4
]}

Fleming, Gini F. ^{[5
]}

Walley, Barbara A. ^{[6
,7
]}

Viale, Giuseppe ^{[8
,9
]}

Colleoni, Marco ^{[10
,11
]}

Lang, Istvan ^{[12
]}

Gomez, Henry L. ^{[13
]}

Tondini, Carlo ^{[14
]}

Pinotti, Graziella ^{[15
]}

Di Leo, Angelo ^{[16
,17
]}

Coates, Alan S. ^{[18
,19
]}

Goldhirsch, Aron ^{[10
,11
]}

Gelber, Richard D. ^{[20
,21
]}

Regan, Meredith M. ^{[22
]}

机构：

[1] Geneva Univ Hosp, Inst Oncol Southern Switzerland, Lugano Viganello, Switzerland

[2] Swiss Grp Clin Canc Res SAKK, Lugano Viganello, Switzerland

[3] St Vincents Hosp, Peter MacCallum Canc Ctr, Melbourne, Vic, Australia

[4] Univ Melbourne, Melbourne, Vic, Australia

[5] Univ Chicago, Med Ctr, Chicago, IL 60637 USA

[6] Univ Calgary, Calgary, AB, Canada

[7] Canadian Canc Trials Grp, Calgary, AB, Canada

[8] European Inst Oncol IRCCS, IEO, Cent Pathol Ctr, Int Breast Canc Study Grp, Milan, Italy

[9] Univ Milan, Milan, Italy

[10] European Inst Oncol IRCCS, IEO, Milan, Italy

[11] Int Breast Canc Study Grp, Milan, Italy

[12] Natl Inst Oncol, Budapest, Hungary

[13] Inst Nacl Enfermedades Neoplas, Lima, Peru

[14] Osped Papa Giovanni XXIII, Bergamo, Italy

[15] ASST Settelaghi Osped Circolo & Fdn Macchi, Varese, Italy

[16] Hosp Prato, AUSL Toscana Ctr, Prato, Italy

[17] Int Breast Canc Study Grp, Prato, Italy

[18] Int Breast Canc Study Grp, Sydney, NSW, Australia

[19] Univ Sydney, Sydney, NSW, Australia

[20] Harvard Med Sch, Harvard TH Chan Sch Publ Hlth, Dana Farber Canc Inst, Int Breast Canc Study Grp,Stat Ctr, Boston, MA 02115 USA

[21] Frontier Sci & Technol Res Fdn Inc, Boston, MA USA

[22] Harvard Med Sch, Dana Farber Canc Inst, Int Breast Canc Study Grp, Stat Ctr, Boston, MA 02115 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2020年 / 38卷 / 12期

基金：

英国医学研究理事会; 美国国家卫生研究院;

关键词：

BREAST-CANCER RECURRENCE; CLINICAL-PRACTICE; OVARIAN SUPPRESSION; HORMONAL-THERAPY; BIOMARKERS; GUIDELINES; DECISIONS; ADHERENCE; SCORE; ASSAY;

D O I：

10.1200/JCO.18.01967

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOSEThe Tamoxifen and Exemestane Trial (TEXT)/Suppression of Ovarian Function Trial (SOFT) showed superior outcomes for premenopausal women with hormone receptor (HR)-positive breast cancer treated with adjuvant exemestane plus ovarian function suppression (OFS) or tamoxifen plus OFS versus tamoxifen alone. We previously reported the magnitude of absolute improvements in freedom from any recurrence across a continuous, composite measure of recurrence risk to tailor decision making. With longer follow-up, we now focus on distant recurrence.METHODSThe TEXT/SOFT HR-positive/human epidermal growth factor receptor 2 (HER2)-negative analysis population included 4,891 women stratified by predetermined chemotherapy use. Kaplan-Meier estimates of 8-year freedom from distant recurrence were analyzed using subpopulation treatment effect pattern plot (STEPP) methodology across subpopulations defined by the continuous composite measure of recurrence risk. For each patient, the composite risk value was obtained from a Cox model that incorporated age; nodal status; tumor size; grade; and estrogen receptor, progesterone receptor, and Ki-67 labeling index expression levels.RESULTSThe overall rate of 8-year freedom from distant recurrence was 91.1% and ranged from approximately 100% to 63% across lowest to highest composite risks. TEXT patients who received chemotherapy had an average absolute improvement with exemestane plus OFS versus tamoxifen plus OFS of 5.1%, and STEPP analysis showed improvements from less than 1% to more than 15% from lowest to highest composite risks. SOFT patients who remained premenopausal after chemotherapy had an average 5.2% absolute improvement with exemestane plus OFS versus tamoxifen and reached 10% across composite risks; for tamoxifen plus OFS versus tamoxifen, the maximum improvement was approximately 3.5%. Women who did not receive chemotherapy had a more than 97% rate of 8-year freedom from distant recurrence, and improvements with exemestane plus OFS ranged from 1% to 4%.CONCLUSIONPremenopausal women with HR-positive/HER2-negative breast cancer and high recurrence risk, as defined by clinicopathologic characteristics, may experience a 10% to 15% absolute improvement in 8-year freedom from distant recurrence with exemestane plus OFS versus tamoxifen plus OFS or tamoxifen alone. The potential benefit of escalating endocrine therapy versus tamoxifen alone is minimal for those at low recurrence risk. (c) 2019 by American Society of Clinical Oncology

引用

页码：1293 / +

页数：28

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