Evidence map›Paper›PMID 31618131›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

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

Olivia Pagani, Prudence A Francis, Gini F Fleming, Barbara A Walley, Giuseppe Viale, Marco Colleoni, István Láng, Henry L Gómez, Carlo Tondini, Graziella Pinotti and 6 more

Open access · hybridAbstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 6 pooled it
14.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 6 syntheses or guidelines pooled it, 145 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  8. Twenty-Year Benefit From Adjuvant Goserelin and Tamoxifen in Premenopausal Patients With Breast Cancer in a Controlled Randomized Clinical Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  9. Trial
  10. Article
  11. Article
  12. Review
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  14. Article
  15. Review
  16. Response to Verma et al., Letter to the editor.Breast (Edinburgh, Scotland) · 2026
    Article
  17. Article
  18. Article
  19. Article
  20. Article

16 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 13 institutions in 7 countries.

Olivia PaganiInstitute of Oncology of Southern Switzerland, Geneva University Hospitals, and Swiss Group for Clinical Cancer Research (SAKK), Lugano Viganello, Switzerland.
Prudence A FrancisPeter MacCallum Cancer Center, St Vincent's Hospital, and University of Melbourne, Melbourne, Victoria, Australia.
Gini F FlemingThe University of Chicago Medical Center, Chicago, IL.
Barbara A WalleyUniversity of Calgary and Canadian Cancer Trials Group, Calgary, Alberta, Canada.
Giuseppe VialeInternational Breast Cancer Study Group Central Pathology Center, IEO, European Institute of Oncology IRCCS, and University of Milan, Milan, Italy.
Marco ColleoniIEO, European Institute of Oncology IRCCS and International Breast Cancer Study Group, Milan, Italy.
István LángNational Institute of Oncology, Budapest, Hungary.
Henry L GómezInstituto Nacional de Enfermedades Neoplásicas, Lima, Peru.
Carlo TondiniOspedale Papa Giovanni XXIII, Bergamo, Italy.
Graziella PinottiASST Settelaghi Ospedale di Circolo e Fondazione Macchi, Varese, Italy.
Angelo Di LeoHospital of Prato-AUSL Toscana Centro and International Breast Cancer Study Group, Prato, Italy.
Alan S CoatesInternational Breast Cancer Study Group and University of Sydney, New South Wales, Australia.
Aron GoldhirschIEO, European Institute of Oncology IRCCS and International Breast Cancer Study Group, Milan, Italy.
Richard D GelberInternational Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health, and Frontier Science and Technology Research Foundation, Boston, MA.
Meredith M ReganInternational Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
SOFT and TEXT Investigators and International Breast Cancer Study Group
Dana-Farber Cancer Institute · USEuropean Institute of Oncology · ITHospital of Prato · ITInstituto Nacional de Enfermedades Neoplásicas · PENational Institute of Oncology · HUOspedale di Circolo e Fondazione Macchi · ITOspedale Papa Giovanni XXIII · ITSwiss Group For Clinical Cancer Research · CHUniversity of Calgary · CAUniversity of Chicago Medical Center · USUniversity of Melbourne · AUUniversity of Milan · ITUniversity of Sydney · AU

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
NCIC Foreign AccrualsU10CA077202 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI EISENHAUER, ELIZABETH · 1998 to 2013
$14.6M
IBCSG STATISTICAL CENTER--A BREAST CANCER STUDY RESOURCEU24CA075362 · NCI · DANA-FARBER CANCER INSTITUTE · PI REGAN, MEREDITH M · 1997 to 2015
$7.5M
EASTERN COOPERATIVE ONCOLOGY GROUPU10CA016116 · NCI · JOHNS HOPKINS UNIVERSITY · PI FORASTIERE, ARLENE ANN · 1985 to 2013
$4.0M
Cancer Research UK CRUKE/03/022Cancer Research UK CRUKE/03/023Department of Health A15955NCI NIH HHS N01 CA032102NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA077202NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA075362NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

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.

Indexed as

AndrostadienesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantClinical Trials, Phase III as TopicErb-b2 Receptor Tyrosine KinasesFemaleHumansNeoplasm Recurrence, LocalOvariectomyOvaryPremenopauseRandomized Controlled Trials as TopicReceptors, EstrogenReceptors, ProgesteroneAndrostadienesAntineoplastic Agents, HormonalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesexemestaneReceptors, EstrogenReceptors, ProgesteroneTamoxifenTriptorelin Pamoate

Identifiers

PMID31618131
PMCPMC7164485
OpenAlexW2980534320

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.