Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008
Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00004205 (A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor), which is not on this map. Cited by 150 papers, 3 of them syntheses that pooled 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.
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.
A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors
Who cites it
150 citing papers in PubMed, 3 syntheses or guidelines pooled it, 341 citations in OpenAlex.
- Clinical practice guidelines for molecular tumor marker, 2nd edition review part 2.International journal of clinical oncology · 2024Guideline
- Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016Guideline
- American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010Guideline
- A nomogram for predicting probability of low risk of MammaPrint results in women with clinically high-risk breast cancer.Scientific reports · 2021Trial
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- Trial
- Human Endometriosis Tissue Microarray Reveals Site-specific Expression of Estrogen Receptors, Progesterone Receptor, and Ki67.Applied immunohistochemistry & molecular morphology : AIMM · 2019Trial
- Prognostic and predictive value of androgen receptor expression in postmenopausal women with estrogen receptor-positive breast cancer: results from the Breast International Group Trial 1-98.Breast cancer research : BCR · 2019Trial
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- Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP.Clinical trials (London, England) · 2016Trial
- Outcomes of special histotypes of breast cancer after adjuvant endocrine therapy with letrozole or tamoxifen in the monotherapy cohort of the BIG 1-98 trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2015Trial
- Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Trial
- Differential effects of metformin on breast cancer proliferation according to markers of insulin resistance and tumor subtype in a randomized presurgical trial.Breast cancer research and treatment · 2014Trial
- Association of molecular subtypes with Ki-67 changes in untreated breast cancer patients undergoing pre-surgical trials.Annals of oncology : official journal of the European Society for Medical Oncology · 2014Trial
- Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial.British journal of cancer · 2013Trial
- Patterns of Recurrence and outcome according to breast cancer subtypes in lymph node-negative disease: results from international breast cancer study group trials VIII and IX.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013Trial
- Randomized phase II study of three doses of oral TAS-108 in postmenopausal patients with metastatic breast cancer.Cancer science · 2012Trial
- Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2011Trial
- Protein expression, survival and docetaxel benefit in node-positive breast cancer treated with adjuvant chemotherapy in the FNCLCC-PACS 01 randomized trial.Breast cancer research : BCR · 2011Trial
- Molecular risk assessment of BIG 1-98 participants by expression profiling using RNA from archival tissue.BMC cancer · 2010Trial
90 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 1 institution in 1 country.
Funding
Abstract
purposeTo evaluate the prognostic and predictive value of Ki-67 labeling index (LI) in a trial comparing letrozole (Let) with tamoxifen (Tam) as adjuvant therapy in postmenopausal women with early breast cancer. PATIENTS AND
methodsBreast International Group (BIG) trial 1-98 randomly assigned 8,010 patients to four treatment arms comparing Let and Tam with sequences of each agent. Of 4,922 patients randomly assigned to receive 5 years of monotherapy with either agent, 2,685 had primary tumor material available for central pathology assessment of Ki-67 LI by immunohistochemistry and had tumors confirmed to express estrogen receptors after central review. The prognostic and predictive value of centrally measured Ki-67 LI on disease-free survival (DFS) were assessed among these patients using proportional hazards modeling, with Ki-67 LI values dichotomized at the median value of 11%.
resultsHigher values of Ki-67 LI were associated with adverse prognostic factors and with worse DFS (hazard ratio [HR; high:low] = 1.8; 95% CI, 1.4 to 2.3). The magnitude of the treatment benefit for Let versus Tam was greater among patients with high tumor Ki-67 LI (HR [Let:Tam] = 0.53; 95% CI, 0.39 to 0.72) than among patients with low tumor Ki-67 LI (HR [Let:Tam] = 0.81; 95% CI, 0.57 to 1.15; interaction P = .09).
conclusionKi-67 LI is confirmed as a prognostic factor in this study. High Ki-67 LI levels may identify a patient group that particularly benefits from initial Let adjuvant therapy.
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Registered trials
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.