Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2011
Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial.
Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2011. 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 44 papers, 2 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
44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 104 citations in OpenAlex.
- 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
- Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group.Journal of the National Cancer Institute · 2011Guideline
- Clinico-pathologic relationships with Ki67 and its change with short-term aromatase inhibitor treatment in primary ER + breast cancer: further results from the POETIC trial (CRUK/07/015).Breast cancer research : BCR · 2023Trial
- Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 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
- Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences.Breast cancer research and treatment · 2014Trial
- CYP2D6 genotype and tamoxifen response in postmenopausal women with endocrine-responsive breast cancer: the breast international group 1-98 trial.Journal of the National Cancer Institute · 2012Trial
- The advantage of letrozole over tamoxifen in the BIG 1-98 trial is consistent in younger postmenopausal women and in those with chemotherapy-induced menopause.Breast cancer research and treatment · 2012Trial
- Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8·1 years median follow-up.The Lancet. Oncology · 2011Trial
- Optimizing adjuvant endocrine therapy in premenopausal patients with HER2-positive, hormone receptor-positive breast cancer.Breast (Edinburgh, Scotland) · 2026Article
- Pathological Complete Response and Safety of Neoadjuvant Pembrolizumab-Based Chemoimmunotherapy in Triple-Negative and Hormone Receptor-Low Breast Cancer: A Real-World Cohort Study.Breast cancer (Dove Medical Press) · 2026Article
- Article
- Telomere Maintenance-Related Genes are Essential for Prognosis in Breast Cancer.Breast cancer (Dove Medical Press) · 2025Article
- Alternative dosing regimen of exemestane in a randomized presurgical trial: the role of obesity in biomarker modulation.NPJ breast cancer · 2024Article
- The Clinical Relevance of the NATALEE Study: Application of the NATALEE Criteria to a Real-World Cohort from Two Large German Breast Cancer Centers.International journal of molecular sciences · 2023Article
- Article
- Definition of High-Risk Early Hormone-Positive HER2-Negative Breast Cancer: A Consensus Review.Cancers · 2022Review
- Refining risk stratification in HR-positive/HER2-negative early breast cancer: how to select patients for treatment escalation?Breast cancer research and treatment · 2022Review
- Accelerating progress to innovation for patients: Trial design and risk stratification.Breast (Edinburgh, Scotland) · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 14 institutions in 9 countries.
Funding
Abstract
backgroundOn average, aromatase inhibitors are better than tamoxifen when used as initial or sequential therapy for postmenopausal women with endocrine-responsive early breast cancer. Because there may be contraindications to their use based on side-effects or cost, we investigated subgroups in which aromatase inhibitors may be more or less important. PATIENTS AND
methodsBreast International Group 1-98 trial randomized 6182 women among four groups comparing letrozole and tamoxifen with sequences of each agent; 5177 (84%) had centrally confirmed estrogen receptor (ER) positivity. We assessed whether centrally determined ER, progesterone receptor (PgR), human epidermal growth factor receptor 2, and Ki-67 labeling index, alone or in combination with other prognostic features, predicted the magnitude of letrozole effectiveness compared with either sequence or tamoxifen monotherapy.
resultsIndividually, none of the markers significantly predicted differential treatment effects. Subpopulation treatment effect pattern plot analysis of a composite measure of prognostic risk revealed three patterns. Estimated 5-year disease-free survival for letrozole monotherapy, letrozole→tamoxifen, tamoxifen→letrozole, and tamoxifen monotherapy were 96%, 94%, 93%, and 94%, respectively, for patients at lowest risk; 90%, 91%, 93%, and 86%, respectively, for patients at intermediate risk; and 80%, 76%, 74%, and 69%, respectively, for patients at highest risk.
conclusionA 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.
Indexed as
Identifiers
What OpenQuestion holds
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.