Evidence map›Paper›PMID 26387144›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2015

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.

E Munzone, A Giobbie-Hurder, B A Gusterson, E Mallon, G Viale, B Thürlimann, B Ejlertsen, G MacGrogan, F Bibeau, G Lelkaitis and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2015. 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 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 35% 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.

NCT00004205 phase3completednot on this map

A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan1998 to 2016Enrolled8,028ConditionsBreast CancerArmsletrozole, tamoxifen citrate
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Rare Breast Cancer Subtypes.Current oncology reports · 2021
    Review
  4. Mucin 2 (MUC2) modulates the aggressiveness of breast cancer.Breast cancer research and treatment · 2019
    Article
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 11 institutions in 7 countries.

E MunzoneDivision of Medical Senology, European Institute of Oncology, Milan, Italy elisabetta.munzone@ieo.it.
A Giobbie-HurderDepartment of Biostatistics and Computational Biology, International Breast Cancer Study Group (IBCSG) Statistical Center, Dana-Farber Cancer Institute, Boston, USA.
B A GustersonInstitute of Cancer Sciences, Glasgow University, Glasgow.
E MallonSouthern General Hospital, Glasgow, UK.
G VialeDepartment of Pathology and Laboratory Medicine, IBCSG Central Pathology Laboratory, European Institute of Oncology, and University of Milan, Milan, Italy.
B ThürlimannBreast Center, Kantonsspital, St Gallen Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.
B EjlertsenDanish Breast Cancer Cooperative Group (DBCG), Rigshospitalet, Copenhagen, Denmark.
G MacGroganDepartment of Pathology, Institut Bergonié, Bordeaux.
F BibeauDepartment of Pathology, Val d'Aurelle Cancer Institute, Montpellier, France.
G LelkaitisDepartment of Pathology, Rigshospitalet, Copenhagen, Denmark.
K N PriceInternational Breast Cancer Study Group (IBCSG) Statistical Center.
R D GelberDepartment of Biostatistics and Computational Biology, International Breast Cancer Study Group (IBCSG) Statistical Center, Dana-Farber Cancer Institute, Boston, USA Harvard T.H. Chan School of Public Health, Harvard Medical School, Frontier Science and Technology Research Foundation, Boston, USA.
A S CoatesInternational Breast Cancer Study Group, Bern, Switzerland University of Sydney, Sydney, Australia.
A GoldhirschProgram of Breast Health, European Institute of Oncology, Milan, Italy.
M ColleoniDivision of Medical Senology, European Institute of Oncology, Milan, Italy.
International Breast Cancer Study Group and the BIG 1-98 Collaborative Group
European Institute of Oncology · ITRigshospitalet · DKDana-Farber Cancer Institute · USHarvard University · USInstitut Bergonié · FRInternational Breast Cancer Study Group · CHKantonsspital St. Gallen · CHSouthern General Hospital · GBThe University of Sydney · AUUniversity of Glasgow · GBUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe investigated the outcomes of postmenopausal women with hormone receptor-positive, early breast cancer with special histotypes (mucinous, tubular, or cribriform) enrolled in the monotherapy cohort of the BIG 1-98 trial. PATIENTS AND

methodsThe intention-to-treat BIG 1-98 monotherapy cohort (5 years of therapy with tamoxifen or letrozole) included 4922 women, of whom 4091 had central pathology review. Histotype groups were defined as: mucinous (N = 100), tubular/cribriform (N = 83), ductal (N = 3257), and other (N = 651). Of 183 women with either mucinous or tubular/cribriform tumors, 96 were randomly assigned to letrozole and 87 to tamoxifen. Outcomes assessed were disease-free survival (DFS), overall survival (OS), breast cancer-free interval (BCFI), and distant recurrence-free interval (DRFI). Median follow-up in the analytic cohort was 8.1 years.

resultsWomen with tubular/cribriform breast cancer had the best outcomes for all end points compared with the other three histotypes, and had less breast cancer recurrence (97.5% 5-year BCFI) than those with mucinous (93.5%), ductal (88.9%), or other (89.9%) histotypes. Patients with mucinous or tubular/cribriform carcinoma had better DRFI (5-year rates 97.8% and 98.8%, respectively) than those with ductal (90.9%) or other (92.1%) carcinomas. Within the subgroup of women with special histotypes, we observed a nonsignificant increase in the hazard of breast cancer recurrence with letrozole [hazard (letrozole versus tamoxifen): 3.31, 95% confidence interval 0.94-11.7; P = 0.06].

conclusionsWomen with mucinous or tubular/cribriform breast cancer have better outcomes than those with other histotypes, although the observation is based on a limited number of events. In postmenopausal women with these histotypes, the magnitude of the letrozole advantage compared with tamoxifen may not be as large in patients with mucinous or tubular/cribriform disease. CLINICALTRIALSGOV: NCT00004205.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, HormonalBreast NeoplasmsCarcinoma, Ductal, BreastChemotherapy, AdjuvantCohort StudiesDisease-Free SurvivalFemaleFollow-Up StudiesHumansLetrozoleMiddle AgedNeoplasm Recurrence, LocalNitrilesAntineoplastic Agents, HormonalLetrozoleNitrilesTamoxifenTriazolesbreast cancercribriformletrozolemucinoustamoxifentubular

Identifiers

PMID26387144
PMCPMC4658543
OpenAlexW2228358102

What OpenQuestion holds

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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.