Evidence mapPaperPMID 29126161Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2018

Early participant-reported symptoms as predictors of adherence to anastrozole in the International Breast Cancer Intervention Studies II.

I Sestak, S G Smith, A Howell, J F Forbes, J Cuzick

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 14% 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.

NCT00072462 phase3completednot on this map

International Breast Cancer Intervention Study II (IBIS-II) (DCIS)

TypeinterventionalSponsorQueen Mary University of LondonRan2003 to 2021Enrolled2,980ConditionsBreast CancerArmstamoxifen citrate, Anastrozole
NCT00078832 phase3completednot on this map

International Breast Cancer Intervention Study

TypeinterventionalSponsorQueen Mary University of LondonRan2003 to 2021Enrolled3,864ConditionsBreast CancerArmsanastrozole, placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Quality of life issues in patients with ductal carcinoma in situ: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Pooled it
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  14. De-Escalation of Locoregional Therapy in Low-Risk Disease for DCIS and Early-Stage Invasive Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Review
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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

5 authors at 4 institutions in 2 countries.

I SestakCentre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK. Electronic address: i.sestak@qmul.ac.uk.
S G SmithLeeds Institute of Health Science, University of Leeds, Leeds, UK.
A HowellDivision of Cancer Sciences, University of Manchester, Manchester, UK.
J F ForbesDepartment of Surgical Oncology, Calvary Mater Newcastle Hospital, Newcastle, Australia.
J CuzickCentre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
Queen Mary University of London · GBCalvary Mater Newcastle Hospital · AUUniversity of Leeds · GBUniversity of Manchester · GB

Funding

Cancer Research UK 16891Cancer Research UK 16893Cancer Research UK 17965Cancer Research UK 5032
6 · The paper itself

Abstract

Background: Anastrozole reduces breast cancer risk in women at high risk, but implementing preventive therapy in clinical practice is difficult. Here, we evaluate adherence to anastrozole in the International Breast Cancer Intervention Study (IBIS)-II prevention and ductal carcinoma in situ (DCIS) trials, and its association with early symptoms. Patients and methods: In the prevention trial, 3864 postmenopausal women were randomized to placebo versus anastrozole. A total of 2980 postmenopausal women with DCIS were randomized to tamoxifen versus anastrozole. Adherence to trial medication was calculated using the Kaplan-Meier method and all P-values were two-sided. Results: In the prevention trial, adherence was 65.8% [anastrozole (65.7%) versus placebo (65.9%); HR = 0.97 (0.87-1.09), P = 0.6]. Adherence was lower for those reporting arthralgia in the placebo group (P = 0.02) or gynecological symptoms in the anastrozole group (P = 0.003), compared with those not reporting these symptoms at 6 months. In the DCIS study, adherence was 66.7% [anastrozole (67.5%) versus tamoxifen (65.8%); HR = 1.06 (0.94-1.20), P = 0.4]. Hot flashes were associated with greater adherence in the anastrozole arm (P = 0.02). In both studies, symptoms were mostly mild or moderately severe, and adherence decreased with increasing severity for most symptoms. Drop-outs were highest in the first 1.5 years of therapy in both trials. Conclusions: In the IBIS-II prevention and DCIS trials, over two-thirds of women were adherent to therapy, with no differences by treatment groups. Participants who reported specific symptoms in the IBIS-II prevention trial had a small but significant effect on adherence, which strengthened as severity increased. Strategies to promote adherence should target the first year of preventive therapy.

Indexed as

Drug MonitoringAdultAgedAnastrozoleAntineoplastic Agents, HormonalBreast NeoplasmsCarcinoma, Intraductal, NoninfiltratingDouble-Blind MethodFemaleHumansMiddle AgedTamoxifenAnastrozoleAntineoplastic Agents, HormonalTamoxifen

Identifiers

PMID29126161
PMCPMC5834118
OpenAlexW2767717564

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.