Evidence map›Paper›PMID 38940981›Full record

Trial reportBreast cancer research and treatment2024

Ovarian function recovery in breast cancer patients receiving adjuvant anastrozole treatment: updated results from the phase 3 DATA trial.

Senna W M Lammers, Sandra M E Geurts, Karlijn E P E Hermans, Irene E G van Hellemond, Astrid C P Swinkels, Carolien H Smorenburg, Maurice J C van der Sangen, Judith R Kroep, Aafke H Honkoop, Franchette W P J van den Berkmortel and 5 more

Registry-linked trialAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00301457 (A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT00301457 phase3completednot on this map

A Prospective Randomised, Open, Multicentre, Phase III Study to Assess Different Durations of Anastrozole Therapy After 2 to 3 Years Tamoxifen as Adjuvant Therapy in Postmenopausal Women With Breast Cancer.

TypeinterventionalSponsorMaastricht University Medical CenterRan2006 to 2022Enrolled1,914ConditionsBreast CancerArmsAnastrozole
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

15 authors.

Senna W M LammersDepartment of Medical Oncology, Maastricht University Medical Centre, GROW, Maastricht University, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.ORCID http://orcid.org/0000-0002-8279-585X
Sandra M E GeurtsDepartment of Medical Oncology, Maastricht University Medical Centre, GROW, Maastricht University, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.
Karlijn E P E HermansDepartment of Medical Oncology, Maastricht University Medical Centre, GROW, Maastricht University, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.
Irene E G van HellemondDepartment of Medical Oncology, Catharina Hospital, Eindhoven, the Netherlands.
Astrid C P SwinkelsClinical Research Department, Netherlands Comprehensive Cancer Organisation (IKNL), Nijmegen, the Netherlands.
Carolien H SmorenburgDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Maurice J C van der SangenDepartment of Radiation Oncology, Catharina Hospital, Eindhoven, the Netherlands.
Judith R KroepDepartment of Medical Oncology, Leiden University Medical Centre, Leiden, the Netherlands.
Aafke H HonkoopDepartment of Medical Oncology, Isala Clinics, Zwolle, the Netherlands.
Franchette W P J van den BerkmortelDepartment of Medical Oncology, Zuyderland Medical Centre Heerlen-Sittard-Geleen, location Sittard-Geleen, Geleen, the Netherlands.
Wilfred K de RoosDepartment of Surgery, Gelderse Vallei Hospital, Ede, the Netherlands.
Alexander L T ImholzDepartment of Medical Oncology, Deventer Hospital, Deventer, the Netherlands.
Ingeborg J H VriensDepartment of Medical Oncology, Maastricht University Medical Centre, GROW, Maastricht University, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.
Vivianne C G Tjan-HeijnenDepartment of Medical Oncology, Maastricht University Medical Centre, GROW, Maastricht University, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands. vcg.tjan.heijnen@mumc.nl.ORCID http://orcid.org/0000-0002-3935-7440
Dutch Breast Cancer Research Group (BOOG) for the DATA investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePatients with chemotherapy-induced ovarian function failure (CIOFF) may experience ovarian function recovery (OFR). Earlier, we showed that OFR during treatment with anastrozole impacted the prognosis of hormone receptor-positive (HR+) breast cancer (BC) patients with CIOFF. Here, we present the long-term follow-up results.

methodsPostmenopausal women with HR+ BC who were 45-57 years of age and received chemotherapy were identified from the phase 3 DATA study (NCT00301457) on the extended use of anastrozole. Eligible patients were categorised into two groups: patients with CIOFF and definitely postmenopausal patients. Patients with CIOFF were monitored for OFR. Disease-free survival (DFS), distant recurrence-free survival (DRFS), and overall survival (OS) were compared between patients with OFR and patients without OFR using multivariable Cox regression analyses, including OFR as a time-dependent covariate. BC-specific mortality (BCSM) was compared between groups using the Fine and Gray method.

resultsThis study included 656 patients: 395 patients with CIOFF and 261 definitely postmenopausal patients. OFR occurred in 39 (12%) of 329 patients with CIOFF who were monitored for OFR. The median follow-up time was 13.3 years. Patients with OFR experienced a deterioration in DFS (hazard ratio (HR) = 1.54; 95% confidence interval (CI) 0.85-2.81), DRFS (HR = 1.51; 95% CI 0.73-3.11), OS (HR = 1.64; 95% CI 0.75-3.55), and BCSM (subdistribution HR = 1.98; 95% CI 0.84-4.63) when compared with patients without OFR.

conclusionIn patients with CIOFF, OFR during treatment with anastrozole was associated with a deterioration in BC outcomes. These findings underscore the importance of adequate ovarian function suppression in this subgroup of patients.

Indexed as

AnastrozoleBreast NeoplasmsNitrilesOvaryTriazolesAntineoplastic Agents, HormonalChemotherapy, AdjuvantFemaleFollow-Up StudiesHumansMiddle AgedPostmenopausePrognosisTreatment OutcomeAnastrozoleAntineoplastic Agents, HormonalNitrilesTriazolesAromatase inhibitorsBreast neoplasmsChemotherapy-induced amenorrheaChemotherapy-induced ovarian function failureOvarian function recovery

Identifiers

PMID38940981
PMCPMC11452455

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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.