Evidence map›Paper›PMID 40285945›Full record

Observational studySupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025

Incidence and management of diarrhoea associated with abemaciclib and endocrine therapy for hormone-receptor positive, HER2-negative metastatic breast cancer: the UK patients' experiences.

Helena Harder, Rachel Starkings, Lesley Fallowfield, Shirley May, Valerie Shilling

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Observational
  2. Review
  3. Oncology's ongoing struggle with evaluating quality of life limiting, treatment-related toxicity.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  4. Exploring the real-world experience of abemaciclib treatment for HR +, HER2 - metastatic breast cancer-a qualitative analysis of the IMPACTOR study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    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

5 authors.

Helena HarderSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK. h.harder@sussex.ac.uk.ORCID http://orcid.org/0000-0002-7296-8227
Rachel StarkingsSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.ORCID http://orcid.org/0000-0002-1947-018X
Lesley FallowfieldSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.ORCID http://orcid.org/0000-0003-0577-4518
Shirley MaySussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.ORCID http://orcid.org/0000-0002-3167-9891
Valerie ShillingSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.ORCID http://orcid.org/0000-0002-5610-0321

Funding

Eli Lilly, United Kingdom 13Y-NS-O013
6 · The paper itself

Abstract

purposeAddition of a CDK4/6 inhibitor to endocrine therapy (ET) prolongs survival in HR + /HER2-metastatic breast cancer (MBC). Gastrointestinal side effects, predominantly diarrhoea and abdominal pain, are common in patients receiving abemaciclib. This can potentially increase symptom burden, reduce quality of life (QoL) and affect treatment adherence. This longitudinal mixed-methods study with a 6-month follow-up explored patients' outcomes and experiences.

methodsParticipants (n = 44) completed validated QoL measures at study-entry and at 1, 3 and 6 months. Weekly diarrhoea diaries with free-text response options assessed bowel movements and self-management strategies. Optional interviews gathered insight in patients' experiences.

resultsForty-two participants completed study measures at study-entry and 24 at 6 months. 17/42 reported no gastrointestinal side-effects. Above threshold diarrhoea (≥ 3 loose/liquid stools daily) was reported at least once by 25/42, with 3/42 having persistent symptoms. Strategies to control diarrhoea, employed by 28/42, included dietary modifications, non-prescribed medication-use and nonadherence (dose interruption or reduction). Meaningful decline on the QoL diarrhoea subscale was observed in 12/37 at 1 month, 13/28 at 3 months and 8/23 at 6 months. Free-text analysis showed that diarrhoea disrupted everyday life in those affected.

conclusionA proportion of this small sample of MBC patients treated with abemaciclib and ET-reported diarrhoea which affected symptom burden and QoL. Close symptom monitoring alongside targeted supportive/educational interventions should be introduced to reduce the negative impact on patients' lives.

trial registrationClinicalTrials.gov Identifier: ISRCTN17281696.

Indexed as

AminopyridinesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBreast NeoplasmsDiarrheaAdultAgedAged, 80 and overErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansIncidenceLongitudinal StudiesMiddle AgedabemaciclibAminopyridinesAntineoplastic Agents, HormonalBenzimidazolesErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenReceptors, ProgesteroneAbemaciclibDiarrhoeaManagementMetastatic breast cancerPatient experienceSide effects

Identifiers

PMID40285945
PMCPMC12033210

What OpenQuestion holds

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Registered trials

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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.