Evidence map›Paper›PMID 32043763›Full record

Trial reportThe oncologist2020

Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy.

Peter A Kaufman, Masakazu Toi, Patrick Neven, Joohyuk Sohn, Eva-Maria Grischke, Valerie Andre, Clemens Stoffregen, Sarah Shekarriz, Gregory L Price, Gebra Cuyun Carter and 1 more

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

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02107703 (MONARCH 2), which is not on this map. Cited by 45 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 10 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT02107703 phase3active not recruitingnot on this map

MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

TypeinterventionalSponsorEli Lilly and CompanyRan2014 to 2027Enrolled669ConditionsBreast NeoplasmsArmsAbemaciclib, Fulvestrant, Placebo
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 10 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
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  9. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5).Annals of oncology : official journal of the European Society for Medical Oncology · 2020
    Guideline
  10. Pooled it
  11. Trial
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  19. Review
  20. Cancer treatment-related cognitive impairment.Neuro-oncology advances · 2026
    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

11 authors at 7 institutions in 4 countries.

Peter A KaufmanUniversity of Vermont Cancer Center, University of Vermont Medical Center, Burlington, Vermont, USA.
Masakazu ToiDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Patrick NevenUniversity Hospitals Leuven, Leuven, Belgium.
Joohyuk SohnYonsei Cancer Center, Seoul, Republic of Korea.
Eva-Maria GrischkeDepartment of Women's Health, University Hospital Tübingen, Tübingen, Germany.
Valerie AndreEli Lilly and Company, Paris, France.
Clemens StoffregenEli Lilly and Company, Bad Homburg, Germany.
Sarah ShekarrizEli Lilly and Company, Bad Homburg, Germany.
Gregory L PriceEli Lilly and Company, Indianapolis, Indiana, USA.
Gebra Cuyun CarterEli Lilly and Company, Indianapolis, Indiana, USA.
George W SledgeStanford University School of Medicine, Stanford, California, USA.
Eli Lilly (Germany) · DEEli Lilly (United States) · USKyoto University · JPStanford University · USUniversity Children's Hospital Tübingen · DEUniversity of Vermont Medical Center · USYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase III MONARCH 2 study (NCT02107703), abemaciclib plus fulvestrant significantly improved progression-free survival (PFS) versus placebo plus fulvestrant in patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC). This study assessed patient-reported pain, global health-related quality of life (HRQoL), functioning, and symptoms. MATERIALS AND

methodsAbemaciclib or placebo (150 p.o. mg twice daily) plus fulvestrant (500 mg, per label) were randomly assigned (2:1). The modified Brief Pain Inventory, Short Form (mBPI-sf); European Organization for Research and Treatment of Cancer (EORTC) QoL Core 30 (QLQ-C30); and Breast Cancer Questionnaire (QLQ-BR23) assessed outcomes. Data were collected at baseline, cycle 2, every two cycles 3-13, thereafter at every three cycles, and 30 days postdiscontinuation. Longitudinal mixed regression and Cox proportional hazards models assessed postbaseline change and time to sustained deterioration (TTSD) by study arm.

resultsOn-treatment HRQoL scores were consistently maintained from baseline and similar between arms. Patients in the abemaciclib arm (n = 446) experienced a 4.9-month delay in pain deterioration (mBPI-sf), compared with the control arm (n = 223), and significantly greater TTSD on the mBPI-sf and analgesic use (hazard ratio, 0.76; 95% CI, 0.59-0.98) and QLQ-C30 pain item (hazard ratio, 0.62; 95% CI, 0.48-0.79). TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning. Only diarrhea significantly favored the control arm (hazard ratio, 1.60; 95% CI, 1.20-2.10).

conclusionHRQoL was maintained on abemaciclib plus fulvestrant. Alongside superior PFS and manageable safety profile, results support treatment with abemaciclib plus fulvestrant in a population of patients with endocrine-resistant HR+, HER2-negative ABC. IMPLICATIONS FOR PRACTICE: In MONARCH 2, abemaciclib plus fulvestrant demonstrated superior efficacy and a manageable safety profile for patients with in hormone receptor-positive (HR+), HER2-negative (-) advanced breast cancer (ABC). Impact on health-related quality of life (HRQoL) is important to consider, given the palliative nature of ABC treatment. In this study, abemaciclib plus fulvestrant, compared with placebo plus fulvestrant, significantly delayed sustained deterioration of pain and other patient-reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning. Combined with demonstrated clinical benefit and tolerability, the stabilization of patient-reported symptoms and HRQoL further supports abemaciclib plus fulvestrant as a desirable treatment option in endocrine resistant, HR+, HER2- ABC.

Indexed as

Breast NeoplasmsQuality of LifeAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesErb-b2 Receptor Tyrosine KinasesFemaleFulvestrantHumansReceptors, EstrogenabemaciclibAminopyridinesBenzimidazolesErb-b2 Receptor Tyrosine KinasesFulvestrantReceptors, EstrogenAbemaciclibAdvanced breast cancerPatient-reported outcomesQuality of life

Identifiers

PMID32043763
PMCPMC7011625
OpenAlexW2981679955

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.