Evidence map›Paper›PMID 37468569›Full record

Trial reportBritish journal of cancer2023

A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance® Patient Program.

Carlo Palmieri, Alison Musson, Catherine Harper-Wynne, Duncan Wheatley, Gianfilippo Bertelli, Iain R Macpherson, Mark Nathan, Ellie McDowall, Ajay Bhojwani, Mark Verrill and 3 more

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03921866 (Observational Cohort Study of Patients With Hormone Receptor-positive Metastatic Breast Cancer Treated With Palbociclib), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–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.

NCT03921866 completednot on this map

Observational Cohort Study of Patients With Hormone Receptor-positive Metastatic Breast Cancer Treated With Palbociclib (Ibrance(Registered)) as Part of the United Kingdom Ibrance (Registered) Patient Program (IPP); the Real Outcomes Ibrance (Registered) Study (ROIS)

TypeobservationalSponsorPfizerRan2019 to 2021Enrolled191ConditionsHR+/HER2- Locally Advanced, Metastatic Breast CancerArmsPalbociclib
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
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  6. Review
  7. 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

13 authors.

Carlo PalmieriThe Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, UK. c.palmieri@liverpool.ac.uk.ORCID 0000-0001-9496-2718
Alison MussonThe Christie NHS Foundation Trust, Manchester, UK.
Catherine Harper-WynneKent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Kent, UK.
Duncan WheatleyDepartment of Oncology, Royal Cornwall Hospitals NHS Trust, Truro, UK.
Gianfilippo BertelliUniversity Hospitals Sussex NHS Trust, Brighton, UK.
Iain R MacphersonSchool of Cancer Sciences, University of Glasgow, Glasgow, UK.ORCID 0000-0003-4295-8885
Mark NathanGuy's and St Thomas' NHS Foundation Trust, London, UK.
Ellie McDowallGuy's and St Thomas' NHS Foundation Trust, London, UK.
Ajay BhojwaniThe Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, UK.
Mark VerrillDepartment of Medical Oncology, Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK.
Joe EvaOPEN Health, The Weighbridge, Brewery Courtyard, High Street, Marlow, UK.
Colm DoodyPfizer UK, Walton Oaks, Dorking Rd, Tadworth, UK.
Ruhe ChowdhuryGuy's and St Thomas' NHS Foundation Trust, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Ibrance® Patient Program was established to provide access to palbociclib for UK National Health Service (NHS) patients with metastatic breast cancer (MBC), pending a funding decision.

methodsNon-interventional cohort study involving a retrospective medical record review of patients commenced on palbociclib between April and December 2017 at eight UK centres. Primary outcomes included clinicopathological characteristics, treatment patterns, clinical outcomes and selected adverse events.

resultsOverall, 191 patients were identified, median age of 57.0 years (range 24.3-90.9); 30% were diagnosed with de novo MBC; 72% received first-line and 10% as ≥ second-line treatment. Median progression-free survival (95% CI) was 22.8 months (16.5-not reached [NR]) in first-line; NR in patients with de novo MBC; 7.8 months (6.8-NR) in ≥ second-line (median follow-up: 24 months). Median overall survival (OS) was NR in the overall cohort; OS rate (95% CI) at 24 months was 74.2% (67.1-81.9%) in first-line; 82.1% (72.6-92.8%) in patients with de novo MBC; 55.0% (37.0-81.8%) in ≥ second-line. Forty-seven per cent of patients developed grade 3-4 neutropenia; 3% febrile neutropenia.

conclusionThis study supports the effectiveness of palbociclib and demonstrates the benefit to patients of early access schemes that bridge the gap between regulatory approval and NHS funding for new medicines. CLINICAL

trial registrationClinical trial: ClinicalTrial.gov:NCT03921866.

Indexed as

Breast NeoplasmsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCohort StudiesErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedPiperazinesPyridinesRetrospective StudiesState MedicineTreatment OutcomeUnited KingdomErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesPyridines

Identifiers

PMID37468569
PMCPMC10449843

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.