Evidence map›Paper›PMID 30048453›Full record

Observational studyPloS one2018

Adherence to prescribing restrictions for HER2-positive metastatic breast cancer in Australia: A national population-based observational study (2001-2016).

Benjamin Daniels, Federico Girosi, Hanna Tervonen, Belinda E Kiely, Sarah J Lord, Nehmat Houssami, Sallie-Anne Pearson

Open access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 36% 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.

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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. 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

7 authors at 3 institutions in 1 country.

Benjamin DanielsMedicines Policy Research Unit, Centre for Big Data Research in Health, UNSW, Sydney, Australia.ORCID 0000-0001-8617-6055
Federico GirosiTranslational Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.
Hanna TervonenMedicines Policy Research Unit, Centre for Big Data Research in Health, UNSW, Sydney, Australia.
Belinda E KielyNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Sarah J LordNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Nehmat HoussamiSydney School of Public Health, Sydney Medical School, University of Sydney, Sydney, Australia.
Sallie-Anne PearsonMedicines Policy Research Unit, Centre for Big Data Research in Health, UNSW, Sydney, Australia.
The University of Sydney · AUUNSW Sydney · AUTranslational Research Institute · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTargeted cancer therapy is often complex, involving multiple agents and chemotherapeutic partners. In Australia, prescribing restrictions are put in place to reflect existing evidence of cost-effectiveness of these medicines. As therapeutic options continue to expand, these restrictions may not be perceived to align with best practice and it is not known if their use in the real-world clinic adheres to these restrictions. We examined the treatment of women receiving trastuzumab for HER2-positive metastatic breast cancer (HER2+MBC) to determine the extent to which treatment adhered to national prescribing restrictions. PATIENTS AND

methodsOur population-based, retrospective cohort study used dispensing records for every Australian woman initiating publicly-subsidised trastuzumab for HER2+MBC between 2001-2013, followed through 2016. We used group-based trajectory models (GBTMs) to cluster patients, first on their patterns of trastuzumab exposure, and then on their patterns of lapatinib and chemotherapy exposure. We described the characteristics of patients within each cluster, and examined their treatments and combinations of treatments to determine restriction adherence.

resultsOf 5,052 patients initiating trastuzumab, 1,795 (36%) received at least one non-adherent HER2-targeted treatment. The most common non-adherent treatments were trastuzumab combinations involving vinorelbine (24% of non-adherent treatments); capecitabine (24%); and anthracyclines (10%). Non-adherent lapatinib use was observed in 4% of patients. GBTM identified three trastuzumab exposure clusters, each containing three further sub-clusters. The largest proportions of non-adherent treatments were in sub-clusters with longer trastuzumab exposure and more non-taxane chemotherapy. Patients in these sub-clusters were younger than those in sub-clusters with less non-adherent treatment.

conclusionsOur study highlights that, even during the relatively simpler treatment era of our study period, a substantial amount of treatment did not adhere to prescribing restrictions. As more trials are conducted exploring pertuzumab and T-DM1 in combination with different chemotherapies and other HER2-targeted therapies, the regulation and funding of HER2-targeted treatment will become more challenging.

Indexed as

AgedAnthracyclinesAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsAustraliaBreast NeoplasmsCapecitabineCluster AnalysisErb-b2 Receptor Tyrosine KinasesFemaleGene ExpressionHumansLapatinibMiddle AgedPatient CompliancePatient SelectionAnthracyclinesAntineoplastic Agents, ImmunologicalCapecitabineERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapatinibTrastuzumabVinorelbine

Identifiers

PMID30048453
PMCPMC6061975
OpenAlexW2949170515

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.