Evidence map›Paper›PMID 33130486›Full record

SynthesisBreast (Edinburgh, Scotland)2020

Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis.

Paul Stewart, Phillip Blanchette, Prakesh S Shah, Xiang Y Ye, R Gabriel Boldt, Ricardo Fernandes, Ted Vandenberg, Jacques Raphael

Abstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Breast (Edinburgh, Scotland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

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

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

  1. Pooled it
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  6. 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

8 authors.

Paul StewartDepartment of Oncology, Division of Medical Oncology, The University of Western Ontario, London, ON, Canada. Electronic address: Paul.Stewart@lhsc.on.ca.
Phillip BlanchetteDepartment of Oncology, Division of Medical Oncology, The University of Western Ontario, London, ON, Canada.
Prakesh S ShahInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada; Department of Pediatrics, Mount Sinai Hospital, Toronto, ON, Canada.
Xiang Y YeDepartment of Pediatrics, Mount Sinai Hospital, Toronto, ON, Canada.
R Gabriel BoldtLondon Regional Cancer Program, London Health Sciences Centre, London, ON, Canada.
Ricardo FernandesDepartment of Oncology, Division of Medical Oncology, The University of Western Ontario, London, ON, Canada.
Ted VandenbergDepartment of Oncology, Division of Medical Oncology, The University of Western Ontario, London, ON, Canada.
Jacques RaphaelDepartment of Oncology, Division of Medical Oncology, The University of Western Ontario, London, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

One year of adjuvant trastuzumab is considered the standard treatment for patients with HER2 positive breast cancer. However, a shorter duration of trastuzumab may be associated with reduced costs and side effects. Results from randomized trials with diverse non-inferiority margins comparing one year to a shorter duration of adjuvant trastuzumab are not consistent and have not been systematically reviewed using a non-inferiority meta-analysis approach. We conducted a systematic review and meta-analysis of randomized trials to assess whether a shorter duration of adjuvant trastuzumab was non-inferior to one year of treatment or not. The non-inferiority margin for the meta-analysis was pre-defined as the median of the margins of all the trials included. Data of 11,376 patients from 5 trials were analyzed. Non-inferiority margins in included studies varied from 1.15 to 1.53 with median of 1.29 for HR of DFS. A shorter duration of trastuzumab was non-inferior to one year of therapy for DFS (HR 1.13, 95%CI 1.03-1.24) but inconclusive for OS (HR 1.14, 95%CI 1.00-1.30). In a subgroup analysis for DFS outcome, shorter therapy was non-inferior in patients with ER positive disease (HR 1.10, 95%CI 0.95-1.28) and those with sequential therapy (HR 0.97, 95%CI 0.75-1.27) and when the duration of treatment was 6 months (HR 1.09, 95%CI 0.98-1.22). Although a shorter duration of adjuvant trastuzumab was non-inferior to one year of therapy for DFS in patients with HER2 positive breast cancer based on our HR margin of 1.29, any benefit of a shorter duration comes at a loss of efficacy with an increase in absolute risk up to 3.9% for 5 year DFS. Whether the potential increased risk is clinically acceptable for the benefits of a shorter duration remains debatable.

Indexed as

AdultAgedAntineoplastic Agents, ImmunologicalBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEquivalence Trials as TopicErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedRandomized Controlled Trials as TopicTime FactorsTrastuzumabTreatment OutcomeAntineoplastic Agents, ImmunologicalErb-b2 Receptor Tyrosine KinasesTrastuzumabAdjuvantBreastHER2Trastuzumab

Identifiers

PMID33130486
PMCPMC7599130

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.