Evidence map›Paper›PMID 18451236›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2008

Cardiac toxicity and efficacy of trastuzumab combined with pertuzumab in patients with [corrected] human epidermal growth factor receptor 2-positive metastatic breast cancer.

Chia C Portera, Janice M Walshe, Douglas R Rosing, Neelima Denduluri, Arlene W Berman, Ujala Vatas, Margarita Velarde, Catherine K Chow, Seth M Steinberg, Diana Nguyen and 2 more

Erratum issuedOpen access · bronzeAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 56 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 2 pooled it
6.4field-weighted citation impact, top 3% 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

56 citing papers in PubMed, 2 syntheses or guidelines pooled it, 157 citations in OpenAlex.

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  20. Advances in systemic therapy for metastatic breast cancer: future perspectives.Medical oncology (Northwood, London, England) · 2017
    Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

Chia C PorteraMedical Oncology Branch, National Cancer Institute, Bethesda, MD, USA.
Janice M Walshe
Douglas R Rosing
Neelima Denduluri
Arlene W Berman
Ujala Vatas
Margarita Velarde
Catherine K Chow
Seth M Steinberg
Diana Nguyen
Sherry X Yang
Sandra M Swain
National Cancer Institute · MYNational Cancer Institute · USCardinal Glennon Children’s Medical Center · USCenter for Cancer Research · USNational Heart Lung and Blood Institute · USWashington Hospital · US

Funding

BIOSTATISTICS AND DATA MANAGEMENT SECTIONZ01SC007202 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI STEINBERG, SETH M · 1996 to 2008
$1.5M
Developmental TherapeuticsZ01BC010435 · NCI · BASIC SCIENCES · PI SWAIN, SANDRA M · 2001 to 2007
$404k
Intramural NIH HHS Z01 BC010435
6 · The paper itself

Abstract

purposeTo evaluate safety and efficacy of trastuzumab with pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who had progressive disease on trastuzumab-based therapy. EXPERIMENTAL

designPatients with measurable HER2(+) metastatic breast cancer, < or = 3 trastuzumab-based regimens, and left ventricular ejection fraction (LVEF) > or = 55% received 8 or 6 mg/kg trastuzumab and 840 mg pertuzumab i.v. followed by 6 mg/kg trastuzumab and 420 mg pertuzumab every 3 weeks. Cardiac evaluation and tumor response were assessed every 3 and 6 weeks, respectively.

resultsEleven patients received 64 cycles of trastuzumab plus pertuzumab. A total of 92 echocardiograms and 8 cardiac magnetic resonance imaging studies were done. With the lower limit of normal LVEF 55%, left ventricular systolic dysfunction was observed in six patients, three grade 1, two grade 2, and one grade 3 according to the National Cancer Institute Common Terminology Criteria for Adverse Events. The objective response rate was 18%. Two patients had partial responses, three had stable disease, and six had progressive disease. The median time to progression was 6 weeks. In baseline tumors from formalin-fixed paraffin-embedded primary and/or metastatic tumor biopsies, pHER2-Y1248 trended toward an increase in patients with partial response compared with those with stable disease/progressive disease (P = 0.095).

conclusionTrastuzumab plus pertuzumab may have clinical benefit in selected patients who have previously been treated with trastuzumab. Cardiac toxicity, although asymptomatic in most cases, was associated with this treatment. Further evaluation of efficacy of this combination is required to define the overall risks and benefits.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsEchocardiographyErb-b2 Receptor Tyrosine KinasesFemaleHeartHumansMiddle AgedTrastuzumabVentricular Dysfunction, LeftAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumab

Identifiers

PMID18451236
PMCPMC4406095
OpenAlexW2121915946

What OpenQuestion holds

Textmetadata
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.