Evidence map›Paper›PMID 15020607›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2004

Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression.

Debu Tripathy, Dennis J Slamon, Melody Cobleigh, Andrew Arnold, Mansoor Saleh, Joanne E Mortimer, Maureen Murphy, Stanford J Stewart

Registry-linked trialOpen access · bronzeAbstract readClinical TrialControlled Clinical Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01367028 (Multicentre Randomized Phase II Study of Neoadjuvant Trastuzumab Plus Docetaxel With and Without Bevacizumab and Trastuzumab Plus Docetaxel Plus Non-pegylated Liposome-encapsulated Doxorubicin), which is not on this map. Cited by 96 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 6 pooled it
10.2field-weighted citation impact, top 1% 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.

NCT01367028 phase2completednot on this mapstarted 2011, after this paper: background citation

Multicentre Randomized Phase II Study of Neoadjuvant Trastuzumab Plus Docetaxel With and Without Bevacizumab and Trastuzumab Plus Docetaxel Plus Non-pegylated Liposome-encapsulated Doxorubicin (NPLD) With and Without Bevacizumab in HER2-positive Early Breast Cancer

TypeinterventionalSponsorAustrian Breast & Colorectal Cancer Study GroupRan2011 to 2014Enrolled100ConditionsBreast CancerArmsTrastuzumab, Docetaxel, Trastuzumab, Docetaxel, Bevacizumab, Trastuzumab+Docetaxel+NPLD, Trastuzumab+Docetaxel+NPLD+Bevacizumab
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 6 syntheses or guidelines pooled it, 283 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Trastuzumab-containing regimens for metastatic breast cancer.The Cochrane database of systematic reviews · 2014
    Pooled it
  6. Lapatinib for treatment of advanced or metastasized breast cancer: systematic review.Sao Paulo medical journal = Revista paulista de medicina · 2009
    Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Adjuvant trastuzumab in HER2-positive breast cancer.The New England journal of medicine · 2011
    Trial
  11. Trial
  12. Trial
  13. Trial
  14. Article
  15. Article
  16. Article
  17. Article
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  20. Article

36 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Debu TripathyUniversity of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd, Dallas, TX 75390-8852, USA. debu.tripathy@utsouthwestern.edu
Dennis J Slamon
Melody Cobleigh
Andrew Arnold
Mansoor Saleh
Joanne E Mortimer
Maureen Murphy
Stanford J Stewart
Eastern Virginia Medical School · USCorixa Corporation · USUniversity of Alabama at Birmingham · US

Funding

Tissue and Outcomes CoreP50CA058207 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRAY, JOE W. · 1992 to 2012
$32.7M
NCI NIH HHS P50 CA 58207
6 · The paper itself

Abstract

purposeIn a pivotal phase III trial, the addition of trastuzumab to chemotherapy significantly improved response rate, time to disease progression, and overall survival in women with HER2 overexpressing metastatic breast cancer. We conducted an extension study to this trial to obtain additional safety information and to provide trastuzumab following disease progression. PATIENTS AND

methodsA total of 247 patients with documented disease progression received weekly intravenous trastuzumab in the extension study. Concurrent therapies were administered at the discretion of the treating physician. Patient groups were based on initial study treatment: chemotherapy alone (group 1, n=154) or chemotherapy plus trastuzumab (group 2, n=93).

resultsSixty-eight percent of group 1 and 76% of group 2 received chemotherapy plus trastuzumab in the extension trial; the remainder received trastuzumab alone or combined with palliative radiotherapy or hormonal therapy. Seventy-six percent of group 1 and 55% of group 2 experienced at least one adverse event, similar to effects observed in the pivotal trial. Symptomatic or asymptomatic cardiac dysfunction occurred in 9% of group 1 and 2% of group 2 patients. Overall objective response rates were 14% in group 1 and 11% in group 2; median durations of response exceeded 6 months in both groups.

conclusionOur results suggest that prolonged use of trastuzumab therapy is safe and well tolerated. Longer durations of therapy did not appear to increase the risk of cardiac dysfunction. Patients progressing on trastuzumab-containing therapy demonstrate some response to a second trastuzumab-containing regimen. The independent contribution of trastuzumab in this setting merits further study.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDisease ProgressionErb-b2 Receptor Tyrosine KinasesFemaleHumansSafetyTrastuzumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsErb-b2 Receptor Tyrosine KinasesTrastuzumab

Identifiers

PMID15020607
OpenAlexW2158158704

What OpenQuestion holds

Textmetadata
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.