Evidence map›Paper›PMID 25144817›Full record

ArticleInternational journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group2014

Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer.

Timothy M Zagar, Zeljko Vujaskovic, Silvia Formenti, Hope Rugo, Franco Muggia, Brigid O'Connor, Robert Myerson, Paul Stauffer, I-Chow Hsu, Chris Diederich and 9 more

Open access · greenAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
7.5field-weighted citation impact, top 2% 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

41 citing papers in PubMed, 107 citations in OpenAlex.

  1. Article
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  9. Therapeutically harnessing extracellular vesicles.Nature reviews. Drug discovery · 2022
    Review
  10. Article
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  14. Deployable ultrasound applicators for endoluminal delivery of volumetric hyperthermia.International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group · 2021
    Article
  15. Review
  16. Ultrasound-Responsive Nanocarriers in Cancer Treatment: A Review.ACS pharmacology & translational science · 2021
    Review
  17. Article
  18. Review
  19. Untargeted Large Volume Hyperthermia Reduces Tumor Drug Uptake From Thermosensitive Liposomes.IEEE open journal of engineering in medicine and biology · 2021
    Article
  20. Article
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

19 authors at 11 institutions in 1 country.

Timothy M ZagarDepartment of Radiation Oncology, University of North Carolina Hospital , Chapel Hill , North Carolina .
Zeljko Vujaskovic
Silvia Formenti
Hope Rugo
Franco Muggia
Brigid O'Connor
Robert Myerson
Paul Stauffer
I-Chow Hsu
Chris Diederich
William Straube
Mary-Keara Boss
Alina Boico
Oana Craciunescu
Paolo Maccarini
David Needham
Nicholas Borys
Kimberly L Blackwell
Mark W Dewhirst
Duke Medical Center · USNYU Langone Health · USUCSF Helen Diller Family Comprehensive Cancer Center · USWashington University in St. Louis · USCelsion (United States) · USDuke University · USNorth Carolina State University · USRhode Island Hospital · USUniversity of California, San Francisco · USUniversity of Maryland, Baltimore · USUniversity of North Carolina Hospitals · US

Funding

Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI DONNA NIEDZWIECKI · 1985 to 2026
$174.8M
Vaccine FacilityP30CA016087 · NCI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ADRIANA HEGUY · 1985 to 2026
$83.1M
TISSUEP01CA042745 · NCI · DUKE UNIVERSITY · PI JONES, ELLEN L · 1987 to 2009
$28.6M
NCI NIH HHS P01 CA042745NCI NIH HHS P01 CA42745NCI NIH HHS P30 CA014236NCI NIH HHS P30 CA016087
6 · The paper itself

Abstract

purposeUnresectable chest wall recurrences of breast cancer (CWR) in heavily pretreated patients are especially difficult to treat. We hypothesised that thermally enhanced drug delivery using low temperature liposomal doxorubicin (LTLD), given with mild local hyperthermia (MLHT), will be safe and effective in this population. PATIENTS AND

methodsThis paper combines the results of two similarly designed phase I trials. Eligible CWR patients had progressed on the chest wall after prior hormone therapy, chemotherapy, and radiotherapy. Patients were to get six cycles of LTLD every 21-35 days, followed immediately by chest wall MLHT for 1 hour at 40-42 °C. In the first trial 18 subjects received LTLD at 20, 30, or 40 mg/m2; in the second trial, 11 subjects received LTLD at 40 or 50 mg/m2.

resultsThe median age of all 29 patients enrolled was 57 years. Thirteen patients (45%) had distant metastases on enrolment. Patients had received a median dose of 256 mg/m2 of prior anthracyclines and a median dose of 61 Gy of prior radiation. The median number of study treatments that subjects completed was four. The maximum tolerated dose was 50 mg/m2, with seven subjects (24%) developing reversible grade 3-4 neutropenia and four (14%) reversible grade 3-4 leucopenia. The rate of overall local response was 48% (14/29, 95% CI: 30-66%), with. five patients (17%) achieving complete local responses and nine patients (31%) having partial local responses.

conclusionLTLD at 50 mg/m2 and MLHT is safe. This combined therapy produces objective responses in heavily pretreated CWR patients. Future work should test thermally enhanced LTLD delivery in a less advanced patient population.

Indexed as

Antibiotics, AntineoplasticHyperthermia, InducedAdenocarcinomaAdultAgedBreast NeoplasmsCombined Modality TherapyDoxorubicinFemaleHumansMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalPolyethylene GlycolsTemperatureTreatment OutcomeAntibiotics, AntineoplasticDoxorubicinliposomal doxorubicinPolyethylene GlycolsHyperthermialow temperature liposomal doxorubicinrecurrent breast cancer

Identifiers

PMID25144817
PMCPMC4162656
OpenAlexW2163342526

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.