Evidence map›Paper›PMID 32232698›Full record

Trial reportBreast cancer research and treatment2020

Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer.

Yvonne Brandberg, Hemming Johansson, Mats Hellström, Michael Gnant, Volker Möbus, Richard Greil, Theodoros Foukakis, Jonas Bergh, Swedish Breast Cancer Group, the Austrian Breast, Colorectal Cancer Study Group, the German Breast Cancer Group

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00798070 (A Randomised Phase 3 Study Comparing Biweekly and Tailored Epirubicin + Cyclophosphamide Followed by Biweekly Tailored Docetaxel Versus Three Weekly Epirubicin + Cyclophosphamide + 5-fluorouracil Followed by Docetaxel in Lymph Node Positive or High Risk Lymph Node Negative Breast Cancer Patients), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT00798070 phase3active not recruitingnot on this map

A Randomised Phase 3 Study Comparing Biweekly and Tailored Epirubicin + Cyclophosphamide Followed by Biweekly Tailored Docetaxel Versus Three Weekly Epirubicin + Cyclophosphamide + 5-fluorouracil Followed by Docetaxel in Lymph Node Positive or High Risk Lymph Node Negative Breast Cancer Patients

TypeinterventionalSponsorKarolinska University HospitalRan2007 to 2028Enrolled2,017ConditionsBreast CancerArmsdtEC→dtT, FEC→T
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Tailored Dose-Dense Versus Standard Adjuvant Chemotherapy for High-Risk Early Breast Cancer: End-of-Study Results of the Randomized PANTHER Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
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  8. Observational
  9. Article
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  13. Impact of Fasting on Patients With Cancer: An Integrative Review.Journal of the advanced practitioner in oncology · 2023
    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

9 authors.

Yvonne BrandbergDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. yvonne.brandberg@ki.se.ORCID http://orcid.org/0000-0001-9840-9266
Hemming JohanssonDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
Mats HellströmDepartment of Oncology, Karolinska University Hospital, Stockholm, Sweden.
Michael GnantDepartment of Surgery, Medical University of Vienna, Vienna, Austria.
Volker MöbusDepartment of Gynecology and Obstetrics, Goethe University Frankfurt/M, Frankfurt, Germany.
Richard GreilMedical Department, Medical University Hospital, Salzburg, Austria.
Theodoros FoukakisDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
Jonas BerghDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
Swedish Breast Cancer Group, the Austrian Breast, Colorectal Cancer Study Group, the German Breast Cancer Group

Funding

Cancerfonden 180842
6 · The paper itself

Abstract

purposeTo prospectively compare HRQoL effects of two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16 months after random assignment.

methodsThe open-label, randomized, Phase 3 "Panther trial" was conducted between February 2007 and September 2011. 760 women, aged 65 years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer were randomized 1:1 to the experimental group (four cycles of tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2 weeks followed by four cycles of tailored dose-dense docetaxel/2 weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3 weeks followed by three cycles of docetaxel/3 weeks). HRQoL was assessed at all Swedish centres using EORTC QLQ-C30 and EORTC QLQ-BR23 at six points during 16 months before randomization.

resultsResponse rates to questionnaires were highest at baseline 728/780 (93%) and lowest 16 months after randomization, 557/750 (74%). HRQoL declined during treatment in both groups. At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects. No differences were found for emotional functioning, body image, and arm and breast symptoms. There were no statistically significant differences between the groups at the first follow-up and at subsequent assessments. HRQoL levels at the 16-month follow-up were similar to baseline values.

conclusionsNegative HRQoL impact of the dose-dense and tailored strategy appears to be prominent during treatment, but HRQoL recover once treatment ends.

trial registrationclinicaltrials.gov Identifier: NCT00798070; isrctn.org Identifier: ISRCTN39017665.

Indexed as

Quality of LifeAdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDocetaxelEpirubicinErb-b2 Receptor Tyrosine KinasesFemaleFluorouracilFollow-Up StudiesHealth StatusHumansCyclophosphamideDocetaxelEpirubicinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFluorouracilReceptors, EstrogenReceptors, ProgesteroneTaxoidsAdjuvantBreast cancerDose denseHealth-related quality of lifeRandomized trial

Identifiers

PMID32232698
PMCPMC7182635

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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.