Evidence map›Paper›PMID 28641315›Full record

Trial reportBritish journal of cancer2017

Sequential vs concurrent epirubicin and docetaxel as adjuvant chemotherapy for high-risk, node-negative, early breast cancer: an interim analysis of a randomised phase III study from the Hellenic Oncology Research Group.

Dimitrios Mavroudis, Emmanouil Saloustros, Ioannis Boukovinas, Pavlos Papakotoulas, Stylianos Kakolyris, Nikolaos Ziras, Charalampos Christophylakis, Nikolaos Kentepozidis, Georgios Fountzilas, Georgios Rigas and 5 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 40% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 1 country.

Dimitrios MavroudisDepartment of Medical Oncology, University Hospital of Heraklion, Heraklion, Greece.
Emmanouil SaloustrosOncology Unit, General Hospital of Heraklion 'Venizelio', Heraklion, Greece.
Ioannis BoukovinasDepartment of Medical Oncology, Bioclinic, Thessaloniki, Greece.
Pavlos Papakotoulas2nd Department of Medical Oncology, 'Theageneio' Cancer Center, Thessaloniki, Greece.
Stylianos KakolyrisDepartment of Medical Oncology, University Hospital of Alexandroupolis, Alexandroupolis, Greece.
Nikolaos Ziras2nd Department of Medical Oncology, 'Metaxas' Cancer Center, Piraeus, Greece.
Charalampos ChristophylakisDepartment of Medical Oncology, 401 General Military Hospital, Athens, Greece.
Nikolaos KentepozidisDepartment of Medical Oncology, 251 Airforce Hospital, Athens, Greece.
Georgios FountzilasAristotle University of Thessaloniki, Thessaloniki, Greece.
Georgios RigasChemotherapy Unit, General Hospital of Volos 'Achilopoulio', Volos, Greece.
Ioannis VarthalitisDepartment of Oncology, General Hospital of Chania, Chania, Greece.
Konstantinos KalbakisDepartment of Medical Oncology, University Hospital of Heraklion, Heraklion, Greece.
Sofia AgelakiDepartment of Medical Oncology, University Hospital of Heraklion, Heraklion, Greece.
Dora HatzidakiHellenic Oncology Research Group (HORG), Athens, Greece.
Vasilios GeorgouliasHellenic Oncology Research Group (HORG), Athens, Greece.
University Hospital of Heraklion · GRHellenic Oncology Research Group · GR401 General Military Hospital of Athens · GRAgios Pavlos General Hospital · GRAristotle University of Thessaloniki · GRChania General Hospital ”St. George” · GRHellenic Airforce General Hospital · GRMetaxa Hospital · GRTheageneio General Hospital · GRThe General Hospital of Heraklion "Venizeleio-Pananio" · GRUniversity Hospital of Alexandroupolis · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSequential anthracyclines and taxanes are standard adjuvant chemotherapy for patients with high-risk axillary node-positive breast cancer. We compared a sequential to a concurrent regimen in high-risk node-negative early breast cancer.

methodsPatients were eligible if they had tumours >2 cm or T1c with two of the following characteristics: no oestrogen receptor (ER) and progesterone receptor (PR) expression, histological grade III, Ki67 >40% and vascular, lymphovascular or perineural invasion. They were randomised to receive four cycles of epirubicin 90 mg m

resultsBetween 2001 and 2013, 658 women received the sequential (n=329) or the concurrent (n=329) regimen. The median age was 53 years, 43.9% of the patients were premenopausal and of the tumours 44.2% were ⩽2 cm, 52.7% histological grade 3 and 35.3% hormone receptor-negative. After a median follow-up of 70.5 months, there were 29 (8.8%) vs 42 (12.8%) disease relapses (P=0.102) and 11 (3.3%) vs 19 (5.8%) deaths (P=0.135), in the sequential and concurrent arm, respectively. The 5-year DFS rates were 92.6% vs 88.2% for sequential and concurrent arm, respectively (hazard ratio (HR): 1.591; 95% confidence interval (CI): 0.990-2.556; P=0.055). Toxicity included grade 2-4 neutropenia in 54% vs 41% (P=0.001), febrile neutropenia 2.7% vs 6.1% (P=0.06), nausea/vomiting 18.5% vs 12.4% (P=0.03) of patients in the sequential and concurrent arm. There were no toxic deaths.

conclusionsSequential compared with the concurrent administration of anthracyclines and taxanes is associated with a non-significant but possibly clinically meaningful improvement in DFS. In the era of molecular selection of patients for adjuvant chemotherapy, this study offers valuable information for the optimal administration of anthracyclines and taxanes in patients with node-negative disease.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDocetaxelDrug Administration ScheduleEpirubicinFemaleHumansMiddle AgedNeoplasm StagingTaxoidsDocetaxelEpirubicinTaxoids

Identifiers

PMID28641315
PMCPMC5584474
OpenAlexW2689114981

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.