Evidence map›Paper›PMID 21965475›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2012

A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by EC in node-positive breast cancer. GOIM (Gruppo Oncologico Italia Meridionale) 9902 study.

P Vici, M Brandi, F Giotta, P Foggi, F Schittulli, L Di Lauro, N Gebbia, B Massidda, G Filippelli, D Giannarelli and 4 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
0.5field-weighted citation impact, top 30% 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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Taxanes for adjuvant treatment of early breast cancer.The Cochrane database of systematic reviews · 2019
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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

14 authors at 3 institutions in 3 countries.

P ViciDivision of Medical Oncology B, Regina Elena National Cancer Institute, Rome. Electronic address: pvici@ifo.it.
M BrandiDivision of Medical Oncology, Oncologic Institute, Bari; Breast Surgery Unit, Oncologic Institute, Bari; Oncologic Unit, Dimiccoli Hospital, Barletta.
F GiottaDivision of Medical Oncology, Oncologic Institute, Bari.
P FoggiDivision of Medical Oncology B, Regina Elena National Cancer Institute, Rome.
F SchittulliBreast Surgery Unit, Oncologic Institute, Bari.
L Di LauroDivision of Medical Oncology B, Regina Elena National Cancer Institute, Rome.
N GebbiaDivision of Medical Oncology, Department of Surgery and Oncology, University of Palermo, Palermo.
B MassiddaDivision of Medical Oncology, Medicine and Surgery, University of Cagliari, Cagliari.
G FilippelliDivision of Medical Oncology, S. Francesco Hospital, Paola.
D GiannarelliDepartment of Statistics.
A Di BenedettoDepartment of Pathology, Regina Elena National Cancer Institute, Rome, Italy.
M MottoleseDepartment of Pathology, Regina Elena National Cancer Institute, Rome, Italy.
G ColucciDivision of Medical Oncology, Oncologic Institute, Bari.
M LopezDivision of Medical Oncology B, Regina Elena National Cancer Institute, Rome.
National Cancer Institute · MYRadiation Oncology Institute · USUniversity of Cagliari · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer. PATIENTS AND

methodsPatients were randomly assigned to EC (E 120 mg/m(2), C 600 mg/m(2), arm A) for four cycles or four cycles of D (100 mg/m(2)) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety.

resultsThere were 750 patients enrolled. With a median follow-up of 64 months, 5-year DFS was 73.4% in both arms, and 5-year OS was 89.5% versus 90.7% in arm A and B [hazard ratio was 0.99 (95% confidence interval for DFS 0.75-1.31; P = 0.95)], respectively. Grade 3-4 toxicity was more common in arm B.

conclusionsThis study did not show advantages from the addition of docetaxel to high-dose EC as adjuvant chemotherapy in node-positive breast cancer. The small sample size and low number of DFS events may have limited the ability to observe statistically significant difference between the two arms.

Indexed as

AdultAlgorithmsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinomaCyclophosphamideDisease-Free SurvivalDocetaxelDose-Response Relationship, DrugEpirubicinFemaleHumansItalyLymphatic MetastasisLymph NodesMiddle AgedCyclophosphamideDocetaxelEpirubicinTaxoids

Identifiers

PMID21965475
PMCPMC3362268
OpenAlexW2114402477

What OpenQuestion holds

Textmetadata
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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.