Evidence map›Paper›PMID 22610153›Full record

Trial reportThe oncologist2012

Extended benefit from sequential administration of docetaxel after standard fluorouracil, epirubicin, and cyclophosphamide regimen for node-positive breast cancer: the 8-year follow-up results of the UNICANCER-PACS01 trial.

Bruno Coudert, Bernard Asselain, Mario Campone, Marc Spielmann, Jean-Pascal Machiels, Frédérique Pénault-Llorca, Daniel Serin, Christelle Lévy, Gilles Romieu, Jean-Luc Canon and 11 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 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.

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

21 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  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

21 authors.

Bruno CoudertCentre Georges-François Leclerc, Dijon, France. bcoudert@cgfl.fr
Bernard Asselain
Mario Campone
Marc Spielmann
Jean-Pascal Machiels
Frédérique Pénault-Llorca
Daniel Serin
Christelle Lévy
Gilles Romieu
Jean-Luc Canon
Hubert Orfeuvre
Gilles Piot
Thierry Petit
Guy Jerusalem
Bruno Audhuy
Corinne Veyret
Marc Beauduin
Jean-Christophe Eymard
Anne-Laure Martin
Henri Roché
UNICANCER Breast Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe initial report from the Programme Action Concertée Sein (PACS) PACS01 trial demonstrated a benefit at 5 years for disease-free survival (DFS) and overall survival (OS) rates with the sequential administration of docetaxel after FEC100 (fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2)) for patients with node-positive, operable breast cancer. We evaluate here the impact of this regimen at 8 years. PATIENTS AND

methodsBetween June 1997 and March 2000, a total of 1,999 patients (age <65) with localized, resectable, non-pretreated, unilateral breast cancer were randomly assigned to receive either standard FEC100 for 6 cycles or 3 cycles of FEC100 followed by 3 cycles of 100 mg/m(2) docetaxel (FEC-D), both given every 21 days. Radiotherapy was mandatory after conservative surgery and tamoxifen was given for 5 years to hormone receptor (HR)-positive patients. Five-year DFS was the trial's main endpoint. Updated 8-year survival data are presented.

resultsWith a median follow-up of 92.8 months, 639 patients experienced at least one event. A total number of 383 deaths were registered. Eight-year DFS rates were 65.8% with FEC alone and 70.2% with FEC-D. OS rates at 8 years were 78% with FEC alone and 83.2% with FEC-D. Cox regression analysis adjusted for age and number of positive nodes showed a 15% reduction in the relative risk of relapse and a 25% reduction in the relative risk of death in favor of FEC-D. Significant relative risk reductions were observed in the HR-positive, HER2-positive, and Ki67 ≥20% subpopulations.

conclusionBenefits for DFS and OS rates with the sequential FEC-D regimen are fully confirmed at 8 years.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCombined Modality TherapyCyclophosphamideDisease-Free SurvivalDocetaxelDrug Administration ScheduleEpirubicinFemaleFluorouracilFollow-Up StudiesHumansLymphatic MetastasisMiddle AgedCyclophosphamideDocetaxelEpirubicinFluorouracilTaxoids

Identifiers

PMID22610153
PMCPMC3399644

What OpenQuestion holds

Textmetadata
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Registered trials

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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.