Evidence map›Paper›PMID 19819914›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2010

Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial.

H Joensuu, L Sailas, T Alanko, K Sunela, R Huuhtanen, M Utriainen, R Kokko, P Bono, T Wigren, S Pyrhönen and 5 more

Registry-linked trialAbstract 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, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00191243 (A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT00191243 phase2completednot on this map

A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer

TypeinterventionalSponsorEli Lilly and CompanyRan2002 to 2009Enrolled237ConditionsBreast CancerArmsGemcitabine, docetaxel
3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Eribulin -- a review of preclinical and clinical studies.Critical reviews in oncology/hematology · 2012
    Review
  11. 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

15 authors.

H JoensuuDepartment of Oncology, Helsinki University Central Hospital, Helsinki, Finland. heikki.joensuu@hus.fi
L Sailas
T Alanko
K Sunela
R Huuhtanen
M Utriainen
R Kokko
P Bono
T Wigren
S Pyrhönen
T Turpeenniemi-Hujanen
R Asola
M Leinonen
M Hahka-Kemppinen
P Kellokumpu-Lehtinen

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlternating administration of docetaxel and gemcitabine might result in improved time-to-treatment failure (TTF) and fewer adverse events compared with single-agent docetaxel as treatment of advanced breast cancer. PATIENTS AND

methodsWomen diagnosed with advanced breast cancer were randomly allocated to receive 3-weekly docetaxel (group D) or 3-weekly docetaxel alternating with 3-weekly gemcitabine (group D/G) until treatment failure as first-line chemotherapy. The primary end point was TTF.

resultsTwo hundred and thirty-seven subjects were assigned to treatment (group D, 115; group D/G, 122). The median TTF was 5.6 and 6.2 months in groups D and D/G, respectively (hazard ratio 0.85, 95% confidence interval 0.63-1.16; P = 0.31). There was no significant difference in time-to-disease progression, survival, and response rate between the groups. When adverse events were evaluated for the worst toxicity encountered during treatment, there was little difference between the groups, but when they were assessed per cycle, alternating treatment was associated with fewer severe (grade 3 or 4) adverse effects (P = 0.013), and the difference was highly significant for cycles when gemcitabine was administered in group D/G (P < 0.001).

conclusionThe alternating regimen was associated with a similar TTF as single-agent docetaxel but with fewer adverse effects during gemcitabine cycles.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularDeoxycytidineDocetaxelErb-b2 Receptor Tyrosine KinasesFemaleGemcitabineHumansImmunoenzyme TechniquesMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisDeoxycytidineDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesGemcitabineReceptors, EstrogenReceptors, ProgesteroneTaxoids

Identifiers

PMID19819914
PMCPMC2860103

What OpenQuestion holds

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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.