Evidence map›Paper›PMID 21407218›Full record

Trial reportBritish journal of cancer2011

Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer.

H J Stemmler, D diGioia, W Freier, H W Tessen, G Gitsch, W Jonat, W Brugger, E Kettner, W Abenhardt, H Tesch and 4 more

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

Trial report in British journal of cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
1.7field-weighted citation impact, top 16% 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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Platinum-containing regimens for triple-negative metastatic breast cancer.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Platinum-containing regimens for metastatic breast cancer.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Trial
  5. A non-inferiority, phase III trial of gemcitabine plus capecitabineTherapeutic advances in medical oncology · 2024
    Article
  6. Review
  7. Article
  8. Review
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  10. Article
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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 6 institutions in 1 country.

H J StemmlerMed. Department III, Ludwig-Maximilians University of Munich, Campus Grosshadern, Munich, Germany. Joachim.Stemmler@med.uni-muenchen.de
D diGioia
W Freier
H W Tessen
G Gitsch
W Jonat
W Brugger
E Kettner
W Abenhardt
H Tesch
H J Hurtz
S Rösel
O Brudler
V Heinemann
Ludwig-Maximilians-Universität München · DEKiel University · DENephrologisches Zentrum Villingen-Schwenningen · DEUniversity Hospital Augsburg · DEUniversity Hospital Magdeburg · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory.

methodsAnthracycline-pretreated patients were randomly assigned to three gemcitabine-based regimens. Chemotherapy consisted of gemcitabine 1.000 mg m(-2) plus vinorelbin 25 mg m(-2) on days 1+8 (GemVin), or plus cisplatin 30 mg m(-2) on days 1+8 (GemCis), or plus capecitabine 650 mg m(-2) b.i.d. orally days 1-14 (GemCap), q3w. The primary end point was response rate.

resultsA total of 141 patients were recruited on the trial. The overall response rates were 39.0% (GemVin), 47.7% (GemCis) and 34.7% (GemCap). Median progression-free survival was estimated with 5.7, 6.9 and 8.3 months, respectively. Corresponding median survival times were 17.5 (GemVin), 13.0 (GemCis) and 19.4 months (GemCap). Neutropenia ≥grade 3 occurred in 16.7% (Gem/Vin), 4.4% (GemCis) and 0% (Gem/Cap), whereas non-haematological toxicities were rarely severe except grade 3 hand-foot syndrome in 2.0% of the GemCap patients (per patient analysis).

conclusionsThis randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineCisplatinDeoxycytidineFemaleFluorouracilGemcitabineHumansMiddle AgedNeoplasm MetastasisVinblastineVinorelbineCapecitabineCisplatinDeoxycytidineFluorouracilGemcitabineVinblastineVinorelbine

Identifiers

PMID21407218
PMCPMC3068513
OpenAlexW1987053256

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.