Evidence map›Paper›PMID 26657657›Full record

Trial reportBritish journal of cancer2016

Predictive role of hand-foot syndrome in patients receiving first-line capecitabine plus bevacizumab for HER2-negative metastatic breast cancer.

Christoph Zielinski, Istvan Lang, Semir Beslija, Zsuzsanna Kahan, Moshe J Inbar, Salomon M Stemmer, Rodica Anghel, Damir Vrbanec, Diethelm Messinger, Thomas Brodowicz

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

Trial report in British journal of cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
0.9field-weighted citation impact, top 24% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Impact of progression type on overall survival in patients with advanced gastric cancer based on randomized phase III study of S-1 plus oxaliplatin versus S-1 plus cisplatin.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017
    Trial
  4. Trial
  5. Hand-foot syndrome in cancer patients on capecitabine: examining prevalence, impacts, and associated risk factors at a cancer centre in Malaysia.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  6. Article
  7. Article
  8. Improvement in adherence to Capecitabine and Lapatinib by way of a therapeutic education program.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Article
  9. Article
  10. Article
  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

10 authors at 8 institutions in 5 countries.

Christoph ZielinskiClinical Division of Oncology, Department of Medicine I and Comprehensive Cancer Center, Medical University Vienna - General Hospital, Waehringer Guertel 18-20, A-1090 Vienna, Austria.
Istvan LangNational Institute of Oncology, Ráth György u. 7-9, H-1122 Budapest, Hungary.
Semir BeslijaInstitute of Oncology, Clinical Center, University of Sarajevo, Bolnicka 27, 71000 Sarajevo, Bosnia and Herzegovina.
Zsuzsanna KahanDepartment of Oncotherapy, University of Szeged, Korányi fasor 12, H-6720 Szeged, Hungary.
Moshe J InbarOncology Division, Tel Aviv Sourasky Medical Center, 6 Weizman Street, Tel Aviv 64239, Israel.
Salomon M StemmerDavidoff Center, Rabin Medical Center, Kaplan Street, Petah Tikva 49100, Israel.
Rodica AnghelUniversity of Medicine and Pharmacy Bucharest, Soseaua Fundeni, Nr 252, Sector 2, Bucharest 022328, Romania.
Damir VrbanecDepartment of Medical Oncology, University Hospital Zagreb-Rebro, Medical University of Zagreb, Kispaticeva 12, 10000 Zagreb, Croatia.
Diethelm MessingerIST GmbH, Soldnerstrasse 1, 68219 Mannheim, Germany.
Thomas BrodowiczClinical Division of Oncology, Department of Medicine I and Comprehensive Cancer Center, Medical University Vienna - General Hospital, Waehringer Guertel 18-20, A-1090 Vienna, Austria.
Central European Cooperative Oncology Group · ATClinical Center University of Sarajevo · BANational Institute of Oncology · HURabin Medical Center · ILTel Aviv Sourasky Medical Center · ILUniversity Hospital Centre Zagreb · HRUniversity of Szeged · HUVienna General Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCorrelations between development of hand-foot syndrome (HFS) and efficacy in patients receiving capecitabine (CAP)-containing therapy are reported in the literature. We explored the relationship between HFS and efficacy in patients receiving CAP plus bevacizumab (BEV) in the TURANDOT randomised phase III trial.

methodsPatients with HER2-negative locally recurrent/metastatic breast cancer (LR/mBC) who had received no prior chemotherapy for LR/mBC were randomised to BEV plus paclitaxel or BEV-CAP until disease progression or unacceptable toxicity. This analysis included patients randomised to BEV-CAP who received ⩾1 CAP dose. Potential associations between HFS and both overall survival (OS; primary end point) and progression-free survival (PFS; secondary end point) were explored using Cox proportional hazards analyses with HFS as a time-dependent covariate (to avoid overestimating the effect of HFS on efficacy). Landmark analyses were also performed.

resultsAmong 277 patients treated with BEV-CAP, 154 (56%) developed HFS. In multivariate analyses, risk of progression or death was reduced by 44% after the occurrence of HFS; risk of death was reduced by 56%. The magnitude of effect on OS increased with increasing HFS grade. In patients developing HFS within the first 3 months, median PFS from the 3-month landmark was 10.0 months vs 6.2 months in patients without HFS. Two-year OS rates were 63% and 44%, respectively.

conclusionsThis exploratory analysis indicates that HFS occurrence is a strong predictor of prolonged PFS and OS in patients receiving BEV-CAP for LR/mBC. Early appearance of HFS may help motivate patients to continue therapy.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsCapecitabineDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleHand-Foot SyndromeHumansLiver NeoplasmsLung NeoplasmsMiddle AgedMultivariate AnalysisBevacizumabCapecitabineERBB2 protein, humanErb-b2 Receptor Tyrosine Kinases

Identifiers

PMID26657657
PMCPMC4815806
OpenAlexW2191413197

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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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.