Evidence map›Paper›PMID 29274030›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2018

Fatigue among patients with renal cell carcinoma receiving adjuvant sunitinib or sorafenib: patient-reported outcomes of ECOG-ACRIN E2805 trial.

Fengmin Zhao, David Cella, Judith Manola, Robert S DiPaola, Lynne I Wagner, Naomi S B Haas

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Cancer-Related Fatigue: Causes and Current Treatment Options.Current treatment options in oncology · 2020
    Review
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

6 authors at 5 institutions in 1 country.

Fengmin ZhaoDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, 02215, USA. fezhao@jimmy.harvard.edu.
David CellaDepartment of Medical Social Sciences, Northwestern University, Chicago, IL, USA.
Judith ManolaDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, 02215, USA.
Robert S DiPaolaRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Lynne I WagnerSocial Sciences & Health Policy Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Naomi S B HaasAbramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
Dana-Farber Cancer Institute · USNorthwestern University · USRutgers, The State University of New Jersey · USUniversity of Pennsylvania · USWake Forest University · US

Funding

ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS UG1 CA189828
6 · The paper itself

Abstract

backgroundE2805 was a phase III trial to test whether adjuvant sunitinib or sorafenib could improve disease-free survival compared to placebo in patients with renal cell carcinoma. Patient-reported outcomes (PRO), focusing on fatigue, were evaluated as a secondary endpoint. PATIENTS AND

methodsA total of 463 patients participated in the PRO study. Fatigue was measured by the FACIT Fatigue scale and PROMIS Fatigue SF1 measure at baseline, week 10, and week 22. The primary endpoint was change in fatigue score from baseline to week 22, measured by the FACIT Fatigue scale. Secondarily, the psychometric properties of PROMIS Fatigue SF1 were assessed in relation to the FACIT Fatigue scale.

resultsFatigue got significantly worse on all arms after 2 cycles of treatment, and especially so in patients on sunitinib (- 9.6 vs. - 5.6 on sorafenib vs. - 4.7 on placebo). Fatigue remained stable during week 10 and week 22. Overall, the mean score change between baseline and week 22 was - 7.9 (p < 0.001) on sunitinib, - 6.4 (p < 0.001) on sorafenib and - 5.6 (p < 0.001) on placebo arm. The difference in score change was not statistically significant between the two experimental arms and the placebo arm (difference = - 2.34 [p = 0.110] and - 0.87 [p = 0.535] for sunitinib vs. placebo and sorafenib vs. placebo). PROMIS Fatigue SF1 had good internal consistency reliability and construct and criterion validity, and was highly correlated with the FACIT Fatigue scale score.

conclusionsFatigue got worse during study period, especially in patients on sunitinib. The PROMIS Fatigue SF1 was highly correlated with FACIT Fatigue and produced similar results.

Indexed as

AdultAgedAntineoplastic AgentsCarcinoma, Renal CellChemotherapy, AdjuvantDisease-Free SurvivalFatigueFemaleHumansKidney NeoplasmsMaleMiddle AgedPatient Reported Outcome MeasuresReproducibility of ResultsSorafenibSunitinibAntineoplastic AgentsSorafenibSunitinibAdjuvant therapyFatiguePatient-reported outcomeRenal cell carcinomaSorafenibSunitinib

Identifiers

PMID29274030
PMCPMC5924580
OpenAlexW2780213231

What OpenQuestion holds

Textmetadata
LicenceTDM
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.