Evidence map›Paper›PMID 20104222›Full record

Trial reportBritish journal of cancer2010

Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis.

D Cella, M D Michaelson, A G Bushmakin, J C Cappelleri, C Charbonneau, S T Kim, J Z Li, R J Motzer

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

Trial report in British journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing 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

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

  1. Targeted therapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Immunotherapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Targeted therapy for advanced renal cell carcinoma.The Cochrane database of systematic reviews · 2008
    Pooled it
  4. Trial
  5. Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
    Trial
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  12. Article
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  14. Validity of a single-item indicator of treatment side effect bother in a diverse sample of cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  15. Article
  16. Article
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  19. Health-related quality of life and its determinants in patients with metastatic renal cell carcinoma.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018
    Article
  20. 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

8 authors.

D CellaRobert H Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL 60611, USA. d-cella@northwestern.edu
M D Michaelson
A G Bushmakin
J C Cappelleri
C Charbonneau
S T Kim
J Z Li
R J Motzer

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn a randomised phase III trial, sunitinib significantly improved efficacy over interferon-alpha (IFN-alpha) as first-line therapy for metastatic renal cell carcinoma (mRCC). We report the final health-related quality of life (HRQoL) results.

methodsPatients (n=750) received oral sunitinib 50 mg per day in 6-week cycles (4 weeks on, 2 weeks off treatment) or subcutaneous IFN-alpha 9 million units three times weekly. Health-related quality of life was assessed with nine end points: the Functional Assessment of Cancer Therapy-General and its four subscales, FACT-Kidney Symptom Index (FKSI-15) and its Disease-Related Symptoms subscale (FKSI-DRS), and EQ-5D questionnaire's EQ-5D Index and visual analogue scale. Data were analysed using mixed-effects model (MM), supplemented with pattern-mixture models (PMM), for the total sample and the US and European Union (EU) subgroups.

resultsPatients receiving sunitinib reported better scores in the primary end point, FKSI-DRS, across all patient populations (P<0.05), and in nine, five, and six end points in the total sample, in the US and EU groups respectively (P<0.05). There were no significant differences between the US and EU groups for all end points with the exception of the FKSI item 'I am bothered by side effects of treatment' (P=0.02). In general, MM and PMM results were similar.

conclusionPatients treated with sunitinib in this study had improved HRQoL, compared with patients treated with IFN-alpha. Treatment differences within the US cohort did not differ from those within the EU cohort.

Indexed as

Quality of LifeAdultAgedAged, 80 and overCarcinoma, Renal CellFemaleGeographyHealth StatusHumansIndolesInterferon-alphaKidney NeoplasmsMaleMiddle AgedPyrrolesResearch DesignIndolesInterferon-alphaPyrrolesSunitinib

Identifiers

PMID20104222
PMCPMC2837567

What OpenQuestion holds

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LicenceCC BY
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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.