Evidence map›Paper›PMID 30502785›Full record

Trial reportValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research2018

Important Group Differences on the Functional Assessment of Cancer Therapy-Kidney Symptom Index Disease-Related Symptoms in Patients with Metastatic Renal Cell Carcinoma.

David Cella, Robert J Motzer, Brian I Rini, Joseph C Cappelleri, Krishnan Ramaswamy, Subramanian Hariharan, Bhakti Arondekar, Andrew G Bushmakin

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Treatments for renal cell carcinoma: NICE Pilot Treatment Pathways Appraisal.Health technology assessment (Winchester, England) · 2026
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Sex differences in health-related quality of life after renal cell carcinoma surgery: a population-based study in Sweden.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
    Article
  6. 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

8 authors at 4 institutions in 1 country.

David CellaDepartment of Medical Social Sciences, Northwestern University, Chicago, IL, USA. Electronic address: d-cella@northwestern.edu.
Robert J MotzerMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Brian I RiniCleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.
Joseph C CappelleriPfizer Inc., Groton, CT, USA.
Krishnan RamaswamyPfizer Inc., New York, NY, USA.
Subramanian HariharanPfizer Inc., New York, NY, USA.
Bhakti ArondekarPfizer Inc., Collegeville, PA, USA.
Andrew G BushmakinPfizer Inc., Groton, CT, USA.
Pfizer (United States) · USCleveland Clinic · USMemorial Sloan Kettering Cancer Center · USNorthwestern University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe Functional Assessment of Cancer Therapy-Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) is important to gauge clinical benefit in metastatic renal cell carcinoma (mRCC).

objectivesTo estimate important difference (ID) in FKSI-DRS scores that is considered to be meaningful when comparing treatment effect between groups, using mRCC trial data.

methodsData were derived from two pivotal phase III mRCC trials comparing sunitinib versus interferon alfa (N = 750) in first-line mRCC, and axitinib versus sorafenib (N = 723) in second-line mRCC. The change from baseline in FKSI-DRS score was examined as a function of a set of anchors using the repeated-measures model. Several anchors were evaluated: FKSI item "I am bothered by side effects of treatment," EuroQol five-dimensional questionnaire utility score, and adverse events.

resultsWhen the "I am bothered by side effects of treatment" score was used as an anchor, the ID ranged between 1.2 and 1.3 points. When change in the EuroQol five-dimensional questionnaire utility score was used as an anchor, the FKSI-DRS ID ranged between 0.62 and 0.63 points. Selecting the adverse events that corresponded to a maximum worsening in the FKSI-DRS score in either trial, the ID ranged between 0.62 and 0.74 points.

conclusionsAmong patients undergoing treatment for mRCC, between-group differences in FKSI-DRS scores as low as 1 point might be meaningful.

Indexed as

Activities of Daily LivingQuality of LifeAntineoplastic AgentsAxitinibCarcinoma, Renal CellFemaleHumansInterferon-alphaKidney NeoplasmsMaleMiddle AgedSorafenibSunitinibSurveys and QuestionnairesAntineoplastic AgentsAxitinibInterferon-alphaSorafenibSunitinibclinically important differencehealth-related quality of liferenal cell carcinomatargeted therapy

Identifiers

PMID30502785
PMCPMC6788639
OpenAlexW2766149988

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.