Evidence map›Paper›PMID 30620389›Full record

Trial reportCancer2019

Association between age and sex and mortality after adjuvant therapy for renal cancer.

Ronac Mamtani, Xin Victoria Wang, Bishal Gyawali, Robert S DiPaola, C Neill Epperson, Naomi B Haas, Janice P Dutcher

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

Trial report in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

10 citing papers in PubMed, 18 citations in OpenAlex.

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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

7 authors at 5 institutions in 1 country.

Ronac MamtaniAbramson Cancer Center, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0002-8267-5356
Xin Victoria WangDana-Farber Cancer Institute, Boston, Massachusetts.
Bishal GyawaliDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.ORCID 0000-0001-7444-8594
Robert S DiPaolaUniversity of Kentucky College of Medicine, Lexington, Kentucky.
C Neill EppersonPenn PROMOTES Research on Sex and Gender in Health, Department of Psychiatry, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.
Naomi B HaasAbramson Cancer Center, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Janice P DutcherCancer Research Foundation Inc, Chappaqua, New York.
University of Pennsylvania · USBrigham and Women's Hospital · USDana-Farber Cancer Institute · USKids' Brain Tumor Cure Foundation · USUniversity of Kentucky · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Insulin resistance in the development and progression of invasive bladder cancerK23CA187185 · NCI · UNIVERSITY OF PENNSYLVANIA · PI MAMTANI, RONAC · 2015 to 2019
$872k
NCI NIH HHS K23 CA187185NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820
6 · The paper itself

Abstract

backgroundIn phase 3 trials of patients with resected high-risk renal cell carcinoma, adjuvant sunitinib has demonstrated no overall survival (OS) benefit, an uncertain disease-free survival (DFS) benefit, and increased toxicity versus placebo. To identify patients who may derive benefit or harm from adjuvant therapy, the authors assessed the effects of age and sex on treatment outcomes in the phase 3 Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Cancer (ASSURE) trial.

methodsThe authors conducted a post hoc subgroup analysis of age and sex among patients in the ASSURE trial. Adjusted hazard ratios (HRs) for OS and DFS were evaluated with sunitinib or sorafenib versus placebo in 4 patient subgroups defined by sex and median age at the time of the study.

resultsSunitinib treatment was associated with decreased OS (HR, 2.21; 95% confidence interval, 1.29-3.80) among women aged >56 years, but not in women aged ≤56 years or men of any age. Similar associations with age and sex were observed for DFS, but these were not statistically significant (women aged >56 years: HR, 1.41 [95% confidence interval, 0.94-2.10]). No such association was found for sorafenib. The interaction by age and sex on mortality was found to be statistically significant for sunitinib (P = .01), but not sorafenib (P = .10).

conclusionsAdjuvant sunitinib may increase mortality among older women with renal cell carcinoma. Given the recent approval of adjuvant sunitinib for patients with high-risk resected renal cell carcinoma, additional studies are needed to confirm these findings.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsSorafenibSunitinibAgedAge FactorsAntineoplastic AgentsChemotherapy, AdjuvantDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateMaleMiddle AgedAntineoplastic AgentsSorafenibSunitinibAdjuvant Sorafenib or Sunitinib for Unfavorable Renal Cancer (ASSURE) trialadjuvant therapyrenal cell carcinomasunitinibvascular endothelial growth factor (VEGF) inhibitors

Identifiers

PMID30620389
PMCPMC6486432
OpenAlexW2909882862

What OpenQuestion holds

Textmetadata
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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.