Evidence map›Paper›PMID 31763512›Full record

ArticleKidney cancer (Clifton, Va.)2019

Everolimus Exposure as a Predictor of Toxicity in Renal Cell Cancer Patients in the Adjuvant Setting: Results of a Pharmacokinetic Analysis for SWOG S0931 (EVEREST), a Phase III Study (NCT01120249).

Timothy W Synold, Melissa Plets, Catherine M Tangen, Elisabeth I Heath, Ganesh S Palapattu, Philip C Mack, Mark N Stein, Maxwell V Meng, Primo Lara, Nicholas J Vogelzang and 2 more

Abstract read
In one paragraph

Article in Kidney cancer (Clifton, Va.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. 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

12 authors.

Timothy W SynoldCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Melissa PletsSWOG Statistical Center/Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Catherine M TangenSWOG Statistical Center/Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Elisabeth I HeathBarbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
Ganesh S PalapattuUniversity of Michigan, Ann Arbor, MI, USA.
Philip C MackUC Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Mark N SteinRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Maxwell V MengUniversity of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, A, USA.
Primo LaraUC Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Nicholas J VogelzangComprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.
Ian Murchie ThompsonThe University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
Christopher W RyanOregon Health & Science University, OHSU Knight Cancer Institute, Portland, OR, USA.

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI STANLEY R. HAMILTON · 1985 to 2026
$86.3M
Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
UCDCCC NCTN UG1 PROGRAMUG1CA233340 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2019 to 2025
$3.7M
NCATS NIH HHS UL1 TR002384NCI NIH HHS P30 CA033572NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233160NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

backgroundS0931 is assessing recurrence-free survival in renal cell carcinoma (RCC) patients randomized to receive everolimus (EVE) versus placebo for one year following nephrectomy. Due to a higher than expected dropout rate, we assessed EVE trough levels in the adjuvant setting to evaluate the relationship between EVE exposure and probability of toxicity.

methodsPatients received 10 mg daily EVE for nine 6-week cycles. Pre-dose whole blood samples were collected pre-cycle 2 and pre-cycle 3 and analyzed for EVE. Patients with pre-cycle 2 and/or pre-cycle 3 EVE results were used in the analysis. Patients were segregated into quartiles (Q) based on EVE levels and logistic regression was used to model the most common adverse event outcomes using EVE trough as a predictor. Hazard and odds ratios were adjusted for age, BMI and performance status.

resultsA total of 467 patients were included in this analysis. Quartiles normalized to an EVE dose of 10 mg/day were < 9.0, 9.0-12.9, 12.9-22.8, and > 22.8 ng/mL, respectively. EVE trough levels increased with increasing age (

conclusionsWe identified significant gender and age-related differences in EVE trough levels in patients receiving adjuvant treatment for RCC. Furthermore, our analysis identified significant associations between EVE exposure and probability of toxicity.

Indexed as

adjuvant chemotherapyeverolimuspharmacokineticsRenal cell carcinomatherapeutic drug monitoring

Identifiers

PMID31763512
PMCPMC6864417

What OpenQuestion holds

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Registered trials

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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.