Evidence map›Paper›PMID 32951293›Full record

ArticleThe oncologist2021

Expanding Beyond Maximum Grade: Chemotherapy Toxicity over Time by Age and Performance Status in Advanced Non-Small Cell Lung Cancer in CALGB 9730 (Alliance A151729).

Melisa L Wong, Junheng Gao, Gita Thanarajasingam, Jeff A Sloan, Amylou C Dueck, Paul J Novotny, Aminah Jatoi, Arti Hurria, Louise C Walter, Christine Miaskowski and 5 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003117 (Single-Agent Versus Combination Chemotherapy in Advanced NSCLC), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.5field-weighted citation impact, top 30% 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.

NCT00003117 phase3completednot on this map

Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan1997 to 2006Enrolled584ConditionsLung CancerArmscarboplatin, paclitaxel
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 12 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

15 authors at 10 institutions in 1 country.

Melisa L WongDivision of Hematology/Oncology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California, USA.ORCID 0000-0001-6390-6959
Junheng GaoAlliance Statistics and Data Center, Duke University, Durham, North Carolina, USA.
Gita ThanarajasingamDepartment of Hematology, Mayo Clinic, Rochester, Minnesota, USA.
Jeff A SloanAlliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.
Amylou C DueckAlliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona, USA.
Paul J Novotny
Aminah JatoiDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Arti HurriaDepartment of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, California, USA.
Louise C WalterDivision of Geriatrics, University of California, San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, California, USA.
Christine MiaskowskiDepartment of Physiological Nursing, University of California, San Francisco, San Francisco, California, USA.
Harvey J CohenCenter for the Study of Aging and Human Development, Duke University, Durham, North Carolina, USA.
William A WoodLineberger Comprehensive Cancer Center, Division of Hematology/Oncology, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, USA.
Josephine L FelicianoSidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Center, Baltimore, Maryland, USA.
Thomas E StinchcombeDuke Cancer Institute, Duke University, Durham, North Carolina, USA.
Xiaofei WangAlliance Statistics and Data Center, Duke University, Durham, North Carolina, USA.
Duke University · USAlliance Data (United States) · USMayo Clinic · USSan Francisco VA Medical Center · USCity of Hope · USMayo Clinic in Arizona · USSidney Kimmel Comprehensive Cancer Center · USUNC Lineberger Comprehensive Cancer CenterUniversity of California, San Francisco · USWinnMed · US

Funding

Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI XIWEI WU · 1985 to 2026
$86.3M
ZESTRIL VS. VERAPAMIL IN THE TREATMENT OF HYPERTENSIONM01RR000585 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 1985 to 2006
$30.4M
VARC CoreP30AG044281 · NIA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Alexander Keliimoeanu Smith · 2013 to 2026
$19.9M
Institutional Career Development Core SupplementKL2TR001870 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KANAYA, ALKA M., SARKAR, URMIMALA · 2016 to 2025
$19.7M
Institutional Career Development CoreKL2TR002379 · NCATS · MAYO CLINIC ROCHESTER · PI NILUFER ERTEKIN-TANER · 2017 to 2026
$14.9M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
NCTN LAPS at Johns HopkinsUG1CA233196 · NCI · JOHNS HOPKINS UNIVERSITY · PI DEBORAH K ARMSTRONG, Julie Renee Brahmer · 2019 to 2026
$4.6M
UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
Johns Hopkins University NCTN Lead Academic Site ProgramU10CA180802 · NCI · JOHNS HOPKINS UNIVERSITY · PI ARMSTRONG, DEBORAH K, BRAHMER, JULIE RENEE · 2014 to 2018
$3.3M
NCTN Lead Academic Participating Sites ApplicationU10CA180838 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A · 2014 to 2018
$2.8M
Advancing patient-centered decision making in older adults with lung cancer: Incorporating risk of functional decline into treatment discussionsK76AG064431 · NIA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI WONG, MELISA L · 2019 to 2023
$1.3M
NCATS NIH HHS KL2 TR001870NCATS NIH HHS KL2 TR002379NCI NIH HHS P30 CA033572NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180838NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233373NCRR NIH HHS M01 RR000585NIA NIH HHS K76 AG064431NIA NIH HHS P30 AG044281NIA NIH HHS R03 AG056439
6 · The paper itself

Abstract

backgroundPrior comparisons of chemotherapy adverse events (AEs) by age and performance status (PS) are limited by the traditional maximum grade approach, which ignores low-grade AEs and longitudinal changes. MATERIALS AND

methodsTo compare fatigue and neuropathy longitudinally by age (<65, ≥65 years) and PS (0-1, 2), we analyzed data from a large phase III trial of carboplatin and paclitaxel versus paclitaxel for advanced non-small cell lung cancer (CALGB 9730, n = 529). We performed multivariable (a) linear mixed models to estimate mean AE grade over time, (b) linear regression to estimate area under the curve (AUC), and (c) proportional hazards models to estimate the hazard ratio of developing grade ≥2 AE, as well as traditional maximum grade analyses.

resultsOlder patients had on average a 0.17-point (95% confidence interval [CI], 0.00-0.34; p = .049) higher mean fatigue grade longitudinally compared with younger patients. PS 2 was associated with earlier development of grade ≥2 fatigue (hazard ratio [HR], 1.56; 95% CI, 1.07-2.27; p = .02). For neuropathy, older age was associated with earlier development of grade ≥2 neuropathy (HR, 1.41; 95% CI, 1.00-1.97; p = .049). Patients with PS 2 had a 1.30 point lower neuropathy AUC (95% CI, -2.36 to -0.25; p = .02) compared with PS 0-1. In contrast, maximum grade analyses only detected a higher percentage of older adults with grade ≥3 fatigue and neuropathy at some point during treatment.

conclusionOur comparison of complementary but distinct aspects of chemotherapy toxicity identified important longitudinal differences in fatigue and neuropathy by age and PS that are missed by the traditional maximum grade approach. Clinical trial identification number: NCT00003117 (CALGB 9730) IMPLICATIONS FOR PRACTICE: The traditional maximum grade approach ignores persistent low-grade adverse events (AEs) and changes over time. This toxicity over time analysis of fatigue and neuropathy during chemotherapy for advanced non-small cell lung cancer demonstrates how to use longitudinal methods to comprehensively characterize AEs over time by age and performance status (PS). We identified important longitudinal differences in fatigue and neuropathy that are missed by the maximum grade approach. This new information about how older adults and patients with PS 2 experience these toxicities longitudinally may be used clinically to improve discussions about treatment options and what to expect to inform shared decision making and symptom management.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinHumansPaclitaxelCarboplatinPaclitaxelChemotherapyFatigueGeriatric oncologyLung cancerNeuropathy

Identifiers

PMID32951293
PMCPMC7930405
OpenAlexW3087548584

What OpenQuestion holds

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Registered trials

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.