Evidence map›Paper›PMID 31759772›Full record

ArticleGynecologic oncology2020

Off-study utilization of experimental therapies: Analysis of GOG249-eligible cohorts using real world data.

Parth A Chodavadia, Corbin D Jacobs, Frances Wang, Laura J Havrilesky, Junzo P Chino, Gita Suneja

Open access · greenAbstract read
In one paragraph

Article in Gynecologic oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 23% 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, 10 citations in OpenAlex.

  1. Trial
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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

6 authors at 1 institution in 1 country.

Parth A ChodavadiaSchool of Medicine, Duke University, Durham, NC, USA.
Corbin D JacobsDepartment of Radiation Oncology, Duke University, Durham, NC, USA.
Frances WangDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
Laura J HavrileskyDivision of Gynecologic Oncology, Department of Obstetrics & Gynecology, Duke University, Durham, NC, USA.
Junzo P ChinoDepartment of Radiation Oncology, Duke University, Durham, NC, USA.
Gita SunejaDepartment of Radiation Oncology, Duke University, Durham, NC, USA. Electronic address: gita.suneja@icloud.com.
Duke University · US

Funding

Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI Laura Fish · 1985 to 2026
$174.8M
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI Nwora Lance Okeke · 2005 to 2026
$50.5M
Cancer Treatment Disparities in the HIV Population: Exploring the Impact of HIV on Physician and Patient Decision-MakingK08CA228631 · NCI · UNIVERSITY OF UTAH · PI SUNEJA, GITA · 2018 to 2022
$1.2M
NCI NIH HHS K08 CA228631NCI NIH HHS P30 CA014236NIAID NIH HHS P30 AI064518
6 · The paper itself

Abstract

objectiveAdjuvant management of women with high-intermediate- and high-risk early-stage endometrial cancer remains controversial. Recently published results of GOG 249 revealed that vaginal brachytherapy plus chemotherapy (VBT + CT) was not superior to whole pelvic radiation therapy (WPRT) and was associated with more toxicities and higher nodal recurrences. This study examined off-study utilization of VBT + CT among women who met criteria for GOG 249 in the period prior to study publication.

methodsWomen diagnosed with FIGO IA-IIB endometrioid, serous, or clear cell uterine cancer between 2004-2015 and treated with hysterectomy and radiotherapy (RT) were identified in the National Cancer Database. Cochrane-Armitrage trend test was used to assess trends over time. Univariate and multivariate Cox analyses were performed to calculate odds ratio (OR) of VBT + CT receipt and hazard ratio (HR) of OS. Propensity-score matched analysis was conducted to account for baseline differences.

results9956 women met inclusion criteria. 7548 women (75.8%) received WPRT while 2408 (24.2%) received VBT + CT in the study period. From 2004-2015, there was a significant increase in VBT + CT use (p < 0.001) with the largest overall increase occurring in 2009 to 22%. Factors significantly associated with VBT + CT receipt included higher socioeconomic status (p < 0.001), higher grade endometrioid cancer (p < 0.001), and aggressive histology (p < 0.001). After propensity-score matching, VBT + CT was associated with improved OS (HR 0.74, 95% CI 0.58-0.93); however, when stratified by FIGO stage, VBT + CT was only associated with improved OS for FIGO stage 1B (HR 0.62, 95% CI 0.44-0.87).

conclusionsThere was significant use of experimental arm off-study treatment in the United States prior to report of GOG 249 results. Providers should be cautious when offering off-study treatment utilizing an experimental regimen given uncertainty about efficacy and toxicity.

Indexed as

Adenocarcinoma, Clear CellAdolescentAdultAgedAged, 80 and overBrachytherapyCarcinoma, EndometrioidCystadenocarcinoma, SerousEndometrial NeoplasmsFemaleHumansHysterectomyMiddle AgedNeoplasm StagingSurvival RateYoung Adult

Identifiers

PMID31759772
PMCPMC8397368
OpenAlexW2990429090

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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.