Evidence map›Paper›PMID 35291965›Full record

Trial reportBMC cancer2022

Patient-reported outcome (PRO) results from the AGITG DOCTOR trial: a randomised phase 2 trial of tailored neoadjuvant therapy for resectable oesophageal adenocarcinoma.

R Mercieca-Bebber, E H Barnes, K Wilson, Z Samoon, E Walpole, T Mai, S Ackland, M Burge, G Dickie, D Watson and 10 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Trial
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

20 authors at 10 institutions in 2 countries.

R Mercieca-BebberNational Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
E H BarnesNational Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
K WilsonNational Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Z SamoonNational Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
E WalpoleDivision of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Qld, Australia.
T MaiFaculty of Medicine, The University of Queensland, Brisbane, Qld, Australia.
S AcklandSchool of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.
M BurgeFaculty of Medicine, The University of Queensland, Brisbane, Qld, Australia.
G DickieCancer Care Services, Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia.
D WatsonDiscipline of Surgery, College of Medicine and Public Health, Flinders University, Adelaide, South Australia.
J LeungGenesisCare St Andrew's Hospital, 352 South Terrace, Adelaide, SA, Australia.
T WangCrown Princess Mary Cancer Center, Westmead hospital; Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
R BohmerHobart Private Hospital, Ground Floor- Suite 6 Corner Argyle & Collins Streets, Hobart, Tasmania, Australia.
D CameronTownsville University Hospital, Townsville, Qld, Australia.
J SimesNational Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
V GebskiNational Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
M SmithersFaculty of Medicine, The University of Queensland, Brisbane, Qld, Australia.
J ThomasGIAST Clinic Mater Medical Centre South Brisbane, Brisbane, Australia.
J ZalcbergSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
A P BarbourDivision of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Qld, Australia. a.barbour@uq.edu.au.ORCID http://orcid.org/0000-0003-3708-9099
The University of Sydney · AUThe University of Queensland · AUFlinders University · AUHobart Private Hospital · AUMater Health Services · AUMonash University · AURoyal Brisbane and Women's Hospital · AUSt Andrew’s Hospital · AUTownsville Hospital · AUUniversity of Newcastle Australia · AU

Funding

national health and medical research council 1011782
6 · The paper itself

Abstract

backgroundAGITG DOCTOR was a randomised phase 2 trial of pre-operative cisplatin, 5 fluorouracil (CF) followed by docetaxel (D) with or without radiotherapy (RT) based on poor early response to CF, detected via PET, for resectable oesophageal adenocarcinoma. This study describes PROs over 2 years.

methodsParticipants (N = 116) completed the EORTC QLQ-C30 and oesophageal module (QLQ-OES18) before chemotherapy (baseline), before surgery, six and 12 weeks post-surgery and three-monthly until 2 years. We plotted PROs over time and calculated the percentage of participants per treatment group whose post-surgery score was within 10 points (threshold for clinically relevant change) of their baseline score, for each PRO scale. We examined the relationship between Grade 3+ adverse events (AEs) and PROs. This analysis included four groups: CF responders, non-responders randomised to DCF, non-responders randomised to DCF + RT, and "others" who were not randomised.

resultsGlobal QOL was clinically similar between groups from 6 weeks post-surgery. All groups had poorer functional and higher symptom scores during active treatment and shortly after surgery, particularly the DCF and DCF + RT groups. DCF + RT reported a clinically significant difference (-13points) in mean overall health/QOL between baseline and pre-surgery. Similar proportions of patients across groups scored +/- 10 points of baseline scores within 2 years for most PRO domains. Instance of grade 3+ AEs were not related to PROs at baseline or 2 years.

conclusionsBy 2 years, similar proportions of patients scored within 10 points of baseline for most PRO domains, with the exception of pain and insomnia for the DCF + RT group. Non-responders randomised to DCF or DCF + RT experienced additional short-term burden compared to CF responders, reflecting the longer duration of neoadjuvant treatment and additional toxicity. This should be weighed against clinical benefits reported in AGITG DOCTOR. This data will inform communication of the trajectory of treatment options for early CF non-responders.

trial registrationAustralia New Zealand Clinical Trials Registry (ANZCTR), ACTRN12609000665235 . Registered 31 July 2009.

Indexed as

AdenocarcinomaNeoadjuvant TherapyAntineoplastic Combined Chemotherapy ProtocolsHumansPatient Reported Outcome MeasuresQuality of LifeGastro-oesophageal adenocarcinomaNeoadjuvant therapyOesophageal adenocarcinomaPatient-reported outcomesQuality of life

Identifiers

PMID35291965
PMCPMC8922838
OpenAlexW4221060391

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.