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

Autor: Mercieca-Bebber R; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia., Barnes EH; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia., Wilson K; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia., Samoon Z; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia., Walpole E; Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Qld, Australia.; School of Clinical Medicine, University of Queensland, Brisbane, Qld, Australia., Mai T; Faculty of Medicine, The University of Queensland, Brisbane, Qld, Australia., Ackland S; School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia., Burge M; Faculty of Medicine, The University of Queensland, Brisbane, Qld, Australia.; Cancer Care Services, Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia., Dickie G; Cancer Care Services, Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia., Watson D; Discipline of Surgery, College of Medicine and Public Health, Flinders University, Adelaide, South Australia., Leung J; GenesisCare St Andrew's Hospital, 352 South Terrace, Adelaide, SA, Australia., Wang T; Crown Princess Mary Cancer Center, Westmead hospital; Faculty of Medicine and Health, University of Sydney, Sydney, Australia., Bohmer R; Hobart Private Hospital, Ground Floor- Suite 6 Corner Argyle & Collins Streets, Hobart, Tasmania, Australia., Cameron D; Townsville University Hospital, Townsville, Qld, Australia., Simes J; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia., Gebski V; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia., Smithers M; Faculty of Medicine, The University of Queensland, Brisbane, Qld, Australia.; Divisions of Surgery and Cancer Services, Princess Alexandra Hospital, Woolloongabba, Australia., Thomas J; GIAST Clinic Mater Medical Centre South Brisbane, Brisbane, Australia., Zalcberg J; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia., Barbour AP; Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Qld, Australia. a.barbour@uq.edu.au.; Faculty of Medicine, The University of Queensland, Brisbane, Qld, Australia. a.barbour@uq.edu.au.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2022 Mar 15; Vol. 22 (1), pp. 276. Date of Electronic Publication: 2022 Mar 15.
DOI: 10.1186/s12885-022-09270-4
Abstrakt: Background: AGITG 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.
Methods: Participants (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.
Results: Global 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.
Conclusions: By 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 Registration: Australia New Zealand Clinical Trials Registry (ANZCTR), ACTRN12609000665235 . Registered 31 July 2009.
(© 2022. The Author(s).)
Databáze: MEDLINE
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