4.6 Article

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

Journal

BMC CANCER
Volume 22, Issue 1, Pages -

Publisher

BMC
DOI: 10.1186/s12885-022-09270-4

Keywords

Oesophageal adenocarcinoma; Gastro-oesophageal adenocarcinoma; Neoadjuvant therapy; Quality of life; Patient-reported outcomes

Categories

Funding

  1. National Health & Medical Research Council [1011782]
  2. Sanofi Aventis Australia Pty Ltd.

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This study evaluates the patient-reported outcomes (PROs) of different treatment groups in patients with resectable oesophageal adenocarcinoma. The results show that similar proportions of patients in different treatment groups had PRO scores within 10 points of their baseline scores, indicating similar symptom experiences. However, non-responders who received docetaxel with or without radiotherapy experienced additional burden compared to responders, reflecting the longer duration of neoadjuvant treatment and additional toxicity.
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.

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