Abstract 1430P
Background
AGITG DOCTOR was a randomised phase II trial of pre-operative cisplatin, 5 fluorouracil (CF) followed by docetaxel (D) with or without radiotherapy (RT) based on poor early response to CF for resectable oesophageal adenocarcinoma. This study describes PROs over two years.
Methods
Participants 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 two years. We calculated the percentage of participants per treatment group who recovered within 10 points (threshold for clinically relevant change) of baseline scores after surgery, for each PRO scale. This analysis included four groups (N=106): 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 mean difference (-13points) in overall health/QOL between baseline and pre-surgery. Similar proportions of patients across groups returned to +/- 10 points of baseline scores within two years for most PRO domains. Table: 1430P
| n (%) who recover to within 10 points of baseline after surgery(key PRO scales, where PRO data available) | ||||
| CF | DCF | DCF+RT | Others | |
| N | 42 | 26 | 28 | 10 |
| Physical fn | 33 (79) | 18 (69) | 18 (64) | 10 (100) |
| Role fn | 28 (67) | 19 (73) | 17 (61) | 6 (60) |
| Cognitive fn | 35 (83) | 20 (77) | 20 (71) | 7 (70) |
| Social fn | 34 (81) | 18 (69) | 22 (79) | 8 (80) |
| Fatigue | 23 (55) | 16 (62) | 14 (50) | 5 (50) |
| Pain | 36 (86) | 23 (88) | 19 (68) | 9 (90) |
| Insomnia | 39 (93) | 22 (85) | 19 (68) | 10 (100) |
| Global health status QoL | 30 (71) | 20 (77) | 21 (75) | 8 (80) |
| Problems eating | 33 (79) | 26 (100) | 23 (82) | 9 (90) |
| Reflux | 32 (76) | 22 (85) | 22 (79) | 8 (80) |
| Choked when swallowing | 41 (98) | 25 (96) | 27 (96) | 10 (100) |
| Dry mouth | 38 (90) | 20 (77) | 25 (89) | 9 (90) |
| Trouble with taste | 39 (93) | 23 (88) | 22 (79) | 8 (80) |
| Trouble with coughing | 36 (86) | 22 (85) | 21 (75) | 7 (70) |
Conclusions
By two years, similar proportions of patients had recovered to within 10 points of baseline PRO scores, suggesting no long term impact of D or RT on overall QOL. Non-responders randomised to DCF or DCF+RT experienced additional burden in the short term compared to CF responders, reflecting the longer duration of neoadjuvant treatment and additional toxicity. This data will assist clinicians in communicating the trajectory of treatment options to patients who do not respond to early CF.
Clinical trial identification
ACTRN12609000665235.
Editorial acknowledgement
Legal entity responsible for the study
Australasian Gastro-Intestinal Trials Group (AGITG).
Funding
National Health & Medical Research Council (Project Grant number 1011782). Sanofi Aventis Australia Pty Ltd (no grant number) provided docetaxel.
Disclosure
J.R. Zalcberg: Honoraria (self): Pfizer, Merck Serono, Specialized Therapeutics, Targovax, Halozyme, Gilead Sciences, Bayer; Advisory/Consultancy: Pfizer, Merck Serono, Targovax, MSD, Sirtex Medical, Halozyme, Lipotek, Novella; Research grant/Funding (institution): Bayer, Merck Serono, Roche, BMS, Pfizer, AstraZeneca, Specialized Therapeutics, Baxalta/Shire, Lilly, Boehringer-Ingelheim,MSD; Travel/Accommodation/Expenses: Merck Serono, AstraZeneca, MSD, Deciphera, Sirtex; Shareholder/Stockholder/Stock options: GW Pharmaceuticals, Aimmune, Vertex, Bluebird Bio, Alnylam, Biomarin, Sage Therapeutics, Dova Pharmaceuticals, Therapeutics MD, Juno Therapeutics, Kite Pharma, Kiadis Pharma, CSL limited, Cochlear, Amarin, Freq Therapeutics, Global Blood Therpeutics, Gile; Non-remunerated activity/ies: Chair, Australian Clinical Trials Alliance Co-Chair, National Oncology Alliance Co_Chair, All.Can Australia. All other authors have declared no conflicts of interest.