A randomized phase III study in advanced esophageal cancer (OC) to compare the quality of life (QoL) and palliation of dysphagia in patients treated with radiotherapy (RT) or chemoradiotherapy (CRT) TROG 03.01 NCIC CTG ES.2.

Authors

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Michael Gordon Penniment

Royal Adelaide Hospital, Adelaide, Australia

Michael Gordon Penniment , Jennifer A Harvey , Rebecca Wong , Sonya Stephens , Heather-Jane Au , Christopher J. O'Callaghan , Andrew Kneebone , Sam Ngan , Iain G. Ward , Rajarshi Roy , Thomas Richard Sullivan , Tirath Nijjar , James Joseph Biagi , Liam A Mulroy

Organizations

Royal Adelaide Hospital, Adelaide, Australia, Princess Alexandra Hospital, Queensland, Australia, Princess Margaret Cancer Centre, Radiation Medicine Program, Ontario Cancer Institute, Toronto, ON, Canada, Cross Cancer Institute, Edmonton, AB, Canada, National Cancer Institute of Canada Clinical Trials Group, Kingston, ON, Canada, Royal North Shore Hospital, Sydney, Australia, Peter MacCallum Cancer Center, Melbourne, Australia, Christchurch Hospital, Christchurch, New Zealand, Castle Hill Hospital, Hull, United Kingdom, University of Adelaide, Adelaide, Australia, Cancer Centre of Southeastern Ontario, Kingston, ON, Canada, QEII Health Sciences Centre, Halifax, NS, Canada

Research Funding

Other

Background: RT is known to relieve dysphagia of advanced oesophageal cancer, there is no data from randomised phase III trials determining response, toxicity, or role of palliative CRT. Aims 1) to establish effective and least toxic treatment for symptom relief of advanced OC 2) determine effects of common cancer treatments on QoL and end of life care 3) establish an evidence base for patient decision making regarding the optimal management for incurable OC. Methods: 220 patients were randomised to receive a course of palliative RT [35 Gy in 15 fractions, (n=115) or 30 Gy in 10 fractions (n=105) in Canada and UK], or concomitant CRT with Cisplatin and 5FU (D1-4) (n=111). Dysphagia was measured using the Mellow score, toxicity using CTCAE v2, and QoL using EORTC QLQ30 and oesophagus module (OES-18). The primary end point was the proportion of patients with improved dysphagia as measured at week 9 and maintained until week 13. Results: The patients receiving radiotherapy alone showed a dysphagia response (at any point) of 67.89% compared to chemotherapy response in 73.87%, this was not a significant difference (p=0.343). There was increased toxicity in patients receiving CRT, with worse bowel conditions (nausea (p=0.0019) and vomiting (p=0.0072)). The median survival was 210 days for CRT and 203 days for RT alone. The baseline parameters of both groups were well matched at randomisation and although the results of the trial showed equally poor survival prognosis in both arms, there were some patients (n=21) still alive at 2 years post treatment. Conclusions: Although the CRT group had slightly better dysphagia response and median survival, the bowel toxicity was worse. Further analysis of QoL, toxicity and durable palliative response will be published. This multicentre trial, conducted in the UK, Canada, Australia and New Zealand reflects practice in several countries RT alone remains an excellent tool for palliation of patients with advanced OC and should remain the standard of care. Clinical trial information: NCT00193882.

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Highlights Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT00193882

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 4009)

DOI

10.1200/jco.2014.32.15_suppl.4009

Abstract #

4009

Poster Bd #

27

Abstract Disclosures