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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. 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, and Liam A. Mulroy The study was carried out in Australia, New Zealand, Canada and the UK and was supported by the Australian Government (NHMRC, Cancer Australia) and the NCI Canada and was independent of pharmaceutical industry support Background • Why did we need to look at palliative treatment for Esophageal cancer? Rapid advances in the treatment of some cancers have lead to more cures. Other cancers have defied our best curative therapies and this leads to either futile toxic treatments or no active treatment at all. We needed better information on which patients could not be cured and how we could help them. Analysis • 90% of patients with advanced esophageal cancer have swallowing problems. Many patients have the cancer bypassed by a stent or a tube. This can be painful and eventually block swallowing. • • Quality of life assessment measures the relief of symptoms and the effects – good and bad – of treatment. This trial measured: Swallowing improvement Overall quality of life How long the benefit lasted Results • • • RT alone improved swallowing in 67.89% of patients compared to 73.87% of those receiving RT + chemo, this was not a significant difference (p=0.34). However, chemo caused increased toxicity with more nausea (p<0.01) and vomiting (p<0.01). Quality of life Eating domain was improved in 74% with RT alone and 68% when chemo was added. 0 .6 0 0 .4 0 0 .0 0 0 .2 0 S u rv iv a l 0 .8 0 1 .0 0 Results – Overall Survival Number at risk Chemo-radiation Radiation only 0 6 12 111 109 65 57 27 29 18 Time (months) 12 15 24 30 36 11 10 8 8 7 6 Group Chemo-radiation • • Radiation only No significant, or even possibly extrapolated difference between the curves. 21 patients (approx. 10%) still alive at 2 years All thought to be incurable with advanced disease, responded to simple treatment. Conclusion • • • • RT alone remains an excellent tool for palliation of patients with advanced OC and should remain the standard of care. The trial better defines people who are not curable, as well as patients who still have hope of cure with active cancer treatment, even a simple 2 week course of RT. Chemotherapy, however, statistically increased toxicity, but not symptom benefit or survival. All patients with esophageal cancer should receive the opinion of a radiation oncologist regarding the best treatment for their disease.