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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.