West, M.; Loughney, L.; Ambler, G.; Dimitrov, B.; Kelly, J.; Mythen, M.; Sturgess, R.;
Calverley, P.; Kendrick, A.; Grocott, M.; Jack, S..
BMC Cancer, December 2016, Vol. 16 Issue: Number 1 p1-8, 8p;
Abstract: In 2014 approximately 21,200 patients were diagnosed with oesophageal and
gastric cancer in England and Wales, of whom 37 % underwent planned
curative treatments. Potentially curative surgical resection is
associated with significant morbidity and mortality. For operable
locally advanced disease, neoadjuvant chemotherapy (NAC) improves
survival over surgery alone. However, NAC carries the risk of toxicity
and is associated with a decrease in physical fitness, which may in
turn influence subsequent clinical outcome. Lower levels of physical
fitness are associated with worse outcome following major surgery in
general and Upper Gastrointestinal Surgery (UGI) surgery in particular.
Cardiopulmonary exercise testing (CPET) provides an objective
assessment of physical fitness. The aim of this study is to test the
hypothesis that NAC prior to upper gastrointestinal cancer surgery is
associated with a decrease in physical fitness and that the magnitude
of the change in physical fitness will predict mortality 1 year
following surgery. This study is a multi-centre,
prospective, blinded, observational cohort study of participants with
oesophageal and gastric cancer scheduled for neoadjuvant cancer
treatment (chemo- and chemoradiotherapy) and surgery. The primary
endpoints are physical fitness (oxygen uptake at lactate threshold
measured using CPET) and 1-year mortality following surgery; secondary
endpoints include post-operative morbidity (Post-Operative Morbidity
Survey (POMS)) 5 days after surgery and patient related quality of life
(EQ-5D-5 L). The principal benefits of this study, if
the underlying hypothesis is correct, will be to facilitate better
selection of treatments (e.g. NAC, Surgery) in patients with
oesophageal or gastric cancer. It may also be possible to develop new
treatments to reduce the effects of neoadjuvant cancer treatment on
physical fitness. These results will contribute to the design of a
large, multi-centre trial to determine whether an in-hospital
exercise-training programme that increases physical fitness leads to
improved overall survival.