Improving surveillance for Barrett’s oesophagus: the AspECT and Boss trials provide an evidence base!
Dear Editor,
We read with interest the quality improvement report for improving
surveillance for Barrett’s oesophagus by Bampton et al (1). This group is
one of the best exponents of research in this area and their findings are
helpful. However, improving adherence to guidelines which are themselves
lacking a sufficient evidence base may not actually improve hard clinical
outcomes such as ‘all causes of mortality’ or even ‘cancer progression’.
The major problem with a surveillance only approach is that only an
estimated 5-10% of patients with Barrett’s oesophagus will benefit as the
rest are either not referred for endoscopy or default the surveillance
programme (2). If we assume for a moment that surveillance is beneficial
on the basis that we more commonly find early grade 1 oesophageal cancers
in surveillance (which have an 80% survival) compared with the norm of
grade 3 or 4 oesophageal cancers in non surveillance endoscopies (15%
survival). Even these generalisations cannot outweigh the lack of cost
effectiveness of surveillance of Barrett’s oesophagus surveillance and
indeed the additional cost of coordinators to mange the process as
described by Bampton and colleagues may make it less so (3). The real
value of surveillance needs to be tested in a randomised trial so that all
confounding issues associated with surveillance such as compliance to
medication, improved optimisation of therapy, reinforcement of health life
style practices, management of co-morbid lesions by agents which could
chemoprevent oesophageal cancer e.g. aspirin for cardiac disease and
putting the patient on an alert status for changing symptoms can be
independently assessed. The Barrett’s Oesophagus Surveillance Study (BOSS)
aims to randomise 2,500 patients with proven Barrett’s oesophagus to
either surveillance endoscopy as recommended in the guidelines recommended
by Bampton et al (1, 4) and no surveillance for patients.
In this trial
full written informed consent of all the relevant issues will take place
and although the trial is about to start at the very least we will be able
to address whether patients in the non surveillance arms will violate the
BOSS protocol by withdrawal from the study due to anxiety over existing
and new ‘reflux’ symptoms. There could be other outcomes however as we
already have provisional evidence to indicate that chemoprevention of
Barrett’s oesophagus may decrease cancer incidence by up to 45% (5). It is
possible therefore that once cancer incidence is stratified by aspirin use
in the surveillance and non surveillance arms the value of surveillance
will be modest and perhaps even neutral when taking into account other
issues such as endoscopic and multiple biopsy induced mortality, morbidity
and anxiety. The role of chemoprevention is itself already being tested is
another large randomised study involving 5000 patients with Barrett’s
oesophagus and is already underway, the Aspirin Esomeprazole
Chemoprevention Trial (AspECT).
In conclusion we applaud this study but wonder whether in the fullness of
time resources might perhaps be proven to be better spent in mass
chemoprevention of patients with reflux disease (> 35 years) for 10 or
more years.
Prof Janusz Jankowski,
University of Oxford,
Chief Investigator to AspECT trial
Prof Hugh Barr,
Gloucestershire Royal Hospital,
Chief Investigator to BOSS trial,
1. Bampton PA, Schloithe A, Bull J, Fraser RJ, Padbury RTA, Watson
DI. Improving surveillance for Barrett’s oesophagus. BMJ;332:1390-1323.
2. Jankowski J, Hawk E. A methodological analysis of chemoprevention
in the Gastrointestinal tract. Nature Clin Pract Gastro 2006:3;101-111.
3. Shaheen NJ, Provenzale D, Sandler RS.Upper endoscopy as a
screening and surveillance tool in esophageal adenocarcinoma: a review of
the evidence.Am J Gastroenterol. 2002 Jun;97(6):1319-27.
4. Sampliner RE; Practice Parameters Committee of the American
College of Gastroenterology. Updated guidelines for the diagnosis,
surveillance, and therapy of Barrett's esophagus. Am J Gastroenterol. 2002
Aug;97(8):1888-95.
5. Jankowski J, Moayyedi P. Aspirin as chemoprevention for Barrett’s
esophagus: a large RCT underway in the UK (extended original research
correspondence). J Natl Cancer Inst 2004;96:885-7.
Rapid Response:
Improving surveillance for Barrett’s oesophagus: the AspECT and Boss trials provide an evidence base!
Dear Editor,
We read with interest the quality improvement report for improving
surveillance for Barrett’s oesophagus by Bampton et al (1). This group is
one of the best exponents of research in this area and their findings are
helpful. However, improving adherence to guidelines which are themselves
lacking a sufficient evidence base may not actually improve hard clinical
outcomes such as ‘all causes of mortality’ or even ‘cancer progression’.
The major problem with a surveillance only approach is that only an
estimated 5-10% of patients with Barrett’s oesophagus will benefit as the
rest are either not referred for endoscopy or default the surveillance
programme (2). If we assume for a moment that surveillance is beneficial
on the basis that we more commonly find early grade 1 oesophageal cancers
in surveillance (which have an 80% survival) compared with the norm of
grade 3 or 4 oesophageal cancers in non surveillance endoscopies (15%
survival). Even these generalisations cannot outweigh the lack of cost
effectiveness of surveillance of Barrett’s oesophagus surveillance and
indeed the additional cost of coordinators to mange the process as
described by Bampton and colleagues may make it less so (3). The real
value of surveillance needs to be tested in a randomised trial so that all
confounding issues associated with surveillance such as compliance to
medication, improved optimisation of therapy, reinforcement of health life
style practices, management of co-morbid lesions by agents which could
chemoprevent oesophageal cancer e.g. aspirin for cardiac disease and
putting the patient on an alert status for changing symptoms can be
independently assessed. The Barrett’s Oesophagus Surveillance Study (BOSS)
aims to randomise 2,500 patients with proven Barrett’s oesophagus to
either surveillance endoscopy as recommended in the guidelines recommended
by Bampton et al (1, 4) and no surveillance for patients.
In this trial
full written informed consent of all the relevant issues will take place
and although the trial is about to start at the very least we will be able
to address whether patients in the non surveillance arms will violate the
BOSS protocol by withdrawal from the study due to anxiety over existing
and new ‘reflux’ symptoms. There could be other outcomes however as we
already have provisional evidence to indicate that chemoprevention of
Barrett’s oesophagus may decrease cancer incidence by up to 45% (5). It is
possible therefore that once cancer incidence is stratified by aspirin use
in the surveillance and non surveillance arms the value of surveillance
will be modest and perhaps even neutral when taking into account other
issues such as endoscopic and multiple biopsy induced mortality, morbidity
and anxiety. The role of chemoprevention is itself already being tested is
another large randomised study involving 5000 patients with Barrett’s
oesophagus and is already underway, the Aspirin Esomeprazole
Chemoprevention Trial (AspECT).
In conclusion we applaud this study but wonder whether in the fullness of
time resources might perhaps be proven to be better spent in mass
chemoprevention of patients with reflux disease (> 35 years) for 10 or
more years.
Prof Janusz Jankowski,
University of Oxford,
Chief Investigator to AspECT trial
Prof Hugh Barr,
Gloucestershire Royal Hospital,
Chief Investigator to BOSS trial,
1. Bampton PA, Schloithe A, Bull J, Fraser RJ, Padbury RTA, Watson
DI. Improving surveillance for Barrett’s oesophagus. BMJ;332:1390-1323.
2. Jankowski J, Hawk E. A methodological analysis of chemoprevention
in the Gastrointestinal tract. Nature Clin Pract Gastro 2006:3;101-111.
3. Shaheen NJ, Provenzale D, Sandler RS.Upper endoscopy as a
screening and surveillance tool in esophageal adenocarcinoma: a review of
the evidence.Am J Gastroenterol. 2002 Jun;97(6):1319-27.
4. Sampliner RE; Practice Parameters Committee of the American
College of Gastroenterology. Updated guidelines for the diagnosis,
surveillance, and therapy of Barrett's esophagus. Am J Gastroenterol. 2002
Aug;97(8):1888-95.
5. Jankowski J, Moayyedi P. Aspirin as chemoprevention for Barrett’s
esophagus: a large RCT underway in the UK (extended original research
correspondence). J Natl Cancer Inst 2004;96:885-7.
Competing interests:
None declared
Competing interests: No competing interests