Oesophageal brachytherapy Pauline Humphrey, Consultant Radiographer Dr Steven Falk, Consultant Clinical Oncologist Dr Gareth Ayre, Consultant Clinical Oncologist Mr Paul Barham, Upper GI Consultant Surgeon 4th March 2016

Background New procedure at BHOC, started Sept 2014 Technique already used in many UK radiotherapy centres Aim to treat medically inoperable oesophageal cancer, as alternative to stent insertion Audit was a condition of approval for new procedure by Trust Clinical Effectiveness Group Need to assess safety and efficacy of the treatment and BHOC protocol Needed to wait until first 10 cases had been completed and some time elapsed for short term follow up data.

Comparison to standard: Homs et al, 2004 Multicentre randomised trial justifying role of brachytherapy: Longer duration of palliation than stents Lower toxicity than stents Cheaper than stents Over 100 patients in each arm, comparing stents to brachytherapy Effectiveness measured by toxicity and dysphagia score Homs et al Single-dose brachytherapy versus metal stent placement for the palliation of dysphagia from oesophageal cancer: multicenter randomised trial. Lancet. 363: 1497-1504

Dysphagia Score (DS) 0 Ability to eat a normal diet 1 Ability to eat some solid food 2 Ability to eat some semisolids only 3 Ability to swallow liquids only 4 Complete obstruction Mellow and Pinkas (Knyrim et al A controlled trial of an expansile metal stent for palliation of esophageal obstruction due to inoperable cancer. N Engl J Med 1993;329:1302-7)

Audit Aim To assess the safety and efficacy of oesophageal brachytherapy against published complications and outcome measures

Objectives To assess complication rates- Minor: mild pain, reflux, radiation oesophagitis, candida or infestation Major: perforation, haemorrhage, fever, fistula formation, severe pain, aspiration pneumonia To assess improvement in dysphagia score Exception for those with DS=0 at brachy To assess duration of benefit: Days with DS= 0 or 1

Standards/Criteria Compared against Homs et al, 2004 No. Standard/criteria Target Any exceptions 1 1 point improvement in dysphagia score at 30 days post brachy >73% Initial DS of 0 or death before 30 days 2 Major complications ≤ 13% 3 Minor complications ≤ 8% 4 Mean # days with almost no dysphagia (DS 0 or 1) >115 Compared against Homs et al, 2004

Methodology Sample number of 10 patients, to allow for a minimum of 4 months follow up data (Trt Sept 14-Oct 15) Initial routine data collected at time of brachytherapy Post brachy data collected from follow up telephone FU, clinic letters, GP and nurse specialists if data missing Unable to collect FU data from one RUH pt, CNS had no contact and no reply from GP, pt called to say well at 4 weeks and cancelled FU appt. Difficulty in deciding if DS = 0 or 1, normal diet? Lots of pts avoided bread, meat but can eat everything else. Number of days DS = 0 or 1, included to date of audit, shortest FU is 7 months to audit date

Results Standard 1: 1 point improvement in dysphagia score at 30 days post brachy 6/10 exceptions as DS= 0 at brachy 2/4 improvement of 1 point, 2/4 no improvement- 50% Overall less effective than Homs et al 73% Standard 2: Major complications None Better than standard of 13% in Homs et al Standard 3: Minor complications 4/10 Worse than standard of 8% in Homs et al

Results Standard 4: Mean number of days with almost no dysphagia 1 pt had no FU data beyond 4 weeks 9 pts- average 262 days, to date of audit (approx 9 months) range 120-360 days Compared with 115 days Homs et al NB 1 pt stented at 4 months, 1 at 9.5 months, 1 deceased at 9.5 months, 9/10 pts alive to date

Results No. Standard/criteria Target Result 1 1 point improvement in dysphagia score at 30 days post brachy >73% 50% 2 Major complications ≤ 13% 3 Minor complications ≤ 8% 25% 4 Mean # days with almost no dysphagia (DS 0 or 1) >115 >262 days

Conclusions No major complications in first 10 cases Effectiveness demonstrated in time to worsening of DS, average > 8.9 months However, numbers for this audit too small to compare to published studies Overall can be considered a safe and effective palliative therapy

Discussions Is our patient selection correct? Age of pts- average age of 82 at BHOC, Homs et al av age 69 Comparison to Homs et al- note entry criteria is DS= 2-4 Their study had far more severe dysphagia than our 10 cases 6/10 cases DS was 0 at brachy, aim to slow down progression rather than improve DS Benefit of early intervention rather than waiting until stent is required

Action plan- ? Your thoughts would be welcomed! No. Agreed action Implementation date Who is going to do it ? 1 Continue data collection - need more patients and longer follow up to determine effectiveness Ongoing 2 3