GI consequences of cancer treatment: (Have we forgotten how to care?)
The Royal Marsden GI consequences of cancer treatment: (Have we forgotten how to care?) Jervoise Andreyev Consultant Gastroenterologist in Pelvic Radiation Disease London, UK 1 The Royal Marsden "It has become appallingly obvious that our technology has exceeded our humanity.” Albert Einstein The Royal Marsden Nothing made sense! The Royal Marsden Toxicity: an outsider’s view • Wrong questions - bleeding v incontinence • Wrong words - proctitis / “typical?” / “grade 1” • What’s not said - immunology / genetics / internal milieu The Royal Marsden Four fundamental truths? The Royal Marsden A truth? All you need to do is your job well? The Royal Marsden Mr B Cured! • • • • • • 46 year old banker Stage IV low rectal cancer Neoadjuvant chemoradiation Low anterior resection with J pouch 2 years out from treatment 3 different clinicians involved in follow up • • • • • • 2 CT scans 3 MRI scans 1 colonoscopy 13 follow up appointments CEA checked 7 times No medication But does anybody care? The Royal Marsden Mr B • • • • • • Bowels open 10-18 times / day Normal – liquid stool Unable to attend meeting > 20 minutes Bowels open 3 times per night Tenesmus +++ Wears nappies The Royal Marsden Truth no. 2 It is no-one’s job to manage quality of life The Royal Marsden Sarah • • • • 38 year, 10 year old son Cervical cancer 2001 Surgery + radiotherapy 5 different clinicians involved in follow up 2008 • • • • • • • • • Bowels open up to 12 times / day Several times at night Liquid stool, urgency, daily incontinence Intermittent steatorrhoea Nausea +++ Abdominal pain +++ Lost 35% body weight Obstructive symptoms every 6 weeks Repeatedly told “no treatment” The Royal Marsden The Royal Marsden A third fundamental truth Curing cancer inevitably risks damage to normal tissues The Royal Marsden Age-standardised one-year relative survival rate, rectal cancer, by sex, England and Wales, 1971-2006 100 Rectal cancer 90 Men Women 80 % survival 70 60 50 40 30 20 10 0 1971-1975 1976-1980 1981-1985 1986-1990 1991-1995 1996-2000* 2001-2003* 2004-2006* Period of diagnosis Symptoms * England only Surgery alone Preoperative radiotherapy Post operative radiotherapy 5-38% 51-72% 49-60% Toilet dependency 6% 30% 53% Excellent function 32% 14% N/A Any incontinence Frykholm 1993, Kollmorgen 1994, Letschert 1994, Lundby 1997, Dahlberg 1998, Miller 1999, Sauer 2004, Peeters 2005, Lundby 2005, Marijnen 2005, Pollack 2006, Pietrzak 2007, Birgisson 2007, Birgisson 2008 The Royal Marsden That third fundamental truth Curing cancer inevitably risks damage to normal tissues OK, that’s not quite right….. The Royal Marsden The third fundamental truth Curing cancer inevitably risks damage to normal tissues and so toxicity isn’t wicked…… The Royal Marsden Surviving cancer • UK: 2 million • USA: 13 million • UK: Increasing > 3% per year • USA: Increasing > 11% per year • 25%: Have chronic physical symptoms affecting QOL MacMillan 2008, Hauer-Jensen 2010, NCSI Vision 2011 The Royal Marsden The use of pelvic radiotherapy to cure cancer • 40% of all patients with pelvic cancer • 17,000+ per annum in the UK • 300,000 in the Western world The Royal Marsden The use of pelvic radiotherapy to cure cancer • • • • • 9 out of 10 have permanent change in bowel habit 1 in 2 have problems which affect daily activities 1 in 3 people “moderate or severe” 3 out of 20 will eventually need surgery bowel problems often worsen other problems Widmark 1994, Kollmorgen 1994, Crook 1996, Denham 1999, Ooi 2000, al Abany 2002, Henningsohn 2002, Bergmark 2002, Gami 2003, Fokdal 2004, Jephcott 2004, Olopade 2005, Abayomi 2009, Barker 2009, Capp 2009 The Royal Marsden “All you do is treat crumble” Professor of Oncology ….. rather naïve Professor of GI Physiology So what do I do? “You don’t really do anything useful” Senior manager Lets ask my colleagues…. “you are provocative, Dr Andreyev” NICE “You are not terribly mainstream…” Professor of Gastroenterology The Royal Marsden “Pay no attention to what the critics say; no statue has ever been erected to a critic” Jean Sibelius The Royal Marsden UK hospitals with ≥1 gastroenterologists with a specialist interest in IBD 8,500 moderate or severe Gl dysfunction after pelvic radiotherapy / year 7,000 GI cancers with toilet dependency / year 12,000 IBD/ year The Royal Marsden The Royal Marsden Workload in GI late consequences clinic at The Royal Marsden Hospital 800 Numbers of patients per 6 month period 700 600 500 400 300 200 100 0 The Royal Marsden We are the GIANTs (GI and Nutrition Teams) So what do we do? We manage symptoms. How? The Royal Marsden Oncological Symptom assessment & control The Royal Marsden The GIANTS Ann Muls MacMillan Nurse Consultant in late effects Endoscopy unit Dr Clare Shaw Consultant Dietitian Lorraine Watson MacMillan Dietitian in Pelvic Radiation Disease The Royal Marsden The multidisciplinary team Team approach Allied health care professionals Specialist nursing input Medical team patient The Royal Marsden Symptom assessment & control What do symptoms mean? - very little! The Royal Marsden Mr. H • 76 year old, normal bowel function pre-RT • Prostate cancer, 1 year after conformal RT • Normal PSA • Bowels open x4 per day • Urgency • Often loose stool • Faecal incontinence weekly • Tenesmus • Perianal soreness Too much fibre Mr. J • 64 year old, normal bowel function pre-RT • Prostate cancer, 1 year after IMRT • Bowels open 3-6 per day • Urgency • Often loose stool • x2 faecal incontinence / month • Tenesmus • Perianal soreness Giardia & 2cm sigmoid polyp The Royal Marsden Why do patients develop GI symptoms? The Royal Marsden The physiological model Inflammatory changes Any insult Oedema ischaemia Cell death Atrophy / loss of stem cells fibrosis Potentially alter specific GI physiological function(s) Unrelated factors • • • • medication side effects stress sepsis premorbid conditions Symptoms The Royal Marsden Radiotherapy is not about anatomy The Royal Marsden Radiotherapy is not a “local” treatment The Royal Marsden Chronic loose stool / Diarrhoea 1:2 n= Ludgate 1985 26 Arlow 1987 11 Danielsson 1991 20 Ford 1992 12 Andreyev 2005 78 % % % % % bile acid malabsorption 50 73 65 83 1 large bowel strictures 15 9 - - 3 bacterial overgrowth 8 - 45 - 12 diverticular disease 8 9 - - 22 relapse 4 - - - 10 (lactose intolerance - - - - 5) pelvic sepsis 4 - - - 3 new GI neoplasia - - - - 8 drug related - - - - 5 IBD - - - - 4 proctopathy - - - - 33 other - - - - 5 The Royal Marsden GI symptoms: the Royal Marsden GI Unit algorithmic approach The Royal Marsden RMH algorithm version 7 Bleeding Nausea Bloating Nocturnal need to defecate Borborygmi Pain - abdomen Change in bowel habit Pain - back (new onset) Constipation Pain – perineal / anal / rectal Flatulence (oral / rectal) Tenesmus Frequency of defaecation Urgency Incontinence / soiling / leakage Vomiting Loss of rectal sensation Weight loss Men Diarrhoea median 11 symptoms (range 1-16) / loose stool Perianal pruritus Evacuationmedian difficulty Steatorrhoea (range 4-16) Women 12 symptoms Mucus excess Benton 2011, Muls 2013 The Royal Marsden RMH algorithm version 7 For each of the 23 symptoms: • defined list of tests • defined sequence of treatments The Royal Marsden Using the concept of physiological algorithmic approach Management of symptoms becomes straightforward Identify each symptom accurately Arrange appropriate tests to identify which physiological deficits are present ->obvious treatment options The Royal Marsden Mr B • • • • • • Bowels open 10-18 times / day Normal – liquid stool Unable to attend meeting > 20 minutes Bowels open 3 times per night Tenesmus +++ Wears nappies The Royal Marsden Mr B • • some inflammation in his pouch no other abnormalities Treatment given • Normacol • Toileting exercises • Glycerine suppositaries After 6 weeks • Bowels open 4 times a day • No urgency incontinence • No nocturnal defaecation The Royal Marsden Sarah • • • • 38 year, 10 year old son Cervical cancer 2001 Surgery + radiotherapy 5 different clinicians involved in follow up 2008 • • • • • • • • • Bowels open up to 12 times / day Several times at night Liquid stool, urgency, daily incontinence Intermittent steatorrhoea Nausea +++ Abdominal pain +++ Lost 35% body weight Obstructive symptoms every 6 weeks Repeatedly told “no treatment” The Royal Marsden Sarah 1. Bile acid malabsorption (SeHCAT scan 0%) Rx: Colesevelam 2. Small bowel bacterial overgrowth (D2 aspirate) Rx: Ciprofloxacin 3. Free fatty acid malabsorption Rx: 40-50g fat diet 4. Gastric bile reflux Rx: Sucralfate suspension • • • • • Within 4 days formed stool 2 /day No more urgency or faecal incontinence No further obstructive episodes Nausea settled Within 3 weeks completely normal The Royal Marsden Sarah “it’s a miracle” The Royal Marsden Algorithm driven management of GI symptoms in patients with pelvic radiation disease: the ORBIT randomised controlled trial. HJN Andreyev, BE Benton, A Lalji, C Norton, K Mohammed, H Gage, K Pennert, JO Lindsay Funded by: “Research for Patient’s Benefit”, a programme of the National Institute for Health Research Lancet in press 2013 The Royal Marsden Aims of this RCT: 1 Is a comprehensive management algorithm for new onset GI symptoms after pelvic radiotherapy effective? 2 Outcomes when patients are managed by a specialist nurse are not inferior to those managed by a gastroenterologist? The Royal Marsden Methodology: study design: Prospective 3 arm trial: Eligible patients • >6 months after radical pelvic radiotherapy • new onset, persisting GI symptoms RANDOMISED MacMillan Cancer Support “late effects” booklet Nurse Gastroenterologist At any time After 6 months The Royal Marsden Methodology: study design: Prospective 3 arm trial: Eligible patients • >6 months after radical pelvic radiotherapy • new onset, persisting GI symptoms RANDOMISED Arm closed After 196 patients randomised MacMillan Cancer Support “late effects” booklet Additional 22 patients recruited Nurse Gastroenterologist Total 218 patients 80% power, one-sided test, 5% significance The Royal Marsden Methodology: end points Primary end point: • Improvement in gastrointestinal symptoms (IBDQ-B) after 6 months Secondary end points: • Improvement in gastrointestinal symptoms (IBDQ-B) after 12 months • Impact on quality of life • Effect on other pelvic symptoms • Change in anxiety and depression scores • Economic evaluation The Royal Marsden Results: Randomised 218 Booklet 68 Nurse 80 Gastroenterologist 70 • Crossed over 30 • Crossed over 4 • Lost to follow-up 3 • Withdrawn 1 • Lost to follow-up 3 • Withdrawn 11 • Lost to follow-up 5 • Withdrawn 2 The Royal Marsden Results: Booklet v combined intervention arms at 6 months p=0.006 No difference between scores at 6 months in gastroenterologist and nurse arms (p=0.2) Improvement in bowel function was sustained at 1 year (p<0.0001) The Royal Marsden The Royal Marsden Line in the sand: • Patients with GI symptoms after radiotherapy must be identified • Patients must be referred to a person trained to manage them • No longer acceptable for a non-expert to say “nothing can be done” The Royal Marsden GUT 2012 Table 4: Critical minimum questions to identify patients in need of specialist assessment • Are they woken from sleep to defaecate? • Do they have troublesome urgency of defaecation and /or faecal leakage/ soiling/incontinence? • Do they have any GI symptoms preventing them from living a full life? The Royal Marsden A third fundamental truth Curing cancer inevitably risks damage to normal tissues and so toxicity isn’t wicked…… 57 The Royal Marsden A third fundamental truth Curing cancer inevitably risks damage to normal tissues and so toxicity isn’t wicked…… but doing nothing about it…… ….is truly wicked. The Royal Marsden Jo’s trust British Society of Gastroenterology Cardiff NACC Macmillan Cancer Support Salford Sussex Leeds "Alone we can do so little; together we can do so much." Helen Keller Kent PRDA Hull Prostate Cancer Charity Bowel Cancer UK Southend Sheffield Darlington The Royal Marsden The Royal Marsden
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