1. TRIAL PARTICIPATION IN THE OVER 60s: A RE-AUDIT OF THE MANAGEMENT OF AML IN THE SOUTH WEST OF ENGLAND South West Cancer Intelligence Service www.swpho.nhs.uk Background A previous SWCIS audit on a 1996 cohort of patients with AML indicated that only 24% of patients aged over 60 were entered into a clinical trial compared with 68% of patients aged under 60 years (1). Despite evidence that AML is characterised by a poorer prognosis in the elderly, the audit showed a statistically significant improvement in survival for patients in both age groups who were treated in a clinical trial. This re-audit was conducted to determine the management and entry into trials of patients aged under 60 years and 60 years and over. Data from this re-audit was compared with the original audit. Aim To ensure that patients with acute myeloid leukaemia (AML) who would benefit from trial entry, including those aged over 60, are included in clinical trials. Objectives To determine current management, investigations carried out and entry into clinical trials for patients aged under 60 and 60 years and over in the South West and Hampshire. To assess whether, as in the initial audit (1996 cohort), age still affects trial enrolment. Method Proformas were sent to haematology departments in all Acute Trusts in the region. Trusts were requested to complete a form for all patients diagnosed with AML from 1 April 2004 to 31 March 2005. East Somerset NHS Foundation Trust Gloucestershire Hospitals NHS Foundation Trust North Bristol NHS Trust North Hampshire Hospitals NHS Trust Northern Devon Healthcare NHS Trust Plymouth Hospitals NHS Trust Poole Hospital NHS Trust Portsmouth Hospitals NHS Trust Royal Bournemouth and Christchurch Hospitals NHS Trust Royal Cornwall Hospitals NHS Trust Royal Devon and Exeter NHS Foundation Trust Royal United Hospital Bath NHS Trust South Devon Health Care NHS Trust Swindon and Marlborough NHS Trust Taunton and Somerset NHS Trust United Bristol Healthcare NHS Trust West Dorset General Hospitals NHS Trust Weston Area Health NHS Trust Trusts participating in the re-audit: 19962004/05 Number of patients included231170 Number of Trusts involved2518 Median age6771 Primary AML60%76% Secondary AML40%24% Patient population details Clinical investigations undertaken (over 18 only) 19962004/05 Immunophenotype153/212 (72%)134/168 (80%) Cytogenetic analysis159/217 (73%)124/170 (73%) Tissue typing32/203 (16%)25/167 (15%) Bone marrow transplant23/195 (12%)15/165 (9%) Age distribution of the cohorts 2004/05 0 10 20 30 40 50 60 70 12345678910 Age (decade) Number FemaleMaleNot specified 1996 0 10 20 30 40 50 60 70 12345678910 Age (decade) Number FemaleMale Multidisciplinary Team (MDT) discussion An MDT discussion took place for 41/45 (91%) of cases aged under 60 and 104/121 (86%) cases aged 60 years and over The NICE guidance published in 2003 (2) recommends that: “MDTs should aim to maximise entry into trials by considering this issue, discussing on-going trials, and, reporting on problems and progress at their regular meetings. The possibility of entry into an appropriate trial should be discussed with every patient who fits the inclusion criteria.” References: 1.Rule S, Poirier V, Singer C. Management of acute myeloid leukaemia. A regional audit in south and west of the United Kingdom. Clin Med 2001;1(4):313–16. 2.National Institute for Health and Clinical Excellence. Guidance on Cancer Services. Improving Outcomes in Haematological Cancers. The Manual. October 2003:106. Treatments given Chemotherapy treatments details 1996 14/61 (patients  60) were treated outside of a clinical trial 43/81 (patients  60) were treated outside of a clinical trial Median age for chemotherapy 62 years Median age for non chemotherapy 78 years 2004/05 11/39 (patients  60) were treated outside of a clinical trial 32/64 (patients  60) were treated outside of a clinical trial Median age for chemotherapy 63 years Median age for non chemotherapy 79 years The 2004/05 audit data showed that Trial entry was discussed with 37/45 (82%) patients under 60 and 45/121 (37%) patients aged 60 and over. Of the patients entered into a clinical trial: 30/31 (patients  60) were entered in AML 15. 24/34 (patients  60) were entered AML 14 and 9/34 were entered in AML 15. Main reasons for not entering the patient in a clinical trial: Patient receiving palliative care only (38/103). Trial not considered to be the best option (24/103). Patient had a co-morbidity (22/103). Clinical trial participation Proportion of patients entered into clinical trials in the two cohorts excluding the paediatric cases (0-18 years old) from the 1996 cohort Conclusions Fewer Trusts were able to participate in the re-audit than the original audit. The median age for the re-audit was greater than that for the original audit, but the re-audit did not include patients under the age of 18 years. The proportion of older patients enrolled into clinical trials has not increased greatly since the first audit. Reasons for non-entry into a trial suggest that either that the therapy being tested is not suitable for some patients or that patients are not suitable for inclusion. It is hoped that new studies (e.g. AML 16) will prove to be more accessible to older people. Most common types of tumours were similar in both audits (types M1 and M2).  60 years  60 years 1996Complete remission37/6832/161 Death23/68114/161 2004/05*Complete remission22/2717/57 Death14/4090/119 Outcome at time of audit * Data for 2004/05 were limited K Ruth 1, A Kruger 2, M Hamon 3, J Verne 1 and V Poirier 1 (veronique.poirier@swpho.nhs.uk), on behalf of the SWCIS Haematology Tumour Panel 1 Cancer Intelligence Service, South West Public Health Observatory (SWCIS), 2 Royal Cornwall Hospitals NHS Trust, 3 Plymouth Hospitals NHS Trust