HTA commissioned call

Transcription

1 HTA commissioned call

2 BACKGROUND 2002 NICE Guidance for Early Breast Cancer Discharge asymptomatic patients from hospital follow-up by 3 years Questioning specialists attitudes to breast cancer follow-up in primary care. NCRI sponsorship Survey. Donnelly P et al. Annals of Oncology Cancer Reform Strategy - Breast cancer patients supported in self care with personalised risk assessment to meet needs NICE Guidance Annual mammograms for patients under Screening for breast cancer with mammography. Gotzsche PC. Cochrane Database System Review The clinical effectiveness and cost effectiveness of different surveillance mammography regimens after the treatment of primary breast cancer: Robertson C Gilbert F. NIHR HTA programme report 2012 Options for early breast cancer follow-up in primary and secondary care a systematic review. Taggart,Donnelly, Dunn BMC Cancer

3 NICE 2009 guidance for mammography in women with a personal history of breast cancer For younger women, annual mammography until qualifies for NHSBSP Annual mammography for 5 years After 5 years, stratify according to risk

4 Benefits of follow up mammography in women who have had breast cancer Better survival for mammo detected IBTR than those detected by PE (1) Detection of metachronous contralateral breast cancer by follow-up mammography is associated with improved survival (2) 1. Taggart F, Donnelly PK, Dunn JA. BMC Cancer 2012; 12(1): Lu W et al. EJC 2009 Nov;45(17):3000-7

5 Harms of follow-up mammography Cost False positives Anxiety Radiation Over-diagnosis

6 How can we keep the benefit but reduce the harms? Almost all the harms could be reduced by a reduction in the frequency of mammography But would a reduction in the frequency of mammography significantly reduce the benefit?

7 Systematic review findings Due to the limited availability of data the studies reviewed and the lack of randomized controlled trials, no conclusions could be drawn about the optimum frequency or duration of mammography after surgery Robertson C et al. Health Technol Assess 2011;15(34):v-vi,1-322

8 What should determine the frequency of mammography in women who have had breast cancer? Lead time of mammography Risk of recurrence

9 Sojourn time For women over 50 yrs range yrs Women aged yrs range yrs Shen Y, et al. J Clin Oncol ;19: Duffy SW, et al. J Natl Cancer Inst Monogr. 1997;22:93-7. Tabar L, et al. Cancer. 1995;75: sojourn time = time spent in the preclinical detectable phase, plays an important role in the design and assessment of screening programmes.

10 Risk factors for IBTR after WLE for DCIS Young age Symptomatic presentation Lesion size Margins Mammographic comedo calcification

11 Age and local recurrence Women under 45 have double the risk of IBTR after WLE for DCIS and the IBTR is more likely to be invasive Vicini FA et al Breast 2013;19:

12

13 DOES IT MATTER? Patient feedback indicates perceived lack of support when presenting with recurrence. Recurrences are treatable and can improve outcome. Impact on survival of early detection of isolated breast recurrences after primary treatment for breast cancer: a meta- analysis Lu W.L. et al. Breast Cancer Res Treatment 2009 Recurrence Treatment is expensive Patterns of breast recurrence and associated health care costs of 1000 patients treated in Leeds: a longitudinal study. Walkington L. et al NCIN Conference 2012 Pathology data on recurrences that may be different from primary tumour.

14 TRIAL SUMMARY Eligibility: Female patients aged 50 years or above at diagnosis who have had previous treatment with curative intent for invasive or non-invasive (DCIS) breast cancer and who are 3 years post curative surgery. Assessed for eligibility, invited to participate in the MAMMO-50 study and consented to be randomised or entered into the observational cohort study, if unsuitable for randomisation. RANDOMISE: Stratified by: type of surgery (conservation, mastectomy), DCIS or invasive disease, age at randomisation (<55, years),hormone therapy (cont., stopped, ER-ve) N=5000 N=2500 Annual surveillance mammography up to 9 years post curative surgery N=2500 Less frequent surveillance mammography: 2 yearly for conservation; 3 yearly for mastectomy up to 9 years post curative surgery

15 OUTCOMES Primary Disease specific survival Cost effectiveness Secondary Recurrence (time to, type and features) Number of referrals back (HES data linkage) Long-term survival (ONS flagging for 20 years) QoL, compliance and experience Pathology to measure markers for relapse

16 SAMPLE SIZE Non-inferiority trial defined as no worse than 3% below standard arm Individual patient randomisation Assuming patients who have survived and are recurrence free at 3 years post-surgery have a 5 year disease specific survival for the next 5 years of 89%, then recruiting 5000 patients (2500 per arm) will allow detection of non-inferiority with a 2.5% 1-sided significance and 95% power

17 ASSESSMENTS All must have baseline mammogram 3-yrs post diagnosis patient questionnaire booklet Administered at time of scheduled mammogram QoL sub-study Annual QoL questionnaires TBC by patient group Considering DT, fear of recurrence, WEMWBS, FACT-B Qualitative sub-study Interviews to assess experiences of patients and professionals Pathology - biobank to assess markers of relapse

18 TIMELINES Grant activated 1 st July months set up Ethics submission October + 70 centres Launch on 19 th December st patient recruited Jan 2014 Integrated feasibility: 100 centres set up within first 24 months;1400 patients Further 3600 patients over next 2 years End of study minimum 5 years follow-up

19 BENEFITS FOR PARTICIPATING Centres: Could we link through to surgical audits? Risk-adjusted follow-up Concept of over diagnosis and over treatment? Patients: Linked and flagged Help to inform future treatment Help to inform future information need to be collected (PROM) Unmet needs Linked to website/communication for patient empowerment

20 Electronic systems Screen clinics every week screen >50yrs & cancer Look at the radiology system Look through surgical diary Look through the breast care nurse diary Pathology list of patients 3 year ago who have breast surgery Exclude benign cancers Exclude diagnostic biopsy Keep prospective list of patients coming through

21 Consent Discuss in your Centre as it could be taken by Surgeon Oncologist Nurse Radiographer Radiologist Pre-consent by post before randomised Compatible with other studies

22 Challenges 2 year feasibility study Number of centres and patients required Contamination with Screening Programme Data linkage Mammo-50 tissue bank Across Surgery, Radiology, Oncology co-investigators!

23 INVESTIGATORS CIs: PPI: Radiologists: Oncologists: Statistician: HE: Nursing: Pathology Surgeons: Qualitative: Janet Dunn, Peter Donnelly, Andy Evans Maggie Wilcox Anthony Maxwell Peter Barrett-Lee David Cameron Andrea Marshall Claire Hulme Peter Hall Sue Hartup Annie Young Sarah Pinder Adele Francis Riccardo Audisio Alistair Thompson Eila Watson Claire Balmer