dcis trial adele francis daniel rea claire gaunt on behalf of the dcis trial development group
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DCIS Trial Adele Francis, Daniel Rea & Claire Gaunt on behalf of the DCIS Trial Development Group. ICPV Study Day, 4 th March 2011. What cancers?. Over diagnosis. Over diagnosis refers to the detection of abnormalities that will never cause symptoms or death during a patients life time.

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dcis trial adele francis daniel rea claire gaunt on behalf of the dcis trial development group

DCIS TrialAdele Francis, Daniel Rea & Claire Gaunt on behalf of the DCIS Trial Development Group

ICPV Study Day, 4th March 2011

over diagnosis
Over diagnosis

Over diagnosis refers to the detection of abnormalities that will never cause symptoms or death during a patients life time.

Over diagnosis of cancer occurs when the cancer grows so slowly that the patient dies of other causes before it produces symptoms or when the cancer remains dormant (or regresses)

over diagnosis and mammography screening
Over diagnosis and Mammography screening

The question is no longer whether, but how often, it occurs

H Gilbert Walsh Editorial BMJ July 2009


Overtreatment of DCIS

  • 21,683 women diagnosed with breast cancer in 2006 equivalent to 7000 unnecessary breast cancer diagnoses per year in UK
  • 2000 women screened 3 yearly over 20 years 17.6- 11.4 lives saved, 8.6 - 2.3 over diagnosed
the original version
The original version

‘I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.’

modern version
Modern Version:

‘I will apply, for the benefit of the sick, all measures that are required, avoiding those twin traps of overtreatment and therapeutic nihilism’

issues a trial must address
Issues a Trial must address

Is surgery necessary for all DCIS

Which DCIS diagnoses don’t require surgery

Can we predict by biopsy which DCIS requires surgery (is life threatening)

Can we quantify these risks better to give ‘patients’ an informed choice


Trial Flow Diagram

Patient is diagnosed with low/intermediate grade DCIS

Obtain written informed consent


Central pathology review confirms low risk DCIS

Patient completes Baseline Questionnaires




Proceed to Surgery +/- radiotherapy

Annual mammograms for 5 years

Follow-up as per local practice

All patients to complete QoL Questionnaires until 5 years post-randomisation

All patients to be followed-up for 10 years



Cancer Stages: In Situ



Basement Membrane

  • Cancer cells localized
  • Did not spread

Cancer Stages: Invasive



Basement Membrane

  • Cancer cells break through basement membrane
  • Invade surrounding tissue
team expertise
Team Expertise
  • Collaboration with SLOANE* and West Midlands Cancer Intelligence Unit (Gill Lawrence)
  • Run through CR UK Clinical Trials Unit, Birmingham
    • Radiologists: Matthew Wallis* and Andy Evans*,
    • Pathologists: Jeremy Thomas* Sarah Pinder* & Andy Hanby
    • Patient Reported Outcomes: Lesley Fallowfield & Alison Broome
    • Translational Science: John Bartlett
    • Oncologists: David Dodwell* & Dan Rea
    • Surgeons: Adele Francis, Hugh Bishop*, Martin Lee*, Mike Hallissey & Malcolm Reed
    • Health Economist: Tracy Roberts
trial end points
Trial End Points

Diagnosis of invasive breast cancer in the same breast

Patient reported outcomes

Overall survival

Translational predictors of progression to invasive disease

Time to surgery/mastectomy/mastectomy rate

Health Economics

annual dcis case load uk
Annual DCIS Case Load UK

Low Grade – 500

Intermediate Grade - 3000

High Grade - 7000

enhancing patient uptake
Enhancing Patient Uptake

There may be debate about the DCIS trial design comparing Active Monitoring +/- treatment

Difficulties recruiting both clinical teams to join trial and patients are acknowledged

Patients/advocates have been involved at an early stage of trial development. Focus groups held with representative sample of patients

Importantly, a Patient Information DVD providing an even-handed and consistent message about rationale and logic will be made

Will be made by LF’s group who have lots of experience

e g patient information dvd for pulmicc trial
e.g. Patient Information DVD for PuLMiCC Trial
  • Contains relevant cartoons and graphics
  • Permits patients to take their time, replay parts and make informed unbiased decisions

Oncologist Dr Pauline Leonard,

explains trial rationale

Professor Tom Treasure describes the lung surgery

Hayley Tapping, research nurse discussing the trial tests

recruitment strategy
Recruitment Strategy

Patient involvement

Focus Day for potential user group

Scoping Day with relevant Health Care Practitioners

Regional start up meetings to provide sites with Consistent information and first approach

Patient Information DVD (based on experience from PROTECT trial)

200 patient Pilot Study to examine:- reasons for accepting/declining trial, reactions to diagnosis, and patient understanding of DCIS

Inform if need for adaptation to recruitment approach

Media publicity

Trial awareness at screen attendance (poster/leaflet)

why we need the trial
Why we need the trial?

There are no randomised data demonstrating survivaladvantages following treatment for low/intermediate grade DCIS

There are no systematically collected Quality of Life data using validated patient reported outcome measures demonstrating harms/benefits of current practice

Very little Health Economic evidence

Probably unacceptable to continue as we are