THE ONE STOP CLINIC FOR BREAST LESIONS. Philippe Vielh MD, PhD For the Breast Cancer Group Institut de cancérologie Gustave Roussy Villejuif, France

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1 THE ONE STOP CLINIC FOR BREAST LESIONS Philippe Vielh MD, PhD For the Breast Cancer Group Institut de cancérologie Gustave Roussy Villejuif, France

2 CONTEXT IN 2004 French breast cancer screening program just launched and efficient, BUT : Post-screening care : not organized Surgical delays : twice as expected and recommended (3 months instead of 1 month) Evolution of breast care towards non palpable lesions: importance of a close collaboration between clinicians radiologists and (cyto)pathologists

3 French & European recommendations Preoperative diagnosis of breast lesions mandatory Delay between first screening test and surgery < 1 month for cancers Preoperative multidisplinary assessment mandatory in many cases Postoperative multidisciplinary assessment mandatory

4 Objectives Be fast: reduce diagnostic delays Medical efficiency, immediate multidisciplinarity Humanity and multiprofessional care as soon as possible Health economic efficiency Early integration of clinical and biological research

5 ORGANISATION Phone call 35 pts once a wk Radiologist Surgeon Oncologist Cytopathol D1 Total agreement No agreement or no diagnosis Appropriate treatment or follow up as required Go further Immediate diagnosis as frequent as possible Shared diagnosis and decision

6 Phone call direct patients to the most appropriate medical visit Information sheet sent to the patient

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8 Phone call Diagnosis of cancer No diagnosis Already treated or advice only Tumor < 3 cm Large tumor or emergency Calcificat ions only Tumor < 3 cm Large tumor or emergency Advice on medical records Surgeon Oncologist Radiologist Surgeon Oncologist

9 Main actors 1,5 surgeons 1,2 oncologists 2 radiologists 1 cytopathologist 1,0 nurse (coordination) 1,2 nurse 1,5 technician (pathology) 1,5 technician (imaging) 1,0 person (patients reception) 3,0 medical secretaries 35 patients in a day once a week

10 Typical itinerary 1 : subclinical mass PATIENT ARRIVES IN THE UNIT VISIT OF THE FIRST SPECIALIST REVIEW OF PREVIOUS IMAGING, CONCERTED DECISION COMPLEMENTARY MAMMOGRAM AND/OR US US-GUIDED FNA LUNCH RESULTS AT BACK VISIT TO THE FIRST SPECIALIST VISIT OF SURGEON PATIENT LEAVES WITH ALL SURGICAL APPOINMENTS

11 Typical itinerary 2 : large mass PATIENT ARRIVES IN THE UNIT VISIT OF FIRST SPECIALIST FNA + CORE BIOPSY + FROZEN SAMPLE BLOOD TESTS, FIRST EXTENSION ASSESSMENTS LUNCH RESULTS AT BACK VISIT TO THE ONCOLOGIST PATIENT LEAVES WITH APPOINTMENTS FOR MEDICAL ONCOLOGIST VISIT AND CHEMOTHERAPY

12 Typical itinerary 3 : calcifications PATIENT ARRIVES IN THE UNIT VISIT OF FIRST SPECIALIST Explanations on breast lesions, the diagnostic procedure, potential diagnostics and implications REVIEW OF PREVIOUS IMAGING Concerted decision STEREOTACTIC MACROBIOPSY PATIENT LEAVES WITH MEDICAL AND SURGICAL APPOINTMENTS

13 Multidisciplinary approach

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16 CLINICAL RESULTS Quantitative data Qualitative data Patients satisfaction

17 Numbers > 6000 women seen at the one stop unit Median delay between first phone call and first visit: 11 days Cancer rate: > 65% 20% calcifications, 70% nodules US-guided FNA: 60% initially, > 80% currently

18 FNA of nodules Age Several successive evaluations Age Median age: 56 yrs 20 0 Lesion Size (mm) Median lesion size: 15 mm s Taille (mm)

19 Perfect concordance is mandatory Clinician Radiologist Pathologist DIAGNOSTIC CONCORDANCE Multidisciplinarity +++ A single discordant element: go further +++

20 FNA: first results In a series of 697 breast lesions (670 patients) Unsatisfactory specimens : 2% Suspicious : 8% Cancer : 55% Benign : 35% Cancer : 80% Fx positive : 0.1% Fx negative : 3%

21 FNA: recent results In a series of 1824 lesions sampled by FNA (1741 pts ; April 2004-March 2007) Unsatisfactory specimens : 3% Suspicious : 8% Cancer : 46% Benign : 43% Cancer : 80% Fx positive: 0.1% Fx negative : 3%

22 Decision tree Birad 4 Birad 5 FNA benign FNA cancer FNA cancer FNA other Biopsy benign cancer Biopsy if mastectomy or primary medical trt Biopsy But exceptional documented cases Follow up Surgery Surgery Surgery

23 Patient s satisfaction x no fair good very good excellent 90% overall satisfied

24 Clinical results Mean delay phone call/first visit : 11 days After on site FNA evaluation and diagnosis, it can be repeated if it is unsatisfactory, suspicious or discordant or the patient may have an on site core needle biopsy For nodules, a one day final and exact diagnosis can be made in 87% of cases: so the planning of the treatment and appointments are given to patient the same day For microcalcifications, a definitive diagnosis is obtained and given to the patient after a maximum of 12 days

25 In summary the main advantages are: Systematic review of images by radiologist: multifocality evidenced in some cases Multidisciplinary approach Early initiation of general work-up Screening for inclusion in national and international clinical trials (imaging, surgery, neoadjuvant chemo/hormone therapy) Banking of samples with patient s written informed consent (leftovers) for translational research activities

26 RESEARCH ASPECTS Imaging: contrast doppler, angio-mammography, tomosynthesis, optic imaging Psychocognitive Health economics Translational research

27 Health economics 697 FNA among 670 successive patients Patient and lesion characteristics Median age (years) N = 670 pts 56 (16-92) Menopausal N = 670 pts 63% Palpable lesion N = 697 lesions 56% Median relative risk (Gail model) N = 670 pts 1.61 Median lesion size (mm) N = 697 lesions 15 (2-150) US-guided FNA N = 697 lesions 66% Birad ACR classification of lesions Birad 2 14 (2%) Birad (22.4%) Birad (24.7%)

28 Cytological diagnosis 697 FNA among 670 successive patients Diagnosis No (%) Malignant 370 (53.08) Benign 247 (35.44) Suspicious 59 (8.46) Unsatisfactory 21 (3.01)

29 Indices of diagnostic performance FNA* One stop unit Sensitivity 96.84% 97.16% Specificity 99.07% 99.20% Efficacy 98.80% 92.40% Youden index Positive likelihood ratio Negative likelihood ratio PPV 99.46% 92.98% NPV 94.69% 90.80% * Does not take into account the suspicious and unclassified lesions

30 Mesure of direct costs Overall measured costs (all included) FNA for palpable lesion Median Min-Max US-guided FNA US-guided biopsy

31 As a result Overall cost for the 697 lesions (670 patients) for an exact diagnosis, including biopsies and surgeries where necessary: Overall cost if 697 biopsies had been used with no false positive or false negative result:

32 In summary Efficacy results were comparable to the best results published in the literature FNA has an equivalent specificity but a slightly lower sensitivity than US-guided biopsy and therefore shall always be used in a cautious multidisciplinary approach, which is able to provide excellent results In this setting, FNA appears as very a cost-effective diagnostic tool for the rapid diagnosis of breast lesions in a one stop multidisciplinary breast unit

33 Ευχαριστώ πολύ!!