silent breast cancer: study of the disease prevalence held ...€¦ · de medicina legal...

1
RESEARCH POSTER PRESENTATION DESIGN © 2015 www.PosterPresentations.com Breast cancer epidemiological patterns 1 vary in European countries, presenting different incidence rates (49 -148 new cases per 100,000 women) with a narrower but still variable range of mortality (15-36 new cases per 100,000 women). In Portugal, there is a gradual and progressive increase of female breast cancer incidence and a progressive decrease of mortality, which according to the latest published data is 118.5 and 30.4 cases per 100,000 women, respectively (DGS, 2016). According to the same report, the national screening program covers 67.70% of the target population with a population adhesion rate of 60.89% 2 . Breast cancer incidence and mortality patterns differ significantly among different regions within Portugal. Moreover, the capital area (Lisbon) of the country is not officially screened and the majority of the population is followed in private or general practice settings. Male breast cancer is a very rare disease and data are generally scant. By increasing public awareness and improving the screening programmes early detection of breast cancer is possible, resulting in an increase in the incidence of small breast tumours. However, the incidence of advanced and metastatic breast cancer remains high. Data suggests that the reduction of breast cancer mortality is not only due just to the early detection of the disease but is, in almost equal parts, the result of both screening and of the advances in molecular medicine and the development of new therapies 3 . The aim of this study is to quantify the real number of breast cancer present in both genders by calculating the prevalence of silent breast cancer in corpses. We intend to quantify the existing cancers, those not being clinically manifest. In the present poster we present the results of our Pilot/Feasibility study. In the international literature there are only three publications based on medical/legal autopsies and designed to define the ‘natural reservoir’ of the disease 4 .The present study is the first one to appraise breast tissue by imaging means thereby orienting the biopsy incision. INTRODUCTION OBJECTIVES STUDY DESIGN Since the true prevalence of the disease is unknown, the worst case scenario was considered. Specifically, it was speculated that if 50% of our population had undetected breast cancer, with a 5% error margin, 384 (n = P × (100 - P) × z2/d2, where P is the anticipated prevalence, d is the desired precision,z is the appropriate value from the normal distribution for the desired confidence) corpses of each gender would then need to be examined . The samples comprising the study population are taken from the National Institute of Legal Medicine and Forensic Science (Lisbon). Once the eligibility criteria are fulfilled, bilateral subcutaneous modified radical mastectomy in each fresh cadaver will be performed at the National Institute of Legal Medicine and Forensic Science. Tissues will then be transported within an appropriate container to the Hospital São Francisco Xavier and submitted to inspection, palpation, echography and mammography by breast radiologists. Breast tissue classified as BI/RADS category 3 or higher will be submitted to wire-guided surgical biopsy by breast surgeon (the proper author/ investigator). These will then be analysed in the pathology department by an experienced hospital breast pathologist and, in case of doubt, a second pathologist, outside the hospital, will review the samples. The Time frame of the study is of 24-36 months, depending on cadaver recruitment rate. PILOT_RESULTS In this Pilot we present (tables 1 and 2) the results of the first 7 of each gender bilateral modified radical mastectomies performed. ACKNOWLEDGMENTS We thank all the hospital staff of both major institutions that support this study, since corpses adequacy to imaging and sample processing technicians. FUNDING This study is supported by the Hospital São Francisco Xavier, CHLO, Lisbon and by the Instituto Nacional de Medicina Legal Delegação do Sul, Serviço de Clínica e Patologia Forenses. The present study aims: to determine silent breast cancer prevalence in both genders to identify the specific profiles that influence the clinical manifestation of the disease and, to characterize the age distribution of the silent breast cancer in the population under study. 1 Hospital São Francisco Xavier CHLO Lisbon, 2 Instituto Nacional de Medicina Legal Delegação do Sul, Serviço de Clínica e Patologia Forenses Lisbon , 3 Breast Unit, Champalimaud Clinical Centre,Lisbon 4 CELLEX - Centre de Recerca Biomèdica, Laboratory of Molecular and Translational Oncology, Barcelona Silent Breast Cancer: Study of the Disease Prevalence Held by Image-Guided Biopsies on Autopsy Specimens: The Pilot study Sidiropoulou, Zacharoula MD,MSc 1 ; Vasconcelos, Ana MD,MSc 1 ; Couceiro, Cristiana MD,MSc 1 ; Araújo, Ana MD 1 ; Alegre, Inês MD 1 ; Santos, Claudia MD 1 ; Costa, Filipa MD 1 ; Santos, Carlos MD 2 ; Henriques, Vanessa MD 1 ; Neves, Carlos MD,MSc 1 ; Cardoso, Fátima MD 3 ; Gascón, Pere PhD 4 DATA COLECTION SHEET Table 1 Female Table 2 Male Yet too early to present any conclusions on our original hypothesis, that is that the silent breast cancer prevalence is going to be higher than the actual breast cancer incidence, in this point we are able to state: -It is feasible to execute the prevalence definition by enlarging our time frame up to 36 months because the actual rate of recruitment is lower than the initially planned. -The tissues collected in fresh cadaver can be analyzed by means of imaging without tissue degradation up to 48H pos-collection -The corpse’s specificities in terms of gynaecologic/obstetric or medication and comorbidities profile cannot be established for legal reasons (no access to personal files). In this way we are not going to be able to determine eventual protective or harming factors. CONCLUSIONS To the best of our knowledge, the design of the present study is the first of its kind, where image-guided biopsies will be used to define the breast cancer prevalence in a population. The authors aim to contribute to the better understanding of the disease and its behaviour. In the case where high prevalence of the disease is detected, this might imply indolent disease frequently identified in older age without compromising either the quality of life or the life expectancy of the patient. In the case where the prevalence of the disease is low, it might be argued that this is due to the fact that the disease is extremely aggressive or rare and therefore, screening protocols could benefit from reviewing age boundaries or imaging and timing protocols. The study hopes to demonstrate that the disease reservoir is higher than we actually believe. According to our Pilot Study this is a feasible protocol. REFERENCES 1. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012, J. Farley et al, European Journal of Cancer, 2013. 2. Portugal, Doenças Oncológicas em números 2015. www.dgs.pt 3. Abstract no: O-410, Friday 08.45hrs, Clinical Science Symposium: New Insights into Epidemiology and Outcomes, ECCO 2014. 4. Using autopsy series to estimate the disease “reservoir” for Ductal Carcinoma in Situ of the Breast: How much more breast cancer can we find? H.G.Welch et al, Annals of Internal Medicine, 127/11 1997.

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Page 1: Silent Breast Cancer: Study of the Disease Prevalence Held ...€¦ · de Medicina Legal Delegação do Sul, Serviço de Clínica e Patologia Forenses. The present study aims: to

RESEARCH POSTER PRESENTATION DESIGN © 2015

www.PosterPresentations.com

Breast cancer epidemiological patterns1 vary in European countries,

presenting different incidence rates (49 -148 new cases per 100,000 women)

with a narrower but still variable range of mortality (15-36 new cases per

100,000 women).

In Portugal, there is a gradual and progressive increase of female breast

cancer incidence and a progressive decrease of mortality, which according

to the latest published data is 118.5 and 30.4 cases per 100,000 women,

respectively (DGS, 2016).

According to the same report, the national screening program covers

67.70% of the target population with a population adhesion rate of 60.89% 2.

Breast cancer incidence and mortality patterns differ significantly among

different regions within Portugal. Moreover, the capital area (Lisbon) of

the country is not officially screened and the majority of the population is

followed in private or general practice settings.

Male breast cancer is a very rare disease and data are generally scant.

By increasing public awareness and improving the screening programmes

early detection of breast cancer is possible, resulting in an increase in the

incidence of small breast tumours. However, the incidence of advanced and

metastatic breast cancer remains high.

Data suggests that the reduction of breast cancer mortality is not only due

just to the early detection of the disease but is, in almost equal parts, the

result of both screening and of the advances in molecular medicine and the

development of new therapies3.

The aim of this study is to quantify the real number of breast cancer

present in both genders by calculating the prevalence of silent breast

cancer in corpses. We intend to quantify the existing cancers, those not

being clinically manifest.

In the present poster we present the results of our Pilot/Feasibility study.

In the international literature there are only three publications based on

medical/legal autopsies and designed to define the ‘natural reservoir’ of the

disease4.The present study is the first one to appraise breast tissue by

imaging means thereby orienting the biopsy incision.

INTRODUCTION

OBJECTIVES

STUDY DESIGN

Since the true prevalence of the disease is unknown, the worst case

scenario was considered. Specifically, it was speculated that if 50% of our

population had undetected breast cancer, with a 5% error margin, 384 (n = P

× (100 - P) × z2/d2, where P is the anticipated prevalence, d is the desired precision,z is the appropriate

value from the normal distribution for the desired confidence) corpses of each gender would

then need to be examined . The samples comprising the study population

are taken from the National Institute of Legal Medicine and Forensic

Science (Lisbon).

Once the eligibility criteria are fulfilled, bilateral subcutaneous modified

radical mastectomy in each fresh cadaver will be performed at the National

Institute of Legal Medicine and Forensic Science.

Tissues will then be transported within an appropriate container to the

Hospital São Francisco Xavier and submitted to inspection, palpation,

echography and mammography by breast radiologists.

Breast tissue classified as BI/RADS category 3 or higher will be submitted

to wire-guided surgical biopsy by breast surgeon (the proper author/

investigator).

These will then be analysed in the pathology department by an experienced

hospital breast pathologist and, in case of doubt, a second pathologist,

outside the hospital, will review the samples.

The Time frame of the study is of 24-36 months, depending on cadaver

recruitment rate.

PILOT_RESULTS

In this Pilot we present (tables 1 and 2) the results of the first 7 of each

gender bilateral modified radical mastectomies performed.

ACKNOWLEDGMENTS We thank all the hospital staff of both major institutions that support this study, since corpses adequacy to

imaging and sample processing technicians.

FUNDING This study is supported by the Hospital São Francisco Xavier, CHLO, Lisbon and by the Instituto Nacional

de Medicina Legal Delegação do Sul, Serviço de Clínica e Patologia Forenses.

The present study aims:

to determine silent breast cancer prevalence in both genders

to identify the specific profiles that influence the clinical manifestation of

the disease and,

to characterize the age distribution of the silent breast cancer in the

population under study.

1 Hospital São Francisco Xavier – CHLO Lisbon, 2 Instituto Nacional de Medicina Legal Delegação do Sul, Serviço de Clínica e Patologia Forenses Lisbon ,

3 Breast Unit, Champalimaud Clinical Centre,Lisbon 4 CELLEX - Centre de Recerca Biomèdica, Laboratory of Molecular and Translational Oncology, Barcelona

Silent Breast Cancer: Study of the Disease Prevalence Held by Image-Guided Biopsies on Autopsy Specimens: The Pilot study

Sidiropoulou, Zacharoula MD,MSc 1; Vasconcelos, Ana MD,MSc 1; Couceiro, Cristiana MD,MSc 1; Araújo, Ana MD 1; Alegre, Inês MD 1;

Santos, Claudia MD 1; Costa, Filipa MD 1; Santos, Carlos MD 2; Henriques, Vanessa MD 1; Neves, Carlos MD,MSc 1;

Cardoso, Fátima MD 3; Gascón, Pere PhD 4

DATA COLECTION SHEET

Table 1 Female

Table 2 Male

Yet too early to present any conclusions on our original hypothesis, that is

that the silent breast cancer prevalence is going to be higher than the actual

breast cancer incidence, in this point we are able to state:

-It is feasible to execute the prevalence definition by enlarging our time

frame up to 36 months because the actual rate of recruitment is lower than

the initially planned.

-The tissues collected in fresh cadaver can be analyzed by means of

imaging without tissue degradation up to 48H pos-collection

-The corpse’s specificities in terms of gynaecologic/obstetric or medication

and comorbidities profile cannot be established for legal reasons (no access

to personal files). In this way we are not going to be able to determine

eventual protective or harming factors.

CONCLUSIONS

To the best of our knowledge, the design of the present study is the first of

its kind, where image-guided biopsies will be used to define the breast

cancer prevalence in a population.

The authors aim to contribute to the better understanding of the disease

and its behaviour.

In the case where high prevalence of the disease is detected, this might

imply indolent disease frequently identified in older age without

compromising either the quality of life or the life expectancy of the patient.

In the case where the prevalence of the disease is low, it might be argued

that this is due to the fact that the disease is extremely aggressive or rare

and therefore, screening protocols could benefit from reviewing age

boundaries or imaging and timing protocols.

The study hopes to demonstrate that the disease reservoir is higher than we

actually believe.

According to our Pilot Study this is a feasible protocol.

REFERENCES

1. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012, J. Farley et

al, European Journal of Cancer, 2013.

2. Portugal, Doenças Oncológicas em números – 2015. www.dgs.pt

3. Abstract no: O-410, Friday 08.45hrs, Clinical Science Symposium: New Insights into Epidemiology

and Outcomes, ECCO 2014.

4. Using autopsy series to estimate the disease “reservoir” for Ductal Carcinoma in Situ of the Breast:

How much more breast cancer can we find? H.G.Welch et al, Annals of Internal Medicine, 127/11

1997.