STAGING AND GRADING OF CANCER

Anabel Maglaya-Lazo,RN
MAN I Lorma Colleges

Mr. Evergisto C. Garcia

Instructor-Cancer Nursing

STAGING

Staging systems for cancer have evolved over time and continue to change as scientists
learn more about cancer.
The TNM staging system is based on the size and/or extent (reach) of the primary tumor
(T), whether cancer cells have spread to nearby (regional) lymph nodes (N), and whether
metastasis (M), or the spread of the cancer to other parts of the body, has occurred.
Physical exams, imaging procedures, laboratory tests, pathology reports, and surgical
reports provide information to determine the stage of a cancer.

1. What is staging?
Staging describes the severity of a persons cancer based on the size and/or extent
(reach) of the original (primary) tumor and whether or not cancer has spread in the body.
Staging is important for several reasons:
o
o
o
o

Staging helps the doctor plan the appropriate treatment.

Cancer stage can be used in estimating a persons prognosis.
Knowing the stage of cancer is important in identifying clinical trials that may be
a suitable treatment option for a patient.
Staging helps health care providers and researchers exchange information about
patients; it also gives them a common terminology for evaluating the results of
clinical trials and comparing the results of different trials.

Staging is based on knowledge of the way cancer progresses. Cancer cells grow and
divide without control or order, and they do not die when they should. As a result, they
often form a mass of tissue called a tumor. As a tumor grows, it can invade nearby tissues
and organs. Cancer cells can also break away from a tumor and enter the bloodstream or
the lymphatic system. By moving through the bloodstream or lymphatic system, cancer
cells can spread from the primary site to lymph nodes or to other organs, where they may
form new tumors. The spread of cancer is called metastasis.
2. What are the common elements of staging systems?
Staging systems for cancer have evolved over time. They continue to change as
scientists learn more about cancer. Some staging systems cover many types of cancer;
others focus on a particular type. The common elements considered in most staging
systems are as follows:

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o
o
o
o
o

Site of the primary tumor and the cell type (e.g., adenocarcinoma, squamous cell
carcinoma)
Tumor size and/or extent (reach)
Regional lymph node involvement (the spread of cancer to nearby lymph nodes)
Number of tumors (the primary tumor and the presence of metastatic tumors, or
metastases)
Tumor grade (how closely the cancer cells and tissue resemble normal cells and
tissue)

What is the TNM system?

The TNM system is one of the most widely used cancer staging systems. This
system has been accepted by the Union for International Cancer Control (UICC) and the
American Joint Committee on Cancer (AJCC). Most medical facilities use the TNM
system as their main method for cancer reporting.
The TNM system is based on the size and/or extent (reach) of the primary tumor
(T), the amount of spread to nearby lymph nodes (N), and the presence of metastasis (M)
or secondary tumors formed by the spread of cancer cells to other parts of the body. A
number is added to each letter to indicate the size and/or extent of the primary tumor and
the degree of cancer spread.
Primary Tumor (T)
TX: Primary tumor cannot be evaluated
T0: No evidence of primary tumor
Tis: Carcinoma in situ (CIS; abnormal cells are present but have not spread to
neighboring tissue; although not cancer, CIS may become cancer and is sometimes called
preinvasive cancer)
T1, T2, T3, T4: Size and/or extent of the primary tumor
Regional Lymph Nodes (N)
NX: Regional lymph nodes cannot be evaluated
N0: No regional lymph node involvement
N1, N2, N3: Degree of regional lymph node involvement (number and location of lymph
nodes)
Distant Metastasis (M)
MX: Distant metastasis cannot be evaluated
M0: No distant metastasis
M1: Distant metastasis is present
For example, breast cancer classified as T3 N2 M0 refers to a large tumor that has
spread outside the breast to nearby lymph nodes but not to other parts of the body.
Prostate cancer T2 N0 M0 means that the tumor is located only in the prostate and
has not spread to the lymph nodes or any other part of the body.

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For many cancers, TNM combinations correspond to one of five stages. Criteria for
stages differ for different types of cancer. For example, bladder cancer T3 N0 M0 is stage
III, whereas colon cancer T3 N0 M0 is stage II.
Stage
Stage 0
Stage I, Stage II, and Stage III
Stage IV

Definition
Carcinoma in situ
Higher numbers indicate more extensive disease: Larger tumor size
and/or spread of the cancer beyond the organ in which it first
developed to nearby lymph nodes and/or tissues or organs adjacent
to the location of the primary tumor
The cancer has spread to distant tissues and organs

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3. Are all cancers staged with TNM classifications?

Most types of cancer have TNM designations, but some do not. For example,
cancers of the brain and spinal cord are staged according to their cell type and grade.
Different staging systems are also used for many cancers of the blood or bone marrow,
such as lymphomas. The Ann Arbor staging classification is commonly used to stage
lymphomas and has been adopted by both the AJCC and the UICC. However, other
cancers of the blood or bone marrow, including most types of leukemia, do not have a
clear-cut staging system. Another staging system, developed by the International
Federation of Gynecology and Obstetrics (FIGO), is used to stage cancers of the cervix,
uterus, ovary, vagina, and vulva. This system is also based on TNM information.
Additionally, most childhood cancers are staged using either the TNM system or the
staging criteria of the Childrens Oncology Group (COG), which conducts pediatric
clinical trials; however, other staging systems may be used for some childhood cancers.
Many cancer registries, such as those supported by NCIs Surveillance,
Epidemiology, and End Results (SEER) Program, use summary staging. This system is
used for all types of cancer. It groups cancer cases into five main categories:
o
o
o
o
o

In situ: Abnormal cells are present only in the layer of cells in which they
developed
Localized: Cancer is limited to the organ in which it began, without evidence of
spread
Regional: Cancer has spread beyond the primary site to nearby lymph nodes or
tissues and organs
Distant: Cancer has spread from the primary site to distant tissues or organs or to
distant lymph nodes
Unknown: There is not enough information to determine the stage.

4. What types of tests are used to determine stage?

The types of tests used for staging depend on the type of cancer. Tests include the
following:
o

Physical exams are used to gather information about the cancer. The doctor
examines the body by looking, feeling, and listening for anything unusual. The
physical exam may show the location and size of the tumor(s) and the spread of
the cancer to the lymph nodes and/or to other tissues and organs.
Imaging studies produce pictures of areas inside the body. These studies are
important tools in determining stage. Procedures such as x-rays, computed
tomography (CT) scans, magnetic resonance imaging (MRI) scans, and positron
emission tomography (PET) scans can show the location of the cancer, the size of
the tumor, and whether the cancer has spread.
Laboratory tests are studies of blood, urine, other fluids, and tissues taken from
the body. For example, tests for liver function and tumor markers (substances
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sometimes found in increased amounts if cancer is present) can provide

information about the cancer.
Pathology reports may include information about the size of the tumor, the
growth of the tumor into other tissues and organs, the type of cancer cells, and the
grade of the tumor. A biopsy may be performed to provide information for the
pathology report. Cytology reports also describe findings from the examination of
cells in body fluids.
Surgical reports tell what is found during surgery. These reports describe the
size and appearance of the tumor and often include observations about lymph
nodes and nearby organs.

5. Does a cancers stage change?

An important point some people have trouble understanding is that the stage of a
cancer does not change over time, even if the cancer progresses. A cancer that comes
back or spreads is still referred to by the stage it was given when it was first found and
diagnosedinformation about the current extent of the cancer is added to it.
For example, lets say a woman was first diagnosed with stage II breast cancer
and the cancer went away with treatment. But then it came back with spread to the bones.
The cancer is still called a stage II breast cancer, now with recurrent disease in the bones.
If the breast cancer did not respond to treatment and spread to the bones its called a stage
II breast cancer with bone metastasis. In either case, the original stage does not change
and its not called a stage IV breast cancer. A stage IV breast cancer refers to a cancer
that has already spread to a distant part of the body when its first diagnosed. A person
keeps the same diagnosis stage, but more information is added to the diagnosis to explain
the current state of the disease.
This is important to understand because survival statistics and information on
treatment by stage for specific cancer types refer to the stage when the cancer was first
diagnosed. The survival statistics related to stage II breast cancer that has recurred in the
bones may not be the same as the survival statistics for stage IV breast cancer.
At some point you may hear the term restaging. Restaging is the term
sometimes used for doing tests to find the extent of the cancer after treatment. This is
rarely done, but it may be used to measure the cancers response to treatment or to assess
cancer that has come back (recurred) and will need more treatment. Often this involves
the same tests that were done when the cancer was first diagnosed: physical exams,
imaging tests, biopsies, and maybe surgery. After these tests a new stage may be
assigned. Its written with a lower-case r before the new stage to note that its different
from the stage at diagnosis. The original stage at diagnosis always stays the same. While
testing to see the extent of cancer is common during and after treatment, actually
assigning a new stage is rarely done, except in clinical trials.

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Tumor Grade

Tumor grade is the description of a tumor based on how abnormal the tumor cells and
tumor tissue look under a microscope.
Tumor grade is an indicator of how quickly the tumor is likely to grow and spread.
Tumor grading systems differ depending on the type of cancer.
Tumor grade may be one of the factors considered when planning treatment for a patient.

1. What is tumor grade?

Tumor grade is the description of a tumor based on how abnormal the tumor cells and
the tumor tissue look under a microscope.
It is an indicator of how quickly a tumor is likely to grow and spread. If the cells of
the tumor and the organization of the tumors tissue are close to those of normal cells
and tissue, the tumor is called well-differentiated. These tumors tend to grow and
spread at a slower rate than tumors that are undifferentiated or poorly
differentiated, which have abnormal-looking cells and may lack normal tissue
structures. Based on these and other differences in microscopic appearance, doctors
assign a numerical grade to most cancers. The factors used to determine tumor
grade can vary between different types of cancer.
Tumor grade is not the same as the stage of a cancer. Cancer stage refers to the
size and/or extent (reach) of the original (primary) tumor and whether or not
cancer cells have spread in the body. Cancer stage is based on factors such as the
location of the primary tumor, tumor size, regional lymph node involvement (the
spread of cancer to nearby lymph nodes), and the number of tumors present.

2. How is tumor grade determined?

If a tumor is suspected to be malignant, a doctor removes all or part of it during a
procedure called a biopsy. A pathologist (a doctor who identifies diseases by studying
cells and tissues under a microscope) then examines the biopsied tissue to determine
whether the tumor is benign or malignant. The pathologist also determines the tumors
grade and identifies other characteristics of the tumor. The NCI fact sheet Pathology
Reports describes the type of information that can be found in a pathologists report about
the visual and microscopic examination of tissue removed during a biopsy or other
surgery.

3. How are tumor grades classified?

Grading systems differ depending on the type of cancer. In general, tumors are
graded as 1, 2, 3, or 4, depending on the amount of abnormality.
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 In Grade 1 tumors, the tumor cells and the organization of the tumor tissue
appear close to normal. These tumors tend to grow and spread slowly.
Grade 3 and Grade 4 tumors do not look like normal cells and tissue.
Grade 3 and Grade 4 tumors tend to grow rapidly and spread faster than
tumors with a lower grade.
If a grading system for a tumor type is not specified, the following system is generally
used.
o
o
o
o
o

GX: Grade cannot be assessed (undetermined grade)

G1: Well differentiated (low grade)
G2: Moderately differentiated (intermediate grade)
G3: Poorly differentiated (high grade)
G4: Undifferentiated (high grade)

4. What are some of the cancer type-specific grading systems?

Breast and prostate cancers are the most common types of cancer that have their
own grading systems.
Breast cancer. Doctors most often use the Nottingham grading system (also
called the Elston-Ellis modification of the Scarff-Bloom-Richardson grading system) for
breast cancer .This system grades breast tumors based on the following features:
o
o
o

Tubule formation: how much of the tumor tissue has normal breast (milk) duct
structures
Nuclear grade: an evaluation of the size and shape of the nucleus in the tumor
cells
Mitotic rate: how many dividing cells are present, which is a measure of how fast
the tumor cells are growing and dividing

Each of the categories gets a score between 1 and 3; a score of 1 means the cells and
tumor tissue look the most like normal cells and tissue, and a score of 3 means the cells
and tissue look the most abnormal. The scores for the three categories are then added,
yielding a total score of 3 to 9. Three grades are possible:
o
o
o

Total score = 35: G1 (Low grade or well differentiated)

Total score = 67: G2 (Intermediate grade or moderately differentiated)
Total score = 89: G3 (High grade or poorly differentiated)

Prostate cancer. The Gleason scoring system is used to grade prostate cancer
.The Gleason score is based on biopsy samples taken from the prostate. The pathologist
checks the samples to see how similar the tumor tissue looks to normal prostate tissue.
Both a primary and a secondary pattern of tissue organization are identified. The primary
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pattern represents the most common tissue pattern seen in the tumor, and the secondary
pattern represents the next most common pattern. Each pattern is given a grade from 1 to
5, with 1 looking the most like normal prostate tissue and 5 looking the most abnormal.
The two grades are then added to give a Gleason score. The American Joint Committee
on Cancer recommends grouping Gleason scores into the following categories.
o
o
o
o

Gleason X: Gleason score cannot be determined

Gleason 26: The tumor tissue is well differentiated
Gleason 7: The tumor tissue is moderately differentiated
Gleason 810: The tumor tissue is poorly differentiated or undifferentiated.

5. How does tumor grade affect a patients treatment options?

Doctors use tumor grade and other factors, such as cancer stage and a patients
age and general health, to develop a treatment plan and to determine a patients prognosis
(the likely outcome or course of a disease; the chance of recovery or recurrence).
Generally, a lower grade indicates a better prognosis. A higher-grade cancer may grow
and spread more quickly and may require immediate or more aggressive treatment.
The importance of tumor grade in planning treatment and determining a patients
prognosis is greater for certain types of cancer, such as soft tissue sarcoma, primary brain
tumors, and breast and prostate cancer.

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PROSTATE CANCER
Epidemiology
Prostate cancer is the most frequently diagnosed malignancy and the second leading
cause of cancer death in men in the United States by the American Cancer Society. Incidence
rates, expected to rise drastically, and by 2025, as the baby boom-population ages, new cases are
estimated to be 38,000per year. The median age at diagnosis is 71 years, with the incidence rate
steadily increasing for each decade after age 50.
The global distribution of prostate cancer reveals predominance in the United States and
Canada. Additionally, Scandinavia and parts of the Caribbean have particularly high rates of
incidence and mortality, whereas, Japan and China have extremely low rates.

Estimated New Cases in 2014 - 233,000

% of All New Cancer Cases - 14.0%
Estimated Deaths in 2014 - 29,480
% of All Cancer Deaths - 5.0%

Etiology and Risk Factors

Exact etiology remains unknown, current scientific thinking suggests that prostate
cancer results from a combination of environmental factors as well as personal
risk factors.
Well established risk factors age, ethnicity and family history
Postulated risk factors, no conclusive evidence and data that supports established
recommendations lifestyle (increased fat intake, consumption of red meat and
increased dietary animal fat.
-occupational exposure ( farming and pesticide exposure)
-infection (chronic inflammation and prior infection)
High-grade prostatic intraepithelial neoplasia (PIN) known marker for the
later development of prostatic cancer, its presence is highly predictive of the
development of cancer within 10 years.
Prevention, screening and detection
No prescriptive recommendations can be made based on clear scientific data.
Advising patients regarding a prudent low-fat and high-fiber diet along with
consumption of lycopene- rich products maybe best advice that can be
offered at this time. Identification of patients at high risk because of family
history is another important nursing function. These men should participate
in PSA testing regularly and begin at an earlier age.
PSA TESTING the single best test for early diagnosis.
Recently updated guideline published by the American Cancer
Society(ACS)- recommend that both PSA testing and DRE should be offered
annually, beginning at age 50, to men who have at least 10 year expectancy
and to younger men who are at high risk(African-american descent and men
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with family history of prostate cancer recommends testing at age 45, men affected
with numerous first-degree relatives testing initiated at age 40.)

Classification
95% - adenocarcinoma
5% - sarcomas and transitional cell tumors
Clinical Features
Elevated PSA level more than 4.0ng/ml
Symptoms early (urinary hesitancy, frequency and feeling of incomplete
emptying)
-late ( blood in the semen, decreased ejaculatory volume and less
commonly is impotence that occurs as the tumor encroaches upion the
neurovascular bundles in the periprostatic tissue)
- late signs with advanced disease (bone pain, pathologic fractures, spinal
cord compression, hematuria and anemia)
Diagnosis
PSA testing with DRE
Extended biopsy with TRUS
CT scan
MRI
Staging and grading
TNM staging system is used in prostate cancer and graded according to the level of
cellular differentiation among biopsy specimens. The most commonly employed grading system
is the Gleason score. The two most malignant cellular patterns noted under microscopic
examination are rated on a score of 1 to 5. Scores are then summed, total scores ranges from 2 to
10. Aggressive disease and poorer prognosis is indicated by high scores.
Treatment Modalities and Nursing Care Considerations
Surgery - retropubic prostatectomy (RP)> vigilant pain assessment,
>administration of analgesia
> maintaining catheter patency
>prevention of thrombophlebitis and pulmonary embolus formation and
>prevention of urinary tract infections
>encourage fluid intake to maintain a minimum urine output of 30cc/hr or more
>rectal manipulation is contraindicated due to risk of rectal injury given the close
proximity of the prostate to the rectal wall
>catheter maintainance following discharge home maybe in place several weeks
postoperatively
>early progressive ambulation, avoidance of vigorous activity until cleared by the
physician
>post-op complications such as incontinence, impotence, urethral stricture are
treated with anticholinergic or alpha adrenergic drug, or artificial sphincter
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placement, use of vasoconstrictive devices, such as the use of vacuum pumps, the
penile implants, the use of intraurethral prostaglandin suppositories, and
intracavernous penile injections to attain erections.
Radiation therapy
external beam radiotherapy
three-dimensional conformal radiotherapy (3DCRT)
brachytherapy radiation delivery is through a permanent
or temporary seed implant performed over a period of 1 to
2 hours
>adequate nutrition and hydration status is important
>encourage patient to take the full course of prophylactic antibiotic as
prescribed
>instructions on sexual intercourse may resume in 2 months and
symptoms may subside within 3 4 months. With seed implant the use of
condom is advised to protect partner from possible seed expulsion.
Hormonal therapy
Aimed at the disruption of androgen stimulation
Bilateral orchiectomy
Leutenizing hormone-releasing hormone (LHRH)
Antiandrogen
Estrogen therapy
>patient education, psychosocial support, and the recognition and
prompt management of side effects.
Expectant management or Watchful Waiting
Conservative management strategy involves no local therapy on
diagnosis, with initiation of treatment when the patient becomes
symptomatic from either locally advanced disease or metastatic
disease
Largely based on patients preference and for patients with low-grade
disease older than70 years of age, with alife expectancy of less than 10
years
>continuous assessment of both the physiologic and psychosocial dimensions of
QOL
Others
Cryotherapy direct application of ice to the prostate gland via
percutaneously inserted cryogenic probes, abandoned due to high
rate of complications.
Laparoscopic and Robotic Prostatectomy- still investigational and
awaits long-term outcome analysis.
Chemotherapy- results are pending.
Emerging therapies
Gene therapy- suicide gene therapy(introduction of toxic or cell-lytic
genes)
Cytokine adjuvant therapy
Vaccines cytokine gene-transduced vaccines
-DNA peptide vaccines
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- dendrite cell-based vaccines

Prognosis
Prognosis is influenced by Gleason stage and cellular architectural patterns, tumor size,
location and the presence or absence of metastasis. Statistics compare the survival of patients
diagnosed with cancer with the survival of people in the general population who are the same
age, race, and sex and who have not been diagnosed with cancer. Because survival statistics are
based on large groups of people, they cannot be used to predict exactly what will happen to an
individual patient. No two patients are entirely alike, and treatment and responses to treatment
can vary greatly. In general, if the cancer is found only in the part of the body where it started it
is localized (sometimes referred to as stage 1). If it has spread to a different part of the body, the
stage is regional or distant. The earlier prostate cancer is caught, the better chance a person has
of surviving five years after being diagnosed. For prostate cancer, 80.7% are diagnosed at the
local stage. The 5-year survival for localized prostate cancer is 100.0% data by SEER.

References:
1. Langhorne,MarthaE; et.al, Oncology
Nursing.(5thedition).Singapore,Elsevier,INC.@2011
2. http://www.cancer.gov/cancertopics/factsheets 2014
3. file:///F;\tumorgradefactsheet-National Cancer Institute.html
4. American Joint Committee on Cancer. AJCC Cancer Staging Manual. 7th ed. New York,
NY: Springer; 2010.
5. http://www.globenewswire.com

6. http://redorbit.com/topics/prostate-cancer/

By: Anabel Maglaya-Lazo,RN

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Tomato-Rich Diets May Help Reduce The

Risk Of Developing Prostate Cancer
August 28, 2014

Chuck Bednar for redOrbit.com Your Universe Online

Men looking to reduce their risk of developing prostate cancer could benefit by consuming at
least 10 servings of tomatoes per week, according to new research appearing in a recent edition
of the journal Cancer Epidemiology, Biomarkers & Prevention.
Doing so can decrease the risk of contracting the disease by 18 percent, Vanessa Er of the
University of Bristols School of Social and Community Medicine and her colleagues claim in
the UK National Institute for Health Research (NIHR)-funded study. The findings follow an indepth analysis of the diets and lifestyles of 1,806 men between the ages of 50 and 69 with
prostate cancer, as well as those of 12,005 cancer-free male patients.
According to BBC News online health editor Helen Briggs, not only did they find that men
consuming a total of at least 10 portions of fresh tomatoes, tomato juice, baked beans and other
similar products experienced the 18 percent reduction in prostate cancer risk, but they also
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discovered that eating five servings of fruits or vegetables per day decreased the risk by 24
percent versus men eating half that amount.
Our findings suggest that tomatoes may be important in prostate cancer prevention, Er, a Ph.
D. student at the university, said in a statement. However, further studies need to be conducted
to confirm our findings, especially through human [clinical] trials. Men should still eat a wide
variety of fruits and vegetables, maintain a healthy weight and stay active.
Er, who also worked with scientists from the University of Cambridge and Oxford University,
explained that the reason tomato products appeared to be the most beneficial in reducing prostate
cancer risk was due to lycopene, an antioxidant which helps combat toxins that can cause DNA
and cell damage. They note that this is the first study of its kind to develop an index of dietary
components that have been linked to prostate cancer.
Only the recommendation on plant foods high intake of fruits, vegetables and dietary fiber
was found to be associated with a reduced risk of prostate cancer, the university explained. As
these recommendations are not targeted at prostate cancer prevention, researchers concluded that
adhering to these recommendations is not sufficient and that additional dietary recommendations
should be developed.
In addition, Anna Hodgekiss of the Daily Mail reported that Er believes the best way to get
lycopene as well as other cancer-fighting dietary components such as selenium and calcium
is directly from food, not through supplements. In all, the study calls for men to make sure they
ingest between 750mg and 1,200mg of calcium and between 105mcg to 200mcg of selenium
daily.
Er and her colleagues are now calling for additional research to aid in the development of
additional dietary recommendations to help prevent prostate cancer. She also told Hodgekiss that
it was important to be cautious with the study because while they have found a link, their
findings do not indicate a proof of causation.
Similarly, Tom Stansfeld of Cancer Research UK told Briggs that while eating foods rich in
lycopene such as tomatoes or selenium may be associated with a reduction in the risk of
prostate cancer, this has not been proven, and this study cant confirm whether there is a link
between diet and prostate cancer risk. Diet and cancer prevention is a complex issue with few
black and white answers; we encourage everyone to eat a balanced diet which is high in fruit and
vegetables and low in red and processed meat, fat and salt.

EDAP Highlights HIFU Expertise at 7th International Symposium on

Focal Therapy and Imaging in Prostate and Kidney Cancer
EDAP TMS SA August 26, 2014 8:30 AM GlobeNewswire

LYON, France, Aug. 26, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (EDAP), the global
leader in therapeutic ultrasound, announced its participation in the Seventh International
Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer, which took place in
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Los Angeles, August 21-23, 2014. The congress is a joint initiative of the University of Southern
California (Los Angeles, USA), Duke University (Durham, USA) and AMC (Amsterdam,
Netherlands).
Focal therapy is a technology based paradigm shift in the treatment of localized prostate cancer
that is gaining acceptance worldwide. EDAP presented the latest scientific and clinical results of
focal-HIFU for prostate cancer with the use of its device, Focal One. Posters, videos and
abstracts were presented by Focal One users and outlined the first experience and clinical results
with Focal One. The data were well received by delegates at the symposium, as Focal One's
unique imaging, treatment and treatment verification technologies position it at the forefront of
focal therapies in the modern approach of prostate cancer treatment.
Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "As discussions on
best prostate cancer treatment strategies continue among urologists, such international
symposiums represent a great opportunity to review the latest in technologies and clinical
strategies. Focal One was highlighted multiple times within the scientific program clearly
establishing its lead in the field. With our long term worldwide experience in HIFU and the
current growing interest in focal therapy, our teams of international experts are already
contributing to strategic discussions and decisions on prostate cancer treatment strategies."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm(R) for high-intensity focused ultrasound (HIFU)
treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and
effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally
recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates
for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment,
Ablatherm-HIFU is approved and commercialized in Europe as a treatment for prostate cancer
and is currently under regulatory review in the U.S. following submission of the Pre-Market
Approval Application in February 2013 after the completion of a multi-center U.S. Phase II/III
clinical trial under an Investigational Device Exemption (IDE) granted by the FDA. In February
2014, the Company introduced a new innovative HIFU device, the Focal One(R) dedicated to
focal therapy of prostate cancer. Focal One(R) is CE marked but is not FDA approved. The
Company also develops its HIFU technology for the potential treatment of certain other types of
tumors. EDAP TMS SA also produces and commercializes medical equipment (the Sonolith(R)
range) for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).

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