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Overview of Breast

Cancer Management

Edith A. Perez, MD

Director, Clinical Investigations

Director, Breast Cancer Program

Division of Hematology/Oncology

Mayo Clinic

Jacksonville, Florida

Incidence of Breast Cancer Compared

With Other Sites (Women)

Breast Uterine corpus

160 Lung and bronchus Ovary

Colon and rectum Non-Hodgkin’s lymphoma

Rate per 100,000 Females









140

120

100

80

60

40

20

0

1975 1980 1985 1990 1995 2000

Year of Diagnosis



Adapted from Jemal A et al. CA Cancer J Clin. 2004;54:8-29; ACS. Breast Cancer Facts and Figures. 2003.

Mortality Rate for Breast Cancer

Compared With Other Sites (Women)

Breast Uterus

60 Lung and bronchus Ovary

Colon and rectum Pancreas

Rate per 100,000 Females









50



40



30



20



10



0

1975 1980 1985 1990 1995 2000

Year of Diagnosis



Adapted from Jemal A et al. CA Cancer J Clin. 2004;54:8-29; ACS. Breast Cancer Facts and Figures. 2003.

.

Risk Factors for Breast Cancer

 Personal history of breast  Childbearing absent or

cancer or proliferative breast delayed until after age

disease 30 years

 Genetic mutations in BRCA1,  Early menarche/

BRCA2, and others late menopause

 Positive family history of  Hormone replacement

breast or ovarian cancer therapy

 History of DES therapy  High body mass index

(exposure to estrogen or  High alcohol intake

progesterone compounds)

 Prior breast irradiation at

young age

BRCA1 = breast cancer 1 gene; BRCA2 = breast cancer 2 gene; DES = diethylstilbestrol.

Hollingsworth AB et al. Am J Surg. 2004;187:349-362.

Breast Cancer Risk Assessment:

Interactions Between Risk Factors

 Modified Gail model used by the National Cancer Institute

and National Surgical Adjuvant Breast and Bowel Project in the

Breast Cancer Prevention Trial

 Assessment tool analyzes combinations of 7 factors to calculate risk

 History of DCIS, LCIS  Age at menarche

 Age (patients ≥35 years)  Age at first live

birth

 First-degree relatives with breast cancer

 Ethnicity

 Prior breast biopsies and presence of

atypical ductal hyperplasia

 Risk of developing breast cancer is indicated by the composite score

of the relative risk for each factor



DCIS = ductal carcinoma in situ; LCIS = lobular carcinoma in situ.

Gail MH et al. J Natl Cancer Inst. 1989;81:1879-1886.

Factors That Influence Survival

in Breast Cancer Patients

 Age at diagnosis

 Tumor size at diagnosis



 Stage at diagnosis

 Biologic characteristics of the tumor



 Hormone receptor status (less significant)

 HER2







HER2 = human epidermal growth factor receptor 2.

ACS. Breast Cancer Facts and Figures. 2003; Lohrisch C, Piccart M. Clin Breast Cancer.

2001;2:129-135; Michaelson JS et al. Cancer. 2002;95:713-723.

Overview of Stages of Breast Cancer

Stage I Stage II Stage III Stage IV









Early disease: Early disease: Locally advanced disease: Advanced (or metastatic)

Tumor confined to Tumor >2 cm in Tumor spread to the disease:

the breast diameter or spread superficial structures of Metastases present

(node-negative) to movable the chest wall; involvement at distant sites such as bone,

ipsilateral axillary of ipsilateral internal liver, lungs, and brain, and

node(s) (node- mammary lymph nodes including supraclavicular

positive) lymph node involvement







Greene FL et al, eds. AJCC Cancer Staging Handbook from the AJCC Cancer Staging Manual. 2003.

TNM Staging in Breast Cancer

Provides information about: Overall T Category N Category M Category

Stage (tumor) (nodes) (metastases)

 Tumor size

Stage 0 Tis N0 M0

 Node involvement Stage I T1 N0 M0

 Whether the cancer Stage IIA T0 N1 M0

has spread to the T1 N1 M0

T2 N0 M0

lymph nodes of the

breast (axilla, internal Stage IIB T2 N1 M0

T3 N0 M0

mammary,

Stage IIIA T0 N2 M0

supraclavicular, T1 N2 M0

intramammary) T2 N2 M0

T3 N1 M0

 Metastasis

T3 N2 M0

 Whether the tumor has Stage IIIB T4 Any N M0

spread to other parts Stage IIIC Any T N3 M0

of the body Stage IV Any T Any N M1

Tis = tumor in situ.

Greene FL et al, eds. AJCC Cancer Staging Handbook from the AJCC Cancer Staging Manual. 2003.

Breast Cancer Treatment:

TNM Stage 0

Objective: To reduce the risk of invasive breast cancer and achieve local

control of carcinoma and decrease risk of death

Surveillance  Physical examination

(LCIS, DCIS)  Mammogram; MRI in some cases

Surgery  Lumpectomy

(DCIS)  If DCIS in 1 area

 Mastectomy

 If DCIS in 2 areas

 If multifocal or “large”

Radiotherapy  Usually (not always) accompanies

(DCIS) lumpectomy

Hormonal therapy  In selected ER-positive cases; for 5 years

(DCIS) to lower cancer risk

LCIS = lobular carcinoma in situ; DCIS = ductal carcinoma in situ; MRI = magnetic

resonance imaging; ER = estrogen receptor.

ACS. Available at:

www.cancer.org/docroot/CRI/content/CRI_2_4_4X_Breast_Cancer_Treatment_by_ stage_5.asp. 2003.

Breast Cancer Treatment:

TNM Stages I and II

Objective: To eradicate local disease by direct localized action on the breast

and axillary lymph nodes (when appropriate)

Breast conservation surgery  Lumpectomy or quadrantectomy

Radiotherapy  Axillary dissection

 Affected breast, chest wall

Adjuvant chemotherapy  Combination chemotherapy

 3-6 months

Adjuvant hormonal therapy  Premenopausal

 Tamoxifen if ER-positive

 Postmenopausal

 Tamoxifen and/or aromatase inhibitor



ACS. Available at:

www.cancer.org/docroot/CRI/content/CRI_2_4_4X_Breast_Cancer_Treatment_by_Stage_5.asp. 2003.

.

Breast Cancer Treatment:

TNM Stage III

Objective: To achieve local control, prevent metastases, and extend overall

survival through aggressive treatment

Surgery  Mastectomy or lumpectomy

Radiotherapy  Chest wall, regional nodes

Adjuvant/neoadjuvant  Combination chemotherapy

chemotherapy  4-6 months

Hormonal therapy  Benefit if tumor ER-positive and/or

PR-positive









ER = estrogen receptor; PR = progesterone receptor.

ACS. Available at:

www.cancer.org/docroot/CRI/content/CRI_2_4_4X_Breast_Cancer_Treatment_by_Stage_5.asp. 2003.

Breast Cancer Treatment:

TNM Stage IV

Objective: To improve symptoms, prolong survival, and enhance quality of life



Surgery  Used in selected cases to relieve

symptoms

Radiotherapy  Used in selected cases to relieve

symptoms and control local

disease

Chemotherapy  Primary therapy; single-agent or

combination chemotherapy

Monoclonal antibody  HER2-positive

Hormonal therapy  ER-positive and/or

PR-positive





ACS. Available at:

www.cancer.org/docroot/CRI/content/CRI_2_4_4X_Breast_Cancer_Treatment_by_Stage_5.asp. 2003.

Local Therapy: Major Surgical

Treatment Options for Breast Cancer

 Local therapy provides adequate control of locoregional disease

 Includes surgery and radiation therapy

 Surgery

 Mastectomy

 Modified radical with sentinel lymph node evaluation

 Radical or total mastectomy with sentinel lymph node

evaluation

 May include breast reconstruction

 Breast-conserving surgery

 Wide local excision

 Quadrantectomy

 Lumpectomy

 Includes axillary dissection if disease is invasive



ACS. Available at: www.cancer.org/docroot/CRI/content/CRI_2_4_4X_Surgery_5.asp. 2003.

Complications Following Breast

Cancer Surgery

 Lymphedema

 May occur in 10% to 30% of women undergoing

axillary dissection

 Reduced to 3% in patients undergoing sentinel

node biopsy alone

 Numbness

 Reduced shoulder mobility

 Psychosocial impact of mastectomy

 Phantom breast sensations

ACS. Available at: www.cancer.org/docroot/NWS/content/NWS_3_1x_New_Procedure_Reduces_

Risk_of_ Lymphedema_After_Breast_Cancer_Surgery.asp, 2001; Rowland JH et al. J Natl Cancer Inst.

2000;92:1422-1429; Staps T et al. Cancer. 1985;56:2898-2901.

Local Therapy: Radiotherapy

in Breast Cancer

 Adjuvant radiotherapy in ESBC

 Reduces risk of recurrence

 May improve survival

 Radiotherapy in MBC

 Relieves symptoms such as pain, for example

in patients with bone and brain metastases,

while not effecting a cure





ESBC = early-stage breast cancer; MBC = metastatic breast cancer.

Cairncross JG et al. Ann Neurol. 1980;7:529-541; Coia LR. Int J Radiat Oncol Biol Phys. 1992;23:

229-238; Early Breast Cancer Trialists’ Collaborative Group. N Engl J Med. 1995;333:1444-1455;

Harris S. Int J Clin Pract. 2001;55:609-612.

Radiotherapy for Breast Cancer:

Methods of Delivery

 External beam radiation

 Most common method

 Typically, radiation is delivered to entire breast

 Partial-breast irradiation, including brachytherapy

 Radioactive seeds or pellets placed internally

near the site of the tumor for local effect

 Can deliver high dose-rate radiation, allowing

for a shorter treatment regimen compared to

traditional radiotherapy



Gordils-Perez J et al. Clin J Oncol Nurs. 2003;7:629-636.

Partial-Breast Irradiation

for Early-Stage Breast Cancer

 Recent trial compared partial-breast to whole-

breast irradiation

 199 patients with ESBC

 Breast-conserving surgery

 Median follow-up of 65 months

 Compared to matched controls, recurrence rate

was similar (1% vs 1%; P = .65)

 Partial-breast irradiation has 5-year local control

rates comparable to those for whole-breast

radiation therapy while sparing normal tissues

Vicini FA et al. J Natl Cancer Inst. 2003;95:1205-1210.

Currently Available Systemic

Therapies for Breast Cancer

 Hormonal

 Chemotherapy

 Targeted

 Clinical trials provide support for optimal

implementation of the above therapies in

patients with breast cancer

Hormone Therapy Options

for Breast Cancer

Mechanism Options

Estrogen receptor blockade  Antiestrogens

 Tamoxifen

 Toremifene

Hormonal ablation  Surgery

 Radiation (infrequently used)

 LHRH analogs

 Goserelin

Estrogen synthesis suppression  Aromatase inhibitors

 Anastrozole

 Exemestane

 Letrozole

Estrogen receptor downregulation  Estrogen receptor antagonist

 Fulvestrant

LHRH = luteinizing hormone-releasing hormone.

Hayes DR, Robertson JFR. In: Robertson JFR et al, eds. Endocrine Therapy of Breast Cancer. 2002.

Leake R. Endocrine-Related Cancer. 1997;4:289-296; NCI. Available at:

www.cancer.gov/clinicaltrials/results/fulvestrant0802.

Hormonal Environment

of the Breast

Gonadotropins Ovarian ablation

(FSH+LH)

Anti-

estrogens

Premenopausal

Ovary

LHRH

analogs Prolactin

Growth hormone



Pituitary gland Corticosteroids

LHRH Aromatase

(hypothalamus) Pre-/post- Adrenal inhibitors

menopausal glands Androgens





ACTH Progesterone

Peripheral conversion

FSH = follicle-stimulating hormone; LHRH = luteinizing hormone-releasing hormone;

ACTH = adrenocorticotropic hormone.

Osborne CK. N Engl J Med. 1998;339:1609-1618; Masamura S et al. Breast Cancer Res Treat.

1995;33:19-26.

Evolution of Systemic Adjuvant

Chemotherapy for Early-Stage

Breast Cancer

Mastectomy alone



Adjuvant CMF

Progressive

Addition of Adjuvant CAF, CEF improvement

tamoxifen, in disease-free

aromatase Adjuvant AC, EC, FEC and overall

inhibitors survival

Adjuvant AC +T





Dose-dense AC + T TAC

Bonadonna G et al. N Engl J Med. 1995;332:901-906; Citron ML et al. J Clin Oncol. 2003;21:

1431-1439; Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998;351:1451-1467;

Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998;352:930-942; Henderson IC et al.

J Clin Oncol. 2003;6:976-983; Nabholtz JM et al. ASCO 2002; Orlando, Fla. Presentation.

Preferred Chemotherapy Regimens for

Management of Metastatic Breast Cancer

 Single-agent options for women with recurrent

or metastatic breast cancer

 Anthracyclines (doxorubicin or epirubicin)

 Taxanes (paclitaxel or docetaxel)

 Capecitabine

 Others not approved by regulatory agencies

 Vinorelbine  Irinotecan

 Combination options for women with recurrent

or metastatic breast cancer

 CAF/FAC  AT  Docetaxel/capecitabine

 FEC  CMF  Paclitaxel/gemcitabine

 AC, EC  Paclitaxel (or docetaxel)/

carboplatin with trastuzumab

NCCN. Breast Cancer: Clinical Practice Guidelines in Oncology. V.1.2004. Available at: www.nccn.org.

Single-Agent vs Combination

Chemotherapy in Metastatic

Breast Cancer

 Optimal treatment for metastatic breast cancer

remains controversial

 Combination therapy is a good option for patients

with symptomatic, metastatic breast cancer

 Recent trials show that newer drug combinations

improve outcomes with manageable safety profiles

 Sequential therapy may be appropriate for patients

with indolent disease or nonvisceral metastatic

breast cancer



Biganzoli L et al. Curr Opin Obstet Gynecol. 2004;16:37-41;

Miles D et al. Oncologist. 2002;7(suppl 6):13-19.

Adjuvant Chemotherapy for Early-Stage

Breast Cancer Improves Outcomes

The Milan Study: Relapse-Free and Overall Survival With CMF

20-year follow-up (N = 386) Optimal Dose (%)

85 (n = 42)

65-84 (n = 94)

100 100 65 (n = 71)

Relapse-Free Survival (%)









Control (n = 179)









Overall Survival (%)

80 80









Probability of

Probability of









60 60



40 40



20 20



0 0

0 5 10 15 20 0 5 10 15 20

Years After Mastectomy

Adapted from: Bonadonna G et al. N Engl J Med. 1995;332:901-906.

Reduced Dose Intensity* in Early-

Stage Breast Cancer Chemotherapy

120 Delay  7 days Reduction  15% RDI 85% in 1 retrospective analysis with CMF

 Regimens containing an anthracycline and/or

a taxane show improved outcomes

 Strong data in node-positive breast cancer

 A study of a dose-dense approach (chemotherapy

Q2W with prophylactic G-CSF support) has

also demonstrated benefit in disease-free and

overall survival

RDI = relative dose intensity; ESBC = early-stage breast cancer; CMF =

cyclophosphamide/methotrexate/fluorouracil; G-CSF = granulocyte colony-stimulating factor.

Targeted Therapy Options

for Breast Cancer

Mechanism Examples

HER2 inhibitor family  Antibodies

 Trastuzumab

 Small molecules

 Gefitinib

 Erlotinib*

 Lapafarnib*

Angiogenesis inhibitor  Antibodies

 Bevacizumab*

*Investigational agents. HER2 = human epidermal growth factor receptor 2.

Goldman B. J Natl Cancer Inst. 2003;95:1744-1746; Gefitinib [package insert]. 2003; NCCN. Breast

Cancer. Clinical Practice Guidelines in Oncology. V.1.2004. Available at: www.nccn.org; Normanno N

et al. Endocrine-Related Cancer. 2003;10:1-21; US FDA. Available at:

www.fda.gov/bbs/topics/NEWS/2004/NEW01027.html; Perez E. ASCO 2004; New Orleans, La.

Presentation.

Conclusions

 Although the incidence of breast cancer is increasing,

mortality has decreased over the past 2 decades

 Advances in conventional therapies include less radical

surgical techniques and reduced radiation fields

 Cytotoxic chemotherapy advances include improved types,

dosing, and scheduling

 Improvements have also been made in hormonal therapy

 Newer targeted therapies are further advancing

the care of patients with breast cancer

 Treatment regimens are becoming more individualized


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