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2007 New Hampshire Chapter American College of Surgeons Breast Cancer Care: Where? By Whom? Monica Morrow, M.D., FACS Chair, Department of Surgical Oncology G. Willing Pepper Chair in Cancer Research Fox Chase Cancer Center Optimal Care State of the Art Practice Structure

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2007 new hampshire chapter american college of surgeons
2007 New Hampshire ChapterAmerican College of Surgeons

Breast Cancer Care: Where? By Whom?

Monica Morrow, M.D., FACS

Chair, Department of Surgical Oncology

G. Willing Pepper Chair in Cancer Research

Fox Chase Cancer Center

optimal care
Optimal Care

State of the Art Practice

Structure

Patient Preference

breast cancer mortality 1975 2000
Breast Cancer Mortality 1975-2000

Weir, HK JNCI 2003;95:1276

what s the issue in breast cancer
What’s the Issue In Breast Cancer?
  • Common disease
  • Standard part of general surgery training ( at least for PGY 1 & 2)
  • 30 day operative mortality well below 1%
  • Morbidity of therapy decreasing

ANYONE CAN DO IT!

evidence of a problem
Evidence of a Problem
  • Significant variation in treatment based on geography and volume
  • Use of non-standard care
  • Volume-outcome data
breast cancer surgery 1972 1981
Breast Cancer Surgery, 1972 - 1981

80

70

60

50

Modified Radical Mastectomy

Failure Rate

40

Radical (Halsted) Mastectomy

30

20

10

0

1972

1976

1977

1981

Year

randomized trials of mastectomy vs cs rt
Randomized Trials of Mastectomy vs. CS + RT

Overall Survival

Trial Follow-up (yrs.)CS+RTMastectomy

Gustave-Roussy 15 73 65

Milan 20 42 41

NSABP B06 20 46 47

NCI 18 59 58

EORTC 10 65 66

Danish 6 79 82

incidence of lr randomized trials
Incidence of LR: Randomized Trials

% LR

Trial Follow-up (yrs) BCT Mastectomy

Institut

Gustave-Roussy 15 9 14

Milan I 20 9 2

NSABP B06 20 14 10

NCI* 18 22 6

EORTC* 10 20 12

Danish 6 3 4

*Negative margin not required

local recurrence in patients receiving systemic therapy nsabp trials
Local Recurrence in Patients Receiving Systemic Therapy: NSABP Trials

StudyER Statusn% 10 yr IBTR

B 13 - 116 3.5

B 14 + 530 3.6

B 19 - 389 6.5

B 20 + 1027 4.7

B 23 - 1084 4.3

Wapnir, ASCO 2005

reasons for high mastectomy rates
Reasons for High Mastectomy Rates
  • Medical Contraindications
  • Lack of Access
  • Physician Bias
  • Patient Preference
slide12

How Common Are Contraindications to BCT?

N = 456

Stage % Eligible BCT

0 67

1 90

2 72

Morrow J Am Coll Surg, 1998

slide13

The ACoS - ACR Collaborative Study of Breast CancerFactors Predicting the Use of Breast Conserving Therapy in Stage I and II Breast Cancer

M Morrow, DP Winchester, JS Chimel, J Moughan, J Owens, T Pajak, J Sylvester, JF Wilson

JCO 2001;192254-61

multivariate analysis of mastectomy vs lumpectomy
Multivariate Analysis of MastectomyVs Lumpectomy

Variable OR 95% CI pvalue

Clinical T2 2.33 2.15, 2.54 .0001

Clinical N+ 1.50 1.29, 1.75 .0001

Grade 2 1.19 1.07, 1.31 .0008

Grade ¾ 1.30 1.17, 1.44 .0001

Favorable Histology 0.75 0.65, 0.88 .0002

Ext. DCIS 1.96 1.76, 2.17 .0001

results of the lynn sage second opinion program
Results of the Lynn Sage Second Opinion Program

n = 231

• DCIS, Stage I or II cancer

• Seen 01/96 - 03/99

• Mean age 51.4 years , 89% Caucasian

• 70% > HS education, 80% employed

• 71% private/PPO insurance

Clauson, Cancer 2002

characteristics of initial consultation
Characteristics of Initial Consultation

• 83 % reported surgical options discussed

46%: BCT, M, M+R

22%: BCT only

27%: M + R only

3%: Couldn’t remember

Clauson, Cancer 2002

slide17

Compliance with BCT Standards of ACoS, ACR, CAP, SSO

Disseminated 1992

Evaluated 1994

n = 7097

White, Cancer 2003

slide18

BCT Standards

Standard% Compliance

Pre biopsy mammogram 88

Size lesion in mammo report 47

Specimen oriented 67

Histologic grade 81

Margins assessed 90

ER done 92

Adjuvant Rx N+ 84

*

*

slide19

Factors Associated with Significant Compliance Variation

% Compliance

VariableDifference

Geographic Region 87

Hospital Type 80

Race 47

Age 33

Payer 20

geographic variation in the use of bct 1994
Geographic Variation in the Use of BCT1994

56%

48%

39%

41%

46%

33%

n = 16,643

Morrow, JCO; 2001.

geographic variation in the use of immediate breast reconstruction 1994 1995
Geographic Variation in the Use of Immediate Breast Reconstruction 1994-1995

7.8%

12.6%

6.6%

11.4%

7.5%

6.4%

n = 68,348

Morrow, J Am Coll Surg; 2001.

the role of patient preference in treatment choice
The Role of Patient Preference in Treatment Choice

Breast Implant Size by Region

New England 200-225cc

Midwest 275-300cc

Texas 400-450cc

Southern California 400-450cc

Data from Mentor Corp.

slide23

Trends in Local Therapy

Nattinger, Lancet 2000;356:1148-53

can anyone treat breast cancer
Can Anyone Treat Breast Cancer?

Effect of Volume on:

• Lumpectomy

• Sentinel Node Biopsy

• Survival

surgeon perspectives on the local therapy of breast cancer
Surgeon Perspectives on the Local Therapy of Breast Cancer
  • Population based sample
  • Treatment 2002
  • Pathology reports used to identify >1 surgeon for 98.5% of patient sample
  • Survey response rate 80.0%

Katz, Cancer 2005

surgeon characteristics
Surgeon Characteristics

n=365

Mean age: 49.4 yrs

Female: 14.4%

Yrs in Practice: 17.2 (1-49)

% Practice Breast: 31.3% (2-100)

Practice Setting

Community 48.2%

Teaching 33.0%

Cancer Center 18.8%

surgeon characteristics28
Surgeon Characteristics

n=365

# Breast Surgeries/yr %Respondents

<10 11.5

11-20 17.0

21-50 37.0

51-100 17.0

>100 14.0

*Definitive cancer surgeries

relationship of volume to practice setting
Relationship of Volume to Practice Setting

High Volume: >50% Breast Surgery

Practice Setting% High Volume

Cancer Center 59Teaching Hospital 30Community 18

Female Surgeons: 14% of sample, 35% of high volume surgeons

scenario 1 invasive carcinoma
Scenario 1: Invasive Carcinoma
  • 40/65 yr old
  • 2 cm palpable mass, clinical N0
  • Bx: Infiltrating Ductal CA

73% BCT 7% Mastectomy

20% No preference

Katz, Cancer 2005

slide31

Surgical Treatment Favored for InvasiveDisease Scenario, by Surgical Volume

100

p<.001

90

80

70

60

Neither

BCS

Mastectomy

%

50

40

30

20

10

0

Low

Moderate

Surgical Volume

High

what is the 5 yr risk of lr after lumpectomy to clear margins and rt
What is the 5 yr risk of LR after lumpectomy to clear margins and RT?

% Risk% Respondents

< 5 33

5-10 53

> 10 14

surgeon perspectives in invasive cancer
Surgeon Perspectives in Invasive Cancer
  • Choice of BCT did not correlate with estimate of risk of local recurrence

72% of surgeons estimating 5 yr LR

<5% chose BCT

72% of surgeons estimating 5 yr LR

11-20% chose BCT

  • Women were more likely to be neutral than men

OR 2.1; 95% CI 0.9, 4.9

surgeon perspectives in invasive cancer34
Surgeon Perspectives in Invasive Cancer
  • Surgeons favoring BCT were significantly more likely to believe QOL was better at 1 yr
  • High volume surgeons significantly more likely to believe QOL better
  • Female surgeons more likely to believe QOL at 1 yr the same (OR 2.0, 95% CI 1.0, 4.2)
scenario 2 dcis
Scenario 2: DCIS
  • 40/65 yr old
  • Mammogram with small area of calcifications
  • Bx: Unicentric, low grade DCIS

96% BCS: 61% with RT, 35% without

3% No Preference

0.9% Mastectomy

surgeon perspectives in invasive cancer36
Surgeon Perspectives in Invasive Cancer
  • Difference in preference for BCS in DCIS (96%) and invasive cancer (73%) significant (p<.001)
  • Preference for BCT in invasive cancer did not correlate with estimates of recurrence
  • Preference for RT in DCIS did not correlate with estimates of recurrence
correlates of between surgeon variation in treatment
Correlates of Between Surgeon Variation in Treatment

Method: 1477 patients matched to 311 surgeons by unique identifier

 65% of eligible patients

 70% of eligible surgeons

Mean # patients/surgeon 4.6 (1-41)

Hawley, Medical Care 2006; 44: 609-16

between surgeon variation in treatment
Between Surgeon Variation in Treatment

Mastectomy rate 15-63% cases

Variable% Variation Explained

Tumor characteristics 23

Patient demographics 1

Surgeon volume 12

Surgeon demographics 5

Surgeon recommendations 5

Hawley, Medical Care 2006; 44: 609-16

goals of lumpectomy
Goals of Lumpectomy

OutcomeSurgical Correlate

Low rate of local Negative margin

recurrence

Good cosmesis Limited excision

normal breast

patient population
Patient Population

• 217 consecutive cancers

163 invasive, 64 DCIS

• Nonpalpable

• Treated with BCT

All surgery at Lynn Sage

Staradub V., JACS 2003; 196: 518-24

surgeon volume
Surgeon Volume

Median % Neg

Case n STVR margin p-value

<10 37 80 78 0.004

10-40 85 104 81

>40 95 44 80

Staradub V., JACS 2003; 196: 518-24

learning curve for sn biopsy
Learning Curve for SN Biopsy

n=226

100

95

90

85

SLN identification rate (%)

SLN false negative rate (%)

80

75

ID rate

70

FN rate

65

1-5

6-10

11-15

16-20

21-25

26-30

>30

# cases performed

McMasters Ann Surg 2001

surgical cases month
Surgical Cases/Month

n=16 surgeons

13.77%  8.3%

11.27%  6.36%

2.19%  0.44%

1-3 Cases (1.72)

3-6 Cases (4.45)

>6 Cases (10.19)

Cox, Moffitt Cancer Ctr

slide44

Volume of Breast Cancer Surgery in the US

LA County SEER Registry

1990 - 1998 n=29,666

Breast Cancer Non-surgical Surgical

Case Volume Oncologist%Oncologist%

per year

1 61 17

< 5 85 39

6 -10 9 17

11-15 4 14

>15 2 31

Skinner, Ann Surg Oncol 2003

patient population45
Patient Population
  • 173,401 patients diagnosed 1985-1991
  • TNM stage available
  • Surgical therapy (r = 0.9 for hospital total breast cancer cases vs. surgical cases)
hospital volume
Hospital Volume

Calculated as mean of the two years between 1985 and 1991 with the greatest number of cases

Survival

Ratio of observed overall survival at each hospital to the survival of the aggregate, corrected for age and stage

patient characteristics and hospital volume
Patient Characteristics and Hospital Volume

Unrelated

SignificantlyDifferent

AGE p = 0.0001

Volume

Mean Age ( ± SEM)

Income (zipcode)

< 10

63.7(0.31)

Stage

Nodal positivity

11 – 25

63.3(0.14)

Histologic Grade

26 – 50

62.7 (7.9 )

Type of surgery

51 – 100

62.1 (5.6)

Systemic therapy

101 – 150

61.4 ( 7.1)

Radiation

> 151

60.4 ( 9.7)

five year overall survival all cases
Five-Year Overall Survival, All Cases

1.1

1.0

O/E Survival (Mean)

0.9

0.8

All Cases (p=0.0001)

DCIS Only (p = NS)

0.7

1 - 10

11 - 25

26 - 50

51 - 100

101 - 150

151+

Hospital Caseload

five year overall survival by treatment
Five-Year Overall Survival by Treatment

1.1

1.0

O/E Survival (Mean)

0.9

MRM + Systemic (p = 0.0001)

BCT+ Systemic (p=0.0001)

0.8

0.7

1 - 10

11 - 25

26 - 50

51 - 100

101 - 150

151+

Hospital Caseload

why does volume influence outcome in breast cancer
Why Does Volume Influence Outcome in Breast Cancer?

Annual # Surgical Cases

1-10 11-25 26-50 51-100 >100

Size T1 Tumors 11.1 11.6 11.8 11.8 11.6

(mm)

% Cases T1 N0 38 38 40 40 41

# Nodes removed 11 12 12 12 13

% Histologic 71 73 73 75 75

Grade

conclusions
Conclusions
  • Low hospital volume is associated with decreased survival for all treatment combinations. This is not explained by failure of referral for systemic therapy.
  • No relationship between volume and outcome is seen in DCIS, suggesting that these findings are not simply a reflection of differences in co-morbidity.
practical facts
Practical Facts
  • All breast surgery cannot be done by high volume, specialty trained surgeons
    • 39 grads SSO Breast Fellowships/yr
    • 46 grads SSO Surgical Oncology Fellowships/yr

180,000 new cases 2007

what can general surgeons do
What Can General Surgeons Do?
  • Follow national guidelines
  • Monitor performance
  • Develop a relationship with a high volume center
  • Avoid unproven therapies outside of a trial
  • Consider voluntary accreditation programs
guidelines surgeons can follow
Guidelines Surgeons Can Follow
  • Diagnosis by Needle Biopsy
  • Standards of BCT
  • Management of the Axilla
slide56
Diagnosis by Needle Biopsy

Guidelines ACOS, ACR, CAP Invasive & Intraductal Carcinoma

Morrow JACS 2007; 205: 145-61

362-76

slide57

Advantages of Core Needle Biopsy

• Quick

• Relatively painless

• Increased likelihood of single operation

• Avoids incision placement on the breast prior to selection of local therapy

• Markers (ER, PR, HER2) readily obtained

• Cost effective

slide59

Proportion of Mammographically Suspicious Lesions Having One Surgical Procedure by Lesion Type

Category 4 + 5

100

80

Core Biopsy

Surgical Biopsy

60

40

20

0

N: 43 26 106 51

Calcifications Masses

p <.001 p<.001

Morrow, Ann Surg 2001;233:537

slide61

Current Results of Stereotactic Biopsy

Technique: 11g vacuum assisted biopsy

7 attending radiologists, 1 trainee

Surgical excision in all cases

Patients: n=318, 9/97 – 12/01

False negatives: 3.3% (n=7)

>15 biopsies: 0.6%

< 15 biopies: 10%

All identified due to discordance or failure

to sample calcifications

Prarl, Ajr 2002

percutaneous vs open biopsy
Percutaneous vs Open Biopsy
  • 5.5 million mammograms, 2 US Government programs + UK National Health Service
  • Screening 1996-99, Age ≥ 50 yrs
  • 51% of US biopsies surgical vs 23% UK biopsies

Smith-Birdman R, JAMA 2003;290:2129

nccn guidelines 2007
NCCN Guidelines 2007

Pre op Evaluation: Stage I, II, T3NO

Indicated:

  • Hx & PE
  • CBC, LFTs, Platelets, Chest Imaging
  • Bilateral diagnostic mammogram + US

Optional:

  • Breast MRI
  • Bone Scan
  • Abd CT, US, MRI
slide64

How Good is Conventional Imaging in

Selecting Patients for BCT?

●263 Stage O, I, II patients seen 1989-93

●Evaluated with clinical exam,diagnostic

mammo

  • BCT candidate : 216 (88%)
  • BCT successful: 210 (97.3%)
  • Morrow et al, Surgery 1995
contraindications to bct
Contraindications to BCT
  • First and second trimester pregnancy
  • Prior therapeutic RT to breast region
  • Multicentricity
  • Persistent positive margins

Morrow et al, 2006, Joint Committee ACOS, ACR,CAP

relative contraindications to bct
Relative Contraindications to BCT
  • Scleroderma, SLE
  • Large tumor in small breast

Morrow et al, 2006

Joint Committee ACOS, ACR,CAP

nccn guidelines 200767
NCCN Guidelines 2007

Lumpectomy + Axillary Staging

Whole Breast RT + boost

* Partial breast irradiation should be performed only as part of a high quality prospective clinical trial

partial breast irradiation definition
Partial Breast Irradiation- Definition -

Delivery of larger doses/fraction of radiation therapy (RT) to the lumpectomy cavity (plus 1-2 cm margin) after breast conserving surgery

  • Patients: Early stage (0, I, II) breast cancer
  • Radiation Modalities: Brachytherapy or external beam irradiation techniques
  • Goal: Complete RT in < 4-5 days after lumpectomy versus conventional of 6-7 weeks
balloon catheter mammosite
Balloon Catheter‘MammoSite’
  • MammoSite device (Cytyc Surgical Products)
  • Inflatable Balloon Placed In Lumpectomy Cavity At Surgery
  • HDR brachytherapy
  • 34 Gy in 10 fractions
  • FDA clearance May 2002
  • Since 2002, > 25,000 cases treated
fda trial updated results benitez et al asbs april 2007
FDA Trial: Updated ResultsBenitez et al: ASBS April 2007
  • 36 (out of 43) evaluable patients/T1N0
  • Median follow-up: 66 months
  • 83% Excellent/Good Cosmesis
  • No local or regional recurrences
  • Fat Necrosis: 9.3% (all asymptomatic)
  • Infection rate: 9.3%
  • Seromas: 32.6% (12% symptomatic)

Am J Surg 194(4):456-62, 2007

asbs registry trial updated analysis
ASBS Registry Trial- Updated Analysis -
  • 3-year Update:
    • 1440 patients enrolled (closed 2004)
    • 87 Institutions/233 Investigators
    • 87% Invasive (median size : 10mm)
    • 13% DCIS (median size: 8 mm)
    • Median f/u: 38 months (first 400 enrolled)
    • 3-year IBTR rate: 1.8%
    • 10% symptomatic seromas/1.5% fat necrosis
    • Cosmesis: > 90% good/excellent
  • Presented at ASCO (September 2007)

In Press: Cancer

nccn guidelines 200773
NCCN Guidelines 2007

Axillary Staging

  • SN biopsy preferred staging for clinical NO patients
  • Axillary dissection is standard for SN positive pts
  • SN involvement defined by serial sectioning + H+E stains
  • The routine use of IHC is controversial
risk of additional metastases by size of metastatic deposit
Risk of Additional Metastases by Size of Metastatic Deposit

Author n Size% Cases

Viale 116 <0.2 mm 14.5

212 0.2 – 1 mm 16.9

Leidenius 39 <0.2 mm 20.5

35 0.2 – 1 mm 34.3

slide75

30

25

20

15

10

5

0

-5

-10

Does Axillary Dissection Influence Survival?

Overall : 5.4% Benefit

Survival Improvement%

COPE

SES

GUYS1

B04

GUYS2

CURIE

Orr, 1999

benefits of a relationship with a cancer center
Benefits of a Relationship with a Cancer Center
  • Videotumor boards for discussion of complex cases
  • Access to clinical trials/potential to participate directly
  • Relationships with providers for referral, consultation, return of appropriate care to the community
monitor performance
Monitor Performance
  • PEER pressure is a valuable tool
  • Leverage with administration for systems issues
  • Necessary for “Pay For Performance”