cco breast cancer dec 2011 ebc cme slides

7/31/2019 CCO Breast Cancer Dec 2011 EBC CME Slides

1/46

December 6-10, 2011

San Antonio, Texas

An Update on Early Breast

CancerCCO Independent Conference Coverageof the 2011 Annual Meeting of the AACR-CTRC San Antonio

Breast Cancer Symposium*

This program is supported by educational grants from

*CCO is an independent medical education company that

provides state-of-the-art medical information to healthcare

professionals through conference coverage and other

educational programs.

Jointly sponsored/Co-provided by the Annenberg Center for Health

Sciences at Eisenhower and Clinical Care Options, LLC


2/46

clinicaloptions.com/oncology

An Update on Early Breast Cancer

About These Slides

In the following slides, you will find highlights of the keystudies from this meeting. Be sure to review the slidenotes field for each slide for insightful commentaryfrom our expert faculty

Users are encouraged to use these slides in their own noncommercialpresentations, but we ask that content and attribution not be changed. Users areasked to honor this intent

These slides may not be published or posted online without permission fromClinical Care Options (email [email protected])

Disclaimer

The materials published on the Clinical Care Options Web site reflect the views of the authors of the

CCO material, not those of Clinical Care Options, LLC, the CME providers, or the companies providing

educational grants. The materials may discuss uses and dosages for therapeutic products that have not

been approved by the United States Food and Drug Administration. A qualified healthcare professional

should be consulted before using any therapeutic product discussed. Readers should verify all information

and data before treating patients or using any therapies described in these materials.


3/46



Faculty

Joyce OShaughnessy, MDCo-Director, Breast Cancer ResearchBaylor Charles A. Sammons Cancer CenterTexas Oncology

US OncologyDallas, Texas

Peter Ravdin, MD, PhDDirector of the Breast Cancer Program

The University of Texas Health Science Center at San AntonioSan Antonio, Texas


4/46



Disclosures

Joyce OShaughnessy, MD, has disclosed that she hasreceived consulting fees from Biogen Idec, BoehringerIngelheim, Bristol-Myers Squibb, Caris Diagnostics, Eisai,Genentech, GlaxoSmithKline, GTx, Johnson & Johnson,Roche, and sanofi-aventis and fees for non-CME servicesfrom Bristol-Myers Squibb, Celgene, and sanofi-aventis.

Peter Ravdin, MD, PhD, has disclosed that he has anownership interest in Adjuvant, Inc.


5/46



Overview of Early Breast Cancer

Adjuvant Therapy

TEACH: lapatinib vs placebo

Bisphosphonate trials

7-yr update of ABCSG-12

5-yr update of ZO-FAST

NSABP B-34: clodronate vs placebo

GAIN: ibandronate vs placebo

Neoadjuvant Therapy

GeparTrio Trial : response-guided vs conventional chemotherapy

Prognosis and Prediction

DCIS score and risk of recurrence


6/46

Adjuvant Therapy


7/46



Women with resected

HER2-positive

stage I-IIIc primarybreast cancer and no

previous trastuzumab

therapy

(N = 3147)

Lapatinib 1500 mg once daily

(n = 1571)

Placebo

(n = 1576)

Yr 1

Stratified by time from diagnosis,

lymph node involvement,hormone receptor status

Goss P, et al. SABCS 2011. Abstract S4-7.

TEACH: Study Design

Primary endpoint: DFS

Secondary endpoints: OS, recurrence-free survival, distant recurrence-freesurvival


8/46



TEACH: Risk of Recurrence in Patients

Without Anti-HER2 Therapy


Yr(s) Disease-FreePatients, %

1 99.9

2 96.7

3 93.14 91.0

5 87.8

6 84.4

7 81.1

8 79.2

9 77.2

10 74.9

0

1.0

0.9

0.8

0.7

0.60.5

0.4

0.3

0.2

0.1ProportionofPatients

WithDF

S

Yrs

0 1 2 3 4 5 6 7 8 9 10

Placebo

Patients at Risk, n

1576 1569 1504 1430 1323 1043 781 539 310 181 96


9/46



TEACH: DFS and OS

No improvement in OS demonstrated with use of lapatinib:HR: 0.99 (95% CI: 0.74-1.31; P= .966)

DFS With Lapatinib vs Placebo Patients, n HR (95% CI) PValue

Overall population 3147 0.83 (0.70-1.00) .053

Time since diagnosis

< 1 yr 647 0.70 (0.50-0.99)

4 yrs 2248 0.84 (0.69-1.03)

> 4 yrs 899 0.81 (0.52-1.26)

Hormone receptor status, %

ER and/or PgR positive 1859 0.98 (0.77-1.25) .886

ER and PgR negative 1288 0.68 (0.52-0.89) .006

Lymph node involvement Positive 1753 0.86 (0.69-1.07)

Negative 1394 0.78 (0.57-1.07)



10/46



TEACH: DFS in Patients With Centrally

Confirmed HER2+ Disease


Outcome Lapatinib,%

(n = 1230)

Placebo,%

(n = 1260)

DFS HR(95% CI)

PValue

All DFS events 13 17 0.82(0.67-1.00)

.04

Local 2 3

Regional 2 2

Distant 8 11

CNS recurrence < 1 2 0.66(0.33-1.34)

.286

Contralateral breast < 1 1

Second primarymalignancy

2 2


11/46



TEACH: Safety

Lapatinib associated with more treatment discontinuation (20%vs 6%), adjustment/interruption (29% vs 9%) vs placebo

No difference in incidence of cardiac events between lapatinib

and placebo arms (3% vs 3%)


Adverse Events, % Lapatinib

(n = 1573)

Placebo

(n = 1574)

Grade 1/2 Grade 3/4 Grade 1/2 Grade 3/4

Diarrhea 55 6 16 1Rash 54 6 15 1

Nausea 17 1 11 1

Fatigue 15 1 13 1


12/46



TEACH: Conclusions

Adjuvant lapatinib after resection of early HER2+ breast cancer failedto show significant statistical improvement in DFS, OS vs placebo

Patients with no previous treatment with trastuzumab

DFS benefit with lapatinib observed in 2 patient subgroups

Patients with hormone receptornegative disease

Patients receiving lapatinib within 1 yr of primary diagnosis

HER2 status reassessed by central review

HER2-positive confirmed by FISH: 79%

Significant improvement in DFS with lapatinib in this subset of patients

Most common AEs associated with lapatinib: diarrhea and rash



13/46



ABCSG-12: Study Design

Key endpoints

Primary: DFS at 5 yrs

Secondary: relapse-free survival, OS, bone mineral density, safety

TAM 20 mg/day

ANA 1 mg/day

1803 premenopausal patientswith breast cancer, stage I/II(goserelin 3.6 mg/ 28 days)

Stratified by: ER+ and/or PgR+ Age Stage Grade Lymph nodes Treatment 3 yrs

(median follow-up: 48 mos)

TAM + ZOL 4 mg q6m

ANA + ZOL 4 mg q6m

R

Long-term

monitoring

for 5 yrs for

recurrence

and survival(DFS, OS)

3-yr

BMD

5-yr

BMDGnant M, et al. N Engl J Med. 2009;360:679-691.


14/46



DFS

ABCSG-12 (84 Mos): Efficacy

100

80

60

40

20

0

DFS(%)

0 12 24 36 48 60 72 84 96 108

Mos Since Randomization

Pts at Risk, n

No ZOL

ZOL

903

900

858

862

833

841

807

822

758

788

653

674

521

544

405

419

191

208

Events,

n

Univariate Multiple CoxRegression

HR

(95% CI)

P

Value

HR

(95% CI)

P

Value

vs no

ZOL

vs no

ZOL

(Log-

rank)No

ZOL

132/903

0.72

(0.56-0.94)

.014 0.71

(0.55-0.92)

.01198/900ZOL

OS

100

80

60

40

20

0

OS(%)

0 12 24 36 48 60 72 84 96 108


Pts at Risk, n

No ZOL

ZOL

903

900

864

868

856

858

839

849

811

818

706

708

576

587

456

454

215

232

Events,

n

Univariate Multiple CoxRegression

HR

(95% CI)

P

Value

HR

(95% CI)

P

Value

vs no

ZOL

vs no

ZOL

(Mantel

-Cox)No

ZOL

49/903

0.63

(0.40-0.99)

.049 0.61

(0.39-0.96)

.03333/900ZOL

Gnant M, et al. SABCS 2011. Abstract S1-2


15/46



Gnant M, et al. SABCS 2011. Abstract S1-2

ABCSG-12 (84 Mos): First DFS Events

140

120

100

80

60

40

20

0

F

irstEvent/Patient

(n)

No ZOL

(n = 903)

ZOL

(n = 900)

Death without

previous recurrence

Secondary

malignancy

Contralateralbreast cancer

Distant

recurrence

Locoregional

recurrence

19

56

11

14

36

65

13

18

3


16/46



Gnant M, et al. SABCS 2011. Abstract S1-2.

ABCSG-12 (84 Mos): Age Effect on DFS

40 Yrs of Age or Younger Older Than 40 Yrs of Age

100

80

60

40

20

0

DFS(%)

0 12 24 36 48 60 72 84 96 108


Pts at Risk, n

No ZOL

ZOL

213

200

202

192

194

185

189

180

177

169

157

148

127

125

102

94

52

48

Events, n

Univariate

HR (95% CI) PValue

vs no ZOL (Log-rank)No ZOL 42/213

0.87 (0.55-1.36) .52535/200ZOL

100

80

60

40

20

00 12 24 36 48 60 72 84 96 108


Pts at Risk, n

No ZOL

ZOL

690

700

656

670

639

656

616

642

581

619

496

526

394

419

303

325

139

160

Events, n

Univariate

HR (95% CI) PValue

vs no ZOL (Log-rank)No ZOL 90/690

0.66 (0.48-0.92) .01363/700ZOL


17/46



ABCSG-12: Conclusions

Survival benefits with addition of ZOL to endocrine therapyfirst reported at median follow-up of 48 mos are still presentat 84 months

Significant improvement in DFS

Relative risk reduction: 28%

Significant improvement in OS

Relative risk reduction: 37% Subanalysis suggests that survival benefits of ZOL may be

restricted to patients older than 40 yrs of age



18/46



Letrozole +

Zoledronic Acid 4 mg

q6m

Letrozole + Delayed*

Zoledronic Acid 4 mg

q6m

*If 1 of the following occurs:BMD T score < -2 SDClinical fractureAsymptomatic fracture at 36 mos

Stage I-IIIa breast cancer

Postmenopausal oramenorrheic due to

cancer treatment ER+ and/or PgR+ T-score -2 SD N = 1065

Treatment duration 5 yrs

De Boer R, et al. SABCS 2011. Abstract S1-3.

ZO-FAST: 5-Yr Final Analysis


19/46




ZO-FAST (Primary Endpoint): Median

Change in Lumbar Spine BMDImmediate ZOL

Delayed ZOLP< .0001 for each

Change

inLS(LS-L4)BMD(%)

12 mos 24 mos 36 mos 48 mos 60 mos-6

-4

-2

0

2

4

6

360

369

339 313290

264

343 311 294 264

5.9% 8.2% 8.8% 9.2% 10.0%


20/46



*Censored patients at initiation of delayed ZOL (n = 144).

Time on Study (Mos)

532

533

518

511

500

491

488

475

475

463

376

368IM-ZOL

D-ZOL

Pts at Risk, n Time on Study (Mos)

532

533

518

459

500

402

488

376

475

350

376

267

IM-ZOL

D-ZOL

Pts at Risk, n

ITT Population

100

90

80

70

6050

40

30

20

10

0

DFS(%

)

0 6 12 18 24 30 36 42 48 54 60 66

HR: 0.66; log-rank P= .0375

IM-ZOL 4 mg (42 events)D-ZOL 4 mg (62 events)

Censored Analysis*

100

90

80

70

6050

40

30

20

10

0

DFS(%

)

0 6 12 18 24 30 36 42 48 54 60 66

HR: 0.62; log-rank P= .024



ZO-FAST: Final 5-Yr DFS


21/46



ZO-FAST: Disease Recurrence


DistantContralateral

Key Sites of DistantRecurrence*

Patients(n)

D-ZOL(n = 533)

0

10

40

50

70

12

Local

LiverLung

Lymph nodeBone

Disease Recurrence

IM-ZOL(n = 532)

53

29

6

41

20

30

60

Patients(n)

D-ZOL(n = 533)

0

10

40

50

70

24

IM-ZOL(n = 532)

145

9

11

9

20

30

60

119

*Multiple sites may be recorded within the same patient.


22/46



OS(%)

100

90

80

70

60

50

40

30

20

10

00 6 12 18 24 30 36 42 48 54 60 66

HR: 0.69; log-rank P= .196

Time on Study (Mos)

532

533

522

519

511

505

502

491

485

480

406

407

IM-ZOL

D-ZOL

Pts at Risk, n



ZO-FAST: Overall Survival (ITT

Population)

A U d E l B C


23/46



ZO-FAST: Conclusions

Immediate initiation of ZOL at start of letrozole significantlyprolonged DFS vs delayed initiation of ZOL inpostmenopausal women with endocrine-responsive EBC[1]

Continued to improve BMD after 5 yrs of follow-up

34% improvement in DFS

Findings consistent with those observed in ABCSG-12 andsubset of patients > 5 yrs postmenopause in AZURE[2,3]

1. De Boer R, et al. SABCS 2011. Abstract S1-3. 2. Coleman RE, et al. N Engl J Med. 2011;365:1396-1405. 3.


A U d t E l B t C


24/46



HR

ZO-FAST[1]

104 events

ABCSG-12[3]

230 events

0.2 0.4 0.6 0.8 1.0 1.2 1.4

N = 1803

N = 1065

n = 1041AZURE: > 5 yrs postmenopausal[2]

263 events

PValue

.02

.0375

.011

0.75

0.66

0.71

Zoledronic Acid Studies: DFS Comparison

1. De Boer R, et al. SABCS 2011. Abstract S1-3. 2. Coleman RE, et al. N Engl J Med. 2011;365:1396-1405. 3.


A U d t E l B t C


25/46



Women with stage I-III

breast cancer

(N = 3323)

Clodronate 1600 mg/day*

(n = 1662)

Placebo*

(n = 1661)

3 YrsStratified by age, number of positive

nodes, and ER/PgR status

*All patients could receive adjuvant systemic chemotherapy with or without tamoxifen or no adjuvant

therapy at investigator discretion.

Paterson A, et al. SABCS 2011. Abstract S2-3.

NSABP B-34: Phase III Study of Adjuvant

Clodronate in Breast Cancer Primary endpoint: DFS (mean follow-up: 8.4 yrs)

Two thirds aged 50 yrs or older; 25% node positive

A U d t E l B t C


26/46



NSABP B-34: Analysis of Specified

EndpointsEndpoint Events, n HR (95% CI) PValue

Clodronate(n = 1655)

Placebo(n = 1656)

DFS 286 312 0.913 (0.778-1.072) .266

OS 140 167 0.842 (0.672-1.054) .131

RFI 148 177 0.834 (0.671-1.038) .101

BMFI 61 80 0.765 (0.548-1.068) .114

NBMFI 78 105 0.743 (0.554-0.996) .046


An Update on Earl Breast Cancer


27/46



NSABP B-34 Subset Analysis: DMFI, RFI,

BMFI, NBMFI in Pts Aged > 50 YrsEndpoint for Patients Aged50 Yrs or Older

HR PValue

DMFI 0.62 .003

RFI 0.76 .05

BMFI 0.61 .024

NBMFI 0.63 .015




28/46



NSABP B-34: Conclusions

No significant benefit in DFS (primary endpoint) with oralclodronate in women with early breast cancer[1]

Clodronate significantly reduced NBMFI vs placebo[1]

HR: 0.743; 95% CI: 0.554-0.996; P= .046

In patients aged 50 yrs or older, clodronate associated withsignificant improvements in RFI, BMFI, NBMFI vs placebo[1]

Findings consistent with those observed in older, postmenopausal

women in other adjuvant bisphosphonate studies[2-4]

Adverse events similar in clodronate and placebo arms[1]

1. Paterson A, et al. SABCS 2011. Abstract S2-3. 2. De Boer R, et al. SABCS 2011. Abstract S1-3.

3. Coleman RE, et al. N Engl J Med. 2011;365:1396-1405. 4. Gnant M, et al. SABCS 2011. Abstract S1-2.



29/46



Patients aged 65 yrs or

younger with previouslyuntreated node-positive

primary breast cancer

(N = 3023)

Ibandronate 50 mg/day PO

(n = 2015)

Observation

(n = 1008)

Yr 2Randomized 2:1*

*Patients in trial also randomized 1:1 to receive ETC vs epirubicin/cyclophosphamide followed by paclitaxel/capecitabine

(EC-TX).

ECT regimen: epirubicin 150 mg/m2 every 2 wks for 3 cycles, followed by paclitaxel 225 mg/m2 every 2 wks for 3 cycles,

followed by cyclophosphamide 2000 mg/m2 every 2 wks for 3 cycles.

EC-TX regimen: concurrent epirubicin 112.5 mg/m2 and cyclophosphamide 600 mg/m2 every 2 wks for 4 cycles, followed by

concurrent paclitaxel 67.5 mg/m2 wkly for 10 wks and capecitabine 2000 mg/m2 on Days 1-14 every 3 wks for 4 cycles.

During chemotherapy, all patients received primary prophylaxis with pegfilgrastim and either epoetin or darbepoetin.

Mobus V, et al. SABCS 2011. Abstract S2-4.

German GAIN Trial: Study Design



30/46



GAIN: Patient Characteristics


Characteristic Ibandronate(n = 1996)

Observation(n = 998)

Age, median yrs 49 50

Premenopausal, % 48.4 47.2

pT4, % 2.1 1.4

pN1, % 38.1 37.1

pN2, % 34.9 36.3

pN3, % 27.0 26.7

Mastectomy, % 44.5 43.3

Ductal invasive, % 77.4 77.1

Grade 3, % 47.3 44.3

Hormone receptor positive, % 76.5 77.7

HER2 positive, % 22.1 21.8



31/46



GAIN: DFS and OS (ITT)


1.0

0.8

0.6

0.4

0.2

0

SurvivalProbability

DFS (Mos)

0 12 24 36 48 60

1996

998

1814

871

1590

727

1057

483

555

264

210

105

3-yrDFS:

Ibandronate 87.6%

Observation: 87.2%

Cox regression:

HR: 0.945 (95% CI: 0.768-1.16; P= .59)

Ibandronate Observation

Product-Limit Survival Estimates

With Number of Subjects at Risk

+ Censored1.0

0.8

0.6

0.4

0.2

0

OS (Mos)

0 12 24 36 48 60

1996

998

1836

886

1653

756

1121

506

586

277

219

112

3-yrOS:

Ibandronate 94.7%

Observation: 94.1%

Cox regression:

HR: 1.04 (95% CI: 0.763-1.42; P= .80)

Product-Limit Survival Estimates

With Number of Subjects at Risk

+ Censored

Pts at risk, n Pts at risk, n



32/46



GAIN: Subgroup Analyses


DFS for Ibandronate in Subgroups

HR

0.5 1.0 1.5

Better with ibandronate Worse with ibandronate

pN1

pN2

pN3ER and/or PgR positive

ER and PgR negative

Pre- and perimenopausal

Postmenopausal

< 60 yrs

60 yrs

HR: 1.04 (95% CI: 0.652-1.65; P= .877)

HR: 0.875 (95% CI: 0.599-1.28; P= .490)

HR: 0.951 (95% CI: 0.710-1.27; P= .734)HR: 0.952 (95% CI: 0.736-1.23; P= .706)

HR: 0.856 (95% CI: 0.604-1.21; P= .383)

HR: 1.02 (95% CI: 0.756-1.37; P= .912)

HR: 0.897 (95% CI: 0.671-1.20; P= .462)

HR: 1.02 (95% CI: 0.807-1.30; P= .842)

HR: 0.746 (95% CI: 0.490-1.14; P= .172)



33/46



GAIN: Conclusions

Adjuvant ibandronate did not improve DFS nor OS followingdose-dense chemotherapy in patients with node-positiveprimary breast cancer

GAIN trial still ongoing to compare the 2 different dose-dense chemotherapy regimens




34/46



Trial Regimen Primary Outcomes

SWOG 0307 ZOL vs clodronate vs ibandronate DFS, OS

NATAN ZOL after neoadjuvant chemo EFS

D-CARE Dmab 120 mg/mo for 6 mos, then 120mg q3m vs placebo

Bone metastasisfreesurvival

HOBOE Triptorelin + tamoxifen vstriptorelin + letrozole vs

triptorelin + letrozole + ZOL

DFS

SUCCESS FEC-D vs FEC-DG

2 yrs ZOL vs 5 yrs ZOL

DFS

ABCSG-18 Dmab 60 mg q6m vs placebo Time to first fracture

Ongoing Phase III Trials of Antitumor

Properties of Bone-Targeted Agents


35/46

Neoadjuvant Therapy



36/46



Women with

operable or locally

advanced

breast cancer

(N = 2072)

TAC-NX*

(4 cycles NX)

(n = 301)

TAC x 6

(4 additional cycles TAC)(n = 321)

TAC x 6

(4 additional cycles TAC)

(n = 704)

TAC x 8

(6 additional cycles TAC)

(n = 686)

TAC*

(2 cycles)

Assess

response

Minimal

response

(n = 622)

CR or PR

(n = 1390)

*TAC regimen: docetaxel 75 mg/m2, doxorubicin 50 mg/m2,

cyclophosphamide 500 mg/m2 all on Day 1 q21d.

NX regimen: vinorelbine 25 mg/m2 on Days 1 and 8,

capecitabine 1000 mg/m2 on Days 1-14 q21d.Response assessed by ultrasound/palpation.< 50% tumor reduction.

Von Minckwitz G, et al. SABCS 2011. Abstract S3-2.

GeparTrio Trial: Study Design

Not working?

Try another type

of chemotherapy

Working?

Give more of the same

chemotherapy



37/46



GeparTrio Trial: DFS and OS

Median follow-up: 62 mos

DFS benefit in early responding and nonresponding patients whoreceived response-guided vs conventional chemotherapy


Endpoint HR for Response-Guided vsConventional Chemotherapy (95% CI)

PValue

DFS 0.71 (0.60-0.85) < .001

OS 0.79 (0.63-0.99) .048

Patient Subgroup Treatment Comparison HR for DFS

(95% CI)

PValue

Responders TAC x 8 vs TAC x 6 0.78 (0.62-0.97) .026

Nonresponders TAC-NX vs TAC x 6 0.59 (0.49-0.82) .001



38/46



GeparTrio Trial: DFS by Patient Subgroup

Response-guided treatments better Conventional treatments better

0.2 0.4 0.6 0.8 1.0 1.2 1.4

Subgroup

OverallAge (yrs)


39/46


p y

GeparTrio Trial: pCR by Breast Cancer

Subtype


pCR(%)

40

35

30

25

20

15

10

5

0

Luminal A (n= 572)

Luminal B(HER2-)(n = 211)

Luminal B(HER2+)(n = 281)

HER2+(Nonluminal)

(n = 178)

Triple Negative(n = 362)



40/46


p y

GeparTrio Trial: Conclusions

Adapting neoadjuvant chemotherapy based on earlyresponse significantly improved DFS and OS vsconventional chemotherapy

Response-guided chemotherapy most effective in patientswith luminal A or luminal B tumors

Low pCR rates in these tumors

pCR not prognostic

No DFS benefit with response-guided chemotherapy inpatients with HER2-positive or triple-negative tumors



41/46

Prognosis and Prediction



42/46


p y

DCIS Score: Determining Risk of

Recurrence After DCIS Resection DCIS Score: gene-based score designed to predict for local

recurrence[1]

Developed using subset of genes prognostic in both tamoxifen-treated and tamoxifen-untreated patients

Proliferation group: Ki67, STK15, survivin, CCNB1 (cyclin B1), MYBL2

Hormone receptor group: PgR

GSTM1

Reference group:ACTB (-actin), GAPDH, RPLPO, GUS, TFRC

Evaluated using samples and data from ECOG E5194 trial[2]

1. Solin LJ, et al. SABCS 2011. Abstract S4-6. 2. Hughes LL, et al. J Clin Oncol. 2009;27:5319-5324.



43/46


y

DCIS Score: Patient Characteristics

(N = 327) Median age: 61 yrs

Postmenopausal: 76%

Median tumor size: 7 mm

Tumor size 10 mm: 80%

Negative margins 5 mm: 65%

ER positive: 97%

Treated with tamoxifen: 29% E5194 cohort 1 (low-/intermediate-grade DCIS, size

2.5 cm): 83%

E5194 cohort 2 (high-grade DCIS, size 1 cm): 17%

Solin LJ, et al. SABCS 2011. Abstract S4-6.



44/46


DCIS Score: Risk of Ipsilateral Breast

Events (IBE)


Factor HR (95% CI) PValue

DCIS Score 2.34 (1.15-4.59) .02

21-gene RS 0.70 (0.15-2.65) .62

Tamoxifen use 0.56 (0.24-1.15) .12

10-Yr IBE by Risk Group

Yrs

5045403530

2520151050

0 2 4 6 8 10

Log-rank P= .02

DCIS Score GroupHighIntermediateLow

n

3645246

10-Yr Risk, % (95% CI)

27.3 (15.2-45.9)24.5 (13.8-41.1)12.0 (8.1-17.6)

Yrs

5045403530

25201510

50

0 2 4 6 8 10

Log-rank P= .01

DCIS Score GroupHighIntermediateLow

n

3645

246

10-Yr Risk, % (95% CI)

19.1 (9.0-37.7)8.9 (2.9-25.8)5.1 (2.8-9.5)



45/46


DCIS Score: Conclusions

DCIS Score predicts 10-yr risk of IBE in patients with DCIStreated with surgery in the absence of radiation therapy

Not affected by adjuvant tamoxifen

Independent prognostic information on IBE risk providedabove that attained with clinical and pathologic variables



46/46

Go Online for More CCO

Coverage of Breast Cancer!Capsule Summaries of all the key data

Expert Analysis of the key early-stage and metastatic breast cancerpresentations as part of downloadable PowerPoint slides

http://www.clinicaloptions.com/oncologyhttp://www.clinicaloptions.com/oncology

cco breast cancer dec 2011 ebc cme slides

Documents