“Senonetwork: incontro centri di senologia 5.0”

9000 eBC

6000 HR+/HER2-

2200 Intermediate clinical-pathologic risk

BACKGROUNDAnnual incidence Lombardia

Systemic risk

<10% 10-25% >25%

9000 eBC

6000 HR+/HER2-

2200 Intermediate clinical-pathologic risk

HT only CT + HT

?

HT +/- CT G

T

Ki67

N

ER

PROSPECTIVE MULTICENTER STUDY ON THE IMPACT OF THE 21-GENE RECURRENCE SCORE IN ADJUVANT CLINICAL DECISIONS FOR PATIENTS WITH ER+/HER2-BREAST CANCER IN LOMBARDY (BONDX STUDY)

Piacentini G, Zambelli A, Sansi C, Gianatti A, Chirco A, Fotia V, Livraghi L, Poletti PL, Rota Caremoli E, Laverde N, Giordano M, Simoncini E, Torri V, Tondini CA

H Papa Giovanni XXIII Bergamo, H Spedali Civili Brescia, H St Anna Como , H Fatebenefratelli Milan, Mario Negri Institute Milan

Consort

1428 consecutive eBC

1082 HR+/HER2-

pT1-3, pN0-1 (max 3N+)

Intermediate/LowRisk

Intermediate Risk(IR)

n = 398

Enrolled

n = 394

No IC

n=1

pT(m)

n = 3

Intermediate/High Risk

Intermed/Low Risk (≥ 4)

G1

T1a-b

Ki67 < 15%

N0

ER > 80%

Intermed/High Risk (≥ 4)

G3

T > 2

Ki67 > 30%

N+

ER < 30%

From Jan 2017 to Jul 2018

237 (60%)134 (34%)

23 (6%)

RS low (< 18) RS medium (18 - 31) RS high (> 31)

RS distribution (n = 394)

RS distribution (I)

68,8%

39,2%

2,7%

30,5%

55,8%

54,1%

0,6% 5,0%

43,2%

RS <18 RS 18-30 RS >30

KI67 <= 15 KI67 16-34 Ki67 >=35

82,3%

17,7%

0,0%

66,8%

31,0%

2,2%

38,5%

45,2%

16,3%

RS <18 RS 18-30 RS >30

G1 G2 G3

62,2% 32,2%5,6%

67,4% 29,0%3,6%

RS <18 RS 18-30 RS >30

N0 N1

19,0%

63,8%17,2%

55,9%

37,8%6,3%

RS <18 RS 18-30 RS >30

PgR<10 PgR>10

Initial RecommendationPre-Test

CT: 25 %

HT: 75 %

97

297

n = 394

61

333

CT: 15 %

HT: 85 %

Final RecommendationPost-Test

12

285

Post-test RecommendationHT >CT

97

12

Post-test RecommendationHT >CT

48

49

Post-test RecommendationCT > HT

4912

Post-test RecommendationCT > HT

48

D: 15.2 %60 pts

D: 49.5%48 pts

D: 4.0%12 pts

ALL

HT

CT

CT

HT

CT/HT

Change of Recommendation

Number Needed to Test Pts recommended for HT

• eBC ER+

• ER+ IR

• ER+ IR HT

• ER+ IR HT-C

• NNT

Number Needed to Test Pts recommended for CT

• eBC ER+

• ER+ IR

• ER+ IR CT

• ER+ IR CT-C

• NNT

Subgroup N0 rec. for CT (49)

D : 51% (25 pts) NNT: 2

TAILORx RS=25

9000 eBC

6000 HR+/HER2-

2200 Intermediate clinical-pathologic risk

HT only HT+CT

N= 600N= 1600N=64 (4%) N=300 (49,5%)

HT only

HT+CT

NTT=1:25 NTT= 1:2

HT only

HT+CT

N= 2000N= 200N=8 (4%) N=1600 (80%)

HT onlyHT+CT

NTT=25:1 NTT= 5:4 D: -1600 CT

9000 eBC

6000 HR+/HER2-

2200 Intermediate clinical-pathologic risk

HT only

HT+CT

N= 2000N= 200N=8 (4%) N=1600 (80%)

HT onlyHT+CT

NTT=25:1 NTT= 5:4 D: -1600 CT

9000 eBC

6000 HR+/HER2-

2200 Intermediate clinical-pathologic risk

1600 x7000 €= 11.200.000 €2000 x 3000 €= 6.000.000 €

1000 x7000 €= 7.000.000 €

Thanks to

The Breast Unit Staff at:

- H Papa Giovanni XXIII Bergamo

- H Spedali Civili Brescia

- H St Anna Como

- H Fatebenefratelli Milan

- Mario Negri Institute Milan

The Genomic Health for supporting the tests

All women and families partecipatingto the study

“Senonetwork: incontro centri di senologia 5.0”