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Highlights in the Management of Breast Cancer Rome, May 25-26, 2007

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Highlights in the Management of Breast Cancer Rome, May 25-26, 2007. CLINICAL CASE. Dott.ssa Simona Gildetti Cattedra di Oncologia Medica Università “G. D’Annunzio” Chieti-Pescara Direttore: Prof. Stefano Iacobelli. 48 years old, female, pre-menopausal No comorbility .

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Highlights in the Management of Breast Cancer

Rome, May 25-26, 2007

CLINICALCASE

Dott.ssa Simona Gildetti

Cattedra di Oncologia Medica

Università “G. D’Annunzio” Chieti-Pescara

Direttore: Prof. Stefano Iacobelli

slide2

48 years old, female, pre-menopausal

  • No comorbility

September 2005: Left breast lumpectomy + axillary dissection

Ductal infiltrating carcinoma, 2.4 cm, G3

ER=0% PR=0% HER2+++

PT2 PN0 M0

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ADJUVANT TREATMENT

Cardiac evaluation at baseline

Ecocardiography

LVEF=66.3%

October 2005 – February 2006: FEC100 q21

6 cycles

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ADJUVANT TREATMENT (2)

Radiotherapy (March 2006)

April 2006: Cardiac evaluation pre-Trastuzumab

Ecocardiography: LVEF=64%

Trastuzumab 6 mg/kg (8 mg/kg loading dose)

q21 x 1 year

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June 2006(after 3 cycles of Trastuzumab)

LVEF=52.5%

18% reduction in LVEF

(asymptomatic patient)

Continue Trastuzumab Therapy?

YES

NO

slide6

Herceptin Temporally Discontinued

July 2006 (after 4 weeks of suspension)

LVEF=64.5%

Reintroduction of Trastuzumab Therapy

Cardiac function closely evaluated

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August 2006 (after two other cycles of T):

LVEF=50%

22% reduction

(asymptomatic patient)

What is the more appropriate management?

slide10

Discontinue Trastuzumab

definitively?

YES

NO

slide11

Pooling of

NSABP-B31

NCCTG N9831

N=3351

Med f-up=2y

Four major adjuvant trials have shown that Trastuzumab reduces the risk of recurrence

No Trast

FinHER

BCIRG006

HERA

HR

N=3222

Med f-up= 1,5y

N=3387

Med f-up=1y

TH or VH FEC

TCH

ChemoH

ACTH

ACP H

0.61

0.54

0.49

0.48

0.46

T=docetaxel

C=cisplatin or carboplatin

P=paclitaxel

Chemo= mostly anthracyclines

Timing of Trastuzumab initiation

Upfront

After 4 months

After 8 months

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The incidence of severe Trastuzumab cardiac related events in adjuvant trials remains within acceptable levels

Summary of cardiac safety with Trastuzumab in early breast cancer

Baselga et al, The Oncologist 2006;11 (suppl 1)

slide13

ADJUVANT TRASTUZUMAB TRIALS

COMPARISON OF CARDIOTOXICITY RISKS

slide14

Observational study

Over a 4-year period, 38 patients with HER2/neu-positive breast cancer, who have received anthracycline before Trastuzumab therapy, were referred for suspected Trastuzumab-related cardiotoxicity

The mean LVEF pre-Trastuzumab was 0.61 ± 0.13

After 4.5 months (median) of Trastuzumab therapy, the mean LVEF decreased to 0.43 ±0.16 …

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…after withdrawal of Trastuzumab, the LVEF increased to 0.56 ± 0.11, with a mean time to recovery of 1.5 months

The median duration of reintroduced Trastuzumab therapy was 8.4 months

Michael S. Ewer; J Clin Oncol 23; 2005

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In summary…

  • The Trastuzumab-related cardiotoxicity in patients with HER2+ breast cancer seems to be largely reversible when trastuzumab is withdrawn
  • Standard therapy for LV dysfunction and CHF may hasten this recovery, allowing Trastuzumab to be reitroduced

Thus, reintroducing Trastuzumab may be appropriate for some individuals who previously have experienced Trastuzumab-related cardiac dysfunction

slide17

Cardiac safety guidelines for the adjuvant use of Trastuzumab [Herceptin] in HER2-positive early breast cancer

Ewer MS.; St. Gallen Conference, 2007

Management of asymptomatic decreases in LVEF during adjuvant Trastuzumab

?

slide18

Cardiac safety guidelines for the adjuvant use of Trastuzumab [Herceptin] in HER2-positive early breast cancer

Management of symptomatic cardiac events during adjuvant Trastzumab

?

Ewer MS.; St. Gallen Conference, 2007

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August 2006

Trastuzumab has been definitively discontinued after the second reduction of LVEF

Patient has been reviewed by a cardiologist:

No therapy for heart failure

Patient in follow-up

LVEF=61.5%

March 2007: Ecocardiography

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Further follow-up of the adjuvant trials will increase our knowledge of the nature and reversibility of cardiac events associated with Trastuzumab use. These data will help to clarify the risk/benefit ratio on an individual patient.

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