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Highlights in the Management of Breast Cancer Rome, May 25-26, 2007 CLINICAL CASE Dott.ssa Jamara Giampietro Cattedra di Oncologia Medica Università G.

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Presentation on theme: "Highlights in the Management of Breast Cancer Rome, May 25-26, 2007 CLINICAL CASE Dott.ssa Jamara Giampietro Cattedra di Oncologia Medica Università G."— Presentation transcript:

1 Highlights in the Management of Breast Cancer Rome, May 25-26, 2007 CLINICAL CASE Dott.ssa Jamara Giampietro Cattedra di Oncologia Medica Università G. DAnnunzio Chieti-Pescara Direttore: Prof. Stefano Iacobelli

2 69 years old, female Comorbility: hypertension and osteoporosis December 2006: mammogram and breast ultrasound showed a 4.3 cm mass Core needle biopsy: ductal infiltrating carcinoma, G3 ER=80% PR=10% HER2+++ Chest immaging Bone scan negative Abdominal ultrasound Echocardiogram LVEF:55%

3 The best therapeutic approach? primary systemic therapy immediate surgery

4 Randomized phase III trials comparing neoadjuvant with adjuvant therapy using the same chemotherapy regimen Sachelarie et al, The Oncologist 2006;11: The goals of PST in breast cancer are to treat occult systemic disease, decrease the tumor bulk (optimally to a complete pathologic response), and reduce the extent of local surgery to allow breast-conserving surgery.

5 Mauri et al, JNCI 2005;3:

6 The best therapeutic approach? primary chemotherapy primary hormonotherapy

7 Munich et al, Ann of Oncology 2001;12: Primary efficacy endpoint: overall objective response. Secondary efficacy endpoint: percentage of patients who underwent BCS.

8 Munich et al, Ann of Oncology 2001;12:

9 The best therapeutic approach? Anthracycline-based chemoterapy Taxane-based chemoterapy Anthracycline-taxane-based chemoterapy Trastuzumab

10 Randomized trials comparing different neoadjuvant chemotherapy regimen Sachelarie et al, The Oncologist 2006;11: The sequential use of an anthracycline with a taxane is associated with better results than their concurrent use. However, it is impossible to determine whether the observed benefit is a result of the sequential use or because of differences in total delivered dose of chemotherapy(higher in the sequential arm) or treatment duration ( longer in the sequential arm).

11 The primary objective of the study was to compare pCR rate between the two arms. Clinical stage II and IIIa HER2 FISH 3+ or HIC + 4 P* + 4 FE (75) C [ 4 P* + 4 FE (75) C ] + H weekly * Paclitazel was administered at 225 mg/mq as a 24-hours continuous infusion.

12 Budzar et al, JCO 2005; 23:

13 4 x AC 60/600 mg/m 2 4 x Docetaxel 100 mg/m 2 6 x Docetaxel and Carboplatin 75 mg/m 2 AUC 6 N=3,222 1 Year Trastuzumab AC T AC TH TCH Her 2+ (Central FISH) N+ or high risk N- 4 x AC 60/600 mg/m 2 4 x Docetaxel 100 mg/m 2 Slamon D., SABCS 2006 BCIRG 006 Stratified by Nodes and Hormonal Receptor Status 1 Year Trastuzumab

14 Endpoints Primary - Disease-free Survival Secondary - Overall Survival - Toxicity - Pathologic & Molecular Markers

15 Disease Free Survival 2 nd Interim Analysis Absolute DFS benefits (from years 2 to 4): AC TH vs AC T: 6% TCH vs AC T: 5% % Disease Free Patients Events AC->T AC->TH TCH 81% 87% 86% 77% 83% 82% 87% 93% 92% HR (AC->TH vs AC->T) = 0.61 [0.48;0.76] P< HR (TCH vs AC->T) = 0.67 [0.54;0.83] P= Year from randomization Slamon D., SABCS 2006

16 Overall Survival 2 nd Interim Analysis HR (AC->TH vs AC->T) = 0.59 [0.42;0.85] P=0.004 HR (TCH vs AC->T) = 0.66 [0.47;0.93] P=0.017 % Survival Patients Events AC->T AC->TH TCH 97% 99% 98% 93% 97% 95% 92% 91% 86% Year from randomization Slamon D., SABCS 2006

17 DFS Lymph Node Negative 2 nd Interim Analysis % Disease Free Patients Events 30935AC->T 31012AC->TH 30917TCH 92% 99% 97% 88% 95% 94% 86% 94% 93% HR (AC->TH vs AC->T) = 0.32 [0.17;0.62] P= HR (TCH vs AC->T) = 0.47 [0.26;0.83] P= Year from randomization Slamon D., SABCS 2006

18 Overall Survival Lymph - Node Negative 2 nd Interim Analysis % Survival Patients Events 30712AC->T 3092AC->TH 3075TCH 99% 100% 98% 96% 100% 98% 93% 97% 98% HR (AC->TH vs AC->T) = 0.16 [0.04;0.73] P=0.018 HR (TCH vs AC->T) = 0.42 [0.15;1.2] P=0.106 Year from randomization Slamon D., SABCS 2006

19 AC-TH better AC-T better Subgroup Node neg Node pos HR - HR + Tsize <2cm Tsize 2cm AC-TH vs AC-T Subgroup Node neg Node pos HR - HR + Tsize <2cm Tsize 2cm TCH vs AC-T TCH better AC-T better DFS - Subpopulations

20 Cardiac Deaths and CHF as per Independent Review Panel AC-T n=1,050 AC-TH n=1,068 TCH n=1,05 6 Cardiac related death Cardiac left ventricular function (CHF) Grade 3 / first interim analysis second interim analysis / 0 / 4/ 20 / 4 P = Slamon D., SABCS 2006

21 Patients with >10% relative LVEF decline AC-T n = 1012 AC-TH n = 1040 TCH n = 1029 Patients % first interim analysis P < P = 0.5 second interim analysis /102 /189/89 /10/18/8.6 /1014 /1042/1030 P = P < P = 0.5 Slamon D., SABCS 2006

22 58 Mean LVEF - All Observations 2 nd Interim Analysis LVEF points % Time since randomization (days) AC->T (N=1014) AC->TH (N=1042) TCH (N=1030) AC->T TCH AC->TH Slamon D., SABCS 2006

23 NEOADJUVANT TREATMENT January 2007 – April 2007: Trastuzumab + Docetaxel + Carboplatin x 6 cycles May 2007QUART SE minimal residual disease ; 15 N – Trastuzumab for a total of 1 year course + aromatase inhibitor


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