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BREAST CANCER Neoadjuvant Chemotherapy

BREAST CANCER Neoadjuvant Chemotherapy. Interest of neoadjuvant CT. % of patients with distant relapse. Tumor N. of nodes diameter 0 1-3 > 3 1.9 cm 21 26 - 3.2 cm 18 48 58 4.2 cm 32 58 74 6.2 cm 32 71 79 9 cm 62 - - . Need for a systemic treatment even in small tumors.

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BREAST CANCER Neoadjuvant Chemotherapy

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  1. BREAST CANCERNeoadjuvant Chemotherapy

  2. Interest of neoadjuvant CT % of patients with distant relapse Tumor N. of nodes diameter 0 1-3 > 3 1.9 cm 21 26 - 3.2 cm 18 48 58 4.2 cm 32 58 74 6.2 cm 32 71 79 9 cm 62 - - Need for a systemic treatment even in small tumors Thames, JCO 99

  3. NVB-Anthra NVB:25 mg/m² D1 Epi: 100 mg/m² D1 CDDP: 50 mg/m² D1 Q3w n = 92 T2 = 71% T3 = 29% OR 75% pCR 18% BCT 67% Neutropenia G3-4 9% cy* N/V G3 16% pts Asthenia G3 4% pts No cardiac toxicity BCT = Breast Conservative Treatment * With G-CSF Barni, ASCO 2002

  4. NVB-AnthraRandomised phase IITOPIC NVB:25 mg/m² D1, D8 Epi: 60 mg/m² D1 NVB: 25 mg/m² D1, D8*MTZ: 12 mg/m² D1 Doxo: 60 mg/m² D1Cyclo: 60 mg/m² D1 n = 147 pts * Arm stopped for toxicity NVB-Epi NVB-MTZ Doxo-Cyclo n = 50 n = 41 n = 26 Tumor size 5 cm 4.8 cm 4.5 cm OR 86% 73% 65% Neutro G3-4 35% 57% 32% Neutro sepsis 12% 21% 7%Alopecia G3 51% 19% 75% Webb, ECCO 2001

  5. 2 drug combination  3 drug combination Experience 5 studies 6 studies* n = 231 n = 367 OR 70.5-100% 75-90% pCR 11-22% 14-34% BCT 15-41% 37-87% NVB-Anthra * 1 study with pCR = 9%, BCT = 16%, n= 56 Webb, Albuquerque, L. Puerto, Nistico, Ferrero, Braud, Abrahamova, Van Praagh, Ardavanis, Cholet, Barni

  6. NVB-Anthra Recommended schedules for neoadjuvant CT • NVB 25 mg/m² D1, D8Doxo 25 mg/m² D1, D8 Q3w for 4 cycles • NVB 25 mg/m² D1, D8Epi 35-50 mg/m² D1, D8 Q3w for 4-6 cycles • NVB 25 mg/m² D1, D8Epi 35 mg/m² D1, D8MTX 20 mg/m² D1, D8 Q4w for 4 cycles

  7. Competitors of NVB-Anthra • CAF/CEF • TXT-Anthra • TXL-Anthra

  8. CAF/CEF or AC/EC 18 studies (n = 1623) OR 36-100% pCR 4-38% BCT 29-96% Febrile Neutrop. 1-34% Nausea/Vomiting 13% Alopecia 100% Cardiotoxicity  of LVEF Standard treatment but: - Large range of data - Cardiac toxicity linked to high dose of Anthra - Toxicity profile poorly documented

  9. TXT-Anthra 31 studies (n = 2413) OR 53-96% pCR 3-35% BCT 12-82% Neutropenia 8-100% Febrile Neutrop. 5-57% Mucositis 15-38% Alopecia 79-100% Main competitor with large experience but: - Large range of data - Toxic combination  Development of sequential schema

  10. TXL-Anthra 21 studies (n = 1679) OR 33-97% pCR 0-35% BCT 47-73% Neutropenia 7-76% Neurotoxicity 6-7% Nausea/Vomiting 22-42% Stomatitis 6-15% cy. Alopecia 100% Development in this segment but: - Large range of pCR with only 1 study reporting 35% - High incidence of clinical toxicities

  11. NVB-Anthra Lower experience compared to the others but : • Studies well documented • Expected OR and pCR rates • Manageable tolerance profilespecially heamatotoxicity

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