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St. Gallen 2007

St. Gallen 2007. Consensusmeeting P. Berteloot. First select the target : better choice of adjuvant treatments for breast cancer patients St Gallen 2005. 1 Target = endocrine sensivity (low – intermediate -high) 2 defining the riskgroups (low – intermediate- high).

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St. Gallen 2007

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  1. St. Gallen 2007 Consensusmeeting P. Berteloot

  2. First select the target : better choice of adjuvant treatments for breast cancer patientsSt Gallen 2005 • 1 Target = endocrine sensivity (low – intermediate -high) • 2 defining the riskgroups (low – intermediate- high)

  3. Break-throughs since 2005 • Herceptin! • Confirmation A.I. • Lower threshold for Taxanes

  4. Present Problems • Past trials : large but not selective • General conclusions • Possibly not suitable for all subgroups • Not pre-planned subgroup analysis are statistically not reliable

  5. Need for • Inclusion criteria for future trials should be selective for important targets • Individualised therapy should be based on reliable and selective tumor information • Pitfalls of diagnostic procedures • DCIS ~ micro-invasion • Passive transportation of malignant cells -> axilla • Error rate in HR assessement • Depending on different kits • Fixation • Eroor rate in HER2 status Viale G.

  6. Importance of local control by surgery and Radiotherapy Improved local control at 5 years of follow-up Proportional survival benefit at 15 years of follow-up Ratio 4:1

  7. Important highlights of St Gallen 2007 • MRI staging in breastcancer • Ipsilateral : 15-20 % • Contralateral : 3-5 % • Independent of : • Age • Pathology • Mammographic density C. Kuhl NEJM

  8. Breast surgery in advanced breast cancer • Regained importance due to : • Better and longer control of distant disease • Ability of detecting small metastatic foci Large retrospective reviews of patients treated by surgical resection of the primary tumor to clear borders have demonstrated longer survival

  9. Predictive factors for chemosensitivity • TOPO II • Sensitivity for anthracyclines • Gene level ~ protein level if proliferation index ( KI67) is elevated • Taxanes • Tau-protein • HER2 pos ? • P-53 mutations

  10. Predictive factors for chemosensitivity • Alkylantia Platinum • ER positive < 35 years HER2 signaling DNA Damaging Agents in BRCA1 patients worse prognosis

  11. Association HER2 – ER-pos • Chances of finding HER2 positivity associated with ER-positivity is higher in young than in older women

  12. Herceptin • Update Hera-trial • 2 years of follow-up • 1 year of Herceptin • DFS : 6,3 % • OS : 2,7 % • Compairable gain for all subgroups • 2 important questions • Sequencing ? • Duration of therapy ? absolute gain

  13. Consensus issues concerning Herceptin • Chemo in Her2 positive patients • Dependent on receptor status : 60 % yes • Anthracyclines to all : 73 % yes • Taxanes to all : 43 % yes • 6 to 8 cycles : 63 % yes

  14. Chemotherapy schedules in HER2 + • CAF ~ CEF : 62 % yes • AC-T : 32 % yes • FEC : 32 % yes • TAC : 30 % yes • FEC-TAX : 32 % yes • TAX + carbo : 51 % yes The opinions are very devided

  15. Sequencing Herceptin-Chemotherapy • Sequential : 38 % • Concommittant : 40 % • No preference : 22 %

  16. Duration of Herceptin administration • Shorter in elderly : 51 % yes • Shorter for node neg : 38 % yes • Is duration riskdependent : 40 % yes • Importance of early onset : 60 % yes • 12 months : 91 % yes • 9 weeks + Docetaxel : 14 % yes • 2 years : ?

  17. Herceptin indications • IHC +++ : 92 % • FISH requested : 15 % yes • T<1 cm Node neg : 56 % yes Receptor neg • Tx node neg : 58 % yes Receptor pos independent of node and receptorstatus

  18. Safety of Herceptin • Avoid low LVEF ( 50-55) : 74 % yes • > 70 years : 30 % yes • Preventive use of ace inhibitors : 7 % yes

  19. Hormonal therapy Postmenopausal consensus topics • Tam alone • Node neg : 50 % • Node pos : / • High ER-PR : 54 % • HER2 neg : 52 %

  20. Hormonal therapy Postmenopausal consensus topics • AI upfront • In all patients : 19 % yes • High risk : 65 % yes • HER2 pos : 66 % yes • HER2 neg : 33 % yes

  21. Hormonal therapy Postmenopausal consensus topics • If started with TAM Switch all : 50 % yes After 2 to 3 years : 89 % yes After 5 years : 60 % yes Only for TAM-intolerance : 65 % yes

  22. Preference • AI upfront : 31 % • TAM  AI : 63 % • TAM x 5  : 5,7 %

  23. After 5 years of TAM  AI • All : 84 % yes • Node pos : 92 % yes • HER2 neg : 40 % yes • HER2 pos : 74 % yes

  24. Total duration of hormonal therapy • 5 years : 58 % • 5 to 10 years : 75 % • > 10 years : ? • Life-time for high-risk patients :37 %

  25. Evaluation ovarian function at the start of AI • By onset : 55 % yes • After 6 to 12 weeks : 48 % yes

  26. Supportive care + AI • Ca + Vit D : 61 % yes • Bifosfanates for all : 3 % • Fysical exercise : 100 % • BMC : 88 %

  27. Pre-menopausal : consensus topics • TAM alone is an option : 92 % yes • OFS + TAM is an option : 83 % yes • OFS alone • For everyone : 7 % yes • For low risk : 32 % yes

  28. Modality of ovarian suppression • LHRH analogue : 100 % • Surgery : 76 % • Radiotherapy : 19 % • Depending on age and : 75 % histological subtype

  29. Duration of ovarian suppression • 2 years for all : 29 % • 2 years node negative : 43 % node positive • 5 years node positive : 66 % HER2 positive • 5 years for all : 25 % • Individualisation : 79 %

  30. Chemo + OFS • Concurrently : 30 % • Sequentially : 82 % • Concurrently to preserve : 65 % fertility

  31. OFS + AI • All : 6 % • Contra-indication for Tam : 68 % • Trials : 54 %

  32. AI : timing attempt to conclusions • Upfront : patients with high risk for early relapse • High tumorload :  T2 ;  N2 • Biological agressiveness • gr III • HER2 pos • vascular invasion • Negative hormone receptor status Mauriac, Ann Oncol

  33. AI : timing • Switch after 2-3 years : intermediate risk • Adjuvant hormonal therapy ≥ 5 years • Relapse curve receptor positive patients • Increased benefit ~ duration extended adjuvant therapy

  34. Long-Term Risk of Breast Cancer Recurrence Remains High in ER+ Patients 0.3 ER+ (n=2257) ER– (n=1305) 0.2 Recurrence hazard rate 0.1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Years Saphner et al. J Clin Oncol. 1996;14:2738.

  35. Annual Risk of Recurrence by Nodal Status • The risk of late recurrence remains substantial even in patientswith node-negative tumors 0.3 N0 N1-3 N4+ 0.2 Recurrence hazard rate 0.1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Years Saphner et al. J Clin Oncol. 1996;14:2738.

  36. Benefit of TAM +/- OS • No clear evidence found ! N. Davidson • No large prospective randomised trials available • Actual SOFT trial and TEXT trial • Meta-analysis by Jack Cuzick • Limited benefit likely • Age dependent ?

  37. Chemotherapy • Hormone sensitivity indicate : • the additional gain of chemotherapy eg postmenopausal patients : hormone receptor positive 3 % and hormone receptor negative 8% • Preference of schedule • No consensus at all • Tendency to be more aggressive in HR neg en HER2 pos patients • HER2 Status

  38. Incorporation of taxanes • Only trials in node pos patients 3 – 7 % gain • Level 1 evidence ? • Only PACS 01 has an optimal control arm • PACS 01: imbalance of ER status and unexplained age difference • Dependent on: • Hormone receptor status • HER2 positivity ?

  39. Conclusion St. Gallen 2007 • No consensus yet • We don’t expect large changes in our home strategy

  40. Guidelines: UZ leuven Adjuvant therapy?

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