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Highlights aus dermedizinischen
OnkologieESIO-Fortbildung 15.09.16
Susanna StollKlinik für Medizinische Onkologie
USZ / Stadtspital Triemli
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Uebersicht
• Neue Substanzen:- Palbociclib- Olaparib
• Adjuvante endokrine Therapie- 10 versus 5 Jahre- OFS + Tamoxifen/AI
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Neue Substanzen
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Lancet Oncol 2015; 16: 25–35
Lancet Oncol 2015; 16: 25-35
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Methoden
• Phase II-Studie
• N = 165, postmenopausal,fortgeschrittener ER+ HER2- BC
• Letrozol 2,5mg/d kontinuierlichoder Letrozol 2,5mg/d + Palbociclib125mg/d für 3 Wochen, 1 WochePause, q4w
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Hintergrund
• Palbociclib (Ibrance®): Oralersmall-molecule Inhibitor derCyclin-abhängigen Kinasen (CDKs)4 und 6
• Präklinische Evidenz:Wachstumshemmende Aktivität beiER+ BC-Zellen und Synergie mitAnti-Oestrogenen
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The cyclin D/cyclin-Dependent kinase
(CDK)4/6/retinoblastoma(Rb) Pathway
and the cell cycle
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ResultateMedian follow-up 29,6 Mte
Palbociclib +Letrozol (N=81)
Letrozol(N=84)
mPFSp=0,0004
20,2 Mte 10,2 Mte
mOSp=0,42
33,3 Mte 37,5 Mte
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Progression-free survival
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Overall survival
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Paloma-22016 ASCO Annual Meeting,
Abstract Number 507
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Methoden
• Randomisierte doppelblinde PhaseIII-Studie zur Bestätigung derResultate von PALOMA-1
• N = 666 postmenopausal,Randomisierung 2:1
2016 ASCO Annual Meeting, Abstract Number 507
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Resutate
2016 ASCO Annual Meeting, Abstract Number 507
Palbociclib +Letrozol
Letrozol
mPFSp<0,000001
24,8 Mte 14,5 Mte
ORRp=0,03
42,1% 34,7%
CBRp<0,0001
84,9% 70,3%
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Toxizität
2016 ASCO Annual Meeting, Abstract Number 507
AE Palbociclib +Letrozol
Letrozol
Neutropenie 79,5% 6,3%
Nausea 35,1% 26,1%
Fatigue 37,4% 27,5%
Alopezie 32,9% 15,8%
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Konklusion
Palbociclib + Letrozol ⇒Signifikant effizient und sicherbei Patientinnen mitfortgeschrittenem ER+ HER2-BC ohne Vortherapie
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Lancet Oncol 2016; 17: 425–39
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Methoden
• Doppelblinde Multizenter Phase III-Studie
• N = 521, ≥ 18y, mBC ER+ HER2-, nachProgress unter endokriner Therapie
• Randomisierung 2:1
• Palbociclib 125mg/d für 3 Wochen, 1Woche Pause, q4w + Fulvestrant oderPlazebo + Fulvestrant
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Resultate
Median follow-up 8,9 Mte
Palbociclib +Fulvestrant
(N=347)
Plazebo +Fulvestrant
(N=174)mPFSp<0,0001
9,5 Mte 4,6 Mte
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Progression-free survival
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Toxizität
AE Grad 3-4 Palbociclib +Fulvestrant
Plazebo +Fulvestrant
Neutropenie 65% 1%
Leukopenie 28% 1%
Fatigue 2% 1%
SAE 13% 17%
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Konklusion
Palbociclib + Fulvestrantß
Signifikate Verbesserungdes PFS, unabhängig von
vorgängigen Therapien
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Olaparib beiBRCA-
Mutationsträgerinnen
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OLYMPIA IBCSG/SAKK
Olaparib300 mg bd12 Monate
Plazebo12 Monate
IDFS
DistantD
FS;OS
Randomi-sierung 1:1
N=1320
BRCA+, post neoadj. CTTNBC, HR+/HER2-
BRCA+, post adjuv. CTTNBC, HR+/HER2-
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N Engl J Med 2012;366:1382-92
Lancet Oncol 2014; 15:852-61
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Methoden
• Doppelblinde Phase II-Studie,N = 265
• Rezidivierte high grade seröse OC• ≥ 2 Platin-haltige Chemotherapien• pR oder cR nach letzter Therapie• Olaparib versus Plazebo als
Erhaltungstherapie
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Progression-free survival
Olaparib Plazebo HR
Alle Patientinnen(N=265)
8,4 Mte 4,8 Mte 0,35p<0,0001
BRCA wild-type(N=136)
7,4 Mte 5,5 Mte 0,54p=0,008
BRCA-mutiert(N=118)
11,2 Mte 4,3 Mte 0,18p<0,0001
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Median Overall survival
Median follow-up 37,3 Mte
Olaparib(N=136)
Plazebo(N=129)
mOSp=0,44
37,1 Mte 37,6 Mte
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Progression-free survival
BRCA-mutated BRCA wild-type
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Overall survival
BRCA-mutated BRCA wild-type
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Toxizität
AE Grad 3-4 Olaparib Plazebo
Fatigue 7% 3%Anämie 5% <1%Nausea 2% 0%SAE 18% 9%
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Cancer 2016;122:1844-52
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Methoden
• 23% mit Switch von Plazebo zuOlaparib bei Progress
• Post hoc-Analyse von 97 BRCA+Patientinnen nach Ausschluss vonZentren mit Patientinnen mitSwitch bei Progress
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Overall survival
AlleHR 0,73 (p=0,192)
Kein SwitchHR 0,52 (p=0,039)
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Adjuvante endokrineTherapie: Neue
Optionen
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ATLAS und aTTomTamoxifen 10 vs 5y (prä-und postmenopausal)
ATLAS aTTom
Rezidive (Event rate ratios)Reduktion Jahr 5-9 0,9 0,9
Reduktion Jahr ≥ 10 0,75(95%CI 0,62-0,90)
0,75(95%CI 0,66-0,86)
BC-Mortalität (Event rate ratios)Reduktion Jahr 5-9 0,97 1,03Reduktion Jahr ≥ 10 0,71
(95%CI 0,58-0,88)0,77
(95%CI 0,64-0,92)
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Toxizität
AE ATLAS aTTom
Lungenembolien RR 1,9
CVI RR 1,1
Endometrium-karzinom- KumulativesRisiko Jahr 5-14
- Mortalität
RR 1,7
3,1% vs 1,6%0,4% vs 0,2%
RR 2,2
1,1% vs 0,6%
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Konklusion
Tamoxifen 10 Jahre vs nihil
ß• Reduktion BC-Mortalität um ca. 1/3
während Jahr 1-10 nach ED
• Um die Hälfte in der 2. Dekadenach ED
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N Engl J Med. 2016; 375(3): 209-19
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Studiendesign MA.17R
Tamoxifen AI
Plazebo
Letrozol
R
4,5-6Jahre
BeliebigeDauer
5 Jahre
5 Jahre
0-2 Jahre
N = 1918postmenopausal
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Resultate
Median follow-up 6,8 Jahre
Letrozol Plazebo
5y DFSHR 0,66, p=0,01
95% 91%
Annual incidence rateof cBCHR 0,42, p=0,007
0,21% 0,49%
5y OSHR 0,9, p=0,83
93% 94%
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DFS und OS
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Kumulative Inzidenz kontraleraler BC
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Toxizität
AE Letrozol Plazebo
Neu Osteoporose 11% 6%
Frakturen 14% 9%
Hitzewallungen 3% 2%
Arthralgien 2% 3%
QoL Kein signifikanterUnterschied
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Konklusion
AI für 10 Jahreß
- DFS signifikant länger- Tiefere Inzidenz für cBC- Bz. OS kein Unterschied
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N Engl J Med 2014;371:107-18
N Engl J Med 2015;372:436-46
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TEXT: Tamoxifen and Exemestan TrialSOFT: Suppression of Ovarian Function Trial
SOFT and TEXT Designs
TEXT (N=2672)
SOFT (N=3066)
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Keine Chemotherapie
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Mit Chemotherapie
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Alle Frauen < 35 Jahre
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Overall survival
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Toxizität
AE Grad 3-4 Tam Tam + OFS Exe + OFS
Hitzewallungen 7,6% 12% 10%
Depression 3,8% 4,4% 3,8%
Schlafstörung 2,9% 4,3% 3,8%
Jeglicher Grad
Muskuloskelettal 69% 76% 88,7%
Vaginale Trockenheit 41,8% 47,7% 52,4%
Libidoverlust 42,4% 40,9% 45%
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Konklusion
• OFS+Tamoxifen: Kein signifikanterBenefit für alle
• Hohes Rückfallrisiko, Indikation fürACT, prämenopausal nach ACT:OFS ⇒ Reduktion Rückfallrisiko, v.a.bei < 35y
• OFS+Exemestan vs OFS+Tamoxifen:Signifikant weniger Rückfälle
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ASCO-Guidelines
J Clin Oncol 2016; 34: 1698-1701
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OFS + Tamoxifen oder Aromatasehemmer
• BC Stadium II oder III, ACTempfohlen
• BC Stadium I oder II, höheresRückfallrisiko, ACT erwogen
• BC ≤ 35y• HER2+: Höherer Bereich des
Risikospektrums
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Nur Tamoxifen oder Aromatasehemmer
• BC Stadium I ohne Indikationfür ACT
• T ≤ 1cm N0
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Take home message
• Palbociclib+endokrine Therapie:Benefit bei fortgeschrittenem/mBC in ≥1. Therapielinie
• Adjuvante endokrine Therapie:- 10y > 5y, für welches Kollektiv?- OFS+Exemestan > OFS+Tamoxifen:
Vorteil bei hohem Rückfallrisiko
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Vielen Dank fürIhre
Aufmerksamkeit!