Terapia della malattia metastatica Domande agli esperti
AIOM Giovani Claudia De Angelis
HR+/HER2- MBC: CDK 4/6 i
MONALEESA-7 41% de novo stage IV 60% ET naive
45% CT naive
No ET for mts disease was allowed
HR+/HER2- MBC: CDK 4/6 i
PALOMA 3
More Benefit in:
Endocrine sensitive DFS ≥24 mos
Disease without visceral metastases
HR+/HER2- MBC: CDK4/6 i
Endocrine sensitive/
Bone only/DFI > 24 mos/
ET naive
Endocrine resistant/
Visceral disease
ET + CDK 4/6i ET+/- CDK4/6 i
OLD Scenario !
HR+/HER2- MBC: CDK4/6 i
Endocrine sensitive/
Bone only/ DFI > 24 mos/
ET naive
Endocrine resistant/
Visceral disease
ET + CDK 4/6i + other target
therapies ET + CDK4/6 i
NEW Scenario ?
HER2+ MBC 1° line: Cleopatra Trial
ASCO 2019 End of study analysis:
mFollow up 99 months ≈ 8 years
PTH mOS 57.1 months vs TH 40.8 months ∆ 16.3 months
8 years Landmark OS rate: 37% pts alive in PTH vs 23% TH
59 pts still on study and have not progressed (At the time of data cut off November 2018)
Immunotherapy like results!
HER2+ MBC beyond the 2° line: NALA trial
8.8 mos vs 6.6 mos p 0.0003 ∆ 2.2 mos G3/4 Diarrhea 24%
vs 13%
(despite prophylaxis with loperamide at
1° cycle)
Toxicity Efficacy
HER2+ MBC beyond the 2° line: SOPHIA trial
PFS analysis in ITT Population: Margetuximab + CT (266) vs Trastuzumab + CT (270) mPFS 5.4 mos vs 4.9 mos HR 0.76 p = 0.033
Is the SELECTION of PATIENT
the right way to investigate drugs in later lines ?
GOOD SAFETY Profile !
TNBC MBC: Immunotherapy
What biomarkers other than PDL1 should be taken into account to better select patients with TNBC in immunotherapy trials?
IMPASSION 130
Grazie ☺
