Sessione breast:
nuove prospettive
Dott.ssa M. Agnese Fabbri UOC Oncologia
AUSL Viterbo
Summary
Early breast cancer:
• MINDACT: Not all small node negative breast cancer are similar
• ALTTO: TRA and Survival
• Trastuzumab Biosimilars
Metastatic breast cancer:
• BEECH: The efficacy of AKT inhibitor
• OLYMPIAD: The outcomes in patients with BRCA mutations
Summary
Early breast cancer:
• MINDACT: Not all small node negative breast cancer are similar
• ALTTO: TRA and Survival
• Trastuzumab Biosimilars
Metastatic breast cancer:
• BEECH: The efficacy of AKT inhibitor
• OLYMPIAD: The outcomes in patients with BRCA mutations
Summary
Early breast cancer:
• MINDACT: Not all small node negative breast cancer are similar
• ALTTO: TRA and Survival
• Trastuzumab Biosimilars
Metastatic breast cancer:
• BEECH: The efficacy of AKT inhibitor
• OLYMPIAD: The outcomes in patients with BRCA mutations
ALTTO Study design:
n=8381 total/6281 analyzed
HER2+
ESBC
+ Trastuzumab X 1 year + Lapatinib X 1 year
+ Trastuzumab+ Lapatinib X 1 year
+ Trastuzumab X 3 months → Lapatinib X 9 months
Chemotherapy
Piccart et al, ASCO 2014
Different treatment approaches
• Sequential anti-HER2 therapy after all chemo (N= 4,613)
• Concurrent anti-HER2 therapy after anthracycline-based chemo (N=3,337)
• Concurrent anti-HER2 therapy with non-anthracycline chemo (N=431)
+ Trastuzumab X 1 year + Lapatinib X 1 year
+ Trastuzumab+ Lapatinib X 1 year
+ Trastuzumab X 3 months → Lapatinib X 9 months
HER2+
ESBC
Chemotherapy
Conclusions:
• In the premenopausal patients with HR+/HER2+ EBC , TIA was associated with significant survival benefits.
• This data support the use of ovarian suppression as a part of adjuvant endocrine therapy in premenopausal HR+/HER2+ EBC patients
Summary
Early breast cancer:
• MINDACT: Not all small node negative breast cancer are similar
• ALTTO: TRA and Survival
• Trastuzumab Biosimilars
Metastatic breast cancer:
• BEECH: The efficacy of AKT inhibitor
• OLYMPIAD: The outcomes in patients with BRCA mutations
• How to define a biosimilar?
• Why do we need them?
• Are PK assay sufficient or do we need non-inferiority efficacy trials?
Important Questions
Any ethical questions for the Biosimilar equivalence trials?
• Patients usually partecipate clinical trials with the aim of possible benefit
• ( efficacy and/or toxicity)
We need BIOBETTERS more than BIOSIMILARS
Summary
Early breast cancer:
• MINDACT: Not all small node negative breast cancer are similar
• ALTTO: TRA and Survival
• Trastuzumab Biosimilars
Metastatic breast cancer:
• BEECH: The efficacy of AKT inhibitor
• OLYMPIAD: The outcomes in patients with BRCA mutations
Summary
Early breast cancer:
• MINDACT: Not all small node negative breast cancer are similar
• ALTTO: TRA and Survival
• Trastuzumab Biosimilars
Metastatic breast cancer:
• BEECH: The efficacy of AKT inhibitor
• OLYMPIAD: The outcomes in patients with BRCA mutations
Among patients with metastatic HER2-negative BC and a germline BRCA1/2 mutation in the OlympiAD study, the objective response rate with olaparib tablet monotherapy was double that seen with standard chemotherapy TPC
