carcinoma della mammella novità in tema di...
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Carcinoma della Mammella Novità in tema di Adiuvante
Antonella Palazzo, MD, PhD
Istituto Europeo Oncologico di Milano
Convegno Nazionale AIOM Giovani, Perugia 8-9 Luglio 2016
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The goal in Early Breast Cancer
Risk of: Overtreatment Suboptimal treatment Toxicities
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What’s news in 2016 for EBC treatment? Some strategies to improve outcomes and
reduce side effects in EBC
Endocrine therapy: for how long?
Cytotoxic adjuvant chemotherapy: - patient’s selection (clinicopathological biomarker versus genomic tests) - which regimens ? - which dose? Bone targeting therapy
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Slide 4
Long Term recurrence risks after use of endocrine therapy for only 5 years
Early Breast Cancer Trialists’ Collaborative Group (EBCTG)
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Slide 13
Presented By H. Pan at 2016 ASCO Annual Meeting
EBCTCG - Long Term recurrence risks after use of endocrine therapy for only 5 years
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Slide 12
Presented By H. Pan at 2016 ASCO Annual Meeting
EBCTCG - Long Term recurrence risks after use of endocrine therapy for only 5 years
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Should Extended Endocrine Therapy improves the outcome in Hormone Receptor Positive Early Breast cancer ?
News in 2016 for EBC treatment
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MA.17R Trial Schema and Design <br />AI x 5 yrs - Following Prior 5 years of AI - preceded or not by Tamoxifen
Presented By Paul Goss at 2016 ASCO Annual Meeting
Primary Endpoint: DFS from Randomization Secondary Endpoint: OS, All CBC, Safety and QofLife
Stat. Met: 196 events in 1800 pts to achieve a power of 80% to detect an HR 0.67 for DFS – Study Emendment : 165 event at 6yrs FUP HR 0.655
Stratification Criteria: Node status, previous CT, interval from IA, Tam duration.
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Slide 10
Presented By Paul Goss at 2016 ASCO Annual Meeting
MA17R Baseline characteristics
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Slide 7
Presented By Paul Goss at 2016 ASCO Annual Meeting
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<br />MA.17R - DFS by pre-specified subgroups<br />
Presented By Paul Goss at 2016 ASCO Annual Meeting
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Slide 15
Presented By Paul Goss at 2016 ASCO Annual Meeting
Few women discontinued treatment because of toxic effects (5.4% in the letrozole group vs. 3.7% in
the placebo group).
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Waiting for some novel strategy in adjuvant tx…
Palbobiclib and Everolimus
New strategies to improve outcome in Endocrine positive EBC
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S1207 Trial of Adjuvant Everolimus
PALLAS Trial of Adjuvant Palbociclib
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What’s news in 2016 for EBC treatment? Some strategies to improve outcomes and
reduce side effects in EBC
Endocrine therapy: for how long?
Cytotoxic adjuvant chemotherapy: - patient’s selection (clinicopathological biomarker versus genomic tests) - which regimens ? - which dose? Bone targeting therapy Surgery of axilla
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Outcomes of Adjuvant Chemotherapy in Breast Cancer
Treatment Individualization: why?
Walgren et al JCO 2005, 23: 7342
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The MINDACT Study
Presented by M. Piccart at AACR Annual Meeting 2016
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Presented by M. Piccart at AACR Annual Meeting 2016
Primary Endpoint: Distant metastasis free survival (DMFS) at 5 years Null hypothesis : 5 yrs DMFS in PT population = 92% Power: 80% when tru 5-yrs DMFS rate = 95% Primary test: 95% 2-sided CI for the 5-yrs DMFS will be compared to 92% . Significant if exceeds 92%
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MINDACT Trial: Patient demographic and compliance with assigned therapy
Presented by M. Piccart at AACR Annual Meeting 2016
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Presented by M. Piccart at AACR Annual Meeting 2016
MINDACT population at 5y median follow up
Discordant Risk group: primary test DMFS in all 4 Risk groups
Discordant group
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MINDACT Trial Efficacy: CT vs no CT in discordant risk group Intent to treat analysis
Presented by M. Piccart at AACR Annual Meeting 2016
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Slide 35
14% reduction
Presented by M. Piccart at AACR Annual Meeting 2016
MINDACT Population: CT assignment according to a Clinical vs a Genomic strategy
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Presented by M. Piccart at AACR Annual Meeting 2016
Proposed future clinica use of MammaPrint
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What’s news in 2016 for EBC treatment? Some strategies to improve outcomes and reduce side effects in
EBC
Endocrine therapy: for how long?
Cytotoxic adjuvant chemotherapy: - patient’s selection (clinicopathological biomarker versus genomic tests) - which regimens ? - which dose? Bone targeting therapy
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Slide 3
Tiffany Traina at 2016 ASCO Annual Meeting
The bridge to a cure
CMF Anthracyclines Taxanes
Adding Capecitabine in Adjv regimens….
Anthra-taxane based regimens?
Dose dense schedule…
CREATE-X SABCS2015
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SABCS 2015, LEE S-J et al
Capecitabine (X): 2500 mg/mq/day po day 1-14 q3wk for 8 cycles
Primary Epoint: DFS Primary E.point Recurence Free Survival (RFS)
Heikki Joensuu at 2016 ASCO Annual Meeting
Are we undertreating in Adjuvant? Adding Capecitabine in Adjvant regimens….
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DFS/RFS OS
All pts ERneg All pts ERneg
CREATE-X* (N= 910) 5 yrs FUP
0.70 p=0.0052
0.58 (0.39 – 0.87)
N=296
0.60 P<0.01
FinXX° (N=1495) 10 yrs FUP
0.88 p=0.22
0.54 p=0.02 N=202
0.84 P= 0.15
0.55 p=0.0037
Are we undertreating in Adjuvant Tx? Adding Capecitabine in Adjvant regimens: Results
*S-J Lee, SABCS 2015 °H. Joensuu, ASCO 2016
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Anthra-taxane based vs taxane based regimens Dose dense schedules
Primary Epoint: IDFS Inferiority of TC to TaxAC pre-defined as HR ≥ 1.18. Secondary Epoint: RFI, OS, Toxicity
Joanne Blum at 2016 ASCO Annual Meeting
Are we overtreating or giving right in Adjuvant Tx?
ABC Joint Analysis PANTHER Trial
Primary E.point: Breast cancer relapse free survival
Jonas Bergh at 2016 ASCO Annual Meeting
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ABC Joint Analysis* mFUP 3,2 yrs
PANTHER Trial° mFUP 5.3 yrs
TC vs TaxAC (N=4242)
tddEC->tddD vs FEC100 -> D100 (N =2003)
IDFS All pts 1.23 p=0.004
HRneg HER2 neg pts 1.46 p< 0.05
BCRFS All pts 0.79 p= 0.062
HRneg HER2neg 0.89 p= 0.6
EFS 0.79 p=0.042
OS 1.08 p=0.6
0.77 p=0.093
Anthra-taxane based vs taxane based regimens and Dose dense schedules: Results
* Joanne Blum, ASCO 2016 °Jonas Bergh, ASCO2016
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From FinXX and CREATE-X trials: Integration of capecitabine into the taxane-anthracycline regimens did not
prolong RFS or overall survival Findings for TNBC need to be interpreted with caution (small sample size) Asian population for favourable results of CREATE-X From ABC trials: IDFS was significant for superiority of TaxAC relative to TC; high 4 yrs OS in both
groups. Minimal if any benefit in ER+/node negative cohorts Small benefit in ER+/1-3 node pos and ER-/node neg cohorts (2,0-2,5%) Large benefit in ER+/≥4 node pos and ER-/node pos cohorts (5,8-11,0%) From PANTHER trial: Higher doses of anthracycline and taxane are not necessarily better Difficult translation in daily practice Metanalysis support that dose dense delivery improves OS
The bridge to a cure Adjuvant chemotherapy: what’s news
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Qualità dell’evidenza SIGN
Raccomandazione clinica Forza della raccomandazione clinica
A Nelle pazienti con carcinoma mammario operato candidate a trattamento chemioterapico adiuvante, dovrebbe essere presa in considerazione una polichemioterapia197.
Positiva forte
A Nelle pazienti con carcinoma mammario operato candidate a chemioterapia adiuvante, dovrebbe essere preso in considerazione in prima intenzione un regime contenente antracicline e taxani in quanto superiore in DFS e in OS rispetto ai regimi senza taxani e contenenti dosi di antracicline simili o moderatamente maggiori198.
Positiva forte
Moderata (GRADE)
Nelle donne con carcinoma mammario operato linfonodi positivi, HER2-negative candidate a chemioterapia gli schemi a base di antracicline e taxani dose dense dovrebbero essere presi in considerazione in prima intenzione
Positiva forte
AIOM Breast Guidelines 2015
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A. Chan et al Lancet Oncology 2016
ExteNET Trial
Adjuvant chemotherapy: what’s news HER2+ EBC
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Waiting for some novel strategy in adjuvant tx …
New strategies to improve outcome in TNBC and HER+ EBC
• N=4800
• Operable HER2+ breast cancer
• Primary endpoint: IDFS
Standard chemotherapy (6-8 cycles) +
Trastuzumab q3 wks x 52 weeks
+ Pertuzumab q3 wks x 52 weeks
Standard chemotherapy (6-8 cycles) +
Trastuzumab q3 wks x 52 weeks
+ Placebo q3 wks x 52 weeks
R
NRG-BR003 Trial APHINITY TRIAL
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What’s news in 2016 for EBC treatment? Some strategies to improve outcomes and reduce side effects in
EBC
Endocrine therapy: for how long? Cytotoxic adjuvant chemotherapy: - patient’s selection (clinicopathological biomarker versus genomic tests) - which regimens ? - which dose? Bone targeting therapy
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ABCSG-18 Trial: The Impact of Adjuvant Denosumab in breast cancer
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ABCSG-18 Primary Endpoint Results (ASCO 2015)
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Sensitivity Analysis DFS (cross-over censored)
ABCSG-18: DSF Analysis
ITT Analysis
Presented M.Gnant at SABCS 2015
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Indirect comparison with bisphosphonates: Metanalyses
Lancet Oncology 2015 Oct, 386
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Conclusion: What’s news for EBC Treatment
Extended Endocrine therapy: yes / changing practice in high risk patients Cytotoxic adjuvant chemotherapy: - patient’s selection (clinicopathological biomarker versus genomic tests) not yet - which regimens ? Adjv CT must include anthracyclines. Anthra-free in special population (HER2 small tumors, low risk pts, cardiac comorbidities) - which dose? Dose dense should be considered in high risk patient Bone targeting therapy: Denosumab and bisphosphonates should be
considered in postmenopausal pts as adjuvant tx (19% RR in DFS and 18% RR in OS respectively)
Have we improved outcomes and efficacy ?
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Grazie