asco 2016 breast cancer review
TRANSCRIPT
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The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
ASCO Annual Meeting 2016 – Breast Cancer Robert Wesolowski, MD June 18, 2016
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Disclosures § Chair or Data Safety Monitoring Board for Helsinn, Inc § Advisory Board member for Agenus, Inc § Advisory Board member for Novartis (Afinitor) 2016
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Highlights § Extending aromatase inhibitor beyond 5 years:
MA17R Study (Plenary Session) § Addition of palbociclib to endocrine therapy for
untreated metastatic breast cancer: Paloma 2 Study § Novel CDK 4/6 inhibitor (abemaciclib): Monarch 2
Study § Role of anthracycline regimen in adjuvant
chemotherapy: ABC Trial
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Adjuvant Tamoxifen and Recurrence of ER(+) Breast Cancer
Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) Lancet 2011; 378: 771–84
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Pooled analysis ATLAS + aTTom:<br />Breast Cancer Mortality
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Slide 5
Presented By Paul Goss at 2016 ASCO Annual Meeting
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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
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MA.17R Hypothesis and Objectives Does extending AI therapy from 5 to 10 years further
improve patient outcomes? Primary Objective: § Disease Free Survival (from randomization to recurrence or
development of contralateral breast cancer (CBC), whichever came first)
Secondary Objectives: § Overall Survival
§ All CBC
§ Safety
§ Quality of life 8
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Slide 11
Presented By Paul Goss at 2016 ASCO Annual Meeting
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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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Presented By Paul Goss at 2016 ASCO Annual Meeting
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Slide 17
Presented By Paul Goss at 2016 ASCO Annual Meeting
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Conclusion § First study to show benefit of extending AI beyond 5 years
resulting in 34% reduction in disease recurrences § No worsening of QOL § No new toxicities § Bone health remains an important risk/benefit consideration § AI are readily accessible around the world
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CDK 4/6 Inhibitors
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Presented By Richard Finn at 2016 ASCO Annual Meeting
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Presented By Richard Finn at 2016 ASCO Annual Meeting
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Presented By Richard Finn at 2016 ASCO Annual Meeting
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PALOMA-2: Primary Results From a Phase 3 Trial of Palbociclib Plus Letrozole Compared With Placebo Plus Letrozole in Postmenopausal Women With ER+/HER2– Advanced Breast Cancer
Presented By Richard Finn at 2016 ASCO Annual Meeting
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Presented By Richard Finn at 2016 ASCO Annual Meeting
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Presented By Richard Finn at 2016 ASCO Annual Meeting
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Slide 14
Presented By Richard Finn at 2016 ASCO Annual Meeting
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Hematologic AEs ─All Causality
Presented By Richard Finn at 2016 ASCO Annual Meeting
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Non-hematologic AEs Occurring in ≥15% of Pts - All Causality
Presented By Richard Finn at 2016 ASCO Annual Meeting
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Consistent Clinical Benefit Seen Across PALOMA Studies
Presented By Richard Finn at 2016 ASCO Annual Meeting
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Presented By Richard Finn at 2016 ASCO Annual Meeting
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MONARCH 1<br />Results from a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for metastatic disease.
Presented By Maura Dickler at 2016 ASCO Annual Meeting
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Abemaciclib is a Selective Inhibitor of CDK4 & 6
Presented By Maura Dickler at 2016 ASCO Annual Meeting
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MONARCH 1: Phase 2 Study Design
Presented By Maura Dickler at 2016 ASCO Annual Meeting
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MONARCH 1: Response Summary
Presented By Maura Dickler at 2016 ASCO Annual Meeting
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MONARCH 1: Treatment Duration
Presented By Maura Dickler at 2016 ASCO Annual Meeting
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MONARCH 1: Most Common Adverse Events
Presented By Maura Dickler at 2016 ASCO Annual Meeting
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Adjuvant Chemotherapy
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US Oncology 9735 Study; 7 year follow up.
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Jones et al. J Clin Oncol 2009; 27:1177-83
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Background § 10 year mortality is reduced by ~30% with anthracycline and taxane
containing regimen vs. no chemotherapy. § 8 year mortality is further reduced by adding a taxane to anthracyclines
(RR=0.86; 95% CI 0.79-0.93). § Cardiac mortality increased by ~56% with anthracyclines (RR 1.56,
2p=0.02) § Increased risk of acute leukemia with anthracycline regimens (~1/200
patients) § Would TC regimen provide similar benefit to anthracycline and taxane
regimen but spare patients long therm cardiac toxicity and risk of AML?
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Lancet 2012;379:432-444
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Presented By Joanne Blum at 2016 ASCO Annual Meeting
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Timeline and Accrual of ABC Trials
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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Statistical Plan for ABC Trials
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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Statistical Plan for ABC Trials
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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ABC Trials<br />Patient Characteristics % all Patients
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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Results of Interim Analysis of ABC Trials
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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ABC Trials: Invasive Disease Free Survival
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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Forest Plot of IDFS By Stratification Variables
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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Slide 17
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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ABC Trials: First IDFS Events (N)
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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ABC Trials: Overall Survival
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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Conclusions
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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Rate Of Stomatitis in Everolimus Treated Patients
Bolero-2 Dexamethasone study
Number receiving Everolimus 485 92*
G1 Stomatitis 26% 17.4%
G2 Stomatitis 33% 2.4%
G3 Stomatitis 8% 0%
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10 mL of commercially available 0.5 mg/5 mL dexamethasone oral solution to swish x 2 min, and spit QID for 8 wks,
*86 patients were available for efficacy
Rugo et al. Abstract 525
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Thank You
Questions?
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