ASCO 2016 Breast Cancer Review
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Transcript of ASCO 2016 Breast Cancer Review
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
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
Pooled analysis ATLAS + aTTom:<br />Breast Cancer Mortality
Slide 5
Presented By Paul Goss at 2016 ASCO Annual Meeting
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
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
Slide 11
Presented By Paul Goss at 2016 ASCO Annual Meeting
Presented By Paul Goss at 2016 ASCO Annual Meeting
<br />MA.17R - DFS by pre-specified subgroups<br />
Presented By Paul Goss at 2016 ASCO Annual Meeting
Presented By Paul Goss at 2016 ASCO Annual Meeting
Slide 17
Presented By Paul Goss at 2016 ASCO Annual Meeting
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
Presented By Richard Finn at 2016 ASCO Annual Meeting
Presented By Richard Finn at 2016 ASCO Annual Meeting
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
Presented By Richard Finn at 2016 ASCO Annual Meeting
Presented By Richard Finn at 2016 ASCO Annual Meeting
Slide 14
Presented By Richard Finn at 2016 ASCO Annual Meeting
Hematologic AEs ─All Causality
Presented By Richard Finn at 2016 ASCO Annual Meeting
Non-hematologic AEs Occurring in ≥15% of Pts - All Causality
Presented By Richard Finn at 2016 ASCO Annual Meeting
Consistent Clinical Benefit Seen Across PALOMA Studies
Presented By Richard Finn at 2016 ASCO Annual Meeting
Presented By Richard Finn at 2016 ASCO Annual Meeting
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
Abemaciclib is a Selective Inhibitor of CDK4 & 6
Presented By Maura Dickler at 2016 ASCO Annual Meeting
MONARCH 1: Phase 2 Study Design
Presented By Maura Dickler at 2016 ASCO Annual Meeting
MONARCH 1: Response Summary
Presented By Maura Dickler at 2016 ASCO Annual Meeting
MONARCH 1: Treatment Duration
Presented By Maura Dickler at 2016 ASCO Annual Meeting
MONARCH 1: Most Common Adverse Events
Presented By Maura Dickler at 2016 ASCO Annual Meeting
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
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
Presented By Joanne Blum at 2016 ASCO Annual Meeting
Timeline and Accrual of ABC Trials
Presented By Joanne Blum at 2016 ASCO Annual Meeting
Statistical Plan for ABC Trials
Presented By Joanne Blum at 2016 ASCO Annual Meeting
Statistical Plan for ABC Trials
Presented By Joanne Blum at 2016 ASCO Annual Meeting
ABC Trials<br />Patient Characteristics % all Patients
Presented By Joanne Blum at 2016 ASCO Annual Meeting
Results of Interim Analysis of ABC Trials
Presented By Joanne Blum at 2016 ASCO Annual Meeting
ABC Trials: Invasive Disease Free Survival
Presented By Joanne Blum at 2016 ASCO Annual Meeting
Forest Plot of IDFS By Stratification Variables
Presented By Joanne Blum at 2016 ASCO Annual Meeting
Slide 17
Presented By Joanne Blum at 2016 ASCO Annual Meeting
ABC Trials: First IDFS Events (N)
Presented By Joanne Blum at 2016 ASCO Annual Meeting
ABC Trials: Overall Survival
Presented By Joanne Blum at 2016 ASCO Annual Meeting
Conclusions
Presented By Joanne Blum at 2016 ASCO Annual Meeting
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
Thank You
Questions?
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