Breast Cancer Highlights- ASCO 2015 Banu Arun, M.D. Professor, Breast Medical Oncology Co-Director Clinical Cancer Genetics The University of Texas MD Anderson Cancer Center Bangkok, August, 2015
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Phase III, randomized study of trastuzumab emtansine ± pertuzumab vs trastuzumab + taxane for first-line treatment of HER2-positive MBC: Primary results from the MARIANNE study
Presented By Paul Ellis at 2015 ASCO Annual Meeting
MARIANNE Study Design
Presented By Shanu Modi at 2015 ASCO Annual Meeting
MARIANNE: Progression-Free Survival
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Overall Survival (First Interim Analysis)
Presented By Paul Ellis at 2015 ASCO Annual Meeting
Maintenance of Health-Related Quality of Life
Presented By Paul Ellis at 2015 ASCO Annual Meeting
Overview of Adverse Events
Presented By Paul Ellis at 2015 ASCO Annual Meeting
MARIANNE: Toxicities
Presented By Shanu Modi at 2015 ASCO Annual Meeting
MARIANNE: CLINICAL IMPACT
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Clinical Pathway HER2+ MBC: 2015
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Future for T-DM1
Presented By Shanu Modi at 2015 ASCO Annual Meeting
ATEMPT: Adjuvant HER2+Trial (TBCRC 033)
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Slide 19
Presented By Shanu Modi at 2015 ASCO Annual Meeting
L Gianni, T Pienkowski, Y-H Im, L-M Tseng, M-C Liu, A Lluch, <br />E Starosławska, J de la Haba-Rodriguez, S-A Im, JL Pedrini, B Poirier, <br />P Morandi, V Semiglazov, V
Srimuninnimit, GV Bianchi, <br />V McNally, H Douthwaite, G Ross, P Valagussa
Presented By Luca Gianni at 2015 ASCO Annual Meeting
NeoSphere: study design and objectives
Presented By Luca Gianni at 2015 ASCO Annual Meeting
NeoSphere: study design and pCR results
Presented By Luca Gianni at 2015 ASCO Annual Meeting
NeoSphere: Phase 2 Neoadjuvant HER2+ Study
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Slide 5
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Adjuvant ExteNET Study Design
Presented By Shanu Modi at 2015 ASCO Annual Meeting
ExteNET Trial: Invasive DFS, N=2840<br />
Presented By Shanu Modi at 2015 ASCO Annual Meeting
HERA: OS<br />(Duration Question: 2y vs 1y)
Presented By Shanu Modi at 2015 ASCO Annual Meeting
ExteNET vs ALTTO and HERA : <br />Why the discrepancy?
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Safety (Adverse Events ≥10%)
Presented By Shanu Modi at 2015 ASCO Annual Meeting
CONCLUSIONS: HER2+ Breast Cancer
Presented By Shanu Modi at 2015 ASCO Annual Meeting
Abstract LBA502 <br /><br /> A Double Blind Phase 3 Trial of Fulvestrant With or Without Palbociclib in Pre- and Post-menopausal Women With Hormone Receptor-positive, HER2-
negative Advanced Breast Cancer That Progressed on Prior Endocrine Therapy<br />(PALOMA3 Study)
Presented By Nicholas Turner at 2015 ASCO Annual Meeting
Slide 2
Presented By Nicholas Turner at 2015 ASCO Annual Meeting
Palbociclib
Presented By Nicholas Turner at 2015 ASCO Annual Meeting
PALOMA3 Study Design
Presented By Nicholas Turner at 2015 ASCO Annual Meeting
Study Endpoints
Presented By Nicholas Turner at 2015 ASCO Annual Meeting
Adverse Events—All Cause
Presented By Nicholas Turner at 2015 ASCO Annual Meeting
Primary Endpoint: PFS (ITT Population)
Presented By Nicholas Turner at 2015 ASCO Annual Meeting
Summary of Key Secondary Efficacy Endpoints
Presented By Nicholas Turner at 2015 ASCO Annual Meeting
Implications
● First line: Paloma-1 Letrozole +/-palpbociclib
● Second line: Bolero-2 Exemestane +/-
everolimus or fulvestrant +/- everolimus
● None showed survival benefit
● Increased toxicity
TITAN: Phase 3 Study of Doxorubicin/Cyclophosphamide (AC) followed by Ixabepilone (Ixa) or Paclitaxel (Pac) in Early-Stage Triple Negative Breast Cancer
Presented By Denise Yardley at 2015 ASCO Annual Meeting
Study Design
Presented By Denise Yardley at 2015 ASCO Annual Meeting
Key Eligibility Criteria<br />
Presented By Denise Yardley at 2015 ASCO Annual Meeting
Hematologic Toxicity
Presented By Denise Yardley at 2015 ASCO Annual Meeting
Non-Hematologic Toxicity (≥ 10%)
Presented By Denise Yardley at 2015 ASCO Annual Meeting
Disease-Free Survival (N=614)
Presented By Denise Yardley at 2015 ASCO Annual Meeting
Overall Survival (N=614)
Presented By Denise Yardley at 2015 ASCO Annual Meeting
Conclusions
Presented By Denise Yardley at 2015 ASCO Annual Meeting
Primary Results of NRG Oncology/NSABP B-35: <br />A Clinical Trial of Anastrozole vs Tamoxifen in <br />Postmenopausal Patients with DCIS
Presented By Richard Margolese at 2015 ASCO Annual Meeting
Slide 5
Presented By Richard Margolese at 2015 ASCO Annual Meeting
N=3,104
Slide 7
Presented By Richard Margolese at 2015 ASCO Annual Meeting
Slide 8
Presented By Richard Margolese at 2015 ASCO Annual Meeting
Slide 12
Presented By Richard Margolese at 2015 ASCO Annual Meeting
B-35: Other Secondary Endpoints
Presented By Richard Margolese at 2015 ASCO Annual Meeting
Slide 14
Presented By Richard Margolese at 2015 ASCO Annual Meeting
Slide 17
Presented By Richard Margolese at 2015 ASCO Annual Meeting
B-35: Average Annual Rate and <br />Number of Uterine Cancers
Presented By Richard Margolese at 2015 ASCO Annual Meeting
B-35: Thromboembolic Events
Presented By Richard Margolese at 2015 ASCO Annual Meeting
B-35: Average Annual Rate and <br />Number of Osteoporotic Fractures
Presented By Richard Margolese at 2015 ASCO Annual Meeting