Manejo do câncer de mama RH+ na adjuvância: o que há de novo?
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1 II Simpósio Internacional de Câncer de Mama para o Oncologista Clínico Manejo do câncer de mama RH+ na adjuvância: o que há de novo? INGRID A. MAYER, MD, MSCI Assistant Professor of Medicine Director, Clinical Core of Breast Cancer SPORE Division of Hematology/Oncology Vanderbilt University
2 Adjuvant Endocrine Therapy for ER+ Breast Cancer EGFR HER2 Growth factor receptor Estrogen Oophorectomy Cytoplasm RAS RAF MEK MAPK SOS GRB2 Shc PI3K Akt/ m-tor Estrogen receptor Aromatase inhibitors (AIs) Nonsteroidal AIs Anastrozole Letrozole Steroidal AIs Exemestane Nucleus P P AF1 AF1 DBD DBD Cofactor complex LBD LBD P Cell growth Selective estrogen receptor modulators (SERMs) Tamoxifen Toremifene Adapted from Yardley DA, et al. J Clin Oncol. 2011;29(suppl 27). Abstract 268.
3 Impact of adjuvant endocrine therapy (Tamoxifen) ~ 50% Risk reduction ~ 30% Risk reduction Early Breast Cancer Collaborative Trialists Group (EBCCTG) 2011
4 AI adjuvant phase III trials for postmenopausal women J Clin Oncol; 26:
5 Meta-analysis of breast cancer outcomes in adjuvant trials: 5 years of AI vs. Tamoxifen Recurrence Mortality Dowsett M et al. JCO 2010;28:
6 Meta-analysis of breast cancer outcomes in adjuvant trials: Tamoxifen x 5 years vs. Tamoxifen AI x 5 years Recurrence Mortality Dowsett M et al. JCO 2010;28:
7 Long-Term Risk of Breast Cancer Recurrence More than 50% of women who take 5 years of endocrine therapy will have a recurrence after year hazard rate ER/PgR+ (n=2257) ER/PgR (n=1305) 0.2 Recurrence Years Saphner et al. J Clin Oncol. 1996;14:2738
8 Adjuvant tamoxifen for 10 years versus 5 years in ER+ breast cancer: ATLAS, a phase III randomized trial ~50% were premenopausal ~50% were postmenopausal Lancet 2012
9 ATLAS: recurrence and mortality benefits Lancet 2012
10 ATLAS: breast CA vs. other causes mortality Lancet 2012
11 attom: 10 vs. 5 years Tamoxifen N=6953 Note: ~ 50% of women participating in the trial had unknown ER status! Recurrence RR = 0.85 (95% CI ; p=0.003) - Absolute reduction 4% Mortality RR = 0.88 (95% CI ; p=0.06) - Absolute reduction 2% Gray et al. Abstract 5, ASCO 2013
12 Impact of menopausal status at initial diagnosis of breast cancer in women in the JMA.17 trial - DFS Pre-menopausal women at diagnosis derive the most benefit from this strategy Goss P E et al. Ann Oncol 2013;24:
13 Optimal duration of extended AI therapy? JMA.17 (N= 5,187) JMA.17R (N= 1,800) Tamoxifen x 5 y (post-menopausal women) Letrozole x 5 years Placebo x 5 years Letrozole x 5 years Placebo x 5 years
14 Possible Surrogate Markers for Hormone Resistance LUM A LUM B ER PR HER2 RS Low Ki-67 High Ki-67 Hormone-sensitive Hormone-resistant
15 Risk of Distant Recurrence Using Oncotype DX (21-Gene RS) in Patients Treated with Anastrozole or Tamoxifen: ATTAC Study Objective was to evaluate the prognostic ability of 21-gene RS assay in patients treated in ATAC study RS score was predictive of risk of recurrence in postmenopausal patients with ER+ with either node negative or node positive disease being treated with either tamoxifen or anastrozole Rate of Distant Recurrence at 9 Years Population N Low RS Intermediate RS High RS Lymph Node Negative 872 4% 10% 22% Tamoxifen 432 3% 10% 30% Anastrozole 440 4% 11% 12% Lymph Node Positive % 27% 46% Tamoxifen % 28% 42% Anastrozole % 25% 50% Dowsett et al. SABCS 2008, Abstract 53
16 Recurrence Score in LN+ (1-3) ER+ breast cancer S1007 SWOG Gonzalez-Angulo
17 Combined Targeting of ER and Growth Factor Receptor Pathways EGFR HER2 Growth factor receptor Estrogen Oophorectomy Cytoplasm Nucleus RAS RAF mtor inhibitors Everolimus Sirolimus Temsirolimus MEK MAPK SOS P AF1 AF1 GRB2 P Shc DBD PI3K Akt/ m-tor DBD Cofactor complex LBD LBD P Estrogen receptor Cell growth Aromatase inhibitors (AIs) Nonsteroidal AIs Anastrozole Letrozole Steroidal AIs Exemestane Estrogen receptor downregulator (ERD) Fulvestrant Selective estrogen receptor modulators (SERMs) Tamoxifen Toremifene Adapted from Yardley DA, et al. J Clin Oncol. 2011;29(suppl 27). Abstract 268.
18 SWOG and UNIRAD: Everolimus in the Adjuvant High-Risk Breast Cancer Setting SWOG-NSABP 1,2 Phase 3 study; N = 3,500 Pre and postmenopausal women with HR + HER2 breast cancer Prior standard neoadjuvant or adjuvant chemotherapy Everolimus 10 mg/day for 1 y + endocrine therapy for 5 y Placebo for 1 y + endocrine therapy for 5 y Primary endpoint: Invasive DFS Secondary endpoints: OS, DRFS, biomarkers, safety Stratification: Node negative (all RS > 25) 1-3 positive lymph nodes (all RS > 25) 4 positive lymph nodes and RS 25 4 positive lymph nodes and RS > 25 Neoadjuvant chemotherapy UNIRAD 3 Phase 3 study; N = 1,984 Pre and postmenopausal women with HR + HER2 breast cancer ( 4+ nodes) Relapse-free after 3 y of adjuvant endocrine therapy Everolimus 10 mg/day for 2 y + AI or tamoxifen Placebo for 2 y + AI or tamoxifen Primary endpoint: DFS at 2 y Secondary endpoints: OS, biomarkers, safety Stratification: Endocrine therapy (tamoxifen vs AIs) Adjuvant chemotherapy (previous adjuvant vs neoadjuvant chemotherapy) 1. Chavez-MacGregor M, et al. SABCS 2012; Abstract OT (poster) Accessed January 15, 2013; 3. Andre F, et al. St. Gallen Poster 220.
19 A phase II neoadjuvant trial of BKM120 or BYL719 in combination with letrozole in post-menopausal patients with operable ER+ breast cancer Breast Cancer Stage II/III ER+/HER2 Post-menopausal (N=360) Ki-67 TUNEL P-Akt, etc. Mutation analysis microarrays RPPA Biopsy 1:1:1 3 weeks Arm 1: Letrozole BKM120 Arm 2: Letrozole BYL719 Arm 3: Letrozole Placebo Biopsy Ki-67 TUNEL P-Akt, etc microarrays RPPA 21 weeks Letrozole BKM120 Letrozole BYL719 Letrozole Placebo Surgery Path CR PEPI score Clinical Response Whole exome analysis Mayer, VICC/ SU2C
20 Phase III Study Evaluating Palbociclib (PD ), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in Patients With Hormone-receptor-positive, HER2-normal Primary Breast Cancer With High Relapse Risk After Neoadjuvant Chemotherapy "PENELOPE-B Pre- and postmenopausal women: ER+ early breast cancer + High risk of relapse (high CPS-EG score*) + No pcr after neoadjuvant taxanecontaining chemotherapy Endocrine therapy + Palbociclib x 1 year Endocrine therapy + Placebo x 1 year 1ary Endpoint: Invasive Disease - Free Survival (idfs) * clinical-pathologic stage - estrogen/grade GBG78/BIG 1-13
21 How do we chose the appropriate adjuvant endocrine therapy agent? Tamoxifen Aromatase Inhibitors Better day/day tolerance but: Risk of thromboembolic events Risk for uterine cancers Worse day/day tolerance: Fatigue Vasomotor symptoms Arthralgia Osteoporosis But potentially more efficacious for resistant tumors
22 How do we chose the appropriate adjuvant endocrine therapy agent? Upfront AI x 5 years Tamoxifen x 2-3 y + AI x 2-3 years Early benefit: Minimize risk of early relapse that could translate into long-term benefit Two effective agents: Minimize risk of late recurrence, hoping that shortterm losses will be more than compensated by long-term gains
23 How do we chose the appropriate duration of adjuvant endocrine therapy? 5 years 10 years Less toxic Potentially enough for low risk cases Better for late relapses, should be considered for high risk cases
24 How do we chose adjuvant endocrine therapy? Menopausal Status/ Clinical Setting Options Duration of Tamoxifen Duration of AI Total duration POST PRE At adjuvant endocrine therapy start AI monotherapy N/A 5 years 5 years Tam AI 2-3 years 2-3 years 5 years Middle of Tamoxifen Tam AI 2-3 years 2-3 years 5 years Middle of AI AI Tam 2-3 years 2-3 years 5 years At 5 years of Tamoxifen completion Tam AI 5 years 5 years 10 years Tam monotherapy Tam monotherapy 10 years N/A 10 years 10 years N/A 10 years
25 How do we chose adjuvant endocrine therapy? Menopausal Status/ Clinical Setting PERI At adjuvant endocrine therapy start Options Tam monotherapy Duration of Tamoxifen Duration of AI Total duration 10 years N/A 10 years Middle of Tamoxifen 2-3 years 2-3 years 5 years Tam AI* * At 5 years of Tamoxifen completion Tam AI* 5 years 5 years 10 years * Only if post-menopausal status is established at the time of the switch
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