Chemotherapy or Not? Anthracycline or Not? Taxane or Not? Does Density Matter? Chemotherapy in Luminal Breast Cancer: Choice of Regimen.
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1 Chemotherapy in Luminal Breast Cancer: Choice of Regimen Andrew D. Seidman, MD Attending Physician Breast Cancer Medicine Service Memorial Sloan Kettering Cancer Center Professor of Medicine Weill Cornell Medical College Question Which of the following chemotherapy regimens are optimal options as adjuvant therapy for a 59 year old woman with a 1.7 cm., ER+, PR+, HER2 negative, node negative breast cancer with an 21 Gene Recurrence Score of 30? 1. doxorubicin, cyclophosphamide and docetaxel ( TAC ) 2. cyclophosphamide + methotrexate + fluorouracil (CMF) 3. doxorubicin + cyclophosphamide followed by a taxane (AC T) 4. docetaxel + cyclophosphamide ( TC ) 5. doxorubicin + cyclophosphamide (AC) 6. FEC or FAC The Questions: Choice of Chemotherapy for Luminal Breast Cancer Chemotherapy or Not? Anthracycline or Not? Taxane or Not? Does Density Matter? 1
2 It s All About The Talk Metastatic Breast Cancer 5 Historical Perspective 1985 NIH Consensus Conference: Premenopausal, node (+) : Chemotherapy Premenopausal, node ( ) : treatment not recommended, consider chemotherapy if "high risk" Postmenopausal, node (+), ER (+) : tamoxifen Postmenopausal, node (+), ER ( ) : consider chemotherapy, but cannot be recommended as standard practice Postmenopausal, node ( ) : no routine adjuvant therapy, may be considered for certain "high risk" patients 2
3 S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score of 25 or Less Ana M. Gonzalez Angulo, M.D. Primary Objective To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high RS by 21-Gene RS Assay Patients with 1-3 positive nodes, and HR+ and HER2- breast cancer with RS 25 DFS for patients treated with chemotherapy compared to no chemotherapy and dependence on the magnitude of RS. Determine the optimal cutpoint for recommending chemotherapy or not. Chemotherapy Second Generation Regimens Third Generation Regimens 3
4 Biologic Heterogeneity Mandates Individualized Treatment Approaches 21 Gene Recurrence Score (RS) Assay 16 Cancer and 5 Reference Genes From 3 Studies PROLIFERATION Ki 67 STK15 Survivin Cyclin B1 MYBL2 INVASION Stromelysin 3 Cathepsin L2 HER2 GRB7 HER2 ESTROGEN ER PR Bcl2 SCUBE2 GSTM1 BAG1 RS = x HER2 Group Score x ER Group Score x Proliferation Group Score x Invasion Group Score x CD x GSTM x BAG1 CD68 Category RS (0-100) REFERENCE Low risk RS <18 Beta actin Int risk RS 18 and <31 GAPDH RPLPO High risk RS 31 GUS TFRC Paik et al. N Engl J Med. 2004;351: Standardized Quantitative 21 Gene RS Assay: Node, ER + Recurrence at 10 Years 40% 35% 30% 25% 20% 15% Low Risk Group Intermediate Risk Group High Risk Group Distant 10% 5% 0% Recurrence Score Lower RS s Higher RS s Lower likelihood of recurrence Greater likelihood of recurrence Greater magnitude of TAM benefit Lower magnitude of TAM benefit Minimal, if any, chemotherapy benefit Clear chemotherapy benefit 1) Paik et al NEJM 2004, 2) Habel et al Breast Cancer Research ) Paik et al JCO 2006, 4) Gianni et al JCO
5 Adjuvant Chemotherapy Regimens CMF = AC CAF/FAC CEF/FEC DC AC P/D DAC(Tac) FEC P/D AC > wkly P ddac P Differential Benefits by Subtype? The Anthracyclines Have Been a Mainstay: Clear Benefits in Unselected Patients 3.7% 4.6% EBCTCG, Lancet 2005 OS Gennari A et al, JNCI
6 Anthracycline sensitivity in HER2 positives TOP2 Deleted TOP2 Normal TOP2 Amplified DiLeo SABCS 2008 (abs 705) Anthracycline for Luminals? Unique, serious, potential late toxicities (cardiac, AML, MDS) Total/near total alopecia Increased likelihood of nausea Some evidence of effectiveness in all subgroups Limited prospective, reproducible data demonstrating a lack of differential benefit in any subset Mixed retrospective, data demonstrating effectiveness limited to subsets Biomarker identification and testing is evolving Adjuvant CMF or AC vs Capecitabine in women >65 Capecitabine Alone for Selected Luminals? Muss et al, NEJM
7 Meta analysis: Adjuvant taxane vs no taxane: DFS De Laurentiis, M. et al. J Clin Oncol; 26: Copyright American Society of Clinical Oncology Meta analysis: Adjuvant taxane vs no taxane: OS Copyright American Society of Clinical Oncology De Laurentiis, M. et al. J Clin Oncol; 26: Disease-free Survival among Patients Treated with or without Paclitaxel According to Estrogen-Receptor Status and HER2 Expression Hayes DF et al. N Engl J Med 2007;357:
8 No paclitaxel benefit Each of these 3 subsets shows a statistically significant benefit from paclitaxel with small sample size E1199: Best Taxane for Luminal BC? Docetaxel Paclitaxel Secondary Comparisons: q3w q1w q3w q1w 5-Year DFS 81.2% 77.6% 76.9% 81.5% compared to paclitaxel l q3w Primary Comparisons: Paclitaxel vs. Docetaxel: HR: 1.032; P = 0.61 q3w vs. q1w: HR: 1.062; P = 0.33 Hormone Receptor Positive* Hormone Receptor Negative* HR: 1.23 HR: 1.09 HR: 1.0 HR: 1.27 P = 0.02 P = HR: 1.28 P = 0.03 HR: 1.08 HR: 1.15 HR: 0.96 HR: 1.0 HR: 1.0 HR: 1.20 HR: 1.40 P = Year OS 87.3% 86.2% 86.5% 89.7% compared to paclitaxel q3w * Exploratory analysis HR: 1.13 HR: 1.02 HR: 1.0 HR: 1.32 P = 0.01 Meta analysis of disease free survival (DFS) according to ER status for Taxanes Copyright American Society of Clinical Oncology De Laurentiis, M. et al. J Clin Oncol; 26:
9 Meta analysis of disease free survival (DFS) according to HER 2 status De Laurentiis, M. et al. J Clin Oncol; 26: Copyright American Society of Clinical Oncology Weekly Paclitaxel was equally superior to every 3 Week Paclitaxel in Luminal or Triple Negs in E1199 HR HER2 No. DFS OS Pos Neg (0.97, 1.72) p=0.05 Neg Neg (0.98, 1.93 P=0.07 (0.92, 2.00) p= (0.91, 1.94) P=0.14 Taxane OR Anthracycline for Luminal BC?: US Oncology 9735 AC x 4 q3w Doxorubicin (60 mg/m 2 ) Cyclophosphamide (600 mg/m 2 ) N= % ER+ 48% N R n=510 TC x 4 q3w Docetaxel (75 mg/m 2 ) Cyclophosphamide (600 mg/m 2 ) n=506 Eligibility: Stage I, II, or III disease Jones et al. J Clin Oncol. 2006;24:
10 TC vs AC: DFS and OS From: Jones, S. et al. J Clin Oncol; 27: Copyright American Society of Clinical Oncology Summary of unplanned, exploratory analyses of disease-free survival hazard ratios (HR) and CI Docetaxel/cyclophosphamide (TC) is favored left of 1. Jones S et al. JCO 2009;27: by American Society of Clinical Oncology US Oncology TC versus TAC in HER2 ( ): (Relative Contribution of A added to to T in Luminals?) N = % power to detect a 3.4% DFS advantage for the anthracycline From: USOncologyResearch/X_ClinicalResearch/X_ClinicalTrialsDetail?PSTUDYNUM=06090 PI: J. Blum 10
11 If AC or Paclitaxel, 4 = 6 D U R A T I O N 6 vs 4 Rx Paclitaxel vs AC PI: L. Shulman Does Dose Density Matter in Luminal Breast Cancer? Conventional Schedule Dose Dense Schedule 1,000,000,000,000 Cell number 10,000,000, ,000,000 1,000,000 10, Weeks ChemoRx Benefit as Function of ER Status: 20 Year Experience of CALGB & U.S. Intergroup DFS OS Average hazard reduction (confidence interval) ER 8541 Lo Hi 36% (15 to 52%) 9344 No Tax Tax 25% (11 to 36%) 9741 q3 q2 23% (0 to 42%) Overall Lo q2 63% (43 to 76%) Neg (15 to 52%) (11 to 36%) (0 to 42%) (43 to 76%) Pos Neg Pos *After adjusting, no significant differences Berry DA, et al. JAMA % (-18 to 37%) 29% (3 to 48%) 8% (-27 to 36%) 12% (-4 to 25%) 25% (11 to 37%) 10% (-10 to 26%) 10% (-19 to 33%) 22% (-5 to 43%) 1% (-44 to 32%) 32% (-7 to 56%) 59% (34 to 74%) 18% (-41 to 52%) 11
12 ChemoRx Benefit as Function of ER Status: 20 Year Experience of CALGB & U.S. Intergroup DFS CALGB 8541 DFS CALGB 9344 DFS CALGB 9741 ER Positive ER R Negative Berry DA, et al. JAMA 2006 Years Years Years Ultimately, It May Be What Comes AFTER ChemoRx That Matters Most in Luminal BCs! COMPARISON OF TAILORX AND MINDACT TRIALS TAILORx MINDACT Groups TBCI BIG Population Node neg, ER+ Node neg, ER+/ Assay 21 gene RS 70 gene Prognostic Signature Utility Scale & Level of Evidence + or ++ II + or ++ III Tissue FPET Fresh or frozen Accrual Goal ~10,500 ~6,000 Randomized group RS (40%) Discordant risk (32%) Treat with hormones Treat by Randomization +/ chemotherapy clinical vs. genomic risk Non randomized groups RS < 11: Hormones RS > 25: Chemo + hormones Both low risk (13%):Hormones Both high risk (55%): Chemo hormones 12
13 Question Which of the following chemotherapy regimens are optimal options as adjuvant therapy for a 59 year old woman with a 1.7 cm., ER+, PR+, HER2 negative, node negative breast cancer with an 21 Gene Recurrence Score of 30? 1. doxorubicin, cyclophosphamide and docetaxel ( TAC ) 2. cyclophosphamide + methotrexate + fluorouracil (CMF) 3. doxorubicin + cyclophosphamide followed by a taxane (AC T) 4. docetaxel + cyclophosphamide ( TC ) 5. doxorubicin + cyclophosphamide (AC) 6. FEC or FAC My Choice: CMF Take Home Points: Adjuvant Chemotherapy for Luminal A Breast Cancer Relative benefit of chemotherapy in this intrinsic subset is modest Anti estrogen therapy plays a (the) major role in risk reduction Incremental differences in efficacy between 1 st, 2 nd, and 3 rd generation regimens are negligible while differences in early and late toxicities may not be First do no harm, or at least first do as little harm as possible 13
14 It s Our Time 14
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