Role of chemotherapy in BRCA and Triple negative breast cancer. Fernando Moreno Servicio de Oncología Médica Hospital Clinico San Carlos
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1 Role of chemotherapy in BRCA and Triple negative breast cancer Fernando Moreno Servicio de Oncología Médica Hospital Clinico San Carlos
2 Association between TNBC & germline mutations in BRCA 1/2
3 TNBC is heterogeneous Invasive Ductal Carcinoma high grade Invasive Lobular Carcinoma high grade, pleomorphic High grade neuroendocrine Metaplastic, high grade Myoepithelial carcinoma Medullary Apocrine Adenoid-cystic Metaplastic, low grade Poor prognosis Good prognosis
4 Prat A, Perou C. Molecular Oncology 2010 TNBC gene expression profiles
5 Heterogeneous disease Heterogeneous response
6 TNBC and treatment. What do we know? Chemotherapy is the only known therapy Everything else is theory
7 (Neo)adjuvant treatment TNBC
8 Neo-adjuvant Chemotherapy Choices Conventional Chemotherapy Classification Residual Disease pcr Basal-like 47 (58%) 34 (42%) Claudin-low 29 (67%) 14 (33%) HER2-enriched 31 (63%) 18 (37%) LumA 110 (98%) 2 /2%) 360 patients Anthracycline/taxane treated Modified PAM50 molecular subtyping Overall pathologic complete response rate (pcr) 22% LumB 56 (85%) 10 (15%) Normal-like 13 (76%) 4 (24%) Basal-like and claudin-low (majority of TNBC) are sensitive to conventional agents Cheang et al, SABCS 2011
9
10 Probability of Being Alive Responsiveness to Neoadjuvant Conventional Chemotherapy TNBC often responsive to conventional NAC with good outcome similar to other subtypes < pcr = poorer outcome % 94% 88% P =.24 P = % 0.6 pcr/non-tnbc 0.5 pcr/tnbc RD/non-TNBC RD/TNBC Yrs After Surgery Liedtke C, et al. J Clin Oncol. 2008;26:
11 Platinum salts Bevacizumab Optimizing Taxanes Are There Better Choices? Neoadjuvant Trials in TNBC Anthracyclines free regimens Nab-paclitaxel
12 Platinum salts Bevacizumab Optimizing Taxanes Are There Better Choices? Neoadjuvant Trials in TNBC Anthracyclines free regimens Nab-paclitaxel
13 Randomized phase II neoadjuvant add-on carboplatin studies in unselected TNBC
14 Alba et al BCRT2012 GEICAM/ : Study design Docetaxel 100 mg/m2 x 4 Epirubicin 90 mg/m2 x 4 Cyclophosphamide 600 mg/m2 x 4 Docetaxel 75 mg/m2 x 4 Carboplatin AUC 6 x 4
15 Alba et al BCRT2012 GEICAM : pcr Breast/Axilla (ypt0/is N0) Docetaxel Docetaxel Carboplatin + Docetaxel Carboplatin + Docetaxel
16 GeparSixto: Therapy Therapy in TNBC in TNBC subgroup subgroup N=315 centrally confirmed TNBC R PM Surgery PMCb Paclitaxel 80 mg/m² q1w Non-pegylated liposomal doxorubicin 20 mg/m² q1w Carboplatin AUC 1.5-2* q1w TNBC: Bevacizumab 15 mg/kg q3w Von Minckwitz et al. Lancet Oncol 2014 von Minckwitz et al. Lancet Oncology, May 2014 Presented at the 2013 ASCO Annual Meeting. Presented data is the property of GBG and AGO-B.
17 ates Overall and in TNBC Subgroup GeparSixto: pcr (ypt0 N0) Rates in TNBC subgroup ypt0 ypn0 rall TNBC ) 107* OR 1.94 ( ) P=0.005 N=295 N=157 N=158 < 0.02 Von Minckwitz et al. Lancet Oncol 2014 on Minckwitz et al. Lancet Oncology, May 2014
18 GeparSixto: DFS in TNBC subgroup von Minckwitz G, et al. SABCS Abstract S2-04.
19 Sikov W, et al. SABCS 2014 CALGB 40603: Study Design
20 San Antonio Breast Cancer Symposium Cancer Therapy and Research Center at UT Health Science Cente CALGB CALGB 40603: pcr 40603: pcr Breast/Axilla pcr Breast/Axilla (ypt0/is (ypt0/is N0) (ypt0/is N0) +/- Carboplatin +/- Bevaci 41% (35-48%) 54% (48-61%) Odds ratio: 1.71 p = % (38-51%) Odds ratio p = 0.0 N=212 N=221 N=218 Sikov W, et al. SABCS 2014 This presentation is the intellectual property of William Sikov, MD. Contact at wsikov@lifespan.org for pe
21 CALGB 40603: DFS in TNBC subgroup SABCS Sikov W, et al. SABCS 2015
22 TNBC neoadjuvant platinum data in context GeparSixto and CALGB show increase in pcr with carboplatin Toxicity increased. Higher discontinuation rate Not conclusive benefit in EFS: Different chemotherapy regimens Different carboplatin schedule (3w/w) Bevacizumab included in both trials Neither trials designed to detect an improvement in EFS
23 TNBC neoadjuvant platinum data in context Optimal way of intoducing carboplatin into combination regimens to be defined Highlights need for biomarkers of platinum response. Germline BRCA mutation status (GeparSixto, PrECOG 0105) Genomic scar due to HR defects (GeparSixto, PrECOG 0105) Tumor lymphocytic infiltration (GeparSixto, PrECOG 0105)
24 TNBC neoadjuvant platinum data in context Optimal way of intoducing carboplatin into combination regimens to be defined Highlights need for biomarkers of platinum response. Germline BRCA mutation status (GeparSixto, PrECOG 0105) Genomic scar due to HR defects (GeparSixto, PrECOG 0105) Tumor lymphocytic infiltration (GeparSixto, PrECOG 0105)
25 BRCA 1/2 mutant breast cancer & Response
26 Telli ML. ASCO 2013
27 Telli ML. ASCO 2013 Results PrECOG 0105
28 SIS OF THE RANDOMIZED PHASE II TRIAL INVESTIGATING THE ADDITION OF CARBOPLATIN TO NEOADJ OSITIVE EARLY BREAST CANCER (GEPARSIXTO) Speaker: Gunter von Minckwitz GeparSixto: pcr Rates by gbrca Status and Carboplatin in TNBC Von Minckwitz G, SABCS 2015
29 GeparSixto: DFS by gbrca Status and Carboplatin in TNBC Von Minckwitz G, SABCS 2015
30 TNBC neoadjuvant platinum data in context Optimal way of intoducing carboplatin into combination regimens to be defined Highlights need for biomarkers of platinum response. Germline BRCA mutation status (GeparSixto, PrECOG 0105) Genomic scar due to HR defects (GeparSixto, PrECOG 0105) Tumor lymphocytic infiltration (GeparSixto, PrECOG 0105)
31 Homologous recombination defects in Homologous breast cancer recombination defects in breast cancer HR deficiency characterizes breast HR cancers deficiency in BRCA 1/2 characterizes mutation breast carriers cancers in BRCA1/2 mutation carriers Due to loss of heterozygosity at BRCA1 or BRCA2 Due to loss of heterozygosity at BRCA1 or BRCA2 HR deficiency implicated in sporadic TNBC Methylation HR deficiency Somatic mutation implicated in sporadic TNBC Other epigenetic mechanisms Methylation Identifies non-brca 1/2 carriers with Somatic BRCA-like mutation cancers who may benefit Other from epigenetic DNA repair-targeted mechanisms strategies Roy R, et al. Nat Rev Cancer Dec 23;12(1):68-78
32 Favorable response (RCB 0/1) by HRD Score PrECOG 0105: Favorable response RCB 0/1 by HRD Score HRD < 10 (n=20) HRD 10 (n=57) Proportion of patients (%) Telli ML. ASCO 2013 elli ML, et al. SABCS 2012 p =
33 pcr Rates by Treatment Arms GeparSixto: pcr Rates (ypt0 by treatment ypn0) arm (ypt0 N0) PM PMCb 100% OR 2.05 ( ) P= % OR 4.13 ( ) P= % 60% 20.0% 33.9% 80% 60% 29.6% 63.5% 40% 40% 20% 20% 0% HR non-deficient HR deficient HR non-deficient HR deficient N=30 N=62 N=27 N=74 0% Test for interaction p=0.327
34 TNBC neoadjuvant platinum data in context Optimal way of intoducing carboplatin into combination regimens to be defined Highlights need for biomarkers of platinum response. Germline BRCA mutation status (GeparSixto, PrECOG 0105) Genomic scar due to HR defects (GeparSixto, PrECOG 0105) Tumor lymphocytic infiltration (GeparSixto, PrECOG 0105)
35 PrECOG 0105: TILs significantly associate with pathologic response by RCB value in multivariate models Vinayak et al ASCO Abst#1000
36 Increased TILs predict benefit from addition of carboplatin to NACT for TN and HER2+ early BC in the GeparSixto trial Denkert et al SABCS S1-6
37 Platinum salts Bevacizumab Optimizing Taxanes Are There Better Choices? Neoadjuvant Trials in TNBC Anthracyclines free regimens Nab-paclitaxel
38 Anti-angiogenesis in NA setting Bear et al & Von Minckwitz et al NEJM 2012; Burnstein Nat Rev Clin Oncol
39 Patients (%) pcr with Bevacizumab + Chemotherapy in TNBC 39% 28% Chemotherapy: EC docetaxel docetaxel AC Von Minckwitz et al. NEJM 2012; Bear et al. NEJM 2012
40 Patients (%) pcr with Bevacizumab + Chemotherapy in TNBC 60 BEV + CT CT alone p= p= % 60% 53% 20 28% 10 0 GeparQuinto (N=663) NSABP-B40 Chemotherapy: EC docetaxel docetaxel AC Von Minckwitz et al. NEJM 2012; Bear et al. NEJM 2012
41 CALGB 40603: pcr Breast and Breast/Axilla pcr Breast pcr Breast and Axilla Sikov W. JCO 2014
42 CALGB 40603: pcr in Basal-like subtype pcr Breast pcr Breast and Axilla SABCS 2 Sikov W. SABCS 2014
43 BEATRICE TRIAL: Bevacizumab in TNBC adjuvant setting Cameron D et al. Lancet Oncol 2013 (SABCS 2012) 43
44 BEATRICE TRIAL: Bevacizumab in TNBC adjuvant setting HR=0.87 (95% CI: ) 3-year IDFS 82.7% vs 83.7% (p=0.18) Cameron D et al. Lancet Oncol 2013 (SABCS 2012) 44
45 Platinum salts Bevacizumab Optimizing Taxanes Are There Better Choices? Neoadjuvant Trials in TNBC Anthracyclines free regimens Nab-paclitaxel
46 Genomic predictors of response to doxorubicin vs docetaxel in primary breast cancer pcr+i p=0.029 R ADM 75mg/m2 q3w x 4 cy DOC 100mg/m2+ G-CSF q3w x 4 cy n=204 pt S U R G E R Y 4 3,5 RCB p= ,5 2 1,5 doxorubicin docetaxel Martin M et al, Br Cancer Res Treat 128:127, ,5 0 lum A lum B HER2-E CLOW basal-like
47 pcr rates with platinum/taxane regimens in TNBC Platinum/Taxane pcr Definition Reference Paclitaxel/Cb 67% breast and axilla Sikov et al Paclitaxel/Cb 33% breast and axilla Chen et al Docetaxel/Cb 44% breast and axilla Roy et al Docetaxel/Cb 77% breast Kern et al Docetaxel/Cb 55% breast Chang et al Von Minckwitz & Martin Ann Oncol 2012; Arun et al JCO
48 Sharma P, et al. Neoadjuvant Carboplatin/Docetaxel TNBC
49 % Carboplatin/Docetaxel pcr by gbrca status % 56% 59% 68% 69% 70% pcr RCB 0/1 All BRCA WT BRCA Mutant Sharma P, et al.
50 Platinum salts Bevacizumab Optimizing Taxanes Are There Better Choices? Neoadjuvant Trials in TNBC Anthracyclines free regimens Nab-paclitaxel
51 San Antonio Breast Cancer Symposium, December 9-13, 2014 Initial Study Design GeparSepto: Study Design N = 1200 Core biopsy* (before study entry) Arm A R Arm B 12 weeks 12 weeks Surgery If HER2 positive: Trastuzumab If HR positive: Tamoxifen, Aromatase inhibitors acc. to AGO Guidelines *Centrally confirmed: - Subtypes HER 2/ HR - Ki 67 - SPARC Core biopsy optional Core biopsy optional Core biopsy Paclitaxel 80 mg/m 2 weekly nab-paclitaxel 150 mg/ m 2 weekly Epirubicin 90 mg/m 2 Cyclophosphamide 600 mg/m 2 If HER2 positive: Trastuzumab 8 mg/kg (loading dose) followed by 6 mg/kg Pertuzumab (absolute dose per application) 840 mg (loading dose) followed by 420 mg Untch M. SABCS 2014
52 100 pcr Breast and Axilla ypt0 ypn0 (TNBC subgroup) 48% 26% 0 Untch M. SABCS 2014 Paclitaxel Paclitaxel Nab-Paclitaxel Nab-Paclitaxel
53 WSG-ADAPT TN: Study Design Biopsy at Baseline and Wk 3 Wk 12 Pts with TNBC, no distant metastasis, LVEF 50% or within normal limits (N = 336) Albumin-Bound Paclitaxel 125 mg/m 2 + Gemcitabine 1000 mg/m 2 * (n = 182) Albumin-Bound Paclitaxel 125 mg/m 2 + Carboplatin AUC2* (n = 154) Surgery or biopsy *Treatment given in 4 cycles in both arms at Wks 1, 2, 4, 5, 7, 8, 10, 11. Standard chemotherapy (4 x EC) recommended after surgery or 12-wk biopsy (if clinical non-pcr). Primary endpoint: pcr (ypt0/is ypn0) Secondary endpoints: pcr by early response, EFS, OS, safety Gluz O, et al. SABCS Abstract S6-07.
54 WSG-ADAPT TN: pcr Breast/Axilla (ypt0/is N0) 100 pcr 45,9 nab-paclitaxel + Carboplatin nab-paclitaxel + gemcitabine 28,7 0 Gluz O, et al. SABCS Abstract S6-07.
55 Metastatic TNBC
56 ASCO guidelines
57 First line therapy Activity of platinum in TNBC Regimens with bevacizumab Later lines of therapy Eribulin mesylate
58 First line therapy Activity of platinum in TNBC Regimens with bevacizumab Later lines of therapy Eribulin mesylate
59 Tutt A et al, SABCS 2014 TNT Trial: Design
60 Tutt A et al, SABCS 2014 Objective response
61 Tutt A et al, SABCS 2014 Progression Free Survival
62 Tutt A et al, SABCS 2014 Overall Survival
63 Predictors of response to platinum salts in TNBC Correlative Biology Correlative Program Biology Program Central ER / PR / HER2 Basal Phenotypes BRCA1/2 genotype 53BP loss HR Genome Scar Somatic BRCA1/2 BRCA1 methylation Whole Exome NGS RNA Seq BRCA 1/2 Status Basal-like/Prosigna PAM50) Homologous Recombination Deficiency (HRD) assay (Myriad Genetics) Recurrent Disease BX Genome Scars Reversion Mutations Whole Exome NGS RNA Seq
64 Tutt A et al, SABCS 2014 Objective response: BRCA 1/2 Status
65 % patients progression free TNT Progression Free Survival by BRCA status 100 PFS by BRCA 1/2 status Median PFS: C + BRCA 1/2 mutated 6.8mnths (95% CI = 4.4 to 8.1) C + BRCA1/2 not mutated 3.1mnths (95% CI = 2.4 to 4.2) Carboplatin + BRCA1/2 mutated Carboplatin + BRCA1/2 not mutated Docetaxel + BRCA1/2 mutated Docetaxel + BRCA1/2 not mutated Median PFS: D + BRCA 1/2 mutated 4.8 (95% CI = 2.2 to 7.2) D + BRCA1/2 not mutated 4.6 (95% CI = 4.2 to 5.5) 17/18 141/ Months from randomisation Interaction: randomised treatment & BRCA 1/2 status (restricted mean survival): p = 0.03 Tutt A et al, SABCS 2014
66 Objective response: Basal-like/Prosigna PAM50) Tutt A et al, SABCS 2014
67 Tutt A et al, SABCS 2014 Objective response: HRD score
68 First line therapy Activity of platinum in TNBC Regimens with bevacizumab Later lines of therapy Eribulin mesylate
69 E2100 Bevacizumab for TNBC Trial / Arm Median PFS (m) in TNBC Subset Paclitaxel (n=110) 5.3 Paclitaxel + bevacizumab (n=122) 10.6 AVADO Docetaxel + placebo (n=52) 5.4 Docetaxel + bevacizumab 15 mg/kg (n=58) 8.2 RIBBON-1 Taxane/anthracycline + placebo (n=46) 6.2 Taxane/anthracycline + bevacizumab (n=96) 6.5 Capecitabine + placebo (n=50) 4.2 Capecitabine + bevacizumab (n=87) 6.1 ATHENA Taxane-based regimen + bevacizumab (n=577) 7.2* *Median PFS vs non-tnbc subgroup. No Survival data available in the TNBC subset
70 First line therapy Activity of platinum in TNBC Regimens with bevacizumab Later lines of therapy Eribulin mesylate
71 Kaufman PA. JCO 2015 Phase III trial: Eribulin vs Capecitabine A&T pretreated
72 Proportion of survival Eribulin: Pooled data analysis study 305 & 301 OS analysis in TN subgroup Median OS (months) Eribulin (n=243) 12.9 Control (n=185) 8.2 HR months difference % CI 0.599, P value Number of subjects at risk Time (months) Twelves C Breast Cancer Res Treat Pooled data analysis study 305 & 301
73 Conclusions TNBC is a heterogeneous disease and a greater understanding of the biology behind the different subtypes is needed to better classify this entity Despite the remarkable progress in other BC subtypes, cytotoxic CT remains the mainstay of systemic therapy for TNBC TNBC responds to a variety of CT agents although no specific standard regimen or agent can be singled out Strong prognostic value of Response to Neoadjuvant Chemotherapy
74 Conclusions Growing evidence that platinum-based therapy is active in both advanced & early-stage TNBC Efficacy influenced by BRCA1/2 mutation status Beyond BRCA1 and BRCA 2 other germline biomarkers associated with therapeutic sensitivity likely exist Ultimately, measures of global genomic inestability (e.g. HRD) may potential to identify patients who benefit most from DNA repair defecttargeted approach. Inmunotherapy approaches may prove relevant for TN & BRCA 1/2 breast cancer TIL s could also be predictors of response
75 Conclusions The definition of prognostic/predictive BIOMARKERS for TNBC is crucial and has to be considered in ongoing and future clinical trials (i.e. BRCA status from the host, TIL infiltration reflecting microenvironment biology, or tumor cell biology subtypes) TNBC is still and UNMET CLINICAL NEED and it lacks of a standard treatment so it s a priority challenge in BC investigation
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