The Platinum Salts in the Treatment of Triple Negative Breast Cancer

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1 The Platinum Salts in the Treatment of Triple Negative Breast Cancer Eric P. Winer, MD Dana-Farber Cancer Institute Harvard Medical School Boston, USA

2 The Platinum Salts Old drugs First report of platinum activity (RR 47%) in breast cancer over 20 years ago (Sledge et al, JCO 2008) Discarded for many years because of toxicity Recent resurrection because of apparent activity in triple negative breast cancer So where are we with respect to the use of the cisplatin and carboplatin?

3 Topics to Consider Metastatic disease Neoadjuvant setting Adjuvant setting BRCA mutation carriers

4 Survival after Metastatic Dx for Triple-Negative Breast Cancer Authors Study type Treatment Median OS Sledge et al, 2007 Prospective Capecitabine mo Phase II Bevacizumab Lin et al, 2008 Retrospective Various 13.3 mo Kassam et al, 2009 Retrospective Various 13.3 mo Isakoff et al, 2015 Prospective ph 2 Platinum 11 mo Tutt et al, 2014 Prospective Ph2 Platinum, Taxane 12.3 mo Response to successive lines of therapy is very short Authors 1 st Line 2 nd Line 3 rd Line Kassam, 2009 (CA) 12 weeks 9 weeks 4 weeks Seah, 2012 (US) 5.8 mo 3.3 mo 2.8 mo

5 TBCRC009: A Phase II Study of Cisplatin or Carboplatin for Triple-Negative Metastatic Breast Cancer Single arm, phase II study, 86 patients. 1 st or 2 nd line therapy Treatment (MD choice) : Cisplatin at 75 mg/m2 IV every 3 weeks OR Carboplatin AUC 6 IV every 3 weeks. Archived tissue collected on all patients Isakoff S, et al JCO 2015

6 TBCRC009: Results Primary Endpoint 1 % (number) (95% CI) Overall Response Rate (RR) 25.6 % ( ) Complete Response (CR) 4.7% Partial Response (PR) 3.5% Exploratory Endpoints Cisplatin RR (43) 32.6% (95% CI ) Carboplatin RR (43) 18.6% (95% CI ) 1 st Line RR (69) 29% 2 nd Line RR (17) 11.8% 6

7 Impact of BRCA Mutation Status Response Rate by BRCA Mutation Status on Response RR BRCA1/2 positive (N-11) 54.5% ( ) BRCA1/2 Wild Type (N=65) BRCA1/2 Unknown (N=10) Progression Free Survival BRCA Mut BRCA WT Median PFS, Mo: P=0.92 HR 1.03 ( ) 19.7% ( ) 33.3% ( ) Overall Survival BRCA Mut BRCA WT Median OS, Mo: P=0.58 HR 1.22 ( ) 7

8 Platinum in combination with Cetuximab in TNBC: The BALI-1 and TBCRC001 Studies BALI-1 Study TNBC 1 Ctx 2:1 cisplatin Cisplatin + cetuximab Cetuximab + Cisplatin (n=115) Cisplatin (n=58) RR 20 % 10 % PFS 3.7 mo 1.5 mo OS 12.9 mo 9.4 mo HR 0.67 ( ), p=0.03 TBCRC001 TNBC 3 Ctx 2:1 cetuximab carboplatin + cetuximab Cetuximab + Carboplatin (n=71) Cetuximab (n=31) RR 17% 6% TTP 2.1 mo 1.4 mo OS 10.4 mo 7.5 mo Baselga et al, JCO 2013, Carey, JCO 2012

9 Metastatic TNBC Trial TNT Triple Negative Trial N=376 Triple negative Met or locally adv No prior chemo for MBC (except for anthracycline). BRCA carriers stratified R A N D O M I Z E Docetaxel 100mg/m2 X 6 cycles Carboplatin AUC 6 x 6 cycles Crossover at progression, limit to 6 cycles of therapy. Tutt et al, SABCS 2014

10 Objective Response 10 Randomised treatment - all patients (N=376) % with OR at cycle 3 or 6 (95% CI) Carboplatin Docetaxel 59/188 (31.4%) 67/188 (35.6%) Absolute difference (C-D) -4.2% (95% CI to 5.3) Exact p = 0.44 Crossover treatment - all patients (N=182) % with OR at cycle 3 or 6 (95% CI) Carboplatin (Crossover=Docetaxel) Docetaxel (Crossover=Carboplatin) 21/92* (22.8%) 23/90* (25.6%) Absolute difference (D-C) -2.8% (95% CI to 9.6) Exact p = 0.73 *Denominator excludes those with no first progression and those not starting crossover treatment

11 % patients progression free Progression-free Survival Median PFS: Carboplatin: 3.1 mths (95% CI = 2.5 to 4.2) Docetaxel: 4.5 mths (95% CI = 4.1 to 5.2) Restricted mean survival to 15 mths: Carboplatin: 4.8 mths Docetaxel: 5.2 mths Absolute difference: -0.4 (95% CI -1.1 to 0.3) p = Carboplatin = 181 / Docetaxel = /188 Months from randomisation Number of events/at risk C: 0/188 90/98 40/56 32/22 9/13 5/8 0/7 D: 0/188 57/130 60/69 48/20 7/13 6/5 2/3

12 % patients alive Overall Survival Median OS: Carboplatin: 12.4 mths (95% CI = 10.4 to 15.3) Docetaxel: 12.3 mths (95% CI = 10.5 to 13.6) Restricted mean survival to 15 mths: Carboplatin: 10.7 mths Docetaxel: 10.8 mths Absolute difference: -0.2 (95% CI -1.1 to 0.8) p = Months from randomisation Number of events/at risk C: 0/188 23/165 18/141 24/114 22/89 14/71 22/44 D: 0/188 11/176 20/151 35/110 19/85 23/58 16/39

13 % patients progression free TNT Trial: Docetaxel vs Carboplatin in TNBC: Influence of BRCA Mutation Status Carboplatin + BRCA1/2 mutated 80 Carboplatin + BRCA1/2 not mutated 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) Tutt et al, SABCS 2014 Months from randomisation 13

14 % patients progression free TNT Trial: Docetaxel vs Carboplatin in TNBC: Influence of BRCA Mutation Status Carboplatin + BRCA1/2 mutated Carboplatin + BRCA1/2 not mutated Docetaxel + BRCA1/2 mutated 60 Docetaxel + BRCA1/2 not mutated / /145 Months from randomisation Interaction Term for treatment & BRCA 1/2 status p =

15 Neoadjuvant Therapy

16 Dana-Farber Preoperative Cisplatin in Triple Negative Breast Cancer > 2cm, Stage II/ III ER/PR/Her Neg Research Core Biopsy N=28 Cisplatin 75mg/m 2 q3wks x 4 cycles Pathologic CR 6 (22%) Clinical CR 4 (14%) Clinical PR 10 (36%) Stable Disease 5 (17%) Standard Adjuvant Therapy per MD Garber et al, SABCS 2006; Silver et al, JCO 2010

17 Surgery GeparSixto: TNBC Schema N=315 centrally confirmed TNBC R PM PMCb Paclitaxel 80 mg/m² q1w Non-pegylated liposomal doxorubicin (M) 20 mg/m² q1w Carboplatin AUC q1w Bevacizumab 15 mg/kg q3w von Minckwitz et al. Lancet Oncology, May 2014

18 Pathologic Complete Response Rates (ypt0 ypn0) in TNBC in GeparSixto N=157 N=158 OR 1.94 [ ] P=0.005 von Minckwitz et al. Lancet Oncology, May 2014

19 DFS: Effect of Carboplatin in TNBC 3 yrs DFS 85.8% 3 yrs DFS 76.1%

20 CALGB 40603: Schema Randomized Phase II of T-AC +/- Carbo Paclitaxel 80 mg/m 2 wkly x 12 ddac x 4 Paclitaxel 80 mg/m 2 wkly x 12 ddac x 4 2 X 2 Randomization Paclitaxel 80 mg/m 2 wkly x 12 Carboplatin AUC 6 q3wks x 4 ddac x 4 Paclitaxel 80mg/m 2 weekly 2 wkly x x Carboplatin AUC 6 q3wks x 4 ddac x 4 Sikov et al. JCO 2015;33:13-21

21 pcr Breast (ypt0/is N any) + / - Carboplatin 46% (40-53%) 60% (54-66%) Odds Ratio: 1.76 p = N=212 N=221 Sikov et al. JCO 2015;33:13-21

22 Intrinsic Subtype of Pre-treatment Samples All samples (n=360) Distribution of subtypes did not vary by arm (Fisher p=0.88) Overall pcr breast rate in subtyped samples did not differ between basal-like (170/314) (54%) and non-basal-like (24/46) (52%) cancers Sikov et al, SABCS 2015

23 CALGB EFS by pcr Breast/Axilla. Sikov et al, SABCS 2015

24 CALGB EFS for carboplatin vs. not Sikov et al, SABCS 2015

25 What About the Adjuvant Setting? Essentially no data Ongoing trial of AC-T with and without carboplatin in high risk TNBC (SWOG) Ongoing trial of platinum in patients with residual disease after neoadjuvant therapy for TNBC If platinum adds, can it be substituted for an agent or does it need to be added to existing regimens Added toxicity must be considered

26 Is Platinum Ready for Primetime in Unselected TNBC in the Adjuvant or Neoadjuvant Setting? Need definitive study showing improvement in DFS and/or OS German trial is not adequate particularly given atypical backbone NO If platinum is ultimately used, should it be added to standard therapy or substituted for one or more drugs? Are there triple negative subtypes that are particularly sensitive to platinum salts?

27 pcr Rates by gbrca Status and Carboplatin in TNBC ypt0 ypn0 100% 80% gbrca wt OR 2.09 ( ) P=0.005 gbrca mut OR 1.60 ( ) P= % 33.1% 50.8% 50.0% 61.5% von Minckwitz G et al., ASCO 2014, updated data; E. Hahnen in prep. 40% 20% 0% PM PM+Cb PM PM+Cb N=121 N=120 N=24 N=26 Polish Neoadjuvant Trial Also Revealed High Path CR With Single Agent Cisplatin in BRCA Carriers

28 DFS by gbrca Status and Carboplatin in TNBC Polish Neoadjuvant Trial Also Revealed High Path CR With Single Agent Cisplatin in BRCA Carriers

29 INFORM: preop cisplatin vs AC for BRCA 1/2 carriers Schema: Randomized Phase 2: 166 patients Stage II/III BC with BRCA1 or 2 mutation Multicenter study AC x 4 CDDP x 4 N = 170; approximately 60 enrolled Designed to show 20% improvement in pcr with cisplatin over AC S U R G E R Y Or Biopsy Principal Investigators: Nadine Tung and Judy Garber B Additional Chemo

30 Do We Have Sufficient Data To Incorporate Platinum in Treatment of BRCA Carriers with TNBC? May never have large, definitive trial Mounting evidence in neoadjuvant and metastatic settings Biology is consistent with clinical observations Probably close to it ideally would like to see results of neoadjuvant INFORM trial How do we do it? Add to standard? Substitute for one or more agents?

31 Is Platinum Preferred For The Treatment Of BRCA-Associated or Sporadic TNBC? Platinum is active in mtnbc No difference observed in the TNT randomized trial between docetaxel and carboplatin Triple negative breast cancer is sensitive to a wide variety of agents with short lived responses?? Selective advantage for mutation carriers Although platinums are not ready for standard use in early stage disease, but they are an option in metastatic disease Assays like HRD Score may help select patients, but more work needs to be done

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