Point of View on Early Triple Negative

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1 Point of View on Early Triple Negative Valentina Rossi, MD UOSD Oncologia dei Tumori della Mammella Azienda Ospedaliera S.Camillo-Forlanini

2 Outline Neoadjuvant Setting IPSY-2 GeparSepto Adjuvant Setting EBCTCG Meta-analysis NSABP-B47 Fertility preservation and Meta-analysis POSTER & ABSTRACT or ONGOING Studies

3 Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC): pcr correlates with long-term oucome Cortazar P et al, The Lancet 2014

4 Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC): pcr correlates with long-term oucome pcr Rates by Tumor Subtypes Cortazar P et al, The Lancet 2014

5 Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC): pcr correlates with long-term oucome Cortazar P et al, The Lancet 2014

6 Neoadjuvant Model as a Platform to test Emerging Therapies/Concepts Accelerated path for drug approval Additive Model to improves DFS/OS Identify subsets for therapy de-escalation Subtractive model to enrich for patients expected to have excellent RFS/OS & reduce toxicity Identify subsets for therapy escalation Additive model to address residual risk

7 Yee et al. SABCS 2017 General Session 3

8 I-SPY 2 Trial pcr Distribution by Subtype EFS Dataset pcr distribution by subtype Evaluable population: (35%) pcr, 487 (65%) non-pcr Median Follow-up: 2.7 yrs ( ) 126 EFS events, 109 DRFS events 12 patients did not go to surgery Considered non-pcr per protocol Yee et al. SABCS 2017 General Session 3

9 I-SPY 2 Trial Results pcr is a highly significant predictor of EFS and DRFS EFS OVERALL DRFS Yee et al. SABCS 2017 General Session 3

10 I-SPY 2 Trial Results pcr is predictive of EFS and DRFS in TNBC EFS DRFS Yee et al. SABCS 2017 General Session 3

11 I-SPY 2 Trial Conclusions pcr is a strong predictor of EFS and DRFS in the setting of a multiple agent platform trial that includes: Standards for eligibility High risk for early recurrence (MP low risk, HR+HER2 excluded) Exclusion of metastatic disease All chemotherapy given before pcr determination Standards for pathologist assessment and multidisciplinary identification (surgeons, radiologists, pathologists) Long term follow-up of patients over time (correlation of early, intermediate, and late endpoints) pcr is equally predictive across all tumor subsets pcr as an endpoint enables rapid evaluation of novel therapy combinations and can accelerate the identification of effective and poentially less toxic regimens Yee et al. SABCS 2017 General Session 3

12 I-SPY 2 Trial The Future of I-SPY 2 Achieving pcr through any therapy for any subtype is a sufficient endpoint Develop minimally invasive techiniques (MRI and Biopsy) to identify pcr prior to definitive surgery Validate robust MRI and tissue predictors of pcr Descalate toxic therapy (AC) if pcr obtained early Re-assign patients to new therapies if pcr is not predicted Validate robust MRI and tissue predictors of non-pcr Assign new therapies based on molecular profiling of tumor and link to investigational agents Yee et al. SABCS 2017 General Session 3

13 Survival Analysis of the Prospectively Randomized Phase III GeparSepto Trial comparing Neoadjuvant Chemotherapy with weekly Nab-Paclitaxel with solvent-based Paclitaxel Followed by Anthracycline/Cyclophosphamide for patients with Early Breast Cancer GBG69 Study Design Main Eligibility Criteria Unilateral or bilateral primary breast cancer Stages: ct2 ct4a.d ct1c and additional high risk: o cn+ or pn SLN+ or ER ad PgR neg or Ki67 >20% or HER2 positive Study Endpoints Primary Endpoint: - pcr Rate (ypt0 ypn0) Secondary Eficacy endpoints (overall and according to stratified subpopulations) - DFS, DDFS, OS Schneeweiss et al. SABCS 2017 General Session 3

14 GeparSepto Trial pcr Analysis Paclitaxel Nab-Paclitaxel TN pcr 26% 48% pcr 22% Untch et al. Lancet Oncol 2016

15 GeparSepto Trial Disease Free Survival Analysis in Overall Population Disease Free Survival at median Follow-up of 49 months Schneeweiss et al. SABCS 2017 General Session 3

16 GeparSepto Trial Disease Free Survival Analysis according to Stratified Subpopulations Disease Free Survival at median Follow-up of 49 months Schneeweiss et al. SABCS 2017 General Session 3

17 GeparSepto Trial Exploratory Analysis Surrogate Value of pcr in the exploratory analysis Schneeweiss et al. SABCS 2017 General Session 3

18 GeparSepto Trial Conclusions GepardSepto demonstrates a significantly improved DFS when patients received nab-paclitaxel instead of paclitaxel (HR=0.69, 95% CI [ ; log rank p=0.0044] A similar treatment effect was observed for patients with TNBC and HR+/HER2- tumors The interaction with Ki67 suggests that nab-paclitaxel generates a long term benefit in particular in tumors with lower proliferation Irrespective of the treatment group, patients achieving a pcr had a significantly better DFS Patients without pcr have a significantly better DFS with nab-paclitaxel than paclitaxel Schneeweiss et al. SABCS 2017 General Session 3

19 Outline Neoadjuvant Setting IPSY-2 GeparSepto Adjuvant Setting EBCTCG Meta-analysis NSABP-B47 Fertility preservation and Meta-analysis POSTER & ABSTRACT or ONGOING Studies

20

21 EBCTCG meta-analysis Background Three ways to increase dose intensity (ie, the drug dose in mg/m² per week) 1. Use higher doses of drugs in each cycle 2. Reduce the interval between treatmen cycles 3. Give drugs sequentially rather than concurrently Norton L. Sem Oncol 1997

22 EBCTCG meta-analysis Pooled analysis of all 25 dose-dense and sequential trials Any Recurrence Breast Cancer Mortality Gray et al. SABCS 2017 General Session 1

23 EBCTCG meta-analysis Pooled Analysis: recurrence by ER Status ER - Negative ER - Positive Gray et al. SABCS 2017 General Session 1

24 EBCTCG meta-analysis Conclusions Shortening the interval between cycles and sequential administration of anthracycline and taxane chemotherapy reduces recurrence and death from breast cancer Reductions in recurrence of about 15% were similar in ER positive and ER negative disease and did not differ significantly by any other tumour or patient characteristic No increase seen in death without recurrence (ovrerall or during chemotherapy Gray et al. SABCS 2017 General Session 1

25

26 B-47: Adjuvant Trastuzumab in HER2 Low Breast Cancer Background NSABP B-31 Study Details NSABP B-31 Central HER2 Assay Result AC Paclitaxel with o without trastuzumab HER2+ node-positive breast cancer Initial study entry criteria included FISH or IHC 3+ HER2 testing performed at local lab site A tissue speciment sent to NSABP for later testing Before amendment (Any lab) After amendment (qualified lab) Central HER2 FISH negative 103/529 (19.5%) 104/1266 (8.2%) Central IHC negative (0-2+) 122/528 (23.1%) 177/1259 (14.1%) Both negative 87/529 (16.4%) 87/1266 (6.8%) NSABP B-31: Central HER2 status performed as quality check after 529 patients enrolled Total Final 207/1795 (11.5%) 299/1787 (16.7%) 174/1795 (9.7%) Fehrenbacher et al. SABCS 2017 General Session 1

27 B-47: Adjuvant Trastuzumab in HER2 Low Breast Cancer Patients characteristics Fehrenbacher et al. SABCS 2017 General Session 1

28 B-47: Adjuvant Trastuzumab in HER2 Low Breast Cancer Results Invasive Disease Free Survival Fehrenbacher et al. SABCS 2017 General Session 1

29 B-47: Adjuvant Trastuzumab in HER2 Low Breast Cancer Conclusions The benefit of trastuzumab in central tested HER2-low patients identified retrospectively from 2 major adjuvant trials that used local testing for eligibility are not really explained and not confirmed in this study There is NO benefit with trastuzumab therapy in patients with FISH ratios <2.0 and IHC staining intensity of 1+ or 2+ Fehrenbacher et al. SABCS 2017 General Session 1

30

31 Pooled analysis of randomized trials investigating GnRHa as a strategy to preserve fertility during chemotherapy in EBC Study & Baseline characteristics Lambertini et al. SABCS 2017 General Session 1

32 Pooled analysis of randomized trials investigating GnRHa as a strategy to preserve fertility during chemotherapy in EBC Results Premature-Ovarian Insufficiency Rate OR* 0.38 (95% CI ) p<0.001 Meta-analysis approach 50% Study GnRHa Events/pts Control Events/pts OR (95% CI) 40% 30% 30.9% PROMISE-GIM6 16/148 POEMS/SWOG S0230 5/66 UCSF-led trial 3/26 40/133 15/69 2/ (0.15, 0.57) 0.33 (0.10, 1.14) 1.17 (0.14, 9.55) 20% 14.1% GBG-37 ZORO OPTION 6/28 21/95 13/29 41/ (0.14, 2.07) 0.41 (0.20, 0.81) 10% Overall (I =0%,p=0.73) 51/ / (0.25, 0.57) 0% GnRHa group n=363 Control group n= GnRHa better Control better *Odds ratio (OR) adjusted for age, estrogen receptor status, type and duration of chemotherapy administered

33 Pooled analysis of randomized trials investigating GnRHa as a strategy to preserve fertility during chemotherapy in EBC Results Post-Treatment Pregnancy Rate GnRHa Group: 37/359 (10.3%) vs. Control Group: 20/367 (5.5%) Meta-analysis approach IRR* 1.83 (95% CI ) p=0.030 Study GnRHa Events/pts Control Events/pts IRR (95% CI) Age distribution, years GnRHa group (n = 37) No. (%) 37 (100) 0 (0.0) Control group (n = 20) No. (%) 20 (100) 0 (0.0) PROMISE-GIM6 8/148 3/133 POEMS/SWOG S /105 12/113 OPTION 7/106 5/121 Overall (I =0%,p=0.85) 37/359 20/ (0.67, 9.50) 1.77 (0.87, 3.57) 1.54 (0.49, 4.85) 1.82 (1.05, 3.14) Estrogen receptor status Positive Negative 6 (16.2) 31 (83.8) 2 (10.0) 18 (90.0) Control better GnRHa better Lambertini et al. SABCS 2017 General Session 1

34 Pooled analysis of randomized trials investigating GnRHa as a strategy to preserve fertility during chemotherapy in EBC Conclusions Administration of GnRHa during chemotherapy was associated with a significant reduction in the risk of chemotherapy-induced POI A greater number of women in the GnRHa group had a post-treatment pregnancy Similar DFS and OS were observed between groups irrespective of the estrogen receptor status of the disease This strategy should be considered as an option to reduce the likelihood of chemotherapy induced POI and potentially improve future fertility in premenopausal early breast cancer patients undergoing (neo)adjuvant chemotherapy Lambertini et al. SABCS 2017 General Session 1

35 Outline Neoadjuvant Setting IPSY-2 GeparSepto Adjuvant Setting EBCTCG Meta-analysis NSABP-B47 Fertility preservation and Meta-analysis POSTER & ABSTRACT or ONGOING Studies

36 Older age Morante et al. SABCS 2017 Mina et al. SABCS 2017 Satram-Hoang et al. SABCS 2017

37 Mittendorf et al. SABCS 2017

38

39 Pusztai et al. SABCS 17

40 Grazie per l attenzione! VRossi@scamilloforlanini.rm.it

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