What Is The Optimal Adjuvant Therapy in Pancreatic Adenoca: Intensified Chemotherapy March 28 th, 2015

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1 What Is The Optimal Adjuvant Therapy in Pancreatic Adenoca: Intensified Chemotherapy March 28 th, 2015 Eileen M. O Reilly, M.D. Associate Director David M. Rubenstein Center Pancreatic Cancer Research Memorial Sloan Kettering Cancer Center

2 Major Questions In Adjuvant Setting What does combination therapy do in the adjuvant setting? Is there a value to inclusion of adjuvant (chemo) radiation? Is there benefit to addition of targeted agent? Where does neoadjuvant therapy fit?

3 What Are the Current Standards in the Adjuvant Setting?

4 CONKO-001: Resected Pancreas Ca Gemcitabine vs Observation R A Gemcitabine N D N= 179 O N= 368 M Observation IZ Resected Pancreas Adeno N= 175 E Randomization 1: 1 Stratification R0 vs R1; T-stage; Node (+) vs (-) Primary Endpoint: Disease-Free Survival Oettle, H. JAMA, Oettle, H. JAMA, 2013

5 CONKO-001: Efficacy Results Median Follow-up 11 years Gemcitabine N= 179 Observation N= 175 P-value Median DFS 13.4 mths 6.9 mths Median OS 22.8 mths 20.2 mths HR 0.55 CI , P < HR 0.76 CI , P = year OS 20.7% 10.4% - 10-Year OS 12.2% 7.7% - Oettle, H. JAMA, Oettle, H. JAMA, 2013

6 ESPAC-1: Benefit for 5-FU/LV 2x2 Factorial: Survival by Adjuvant Chemotherapy 2-Year 5-Year Med OS 5-FU/LV 40% 21% 20.1 mths No Chemo 30% 8% 15.5 mths HR= 0.71 (CI ), p= Neoptolemos, JP. NEJM, 2004

7 ESPAC- 3 (v2) Resected PC R0/R1 N= 1,030 R A N D O M IZ E Observation 5-FU/Leucovorin Gemcitabine Primary Endpoint: 10% improvement in 2-year OS Neoptolemos, J. JAMA, 2010

8 ESPAC-3(v2): Results 1,088 pts, 17 countries 1/00-1/07 35% R1; 72% node positive; 25% poorly diff Median follow up 34.2 months 5FU + LV N= 551 Gemcitabine N= 537 Log-rank Med Overall Survival 23 mths 23.6 mths HR= 0.94 ( ) p= 0.39 Grade 3-4 Toxicity 14% 7.5% P< Neoptolemos, et al. JAMA, 2010

9 Adjuvant Chemoradiation Phase III s Earlier Studies Mixed Results Trial Therapy N Med Surv 2-Yr Surv 5-Yr Surv GITSG FU+RT+FU mths 43% 19% Observation mths 18% 5% EORTC FU + RT mths 37% 20% Observation mths 26% 10% Kalser. GITSG. Arch Surg, Klikenbilj. EORTC. Ann Surg, 1999

10 ESPAC-1: No Benefit for ChemoRT 2x2 Factorial: Survival by Adjuvant ChemoRT 2-Year 5-Year Med OS No ChemoRT 41.4% 20% 17.9 mths ChemoRT 28.5% 10% 15.9 mths HR= 1.28 (CI ), p= Neoptolemos, JP. NEJM, 2004

11 RTOG R A N D O Gemcitabine 5-FU + RT Gemcitabine Resected PC N= 518 M 5-FU infusion IZ E 5-FU + RT 5-FU infusion Regine, et al. JAMA, 2008

12 Pancreatic Head Tumors (N= 388) Gemcitabine Arm 5-FU Arm Median Survival 20.5 mths 16.9 mths 3-Year Survival 31% 21% HR 0.82 (CI , p= 0.09) Survival trend for gemcitabine, but not significant Body/tail tumors included (N= 451, p= 0.013) Regine, et al. JAMA, 2008

13 State of the Art Adjuvant in 2015 Single-agent gemcitabine x 6 mths 5-FU/leucovorin x 6 mths +/- (chemo)radiation (RTOG 0848) Anticipated survival < 2 years Anticipated incremental survival ~ 10% We need better options

14 Combination Cytotoxic Therapy Combinations improve outcome in M1 disease FOLFIRINOX Gemcitabine + nab-paclitaxel Both regimens Improve tumor response, progression-free and overall survival compared to single-agent gemcitabine Increased toxicity Maintained Qol (FOLFIRINOX) Conroy, TJ. NEJM, Von Hoff, D. NEJM, 2013

15 FOLFIRINOX vs Gemcitabine Overall Survival P roba bility Number at risk Gemcitabine FOLFIRINOX Median 6.8 mo Median 11.1 mo FOLFIRINOX Gemcitabine M onths HR = 0.57 P < Conroy, T. NEJM, 2011

16 MPACT: Overall Survival OS, months Median (95% CI) 8.5 ( ) 6.7 ( ) HR = % CI ( ) P = Von Hoff DD et al. N Engl J Med. 2013

17 Adjuvant Trials Sponsor Trial N ESPAC-4 Newlink Genetics RTOG 8048 PRODIGE/ UNICANCER APACT Gemcitabine +/- Capecitabine Primary: OS Gemcitabine +/- ChemoRT +/- Algenpantucel-L Primary: OS (accrued) Gemcitabine +/- ChemoRT Primary: OS FOLFIRINOX vs Gemcitabine Primary: DFS at 3 yrs Gemcitabine +/- Nab-Paclitaxel Primary: DFS 1,080 ~

18 Why Neoadjuvant Therapy in PC? Near absolute risk of systemic failure Selects out biology, avoidance of surgery Enhanced treatment delivery: 20-25% not well enough/ don t receive adjuvant therapy Theoretically, R0, lymph node positivity, local recurrence, possible downstaging

19 Ongoing Phase II-III Studies Neoadjuvant vs Adjuvant Therapy NEOPAC Adjuvant Gemcitabine Versus NEOAdjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer N= 165/arm Primary Endpoint: Progression-free survival at 9 mths Secondary Endpoints: OS, surgery complication rate PACT 15 3-arm Italian Study randomized phase II-III PEXG (cisplatin, epirubicin, capecitabine, gemcitabine) N= 370 Adjuvant gem; Adjuvant PEXG; Neo+Adj PEXG Primary Endpoint: Event-free survival at 1-year NCT (PI Clavien, Switzerland). NCT (PI Reni, Italy)

20 Conclusions Single-agent therapy modest efficacy with survival improvement of ~10% in adjuvant setting Very strong rationale for combination adjuvant cytotoxic therapy Clearly more effective in metastatic disease Higher toxicity yes, but many willing to accept if longer life Future: Combination adjuvant therapy Combination neoadjuvant therapy

21 This One is For Jordan

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