Who is the Ideal Candidate for PEG Intron?
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1 Who is the Ideal Candidate for PEG Intron? Sanjiv S. Agarwala, MD Chief, Oncology & Hematology St. Luke s Cancer Center Professor, Temple University School of Medicine Philadelphia, PA, USA
2 Overview Introduction and Review of EORTC Is there an impact of stage on benefit? Is there an impact of ulceration on benefit? Who is the best candidate?
3 Pegylated IFN-α EORTC Regimen Schedule Dose Frequency Duration Induction 6 μg/kg SC Q weekly 8 weeks Maintenance 3 μg/kg SC Q weekly up to 5 years PEG IFN is an intermediate dose regimen
4 EORTC (peginterferon alfa-2b): Study Design 1 N=1,256 Stage III, Enrolled Stratification Microscopic, palpable nodes Number of nodes (1, 2 4, 5+) Ulceration Breslow thickness Sex Institution R A N D O M I Z E Weekly PEG-IFN Observation Weekly PEG-IFN First 8 doses: 6 mcg/kg SC weekly x 8 Doses 9 260: 3 mcg/kg SC weekly for up to 5 years Dose adjustments: 3, 2, 1 mcg/kg for safety and maintenance of ECOG Performance Status at 0 or 1 SC=subcutaneous; ECOG=Eastern Cooperative Oncology Group. 1. Eggermont AMM et al. Lancet. 2008;372:
5 Baseline Characteristics 1 Sex, % Female Male PEG-IFN (n=627) Observation (n=629) Age, y Median, range 50, , Age, % 18 to <50 yrs 50 to <65 yrs 65 yrs Eggermont AMM et al. Lancet. 2008;372:
6 Disease Characteristics 1,a PEG-IFN n=627 Patients, % Observation n=629 Nodal involvement Microscopic Palpable Node, n 1 Node Nodes Nodes Not Evaluable 1 1 Ulceration No Yes Unknown Breslow <1.5 mm mm mm Unknown a At baseline, used for stratification of randomization. 1. Eggermont AMM et al. Lancet. 2008;372:
7 Primary Analysis Relapse-Free Survival: Intent-to-Treat, Independent Review 1 PEG-IFN Observation Patients RFS events Hazard ratio % CI 0.71, 0.96 P value 0.01 Median RFS, mo RFS=relapse-free survival; CI=confidence interval. 1. Eggermont AMM et al. Lancet. 2008;372:
8 Relapse-Free Survival (ITT) 2007 evaluation 2011 evaluation Trial (years) O N Number of patients at risk : Observation Peg-IFN alfa (years) O N Number of patients at risk : Observation Peg-IFN alfa P=0.01 HR = 0.82 (95% CI 0.71, 0.96) P=0.05 HR = 0.87 (95% CI 0.76, 1.00)
9 Overview Introduction and Review of EORTC Is there an impact of stage on benefit? Is there an impact of ulceration on benefit?
10 Design EORTC Intermediate dose IFN Patients (n=1,388): Resected IIB or TxN1-2M0 melanoma, Randomization Stratified by: IIB, III-N1 vs. III-N2 1 vs. 2-4 vs. 5+ nodes Breslow Ulceration Gender Site Observation IFN alfa-2b 10 MIU, qd, 4wks, 10 MIU, tiw 12 Mts IFN alfa-2b 10 MIU, qd, 4 wks, 5 MIU, tiw 24 Mts Primary Endpoint: Distant Metastasis-Free Interval (DMFI) Eggermont
11 Intermediate dose IFN Trial EORTC NORDIC Stage Treatment DFS OS IIB-III 1388 pts IIB,III 855 pts IFNα2b, 10 MIU/qd1-5/sc, 4wk +3x10MIU/wk,sc,12mts or + 3x5MIU/wk,sc,24mts IFNα2b, 10MIU/qd1-5, sc,4 wk +3x10MIU/wk,sc,12mts or3x10miu/wk,sc,24mts 4.65-yr; HR=0.81; p= yr; HR=0.83 p= yr; HR=0.88; p= yr; HR =0.88 p = 0.47 HR=0.82 PEG-IFN EORTC III 1256 pts PEG-IFNα2b, 180 MIU/wk, sc, 8 wks MIU//wk,sc,5yr 3.65 yr; HR=0.82; p= yr; HR = 0.98; p= 0.98 BIOAVAILIBILITY 50% HR=0.82
12 INTERFERON SENSITIVITY LIMITED TO STAGES IIB AND III-N1 EORTC (1388 pts): Efficacy EORTC (1256 pts): Efficacy IIB > N1 > N2 at 4.9 yrs N1 > N2 at 7.6 yrs RFS/DMFI DMFS OS: HR estimate EORTC month interferon alfa-2b (4 wk 10MU + 12 mts 10MU) OR 25-month interferon alfa-2b (4wk 10MU 24 mts 5 MU) EORTC wks Peg-IFN alfa-2b at 6 µg/kg + up to 5 years Peg-IFN alfa-2b At 3 µg/kg Stage IIb III N1 III N2 IIb III N1 III N2 n subjects RFS or DMFI DMFS OS
13 Overview Introduction and Review of EORTC Is there an impact of stage on benefit? Is there an impact of ulceration on benefit?
14 ULCERATED MELANOMA : A DISTINCT BIOLOGIC ENTITY Survival much lower for same Breslow Stromal Response Ulcerated Melanoma EJC 2004 Geneprofile Signature JNCI 2006 PlosOne 2013 Sentinel Node Suppression Clin Cancer Res 2009 Balch CM et al. AJCC staging and Prognostic factors analysis JCO. 2001; 19:
15 EORTC RFS in the SLN+ Ulcerated Primary Population Hazard Ratio 0.72 (99% CI 0.46, 1.13) Median RFS 2.7 years vs 1.7 years Eggermont et al, J Clin Oncol 2012;30:3810
16 EORTC OS in the SLN+ Ulcerated Primary Population Hazard Ratio 0.59 (99% CI 0.35, 0.97) Median OS not reached vs 3.6 years Eggermont et al, J Clin Oncol 2012;30:3810
17 Summary from EORTC trial III- N1 (Sentinel Node +) pts experienced greater benefit in terms of RFS and trend for DMFS and OS (HRs 0.82; 0.86; 0.86) ULCERATED primary - SN-positive III-N1 pts significantly benefited on all endpoints (HRs: RFS 0.72; DMFS 0.65; OS 0.59; median OS difference of 3.7 yrs vs > 8 years)
18 Stage IIb & III-N1 & Ulceration: OVERALL SURVIVAL by trt by study Consistency between and (ASCO2009) HR = % CI (0.38, 0.83) P = HR = % CI (0.39, 0.96) P = O N or 25-month IFN Obs 0 (yrs) O N yr PEG-IFN Obs
19 Who is the best candidate? Appears to be. The surgically staged patient who has had a sentinel LN biopsy and has only microscopically positive lymph nodes in the presence of an ulcerated primary melanoma
20 But..
21 Is Effectiveness of HDI Stage Dependent? Not in US Trials of HDI Trial/Yr Eligibility N Total # of Patients w/ micromet LN IFN Obs only E1684* 1996 IIB, III E IIB, III E IIB, III MD Anderson 2007 III Subgroup findings Major impact on patients with clinically evident lymph node positive disease Major impact on patients with lymph node + disease, particularly those with 2 3+ lymph nodes High-dose IFN was of the most benefit for patients with no lymph node involvement (IIB) (P=.01). Stage IIIA absolute increase in RFS of 9% (P=.09); P=.02 after adjustment for multiple variables Anaya DA, et al. Cancer. 2008;112:2030.
22 EORTC 18991: RFS in Stratified Subsets The result is internally consistent across relevant subgroups defined by baseline demographics and prognostic variables Herndon et al. Oncologist 2012;17:1323 Unpublished data presented to FDA ODAC, October 5, 2009
23 Conclusions Maximal benefit of PEG-IFN seen in patients with ulcerated N1 disease Pre-specified subset but not a prospective trial in that subset Needs to be validated in a prospective trial In the US it is approved for all stage III patients
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