Surgical Issues in Melanoma
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1 Surgical Issues in Melanoma Mark B. Faries, MD, FACS Director, Donald L. Morton Melanoma Research Program Director, Surgical Oncology Training Program Professor of Surgery John Wayne Cancer Institute
2 Surgical Issues Margins How narrow? Sentinel Lymph Node Biopsy Who Why Completion Lymph Node Dissection Why? Why not? Metastatic Disease (Stage IV) Where does surgery fit?
3 Margin Recommendations:pre-1970* 2 cm Cooling (1966) 5 cm Hadley (1907) Raven (1953) Petersen (1962) Olsen (1966) 8 cm Pack (1953) As wide as possible - Veronesi (1966) 15 cm Petersen (1962) * Wong CK, Dermatologica 141: 215, 1970
4 Randomized Trials: <2 mm French Cooperative Group (n=326) DFS < 2 mm 2 cm Swedish Melanoma Trial Group (n=989) 5 cm 1cm 3 cm WHO #10 (n= 712) 8 vs. 3 local recurrences (NS) Khayat et al, Cancer, 2003 Apr; 97(8): Cohn-Cedermark, Cancer, 2000; 89: 1495 Veronesi U, Arch Surg, 1991 Apr; 126(4):
5 Randomized Trials: Intergroup n=468 Median follow up >10 years 1-4 mm 2 cm 4 cm No difference in local recurrence 2.6% (4cm) vs. 2.1% (2cm) Skin grafts 46% (4cm) vs. 11% (2cm) Risk of LR based on primary tumor
6 Randomized Trials: UK Trial Sweden n=900 n = 936 pts 1cm 3 cm 2 cm 4 cm > 2 mm Thomas et al. NEJM 2004 Gillgren et al, Lancet, November 2011
7 Answer Key: Current (NCCN) Recommendations Melanoma-in-situ Breslow <1mm Breslow mm Breslow mm Breslow >4mm 5 mm 1 cm 1-2 cm 2 cm 2 cm
8 Clinical vs. Pathological Margins
9 Lymph Node Treatment
10 Lymph Node Treatment
11 Regional Lymph Nodes
12 Elective Lymph Node Dissection: WHO #14 All (>1.5mm) mm >4.0mm
13 Intergroup ELND: Overall Survival Balch, Ann Surg Oncol, 2000
14 Sentinel Node
15 Problem: Identification of patients 80% of patients undergoing ELND had negative nodes Others have concomitant systemic spread not cured by ELND Only a subset can benefit from nodal surgery
16
17 MSLT-I Melanoma >1 mm or > Clark IV (primary analysis mm) Randomization Wide excision alone 40% 60% Wide excision + SLN SLN + SLN - CLND for Recurrence Immediate CLND No recurrence: observation Observation
18 MSLT-I prognosis
19 SLN Biopsy and Disease-Free Survival: MSLT-I Intermediate Thickness ( mm) Thick ( 3.5mm)
20 Delayed treatment metastatic spread within the regional nodal basin ± 0.5 Mean # Pos. Nodes ± 0.1 SNB Watch & Wait 0 Immediate CLND Delayed CLND
21 Impact of Clinical Recurrence: Morbidity MSLT 1
22 Overall Melanoma Related Survival (Breslow mm) Final Dataset Survival (%) HR: 0.84 P=0.18, 95% CI ( ) Group OBS SNB # Event / Total N 97 / / 770 Estimate S(t) ± SE 5-year 10-year 85.7 ± 1.6 % 78.3 ± 2.0% 86.6 ± 1.3 % 81.4 ± 1.5 % Time (years) OBS SNB
23 MSLT-I Melanoma >1 mm or > Clark IV (primary analysis mm) Randomization DSS: Primary Endpoint DFS: Secondary Endpoint Wide excision alone 40% 60% Wide excision + SLN SLN + SLN - Occult Stage III CLND for Recurrence Immediate CLND No recurrence: observation Observation
24 Morton A 50 Year Odyssey Melanoma Specific Survival Node+ ( mm) Final Dataset 100 Group # Event / Estimate S(t) ± SE % Total N 5-year 10-year OBS, had nodal recur. 48/ ± ± 5.6 SNB+ 70 / ± ± 4.8 Survival (%) HR: % C.I. (0.37, 0.84) Log Rank P=0.006 OBS SNB Time (years)
25 Latent Subgroup Analysis
26 Morton A 50 Year Odyssey Melanoma Specific Survival Node+ ( mm) Final Dataset 100 Group # Event / Estimate S(t) ± SE % Total N 5-year 10-year OBS, had nodal recur. 48/ ± ± 5.6 SNB+ 70 / ± ± 4.8 Survival (%) HR: % C.I. (0.37, 0.84) Log Rank P=0.006 OBS SNB Time (years)
27 Selection for SLN: Thick Melanoma? Overall Survival
28 Melanoma-specific Survival Thin Melanoma?
29 Node-Positive Thin Melanoma: Outcomes
30 Thin Melanoma SLN predictors Problems: SLN population is selected SLN has false negatives SLN has shorter follow up Use clinical nodal recurrence instead
31 Predictors Breslow Clark Ulceration I II III IV V UNK 0.0 Yes No Unknown Gender Primary Site Age Female Male 0.0 Extremity Head/neck Trunk 0.0 < >=70
32 Predicted probabilities of Nodal Recurrence > <50 Female Male < Concordance index = 0.79 Breslow Age Sex Predicted % node recurrence <0.5 >70 female 0.1 <0.5 >70 male 0.4 < female 0.3 < male 0.9 <0.5 <50 female 0.6 <0.5 <50 male >70 female >70 male female male <50 female <50 male >70 female >70 male female male <50 female <50 male 17.4
33 CLND: Rationale and Data
34 MSLT2: Is CLND necessary in SN(+) LN basins? 79-88% of patients have Negative NSN nodes in CLND specimen MSLT-I JWCI Cochran # SN(+) Stain CLND(+) n (%) H&E H&E IHC 22 (11.8%) 39 (12.1%) 19 (21.1%) NSN(-) % 88% 88% 79%
35 Equipoise: Advantages Potential removal of more cancer (10-20%) Complete Staging Information Clinical trial eligibility? Disadvantages Additional surgery Larger incision JP drain Potential complications: Lymphedema Disease may already be systemic Ultrasound may pick up any recurrence at an early time point
36 Is CLND necessary in SN(+) LN basins? RFS MSS Multivariable: HR 1.51, p=0.09
37 JWCI Retro Data
38 DeCOG Trial Randomized 1:1 to CLND or observation Powered to detect 10% absolute survival difference with 80% power No Head/Neck Melanomas Median Breslow 2.4 mm About 2/3 of patients SLN disease <1 mm
39
40 DeCOG Trial: Discussion/Conclusions Better nodal recurrence rate (14.6 vs 8.3%) Not better MSS Based on our findings, complete lymphadenectomy cannot be recommended in melanoma patients with micrometastases. Difficult recruitment - High refusal/dropout Did not achieve target accrual -Decreased statistical power Follow up <3 years
41 MSLT-II and MILND
42 MSLT II: Trial Design Melanoma >1.2 mm or > Clark IV, n=3500 LM/SL: standard and molecular assessment Melanoma: + SLN (Outside Center) n= Observation Randomization n=1926 Stratification: MSLT1 Center Breslow Ulceration SLN H&E vs. PCR Immediate CLND Nodal Ultrasound Recur No Recur Observation Delayed CLND Observation
43 64
44 Accrual: Complete All North Am Europe Australia Target
45 MSLT-II Possible Outcomes Morton SSO PI 5Mar11 45
46 Minimally Invasive: MILND
47 Minimally Invasive: MILND
48 Minimally Invasive: MILND
49 Minimally Invasive: MILND
50 Minimally Invasive: MILND
51 Distant Metastases
52 Surgery for Metastatic Melanoma: Heresy? It s too late for surgery, a local therapy Surgery is morbid and complicated Risk/Benefit Ratio very high
53 Meta-analysis of Phase 2 Trials Korn et et al. J Clin Oncol. Feb Feb ,
54 Better Staging 2008 CT scanning Circa
55
56 Vaccines: CancerVax AJCC Stage IV Melanoma Resection of Metastatic Lesions Stratification Factors Site of metastasis: M1a: soft-tissue & nodal mets M1b: visceral mets # individual lesions: 1, 2-3, 4-5 Randomize N=496 BCG + Canvax. BCG + Placebo
57 MMAIT-IV Overall Survival (Intent To Treat) Overall Survival Median Survival (months) Survival at 5 years Canvaxin TM Placebo % 45% BCG + Placebo n=250 BCG + Canvaxin TM n= HR=1.18 P=0.245 BCG/Pl BCG/Cv Time (months)
58 Morton ACS Stage IV Metastasis Location Soft Tissue Visceral 100 Placebo Median Survival (months) 60 Survival at 5 years 52% Canvaxin 36 43% 100 Placebo Median Survival (Months) 32 Survival at 5 years 39% Canvaxin 29 36% % Survival BCG + Placebo n=108 BCG + Canvaxin TM n=107 % Survival BCG + Placebo n=138 BCG + Canvaxin TM n= HR=1.37 P= HR=1.06 P= Time (months) Time (months)
59 JWCI Metastasectomy Series Lung Small Bowel Adrenal Surgery No Surgery Median OS 29.2 months Tafra, J Thorac CV Surg, 1995 Liver P< Ollila, Arch Surg 1996 Solid Organ Median OS 9.4 months p <.001 Flaherty, Am Surg, 2015 Overall Survival Surgical, n=58 Non-surgical, n=1020 Months Faries, J Am Coll Surg, 2014 Wood, Ann Surg Oncol, 2001
60 Trial Patient Outcomes Over the Years Ipi/PD-1 combo BRAF/MEK combo SWOG PD-1 vemurafenib JWCI Vax Phase 2 MMAIT Vax (Surgery) Ipi + DITC Ipi +/- gp Korn et al. J Clin Oncol. Feb ,
61 Selection! Selection! Selection! Surgery is not appropriate for all patients. True predictive factors are not available Factors for post-resection prognosis are available (TVDT, DFI, Prior Stage III) prognostic predictive
62 Selection Factors Number of Metastases 1 Met: HR=0.537, p= Mets (reference) 2-3 Mets: HR=0.591, p=0.0664
63 Not competition, but collaboration Neoadjuvant trials Biomarker development Adjuvant Surgery Consolidation Selective resection
64 Metastasectomy: Consolidation Liver Stabilization on Prior Therapy P< Melanoma-Specific Survival Overall Survival Surgical, n=58 Non-surgical, n=1020 Months Faries, J Am Coll Surg, 2014 Yes, n=20 No, n=33 p=0.01 Months Faries, et al, JACS, 2014
65 Metastasectomy: Selective Resection Adrenal Surgery No Surgery Curative Surgery Non-Curative Surgery No Surgery Median OS 29.2 months Median OS 9.4 months p <.001 Flaherty, Am Surg, = Censored Treatment Approach Curative Surgery No Surgery Median Survival (mos.) Overall Survival (p value) Flaherty et al, Am Surg, 2014 Non-Curative Surgery No Surgery
66 Ipilimumab with resection 5 year MSS Med. MSS (months) p-value Ipi after Resection 61% (CI 21-62%) Ipi before Resection 42% (CI 30-82%) 47 p=0.37
67 Resection following Ipilimumab: Resection for: n 5 year MSS Isolated Persistent Disease 7 69% (CI 21-91%) Symptomatic 7 53% (CI 17-79%) Progressive 10 14%(0.7-47%)
68 Unresectable
69 Percutaneous Hepatic Perfusion
70
71 Thank you
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