1. Opdivo + Ipilumimab is now the first line therapy for metastatic melanoma.

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1 Melanoma UpToDate: Introduction: Risk Factors: 1. Opdivo + Ipilumimab is now the first line therapy for metastatic melanoma. Median age = 50 yrs Incidence is rising - Sun exposure: UVB ( nm) > UVA ( nm) - History of blistering sunburn: intermittent intense sunburn > chronic sun exposure. - Nevi: increased number of benign moles, dysplastic nevi - Family history (2-8%): melanoma in first-degree relatives, xeroderm pigmentosum, familial atypical mole melanoma syndrome (FAMMS) - Immune suppression - Ethinic: fair skin color (northern Europeans) Biology: A. FAMMS, Dysplastic nevus syndrome - CDKN2A/p16 and CDK4 germline mutations on chromosome 9 (block cell cycle function) 60-90% lifetime risk of melanoma, also a/w pancreatic cancer. - But genetic testing is NOT routinely recommended. B. Sporadic (90%): - BRAF V600E mutation: 60% of all melanoma, pts are younger, a/w intermittent sun exposure - c-kit mutation: elderly patients, a/w chronic sun expsoure - MITF (Microphthalmia-associated transcription factor) - Loss of PTEN Symptoms: Diagnosis: ABVDE - most importan is the change of the exisiting mole Occular melanoma can metasize to liver. Mets to brain common. A. Diagnosis: Incisional biopsy with full thickness, avoid shave biopsy or curettage. B. Staging work-up: 1) Stage I/II: - CXR (pa and lat), additional imaging as clinically indicated - CBC with diff, LFT, LDH - Full skin exam 2) Stage III/IV: - CT C/A/P or PET/CT - Brain MRI with or without gadoliniu, - CBC with diff, LDH - Full skin exam - Molecular typing (BRAF V600E mutation for all stage IV melanoma) Page 1 of 5

2 Pathology: A. Pathological evaluation: - Primary vs metastatic, - Thickness (mm), Deep margin, Ulceration, Mitoses (per mm2) - Histology, Lymphovascular invasion, Microsatellites B. Classification: A. Types of Melanoma: - Cutaneous melanoma - Mucosal epithelial melanoma - Ocular melanoma - Uveal melanoma B. Cutanous Melanoma in the order of decreasing frequency: - Superficial spreading melanoma: BRAF mutation, intermittent sun exposure, young - Nodular melanoma: BRAF mutation - Lantigo maligna melanoma (evolved from noninvasive lantigo maligna = carcinoma in situ): c-kit, chronic sun exposure, elderly - Acral lentiginous melanoma: c-kit, palm, sole and nail bed C. Staging: A. Simplified Clinical Staging: - Stage I/II: confined to skin. - Stage III: positive lymph nodes, or in transit metastasis or satellite. - Stage IV: distant metastasis B. TMN Staging Thickness Mitoses Ulceration T1: < 1mm a: <1/mm2 no b: >1/mm2 or yes T2: 1-2mm a: no T3: 2-4mm a: no T4: >4mm a: no N1: 1 node (a: microstasis; b: macrostatsis) N2: 2-3 nodes (a: microstasis, b: macrostasis, c: in transit mets (satellite lesions between primary tumor and lymph nodes) N3: > 4 nodes M1a: mets to skin, subcutaenous or distant lymph nodes, normal LDH M1b: mets to lung, normal LDH M1c: mets to all other viceral sites or distant mets to any sites combined with an elevated LDH Page 2 of 5

3 Stage IA: T1aN0M0 IB: T1bN0M0, T2aN0M0 Stage IIA: T2b-3aN0M0 IIB: T3b-4aN0M0 Stage III: positive lymph nodes Stage IV: distant metastasis C. Clark Level: no longer used in staging (just list for historical reason) - Melanoma confined to the epidermis (melanoma in situ) - Invasion into the papillary dermis - Invasion to the junction of the papillary and reticular dermis - Invasion into the reticular dermis - Invasion into the subcutaneous fat Prognosis: Tx Principle: - Tumor thickness: most important! <1mm - good. - Ulceration - bad - High mitotic rate - bad - Lack of tumor infiltrating lymphocyte - Microscopic satellites - bad - Positive lymph node - bad A. Surgery and SLN Biopsy for Primary Melanoma 1). Wide excision with negative margins (all category 1) Tumor Thick Clinical Margin Required in Situ 0.5 cm <1mm 1 cm 1-2mm 1-2 cm 2-4mm 2 cm > 4mm 2 cm 2). Sentinel Lymph Node Biopsy (SLNB): for staging purpose only without survival benefit - Indicated for tumor depth >1mm or clark level IV/V * for T<1mm, do SLNB if ulceration or mitoses >1, >0.75mm with positive deep margins, lymphvascular invasion, young age. 3). If (+) for SLN or clinical positive nodes, lymph node dissection (minimal nodes) B. Node-negative local disease: Observe post wide excision C. Adj Thearpy of Melanoma: 1) Indication: Tumor depth >4mm or positive lymph node (either positive SLN or palpable), or any tumor with ulceration/high mitosis 2) High-Dose IFN: only drug approved by FDA approved for adj therapy - improved PFS by 10 months,? OS 3) Consider Adj RT: to nodal basin if multiple nodes involved (>4) or macroscopic extranodal extension. local recurrence without OS benefit. Page 3 of 5

4 - Adj RT also considered for head and neck melanoma post dissection or local recurrence. 4) Adj Vaccine: not effective (EORTC 18961) D. Metastatic Melanoma: median survival = 9 months 1) Surgical management of metastatic melanoma: - Post initial tx of cutanenous melanoma regular monitoring document recurrence define extent of disease consider metastasectomy prolong survival and morbidity - Even for symptomatic limited mets surigical resection quick and durable palliation. 2) Algorithm: BRAF V600E in all stage IV or unresectable melanoma - If (-) for BRAF mutation and NOT a candidate for IL-2: prefer Ipilimumab, rather then chemo - If (+) for BRAF V600E two options: * Prefer Vemurafenib if symptomatic, bulky, or prompt response is desired or contraindication to Ipilimumab * or tx with Ipilimumab if minimal sx, limited disease. - If pts are able to tolerate intensive tx, high dose IL-2 regardless of BRAF status, rather than ipilimumab or vemurafenib, because high-dose IL prolonged durable DFS and possible cure 3) Active chemo agents (no surval benefit) is out of favor now: DITC (13% RR), Temozolomide (13%RR), Carb/Taxel (20% RR). 4) Tx Note: - DO NOT use IFN in metastatic setting - High dose IL-2 candidate: good PS, organ function preserved, no brain mets. Slow response potential cure - Vemurafenib (Zelboraf): inhibit BRAF V600E -prolong PFS and OS. Rapid respose - Ipilimumab (Yervoy): Anti-CTLA-4 monoclonal antibody - prolong PFS and OS. Slow response and potential cure, and has CNS disease activity. - Always treat brain mets first before initiating systematic therapy. - Melanoma with brain mets, treat CNS disease first, then offer high-dose IL-2, or temozolamide which can penetrate BBB. E) Metastatic melanoma with brain metastasis: 1) For faviorable prognostic pts: single or limited number of brain mets, good PS, limited or no extracranial disease - Surgical resection, followed by WBRT, or - Stereotactic radiosurgery (SRS), followed by WBRT, both prolong survival 2) For poor prognostic pts: extensive extracranial dieases, poor PS - WBRT or BSC. Follow-Up: A. Surveillance post resection and adj therapy (IFN-α): Page 4 of 5

5 - q3-4 months LFT and LDH, skin exam. CT twice a year. After 5 yrs, no more imaging. Imaging? Pharmacology: A. High dose IFN-α 2b: - Induction: 5 days/wk x 4 weeks, - Maintenance: 10mu/m2, 3/wk x 4 wks B. Vemerafenib: - FDA approved in 2011 for unresectable or metastatic stage IV melanoma with BRAF V600E as tested by Cobas test. Not indicated for wild-type BRAF - Clinical trial: DFS, OS compared DITC - SE: rash, skin squamous cell carcinoma, keratoacanthoma, QT prolongation, diarrhea, photosensitivity C. Ipilimumab: 3mg/kg IV, q3wks x4, no approval for maintenance - Indicated for stage IV melanoma or unresectable stage III melanoma - MOA: Ipilimumab blocks CTLA-4 (a negartive regulator of T cell activation) T- cell activation. * MDX trial: Ipilimumab OS benefit (Hr=0.66) compared to gp100 * Study 024: "Ipilimumab + DITC" OS (11.2 vs 9.1 mos) compared to DITC alone. - SE: auto-immune disease type of side effects Tx: r/o infection. Corticosteroid (2-5mg/kg/d prednisone) - Monitoring during Ipilumumab * CBC, LFT, thyroid function tests prior to each cycle of Ipi. Page 5 of 5

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