2017/2018 Sentinel Lymph Node Biopsy in Malignant Melanoma M Rice, V Valeanu, I Delikonstantinou, E Wilson, A Orlando

SLNB Surgical Protocol 1 Pre-op lymphoscintigraphy with radio colloid 2 Dermal injection with patent blue 3 WLE of MM scar 4 Gamma probe guided SLNB (>95% accuracy when performed with dermal injection)

Why Perform SLNB? A Staging Procedure Key prognostic indicator in Melanoma and determinant of access to adjuvant therapy NICE (2015): indicate SLNB in Stage 1B with Breslow >1.0mm AJCC 8th edition : 0.8mm Breslow or ulcerating lesion Melanoma Focus Group 2019: pT1b, particularly when: a. Lymphovascular invasion b. Mitotic rate ≥2/mm2 1. Staging procedure for malignant melanoma + to detect lymph node micrometastasis, avoiding extensive dissection 2. 1 out of 10 patients die within 10 years if SLNB NEG, compared to 3 out of 10 in SLNB POS However, 3 out of 100 SLNB neg will subsequently develop recurrence in same group of LNs

Aims Continue Annual Audit of SLNB @ NBT Measure Surgical Outcomes of SLNB @ NBT Compare practice against NICE guidance Retrospective review from July 2017 —> June 2018 using notes and ICE Evaluate and compare our practice against recommended guidelines from NICE and the Melanoma Focus Group To measure surgical outcomes of SLNB in NBT Retrospective review (notes and ICE) from June 2016 to July 2017 Compare current practice to NICE Re-audit in the future Cycle 1 July 2014 – June 2016 Cycle 2 July 2016 – June 2017 Cycle 3 July 2017 – June 2018

Methods Retrospective review of Medical Records: Demographics Timings Histopathology reports Outcomes Patients coding for Melanoma identified from Business Intelligence Services Electronic notes, Discharge Summaries and ICE reports reviewed Compare to previous data and guidelines

Results: Case Load Increase in patients seen since last year – 10% 99 90 85 50 Steady increasing trend in patients referred for consideration of SLNB 10% more cases seen this year, resulted in a 14% increase in SLNB procedures Increase in patients seen since last year – 10% Increase in SLNB procedures since last year – 14%

Results: Gender Distribution 99 Patient identified in 2017 – 2018 Male to Female: 1.41 / 1 Gender Distribution 2014-2016 Male 52.2% Female 47.8% 2014-15 50 patients 2015-16 85 patients Female 41% Male 59% Male 69.1% Female 30.9% Gender Distribution 2016-2017 99 Patients referred over the course of June – July 2017/18 Gender distribution again demonstrates a slight preponderance towards males 90 patients

Results: Age Distribution Average: 64 yrs Median: 60 yrs Average: 59.7 yrs (prev 58.7) Median: 60 yrs Age Distribution 2016-17 Similar spread compared to 2016 / 17

Results: Melanoma Referral Geography Referral by Geography 21 15 18

Results: Diagnosis of Primary Lesion 2016-17 n % Excision biopsy 68 84.0 Unknown 6 7.4 Shave biopsy 5 6.2 Punch biopsy 1 1.2 Incisional biopsy 0.0 Mainly GPs 4/5 Reflection education 2017-18 n % Excision biopsy 87 88% Incisional biopsy 6 6% Unknown 3 3% Shave biopsy The excision biopsy should include the whole tumour with a clinical margin of 2 mm of normal skin, and a cuff of fat. This allows confirmation of the diagnosis by examination of the entire lesion, such that subsequent definitive treatment can be based on Breslow thickness. Diagnostic shave biopsies should not be performed as they may lead to incorrect diagnosis due to sampling error, and make accurate pathological staging of the lesion impossible (Level III). For the same reasons partial removal of naevi for diagnosis must be avoided and partial removal of a melanocytic naevus may result in a clinical and pathological picture very like melanoma (pseudomelanoma). This gives rise to needless anxiety and is avoidable. Incisional or punch biopsy is occasionally acceptable, for example in the differential diagnosis of lentigo maligna (LM) on the face or of acral melanoma, but there is no place for either incisional or punch biopsy outside the skin cancer MDT (Level III). 3 GPs

Histology report to SLNB Results: Time Targets Time Difference 2014-2016 2016-2017 2017-2018 Referral to OPD clinic 16.45 20.95 14.5 (0-49) Histology report to SLNB 51.45 60.89 83.1 (22-158) OPD clinic to SLNB - 42.34 73.7 (20-185) Referral to SLNB 64.15 87.3 (20-172) SWAG Network Skin Cancer SSG Meeting Sept 2017 http://www.swscn.org.uk/wp/wp-content/uploads/2014/11/ https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2017/06/Cancer-Waiting-Times-Annual-Report-201617-1.pdf SWAG_Skin_SSG_Draft_Notes_13092017.pdf

Results: Breslow Thickness Average BT = 2.54 (2.18) SLNB -VE = 2.43 (2.04) SLNB +VE = 2.72 (2.17) 2 results unknown BT NICE Guidelines “Melanoma: assessment and management: 1.5.1 Do not offer imaging or SLNB to people who have stage 1A melanoma or those who have stage 1B melanoma with a Breslow thickness of 1mm or less.

Results: Primary MM Site 2016/17 26 4 PUT SOME % Leg / Thigh = lower limb except foot Back = shoulder and back Upper limb Trunk Foot With percentages and maybe a body outline 18

Results: WLE Margins 27 69 1 Breslow Thickness (mm) 2014-2016 2016-2017 2017-2018 1 cm 11 23 27 1.5cm 7 2 cm 106 43 69 2.5 cm 6 2 1 3 cm 3 3 WLE margins unknown GUIDELINES ARE FOLLOWED Breslow Thickness (mm) Recommended Margin (cm) In-situ 0.5 <1.0 1 1.01 – 2.0 1 – 2 2.01 – 4.0 2 >4 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Melanoma, version 1.2013. National Comprehensive Cancer Network; Fort Washington, PA: 2013. www.NCCN.org NICE Melanoma: assessment and management (NG14) . July 2015 https://www.nice.org.uk/guidance/ng14

Results: Sentinel Node Basins 2.9% 7.6% 54.8% Basin 2014-16 % 2016-17 2017-18 Axilla 65 47.1 49 50.5 57 54.8 Groin 55 39.9 31 31.9 36 34.6 Parotid 4 2.9 2 2.1 Neck 14 10.1 7 7.3 8 7.6 Other 0.0 8.2 3 TOTAL 138 97 104 34.6%

Results: Sentinel Node Basins Number of Basins 2014-2016 % 2016-2017 2017-2018 1 121 87.7 63 78.7 89 86 2 17 12.3 13 16.3 15 14 3 or more 0.0 4 5.00

Results: Sentinel Node Biopsy Status 2017-18 SLNB Status 2014-2016 % 2016-2017 2017-2018 Negative 97 72.4 62 77.5 69 71.1 Positive 37 27.6 19 22.5 28 28.9 CLND = 22 Performed* 7 declined 1 died 2016-17 We performed 97 SLNB procedures in total which is 14% more than last year. 69 (71.1%) returned with negative findings. According to MSTL1 80% of Intermediate MM should be SLNB negative We are at 71.1% however this included more advanced thick melanoma >4mm Breslow thickness We also performed 22 completion dissections although we offered 30 in total. 7 declined surgery opting for CT interval scans and 1 patient passed away. CLND = 14 Performed 4 declined * 22 Dissections performed – 2 on different sites of same patient

Results: Complications 2016/17 SLNB Complication : 14 cases (17.2%) 2016/17 CLND Complications : 4/11 (36%) 2016-17 Complications SLNB Dissection Infection 9 3 Bleeding Infected Seroma 5 1 Haematoma 2017-18 2017/18 SLNB Complication : 14 cases (13.7%) 2017/18 CLND Complications : 8/22 (36%) Complications SLNB Dissection Infection 2 Seroma 7 Infected Seroma 4 3 Bleeding 1 Apnoea Pneumothorax Hypoglossal injury Public Health England Surveillance of surgical site infections in NHS hospitals in England 2017: Cumulative SSI incidence April 2016 to March 2017 9.2% Enterobacteriaceae SSI incidence is slowly rising to 29% Staph aereus and MRSA continue to decrease NICE Surgical site infections report 2017: nasal decontamination of Staph Aureus both Chlorhexidine and Povidine Iodine (water and alcohol-based solutions) recommended Intra-operative antimicrobials Antibiotics sutures 1. nasal decontamination of Staph Aureus key but still undergoing review 2. both Chlorhexidine and Povidine Iodine (water and alcohol-based solutions) recommended 3. Intra-operative gentamicin-collagen sponges MAY reduce infection but concern over resistance so needs further evaluation 4. No evidence for triclosan-coated sutures outside of abdominal surgery https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/666465/SSI_annual_report_NHS_hospitals_2016-17.pdf https://www.nice.org.uk/guidance/cg74/resources/surveillance-report-2017-surgical-site-infections-prevention-and-treatment-2008-nice-guideline-cg74-pdf-5649242244037

Results: Complications SLNB complications most often occurred in the Groin: 64% - Seroma or Infected Seroma Completion Dissection complications were most common following Groin Dissection: 50% - Seroma or Infected Seroma

Conclusions Increase in Overall Case Load (99 vs 85 patients) Most referrals are from Dermatology and from Gloucester / Cheltenham region Less Shave Biopsies performed (3% vs 6.6%) Problem with meeting service time target – reduced surgical capacity for a period, higher number of metastatic cases requiring more complex procedures, reduced surgical team for a period 14% increase in SLNB procedures performed (97 vs 81) 36.4% increase in number of lymph node dissections undertaken (22 vs 14) SLNB Complication rate decreased for 2nd consecutive cycle (13.7% vs 17.2%) Dissection Complication rate remained the same (36%) – however zero mortality, no major complications, and several unusual complications unlikely to recur

Recommendations Focus on improving hit rate regarding service time targets – increased surgical capacity and back to a full team. Be aware of steadily increasing case load year-on-year and account of this in planning future provision Thank you slide