David B. Troxel, MD. Common Medicolegal Situations: Misdiagnosis of Melanoma

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1 Common Medicolegal Situations: Misdiagnosis of Melanoma David B. Troxel, MD Medical Director, The Doctors Company, Napa, California Clinical Professor Emeritus, University of California at Berkeley Past President, The American Board of Pathology 2005 The Doctors Company David B. Troxel, MD. Materials are used by the CAP with the permission of The Doctors Company and David B. Troxel, MD. 1

2 Diagnoses Are Usually Predictive of Patient Outcomes 2

3 BUT - Sometimes Unanticipated Events Occur 3

4 Pathology Claims Frequency Frequency - the number of claims reported each year per 100 insured physicians Pathologists have Low Frequency 8.3% per year 1 claim every 12 yrs 4

5 Frequency by Specialty Frequency 60% 50% 40% 30% 20% 10% 0% NSU01 PLA01 ORT01 GES01 OBG01 FGP02 INT01 ANE01 PAT01 Specialty 5

6 Pathology Claims Severity Pathology claims have High Severity (second only to neurosurgery): Severity = average indemnity & associated expense per closed paid claim: $453,200 High due to failure to diagnose cancer -with delay in dx and/or inappropriate treatment Melanoma Claim Severity: $757,200 6

7 Of 490 Surgical Pathology Claims from 1995 through % (67claims) involved dx of melanoma today, the most common reason for suing a pathologist 87% of these were false negatives 1/3 were misdx as Spitz nevus; dysplastic nevus; spindle cell SCC; or AFX - or were unrecognized desmoplastic melanomas 7

8 Melanoma Risk Management Claims Review Panel (2002): ALISTAIR J. COCHRAN, MD UCLA School of Medicine SCOTT BINDER, MD UCLA School of Medicine PHILIP LeBOIT, MD UCSF School of Medicine CLIFTON WHITE, MD Oregon Health Sciences Univ. 8

9 Recurrent Problems Identified: 1.) Nodular melanoma - misdiagnosed as benign nevus without explanation: Emphasize diagnostic criteria for melanoma in residency training and CME programs Slide Mills resulting from steeply discounted managed care contracts with mandated referrals too many slides, too fast? Poor inter-observer reproducibility in diagnosis of melanoma 9

10 Inter-observer Reproducibility in Diagnosis of Melanoma 11 experts reviewing 37 classic melanocytic tumors agreed unanimously on benign vs malignant on only 35% of cases. 6 university pathologists reviewed 94 melanoma slides: agreement was good for Breslow thickness, moderate for growth phase, and fair for Clark level. 10

11 1.) Nodular Melanoma misdiagnosed as benign without explanation Pathologists should focus on: 1. Thorough sampling of a lesion 2. Multiple levels through the block 3. Insisting on good histologic sections 4. No frozen sections on melanocytic lesions 11

12 1.) Nodular Melanoma misdiagnosed as benign without explanation Adequate sampling is important since diagnostic features may be seen in only 1 or 2 sections taken from one of multiple levels Serially section the entire biopsy and examine multiple sections from each of three levels Save the intervening sections - they can be stained if needed or used for IPOX 12

13 Recurrent Problems Identified: 2.) Nodular melanoma with the low power architecture of a nevus, but the cytology of melanoma (Nevoid Melanoma) - suggesting that a hasty diagnosis was made under low power 13

14 2.) Nevoid Melanoma Routinely examine all melanocytic lesions under high power even if they appear to be typical nevi under low power Look for mitoses (frequent and/or deep), cytologic atypia, coalescence of nests, melanin in deep tumor cells, and lymphocytic infiltrates Low power symmetry can be misleading 14

15 Recurrent Problems Identified: 3.) Superficial spreading melanoma misinterpreted as a chronically inflamed nevus Melanocytic lesions that contain lymphocytes must be carefully examined for other features of melanoma - and completely excised 15

16 Case 1 A punch biopsy was diagnosed chronically inflamed melanocytic nevus. 2 years later the patient developed metastatic melanoma. Review showed a melanocytic lesion obscured by lymphocytes with few junctional nests and no Pagetoid melanocytosis. Atypical melanocytes were present. Definitive dx of melanoma would be difficult. Excisional bx or expert consultation should have been obtained. 16

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21 3.) Superficial spreading melanoma misdiagnosed as chronically inflamed nevus Lymphocytes Are Better Than Pathologists In Recognizing Melanomas 21

22 Recurrent Problems Identified: 4.) Claims involving partial biopsies (shave or punch biopsies) that inadequately sample the lesion, and result in incomplete excision 22

23 4.) Partial biopsies (shave or punch biopsies) Of 23 Melanoma Claims from : 56% were shave or punch biopsies diagnosed as benign nevi 27% involved melanomas recurring locally and therefore incompletely excised (type of biopsy unknown) Only 17% were melanomas adequately excised 23

24 4.) Partial biopsies (shave or punch biopsies) Despite admonitions to completely excise pigmented lesions, PCP s and dermatologists continue to perform punch and shave biopsies - and this practice is increasing under managed care driven by productivity standards and cost considerations Excisional biopsy is indicated for all melanocytic lesions 24

25 4.) Partial Biopsy (shave or punch biopsy) Limitations: Sample non-diagnostic areas of a melanoma - or an associated benign nevus Don t include the deepest portion of the lesion or the radial growth phase Unlike excisional biopsy there is a residual lesion that may recur or metastasize 25

26 Recurrent Problems Identified: 5.) Melanoma misdiagnosed as Spitz nevus The diagnosis of Spitz nevus in an adult is a high risk and low frequency diagnosis for most pathologists - Analogous to soft tissue tumors or bone tumors 26

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32 Case 2 Biopsy of a non-pigmented nodular lesion in a 31 year old was diagnosed as atypical Spitz nevus. One year later it metastasized to a LN. Review showed a symmetric nodular melanoma, composed of epithelioid melanocytes, with a modest lymphocytic infiltrate and an abnormal mitosis. 32

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36 5.) Melanoma misdiagnosed as Spitz nevus When considering the diagnosis of Spitz nevus in an adult, obtain consultation from an expert 3 Rules for seeking expert opinion Even experts may disagree on problematic or Atypical Spitzoid Lesions 36

37 5.) Melanoma misdiagnosed as Spitz nevus When this occurs some referral centers perform sentinel lymph node biopsy In one published report metastatic cells were found in the sentinel lymph node in 5 of 10 such problematic cases 37

38 Recurrent Problems Identified: 6.) Unrecognized Desmoplastic Melanoma Over half were shave biopsies - often misdiagnosed as dermatofibroma Most desmoplastic melanomas are associated with lentigo maligna or atypical lentiginous proliferations 38

39 Case 3 A 40 year old had a lesion thought to be a BCC. Biopsy was interpreted as benign nevus with dermal fibrosis. One year later an ulcer at the biopsy site was excised and desmoplastic melanoma diagnosed. 6 months later there was lymph node metastasis. 39

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43 6.) Desmoplastic Melanoma The appearance is deceptively subtle so routinely look for DM in all biopsies of LM Pigmented actinic keratosis can be difficult to differentiate from LM In the presence of an actinic keratosis, always assess if LM coexists 43

44 6.) Desmoplastic Melanoma If uncertain, ask the clinician to consider LM and do additional sampling if indicated Useful Rule: Actinic damaged skin + Scar or Desmoplasia = rule out DM This requires stains for S100 protein HMB45 is not useful 44

45 Recurrent Problems Identified: 7.) Melanoma misdiagnosed as Dysplastic or Atypical nevus involving margins Re-excision was requested but not performed - due to miscommunication between the pathologist and the dermatologist 45

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51 7.) Dysplastic or Atypical nevus Pathologists may use the terms atypical or dysplastic in a generic sense - meaning that disturbing cells or architectural features are present in a lesion which lacks other criteria required for the diagnosis of melanoma 51

52 7.) Dysplastic or Atypical nevus Complete excision may be requested - - but dermatologists may be reluctant to do so, since to them these terms have a specific meaning - connoting a clinical syndrome or benign clinical entity with characteristic histologic features 52

53 7.) Dysplastic or Atypical nevus For lesions with an unpredictable biologic potential in the diagnostic gray area between melanocytic nevus and melanoma, use the term: Atypical Melanocytic Proliferation - and request complete excision 0.5 cm margin if superficial; 1.0 cm if deep 53

54 Recurrent Problems Identified: 8.) Spindle cell melanoma misdiagnosed as spindle cell squamous carcinoma. IPOX stains were not performed For amelanotic spindle cell lesions, stains for S100 protein, MART-1/Melan-A, and CK AE1/AE3 are required to differentiate squamous carcinoma from desmoplastic/spindle cell melanoma and atypical fibroxanthoma HMB45 is not useful in this differential dx 54

55 SUMMARY 14% of all surgical pathology claims involve the misdiagnosis of melanoma Today, the most common reason for suing a pathologist is a false negative dx of melanoma (87%) 1/3 of these claims were melanoma misdx as Spitz nevus; dysplastic nevus; spindle cell SCC; or AFX - or were unrecognized desmoplastic melanomas Pathologists and CME programs need to focus on this difficult area of diagnosis 55

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