Michael T. Tetzlaff MD, PhD

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1 Update on American Joint Cancer Committee (AJCC) staging system for primary cutaneous melanoma Emphasis on concise and accurate reporting of primary and metastatic melanoma for effective risk stratification and prognosis Michael T. Tetzlaff MD, PhD Associate Professor Department of Pathology, Section of Dermatopathology Department of Translational and Molecular Pathology The University of Texas MD Anderson Cancer Center Executive Officer Translational Research Program The Alliance for Clinical Trials Outline Pathology report and cancer templates What we report and why? 8 th Edition of AJCC staging system Parameters of the primary lesion that direct pathologic T-category Additional informative and prognostic parameters of the primary melanoma Lymph node metastases and satellitosis: criteria of pathologic N-category Distant metastases: M-category

2 8 th Edition AJCC for cutaneous melanoma Does not apply to melanomas of the conjunctiva, uvea, or mucosal melanomas of the head/neck, vulva/vaginal, or anorectum. Conjunctival Anorectal Urothelial Vulvar Pathology report for primary cutaneous melanoma Improved scientific knowledge of the biology and pathogenesis of melanoma improve our capacity to stratify risk. Pathology reports have become more comprehensive Diagnosis Prognostic factors Mutation information Include cancer protocol templates Impact clinical decisions and treatment modalities Earlier intervention and neoadjuvant therapy on the horizon

3 Pathology report for primary cutaneous melanoma (A) RIGHT SHOULDER, SKIN PUNCH BIOPSY: MELANOMA, INVASIVE, SUPERFICIAL SPREADING TYPE CLARK LEVEL, IV BRESLOW THICKNESS, 2.25 MM RADIAL (NON-TUMORIGENIC) GROWTH PHASE, PRESENT VERTICAL (TUMORIGENIC) GROWTH PHASE, PRESENT MITOTIC FIGURES/MM 2,6 ULCERATION, PRESENT (3.2 MM) REGRESSION, PRESENT VASCULAR INVASION, PRESENT PERINEURAL INVASION, PRESENT MICROSCOPIC SATELLITOSIS, PRESENT (3 X 2 MM) TUMOR-INFILTRATING LYMPHOCYTES, NON-BRISK ASSOCIATED MELANOCYTIC NEVUS, PRESENT INTRADERMAL) PREDOMINANT CYTOLOGY, EPITHELIOID SURGICAL MARGINS: INVASIVE MELANOMA PRESENT AT PERIPHERAL TISSUE EDGES Required by CAP Required by AJCC Recommended by AJCC Why report all 15 parameters? Provide complete pathology report Important information from non-required elements Clark level can be informative (e.g. Breslow thickness not available) Fragmented tissue (e.g. curettage specimens) Maloriented specimens Regression Ongoing studies assessing depth of regression versus depth of persistent melanoma Considered an adverse prognostic indicator Presence may drive subsequent management May have relevance to immunotherapy

4 Why report all 15 parameters? Provide complete pathology report Important information from non-required elements Perineural invasion Included in Breslow thickness by many centers May upstage T category (e.g. change T1 to T2) Associates with increased risk of local recurrence May indicate a need for adjuvant radiation therapy Tumor infiltrating lymphocytes May inform subsequent immunotherapy decisions Why report all 15 parameters? Provide complete pathology report Important information from non-required elements Associated melanocytic nevus Primary lesion (versus metastasis) Associates with better survival in some studies Predominant cytology Aids in examination of excision specimens, sentinel lymph nodes and/or subsequent distant metastases Epithelioid, Spindle, nevoid

5 T = Primary tumor Breslow (Tumor) thickness Mitotic rate (7 th Edition) Ulceration TNM staging N = Regional metastasis Lymph node Microscopic/ clinically occult (A) Macroscopic/ clinically detected (B) Skin/subcutaneous tissue (In-transit metastasis/satellites) M = Distant metastasis Lymph node Skin/subcutaneous tissue Visceral metastasis Pulmonary Non-pulmonary Brain metastasis Serum LDH T-category driven by Breslow thickness and ulceration T = Primary tumor Breslow (Tumor) thickness Ulceration Mitotic rate (7 th Edition) Breslow (Tumor) thickness Ulceration Mitotic figures

6 Melanoma staging T-category: thickness and ulceration All principle T- category ranges are preserved in the 8 th Edition AJCC Melanoma staging T-category: thickness and ulceration 7 th Edition pt1 pt1a pt1b mm NO ulceration and mitotic rate <1/mm 2 With ulceration or mitotic rate>1/mm 2 8 th Edition pt1 pt1a <0.8 mm NO ulceration pt1b <0.8 mm With ulceration pt1b mm With or without ulceration

7 Melanoma staging T-category: thickness and ulceration Breslow thickness for pathologic staging Includes the thickness measured in the biopsy If the biopsy is transected, Breslow thickness is recorded as AT LEAST Includes the thickness measured in the excision WHICHEVER IS GREATEST (NOT ADDITIVE) Tumor thickness now recorded to the nearest 0.1 mm (instead of the nearest 0.01 mm) Due to impracticality and imprecision of 0.01 mm measurements particularly for tumors > 1 mm Important pathologic staging implications: 0.75 mm to 0.84 mm now recorded as 0.8 mm (pt1b) 0.95 mm to 1.04 mm now recorded as 1.0 mm (pt1b) Melanoma staging T-category: thickness and ulceration Clarification on ptis, pt0 and ptx ptis: Melanoma in situ pt0: No evidence of primary tumor ( melanoma of unknown primary ) ptx: Tumor thickness cannot be determined Tangential sectioning or the epidermis is not visualized

8 Melanoma staging T-category: Breslow thickness Breslow thickness Breslow thickness: Measured from (1) top of granular layer or (2) base of the ulcer to the deepest point of invasion Breslow thickness: Top of granular layer to deepest point of invasion Top of granular layer to deepest invasion If a primary tumor lacks an intraepidermal component, the tumor thickness should still be measured in the standard manner (from the top of the granular to the deepest point of invasion)

9 Breslow thickness: Base of ulcer to deepest point of invasion Top of granular layer to deepest invasion Base of ulcer to deepest invasion Breslow thickness pitfalls Measure only to invasive melanoma not associated nevus 1 2

10 Breslow thickness pitfalls Avoid A void m measuring easuring a around round a adnexal dnexal s structrues tructrues Breslow thickness pitfalls Include to perineural invasion (if deepest) 1 2 In our practice we provide both conventional Breslow thickness and designate a thickness as measured to PNI separately.

11 Impact of regression on Breslow thickness Breslow thickness measured to the deepest viable tumor cell Insufficient evidence yet to support measuring to regression If a tumor has undergone complete regression, then pt0. Breslow thickness pitfalls Avoid measuring tangential sections If a tumor cannot be measured due to tangential sectioning, then ptx.

12 Breslow thickness pitfalls Tumor is transected in the primary biopsy Breslow thickness reported as AT LEAST 1.1 MM Breslow thickness pitfalls Breslow thickness is not additive Biopsy specimen 1 Biopsy specimen Breslow thickness reported as AT LEAST BT1 mm

13 Melanomas lacking an intraepidermal component: Primary or metastatic In melanomas lacking an intraepidermal component, consideration should be given to a cutaneous metastasis. Features favoring a primary origin: (Overlying melanoma in situ) Associated nevus Superficial regression Exercise caution when diagnosing melanoma as metastatic without knowledge (e.g. is there clinical evidence of a prior melanoma?) Melanomas lacking an intraepidermal component: Primary or metastatic (A) PARIETAL SCALP, SKIN PUNCH: MELANOMA IN DERMIS, PRESENT AT PERIPHERAL TISSUE EDGES. SEE COMMENT. Comment Sections reveal a proliferation of malignant epithelioid melanocytes forming an expansile nodule in the dermis, abutting the epidermis. An intraepidermal component is not identified. A primary or metastatic origin is possible. If this were interpreted as a primary melanoma at this anatomic site, the following prognostic indicators would apply.

14 Primary tumor ulceration Ulceration Defined as absence of intact epidermis overlying invasive melanoma with host reaction above the primary melanoma: Fibrin deposition and neutrophils Based on microscopic examination Must be distinguished from artifactual or traumatic disruption of epidermis Pitfalls in primary tumor ulceration Transepidermal elimination of tumor Scale crust over intact epidermis Prior trauma or biopsy site Detached but in tact epidermis

15 Detached epidermis Not ulcerated Detached De D e tta ac ch hed ed e epidermis piid p de erm rmiis s Absent fibrin crust Not N No ot ulcerated ullce u ce ra rate ted Pitfalls in primary tumor ulceration Not ulcerated Ulcer likely from trauma No melanoma beneath ulcer

16 Melanoma of unknown primary: pt0 Patient presents with a regional lymph node metastasis or distant visceral metastasis but no known primary origin Potential sources of primary melanoma: Iatrogenic or non-iatrogenic procedures caused regression Spontaneously regressed primary melanoma Patients with lymph node metastases should be considered as regional stage III disease if there is not evidence of disease elsewhere. Such patients have a prognosis and natural history similar to if not MORE FAVORABLE than those same staging characteristics from a known primary cutaneous melanoma Pathology report for primary cutaneous melanoma Other reported parameters (A) RIGHT SHOULDER, SKIN PUNCH BIOPSY: MELANOMA, INVASIVE, SUPERFICIAL SPREADING TYPE CLARK LEVEL, IV BRESLOW THICKNESS, 2.25 MM RADIAL (NON-TUMORIGENIC) GROWTH PHASE, PRESENT VERTICAL (TUMORIGENIC) GROWTH PHASE, PRESENT MITOTIC FIGURES/MM 2,6 ULCERATION, PRESENT (3.2 MM) REGRESSION, PRESENT VASCULAR INVASION, PRESENT PERINEURAL INVASION, PRESENT MICROSCOPIC SATELLITOSIS, PRESENT (3 X 2 MM) TUMOR-INFILTRATING LYMPHOCYTES, NON-BRISK ASSOCIATED MELANOCYTIC NEVUS, PRESENT INTRADERMAL) PREDOMINANT CYTOLOGY, EPITHELIOID SURGICAL MARGINS: INVASIVE MELANOMA PRESENT AT PERIPHERAL TISSUE EDGES CAP required elements Elements for AJCC Recommended by AJCC

17 Primary cutaneous melanoma Histopathologic subtypes Superficial spreading Lentigo maligna Acral-Lentiginous Nodular Melanoma staging and reporting Mitotic figures Mart-1/PHH3 Numerous studies correlate mitotic figure count with prognosis Use the hot spot method: Identify the high-power field containing the most mitotic figures and count 1 mm 2. Do not cut additional sections in excess of those normally used to report and diagnose melanoma Immunohistochemical studies are not used to determine mitotic rate for staging and reporting purposes.

18 Melanoma staging and reporting Lymphovascular invasion MiTF/D2-40 Numerous studies correlate lymphovascular invasion by tumor cells with prognosis Do not cut additional sections in excess of those normally used to report and diagnose melanoma Immunohistochemical studies MAY BE USED to determine the presence of lymphovascular invasion for staging and reporting purposes. Lymphovascular Prognostic Implication invasion of as a prognostic Lymphovascular factor Invasion in melanoma. Detected by Am Double Surg. Immunostaining (8): for D2-40 and MITF1 in Primary Cutaneous Melanoma. Am J Dermatopathol (7): Melanoma reporting: Clark Levels I: Intra-epidermal II: Into papillary dermis III: Fills/expands papillary dermis Papillary dermis IV: Reticular dermis V: Subcutaneous adipose Reticular dermis Clark level of invasion have prognostic significance in univariate analyses, numerous studies have now confirmed that it: Loses significance in multivariate analyses Less reproducible among pathologists Less robust a predictive factor than thickness

19 Melanoma staging and reporting Regression Associated nevus Regression viewed as an adverse prognostic indicator Underestimates true Breslow depth Correlation with response to immune checkpoint blockade? Important implication for staging: Primary melanoma Perineural invasion by tumor cells Seen more frequently in LMM and ALM with desmoplastic features Presence of PNI indicator for increased likelihood of local recurrence or for further adjuvant radiation therapy Include area of PNI in Breslow thickness measurement Nerve entrapment in central aspect of tumor is not PNI.

20 Multiple primary melanomas Each primary melanoma is staged independently. For those rare cases where patients present with multiple simultaneous melanomas that drain to the same regional lymph node basin and nodal metastases are present, the tumor with the highest T- category should be assigned the origin. pt2a pt3b Melanoma staging N-category: number, extent and satellites Major modifications: Clinically occult replaces microscopic [pnxa] Clinically evident replaces macroscopic [pnxb] Microsatellite, satellite or in-transit metastasis [pnxc]

21 Melanoma staging N-category: number, extent and satellites Key points: Clinically occult [pnxa] versus clinically evident [pnxb] Presence of a microsatellite, satellite or in-transit metastasis modifies to [NXc] Template for reporting lymph nodes Number of lymph nodes assessed (SLN and non- SLN) Number of lymph nodes containing metastasis Tumor size Reported in mm Measured on slide Tumor location Subcapsular 5.3 x 1.8 mm Intraparenchymal Currently NOT a component of the staging system but envisioned to guide future prognostic models and possibly direct how (neo)adjuvant therapy is deployed Extracapsular extension

22 Sentinel lymph node evaluation Extracapsular extension Defined as the presence of nodal metastasis extending through the lymph node capsule into adjacent tissues usually seen as microscopic extension of metatatic mleanoma into the perinodal adipose tissue. N-category: Microsatellitosis, Satellitosis and in-transit metastases Deposit separated by normal tissue 8 th Edition of the AJCC does not require minimum size threshold or minimum distance from the primary lesion. Microsatellites situated close to the primary lesion should be subjected to additional sections to exclude a connection.

23 N-category: Microsatellitosis, Satellitosis And in-transit metastases All thought to occur via lymphatic spread of tumor (pnxc) Microsatellite: focus of metastatic melanoma in the skin or subcutis adjacent to or deep to the primary melanoma. The tumor cells are discontinuous from the primary tumor and separated from the primary lesion by normal tissue (rather than fibrosis or inflammation) Satellite: focus of metastatic melanoma in the skin or subcutis detected clinically within 2 cm but discontinuous from the primary tumor. In transit metastasis: clinically evident metastasis in the skin or subcutis located > 2 cm from the primary tumor in the region between the tumor and the regional lymph node basin. N-category: Microsatellitosis, Satellitosis And in-transit metastases In transit Metastasis Microsatellite Satellite Primary Melanoma

24 Pitfalls of satellitosis Intravascular deposit (IHC informative) Lesion contiguous on deeper sections Incidental nevus? Mart-1/K-67 Melanoma staging M-category: site and LDH

25 Thank you! Victor G. Prieto MD, PhD Carlos A. Torres-Cabala MD Jonathan L. Curry MD Priya Nagarajan MD PhD Phyu Aung MD, PhD Jeff Gershenwald MD Michael A. Davies MD, PhD Jennifer A. Wargo MD N-category determined by sentinel node evaluation in most cases If at least one node is detected clinically and others are detected microscopically, then [pnxb] Sentinel lymph nodes in melanoma Positive in 20% of patients 15% > 1.0 mm 5% < 1.0 mm 16% detected on initial H&E 4% detected with additional sections/ihc <5% with extracapsular extension

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