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Precursors To Melanoma And The Problematic Nevomelanocytic Proliferation
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Section 12 -
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Prognostication Including Microstaging of Malignant Melanoma

Neil Crowson, MD Cynthia M. Magro, MD Martin C. Mihm, Jr., MD
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The prognosis of patients with invasive malignant melanoma in vertical growth phase can be predicted
by specific light microscopic parameters including the measured depth, mitotic count, host response, sex,
anatomic site, and presence or absence of regression, angioinvasion, or ulceration. All of this
information should appear in the pathology report.

Level and Depth of Invasion
A critical factor is the extent of invasion into the dermis. Tumor invasion may be qualitatively
expressed according to the anatomic compartment (i.e., papillary or reticular dermis or subcutis) of
invasion, referred to as the Clark level, or quantitatively assessed as the so called Breslow
measurement, the thickness of the melanoma from the most superficial aspect of the granular cell layer to
the deepest point of invasion in the dermis. Adventitial dermal invasion is not measured unless it is
the only site of dermal invasion, and one then measures from the inner luminal surface of the eccrine
gland or duct or the inner aspect of the outer root sheath epithelium of the hair follicle (Breslow,
1970).

Clark 's levels are defined as follows (Clark et al, 1969):

Level I: Malignant melanocytes are confined to the epidermis

Level II: Partial infiltration of the papillary dermis by single cells or small nests of cells that
do not exceed the size of any intraepidermal nest. The presence of a large nest, even if the entire
depth of the papillary dermis is not occupied, may represent incipient vertical growth phase.

Level III: Tumor cells fill and expand the papillary dermis with extension of tumor to the
papillary-reticular dermal interface, the latter identifiable through the routine use of a polarizer and
compensator to take advantage of the birefringence patterns of the dermal collagen; the papillary dermal
collagen fibers are oriented vertically whereas the reticular dermal collagen bundles have a more
horizontal orientation. In level III invasion, a few cells may infiltrate the superficial reticular
dermis, but the growth is not permeative. Level III penetration usually signifies vertical growth phase
melanoma (Mihm and Googe, 1990).

Level IV: Melanoma cells infiltrate the reticular dermis in a significant fashion.

Level V: Melanoma cells infiltrate the subcutaneous fat.

The Breslow measurement is taken from the epidermal surface or, in the event that the surface is
ulcerated, from the base of the ulcer, and is made with a calibrated ocular micrometer. It is the most
important means of prognosticating mucosal melanomas that lack the anatomic compartmentalization of the
corium seen in the skin. In most prognostic studies, the measured depth emerges as the most powerful
independent factor for prediction of lymph nodes metastasis and survival (Vollmer and Seigler,
2000).

Other prognostic variables include:
 Mitotic Count Per Square Millimeter
This index is reported as the number of mitoses in a square millimeter. From 3 to 10 high-power
fields is equivalent to one square millimeter, depending upon the nature of optical equipment used.
There is wide variance between different microscope makes and models and thus we recommend formal
calibration using a stage micrometer (Mihm and Googe, 1990; Crowson et al, 2001).
 Inflammatory Host Response
A lymphocytic response to the vertical growth phase component influences prognosis in some studies.
If there is no host response the designation is "absent", while infiltration focally either along the
base or within the tumor is considered to be "present, non-brisk". Infiltration either of the entire
base of the tumor or diffuse permeation of the vertical growth phase is designated "present, brisk". To
be significant lymphocytes must infiltrate and disrupt tumor nests and show apposition to tumor cells;
lymphocytes in a perivenular array within the tumor nodule but not permeative of it are designated as an
absent host response, as are lymphocytes in a cuff about the base of the tumor but not infiltrating
it (Clark et al, 1989; Mihm and Googe, 1990; Crowson et al, 2001).
 Regression
Complete regression is characterized by an area of absent melanocytic growth in the epidermis and
dermis, often bordered on one or both sides by melanoma. This signifies a worse prognosis. The
epidermis is often attenuated with loss of the retiform pattern. The subjacent dermis shows a
nonlaminated fibroplasia containing a few inflammatory cells and melanophages with variable edema and
telangiectasia, the vessels typically assuming a perpendicular orientation to the long axis of the
epidermis. Regression of over 75% of a given tumor may be the critical volume that portends metastasis
(Ronan et al, 1987; Byers and Bahwan, 1988).
 Microscopic Satellites
Microscopic satellites, characterized by reticular dermal and/or subcuticular nodules of tumor
greater than 0.05 mm in width separated from the main vertical growth phase component, are associated
with lymph node metastasis, decreased disease-free and overall survival (Day et al, 1981; Harrist et al,
1984; Leon et al, 1991; Balch et al, 2000).
 Ulceration
By convention we measure size of any ulcer (Balch et al, 1980), even though recent studies
suggest that any evidence of ulceration that cannot be attributed to trauma portends a grave prognosis
(Balch et al, 2000). To qualify as ulceration there must be evidence of host response, ie fibrin and
cellular debris, to distinguish the process from an in vitro artifact
induced by trauma of processing artifact or surgery.
 Blood Vessel and Lymphatic Invasion
The presence or absence of blood vessel and lymphatic invasion should be reported, although it is
unclear that angiolymphatic invasion will prove ultimately to be an independent prognostic variable.
Some studies have correlated the frequency of angiolymphatic invasion with increasing depth and level of
tumor invasion (Schmoeckel, et al, 1983), while others have shown vascular invasion to be a
significant predictor of metastasis (Mraz-Gernhard, et al, 1998) or of reduced survival (Barnhill et al, 1996). It is perhaps the low frequency of this finding which precluded its
emergence as an independent prognostic variable in many series (Clark et al, 1989).
 Anatomic Site
Melanomas in the head and neck area, upper back, axial skeleton, subungual region and/or on the palms
or soles have a worse prognosis than do extremity based lesions (Clark et al, 1969; Balch et
al 2000).
 Sex
Women have a better prognosis than men in some but not all studies (Clark et al., 1989;
Balch et al, 2000). The statistical significance of gender is confounded by anatomic site.
 Age
Some studies indicate that patients over age 60 years have a worse prognosis (Clark et al,
1989; Balch et al, 2000).

The Molecular Diagnosis of Melanoma through Microarray Techniques
Immunohistochemical analyses are routinely used to detect the protein products of gene expression and
thereby to predict the malignant phenotype or, more commonly, to identify the melanocytic histogenesis of
a given neoplasm. The use of reverse transcriptase polymerase chain reaction (RT-PCR) methodologies to
detect mRNA in tissue provides similar and complimentary information. A novel scientific approach
employs microarray technology to assess biomolecules in high-throughput analytical systems. These
microarray technologies are broadly classed as complimentary DNA (cDNA) microarrays, oligonucleotide
arrays, protein microarrays and tissue microarrays (Rimm, 2001). The information derived from such
studies, compiled as large databases, permits meta-analysis of quantities of information that can be
correlated mathematically for the extraction of the maximum amount of information (Khna te al, 1999).

The cDNA microarray is a miniature display of large numbers of DNA sequences on a solid support
system, either a microchip or a slide. The methodology employed to create a cDNA microarray involves the
generation of cDNA copies from mRNA derived from tumor samples synthesized in
vitro with fluorescent-labeled nucleotides which are then hybridized into the array. Thousands of
separate and distinct DNA probes applied per square centimeter of slide or microchip array are then
analyzed using complex biochemical-optical systems which employ analytical computer technologies
including neural nets and hierarchical data analysis and processing to decode the data obtained (Kim et
al, 2000). These technologies enable the identification of amplification of genes and of chromosomes at
a level of only five times above background (Heiskanen et al, 2000). Using current technologies, a
single mRNA species can be detected from among 500,000 different mRNAs. For analysis using a cDNA
microarray, specific sets of tissue-appropriate cDNA probes must first be generated from the mRNA derived
from relevant clones. The expressed sequenced tag database (dbEST) for neural crest-derived melanocytic
cDNA sets has been created to facilitate this. (Loftus et al, 1999). The Stanford University microarray
database lists specific sets of tissue-appropriate cDNA for use in various human cancers and is
accessible to researchers through their web site (http://genome-www.stanford.edu/microarray) (Sherlock
et al, 2001). Using such technology, one group analyzed melanoma samples with an array of 7,000 discrete
genes and thus identified a distinct melanoma subset capable of producing primitive tubular networks
in vivo that correlated to aggressive biological behaviour (Bittner et al,
2000). This technology can also be used to identify novel aberrant tumor suppressor genes and other
genes predisposing to the metastatic phenotype. Su and co-workers analyzed the expression of 3317 genes
in 3 different melanoma cell lines, analyzed in pairs by cDNA microarray technology and thus identified
specific tumor suppressor genes including the Cx43 suppressor gene, monocyte chemotactic protein-1 and
the cystein proteinase P32- a gene responsible for apoptosis (Su et al, 2000). Transfection of the Cx43
gene suppressed anchorage-independent growth of a melanoma cell line. The ability to alter cellular
phenotype in concert with the global gene expression profile enabled identification of previously
unrecognized tumor suppressor genes. The cDNA microarray can also be used to establish how a
neoplasm metabolizes and responds to a given cheomotherapeutic agent (Scherf et al, 2000), and to
identify signalling and metabolic pathways as potential therapeutic targets (Roses, 2000).

The oligonucleotide microarray uses silicone wafers similar to those employed in the computer
industry to construct an oligonucleotide array. This chip technique is best used to search for specific
genetic mutations.

Complimentary to genomic initiatives is the science of proteomics, or the study of expressed proteins
in tissue and cell types (Bans et al, 2000) enhanced by the use of laser capture microdissection to
enable isolation of neoplastic cells under study. Proteins are the functional products of
genes modified by post-translational events such as phosphorylation or glycosylation as well as by
environmental or epigenetic factors that impact the aging host. Proteomic research analyzes the
functional state of the protein products of genes identified by cDNA microarray technology.

Tissue micro-array involves the performance of a core biopsy of a paraffin embedded tissue block with
relocation of the tissue core to an array block which is then sectioned to reveal 0.5-0.6 mm cross
sections. Hundreds of unique sections thus consitute a single slide-based array that is then probed
using conventional immunohistochemical reagents to detect in tissue the protein products of gene
expression (Koonen et al, 1999. This technology can be applied to cytologic preparations as well.

Proteomic and genomic investigation provides a novel molecular diagnostic strategy for melanoma that
may reveal new therapeutic insights. Clinical and histologic data will remain necessary adjuncts to
guide proteomic/genomic analyses as they evolve.

Table 1 : Antibodies commonly used to determine melanocytic
histogenesis
| Antibody [Clone] | Manufacturer* | Antigenic Target |
| HMB-45 | Novacastra | Gp100 antigen of premelanosome complex |
| Mel 5 [TRP-1 and TRP-2] | Signet Laboratories | Gp75 antigen (75kDa tyrosinase-related glycoprotein) |
| Tyrosinase [T311] | Lab Vision | 70-80 kDa protein moities |
| Microphthalmia transcription factor | Novacastra | |
| Anti-S-100 PROTEIN (polyclonal) | Ventana | Ca++-channel regulatory protein |
| Anti-Melan-A [SKMEL-29] | Novacastra | A103; tyrosinase pathway antigen |
| Anti-MART-1 [M2-7C10] | Oncogene Research Products | tyrosinase pathway antigen |
* of reagents commonly used at Regional Medical Laboatories, Tulsa, OK. This does not constitute a
specific endoresment of the product or manufacturer.

Table 2: The Synoptic Report for Primary Cutaneous Malignant Melanoma, Regional Medical Laboratory, Tulsa, OK
| Name: ______________________ | Case #: ___________ |
| Location: _________________________________________ |
| Histological type: |
| lentigo maligna........... | __ |
| superficial spreading... | __ |
| nodular..................... | __ |
| acral lentiginous.......... | __ |
| not otherwise specified.. | __ |
| Clark's level: | I...... __ |
| | II..... __ |
| | III.... __ |
| | IV..... __ |
| | V...... __ |
| Thickness (Breslow): | ________ mm. |
| Mitotic index (mitoses /mm2): | ________ |
| Radial Growth Phase | Y__ N__ |
| Vertical Growth Phase | Y__ N__ |
| Microscopic satellites | Y__ N__ |
| Regression | Y__ N__ |
diameter ____________ |
| Host immune response | Y__ N__ |
Brisk |
Non-brisk |
Absent |
| Neurotropism | Y__ N__ |
| Vascular invasion | Y__ N__ |
| Microscopic Satellites | Y__ N__ |
| Precursor lesion | Y__ N__ |
type _____________________ |
| Margin positive | Y__ N__ |
location if positive ________________ |
minimum distance from tumor if negative _____________ |
| Lymph nodes involved............ | Y__ N__ |
number _____________ |
| sentinel lymph node positive | Y__ N__ not assessed__ |
| Distant metastases | Y__ N__ |
site _____________________ |
This synoptic report is appended to a narrative description of all malignant melanomas except for in situ disease, where the "microstaging" of prognostic risk factors, i.e., ulceration, regression, Breslow depth, etc., is not given.

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