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Protocol for the Examination of Specimens From Patients With Carcinomas of the Skin, Excluding Eyelid, Vulva, and Penis(*).

A Basis for Checklists

This protocol is intended to assist pathologists in providing clinically useful and relevant information as a result of the examination of surgical specimens. Use of this protocol is intended to be entirely voluntary. If equally valid protocols or similar documents are applicable, the pathologist is, of course, free to follow those authorities. Indeed, the ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of the individual circumstances presented by a specific patient or specimen.

It should be understood that adherence to this protocol will not guarantee a successful result. Nevertheless, pathologists are urged to familiarize themselves with the document. Should a physician choose to deviate from the protocol based on the circumstances of a particular patient or specimen, the physician is advised to make a contemporaneous written notation of the reason for the procedure followed.

The College recognizes that this document may be used by hospitals, attorneys, managed care organizations, insurance carriers, and other payers. However, the document was developed solely as a tool to assist pathologists in the diagnostic process by providing information that reflects the state of relevant medical knowledge at the time the protocol was first published. It was not developed for credentialing, litigation, or reimbursement purposes. The College cautions that any uses of the protocol for these purposes involve considerations that are beyond the scope of this document.

PROTOCOL FOR THE EXAMINATION OF SPECIMENS FROM PATIENTS WITH CARCINOMAS OF THE SKIN, EXCLUDING EYELID, VULVA, AND PENIS
I. Biopsy
 A. Clinical information
 1. Patient identification
 a. Name
 b. Identification number
 c. Age (birth date)
 d. Gender
 e. Skin type (eg, Fitzpatrick type, other)
 2. Responsible physician(s)
 3. Date of procedure
 4. Other clinical information
 a. Relevant history
 (1) Duration of lesion
 (2) Previous excision of present lesion
 (3) Previous similar lesions
 (4) Family history of similar lesions
 (5) Immunosuppression
 (6) Radiation exposure
 b. Relevant findings
 (1) Number of lesions and their distribution
 (2) Nature of advancing borders of lesion
 (3) Nature of pigmentation, if any
 (4) Ulceration
 (5) Palpable qualities of lesion (eg, hard,
 tender, nontender)
 (6) Fixation to deeper tissues on palpation
 5. Clinical diagnosis
 6. Procedure (eg, punch biopsy, incisional biopsy)
 a. Anatomic site of specimen(s)
 B. Macroscopic examination
 1. Specimen
 a. Tissues received (specify nature and site)
 b. Unfixed/fixed (specify fixative)
 c. Number of pieces of tissue
 d. Shape/type of specimen (eg, ellipse, punch
 core, shave fragments)
 e. Dimensions
 f. Results of intraoperative consultation, if
 performed
 2. Tumor, if discernible
 a. Location
 b. Descriptive features
 (1) Color (eg, pigmentation)
 (2) Consistency
 (3) Ulceration
 (4) Hemorrhage
 c. Dimensions
 d. Configuration
 3. Tissue submitted for microscopic examination
 a. Submit all
 b. Frozen section tissue fragment(s)
 4. Special studies (specify) (eg, histochemical
 stains, immunohistochemistry, electron microscopy,
 flow cytometry, cytogenetics)
 C. Microscopic evaluation
 1. Tumor
 a. Histologic type (note A)
 b. Histologic grade, if applicable (note B)
 c. Depth of invasion, if appropriate (note C)
 (1) Measurement in millimeters for squamous
 carcinoma (note C)
 d. Perineural invasion (note D)
 e. Blood/lymphatic vessel invasion (note D)
 f. Nature of advancing margin of tumor, if
 able to be evaluated (eg, pushing, infiltrative)(*)
 (note D)

(*) Applies principally to basal cell carcinomas.

 2. Associated skin lesions
 a. Actinic keratosis
 b. Bowen disease
 3. Additional pathologic findings, if present
 4. Results of special studies (specify)
 5. Comments
 a. Correlation with intraoperative consultations,
 if any
 b. Correlation with prior specimens, if any
 c. Correlation with clinical findings, as appropriate

II. Excision
 A. Clinical information
 1. Patient identification
 a. Name
 b. Identification number
 c. Age (birth date)
 d. Gender
 e. Skin type (eg, Fitzpatrick type, other)
 2. Responsible physician(s)
 3. Date of procedure
 4. Other clinical information
 a. Relevant history
 (1) Duration of lesion
 (2) Previous excision of present lesion
 (3) Previous similar lesions
 (4) Family history of similar lesions
 (5) Immunosuppression
 (6) Radiation exposure
 b. Relevant findings
 (1) Lesion number and distribution
 (2) Nature of advancing borders of lesion
 (3) Nature of pigmentation, if any
 (4) Ulceration
 (5) Palpable qualities of lesion (eg, hard,
 tender, nontender)
 (6) Fixation to deeper tissues on palpation
 c. Clinical diagnosis
 d. Procedure
 e. Anatomic site of specimen(s)
 B. Macroscopic examination
 1. Specimen
 a. Tissues received (specify type and site)
 b. Unfixed/fixed (specify fixative)
 c. Orientation of specimen, if indicated by surgeon
 d. Number of pieces of tissue
 e. Shape/type of specimen (eg, ellipse, punch
 core, shave fragments, curettings)
 f. Dimensions
 g. Results of intraoperative consultation, if any
 2. Tumor
 a. Location
 b. Configuration
 c. Pigmentation (nature and extent)
 d. Dimensions (3)
 e. Descriptive characteristics
 (1) Color
 (2) Consistency
 (3) Ulceration
 (4) Fixation to other tissues
 (5) Necrosis
 (6) Hemorrhage
 f. Estimated depth of invasion from skin surface
 (specify compartment, eg, deep dermis,
 subcutis)
 3. Margins (specify if involved or uninvolved by
 tumor, if appropriate to specimen)
 4. Regional lymph nodes, if any
 a. Location (as specific as possible)
 b. Number
 c. Gross appearance (with measurement of
 macroscopically obvious tumor deposits
 within the nodes)
 5. Additional pathologic findings, if present
 a. Actinic keratoses
 b. Melanocytic nevi
 c. Other
 6. Tissue submitted for microscopic examination
 (specify location in specimen of each)
 7. Special studies (specify) (eg, histochemical
 stains, immunohistochemistry, electron microscopy,
 flow cytometry, cytogenetics)
 C. Microscopic evaluation
 1. Tumor
 a. Histologic type (note A)
 b. Histologic grade, if applicable (note B)
 c. Depth of invasion (note C)
 (1) Measurement in millimeters for squamous
 carcinoma (note C)
 d. Perineural invasion (with extent) (note D)
 e. Blood/lymphatic vessel invasion (with extent)
 (note D)
 f. Nature of advancing margin of tumor (eg,
 pushing, infiltrative) (note D)
 g. Presence and approximate percentage of extent
 of regression, if present(*) (note D)
 h. Mitotic count per 10 high-power fields([dagger])
 (note D)

(*) Applies principally to basal cell carcinomas.

([dagger]) Applies only to Merkel cell carcinomas.

 2. Margins (note E)
 3. Additional pathologic findings, if present
 a. Actinic keratosis
 b. Bowen disease
 4. Regional lymph nodes (pN) (note F)
 a. Number
 b. Number containing metastases
 (1) Measurement of metastatic focus
 (2) Extranodal extension, if present
 5. Metastases to other organs (pM)
 6. Results of special studies (specify)
 7. Comments
 a. Correlation with intraoperative consultations,
 if any
 b. Correlation with prior specimens, if any
 c. Correlation with clinical findings, as appropriate
 d. Comments on prognostic findings


EXPLANATORY NOTES
 A: Histologic Subtypes.--The World Health Organization
(WHO) classification of carcinomas of the skin is
shown below.

Epidermal carcinomas

Basal cell carcinoma (BCC) and variants listed below:
 Superficial BCC
 Nodular BCC (solid, adenoid cystic)
 Infiltrating BCC
 Sclerosing BCC (desmoplastic, morpheic)
 Fibroepithelial BCC[1]
 BCC with adnexal differentiation
 Follicular BCC
 Eccrine BCC
 Basosquamous carcinoma
 Keratotic BCC
 Pigmented BCC
 BCC in basal cell nevus syndrome
 Micronodular BCC

Squamous cell carcinoma (SCC) and variants listed below:
 Spindle cell (sarcomatoid) SCC
 Acantholytic SCC
 Verrucous SCC
 SCC with horn formation
 Lymphoepithelial SCC

Variants not included in the WHO classification are as follows:
 Papillary SCC
 Clear cell SCC
 Small cell SCC
 Posttraumatic (eg, Marjolin ulcer)
 Metaplastic (carcinosarcomatous) SCC
 Paget disease
 Mammary Paget disease
 Extramammary Paget disease
 Adnexal carcinomas

Eccrine carcinoma and variants listed below:
 Sclerosing sweat duct carcinoma (syringomatous carcinoma,
 microcystic adnexal carcinoma)
 Malignant mixed tumor of the skin (malignant chondroid
 syringoma)
 Porocarcinoma
 Malignant nodular hidradenoma
 Malignant eccrine spiradenoma
 Mucinous eccrine carcinoma
 Adenoid cystic eccrine carcinoma
 Aggressive digital papillary adenoma/adenocarcinoma

Apocrine carcinoma
Sebaceous carcinoma

Tricholemmocarcinoma and its variant listed below:
 Malignant pilomatricoma (matrical carcinoma)

 Note.--Merkel cell carcinoma is not included in the
WHO classification of skin tumors.

 B: Histologic Grade.--Histologic grading is appropriate
only for SCCs and adnexal carcinomas. Suggested histologic
grades are as follows:

 Grade 1 Well differentiated
 Grade 2 Moderately differentiated
 Grade 3 Poorly differentiated
 Grade 4 Undifferentiated

 C: TNM and Stage Groupings.--The authors of this
protocol recommend the TNM Staging System of the
American Joint Committee on Cancer/International Union
Against Cancer (AJCC/UICC).[1,2]

Primary Tumor (T)

 TX Primary tumor cannot be assessed
 T0 No evidence of primary tumor
 Tis Carcinoma in situ
 T1 Tumor [is less than or equal to] 2 cm in greatest
 dimension
 T1a Limited to dermis or [is less than] 2 mm in thickness(*)
 T1b Limited to dermis and [is greater than] 2 mm in thickness,
 but [is less than or equal to] 6 mm in thickness(*)
 T1c Invading the subcutis and/or [is greater than] 6 mm in
 thickness(*)
 T2 Tumor [is greater than] 2 cm but
 [is less than or equal to] 5cm in greatest dimension
 T2a Limited to dermis or [is less than] 2 mm in thickness(*)
 T2b Limited to dermis and [is greater than] 2 mm in thickness,
 but [is less than or equal to] 6 mm in thickness(*)
 T2c Invading the subcutis and/or [is greater than] 6 mm in
 thickness(*)
 T3 Tumor [is greater than] 5 cm in greatest dimension
 T3a Limited to dermis or [is less than] 2 mm in thickness(*)
 T3b Limited to dermis and [is greater than] 2 mm in thickness
 buy [is less than or equal to] 6 mm in thickness(*)
 T3c Invading the subcutis and/or [is greater than] 6 mm in
 thickness(*)
 T4 Tumor invades the deep extradermal tissue (eg,
 bone, cartilage, muscle)
 T4a [is less than or equal to] 6 mm in thickness(*)
 T4b [is greater than] 6 mm in thickness(*)

(*) Optional expansions suggested by the TNM Supplement.[3]

Regional Lymph Nodes (N)

 NX Regional lymph nodes cannot be assessed
 N0 No regional lymph node metastasis
 N1 Regional lymph node metastasis

Distant Metastasis (M)

 MX Presence of distant metastasis cannot be assessed
 M0 No distant metastasis
 M1 Distant metastasis

Stage Groupings

Stage 0 Tis N0 M0
Stage 1 T1 N0 M0
Stage 2 T2 N0 M0
 T3 N0 M0
Stage 3 T4 N0 M0
 Any T N1 M0
Stage 4 Any T Any N M1


Important Note.--By AJCC/UICC convention, the designation "T" refers to a primary tumor that has not been previously treated. The symbol "p" refers to the pathologic classification of the TNM, as opposed to the clinical classification and is based on gross and microscopic examination. pT entails a resection of the primary tumor or biopsy adequate to evaluate the highest pT category, pN entails removal of nodes adequate to validate lymph node metastasis, and pM implies microscopic examination of distant lesions. Clinical classification (cTNM) is usually carried out by the referring physician before treatment during initial evaluation of the patient or when pathologic classification is not possible.

Tumor remaining in a patient after cancer-directed therapy (eg, surgical resection for cure) is categorized by a system known as the R classification, shown below.
RX Presence of residual tumor cannot be assessed
R0 No residual tumor
R1 Microscopic residual tumor
R2 Macroscopic residual tumor


For the surgeon, the R classification may be useful to indicate the known or assumed status of the completeness of a surgical excision. For the pathologist, the R classification is relevant to the status of the margins of a surgical resection specimen; that is, tumor involving the resection margin on pathologic examination may be assumed to correspond to residual tumor in the patient and may be classified as macroscopic or microscopic according to the findings at the specimen margin(s).

In contrast, tumor remaining in a resection specimen from a patient who has undergone previous (neoadjuvant) treatment of any type (radiation therapy alone, chemotherapy therapy alone, or any combined modality treatment) is codified by the TNM using a prescript "y" (eg, ypT1). Thus, yTNM indicates the posttreatment status of the tumor. For many neoadjuvant therapies, the classification of residual disease may be a strong predictor of postoperative outcome. In addition, the ypTNM classification provides a standardized framework for the collection of data needed to accurately evaluate new neoadjuvant therapies.

In contrast to residual tumor, classification of a tumor as recurrent requires a documented disease-free interval after definitive therapy. Recurrent tumor may also be classified according to the TNM categories, but the prefix "r" (eg, rpT1) is used to indicate the recurrent status of the tumor.

D: Adverse Prognostic Factors.--Important adverse prognostic factors for cutaneous malignancies are as follows:
Basal cell carcinoma
 Infiltrative, morpheaform, or micronodular histologic
 subtype
 Invasion into deep subcutaneous fat, muscle, or cartilage
 Perineural invasion
 Positivity of surgical margins
 Presence of scar within the tumor

Squamous cell carcinoma
 Adenoid, basaloid, small cell or spindle cell histologic
 subtypes
 Posttraumatic clinicopathologic subtype
 Extensive perineural, lymphatic, or vascular invasion
 Invasion into subcutis
 Positivity of surgical margins

Acantholytic subtype

Merkel cell carcinoma
 Gross size [is greater than] 2 cm
 Mitotic activity (10 division figures/10 high-power
 [x400] microscopic fields)
 Extensive lymphatic or vascular invasion
 Presence of associated Bowen disease
 Divergent squamous differentiation in invasive tumor
 Positivity of surgical margins


E: Margins.--If the specimen is oriented, the position of lateral margins involved by tumor should be indicated. A comment on margins is necessary only for excisional biopsies or formal resections. Measurements of distance from tumor to margins are generally not considered useful or helpful and need not be routinely reported. However, distance to margins may be reported in special circumstances and/or when requested by the treating physician.

F: Lymph Node Dissections.--Lymph node dissections are not routinely performed for any cutaneous malignancy. Therefore, a comment may be needed that documents the clinical nodal status (cN substage) instead of pathologic (pN substage) status in assembling the final stage grouping for the tumor.

Lyn Duncan, MD; Harley A. Haynes, MD; Gregg M. Menaker, MD; and Nicholas E. O'Connor, MD contributed to the development of this monograph.

References

[1.] Fleming ID, Cooper JS, Henson DE, et al. AJCC Manual for Staging of Cancer. 5th ed. Philadelphia, Pa: Lippincott Raven; 1997.

[2.] Sobin LH, Wittekind C, eds. TNM Classification of Malignant Tumours: International Union Against Cancer. 5th ed. New York, NY: Wiley; 1997.

[3.] Hermanek P, Henson DE, Hutter RVP, Sobin LH. TNM Supplement. New York, NY: Springer-Verlag; 1993.

Bibliography

Bielamowicz S, Smith D, Abemayor E. Merkel cell carcinoma: an aggressive skin neoplasm. Laryngoscope. 1994;104:528-532.

De Rosa G, Vetrani A, Zeppa P, et al. Comparative morphometric analysis of aggressive and ordinary basal cell carcinoma of the skin. Cancer. 1990;65:544-549.

Elder DE, Guerry D IV, Epstein MN, et al. Invasive malignant melanomas lacking competence for metastasis. Am J Dermatopathol. 1983;6(suppl):55-61.

Fleming ID, Amonette R, Monaghan T, Fleming MD. Principles of management of basal and squamous cell carcinoma of the skin. Cancer. 1995;75(suppl 2): 699-704.

Haag ML, Glass LF, Fenske NA. Merkel cell carcinoma: diagnosis and treatment. Dermatol Surg. 1995;21:669-683.

Johnson TM, Rowe DE, Nelson BR, Swanson NA. Squamous cell carcinoma of the skin (excluding lip and oral mucosa). J Am Acad Dermatol. 1992;26:467-484.

Kuflik AS, Schwartz RA. Actinic keratosis and squamous cell carcinoma. Am Fam Physician. 1994;49:187-201.

Marghoob AA, Slade J, Salopek TG, Kopf AW, Bart RS, Rigel DS. Basal cell and squamous cell carcinomas are important risk factors for cutaneous malignant melanoma: screening implications. Cancer. 1995;75(suppl 2):707-714.

Park AJ, Strick M, Watson JD. Basal cell carcinomas: do they need to be followed up? J R Coil Surg Edinb. 1994;39:109-111.

Ratner D, Nelson BR, Brown MD, Johnson TM. Merkel cell carcinoma. J Am Acad Dermatol. 1993;29:143-156.

Rowe DE, Carroll RJ, Day CL Jr. Prognostic factors for local recurrence, metastasis, and survival rates in squamous cell carcinoma of the skin, ear, and lip: applications for treatment modality selection. J Am Acad Dermatol. 1992;26:976-990.

Schwartz RA, ed. Skin Cancer Recognition and Management. New York, NY: Springer-Verlag; 1988.

Smith DE, Bielamowicz S, Kagan AR, Anderson PJ, Peddada AV. Cutaneous neuroendocrine (Merkel cell) carcinoma: a report of 35 cases. Am J Clin Oncol. 1995;18:199-203;

Smith KJ, Skelton HG, Holland TT. Recent advances and controversies concerning adnexal neoplasms. Dermatol Clin. 1992;10:117-160.

Weinstock MA, Bogaars HA, Ashley M, Little V, Bilodeau E, Kimmel S. Nonmelanoma skin cancer mortality: a population-based study. Arch Dermatol. 1991; 127:1194-1197.

Wick MR, Swanson PE. Cutaneous Adnexal Tumors: A Guide to Pathologic Diagnosis. Chicago, Ill: American Society of Clinical Pathologists Press; 1991.

Accepted for publication April 17, 2001.

From the Departments of Pathology, University of Virginia Health Sciences Center, Charlottesville, Va (Dr Wick); and McGill University, Montreal, Quebec (Dr Compton).

(*) The protocol excludes malignant melanoma, sarcoma, and hematopoietic malignancy

This protocol was developed by the Cancer Committee of the College of American Pathologists and submitted for editorial review and publication, it represents the views of the Cancer Committee and is not the official policy of the College of American Pathologists.

Reprints: See Archives of Pathology 8, Laboratory Medicine Web site at www.cap.org.
COPYRIGHT 2001 College of American Pathologists
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001 Gale, Cengage Learning. All rights reserved.

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Author:Wick, Mark R.; Compton, Carolyn
Publication:Archives of Pathology & Laboratory Medicine
Geographic Code:1USA
Date:Sep 1, 2001
Words:2766
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