Protocol applies to all carcinomas of the upper
aerodigestive tract: carcinomas of the oral cavity (including lip and tongue),
pharynx, oropharynx, hypopharynx, nasopharynx, larynx, paranasal sinuses, and
salivary glands.
Procedures
·
Cytology
·
Biopsy
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. Where a physician chooses 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.
I. Cytologic material back Top Main Page
A. Clinical Information
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
d. Gender
2. Responsible physician(s)/clinic(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
b. Clinical findings, as indicated
c. Clinical diagnoses
d. Procedure (e.g. FNA)
e. Anatomic site(s) of specimen(s)
B. Macroscopic Examination
1. Specimen
a. Unfixed/fixed (specify fixative)
b. Number of slides received
c. Quantity and appearance of fluid
specimen (if appropriate)
d. Other (e.g. tissue received for
cytologic preparation)
e. Results of intraprocedural consultation
2. Material submitted for microscopic
evaluation (e.g. smear, cytocentrifuge, touch or filter preparation, cell
block)
3. Special studies (specify)
C. Microscopic evaluation
1. Adequacy of specimen (if unsatisfactory
for evaluation, specify reason)
2. Tumor, if present
a. Histologic type, if possible (Note A)
b. Other characteristics (e.g. nuclear
grade/necrosis)
c. Indeterminate
3. Additional pathologic findings, if
present
4. Results/status of special studies
(specify)
5. Comments
a. Correlation with intraprocedural
consultation, as appropriate
b. Correlation with other specimens, as
appropriate
c. Correlation with clinical information
as appropriate
A. Clinical information
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
d. Gender
2. Responsible physician(s)/clinic(s)
3. Date of procedure
4. Other
clinical information
a. Relevant history
(1) surgery and date(s)
(2) radiation and date(s)
(3) chemotherapy and date(s)
(4) others (e.g. hyperthermia, photodynamic
therapy)
b. Clinical findings (e.g. imaging
studies)
c. Clinical diagnosis
d. Procedure
e. Operative findings
f. Anatomic site(s) of specimen(s) (e.g.
tongue, tonsil, pharynx, epiglottis, false cord, true cord.Specify right, left,
midline, etc.)
B. Macroscopic Examination
1. Specimen
a. Unfixed/fixed (specify fixative)
b. Size (three dimensions)
c. Results of intraoperative consultation
2. Tissue(s) submitted for microscopic
evaluation (all or selected samples).
3. Special studies (specify)
C. Microscopic evaluation
1. Tumor if present
a. Histologic type (Note A)
b. Histologic grade (Note B)
c. Extent of invasion
(1) Noninvasive (in situ)
(2) Subepithelial connective tissue
(microinvasion, ____mm from the basement membrane)
(3) Muscle, when applicable
(4) Bone or cartilage, when applicable
(5) Indeterminate (state reasons)
d. Vascular invasion (if identified)
(1) Lymphatic (specify location)
(2) Blood vessel (specify location)
(3) Indeterminate
e. Perineural invasion (if identified)
2. Tissue changes adjacent to the tumor,
if present
a. Dysplasia or atypia
b. Flat carcinoma in situ (CIS)
c. Others (e.g. hyperkeratosis, radiation
change, scar)
3. Results/status of special studies
(specify)
4. Comments
a. Correlation with intraoperative
consultation, as appropriate
b. Correlation with other specimens, as
appropriate
c. Correlation with clinical information,
as appropriate
III. Resection back
Top
Main
Page
A. Clinical Information
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
d. Gender
2. Responsible physician(s)/clinic(s)
3. Date of procedure
4. Other clinical information
a. Relevant history
(1) previous diagnoses
(2) previous cervical lymph node biopsy, if
applicable
(3) surgery and date(s)
(4) radiation and date(s)
(5) chemotherapy and date(s)
(6) others (e.g. hyperthermia, photodynamic
therapy)
b. Relevant findings
c. Clinical diagnosis
d. Procedure (specify anatomic site(s))
(1) excision (e.g. right hemiglossectomy)
(2) list all anatomical structures removed (Note C)
(3) lymph node dissection (Note
D)
e. Operative findings (documentation of
areas of concern marked by surgeon)
f. Anatomic site(s) of specimen(s)
B. Macroscopic Examination
1. Specimen
a. Unfixed/fixed (specify fixative)
b. Size (three dimensions)
c. Constituent organs/tissues
d. Margins (tumor present/absent, distance
from free margin)
(1) note areas designated by surgeon
(2) ink margin(s) of clinical relevance
e. Neck contents accompanying specimen in continuity or separately
(specify)
f. Results of intraoperative consultation
2. Neoplasm
a. Anatomical site(s) involved by tumor
b. Size (three dimensions) (Note
E)
c. Pattern of growth
(1) exphytic
(2) endophytic
(3) others
d. Anatomic extent (structures involved by
tumor and depth of invasion) (Note E)
e. Relation to margins
f. Additional tumors (describe each
primary tumor as above)
(1) size
(2) number
(3) location
3. Additional pathologic findings, if
present
a. Abnormal mucosa (e.g. leukoplakia)
b. Other lesions (e.g. scar)
4. Lymph nodes submitted as part of
specimen
a. Location by levels (Note
F)
b. Number, each level (Note
G)
c. Description
(1) matted
(2) gross metastasis
(3) size (largest) (Note H)
(4) extra nodal extension
5. Separately submitted lymph
nodes(designate according to the regional lymph node groups or levels)(Note F)
6. Other separately submitted
organ(s)/tissue(s)
a. Location (as specified by surgeon)
b. Description
(1) salivary gland
(2) thyroid
(3) parathyroid
(4) others
7. Tissue submitted for microscopic
evaluation
a. Tumor, representative
b. Tumor at point of deepest penetration
c. Interface of tumor with adjacent
non-tumorous mucosa
d. Mucosa remote from cancer
e. Margin(s) of resection
f. Areas designated by surgeon
g. Areas with additional pathologic
findings
h. Other organ(s)/tissue(s)
8. Special studies (specify)
C. Microscopic evaluation
1. Tumor, if present
a. Histologic type (Note A)
b. Histologic grade (Note B)
c. Location
d. Extent of invasion (Note
E)
(1) noninvasive (carcinoma in situ)
(2) subepithelial connective tissue
(3) muscle (if applicable)
(4) bone or cartilage (if applicable)
(5) adjacent structures
e. Vascular invasion
f. Perineural invasion (designate the
name of nerve, if applicable)
2. Margins
3.
Status of area(s) marked by
surgeon
4. Additional pathologic findings, if
present
a. Dysplasia or atypia
b. Flat carcinoma in situ (CIS)
c. Others (e.g. radiation changes or
scars)
5. Lymph nodes
a. Site(s) (according to levels) (Note F)
(1) included in specimen (report according
to level)
(2) Separately submitted (report as
specified)
b. Number
(1) Total number, according to level
(2) Number involved by tumor according to
level
c. Extracapsular extension
6. Results/status of special studies
(specify)
7. Comments
a. Correlation with intraoperative consultation,
as appropriate
b. Correlation with other specimens, as
appropriate
c. Correlation with clinical information,
as appropriate
EXPLANATORY NOTES
A. Histological Type back
Top Main
Page
A modification of the World Health Organization
(WHO) classification of carcinomas of the head and neck is shown below. This
protocol applies only to carcinomas and does not apply to melanomas, lymphomas
or sarcomas.
Carcinomas of upper aerodigestive tract
·
Carcinoma in situ* (specify the histologic type,
e.g. squamous)
·
Squamous cell carcinoma
·
Verrucous squamous cell carcinoma
·
Spindle cell carcinoma
·
Adenoid squamous cell carcinoma
·
Basaloid squamous cell carcinoma
·
Adenocarcinoma
·
Acinic cell carcinoma
·
Mucoepidermoid carcinoma
·
Adenoid cystic carcinoma
·
Carcinoma in pleomorphic adenoma
·
Epithelial-myoepithelial carcinoma
·
Clear cell carcinoma
·
Adenosquamous carcinoma
·
Giant cell carcinoma
·
Salivary duct carcinoma
·
Carcinoid tumor
·
Atypical carcinoid tumor
·
Small cell carcinoma
·
Lymphoepithelial carcinoma
·
Undifferentiated carcinoma*
·
Other*
*Diagnoses not included in WHO classification.
Carcinomas of salivary gland. The histologic
classification recommended is a modification of the WHO classification of
salivary gland tumors. The major malignant varieties include the following:
·
Acinic cell carcinoma
·
Adenoid cystic carcinoma (cylindroma)
·
Adenocarcinoma
·
Squamous cell carcinoma
·
Carcinoma in pleomorphic adenoma(malignant mixed
tumor)
·
Mucoepidermoid carcinoma
Well
differentiated (low grade)
Poorly
differentiated (high grade)
·
Undifferentiated carcinoma*
·
Other
*Diagnosis not included in WHO classification.
B. Histologic Grade back
Top Main
Page
For histologic types of carcinomas that are
amenable to grading, four histologic grades are suggested as shown below.
Grade X Cannot
be assessed
Grade 1 Well
differentiated
Grade 2 Moderately
differentiated
Grade 3 Poorly
differentiated
Grade 4 Undifferentiated
C. Orientation of
Specimen back Top Main Page
Complex specimens should be examined and
oriented with the attending surgeon.
Optimally, the attending surgeon should submit a diagram in which the
extent of the tumor and line of resection are graphically illustrated as shown
in the exhibit samples (Figure 1).
D. Classification of Neck Dissection(1) back
Top Main
Page
1. Radical
neck dissection
2. Modified
radical neck dissection
Type
1. 11th nerve saved
Type
2. Nerve, internal jugular and
vein spared
Type
3. Nerve, internal jugular
vein, sternocleidomastoid muscle saved
3. Selective
neck dissection
a. Supra myahyoid neck dissection
b. Posterolateral neck dissection
c. Lateral neck dissection
d. Anterior compartment neck dissection
e. Others
4. Extended
radical neck dissection
E. TNM and Stage Groupings back Top Main Page
The protocol recommends the TNM Staging System
of the American Joint Committee on Cancer (AJCC) and the International Union
Against Cancer (UICC) for head and neck cancer.(2) Separate categories and stage grouping classifications for the
various specific sites of the aerodigestive tract (including salivary glands)
are enumerated individually below.
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 the Patient
Tumor remaining in a patient after therapy with
curative intent (e.g., surgical resection for cure) is categorized by a system
known as 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).
Tumor
Remaining in a Specimen
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” (e.g.,
ypT1). Thus, yTNM indicates the
post-treatment 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.
Locally
Recurrent Tumor
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” (e.g.,
rpT1) is used to indicate the recurrent status of the tumor.
Lip
and Oral Cavity
Primary
Tumor (T)
TX Primary
tumor cannot be assessed
T0 No
evidence of primary tumor
Tis Carcinoma
in situ
T1 Tumor
2 cm or less in greatest dimension
T2 Tumor
more than 2 cm but not more than 4 cm in greatest dimension
T3 Tumor
more than 4 cm in greatest dimension
T4 Lip: Tumor invades adjacent structures, e.g.
through cortical bone, inferior alveolar nerve, floor of mouth, skin of face.
Oral
Cavity: Tumor invades adjacent
structures e.g. through cortical bone, into
deep
(extrinsic) muscle of tongue, maxillary sinus, skin. (Superficial crosion alone of
bone/tooth
socket by gingival primary is not sufficient to classify a tumor as T4.)
Pharynx
Primary
Tumor (T)
TX Primary
tumor cannot be assessed
T0 No
evidence of primary tumor
Tis Carcinoma
in situ
Oropharynx
Primary
Tumor (T)
T1 Tumor
2 cm or less in greatest dimension
T2 Tumor
more than 2 cm but not more than 4 cm in greatest dimension
T3 Tumor
more than 4 cm in greatest dimension
T4 Tumor
invades adjacent structures, e.g. pterygoid muscles, mandible, hard palate, deep
muscle of tongue, larynx
Hypopharynx
Primary Tumor (T)
T1 Tumor
limited to one subsite of hypo-pharynx and 2 cm or less in greatest dimension
T2 Tumor
invades more than one subsite of hypopharynx or an adjacent site, or measures
more than 2 cm
but
not more than 4 cm in greatest dimension, without fixation of hemilarynx
T3 Tumor
measures more than 4 cm in greatest dimension, or with fixation of hemilarynx
T4 Tumor
invades adjacent structures, e.g. thyroid/cricoid cartilage, carotid artery,
soft
tissues of neck, prevertebral
fascia/muscles, thyroid and/or esophagus
Regional
Lymph Nodes (N)
(applicable
to Lip and Oral Cavity, Pharynx, Oropharynx, and Hypopharynx)
NX Regional
lymph nodes cannot be assessed
N0 No
regional lymph node metastasis
N1 Metastasis
in a single ipsilateral lymph node, 3 cm or less in greatest dimension
N2 Metastasis
in a single ipsilateral lymph node, more than 3 cm but not more than 6 cm in
greatest dimension;
or
in multiple ipsilateral lymph nodes, none more than 6 cm in greatest dimension;
or in bilateral
or
contralateral lymph nodes, none more than 6 cm in greatest dimension
N2a Metastasis in a single
ipsilateral lymph node, more than 3 cm but not morethan 6 cm in greatest
dimension
N2b Metastasis in multiple
ipsilateral lymph nodes, none more than 6 cm in greatest dimension
N2c Metastasis in bilateral or
contralateral lymph nodes, none more than 6 cm in greatest dimension
N3 Metastasis
in a lymph node more than 6 cm in greatest dimension
Distant
Metastasis (M)
MX Distant
metastasis cannot be assessed
M0 No
distant metastasis
M1 Distant
metastasis
Stage
Groupings
(applicable
to Lip and Oral Cavity, Pharynx, Oropharynx, and Hypopharynx)
Stage 0 Tis N0 M0
Stage I T1 N0 M0
Stage II T2 N0 M0
Stage III T1 N1 M0
T2 N1 M0
T3 N0,N1 M0
Stage IVA T4 N0,N1 M0
Any
T N2 M0
Stage IVB Any
T N3 M0
Stage IVC Any
T Any N M1
Nasopharynx
Primary
Tumor (T)
T1 Tumor
confined to nasopharynx
T2 Tumor
extends to soft tissue of oropharynx and/or nasal fossa
T2a T2 without parapharyngeal
extension*
T2b T2 with parapharyngeal
extension*
T3 Tumor
invades bony structures and/or paranasal sinuses
T4 Tumor
with intracranial extension and/or involvement of cranial nerves, infratemporal
fossa, hypopharynx or orbit
*Parapharyngeal extension denotes
postero-lateral infiltration of tumor beyond the pharyngo-basilar fascia.
Regional
Lymph Nodes (N)
NX Regional
lymph nodes cannot be assessed
N0 No
regional lymph node metastasis
N1 Unilateral
metastasis in lymph node(s),* 6 cm or less in greatest dimension, above
supraclavicular fossa
N2 Bilateral
metastasis in lymph node(s), 6 cm or less in greatest dimension, above
supraclavicular fossa
N3 Metastasis
in lymph node(s)
(a)
greater than 6 cm in dimension
(b)
extension to supraclavicular fossa
* Midline nodes are considered ipsilateral nodes
Distant
Metastasis (M)
MX Distant
metastasis cannot be assessed
M0 No
distant metastasis
M1 Distant
metastasis
Stage
Groupings
Stage 0 Tis N0 M0
Stage I T1 N0 M0
Stage IIA T2a N0 M0
Stage IIB T1 N1 M0
T2a N1 M0
T2b N0,N1 M0
Stage III T1 N2 M0
T2a,
T2b N2 M0
T3 N0,N1,N2 M0
Stage IVA T4 N0,N1,N2 M0
Stage IVB Any
T N3 M0
Stage IVC Any
T Any N M1
Larynx
Rules
for Classification
The classification applies only to
carcinomas. There should be
histological confirmation of the disease.
The following are the procedures for assessing T, N, and M categories:
T categories Physical
examination, laryngoscopy and imaging
N categories Physical
examination and imaging
M categories Physical
examination and imaging
Anatomical
Sites and Subsites for Larynx:
-Supraglottis
- Epilarynx, including marginal zone
-
Suprahyoid epiglottis, including
tip,
lingual
(anterior) and laryngeal surfaces
-
Aryepiglottic fold, laryngeal
aspect
-
Arytenoid
- Supraglottis, excluding epilarynx
-
Infrathyroid
-
Ventricular bands (false cords)
-Glottis
- Vocal cords