Protocol for the Examination of Specimens from Patients with Primary Non-Small Cell Carcinoma, Small Cell Carcinoma, or Carcinoid Tumor of the Lung

Patients with Primary Non-Small Cell Carcinoma, Small Cell Carcinoma, or Carcinoid Tumor of the Lung Based on AJCC/UICC TNM, 7th edition Protocol web posting date: February 1, 2011 Proce

Patients with Primary Non-Small Cell Carcinoma, Small Cell Carcinoma, or Carcinoid Tumor of the Lung

Based on AJCC/UICC TNM, 7th edition

Protocol web posting date: February 1, 2011

Procedure

• Resection

Authors

Kelly J Butnor, MD, FCAP*

Department of Pathology and Laboratory Medicine, Fletcher Allen Health Care/University

of Vermont, Burlington, Vermont

Mary Beth Beasley, MD, FCAP

Department of Pathology, Mt Sinai Medical Center, New York, New York

Philip T Cagle, MD, FCAP

Department of Pathology, The Methodist Hospital, Houston, Texas

Steven M Grunberg, MD

Department of Hematology/Oncology, Fletcher Allen Health Care/University of Vermont, Burlington, Vermont

Feng-Ming Kong, MD, PhD, MPH

Veteran Administration Health Center/University of Michigan, Ann Arbor, Michigan Alberto Marchevsky, MD, FCAP

Department of Pathology, Cedars-Sinai Medical Center, Los Angeles, California

Nader T Okby, MD, FCAP

Orange Pathology Associates, Orange Regional Medical Center, Middletown, New York Victor L Roggli, MD, FCAP

Department of Pathology, Duke University Medical Center, Durham, North Carolina Saul Suster, MD, FCAP

Department of Pathology, The Medical College of Wisconsin, Milwaukee, Wisconsin Henry D Tazelaar, MD

Department of Laboratory Medicine and Pathology, Mayo Clinic Scottsdale,

Scottsdale, Arizona

William D Travis, MD, FCAP

Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York For the Members of the Cancer Committee, College of American Pathologists

* denotes primary author All other contributing authors are listed alphabetically.

Previous lead contributors: Anthony A Gal, MD, Alberto Marchevsky, MD, William D Travis,

MD

© 2011 College of American Pathologists (CAP) All rights reserved.

The College does not permit reproduction of any substantial portion of these protocols without its written authorization The College hereby authorizes use of these protocols by physicians and other health care providers in reporting on surgical specimens, in teaching, and in carrying out medical research for nonprofit purposes This authorization does not extend to reproduction or other use of any substantial portion of these protocols for commercial purposes without the written consent of the College

The CAP also authorizes physicians and other health care practitioners to make modified

versions of the Protocols solely for their individual use in reporting on surgical specimens for individual patients, teaching, and carrying out medical research for non-profit purposes

The CAP further authorizes the following uses by physicians and other health care practitioners,

in reporting on surgical specimens for individual patients, in teaching, and in carrying out medical

research for non-profit purposes: (1) Dictation from the original or modified protocols for the

purposes of creating a text-based patient record on paper, or in a word processing document; (2)

Copying from the original or modified protocols into a text-based patient record on paper, or in a word processing document; (3) The use of a computerized system for items (1) and (2),

provided that the Protocol data is stored intact as a single text-based document, and is not stored

as multiple discrete data fields

Other than uses (1), (2), and (3) above, the CAP does not authorize any use of the Protocols in electronic medical records systems, pathology informatics systems, cancer registry computer systems, computerized databases, mappings between coding works, or any computerized system without a written license from CAP Applications for such a license should be addressed

to the SNOMED Terminology Solutions division of the CAP

Any public dissemination of the original or modified Protocols is prohibited without a written license from the CAP

The College of American Pathologists offers these protocols to assist pathologists in providing clinically useful and relevant information when reporting results of surgical specimen

examinations of surgical specimens The College regards the reporting elements in the “Surgical Pathology Cancer Case Summary (Checklist)” portion of the protocols as essential elements of the pathology report However, the manner in which these elements are reported is at the

discretion of each specific pathologist, taking into account clinician preferences, institutional policies, and individual practice

The College developed these protocols as an educational tool to assist pathologists in the useful reporting of relevant information It did not issue the protocols for use in litigation, reimbursement,

or other contexts Nevertheless, the College recognizes that the protocols might be used by hospitals, attorneys, payers, and others Indeed, effective January 1, 2004, the Commission on Cancer of the American College of Surgeons mandated the use of the checklist elements of the protocols as part of its Cancer Program Standards for Approved Cancer Programs Therefore, it becomes even more important for pathologists to familiarize themselves with these documents

At the same time, the College cautions that use of the protocols other than for their intended educational purpose may involve additional considerations that are beyond the scope of this document

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to be construed as disapproval

CAP Lung Protocol Revision History

Version Code

The definition of the version code can be found at www.cap.org/cancerprotocols

Version: Lung 3.1.0.0

Summary of Changes

The following changes have been made since the October 2009 release

Resection Checklist

Primary Tumor (pT)

pT3 was changed to include the descriptor “parietal pleural” of “chest wall,” as follows: _ pT3: Tumor greater than 7 cm in greatest dimension; or

Tumor of any size that directly invades any of the following: parietal plural chest wall (including superior sulcus tumors), …

Regional Lymph Nodes (pN)

Specify: Number examined / Number involved, has been changed to:

_ No nodes submitted or found

Number of Lymph Nodes Examined

Specify:

_ Number cannot be determined (explain):

Number of Lymph Nodes Involved

Specify:

_ Number cannot be determined (explain):

Distant Metastasis (pM)

pM1b, “outside the lung/pleura” was changed to “(in extrathoracic organs)”, as follows: _ pM1b: Distant metastases (in extrathoracic organs)

Surgical Pathology Cancer Case Summary (Checklist)

Protocol web posting date: February 1, 2011

LUNG: Resection

Select a single response unless otherwise indicated.

Specimen

_ Lung

_ Lobe(s) of lung (specify):

_ Bronchus (specify): _

_ Other (specify):

_ Not specified

Procedure

_ Major airway resection

_ Wedge resection

_ Segmentectomy

_ Lobectomy

_ Bilobectomy

_ Pneumonectomy

_ Other (specify):

_ Not specified

Specimen Integrity

_ Intact

_ Disrupted

_ Indeterminate

Specimen Laterality

_ Right

_ Left

_ Not specified

Tumor Site (select all that apply)

_ Upper lobe

_ Middle lobe

_ Lower lobe

_ Other(s) (specify):

_ Not specified

Tumor Size

Greatest dimension: _ cm

*Additional dimensions: _ x _ cm

_ Cannot be determined

Tumor Focality (Note A)

_ Unifocal

_ Separate tumor nodules in same lobe

_ Separate tumor nodules in different lobes (specify sites): _

_ Synchronous carcinomas (specify sites):

_ Cannot be determined

Histologic Type (Note B)

_ Carcinoma, type cannot be determined

_ Non-small cell carcinoma, subtype cannot be determined

_ Small cell carcinoma

_ Combined small cell carcinoma (small cell carcinoma and non-small cell component) (specify type of non-small cell carcinoma component:

_)

_ Squamous cell carcinoma

_ Squamous cell carcinoma, papillary variant

_ Squamous cell carcinoma, clear cell variant

_ Squamous cell carcinoma, small cell variant

_ Squamous cell carcinoma, basaloid variant

_ Adenocarcinoma

_ Adenocarcinoma, mixed subtype

_ Acinar adenocarcinoma

_ Papillary adenocarcinoma

_ Bronchioloalveolar carcinoma

_ Bronchioloalveolar carcinoma, nonmucinous

_ Bronchioloalveolar carcinoma, mucinous

_ Bronchioloalveolar carcinoma, mixed nonmucinous and mucinous

_ Solid adenocarcinoma

_ Fetal adenocarcinoma

_ Mucinous (colloid) adenocarcinoma

_ Mucinous cystadenocarcinoma

_ Signet ring adenocarcinoma

_ Clear cell adenocarcinoma

_ Large cell carcinoma

_ Large cell neuroendocrine carcinoma

_ Combined large cell neuroendocrine carcinoma (specify type of other non-small cell carcinoma component: _)

_ Basaloid carcinoma

_ Lymphoepithelioma-like carcinoma

_ Clear cell carcinoma

_ Large cell carcinoma with rhabdoid phenotype

_ Adenosquamous carcinoma

_ Sarcomatoid carcinoma

_ Pleomorphic carcinoma

_ Spindle cell carcinoma

_ Giant cell carcinoma

_ Carcinosarcoma

_ Pulmonary blastoma

_ Typical carcinoid tumor

_ Atypical carcinoid tumor

_ Mucoepidermoid carcinoma

_ Adenoid cystic carcinoma

_ Epithelial-myoepithelial carcinoma

_ Other (specify):

Histologic Grade (Note C)

_ Not applicable

_ GX: Cannot be assessed

_ G1: Well differentiated

_ G2: Moderately differentiated

_ G3: Poorly differentiated

_ G4: Undifferentiated

_ Other (specify):

Visceral Pleura Invasion (Note D)

_ Not identified

_ Present

_ Indeterminate

Tumor Extension (select all that apply) (Note E)

_ Not applicable

_ Not identified

_ Superficial spreading tumor with invasive component limited to bronchial wall _ Tumor involves main bronchus 2 cm or more distal to the carina

_ Parietal pleura

_ Chest wall

*Specify involved structure(s): _

_ Diaphragm

_ Mediastinal pleura

_ Phrenic nerve

_ Parietal pericardium

_ Tumor in the main bronchus less than 2 cm distal to the carina but does not involve the carina

_ Mediastinum

*Specify involved structure(s): _

_ Heart

_ Great vessels

_ Trachea

_ Esophagus

_ Vertebral body

_ Carina

_ Other (specify):

Margins (select all that apply) (Note F)

Bronchial Margin

_ Not applicable

_ Cannot be assessed

_ Uninvolved by invasive carcinoma

_ Involved by invasive carcinoma

_ Squamous cell carcinoma in situ (CIS) present at bronchial margin

_ Squamous cell carcinoma in situ (CIS) not identified at bronchial margin

Vascular Margin

_ Not applicable

_ Cannot be assessed

_ Uninvolved by invasive carcinoma

_ Involved by invasive carcinoma

Parenchymal Margin

_ Not applicable

_ Cannot be assessed

_ Uninvolved by invasive carcinoma

_ Involved by invasive carcinoma

Parietal Pleural Margin

_ Not applicable

_ Cannot be assessed

_ Uninvolved by invasive carcinoma

_ Involved by invasive carcinoma

Chest Wall Margin

_ Not applicable

_ Cannot be assessed

_ Uninvolved by invasive carcinoma

_ Involved by invasive carcinoma

Other Attached Tissue Margin (specify):

_ Not applicable

_ Cannot be assessed

_ Uninvolved by invasive carcinoma

_ Involved by invasive carcinoma

If all margins uninvolved by invasive carcinoma:

Distance of invasive carcinoma from closest margin: _ mm

Specify margin:

Treatment Effect (Note G)

_ Not applicable

_ Cannot be determined

_ Greater than 10% residual viable tumor

_ Less than 10% residual viable tumor

*Tumor Associated Atelectasis or Obstructive Pneumonitis (Note H)

* _ Extends to the hilar region but does not involve entire lung

* _ Involves entire lung

Lymph-Vascular Invasion (Note I)

_ Not identified

_ Present

_ Indeterminate

*Lymph Nodes (Note J)

*Extranodal extension

* _ Not identified

* _ Present

Pathologic Staging (pTNM) (Note J)

TNM Descriptors (required only if applicable) (select all that apply)

_ m (multiple primary tumors)

_ r (recurrent)

_ y (post-treatment)

Primary Tumor (pT)

_ pTX: Cannot be assessed, or tumor proven by presence of malignant cells in

sputum or bronchial washings but not visualized by imaging or

bronchoscopy

_ pT0: No evidence of primary tumor

_ pTis: Carcinoma in situ

_ pT1a: Tumor 2 cm or less in greatest dimension, surrounded by lung or visceral

pleura, without bronchoscopic evidence of invasion more proximal than the lobar bronchus (ie, not in the main bronchus); or

Superficial spreading tumor of any size with its invasive component limited to the bronchial wall, which may extend proximally to the main bronchus

_ pT1b: Tumor greater than 2 cm, but 3 cm or less in greatest dimension,

surrounded by lung or visceral pleura, without bronchoscopic evidence of invasion more proximal than the lobar bronchus (ie, not in the main

bronchus)

_ pT2a: Tumor greater than 3 cm, but 5 cm or less in greatest dimension surrounded

by lung or visceral pleura, without bronchoscopic evidence of invasion more proximal than the lobar bronchus (ie, not in the main bronchus); or

Tumor 5 cm or less in greatest dimension with any of the following features

of extent: involves main bronchus, 2 cm or more distal to the carina; invades the visceral pleura; associated with atelectasis or obstructive pneumonitis that extends to the hilar region but does not involve the entire lung

_ pT2b: Tumor greater than 5 cm, but 7 cm or less in greatest dimension

_ pT3: Tumor greater than 7 cm in greatest dimension; or

Tumor of any size that directly invades any of the following: parietal plural chest wall (including superior sulcus tumors), diaphragm, phrenic nerve, mediastinal pleura, parietal pericardium; or

Tumor of any size in the main bronchus less than 2 cm distal to the carina but without involvement of the carina; or

Tumor of any size associated with atelectasis or obstructive pneumonitis of the entire lung; or

Tumors of any size with separate tumor nodule(s) in same lobe

_ pT4: Tumor of any size that invades any of the following: mediastinum, heart,

great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina; or

Tumor of any size with separate tumor nodule(s) in a different lobe of

ipsilateral lung (Note A)

Regional Lymph Nodes (pN)

_ pNX: Cannot be assessed

_ pN0: No regional lymph node metastasis

_ pN1: Metastasis in ipsilateral peribronchial and/or ipsilateral hilar lymph nodes,

and intrapulmonary nodes, including involvement by direct extension

_ pN2: Metastasis in ipsilateral mediastinal and/or subcarinal lymph node(s)

_ pN3: Metastasis in contralateral mediastinal, contralateral hilar, ipsilateral or

contralateral scalene, or supraclavicular lymph node(s)

_ No nodes submitted or found

Number of Lymph Nodes Examined

Specify:

_ Number cannot be determined (Note J) (explain):

Number of Lymph Nodes Involved

Specify:

_ Number cannot be determined (Note J) (explain):

If lymph node(s) involved, specify involved nodal station(s): Distant Metastasis (pM)

_ Not applicable

_ pM1a: Separate tumor nodule(s) in contralateral lung; tumor with pleural nodules or

malignant pleural (or pericardial) effusion (Note A)

_ pM1b: Distant metastases (in extrathoracic organs)

*Specify site(s), if known:

*Additional Pathologic Findings (select all that apply)

* _ None identified

* _ Atypical adenomatous hyperplasia

* _ Squamous dysplasia

* _ Metaplasia (specify type):

* _ Diffuse neuroendocrine hyperplasia

* _ Inflammation (specify type):

* _ Emphysema

* _ Other (specify):

*Ancillary Studies (select all that apply) (Note K)

* _ Epidermal growth factor receptor (EGFR) analysis results

(specify method):

* _ KRAS mutational analysis (specify results): _

* _ Other (specify): _

*Comment(s)