Staging for Residents, Nurses, and Multidisciplinary Health Care Team

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Staging for Residents, Nurses, and Multidisciplinary Health Care Team Donna M. Gress, RHIT, CTR Validating science. Improving patient care.

Learning Objectives Introduce the concept and history of stage Recognize the reason for assigning stage Understand the various uses of staging: patient care, research, surveillance Understand stage classification based on different points in time of a patient s care Learn the components of stage Appreciate the general guidelines 2

Introduction

What is Staging Staging is a common language Developed by medical professionals Used to communicate information about a disease to others Staging is designed to Aid in the planning of treatment Give some indication of prognosis Assist in evaluation of the results of treatment Facilitate the exchange of information Contribute to the continuing investigation of cancer Support cancer control activities 4

History of Staging Concept of describing disease by stage or extent of the disease Introduced in 1929 by League of Nations' World Health Organization TNM introduced by Pierre Denoix in France in 1940 s Globally accepted method of describing extent of cancer is TNM 5

Disease Process of Cancer Theory of cancer growth or natural history Cancer originates in a single cell Cell continues to divide and grow In organ of origin Spreads to adjacent tissue or regional node drainage areas Spreads to distant organs or structures Cancer spreads From organ of origin through bloodstream or lymphatics into distant organs Without involving adjacent organs and regional nodes 6

Disease Process of Cancer Many cancers go through a matured course Advancing in tumor size or involvement To regional nodal involvement Eventually to distant metastasis Small tumors can metastasize First sign of cancer is metastatic disease 7

TNM Stage Process Determine timeframe for stage assignment At time of diagnostic workup After surgical resection Assign categories: T, N, M, others Primary tumor Regional nodes Distant metastasis Assign stage group that contains those categories 0 I - IV 8

TNM Stage Structure Stage groups are 0, I, II, III, and IV Groups consist of detailed anatomic categories Local tumor extent, spread from organ/site of origin (primary site) - T category Involvement of regional lymph nodes N category Distant metastatic spread M category Groups increasingly use non-anatomic factors Additional prognostic information Potentially predict value of specific therapies 9

TNM Stage by Type of Cancer Definition of each category depends on Site of cancer Histology of cancer Definitions for breast T, N, M are not the same as those for colon, prostate, and other sites AJCC Cancer Staging Manual has chapters for Each major organ or site of cancer Histology specific such as separate chapters for Merkel Cell Carcinoma of the skin and Melanoma of the skin 10

Staging Systems Currently in Use

Staging Systems Two main staging systems in use AJCC TNM Shared with Union for International Cancer Control (UICC) Used throughout the world to describe cancer and help make treatment decisions Summary Stage Used for tracking cancer data for epidemiologic purposes Each serves a different purpose 12

AJCC Stage Features Provides more detailed information Adds in assigning stage at different points in patient s care Allows analysis of cases at the same point in their care Ensures comparison of cases at similar times Different points in time of the patient s care are: Clinical Retreatment Pathologic Autopsy Neoadjuvant Therapy 13

AJCC Stage Meets decision making needs of clinicians Incorporated in most diagnostic and treatment guidelines Choose appropriate treatment methods Evaluation of treatment results Revised as medical science progresses Changes when data analysis proves it is necessary Provides forward flexibility and clinical utility Choosing treatment and estimating prognosis for individual cancer cases 14

AJCC Stage AJCC Cancer Staging Manual editions New editions developed when significant changes warrant it Each edition is used for specific years, Jan 1 Dec 31 Edition Publication Date Effective for Cancers Diagnosed 1 1977 1978 1983 2 1983 1984 1988 3 1988 1989 1992 4 1992 1993 1997 5 1997 1998 2002 6 2002 2003 2009 7 2009 2010 15

Summary Stage Features Broad categories that rarely change over time Provides a simple grouping with longitudinal stability Mainly used by population registries Less complex than other systems Developed for epidemiologists who want some information Do not need more detailed information 16

Summary Stage Useful when a series of cases is small Only general categories produce enough data for meaningful analysis Only captures data once Put together best information from diagnostic workup and pathologic exam of resected specimens 17

Purpose of Staging

Purpose of Staging Patient Care Adequately assess extent of cancer in order to treat in most appropriate manner Understanding extent of disease assists the physician in determining treatment to Cure the disease Decrease the tumor burden Relieve symptoms Allows clear communication with the patient and other physicians 19

Purpose of Staging Patient Care Staging used to indicate prognosis Data from historical sources provide estimate of expected survival rate for the patient Determines prognosis and quality of survival along with Histology Tumor grade Age Sex Race Efficacy of therapy 20

Purpose of Staging Quality Improvement Staging provides a means of comparing local institutional experience with national data Used to compare treatment results based on common criteria Staging expedites exchange of data and assists in continuing research Health information record is primary source of documentation for staging 21

Purpose of Staging - Research Research types Clinical Epidemiologic Health services Purpose of research Evaluate cause and effect Evaluate new diagnostic tests and procedures Monitor efficacy of treatment modalities 22

Purpose of Staging - Research Comparative effectiveness research for cancer Identify new and emerging clinical interventions Review and synthesize current medical research Identify gaps between existing medical research and the needs of clinical practice Promote and generate new scientific evidence and analytic tools Train and develop clinical researchers Translate and disseminate research findings to diverse stakeholders Reach out to stakeholders via a citizens forum 23

Purpose of Staging - Surveillance Population surveillance Cancer incidence trends over time Cancer diagnosed at early or late stages Show cancer patterns in various populations Guide planning and evaluation of cancer control programs Mortality information 24

Purpose of Staging - Surveillance Public health information available to Identify underserved communities Determine need for screening Determine need for awareness campaigns Identify access to care issues Maximize effectiveness of limited funds Help set priorities for allocating health resources 25

Stage Classifications

Stage Classifications Points in Time for Patient Care Clinical Classification T primary tumor N regional nodes Stage Group M distant mets Pathologic Classification 27

Stage Classifications Stage defined at a number of points in patient care Clinical before any treatment - c Pathologic based on pathology at time of surgery - p Posttreatment after neoadjuvant therapy - y, used as yc or yp Retreatment recurrence after disease free interval - r Autopsy unsuspected prior to death, incidental finding - a Clinical and pathologic are the most commonly used 28

Clinical Stage Classification Clinical classification uses diagnostic workup History Physical examination Imaging Endoscopy Biopsy of primary site Biopsy of single node or sentinel nodes as part of diagnostic workup Biopsy of metastatic sites as part of diagnostic workup Surgical exploration Other relevant examinations ct1n0m0 or T1N0M0, Clinical Stage I 29

Clinical Stage Classification Timing rule for clinical staging includes Any information about extent of cancer before initiation of definitive treatment Surgery Systemic therapy Radiation therapy Active surveillance Palliative care Or within four months after date of diagnosis Whichever is shorter Has NOT clearly progressed during that time 30

Clinical Stage Classification Need for clinical stage clearly identified Monitoring of appropriateness of treatment Treatment based on clinical stage Treatment guidelines assess appropriateness Only point in time where all cases can be compared Clinical stage takes place prior to treatment All cases can be compared regardless of treatment Not all patients have surgery and Pathological Stage By staging at diagnosis, the validity of epidemiological analysis, screening, analysis of treatment outcomes and proper healthcare planning is ensured 31

Pathologic Stage Classification Pathologic classification based on Information acquired before treatment supplemented and modified by Evidence acquired during and from surgery (surgical observations) Particularly from pathologic examination of resected tissues Need sufficient tissue resected, criteria varies by chapter pt1n0m1 Pathologic Stage IV 32

Pathologic Stage Classification Timing rule for pathologic staging includes Any information obtained about extent of cancer through completion of definitive surgery in first course treatment Or within four months after date of diagnosis Whichever is longer No systemic or radiation therapy initiated Has not clearly progressed during that time 33

Pathologic Stage Classification Need for pathologic stage clearly identified Used to determine further postoperative therapy Estimate prognosis and survival for individual patient Monitoring of outcomes and survival By stage group By treatment choices compare efficacy of treatment 34

Stage Classification Rules Stage classification only includes information from that point in time, clinical or pathologic ct and cn or pt and pn Cannot mix and match c and p Exception M designation can be either c or p Based on how the metastases are determined: physical exam and imaging, or biopsy/surgery Examples ct1 cn2 pm1 clinical stage IV pt3 pn1 cm0 pathologic stage II 35

Post Therapy / Postneoadjuvant Therapy Classification yc prefix Clinical stage assigned after systemic and/or radiation therapy yp prefix Pathologic stage assigned after surgical resection following the neoadjuvant (systemic and/or radiation) therapy yp stage Utilized in conjunction with clinical stage Assess response to neoadjuvant therapy 36

Retreatment Classification Retreatment classification based on Recurrence information after disease-free interval Progression of disease needing subsequent treatment Retreatment stage Used to select appropriate further treatment Biopsy confirmation Important if clinically feasible rt2n1m1, Retreatment Stage IV 37

Autopsy Classification Autopsy classification based on Postmortem examination Cancer was not evident prior to death Includes all clinical and pathologic information obtained at time of death and autopsy at3n1m0 Autopsy Stage III 38

Categories T, N, M

Categories T, N, M Assigning the T, N, and M Clinical Classification T primary tumor N regional nodes Stage Group M distant mets Pathologic Classification 40

T T category Designates size and invasiveness of primary tumor Numerical value increases with size and invasiveness Categories range from 0-4 For example Small lesion confined to the organ T1 Larger size or deeper extension into adjacent structures T2 Larger size or extension confined to the region T3 Massive lesion or directly invades another organ T4 41

T Examples Obvious differences, some use size, invasion of tissues, or location Breast pt1a Tumor >1mm but <5mm in greatest dimension Lung pt2a Tumor >3cm, invades visceral pleura (PL1) Colon pt3 Invades through muscularis propria into pericolic tissues Prostate pt2a Unilateral, one-half of one side or less 42

T Examples Even with similar size the T category is not the same, and some use involvement of other structures Breast pt3 Tumor >50mm in greatest dimension Lung ct2b Tumor >5cm but <7cm, invades visceral pleura (PL1) Colon pt4a Tumor penetrates to surface of visceral peritoneum Prostate ct4 Tumor fixed to rectum and bladder 43

N N category Designates presence or absence of regional node involvement Numerical value based on number or location or nodes Increasing numerical value based on size, fixation, capsular invasion, or multiple node involvement Categories range from 0-3 44

N - Isolated Tumor Cells Isolated tumor cells (ITC) are single tumor cells or small clusters of cells not more than 0.2 mm in greatest extent that can be detected by routine H and E stains or immunohistochemistry ITCs do not typically show evidence of metastatic activity (e.g., proliferation or stromal reaction) Considered N0 negative lymph nodes for most sites N0(i+) or N0(i-) 45

N - Sentinel Lymph Node Sentinel lymph node is first lymph node to receive lymphatic drainage from a primary tumor If it contains metastatic tumor this indicates that other lymph nodes may contain tumor If it does not contain metastatic tumor, other lymph nodes are not likely to contain tumor May be more than one sentinel lymph node 46

N Examples Obvious differences, some use size, number positive, or location (nodal chain) Breast pn1a Mets in 1-3 axillary nodes, at least one >2.0mm Lung pn1 Mets in ipsilateral hilar nodes Colon pn0 No regional node metastasis Prostate pn0 No regional node metastasis 47

N Examples Even with similar number the category is not the same, and some use which nodal chains are involved, and whether ipsilateral or contralateral Breast pn3a Mets in 11 axillary nodes, at least one >2.0mm Lung cn3 Mets in contralateral hilar and mediastinal nodes Colon pn2b Metastasis in 8 regional nodes Prostate cn0 No regional node metastasis 48

M M category Identifies presence or absence of distant metastases Including lymph nodes that are not regional Categories range from 0-1 AJCC 7th Edition added concept of isolated tumor cells in metastatic sites Circulating tumor cells are found in blood (CTCs) Disseminated tumor cells are found in bone marrow or other structures (DTCs) Considered M0 similar to the concept of isolated tumor cells in lymph nodes, M0(i+) 49

M Examples Note, isolated tumor cells are still considered M0 Breast cm0(i+) No distant metastasis but microscopically detected tumor cells in circulating blood Lung cm0 No distant metastasis Colon cm0 No distant metastasis Prostate cm0 No distant metastasis 50

M Examples Note, some sites with subcategories for M1, such as colon with M1a and M1b Breast cm0 No distant metastasis Lung cm0 No distant metastasis Colon pm1a Metastasis confined to one organ or site (liver) Prostate cm0 No distant metastasis 51

Combinations of T, N, M Physician chooses T, N, and M that best describes the patient s cancer Many possible combinations of T, N, M For example: T1 N0 M0 T2 N1 M0 T4 N2 M1 52

Stage Group

Stage Group Assigning the Stage Group Clinical Classification T primary tumor N regional nodes Stage Group M distant mets Pathologic Classification 54

Stage The combinations of T, N, and M are put into what is called a stage group, or simply, stage Stage There are many possible combinations of the numbered categories for T, N, and M Organizes combinations into four or five main stages Allows for easier comparison of cases 55

Stage Stage is assigned a Roman numeral (0, I, II, III, IV) Higher numbers indicate more extensive disease Stage 0 is minimal involvement, usually carcinoma in-situ Stage I is minimal disease Stage IV is greatest tumor involvement or distant metastasis Some stages have subdivisions Listed as IIA, IIB Based on survival rates 56

Prognostic Factors Prognostic factors include anatomic and non-anatomic characteristics about a case Prognostic factors can Play a role in describing the disease and May be a part in how a stage group is assigned Prognostic factors Personalize the information for that patient Provide information for individualized or personalized prognosis 57

Prognostic Factors Required for staging in various chapters Grade Tumor location Mitotic rate PSA (prostatic specific antigen) Gleason score Serum tumor markers for testis Clinically significant Many other factors are important to collect Affect patient care or prognosis, but not used in staging 58

Anatomic Stage/Prognostic Group In the 7 th edition Stage Group was renamed Commonly referred to as stage Anatomic Stage/Prognostic Groups New term for stage Signifies inclusion of prognostic factors to assign group 59

Stage Examples Criteria for assigning stage is specific to each chapter All cases are stage IIA Vary from T1 to T3, and from N0 to N1 Breast pt1a pn1a cm0(i+) Pathologic stage IIA Lung pt2a pn1 cm0 Pathologic stage IIA Colon pt3 pn0 cm0 Pathologic stage IIA Prostate pt2a pn0 cm0 PSA<20 Gleason 7 Pathologic stage IIA 60

Stage Examples Different criteria by site Differences in stage III and in stage IV Note prostate is stage IV without distant mets (M1) Breast pt3 pn3a cm0 Pathologic stage IIIC Lung ct2b cn3 cm0 Clinical stage IIIB Colon pt4a pn2b pm1a Pathologic stage IVA Prostate ct4 cn0 cm0 PSA>20 Gleason 8 Clinical stage IV 61

Staging Guidelines

Staging Guidelines Rules for assigning stage ensure data consistency Stage applied to cancers that are similar Specific criteria for different primary sites Some specific criteria are based on histology Some specific criteria are based on both site and histology Accurate and complete assessment necessary Important to seek further information if staging documentation is unclear 63

Staging Guidelines A few cases are unstageable Unknown stage if unable to identify extent of disease Site or histology do not meet criteria for staging No system for rare sites with not enough cases to establish validated criteria Mandatory to stage uniformly using the same staging system In order to compare data or results 64

Summary

Summary Stage allows for clear communication between multidisciplinary physicians involved in cancer care Many patients understand broad concept of stage Stage used in physician discussions with the patient Patient's treatment based on stage Many national treatment guidelines available Prognosis estimated by stage and other factors Patients want to know their prognosis 66

Summary Uses of stage Monitor patient care and outcomes Clinical trials, research studies, data analysis Monitor regional/national treatment patterns and outcomes Survival data by stage monitored over the years Influences subsequent editions of AJCC Cancer Staging Manual 67

Resources Staging Moments case-based scenarios, clarify finer points of staging, https://cancerstaging.org/cse/general/pages/staging- Moments.aspx On-Demand AJCC Webinars various topics, https://cancerstaging.org/cse/physician/pages/webinars.aspx Staging Posters breast, cervix, colorectal, lung, melanoma, pancreas, and prostate, https://cancerstaging.org/referencestools/quickreferences/pages/default.aspx You Tube AJCCancer Channel http://www.youtube.com/user/ajccancer More resources under Cancer Staging Education on AJCC website, https://cancerstaging.org/pages/default.aspx 68

American Joint Committee on Cancer TNM Staging: The Common Language of Cancer AJCC Web Site: http://cancerstaging.org 69