The Voyage to Direct Coding of AJCC TNM & Stage... Jayne Holubowsky, CTR DelMarVa-DC Educational Meeting Annapolis, MD October 8, 2015.

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The Voyage to Direct Coding of AJCC TNM & Stage... Jayne Holubowsky, CTR DelMarVa-DC Educational Meeting Annapolis, MD October 8, 2015 outline Evolution General Rules Site-specific Rules How well do you remember... objectives Learn general rules for TNM Staging Recognize and understand site specific rules for staging Learn principles of stage grouping Demonstrate understanding of staging 1

TNM background AJCC organized Develop a system of clinical staging Governance Describes the anatomical extent of the disease TNM Utilize as a guide to treatment Allows comparison of end results Evolution TNM Staging premise Cancer has a finite length and certain measurable events along time continuum Mutations of a single cell Local growth (increase in size) Invasion of organ s parenchyma Invasion of lymphatics within organ Cancer timeline continued Spread to regional lymph nodes Direct inv of adjacent tissues Invasion of blood vessels and spread to distant organs Time continuum varies by cancer type Marker points defined for each type of cancer 2

General rules Microscopic confirmation Required for TNM classification Rare cases without micro confirm should be analyzed separately Cancers classified by ICD-O-3 Recommend pathology reporting using CAP cancer protocols Timing of data eligible for clinical staging Data obtained before definitive tx as part of primary tx or w/in 4 months, whichever is shorter Time frame for collecting clinical stage data also ends when a decision is made for watchful waiting without therapy Timing of data eligible for pathological staging Data obtained through definitive surgery as part of primary tx or w/in 4 months, whichever is longer Timing of data eligible for staging with neoadjuvant therapy Stage in cases w/neoadjuvant tx is: (a) clinical as defined earlier before initiation of therapy; and, (b) clinical or pathological using data obtained after completion of neoadj therapy (yctnm or yptnm) Cases w/uncertainty among T, N, or M categories Assign the lower (less advanced) category of T, N, or M, prognostic factor or stage grouping Absence of staging-required nonanatomic prognostic factor Assign stage grouping by the group defined by the lower (less advanced) designation for that factor Mult synchronous primary tumors in single organ Stage T by most advanced tumor; use m suffix or the number of tumors in parentheses, e.g., pt3(m)n0 M0 or pt3(4)n0m0 Synchronous prim tumors in paired organs Stage and report independently Metachronous prim tumors in single organ (not recurrence) Stage and report independently T0 staging unknown primary Stage based on clinical suspicion of primary tumor (e.g., T0 N1 M0 Stg IIA breast cancer) Adapted from AJCC Cancer Staging Manual, 7 th ed, Table 1.3, page 8 1. Microscopic confirmation Required for TNM classification Rare cases without microscopic confirmation Should be analyzed separately Cancers are classified by their ICD-O-3 primary site code Recommend pathology reporting using CAP cancer protocols 2. Timing: Clinical STAGE All information obtained prior to initiation of any treatment or within 4 months of diagnosis, whichever is shorter, with no disease progression Treatment decision includes watchful waiting 3

Clinical STAGING continued May be only common factor for some sites Information used includes: Symptoms Physical exam Endoscopies Biopsy for diagnosis Imaging Tumor, Lymph nodes, Distant sites http://www.acr.org/quality-safety/appropriatenesscriteria/new-and-revised Surgical exploration w/o resection Application Define initial treatment choice International population comparison 3. Timing: Pathological STAGE All information obtained through completion of 1st course tx or within 4 months of diagnosis whichever is longer, with no neoadjuvant tx or disease progression Pathological staging continued Most precise estimate of prognosis Based on: Clinical information acquired before tx PLUS Pathologic examination of surgical specimen EXCEPTION If only ct, then ANY LN bx = cn Primary tumor cannot be removed Case may be pathologically staged Specific requirements for pt, pn, pm Presence of a path report is not automatically pathological staging 4

4. timing: Neoadjuvant therapy Cases treated with neoadjuvant therapy may have a 2nd staging after treatment Should have clinical staging as baseline Post-treatment staging is labeled yc or yp Also called intercurrent staging Neoadjuvant therapy continued Measures response to neoadjuvant treatment Pt had systemic and/or radiation tx before surgery Case staged at conclusion of therapy Clinical if no further treatment (yctnm) Pathological if resection (yptnm) No stage group for no residual ypt0 ypn0 ycm0 staging basis c - Clinical Stage essential to select & evaluate therapy options p Pathological Stage provides most precise data to estimate prognosis, plan subsequent therapy & calculate end results r Recurrence/Retreatment Stage Assessment of extent of recurrent tumor after disease-free interval when further tx is planned a Autopsy Stage Classification 1st determined @ autopsy (no previous dx of cancer) 5

5. Uncertain t n m categories If in doubt about correct T, N, or M value, Stage grouping, or Prognostic factor, use the less advanced category Also known as downstaging THERE ARE NO AMBIGUOUS TERMS IN TNM! Uncertain TNM continued Uncertain information examples Imaging unclear if one node (N1) or two nodes (N2) are involved Use N1 which is lower category Colonoscopy does not provide information on T category for colon Use TX since information is unknown Cannot assign T1 as this falsely skews data Lung cstage group for T2a NX M0 Use stage group UNK since no info on LNs Cannot assign stage group using N0 as this falsely skews data 6. Missing prognostic factor Assign stage grouping defined by the lower (less advanced) designation for that factor Example: T2a, N0, M0 prostate CA but Gleason score & PSA unknown Assign Stage Group I (PSA x, Gleason x) 6

OPTIONAL DESCRIPTORS Lymphatic Invasion Perineural Invasion LX Lymphatic inv cannot be assessed PnX Perineural inv cannot be assessed L0 No lymphatic invasion Pn0 No perineural invasion L1 Lymphatic invasion Pn1 Perineural invasion Venous Invasion Residual Tumor VX Venous inv cannot be assessed RX Presence of resid tumor cannot be V0 No venous invasion R0 No residual tumor V1 Microscopic venous inv R1 Microscopic resid tumor V2 Macroscopic venous inv R2 Macroscopic resid tumor assessed 7. Mult synchronous tumors in same organ Classify by highest T category Add suffix of m for multiplicity or # of tumors Mastectomy specimen: 1cm IDC UOQ & 23mm IDC LOQ Use largest tumor (23mm) for staging; assign pt2m or pt2(2) 8. Synchronous bilat tumors Classify separately Exceptions: Thyroid, ovary, fallopian tube, liver Multiplicity part of T definitions Lung exception Multiple tumors may be classified in T or M depending on location 7

9. Metachronous tumors in single organ Abstract as new tumor Do not use MPH Rules! 10. UNKNOWN PRIMARY No evidence of primary tumor (T0) Stage according to site suspected by clinician T classification rules T determined by site-specific rules based on size and/or local extension Clinical assessment of T (ct) based on PE, imaging, endoscopy and biopsy and surgical exploration w/o resection Pathologic assessment of T (pt) entails a resection of the tumor or may be assigned with biopsy only of it assigns the highest T category pt generally based on resection in single specimen; if resected in >1 specimen, make reasonable estimate of size/extension. Disease-specific rules may apply Tumor size should be recorded in whole millimeters. If the size is reported in smaller units, such as tenths or hundredths of a millimeter, it should be rounded to the nearest whole millimeter for reporting stage. Rounding is performed as follows: 1 thru 4 are rounded down, 5 through 9 are rounded up. If not resected, and highest T and N category can be confirmed microscopically, case may be classified as pt or pn w/o resection Taken from AJCC Cancer Staging Manual, 7 th ed, Table 1.5, page 10 8

T classification rules Based on different criteria by site Tumor Size Breast, parotid gland, oral cavity Depth of Invasion Colon, bladder, melanoma Location and Extension Lung, larynx, pancreas Other factors Multiplicity, grade, prognostic factors T classification rules Clinical assessment Based on PE, imaging, endoscopy, bx Pathological assessment Resection of tumor or bx of highest T pt based on resect in single specimen Estimate size if >1 specimen Disease specific rules apply Tumor size In whole mm or rounded T classification rules pt minimal requirements Gross resection Microscopically positive margin Should eval highest T category pt without resection If highest T and highest N category is microscopically confirmed 9

n classification rules Categorize N by disease-specific rules based on number & location of positive LNs Minimum expected number & location of LNs to examine for staging defined by disease type If LN surgery is performed, classify N category as pathologic even if minimum number is not examined Pathological assessment f the primary tumor (pt) is necessary to assign pathological assessment of LNs (pn) except w/unknown primary (T0). If pathological T (pt) is available, then any microscopic evaluation of LNs is pn In cases with only clinical T in the absence of pt excision of a single LN or SLN(s) is classified as clinical nodal status (cn) Microscopic examination of a single LN or LNs in the highest N category is classified as pn even in the absence of pathological information on other LNs Sentinel LN biopsy is denoted with (sn), e.g. pn0(sn); pn1(sn) LNs with ITC only generally staged as pn0; disease-specific rules may apply (e.g., melanoma) Direct extension of primary tumor into regional LN is classified as node positive Tumor nodule with smooth contour in regional LN area are classified as positive LNs When size is the criterion for N category, stage by size of metastasis, not size of node when reported (unless specified in disease-specific rules) Adapted from AJCC Cancer Staging Manual, 7 th ed, Table 1.6, page 10 n classification rules N1 N3 Increasing involvement of regional lymph nodes by number or location Subcategories such as N0(i+), N1mi, N2a may be used Minimal number required Exception: sentinel node procedure EXAMPLE: Lumpectomy for breast cancer with sentinel LN bx of only Level I nodes=pt_ pn_(sn) Min number NOT removed still pn N classification rules pn assigned in conjunction with pt If removal of prim tumor meets criteria for pt, then not necessary to have micro confirmation of highest N category If highest N category microscopically proven, then case is pn regardless of status of T EXAMPLE: Bladder cancer w/+ FNA of common iliac LN = pn3 regardless of how T is determined If no removal of prim tumor, then any LN procedure or SLN procedure is cn 10

N classification rules Isolated Tumor Cells (ITCs) Identified by immunohistochemistry or molecular techniques, flow cytometry or DNA analysis Definition: Single tumor cells or small clusters of cells 0.2mm or less in diameter Breast classified as pn0 Melanoma & Merkel cell carcinoma classified as pn1 N classification rules Direct ext into reg LN = +LNs Tumor nodule(s) in LN area Smooth contour = +LN(s) When size criterion, code size of MET not LN m classification rules Clinical M classification only requires H&P; imaging of distant organ sites not required to assign cm0; infer status as clinical M0 status unless known clinical M1 MX is not a valid category and my not be assigned. Elimination of MX is new with AJCC/UICC, 7th ed Pathological M classification requires a positive biopsy of the metastatic site (pm) Pathological M0 (pm0) is not a valid category and may not be assigned. Stage a case with a negative biopsy of suspected metastatic site as cm0 Case with pathological T and N may be grouped as pathological TNM using clinical M designator (cm0 or cm1) (e.g., pt1 pn0 cm0 = pathological stage I) Case with pathological M1 (pm1) may be grouped as clinical and pathological Stage IV regardless of c or p status of T and N (e.g., ct1 cn1 pm1 = clinical or pathological Stage IV) ITC in metastatic sites (e.g., bone marrow) or circulating or DTCs classified as cm0(i+). Disease-specific rules may apply Adapted from AJCC Cancer Staging Manual, 7 th ed, Table 1.7, page 11 11

M classification rules M Distant Metastases/Systemic Involvement Absence or presence of distant metastases Blood-borne metastases Discontinuous from primary site Direct distant extension Progressive LN involvement Seeding w/in cavity Picture source: http://www.fanpop.com/clubs/oncology/images/6569591/title/cancer-metastasis-photo M classification rules M1-Presence of @least 1 area of distant mets Example: Prostate M1 category M1a M1b M1c Non-regional lymph nodes Bone(s) Other site(s) Notes MX Not available in classification Minimal physical examination results in cm0 pm0 not possible except at autopsy Classification choices: cm0, cm1, pm1 M classification rules pt pn cm yields a path stage group pm1 yields clinical and path Stage IV CTCs and DTCs or bone marrow micrometastasis are cm0(i+) 12

Anatomic stage/prognostic grouping rules Define separate clinical and pathological group for each case. May combine clinical and pathological information as a working stage in either the pathological or clinical classification when only partial information is available this may be necessary for clinical care. Minimize use of Tx and Nx; use of x for any component makes case unstageable. Case will not be usable in comparison analyses (exception: any combination of T and N including Tx and/or Nx with M1 is Stage IV) For grouping that require a nonanatomic factor, if factor is missing, stage using lowest category for that factor. Case with pt and pn and cm0 or cm1 staged as pathological stage group. Case with ct and cn and pm1 staged as clinical AND pathological stage group. Carcinoma in situ, stage ptis cn0 cm0 stage as both clinical AND pathological stage 0. Adapted from AJCC Cancer Staging Manual, 7 th ed, Table 1.8, page 12 Anatomic stage/prognostic grouping rules Generally pure clinical and pure pathological stage groups defined Elements can be combined in a working stage while tx decisions are being made or when only partial information is available for either Missing SSF downstage pt pn and cm OR cm1 = pstage ct cn and pm1 = cstage AND pstage CODING IN SITU Must be a pathological diagnosis Assign ONLY ptis Staging pathologically must meet requirements ct blank cn0 cm0 cstage 0 ptis pn blank pm blank pstage 0 13

Blank vs x T, N, and M data fields Values allowed by FORDS Further explanations from AJCC Blank indicates No information in medical record Do not know if any assessment was performed Criteria not met for this stage classification so each category (T,N,M) is blank X indicates not assessed T cannot be assessed N cannot be assessed Does not apply to M, if patient was examined it can be assigned Criteria met for this stage classification so each category is valid value or X 88 indicates not applicable, not defined by AJCC Blank vs x Does patient meet criteria for that stage classification? Yes patient meets classification criteria If phys could not assess T and/or N for the pt, and, Definitive information for T and N not in chart; Use TX and/or NX Yes patient meets classification criteria No information about diagnostic workup or resection pathology in chart Do not use X Implies physician did not assess or have info on patient s T and/or N Use blank Indicates registrar could not find information in chart Blank vs x Does patient meet criteria for that stage classification? No patient does NOT meet classification criteria Do NOT use X Indicates patient eligible for staging Implies physician did not assess or have info on patient s T and/or N Must use blanks Indicates patient did not meet classification criteria 14

Exceptions to the rules... Melanoma T based on depth of invasion, not size of the tumor Horizontal spread is collected in SSF Melanoma and Merkel Cell ITC s are considered node positive Breast Lumpectomy with grossly negative margin is acceptable for pathological staging Prostate and Bladder MUST have a total resection for path staging Exceptions to the rules... Bladder In situ or noninvasive tumors are classified as: ct blank cn0 cm0 cstage 0/A (dependant on T) ptis/a pn blank pm blank pstage BLANK Ambiguous terminology AJCC does NOT: Define ambiguous terminology Mandate how words should be interpreted How to interpret words for cancer involvement Review clinician s statements Treatment choices may indicate clinician s impression Review and analysis of entire case Physical exam 15

Ambiguous terminology Duodenum case CT abd/pelvis reports duodenal tumor w/extensive inflamm, exudate & adherent to other loops of small bowel Patient scheduled for resection of tumor in duodenum Does adherence mean other bowel involved with cancer? Imaging and treatment analysis Exudate is fluid leaking from blood vessels due to inflammation Inflammation causing adherence, not tumor; if extensive adherence they would not resect just local tumor - more treatment, either more surgery or chemotherapy would be done Decision: other small bowel is NOT involved Colon Staging CT abd/pelvis-marked dilatation terminating abruptly in mid prox sigmoid w/area of bowel wall thickening; no LNs enl 41mm AdenoCA, mod diff, sigmoid colon, extends thru full thickness muscularis propria into pericolonic tissue, partial colectomy. Prox, distal, radial marg negative. LVI present. 2/16 pericolonic LNs pos w/3 satellite nodules in the pericolonic fat pos for adenoca. What is the pathologic stage T category? A. pt2 B. pt3 C. pt4a D. pt4b What is the pathologic stage N category? A. pn0 B. pn1b C. pn1c D. pn2a Bladder staging Pt had blood in urine, physical exam negative. TURB showed multiple non-invasive papillary urothelial carcinomas in trigone and lateral wall, and flat urothelial carcinoma in situ in dome. Bimanual exam negative. What is the clinical stage T category? A. cta B. ctis C. pta D. ptis 16

lung staging CT chest-tumor LLL & 2 tumors LUL. Phys exam neg. Bx LLL adenoca: 12mm adenoca w/bronchoalveolar features, visceral pleura & marg involv. LUL wedge:25mm adenoca, margin involved, LLL lobectomy. 1 Level 7 subcarinal LN pos & 2 Level 4L lower paratracheal nodes neg. What is the pathologic stage T category? A. pt1b B. pt2a C. pt3 D. pt4 What is the pathologic stage N category? A. pn0 B. pn1 C. pn2 D. pn3 breast staging Bx 5:00 & 10:00 RT breast infiltrating lobular ca, Nottingham gr 2/3, LCIS, ER/PR pos, HER2 unamplified. >2cm Lobular ca, LCIS present, Nottingham 3+2+1=6 Gr2, marg neg, RT mastectomy. 1/3 sentinel nodes with mets meas 2.mm, 17 axillary nodes negative. What is the pathologic stage T category? A. pt1a B. pt1b C. pt1c D. pt2 What is the pathologic stage N category? A. pn1mi B. pn1a C. pn1b D. pn1c summary How To: Direct Coding T, N, M and Stage 1.Determine primary site & histology Ask: Where did it start? (primary site) Ask: Where did it go? (spread to LNs &/or distant sites) Ask: How did it get there? Direct extension (T) Lymphatics (N) Discontinuous mets (M) Blood Seeding/Nodules 2.Look up site chapter 3.Is histology included in this chapter? 17

summary How To: Direct Coding T, N, M and Stage - continued 4.Review list of regional LNs 5.Review rules for classification Clinical vs Pathological 6.Find staging information in tables Look for key words in medical record Match key words to lists in staging manual section for primary site 7.Assign appropriate SSF s Some have impact on Stage Group 8.Determine T, N, M, assign Stage Group summary TNM Wrap-Up General rules apply to all chapters Site-specific rules provide additional information and over-rides general rules Four staging classifications T, N, M categories define anatomic extent of disease Prognostic factors provide additional info for some sites Staging basis defined by timing of treatment Cases grouped for staging Comparison and analysis 18

804-864-7873 jayne.holubowsky@vdh.virginia.gov 804-864-7870 19