1. c/p Indicators for T, N, M Presentation developed by April Fritz, RHIT, CTR

2. 2016 c/p Indicators for TNM  Currently in registry software, TNM data elements are mutually exclusive Clinical T ___N ___M ___Stage ___ PathologicT ___N ___M ___Stage ___  No way to document “mixed stage”  Per AJCC website  “This discrepancy between registry software data items and AJCC staging classification rules causes a dilemma for registrars when abstracting the T, N, and M data items and results in inconsistent coding practices and data loss.”

3. 2016 c/p Indicators for TNM  2016 c/p indicators enable complete documentation of clinical and/or pathologic staging  Allow necessary ‘p’ values within the clinical staging data elements  Allow necessary ‘c’ values within the pathologic staging data elements

4. 2016 c/p Indicators for TNM  Per AJCC website  “This implementation will allow registrars to comply with AJCC rules while abstracting, thus reducing stage assignment confusion and increasing registrar confidence in assigning AJCC stage, increasing data integrity, and reducing the time and resources registrars and AJCC and CoC staff currently spend addressing these issues.  “The CoC would like to whole-heartedly thank registrars for their persistence in reporting this issue to AJCC and National Cancer Data Base (NCDB) and in pursuing answers to your questions.”

5. Examples of 2016 Indicators Previous Value Value for 2016 + cT1c1 cT2ac2A cT3bc3B cT4dc4D cTXcX cN0i+c0I+ cN1ac1A cN2ac2A cM0c0 cM1cc1C Previous Value Value for 2016 + pTispIS pTapA pT1mip1MI pT1a1p1A1 pT4cp4C pNXpX pN1cp1C pM1ap1A [Blank] allowed in each data field

6. Example 1 DCIS of breast diagnosed on core biopsy; excisional biopsy with clear margins. No nodes palpable or removed. Clin T: pISN: c0M: c0Stage 0 Path T: pISN: c0M: c0Stage 0 Per AJCC rules (Chapter 1), mixed stage allowed  In situ must be pT in clinical  Nodes cannot be involved so are not removed (cN0 in pathologic)  Distant sites cannot be involved by in situ tumor

7. Example 2 Patient with obstructive urinary symptoms had TURP. Path report shows Gleason 2+2 adenocarcinoma in half of chips. DRE: no abnormalities. Patient chose active surveillance. Clin T: c1BN: c0M: c0Stage I Path T: BlankN: BlankM: BlankStage 99 Per AJCC rules (prostate chapter), case does not meet path staging criteria  All pathologic stage fields should be blank  TURP findings used for clinical T  Missing PSA information grouped in lowest category

8. Example 3 Woman elects TAH-BSO for menorrhagia. Otherwise asymptomatic. Path report shows FIGO grade 2 endometrioid adenocarcinoma penetrating to inner half of myometrium. No nodes in specimen. Clin T: BlankN: BlankM: BlankStage 99 Path T: p1AN: pXM: c0Stage 99 Per AJCC rules, tumor not known prior to definitive treatment  Clinical stage fields should be blank  No nodes examined, so cannot path stage case

9. Example 4a  Patient evaluated for back pain; CT spine shows 8 cm mass in kidney, no involved nodes, and multiple osteolytic lesions along spine. Core needle biopsy of kidney mass confirms adenocarcinoma. No resection of primary. ClinT: c2AN: c0M: c1Stage 4 PathT: BlankN: BlankM: BlankStage 99 Per AJCC rules  No resection = no path staging (all fields blank)  No special rule for cM1; cannot carry over to path stage 4.

10. Example 4b  Patient fell at home and broke hip. Tissue from hip repair shows metastatic adenocarcinoma. CT abd/pelv shows 8 cm mass in kidney, but no involved nodes. No resection of primary. Patient discharged to long-term skilled care facility. ClinT: c2AN: c0M: p1Stage 4 PathT: BlankN: BlankM: p1Stage 4 Per AJCC rules  pM1 stage-grouped as clinical AND pathologic Stage 4 regardless of c/p status of T and N  Leave pT, pN blank if no resection

11. General Rules Chapter 1 Based on anatomic extent of: – “T” tumor by size and contiguous extension – “N” regional draining lymph nodes defined by number or location of positive LNs – “M” presence/absence distant metastasis

12. Rules All cases should be micro confirmed – Histo or cytology – Including clinical TNM If cTNM done w/o path, pull them from studies Timing when data eligible for – Clinical staging – Pathologic staging – Staging with neoadjuvant therapy

13. Clinical Staging - Macroscopic Timing: – Before ANY treatment starts – OR whichever is – Within 4 months diagnosis date SHORTER Information used: SymptomsPhysical exam EndoscopiesBiopsy for diagnosis Imaging (tumor, lymph nodes, or distant sites) Surgical exploration w/o resection May be ONLY common factor of some sites Uses – Define initial treatment choice – International population comparison

14. Pathologic Staging - Microscopic Timing: – Thru completion surgery(ies) – OR whichever – Within 4 months diagnosis date is LONGER Information used: – Information from c)TNM – Pathology from resected tissue (T, N, or M) EXCEPTION: IF only clinical T, THEN sentinel LN = c)N NO p)M0 (would require autopsy), only p)M1 Uses – Most precise prognosis – Adjuvant treatment decisions

15. Other Staging Post-Therapy Stage – Result after Neoadjuvant therapy - y)P staging at surgical resection – Patient treated with systemic therapy or RT WITHOUT surgery – y)C staging after therapy Not possible in USA registries software – Allows these cases to be removed when treatment or survival evaluations Retreatment Stage – Stage of recurrence AFTER disease-free interval – May be needed for clinical trial enrollment Autopsy Stage – No diagnosis of cancer prior to death

16. Rules Progression of disease: only info BEFORE progression used for staging Uncertainty (T, N, M, group stage, or modifying factor): use lower/lesser definition Nonanatomic factor not available: assign case based on lowest factor allowed Multiple simultaneous tumors in one organ? Describe tumor with highest “T”

17. pTNM pT = resection of primary tumor enough to satisfy the highest T pN = # LN to evaluate highest pN category – Exception: Sentinel LN surgery M may be c) or p) – If pM1, may be p)TxNxM1

18. pTNM w/o Resection Chapter 1 says: If biopsied tumor canNOT be removed AND Highest T OR Highest N OR M1 category can be confirmed pathologically THEN Criteria for pT OR pN OR pM has been met However………….

19. Conflict Conflicts with rule that must have tumor resection for a pN Per Donna Gress, use tumor resection rule which means you cannot code a pathologic N unless the primary tumor is resected

20. pTNM w/o Resection Examples Rectal biopsy shows prostate cancer = pT4 Supraclavicular LN biopsy = lung cancer pN3 – BUT violates another rule in AJCC – can’t have pN w/o pT Biopsy of any distant mets = pM1

21. Rules for Classification Site-specific – read chapter Defines what is needed for cTNM vs pTNM – What tests fit in cTNM – What must be resected for pTNM Tumor only? Entire organ? – Where does surgical exploration fit?

22. pTNM Surgery Site-specific guidelines for pTNM – Not all surgeries, even curative, qualify for pTNM – EX: TURB for bladder (clinical) vs cystectomy (pathologic)

23. T for Tumor Tx – Primary tumor can NOT be assessed – Not enough info T0 – No evidence primary tumor – EX: Tissue from met to prove dx of site, but no lesion found in site Tis – in situ T1 – early invasive T2, T3, T4 – ↑ size, regional tiss extension Tumor size recorded in mm – Doctor may estimate or aggregate if > 1 piece T usually requires resection of lesion and/or of organ May be subdivided into a or b or c

24. N for Regional Nodes Nx – Nodes canNOT be assessed – Not enough info N0 – No evidence LN mets N1, N2, N3 – based on number or location positive nodes May be subdivided into a or b or c

25. N Cont’d Any LN not listed as regional are distant Recommended minimal number excised by chapter – Any LN examined by path = pN (with tumor resection) – Biopsy LN = pN (with tumor resection) Clinical T w/o resection, sentinel LN = cN Isolated Tumor Cells (ITC) = N0 usually Direct extension tumor into regional LN area = + LN Size of mets vs size of LN per chapter

26. M (Distant) Metastasis c)M0 – No distant mets – ONLY clinical (no pM0) – Imaging distant organ sites not required M1 – Distant mets – Clinical OR pathologic – May be subdivided into a or b No Mx any longer – Removed from CAP protocol & staging forms – Unless there is clinical or pathologic M1, cM = M0 Isolated tumor cells in mets sites (ITC) Circulating or disseminated tumor cells (DTC) If not noted in “T” or “N”, it’s distant Mx

27. Stage Group Stage 0 – in situ Stage I – confined to primary site Stage II or III – increasing organ and/or regional LN involved Stage IV – distant metastasis May be subdivided into a or b “ Pure” cTNM or pTNM Working stage – combined c) or p) in midst of workup – Only for tumor conference discussion Tx or Nx may make unstageable unless “Any T” or “Any N” allowed If anatomic factor required, may use lowest category if factor not found

28. Mixed Staging Yikes Purely p) or c) TNM staging for comparisons – EXCEPTION – cM can be combined with pT pN No pMX any longer cM0 used when creating p) group stage – EXCEPTION – cM can be combined with c or p T,N cTx cNx cM1 = stage IV, cT# cN# pM1 = stage IV – EXCEPTION – In situ pTis cN0 cM0 can be used for p) AND c) group stage Computer logic: pTis pNx M0= Group Stage 0

29. Per Donna Gress Do NOT use blanks in middle of staging Example: Pt has lumpectomy; refuses LN sampling or dissection pT1 Nx M0

30. X VS Blank “The X category is used when information on a specific component is unknown.” pg 8 Cancer Staging Manual Per chapters, using X means that element “cannot be assessed” Donna Gress lecture 2013 states BLANK should be used when – No information in chart – Cannot assign a valid AJCC value – Patient not eligible for pathologic staging

31. T0 VS TX Tx – primary tumor cannot be assessed T0 – No evidence of primary tumor – A primary tumor was not found by any clinical methods – Per AJCC Q&A, T0 implies you looked for tumor and couldn’t find – Used for cT or pT staging Historically only used for pT

32. 88 Not applicable – Used when chapter does not accept histology (EX: carcinoid of lip) – Used when no chapter for staging CNS, hematopoietic Historical: used when cT could not be defined (ex. Melanoma must be excised or testicle must be removed to diagnose)

33. Brief TNM Staging Exercises

34. Case Study: Lung CT Chest: large R infrahilar mass with 4.2 cm RLL mass occluding RLL bronchus and narrowing of pulmonary veins. R mediastinal adenopathy. R pleural effusion associated with the large mass. Two smaller lesions L lung at level of hilum. All other workup negative. Core bx: R mediastinal node positive for small cell carcinoma. 1. What is the clinical T? a. c3b. c2Ac. Blank d. c4 Source: Cancer Case Studies, NCRA

35. Clinical T  cT4 Rationale: Tumors in Rt infrahilar and RLL – meet cT4 criteria of tumors in different ipsilateral lobes 1. Narrowing of pulmonary veins is not = invasion of pulmonary veins 2. Metastasis in mediastinal node cannot be coded; contradicts resection rule. If could be used, would be coded In the N category 3. Malignant pleural effusion and tumors in contralateral lung are coded in the M category

36. Case Study: Lung CT Chest: large R infrahilar mass with 4.2 cm RLL mass occluding RLL bronchus and narrowing of pulmonary veins. R mediastinal adenopathy. R pleural effusion associated with the large mass. Two smaller lesions L lung at level of hilum. All other workup negative. Core bx: R mediastinal node positive for small cell carcinoma. 2. What is the pathologic N? a. p2b. pXc. Blank d. p0 Source: Cancer Case Studies, NCRA

37. Pathologic N  Blank Did not meet criteria for pathologic N. There was no surgical resection of the primary site. The LN biopsy was part of the staging workup. The N category is clinical. Pathologic N ONLY when the biopsy proved an N3, the highest N category. T Blank N Blank M Blank Stage Grouping 99

38. Case Study: Lung CT Chest: large R infrahilar mass with 4.2 cm RLL mass occluding RLL bronchus and narrowing of pulmonary veins. R mediastinal adenopathy. R pleural effusion associated with the large mass. Two smaller lesions L lung at level of hilum. All other workup negative. Core bx: R mediastinal node positive for small cell carcinoma. 3. What is the clinical M? a. c1Ab. c0c. Blank d. cX Source: Cancer Case Studies, NCRA

39. Clinical M c1a Rationale: pre-surgical workup showed right pleural effusion. Nodules in the contralateral lung may or may not be metastatic. Without physician’s confirmation, would not code

40. Case Study: Rectum PTA: Biopsy proven carcinoma in rectal mass. Remainder of exam negative. Rectosigmoid colectomy: 5.0 cm moderately differentiated adenocarcinoma extending through muscularis propria to pericolonic soft tissue of rectum. Radial margin positive for adenocarcinoma. 7/17 lymph nodes positive for metastatic adenocarcinoma. 1. What is the pathologic T? a. p4Ab. p3c. pXd. p2 Source: Cancer Case Studies, NCRA

41. Pathologic T  PT3  Rationale: Tumor was completely resected; pathology shows invasion through the muscularis propria into the pericolonic/pericolorectal tissue

42. Case Study: Rectum PTA: Biopsy proven carcinoma in rectal mass. Remainder of exam negative. Rectosigmoid colectomy: 5.0 cm moderately differentiated adenocarcinoma extending through muscularis propria to pericolonic soft tissue of rectum. Radial margin positive for adenocarcinoma. 7/17 lymph nodes positive for metastatic adenocarcinoma. 2. What is the clinical T? a. c4Ab. c3c. cXd. c2 Source: Cancer Case Studies, NCRA

43. Clinical T  Tx  Rationale: Biopsy alone cannot show depth of invasion  SOMETIMES possible to get cT when patient has endoscopic ultrasound biopsies

44. Case Study: Rectum PTA: Biopsy proven carcinoma in rectal mass. Remainder of exam negative. Rectosigmoid colectomy: 5.0 cm moderately differentiated adenocarcinoma extending through muscularis propria to pericolonic soft tissue of rectum. Radial margin positive for adenocarcinoma. 7/17 lymph nodes positive for metastatic adenocarcinoma. 3. What is the pathologic N? a. p2Bb. p1Cc. pXd. p2 Source: Cancer Case Studies, NCRA

45. Pathologic N  N2b Metastases in 7 or more LN  Rationale: Primary site surgery removed enough nodes to pathologically stage N.  17 LN examined, 7 positive

46. Case Study: Rectum PTA: Biopsy proven carcinoma in rectal mass. Remainder of exam negative. Rectosigmoid colectomy: 5.0 cm moderately differentiated adenocarcinoma extending through muscularis propria to pericolonic soft tissue of rectum. Radial margin positive for adenocarcinoma. 7/17 lymph nodes positive for metastatic adenocarcinoma. 4. What is the clinical M? a. c1Ab. Blankc. pXd. c0 Source: Cancer Case Studies, NCRA

47. Clinical M  c0  Rationale: There is no evidence of distant metastasis. Default is c0  Only thing necessary to get a cM0 is a PE. Patient had to have PE prior to surgery.  Real charts would have better information.

48. Case Study: Lymphoma PE: Night sweats, 35 pound weight loss in 2 months, abdominal pain. Supraumbilical abdominal mass. Imaging: no lymphadenopathy or organomegaly Partial gastrectomy: mass in greater curvature of stomach completely excised Pathology: Diffuse large B-cell lymphoma confined to stomach wall 1. What is the clinical Stage Group? a. c1BEb. c1BAc. cXd. c1A

49. Clinical Stage Group Stage IBE Rationale: DLBCL is a non-Hodgkin lymphoma. See page 607-611. 1. Most lymphomas staged clinically and use pre-surgical and surgical information (E for Extranodal). Path staging requires exploratory lap. 2. Symptomatic (night sweats). Cannot determine that 35 pounds is 10% of total body weight

50. Case Study: Lymphoma PE: Night sweats, 35 pound weight loss in 2 months, abdominal pain. Supraumbilical abdominal mass. Imaging: no lymphadenopathy or organomegaly Partial gastrectomy: mass in greater curvature of stomach completely excised Pathology: Diffuse large B-cell lymphoma confined to stomach wall 2. What is the pathologic Stage Group? a. p1BEb. p1Bc. 99 d. p1E

51. Pathologic stage group  99  Rationale: Patient did not have a staging laparotomy, so does not meet the criteria for pathologic staging.

52. Case Study: Breast 10/17 PE: R breast: marked skin erythema and peau d’orange. 8.0cm by 7.0cm vertical mass above the nipple in the 12 o’clock radial. Palpable 3.0 cm x 2.0 cm right axillary lymph node. No other adenopathy. 10/19 Imaging: no distant metastases 10/20 Excisional biopsy R axillary node confirms metastasis 10/26 R modified radical mastectomy: 6 cm infil ductal carcinoma, BR 6/9. 8 axillary nodes negative. 1. What is the clinical T? a. c3b. c4Bc. cXd. c4D

53. Clinical T  4B  Clinical diagnosis of peau d’orange and erythema

54. Case Study: Breast 10/17 PE: R breast: marked skin erythema and peau d’orange. 8.0cm by 7.0cm vertical mass above the nipple in the 12 o’clock radial. Palpable 3.0 cm x 2.0 cm right axillary lymph node. No other adenopathy. 10/19 Imaging: no distant metastases 10/20 Excisional biopsy R axillary node confirms metastasis 10/26 R modified radical mastectomy: 6 cm infil ductal carcinoma, BR 6/9. 8 axillary nodes negative. 2. What is the pathologic T? a. p3b. p4Bc. pXd. p4D

55. Pathologic T  4B  Rationale: P staging based on both clinical and surgical information. Pathology report says a 8 X 7 cm mass. Pre-surgical PE shows peau d’orange skin which is a 4B  Note: Staging is different when patient has neoadjuvant treatment. Do NOT carry over clinical information when doing Y staging (surgery after neoadjuvant RX)

56. Case Study: Breast 10/17 PE: R breast: marked skin swelling and peau d’orange. 8.0cm by 7.0cm vertical mass above the nipple in the 12 o’clock radial. 3.0 cm x 2.0 cm right axillary lymph node. No other adenopathy. 10/19 Imaging: no distant metastases 10/20 Excisional biopsy R axillary node confirms metastasis 10/26 R modified radical mastectomy: 6 cm infil ductal carcinoma, BR 6/9. 8 axillary nodes negative. 3. What is the clinical N? a. cXb. c0c. c1d. c1A

57. Clinical N  cN1 metastasis to clinically movable ipsilateral level I, II axillary LN  Rational: Biopsy done pre-operatively. Separate definitions for c and pN. The clinical information does not state LN was positive, just a 3 cm LN

58. Case Study: Breast 10/17 PE: R breast: marked skin swelling and peau d’orange. 8.0cm by 7.0cm vertical mass above the nipple in the 12 o’clock radial. 3.0 cm x 2.0 cm right axillary lymph node. No other adenopathy. 10/19 Imaging: no distant metastases 10/20 Excisional biopsy R axillary node confirms metastasis 10/26 R modified radical mastectomy: 6 cm infil ductal carcinoma, BR 6/9. 8 axillary nodes negative. 4. What is the pathologic N? a. p2b. p0c. p1d. p1A

59. Pathologic N  p2a  Rationale: Pathologic information includes clinical and path. Bx was excisional, so the node biopsied plus the 9 nodes exicised makes this a p1a  Do not confuse pathologic N with rules for coding number of nodes examined

60. Case Study: Melanoma Pathology report for skin, left arm, excision: Conventional invasive melanoma originating in a dermal nevus with no adjacent intraepidermal component.  - Breslow’s tumor thickness 1.8 mm; Clark’s level III  - No epidermal ulceration  - Foci suspicious for vascular space invasion  - No regression  - High mitotic rate (>40 per 10 HPF)  - Tumor nodule appears completely excised; nearest  inked margin at 0.4 mm 1. What is the clinical T? a. c2Ab. c2Ac. cXd. c2B

61. Clinical T  cT2a  Rationale: Melanoma clinical staging includes removal of primary lesion to determine thickness. Thickness = T2. There is no ulceration which = a.

62. Case Study: Melanoma Pathology report for skin, left arm, excision: Conventional invasive melanoma originating in a dermal nevus with no adjacent intraepidermal component.  - Breslow’s tumor thickness 1.8 mm; Clark’s level III  - No epidermal ulceration  - Foci suspicious for vascular space invasion  - No regression  - High mitotic rate (>40 per 10 HPF)  - Tumor nodule appears completely excised; nearest  inked margin at 0.4 mm 2. What is the pathologic T? a. p2Ab. p2c. pXd. Blank

63. Pathologic T  Blank  Rationale: AJCC website lecture on staging melanoma: pathologic staging requires a biopsy/excision AND a re-excision (usually a wide excision) to meet pathologic criteria

64. Case Study: Bladder Transurethral resection of bladder tumor: 0.5 cm papillary tumor at ureteral orifice. PE and Abdominal Ultrasound: within normal limits Pathology: Non-invasive papillary carcinoma confined to mucosa; no penetration of basement membrane. 1. What is the clinical T? a. cISb. cAc. Blankd. cX Source: Cancer Case Studies, NCRA

65. Clinical T cTa Rationale: This is a non-invasive papillary tumor. TUR is part of clinical staging. Pathology from TUR showed papillary tumor confined to mucosa (Tis).

66. Case Study: Bladder Transurethral resection of bladder tumor: 0.5 cm papillary tumor at ureteral orifice. PE and Abdominal Ultrasound: within normal limits Pathology: Non-invasive papillary carcinoma confined to mucosa; no penetration of basement membrane. 2. What is the pathologic T? a. pISb. pAc. Blankd. pX Source: Cancer Case Studies, NCRA

67. Pathologic T  pTx  Rationale: Can use positive clinical M for clinical staging. Other elements are X and stage group is 99  cTX cNX cM1b Stage group IV

68. Case Study: Prostate Elderly patient admitted for hip fracture after a fall. Pathology report from hip fracture internal fixation showed metastatic prostatic adenocarcinoma. Patient discharged to nursing home on hormone therapy. 1. What is the clinical M? a. c1Bb. c1c. p1Bd. Blank

69. Clinical M  Blank  Rationale: Prostate cancer was an incidental finding during hip surgery, so there were no pre- operative scans or biopsies to confirm metastatic disease.  T Blank N Blank M Blank Stage Group 99

70. Case Study: Prostate Elderly patient admitted for hip fracture after a fall. Pathology report from hip fracture internal fixation showed metastatic prostatic adenocarcinoma. Patient discharged to nursing home on hormone therapy. 2. What is the pathologic stage group? a. 4b. 4Bc. Unknown d. 99

71. Pathologic Stage Group  4  Rationale: Microscopic proof of bone involvement  Tx Nx M1b Stage Group IV  Note: With M1, can have any T and any N

72. Take-Home Messages  c/p indicators allow complete classification and stage grouping of cases  In some situations, p information used in c  In fewer situations c information used in p  Use appropriate category according to rules  Use AJCC rules from Chapter 1 and site- specific chapter  Sometimes more than one rule applies  Should reduce confusion and frustration in assigning T, N, M data fields for clinical and pathologic staging

73. Recommendations  Do not change procedures or coding instructions in middle of diagnosis year.  Doing so will result in inconsistent data for analysis  Document any rules changes and the effective date in the registry’s procedure manual  Until there are further written instructions,  Follow the guidelines for coding blanks vs. X vs. 0 established by your registry software vendor or state registry

74. Recommendations and Reminders  Finish 2015 cases before you start 2016 diagnoses  Use consistent rules for entire diagnosis year  New data fields, new c/p indicators, discontinued data items effective for 01/01/2016 diagnoses and forward  Follow your standards setter(s) instructions  Do not try to use new c/p indicators until you receive 2016 vendor software updates

75. Any Questions?