1. Presentation developed by
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 ___
Pathologic T ___ 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
cT1 c1
cT2a
c2A
cT3b
c3B
cT4d
c4D
cTX cX
cN0i+
c0I+
cN1a
c1A
cN2a
cM0 c0
cM1c
c1C
Previous Value
Value for
pTis
pIS
pTa pA
pT1mi
p1MI
pT1a1
p1A1
pT4c
p4C
pNX pX
pN1c
p1C
pM1a
p1A
[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: pIS N: c0 M: c0 Stage 0
Path T: pIS N: c0 M: c0 Stage 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
AJCC TNM indicators presentation

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: c1B N: c0 M: c0 Stage I
Path T: Blank N: Blank M: Blank Stage 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
AJCC TNM indicators presentation

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: Blank N: Blank M: Blank Stage 99
Path T: p1A N: pX M: c0 Stage 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
AJCC TNM indicators presentation

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.
Clin T: c2A N: c0 M: c1 Stage 4
Path T: Blank N: Blank M: Blank Stage 99
Per AJCC rules
No resection = no path staging (all fields blank)
No special rule for cM1; cannot carry over to path stage 4.
Adapted from AJCC TNM indicators presentation

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.
Clin T: c2A N: c0 M: p1 Stage 4
Path T: Blank N: Blank M: p1 Stage 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
Adapted from AJCC TNM indicators presentation

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:
Symptoms Physical exam
Endoscopies Biopsy 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 Autopsy Stage Post-Therapy Stage Retreatment 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
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 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

19. 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

20. 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?

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

22. T for Tumor Tumor size recorded in mm
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

23. 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

24. N Cont’d Any LN not listed as regional is 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

25. 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

26. Stage Group “Pure” cTNM or pTNM 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

27. Mixed Staging Yikes Purely p) or c) TNM staging for comparisons
EXCEPTION – cM can be combined with pT pN
No pM0 any longer
cM0 used when creating p) group stage
EXCEPTION – pM can be combined with c or p T,N
pTx pNx pM1 = 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 OR cTx cN0 = Group Stage 0

28. 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

29. 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

30. 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)

31. Brief TNM Staging Exercises

32. 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. c3 b. c2A c. Blank d. c4
Answer b. Clinical T2a based on size of tumor from CT chest.
NCRA case 24
Source: Cancer Case Studies, NCRA

33. 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. c2 b. pX c. Blank d. p0
Answer: c. Blank. Case does not meet the requirements for pathologic staging (no resection of primary), so all pathologic elements are blank. Biopsy proven mediastinal node information in clinical N because it was diagnostic, not therapeutic.
NCRA case 24
Source: Cancer Case Studies, NCRA

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.
3. What is the clinical M?
a. c1A b. c0 c. Blank d. cX
Answer: a. c1A based on R pleural effusion and separate lesions in contralateral hilum.
NCRA case 24
Source: Cancer Case Studies, NCRA

35. 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. p4A b. p3 c. pX d. p2
Answer: b. p3 based on rectal tumor extending into pericolonic soft tissue. There is no mention of penetration of a serosal layer, so case cannot be classified as pT4a.
NCRA case 34
Source: Cancer Case Studies, NCRA

36. 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. c4A b. c3 c. cX d. c2
Answer: c. cX. No information about depth of invasion (usually cannot be done on a biopsy).
NCRA case 34
Source: Cancer Case Studies, NCRA

37. 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. p2B b. p1C c. pX d. p2
Answer: a. p2b based on 7 positive lymph nodes.
NCRA case 34
Source: Cancer Case Studies, NCRA

38. 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 pathologic M?
a. c1A b. Blank c. pX d. c0
Answer: d. c0. Exam was negative. When there is a resection that meets the criteria for pathologic T and lymph nodes are also removed, clinical M information can be “carried forward” to complete pathologic staging.
NCRA case 34
Source: Cancer Case Studies, NCRA

39. 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. c1BE b. c1B c. cX d. c1E
Answer: a. c1BE based on B symptoms mentioned in PE and tumor confined to stomach (extralymphatic site) on pathology report.
NCRA case 34

40. 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. p1BE b. p1B c d. p1E
Answer: c Patient did not have staging laparotomy, so pathologic stage group cannot be assigned. Abdominal surgery does not meet criteria for pathologic staging for lymphoma.
NCRA case 34

41. 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. c3 b. c4B c. cX d. c4D
Answer: b. c4B. Erythema and peau d’orange are clinical symptoms of T4b skin involvement.

42. 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. p3 b. p4B c. pX d. p4D
Answer: b. p4B. Erythema and peau d’orange are clinical symptoms of T4b skin involvement. The mastectomy showed only a T3 tumor, but the skin symptoms carry over into the pathologic staging because the case met the requirement for resection of the primary. Pathologic staging includes all clinical information obtained plus examination of the resected specimen.

43. 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 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. cX b. c0 c. c1 d. c1A
Answer: c. c1. There are separate definitions for clinical and pathologic N. Although the single node was positive on excisional biopsy, at that point the status of other lymph nodes is unknown. For this case, the lymph node biopsy was performed prior to resection of the primary so that information goes in clinical N.

44. 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 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. p2 b. p0 c. p1 d. p1A
Answer: d. p1A. There are separate definitions for clinical and pathologic N. Pathologic information includes all examination of tissues, so after the mastectomy there is 1 of 9 nodes positive, which falls in the pathologic N definition of pN1a.

45. 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. p2A b. c2A c. cX d. p2B
Answer: a. p2A. Melanoma clinical staging includes microstaging (removal of primary lesion to determine thickness) mm depth of invasion is T2; no ulceration is T2a. Beyond T1, high mitotic rate does not affect T category.

46. 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. c2A b. c2 c. pX d. Blank
Answer: a. c2a. Also, because the margin was clear, the excision was both diagnostic and therapeutic, so same information can be used for pathologic T.

47. Case Study: Bladder
Transurethral resection of bladder tumor: 0.5 cm papillary tumor at ureteral orifice.
PE and Abdominal Ultrasound: within normal limits
Pathology: Urothelial carcinoma confined to mucosa; no penetration of basement membrane.
1. What is the clinical T?
a. pIS b. cA c. Blank d. cX
Answer: b. cA. Papillary tumor is described in the TURBT report. Although path report calls it just urothelial carcinoma, the combined information makes this non-invasive (no penetration of basement membrane) papillary urothelial carcinoma (Ta), not carcinoma in situ. Because there is a definite statement that the basement membrane has not been penetrated, clinical T classification is possible.
NCRA bladder case 2
Source: Cancer Case Studies, NCRA

48. Case Study: Bladder
Transurethral resection of bladder tumor: 0.5 cm papillary tumor at ureteral orifice.
PE and Abdominal Ultrasound: within normal limits
Pathology: Urothelial carcinoma confined to mucosa; no penetration of basement membrane.
2. What is the pathologic T?
a. pIS b. pA c. Blank d. pX
Answer: c. Blank. This case does not meet the requirement for pathologic staging, which is a radical cystectomy, so all pathologic elements are blank.
NCRA bladder case 2
Source: Cancer Case Studies, NCRA

49. 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. c1B b. c1 c. p1B d. Blank
Answer: c. p1B. Biopsy proven bone metastases are both clinical and pathologic stage group IV when the biopsy is done during workup (diagnostic). pM1 cases can be grouped as both clinical and pathologic stage IV regardless of T and N.
AJCC presentation on new T, N, M indicators, slide 10.

50. 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. 4 b. 4B c. Unknown d. 99
Answer: a. 4 (or IV). Prostate stage IV is not subcategorized like M1. Even without a prostatectomy (pT blank, pN blank), pM1 cases are pathologic stage IV because the highest stage group is documented.
AJCC presentation on new T, N, M indicators, slide 10.

51. 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

52. 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

53. 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

54. Any Questions?