Diagnosing/Staging Guidelines
The National Comprehensive Cancer Network (NCCN) publishes guidelines that follow
the American Joint Committee on Cancer (AJCC) system, also known as the TNM (tumor/node/metastasis)
system.
Health care professionals should base treatment decisions for colorectal cancer
on pathologic staging using the TNM classification. The following is a summary of
the staging guidelines outlined by the NCCN. More specifically, you will find:
Stage Grouping1
|
Stage 0
|
Tis
|
N0
|
M0
|
|
Stage I
|
T1
|
N0
|
M0
|
|
T2
|
N0
|
M0
|
|
Stage IIA
|
T3
|
N0
|
M0
|
|
Stage IIB
|
T4a
|
N0
|
M0
|
|
Stage IIC
|
T4b
|
N0
|
M0
|
|
Stage IIIA
|
T1-T2
|
N1/N1c
|
M0
|
|
T1
|
N2a
|
M0
|
|
Stage IIIB
|
T3-T4a
|
N1/N1c
|
M0
|
|
T2-T3
|
N2a
|
M0
|
|
T1-T2
|
N2b
|
M0
|
|
Stage IIIC
|
T4a
|
N2a
|
M0
|
|
T3-T4a
|
N2b
|
M0
|
|
T4b
|
N1-N2
|
M0
|
|
Stage IVA
|
Any T
|
Any N
|
M1a
|
|
Stage IVB
|
Any T
|
Any N
|
M1b
|
TNM Definitions
Primary Tumor (T)1
|
Primary tumor cannot be assessed
|
|
No evidence of primary tumor
|
|
Carcinoma in situ: intraepithelial or invasion of lamina propria*
|
|
Tumor invades submucosa
|
|
Tumor invades muscularis propria
|
|
Tumor invades through the muscularis propria into pericolorectal tissues
|
|
Tumor invades through the muscularis propria into pericolorectal tissues†
|
|
Tumor directly invades or is adherent to other organs or structures†,‡
|
* Tis includes cancer cells confined within the glandular basement membrane (intraepithelial)
or mucosal lamina propria (intramucosal) with no extension through the muscularis
mucosae into the submucosa.
† Direct invasion in T4 includes invasion of other organs or other
segments of the colorectum as a result of direct extension through the serosa, as
confirmed on microscopic examination (for example, invasion of the sigmoid colon
by a carcinoma of the cecum) or, for cancers in a retroperitoneal or subperitoneal
location, direct invasion of other organs or structures by virtue of extension beyond
the muscularis propria (that is, a tumor on the posterior wall of the descending
colon invading the left kidney or lateral abdominal wall; or a mid or distal rectal
cancer with invasion of prostate, seminal vesicles, cervix, or vagina).
‡ Tumor that is adherent to other organs or structures, grossly,
is classified cT4b. However, if no tumor is present in the adhesion, microscopically,
the classification should be pT1-4a depending on the anatomical depth of wall invasion.
The V and L classifications should be used to identify the presence or absence of
vascular or lymphatic invasion, whereas the PN site-specific factor should be used
for perineural invasion.
Back to top
Regional Lymph Nodes (N)1
|
Regional lymph nodes cannot be assessed
|
|
No regional lymph node metastasis
|
|
Metastasis in 1 to 3 regional lymph nodes
|
|
Metastasis in one regional lymph node
|
|
Metastasis in 2–3 regional lymph nodes
|
|
Metastasis in 4 or more regional lymph nodes
|
|
Metastasis in 4–6 regional lymph nodes
|
|
Metastasis in 7 or more regional lymph nodes
|
A satellite peritumoral nodule in the pericolorectal adipose tissue of a primary
carcinoma without histologic evidence of residual lymph node in the nodule may represent
discontinuous spread, venous invasion with extravascular spread (V1/2), or a totally
replaced lymph node (N1/2). Replaced nodes should be counted separately as positive
nodes in the N category, whereas discontinuous spread or venous invasion should
be classified and counted in the Site-Specific Factor category Tumor Deposits (TD).
Back to top
Distant Metastasis (M)1
|
No distant metastasis
|
|
Distant metastasis
|
|
Metastasis confined to one organ or site (for example, liver, lung, ovary, nonregional
node)
|
|
Metastases in more than one organ/site or the peritoneumANATOMIC
|
Back to top
Important Safety Information
Anaphylactic-like reactions to ELOXATIN have been reported and may occur within
minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines
have been employed to alleviate symptoms.
- ELOXATIN should not be administered to patients with a history of known allergy
to ELOXATIN or other platinum compounds. Hypersensitivity and anaphylactic/anaphylactoid
reactions to ELOXATIN have been reported and were similar in nature and severity
to those reported with other platinum compounds (ie, rash, urticaria, erythema,
pruritus, and, rarely, bronchospasm and hypotension). These reactions occur within
minutes of administration and should be managed with appropriate supportive therapy.
Drug-related deaths from this reaction have been reported.
- ELOXATIN may cause fetal harm when administered to a pregnant woman. Women of childbearing
potential should be advised not to become pregnant while receiving ELOXATIN. It
is not known whether ELOXATIN or its derivatives are excreted in human milk.
- ELOXATIN has been associated with pulmonary fibrosis (<1% of study patients),
which may be fatal. The combined incidence of cough and dyspnea was 7.4% (<1%
grade 3, no grade 4) in the ELOXATIN plus 5-FU/LV arm compared to 4.5% (no grade
3, 0.1% grade 4) in the 5-FU/LV alone arm in the adjuvant colon cancer study. In
this study, one patient died from eosinophilic pneumonia in the ELOXATIN combination
arm. The combined incidence of cough, dyspnea, and hypoxia was 43% (7% grade 3 and
4) in the ELOXATIN plus 5-FU/LV arm compared to 32% (5% grade 3 and 4) in the irinotecan
plus 5-FU/LV arm in patients with previously untreated colorectal cancer. In case
of unexplained respiratory symptoms, ELOXATIN should be discontinued until pulmonary
investigation excludes interstitial lung disease or pulmonary fibrosis.
- ELOXATIN is associated with two types of primarily peripheral sensory neuropathy:
an acute, reversible type of early onset and a persistent type (>14 days). In
patients with advanced colorectal cancer paresthesias occurred in 77% (all grades)
and 18% (grade 3/4) of previously untreated patients. In previously treated patients,
acute neuropathy occurred in 56% (all grades) and 2% (grade 3/4) of patients; persistent
neuropathy occurred in 48% (all grades) and 6% (grade 3/4) of patients. In patients
with stage II and III colon cancer, paresthesia was seen in 92% (all grades) and
13% (grade 3/4) of patients; 21% (all grades), 0.5% (grade 3/4) had residual paresthesia
at 18-month follow-up.
- Hepatotoxicity, as evidenced in the adjuvant study by increase in transaminases
and alkaline phosphatase was observed more commonly in the ELOXATIN combination
arm. The incidence of increased bilirubin was similar on both arms. Changes noted
on liver biopsies include: peliosis, nodular regenerative hyperplasia or sinusoidal
alterations, perisinusoidal fibrosis and veno-occlusive lesions. Hepatic vascular
disorders should be considered and, if appropriate, investigated in case of abnormal
liver function test results or portal hypertension not explained by liver metastases.
- Monitoring of white blood cell count with differential, hemoglobin, platelet count
and blood chemistries (including ALT, AST, bilirubin and creatinine) is recommended
before each ELOXATIN cycle.
- The safety and effectiveness of ELOXATIN plus 5-FU/LV in patients with renal impairment
have not been evaluated. Since the primary route of platinum elimination is renal,
this combination should be used with caution in patients with preexisting renal
impairment. Clearance of these products may be decreased by coadministration of
potentially nephrotoxic compounds, although this has not been specifically studied.
- The incidence of diarrhea, dehydration, hypokalemia, leukopenia, fatigue and syncope
were higher in patients ≥65 years old.
- Extravasation may result in local pain and inflammation that may be severe and lead
to complications, including necrosis. Injection site reaction, including redness,
swelling and pain, has been reported.
- There have been reports of prolonged prothrombin time and INR occasionally associated
with hemorrhage in patients receiving ELOXATIN plus 5-FU/LV while on anticoagulants.
Patients receiving ELOXATIN plus 5-FU/LV and requiring oral anticoagulants may require
closer monitoring.
- The most common adverse reactions in patients with stage II or III colon cancer
receiving adjuvant therapy were peripheral sensory neuropathy, neutropenia, thrombocytopenia,
anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis,
fatigue, and stomatitis. The most common adverse reactions in patients with advanced
colorectal cancer were peripheral sensory neuropathy, fatigue, neutropenia, nausea,
emesis, and diarrhea.
Please
click here for full prescribing information including boxed WARNING »
Reference
- American Joint Committee on Cancer Web site, Staging Resources section, Colon and Rectum Poster. "AJCC Cancer Staging Seventh Edition: Colon and Rectum Cancer Staging." Available at: http://www.cancerstaging.org/staging/index.html. Accessed April 22, 2011.
