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Glossary

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Adenocarcinoma
Carcinoma derived from glandular tissue or in which the tumor cells form recognizable glandular structures.

Adenoma
A benign epithelial tumor in which the cells form recognizable glandular structures or in which the cells are clearly derived from glandular epithelium.

Adenomatous
Pertaining to adenoma.

Adjuvant therapy
Treatment used in addition to the main treatment. It usually refers to hormonal therapy, chemotherapy, radiation therapy, or immunotherapy added after surgery to increase the chances of keeping the disease in check.

Anemia
Lower than normal red blood cell count; a possible side effect of chemotherapy.

Antiemetics
A medication that helps decrease or prevent nausea and vomiting.

Biologicals
Medicinal preparations made from living organisms and their products, including serums, vaccines, antigens, cell regulators and antitoxins. Rapidly growing, increasingly complex and sophisticated, biological products and technologies are life-saving components of medicine worldwide.

Biological therapy
Uses medicines made from living organisms to fight cancer.

Biopsy
The removal and examination of tissue from the living body, performed to establish precise diagnosis.

Cancer
Diseases characterized by abnormal and uncontrolled cell division. Cancer cells can attack tissues in the body and possibly spread to other parts of the body. There are many different kinds of cancer.

Carcinoembryonic antigen (CEA)
A substance normally found in fetal tissue. If found in an adult, it may suggest that a cancer, especially one starting in the digestive system, may be present. Tests for this substance may help in finding out if colorectal cancer has come back after treatment. The test is not helpful for screening for colorectal cancer because of the large number of false positives and false negatives.

Carcinoma in situ
Describes a condition in the earliest stage, also known as precancerous, or stage 0.

Catheter
A tubular, flexible, surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid.

Chemotherapy
Type of cancer treatment using drugs to destroy cancer cells.

Colon
The first and longest part of the large intestine.

Colon cancer
Cancer of the colon tissue.

Colonoscopy
A procedure to screen for cancer, in which a flexible tube is placed in the rectum into the colon so the doctor can see the entire colon.

Colorectal cancer
Cancer of the colon and/or rectum.

Colostomy
An opening in the abdomen used to rid the body of waste; sometimes needed after surgery for cancer of the rectum (usually temporarily).

Combination chemotherapy
Treatment consisting of the use of two or more chemicals to achieve maximum kill of tumor cells.

Comorbidity
The condition of having two or more diseases at the same time. Generally used with cancer patients to refer to conditions not related to the cancer.

CT scan
A computer-assisted X-ray technique. A CT scan can show where metastases are and help an oncologist, surgeon, and radiologist decide together how best to treat cancer.

Cytotoxic
Pertaining to or exhibiting cytotoxicity.

Cytotoxicity
The degree to which an agent possesses a specific destructive action on certain cells.

Dehydrated
Condition that occurs when the body loses too much water. Dehydration can be caused by severe diarrhea or vomiting.

Digestive system
The organs (salivary glands, mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines, and rectum) that turn food into energy for the body and allow waste products to leave the body through bowel movements.

Disease-free survival
The time following treatment in which no cancer is detected in the body.

Digital rectal exam (DRE)
A test in which a doctor or nurse uses a gloved finger to feel the lower part of the rectum for abnormal areas.

Diverticulosis or Diverticulitis
A condition that occurs in organs like the stomach or colon when small pouches or sacs (diverticula) in the organ walls become inflamed. Diverticulitis may be a risk factor of certain cancers.

Double-contrast barium enema (DCBE)
A DCBE is a series of X-rays of the colon and rectum. The patient is given an enema with a barium solution, and air is pumped into the rectum. The barium and air outline the colon and rectum on the X-rays. Polyps may show up on the X-rays.

Dysesthesia
Condition that distorts the senses – usually touch. Normal stimuli, such as a light touch, may feel unpleasant or painful to someone with dysesthesia.

Endorectal ultrasound (EUS)
A procedure in which an endoscope (a thin, lighted tube) is inserted into the body and used to bounce high-energy sound waves (ultrasound) off internal organs to make a picture (sonogram). Also called endosonography.

Fecal occult blood test (FOBT)
A test used to screen for colorectal cancer, in which a stool sample is examined for blood.

Familial adenomatous polyposis (FAP)
FAP is caused by a change in a specific gene called APC and accounts for less than 1% of all colorectal cancer cases.

First-line therapy
In patients with cancer, it can be surgery, chemotherapy, radiation therapy, or a combination of these therapies.

Flexible sigmoidoscopy
A test to screen for cancer, in which a lighted tube is placed in the rectum so the doctor can look inside.

Gastrointestinal or digestive system
Pertaining to or communicating with the stomach or intestine.

Hand-foot syndrome
A condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet. It sometimes occurs as a side effect of certain anticancer drugs.

Hereditary nonpolyposis colon cancer (HNPCC)
Accounts for about 2% of all colorectal cancer cases and is caused by changes in a specific gene.

Immunotherapy
A general term encompassing active and passive immunization. Treatment with immunopotentiators and immunosuppressants.

Inflammatory bowel disease (IBD)
A general term to describe conditions that cause the colon and rectum to become inflamed. Conditions within IBD include Crohn’s disease and ulcerative colitis.

Infusion
A method of putting fluids, including drugs, into the bloodstream.

Irritable bowel syndrome (IBS)
A colon disorder involving diarrhea, constipation, diarrhea alternating with constipation, abdominal bloating, abdominal pain or discomfort, and passing mucus in the stool.

K-ras test
A test done on a tissue sample from a tumor in a lab. It can tell whether or not the tumor is likely to respond to certain biologic therapies.

Leukopenia
Lower than normal white blood cell count; a possible side effect of chemotherapy.

Liver metastases
The spread of cancerous tumors from a distant organ to the liver.

Liver resection
Surgery to remove a diseased or cancerous portion of the liver. In some mCRC patients, a liver surgeon can remove metastases, improving the patient’s prospects.

Local therapy
A treatment that affects cancer cells and the area close to the tumor.

Lymph nodes
Small bean-shaped collections of immune system cells that help fight infections and also have a role in fighting cancer. Also called lymph glands. Cancers of the colon and rectum may spread to regional (nearby) lymph nodes.

Metastasis
A process that takes place in advanced cancer, in which cancer spreads from the primary site to other parts of the body.

Metastatic
When cancer has spread from one body part to another.

Neoadjuvant therapy
Treatment given before primary treatment, such as chemotherapy before surgery.

Neuropathy
Nerve condition that affects nerve function (parts of the nervous system besides the brain and spinal cord). Neuropathy causes pain, tingling, numbness, swelling and muscle weakness. Injury, infection, toxic substances, drugs (such as anticancer drugs), or diseases (such as cancer, diabetes, kidney failure or malnutrition) can cause neuropathy.

Neurotoxicity
The tendency of some treatments to cause damage to the nervous system.

Neutropenia
An abnormally low number of a particular type of white blood cell, which can sometimes be a side effect of chemotherapy. Neutropenia increases a patient’s susceptibility to infection.

Palliative care
Also called supportive care or symptom management, treatment not to cure cancer but instead to improve the quality of life of patients who have serious or life-threatening diseases.

PET scan
A procedure in which small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used.

Polyp
A small growth of tissue on the lining of the colon or rectum that can sometimes become cancerous.

Polypectomy
Surgery performed to remove a polyp (organ growth that may develop into cancer, such as those found in the colon and rectum).

Polyposis
The development of multiple polyps.

Radiation or radiotherapy
The use of X-rays to kill cancer cells.

Rectum
The last several inches of the large intestine.

Resection surgery
Surgery performed to remove tissue in an organ, part of an organ (segmental resection), or an entire organ.

Second-line therapy
Treatment that is given when initial treatment (first-line therapy) is not working.

Segmental resection
Surgery performed to remove part of an organ.

Sigmoidoscopy
A procedure in which a doctor can look into the rectum and the descending portion of the colon for polyps or other abnormalities.

Staging
A way to describe how advanced cancer is; helps a doctor forecast how well a cancer patient may do over time and how to best treat a patient.

Syncope
A loss of consciousness resulting from insufficient blood flow to the brain.

Systemic therapy
Treatment that enters the bloodstream and can affect cells all over the body.

Thrombocytopenia
A lower than normal platelet count that results in increased risk of bleeding; a possible side effect of chemotherapy.

INDICATIONS

Eloxatin® (oxaliplatin injection), used in combination with infusional 5-FU/LV, is indicated for

  • Adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor.
  • Treatment of advanced carcinoma of the colon or rectum.

Clinical Safety Considerations

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.

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