BioOncology Glossary of Terms adjuvant therapy: Treatment given after the primary therapy, usually surgery. Adjuvant therapy for cancer may include immune therapy, chemotherapy, radiation therapy or hormone therapy.

angiogenesis: Blood vessel formation. Angiogenesis that occurs in cancer is the growth of blood vessels from surrounding tissue to a solid tumor. This is caused by the release of chemicals by the tumor, which activates normal angiogenic pathways.

angiogenesis inhibitor: A substance that may prevent the formation of blood vessels. In anti-cancer therapy, an angiogenesis inhibitor prevents the growth of blood vessels from surrounding tissue to a solid tumor.

anti-angiogenesis: Prevention of the growth of new blood vessels.

antibody therapy: Treatment with an antibody, a substance that can directly kill specific tumor cells or stimulate the immune system to kill tumor cells.

antigens: Substances that cause the immune system to make a specific immune response. An example would be a murine antibody, which is derived solely from mouse proteins and therefore is viewed as foreign by the host body.

apoptosis: A normal series of events in a cell that leads to its death.

B-cells/B lymphocytes: White blood cells that make antibodies and are an important part of the immune system.

bone marrow: The soft, sponge-like tissue in the center of bones that produces white blood cells, red blood cells, and platelets.

bone marrow toxicity: The destruction of bone marrow using radiation or drugs.

breast cancer: A malignant tumor that has developed from cells in the breast. It is the most common form of cancer in women and is the second-leading cause of cancer death in women, exceeded only by lung cancer.

chimeric antibody: Refers to the fact that the antibody is made of sequences from two different species, usually human and mouse sequences and usually a 70/30 split, respectively.

colon: The long, coiled, tube-like organ that removes water from digested food. The colon separates nutrients and waste from food and stores the latter until it can be passed from the body.

colorectal cancer: A disease in which malignant (cancer) cells are found in the colon or rectum.

combination therapy: Treatment using more than one anti-cancer drug.

complete remission: The disappearance of all detectable signs of cancer. Also called a complete response.

complete response: The disappearance of all detectable signs of cancer in response to treatment. This does not mean the cancer has been cured.

concurrent/concomitant therapy: A treatment that is given at the same time as another.

consolidation therapy: Chemotherapy treatments given after induction chemotherapy to further reduce the number of cancer cells.

disease-free survival: Length of time after treatment during which no cancer is found. Can be reported for an individual patient or for a study population.

disease progression: Cancer that continues to grow or spread.

double blind: A clinical trial in which the method for analyzing data had been specified in the protocol before the study has begun (prospective), the patients have been randomly assigned to receive either the study drug or alternative treatment, and in which neither the patient nor the physician(s) conducting the study know which treatment is being given to the patient.

duration of response: Refers to the length of time between anticancer treatments where a patient's cancer shrinks, disappears, or remains stable.

EGFR: Epidermal growth factor receptor. The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor. Also known as ErbB1 or HER1.

extensive-stage small cell lung cancer: Cancer that has spread outside the lung to other tissues in the chest or to other parts of the body.

first-line therapy: The first therapy given in the treatment for cancer" then "Fast Track status: Under the FDA Modernization Act of 1997, the Fast Track Program of the FDA is designed to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential, of a drug candidate, to address unmet medical needs for such a condition." then "hazard ratio: A summary of the difference between two survival curves, representing the reduction in the risk of death on treatment compared to control. A control experiment is an experiment where the variable that is being investigated is kept constant.

growth factors: Substances made by the body that function to regulate cell division and cell survival. Some growth factors are also produced in the laboratory and used in biological therapy.

HER1 (human epidermal growth factor receptor-1): See definition of EGFR.

HER2 (human epidermal growth factor receptor-2): HER2 is another component of the HER/EGFR signaling pathway. The HER2 gene is responsible for making HER2 protein. When two copies of the gene are present in normal amounts, the protein plays an important role in normal cell growth and development. At abnormally high levels, HER2 may contribute to the uncontrolled growth of tumor cells (see HER2 overexpression).

HER2 overexpression: A genetic alteration in the HER2 gene that produces an increased amount of the growth factor receptor protein on the tumor cell surface, causing cells to divide, multiply and grow more rapidly than normal. Women whose breast cancers overexpress the HER2 protein are likely to have a more aggressive type of breast cancer with a poorer prognosis, shorter time to disease progression, increased relapse rate, shortened survival and disease that is not as responsive to standard therapies, including certain chemotherapy regimens.

HER2 tumor marker test: Detects overproduction of HER2 protein and/or gene amplification, both of which contribute to aggressive growth of the cancer and its spread to other parts of the body. HER2 overexpression occurs in approximately 25 percent of women with breast cancer.

humanized antibody: The antibody contains over 90 percent human material.

immune response: The activity of the immune system against foreign substances (antigens). This type of response can occur in response to viral or bacterial infections or in response to the presence of a foreign protein, such as when a mouse or murine antibody is administered.

induction therapy: Treatment designed to be used as a first step toward shrinking the cancer and in evaluating response to drugs and other agents. Induction therapy is followed by additional therapy to eliminate whatever cancer remains.

irreversible toxicity: Side effects caused by toxic substances or something harmful to the body that do not go away.

limited-stage small cell lung cancer: Cancer found in one lung and in nearby lymph nodes.

maintenance therapy: Scheduled retreatment that is given to help a primary (original) treatment keep working. Maintenance therapy is often given to help keep cancer in remission or prolong a response to a specific therapy regardless of disease progression.

median survival: In a clinical trial, the time at which half of the patients enrolled in the study are still alive. This is often an efficacy endpoint in large, Phase III clinical trials.

metastasis: The spread of cancer from one part of the body to another. Tumors formed from cells that have spread are called "secondary tumors" and contain cells that are like those in the original (primary) tumor. The plural is metastases.

metastasize: To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor.

murine (mouse) antibody: The antibody is derived solely from mouse proteins and is viewed as foreign by the body.

neo adjuvant: Initial treatment which is not the primary therapy, for instance chemotherapy or radiation prior to surgery. Often administered in instances of locally advanced disease in the hope that the size of the tumor is reduced in order that it might be surgically removed." then "New Drug Application (NDA): the vehicle through which drug sponsors formally propose that the U.S. Food and Drug Administration approve a new pharmaceutical for sale and marketing. The data gathered during pre-clinical studies and clinical trials, as well as manufacturing specifications of an Investigational New Drug are part of the NDA filing.

non-Hodgkin's lymphoma: A cancer that develops in the lymphatic system. A vital part of the immune system, the lymphatic system is a network of thin vessels that branch into tissues throughout the body to help fight disease and infection.

non-small cell lung cancer: A group of lung cancers that includes squamous cell carcinoma, adenocarcinoma, and large cell carcinoma.

overall survival: The percentage of subjects in a study who have survived for a defined period of time. Usually reported as time since diagnosis or initial treatment. Often called the survival rate.

partial response: A decrease in the size of a tumor, or in the extent of cancer in the body has regressed by more than 50 percent in response to anticancer treatment.

Pilot 1: Under the FDA's Continuous Marketing Approval program, the Pilot 1 program allows applicants submitting New Drug Applications (NDAs) to submit portions of their marketing applications (reviewable units) before submitting the complete marketing application. The FDA has agreed to complete reviews of these reviewable units within a specified period of time and to provide early feedback for the pre-submissions. Pilot 1 also will evaluate the benefits and costs of providing applicants with such early review feedback.

Pivotal trial: A controlled trial to evaluate the safety and efficacy of a drug in patients who have the disease or condition to be treated. These trials usually represent the most rigorous demonstration of the therapeutic's efficacy and safety, and are the basis for the NDA filing with the FDA.

Priority Review: is a designation for an application after it has been submitted to the FDA for review for approval of a marketing claim. Under the food and Drug Administration Modernization Act (FDAMA), reviews for New Drug Applications are designated as either Standard or Priority. A Standard designation sets the target date for completing all aspects of a review and the FDA taking an action on the application (approve or not approve) at 10 months after the date it was filed. A Priority designation set the target date for the FDA action at six months. A Priority designation is intended for those products that address unmet medical needs.

placebo-controlled: Refers to a clinical study in which the "control" patients receive a placebo. The experience of the control group of patients is compared with that of the patients who received the investigational drug to determine the safety and efficacy of the therapy being studied.

Progression-free survival: This term defines the length of time during and after treatment that the cancer does not grow. Progression-free survival includes the amount of time patients have experienced a complete response or a partial response, as well as the amount of time patients have experienced stable disease.

Progressive disease: Progressive disease is defined in clinical trials as tumor growth of more than 20 percent since treatment began. Tumor growth means that the tumor is getting bigger, but it may also mean that the tumor is spreading. Progression generally indicates that treatment has stopped working. The bottom line is that your cancer is getting worse.

p value: A measure of probability that a difference between groups during an experiment happened by chance. For example, a p-value of .01 (p=.01) means that there is a 1 in 100 chance the result occurred by chance. The lower the p-value, the more likely it is that the difference between groups was caused by treatment.

radioimmunotherapy: Treatment with a radioactive substance that is linked to an antibody, usually a mouse antibody.

radioisotope: An unstable element that releases radiation as it breaks down. Radioisotopes can be used in imaging tests or as a treatment for cancer.

radiolabeled: Any compound that has been joined with a radioactive substance.

radiotherapy: The use of high-energy radiation from x-rays, neutrons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy) or from materials called radioisotopes. Radioisotopes produce radiation and can be placed in or near the tumor or in the area near cancer cells. This type of radiation treatment is called internal radiation therapy, implant radiation, interstitial radiation, or brachytherapy. Systemic radiation therapy uses a radioactive substance, such as a radiolabeled antibody, that circulates throughout the body. Radiotherapy is also called radiation therapy, irradiation, and x-ray therapy.

recurrence/relapse: The return of cancer after the tumor has disappeared.

refractory: Cancer that has not responded to treatment.

response rate: The percentage of patients whose cancer shrinks more than 50 percent or disappears after treatment.

retreatment: Treatment that is given again to help a patient who has not responded completely to previous rounds of therapy after a recurrence of signs and symptoms of a cancer that had been in remission.

second-line treatment: Treatment that is given after the cancer has not responded to a first course of therapy or a patient ceases first-line of therapy.

salvage therapy: Treatment that is given after the cancer has not responded to other treatments.

small cell lung cancer: A type of lung cancer in which the cells appear small and round when viewed under the microscope.

squamous cells: Flat cells that look like fish scales under a microscope. These cells cover internal and external surfaces of the body.

squamous cell carcinoma: Cancer that begins in squamous cells, which are thin, flat cells resembling fish scales. Squamous cells are found in the tissue that forms the surface of the skin, the lining of the hollow organs of the body, and the passages of the respiratory and digestive tracts.

stable disease: A tumor may shrink, but not enough to be categorized as a partial response (that is, tumor reduction greater than 50 percent). Or a tumor may increase in size, but not enough to be considered progressive disease (that is, tumor growth greater than 20 percent). Such tumors, in which there is no significant change in size, are classified as stable disease.

stage IIIB NSCLC: Cancer has spread to structures near the lung; to the lymph nodes in the area that separates the two lungs (mediastinum); or to the lymph nodes on the other side of the chest, or in the lower neck. Stage III is further divided into stage IIIA (usually can be resected and is sometimes treated with surgery) and stage IIIB (usually cannot be resected and is rarely treated with surgery).

stage IV NSCLC: Cancer has spread to other parts of the body or to another lobe of the lungs.

standard therapy: A currently accepted and widely used treatment for a certain type of cancer, based on the results of past research and FDA approval.

symptom deterioration: A deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression.

targeted therapy: A type of treatment that uses drugs or other substances to identify and attack specific cancer cells while limiting affect on normal cells.

therapeutic antibodies: Laboratory-produced substances that can locate and bind to specific cancer cells wherever they are in the body. Many therapeutic antibodies are used in cancer detection or therapy; each one recognizes a different protein on certain cancer cells. Therapeutic antibodies can be used alone, in combination with other therapies, or they can be used to deliver drugs, toxins, or radioactive material.

third-line treatment: Treatment that is given after the cancer has not responded to a second course of therapy or a patient ceases second-line of therapy.

tyrosine kinase activity: A large group of enzymes important in cell growth, differentiation and development.

tumor marker testing: Tumor marker testing includes a variety of tests for breast cancer that can be performed on cells of a tissue sample from a newly biopsied or stored tumor, providing the patient and oncologist with vital information about the tumor at the cellular level and expanding traditional pathology reports based primarily on tumor size, appearance and staging of the disease.

VEGF (vascular endothelial growth factor): A protein that is secreted by oxygen-deprived cells, such as cancerous cells. VEGF stimulates new blood vessel formation, or angiogenesis, by binding to specific receptors on nearby blood vessels, encouraging new blood vessels to form.

Glossary of terms was adapted from the National Cancer Institute Dictionary of Cancer Terms located at www.cancer.gov.