Glossary of Terms

Adjuvant therapy: Cancer treatment used in addition to the main treatment, such as surgery. Adjuvant therapy usually refers to hormonal therapy, chemotherapy, radiation therapy, or immunotherapy added after surgery to increase the chances of curing the disease or minimizing symptoms.

Adjuvant chemotherapy: The use of one or more chemotherapy drugs following the removal of a tumor or after radiotherapy. The aim is to kill any remaining cancer cells.

Apoptosis: A normal cellular process involving a genetically programmed series of events leading to the death of a cell. Referred to as "programmed cell death," this is a process that happens to us all and is essential in order to replace damaged or unneeded cells with new, healthy cells.

Ascites: Abnormal build-up of fluid in the abdomen that may cause swelling. In late-stage cancer, tumor cells may be found in the fluid in the abdomen. Ascites also occur in patients with liver disease.

Assay: A laboratory test to find and measure the amount of a specific substance.

Assay-assisted therapy: A treatment program designed after laboratory analysis of an individual patient's tumor cells. The therapy plan is created taking into consideration the response of patient’s cancer cells to chemotherapy regimens and combinations.

Benign tumor: A tumor or swelling that is not cancerous and remains in its site of origin, and does not invade surrounding tissue or spread throughout the body. Benign tumors that contain normal cells can almost always be removed by surgery.

Biological therapy: The use of the body's immune system, either directly or indirectly, to fight cancer or to lessen side effects that may be caused by some cancer treatments. Also known as immunotherapy, biotherapy, or biological response modifier therapy.

Biological response modifiers: Substances that are used to boost the ability of the immune system to fight disease more effectively. The use of biological response modifiers in the treatment of cancer is an active and promising area of research. Types of biological response modifiers include interferons, interleukins and granulocyte colony-stimulating factor (G-CSF). The use of biological response modifiers is also known as immunotherapy.

Biopsy: A diagnostic test in which cells are removed from the body for examination under the microscope for diagnosis or special testing.

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CA-125: A protein that can be found in the blood and is useful in detecting and evaluating ovarian cancer.

Cancer: A term for diseases characterized by abnormal and uncontrolled growth of cells. The resulting mass, a tumor, can invade and destroy surrounding normal tissues. Cancer cells can spread (metastasize) throughout the body via blood and lymph systems. Cancer can originate almost anywhere in the body.

Cell-growth, proliferation-based assays: Response testing methods that select drugs based upon their ability to stop cell growth or division.

Chemosensitivity: The susceptibility of tumor cells to the cell-killing effects of chemotherapy drugs.

Chemoresponse Assay or Test: A laboratory test that measures the number of tumor cells that are killed by a cancer drug. The test is done after the tumor cells are removed from the body. A chemosensitivity test may help in choosing the best drug or drugs for the cancer being treated.

Chemotherapy: Treatment with anti-cancer drugs that usually act by interfering with the replication of cancer cell DNA, resulting in cancer cell death. There are several different ways drugs can damage cancer cells, and these different mechanisms often define different classes of chemotherapeutic drugs. Advances in the treatment of cancer over the past two decades are due largely to the development and study of chemotherapy.

Chemotherapy Regimen: A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

Clinical trial: A scientific means of evaluating the effectiveness and safety of a treatment, drug, or device in one or more human subjects including surgery, chemotherapy, or radiotherapy. There are different clinical trial phases:
  • Phase I Trial: The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, Phase I trials usually include only a small number of patients who have not been helped by other treatments.
  • Phase II Trial: A study to test if a new treatment has an anticancer effect (for example, shrinks a tumor or improves blood test results) and if it works against a certain type of cancer.
  • Phase III Trial: A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into Phase III only after a treatment seems to work in Phases I and II. Phase III trials may include hundreds of people.
  • Phase IV Trial: After a treatment has been approved and is being marketed, it is studied in a Phase IV trial to evaluate side effects that were not apparent in the Phase III trial. Thousands of people are involved in a Phase IV trial.
Combination chemotherapy: Use of two or more anti-cancer drugs. This approach can enhance the effectiveness of treatment. Combinations of drugs are used to target many types of cancerous cells and prevent or slow the development of resistant cells. A tumor may respond to more than one drug's mechanism of action; therefore a combination of drugs can provide better results.

Combined modality therapy: The use of two or more modes of treatment - surgery, radiotherapy, chemotherapy, immunotherapy—in combination, alternately or together, to achieve optimum results against disease.

Cycle: A predetermined schedule for chemotherapy administration. Some cycles of chemotherapy repeat every 3 weeks, while others repeat every 4 or even 8 weeks. Each cycle consists of a group of drugs given on particular days according to a specific treatment plan.

Cytotoxic: A toxin or antibody that has a special toxic effect on cells (cell-killing).

Cytotoxic Chemotherapy: Anti-cancer drugs that kill cells, especially cancer cells.

Disease: Illness, sickness: an interruption, cessation or disorder of body functions, systems, or organs.

Drug (medical): Any substance, other than food, that is used to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition.

Drug Resistance: The ability of cancer cells to become resistant to the effects of the chemotherapy drugs used to treat cancer. The cells may be resistant to the drug at the beginning of treatment, or may become resistant after being exposed to the drug.

Drug Sensitivity: The assessment of a tissue’s response and vulnerability to a particular drug.

DNA (deoxyribonucleic acid): The carrier of genetic information in a cell. In order to divide, a cell must duplicate DNA. Many chemotherapeutic agents work to block this process, which eventually leads to cell death.

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Efficacy: The ability of a substance to produce the desired effect.

Ex-vivo: A Latin term meaning, 'Outside of the living body'.

First-line treatment: The initial treatment of a disease (see Second-line, below).

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Genotype: The "internally coded, inheritable information" carried by all living organisms. This stored information is used as a "blueprint" or set of instructions for building and maintaining a living creature. These instructions are found within almost all cells (the "internal" part), they are written in a coded language (the genetic code), they are copied at the time of cell division or reproduction, and are passed from one generation to the next ("inheritable"). These instructions are intimately involved with all aspects of the life of a cell or an organism. They control everything from the formation of protein macromolecules, to the regulation of metabolism and synthesis.

Grade [in cancer]: The grade of a cancer reflects how abnormal it looks under the microscope. There are several grading systems for different types of cancer.

Gynecologic Oncology: The study and treatment of cancers of the female reproductive organs.

HER-2/neu: A cancer gene found in some breast and ovarian cancer patients that is associated with a poor prognosis. In about 30% of breast cancers, a specific protein found on the surface of a cancer cell - called Her-2/neu (pronounced 'her two new') - is overexpressed, meaning it is “overactive.” This condition causes cancer cells to multiply.

Herceptin: This is the brand name for the drug trastuzumab, a genetically engineered substance, which attacks breast cancer by interfering with the production of cancerous cells. Herceptin binds to the Her-2/neu protein and prevents cancer cells from multiplying. Recent studies have indicated that a combination of Herceptin plus chemotherapy may prove to be a significant advance in the treatment of breast cancer.

Hormone: A specific substance, secreted by an endocrine gland (eg, the thyroid) into the bloodstream to regulate the functions of tissues and organs elsewhere in the body. Hormones control the actions of certain cells or organs.

Hormone therapy: Treatment that involves removing, blocking or adding hormones. Hormone therapy is sometimes used to treat breast cancer, prostate cancer and other types of cancer as it prevents certain cancer cells from getting the hormones they need to grow.

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Immune system: A complex network of organs, cells, and specialized substances that defend the body from foreign invaders (eg, bacteria, viruses, carcinogens) that cause infection or disease.

Immunotherapy: A method of treating cancer, using substances that stimulate the body's immune defense system to attack cancer cells.

Informed Consent: A legal document used during the consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. This is the process by which patients agree to treatment.

Invasion: Refers to the direct migration and penetration by cancer cells into neighboring tissues.

Investigational new drug: A drug that is authorized for evaluation/study in clinical trials but is not yet approved for the commercial market.

Investigator: An investigator is the experienced clinical researcher—a physician—who prepares and conducts a clinical trial protocol.

In-vitro: A Latin term for “Observable in the laboratory.”

In-vivo: A Latin term for 'Within the living body.”

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Leukemia: Cancers of the immature blood cells that grow in the bone marrow and tend to accumulate in large numbers in the bloodstream. Precision Therapeutics does not currently accept these specimens for testing with ChemoFx®.

Lymphoma: Cancers that arise in the lymph nodes and tissues of the body's immune system. Lymphomas are divided into two categories: Hodgkin's and non-Hodgkin's lymphomas. Precision Therapeutics does not currently accept these specimens for testing with ChemoFx®.

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Malignant: Characterizes cells that can be distinguished from normal cells based on their microscopic appearance, expression of abnormal proteins and capacity to invade and spread to other portions of the body via invasion or metastasis. By definition, the term "cancer" applies only to malignant tumors.

Malignant tumor: A cancerous tumor, which may spread from its original location to invade normal tissues and interfere with organ functions. If it is not treated, abnormal cells may spread through the blood stream or lymphatic system and form a tumor elsewhere in the body.

Malignant effusion: An abnormal fluid collection containing cancerous cells.

Medical Oncologist: A physician who is specially trained to diagnose and treat cancer.

Metastasis: The spread of disease from one part of the body to another. In cancer, metastasis is the migration of cancer cells from the original tumor site through the blood and lymph vessels to produce cancers in other tissues.

Metastatic cancer: Cancer that has spread from its original site to one or more additional body sites.

National Cancer Institute (NCI): A U.S. Government organization that conducts and supports research, training, health information dissemination and other programs relating to the cause, diagnosis, prevention, and treatment of cancer. The NCI is one of the institutes within the National Institutes of Health (NIH) in Bethesda, MD.

Neoadjuvant chemotherapy: Chemotherapy given prior to an operation to shrink the tumor with the aim of reducing the extent of surgery needed.

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Oncology: The branch of medicine concerned with the diagnosis and treatment of cancer.

Oncologist: A Board-Certified medical specialist who specializes in treating cancer patients.

Phenotype: The entire physical, biochemical, and physiological makeup of an individual cell as determined both genetically and environmentally. This is the "outward, physical manifestation" of the organism. These are the physical parts, the sum of the atoms, molecules, macromolecules, cells, structures, metabolism, energy utilization, tissues, organs, reflexes and behaviors; anything that is part of the observable structure, function or behavior of a living organism.

Pleural fluid: A collection of fluid that accumulates in the chest cavity in the space surrounding the lung known as the pleural cavity.

Positive Cancer Response: Clinical benefit from cancer therapy, as measured by objective tests: x-ray, blood markers, etc. A positive or favorable response reflects the measurable shrinkage of disease lasting greater than one month.

Primary Site: The place where cancer begins. Primary cancer is named after the organ in which it starts. For example, cancer that starts in the kidney is always kidney cancer even if it spreads (metastasizes) to other organs such as bones or lungs.

Progression: Disease progression is noted when the tumor size has increased by more than one-quarter or new areas of cancer have been found.

Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial.

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Quality of life: When used as a clinical trial endpoint, quality of life refers to the effect of treatment on a patient's ability to cope with daily life. For example, a treatment that is painful, disturbs sleep, or affects mobility will have an adverse effect on a patient's quality of life.

Radiation: Cancer therapy which refers to beam and non-beam therapy; non-beam therapy includes implants and radioactive isotopes.

Radiotherapy: Treatment using x-rays, cobalt-60, radium, neutrons, or other types of cell-destroying radiation.

Randomized clinical trial: A study in which patients with one or more similar traits (eg, tumor type, gender, age, extent of disease, prior treatment, history, etc.) are arbitrarily distributed into separate groups, each receiving a different treatment regimen. Because the distribution of patients is arbitrary, or random, there is no risk of selection bias. The treatment groups can therefore be considered comparable and the results of the different treatments used in different groups can be directly compared.

Recurrent: Returning after remission, when applied to cancer.

Regression: Describes the shrinkage or disappearance of a cancer.

Relapse: A return of disease symptoms after recovery had apparently been achieved. In cancer patients, this means cancer cells have returned after initial success in eradicating those cells with treatment.

Remission: The decrease or disappearance of evidence of a disease; also the period during which this occurs.

Resistance: The ability of tumor cells to withstand the effects of a chemotherapeutic drug that should normally kill them.

Response rate: A determination of the effectiveness of treatment that usually requires a measurable amount of cancer. A complete clinical response means that a previously measurable cancer has gone away with treatment, and cannot be detected by examination, x-ray or scan. A complete surgical response means that even with a surgical exploration there is no trace of a cancer previously known to be present. A partial response means that the measurable amount of cancer has substantially decreased.

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Sarcomas: Cancers arising from cells found in the supporting tissues of the body such as bone, cartilage, fat, connective tissue, and muscle.

Second-line therapy: Treatment when a patient has failed to respond to first-line therapy (see above).

Sensitivity Tests: Generally refers to the laboratory methodologies applied to measure sensitivity or resistance of cancer cells to drugs.

Side effect: A secondary and usually adverse effect, as from a drug or other treatment. For example, nausea is a side effect of some anti-cancer drugs.

Solid Tumor: An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancerous), or malignant (cancerous). Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Leukemias (cancers of the blood) generally do not form solid tumors.

Staging: The process of determining whether cancer has spread and, if so, how far. There is more than one system for staging.

Standard treatment: A treatment or other intervention currently being used and considered to be of proven effectiveness based on past studies.

Study arm: Patients in clinical trials are assigned to one part or segment of a study “arm.” Each arm receives a different treatment or dose.

Survival: The proportion of patients who survive for a given period of time.

Surgery: Treating diseases or other medical conditions by operating on a patient to remove or repair parts of the body.

Surgical Oncology: Treating cancers by surgically removing tumors.

Tumor: An abnormal lump or mass of tissue. Tumors can be benign (not cancerous) or malignant (cancerous).

Time to progression: The length of time from the first day of randomization into a clinical trial, until the date progression of the disease is first noted.

Toxicity: The degree to which something causes poisonous effects. It refers to the extent to which a drug adversely affects cancer cells as well as healthy tissue. Toxicity is the dose-limiting factor in the administration of most chemotherapeutic agents.

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