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Biological therapy is a relatively new addition to the family of cancer treatments that also includes surgery, chemotherapy, and radiation therapy. Biological therapies use the body's immune system, either directly or indirectly, to fight cancer or to lessen the side effects that may be caused by some cancer treatments (1).
Biological Therapy is a treatment that works with immune system. It can help to fight cancer or helps control side effects from other treatments like chemotherapy (2).
In other words, any form of treatment that use body's natural abilities to stimulate or restore the ability of immunologic response against the infection and disease is called biotherapy.
Biotherapy also called biological therapy, immunotherapy or biological response modifier therapy.
Biological response modifiers
Biological response modifiers (BRM) are the substances use in biotherapy. They are naturally occur in the body and can be produced in the laboratory (1).
BRMs alter the interaction between the body's immune defenses and cancer cells to encourage, either directly or indirectly, or restore the body's ability to fight the disease (1). Physicians are not sure how biological therapy helps immune system fight cancer. But they think it may:
â€¢ Stop or slow the growth of cancer cells.
â€¢ Make it easier for immune system to destroy, or get rid of, cancer cells.
â€¢ Keep cancer from spreading to other parts of the body (1).
Biological therapy has become an important weapon for the treatment of a variety of diseases. Because of their action, they are most commonly used for the treatment of cancer and immune-related disorders.
Treatments for cancer
Cancer is treated in several ways, depending on each person's medical condition, type of cancer, and how far it has spread. Common treatments involve chemotherapy and radiation therapy. Other treatments include surgery and biological therapies.
For many people with cancer, treatment is a process that is designed to meet their needs. Physicians plan treatments based on several key factors, such as the type and stage of the cancer, as well as the person's age, health, and lifestyle (3).
Common treatments for cancers are chemotherapy and radiation therapy; other treatments include surgery and biological therapies.
Chemotherapy is the use of potent drugs to destroy cancer cells and is a systemic therapy that it circulates through the bloodstream and affects all parts of the body.
Unfortunately, chemotherapy also affects healthy cells; this accounts for its well-known side effects. The side effects of chemotherapy depend on to a degree the drugs used and the doses.
The most common side effects of chemotherapy include;
suppression of blood counts, which could result in increased susceptibility to infection (low white blood cell count)
anemia (low red blood cell count)
blood-clotting problems (low platelet count)
loss of appetite
sores in the mouth
Changes in fingernails and toenails (4).
The difference between biotherapy and chemotherapy
Biological therapy and chemotherapy are both treatments that fight cancer. While they may seem alike, they work in different ways. Biological therapy helps immune system fight cancer. Chemotherapy attacks the cancer cells directly (5).
High energy rays are used in radiation therapy to destroy cancer cells. This therapy is used target areas of the body involved by tumor masses; hence it is considered as a local therapy.
The radiation is targeted at the affected lymph node region or organ. Infrequently, nearby areas are also irradiated to destroy any cells that might have spread their unobserved.
Radiation therapy can cause irritation and inflammation in the tissues and organs in the path of the radiation beam. . Radiation therapy may damage normal cells, in addition to the cancerous cells. This damage to the normal cells may cause side effects (6).
Side effects of radiation therapy are as follows,
Hair loss ( alopecia)
Blood cell count decreasing
Biotherapy as a treatment of cancer
For some people, biological therapy is the best selection and as well as it can be the only treatment that patient need. Others are treated with chemotherapy and radiation treatment while they get this type of treatment.
Types of biotherapy
Biologic therapy refers to a various group of drugs that act straightly on the immune system. Biologics are proteins and these proteins can be divided into categories based on their type or their intended effect.
E.g. Type- monoclonal antibody (mAB)
Effect- tumor necrosis factor (TNF) inhibitor
Biological therapies include interferons, interleukins, colony-stimulating factors, monoclonal antibodies, vaccines, gene therapy, and nonspecific immunomodulating agents.
There are three types of biological therapies by considering how they act with the immune system (7).
Immunotherapy - immunotherapy helps repair, stimulate, or enhance the body's natural ability to fight cancer. Cancer vaccines, interferons, interleukin-2 treatments are examples of immunotherapy.
Targeted therapy -Targeted therapy uses non-chemotherapy drugs to target specific cancer cells. Unlike chemotherapy, targeted therapy spares normal cells and may reduce the side effects of other therapies.
Anti- angiogenesis - The formation of new blood vessels (angiogenesis) in a tumor is prevented by anti-angiogenesis. Because tumors need to develop blood vessels to grow or spread, this therapy helps stop them from growing.
There is another type of categorization as follows,
Nonspecific immunomodulating agents - Nonspecific immunomodulating agents are biological therapy drugs that stimulate the immune system, causing it to produce more cytokines and antibodies to help fight cancer and infections in the body. Fighting infection is important for a person with cancer.
E.g. bacillus Calmette-Guerin (BCG), levamisole
Biological response modifiers - BMRs are change the way the body's defenses interact with cancer cells as described above. BRMs include interferons, interleukins, colony-stimulating factors, monoclonal antibodies, cytokine therapy, and vaccines (6).
Interferons (IFN) - Interferons are naturally occuring citokines that mediate the cellular immune response (4). They are also produced in the laboratory and given to cancer patients in biological therapy. They have been shown to improve the way a cancer patient's immune system acts against cancer cells. Interferons may work directly on cancer cells to slow their growth, or they may cause cancer cells to change into cells with more normal behavior. Some interferons may also stimulate natural killer cells (NK) cells, T cells, and macrophages - types of white blood cells in the bloodstream that help to fight cancer cells.
Three major types are present, interferon alpha, interferon beta, interferon gamma. Interferon alpha is the type broadly used in cancer treatment.
Interleukins (IL) - The human body produce 37 different types of endogenous interleukins. Interleukins stimulate the growth and activity of many immune cells. They are proteins (cytokines) that occur naturally in the body, but can also be made in the laboratory. Some interleukins stimulate the growth and activity of immune cells, such as lymphocytes, which work to destroy cancer cells (8).
Many interleukins have been identified. Interleukin-2 has been generally studied in cancer treatment.
Colony-stimulating factors (CSFs) - Colony-stimulating factors are proteins given to patients to encourage stem cells within the bone marrow to produce more blood cells. The body constantly needs new white blood cells, red blood cells, and platelets, especially when cancer is present. CSFs are given, along with chemotherapy, to help boost the immune system. When cancer patients receive chemotherapy, the bone marrow's ability to produce new blood cells is suppressed, making patients more prone to developing infections. Parts of the immune system cannot function without blood cells, thus colony-stimulating factors encourage the bone marrow stem cells to produce white blood cells, platelets, and red blood cells. With proper cell production, other cancer treatments can continue enabling patients to safely receive higher doses of chemotherapy (8).
E.g. Erythropoietin, Interleukin- 11, G- CSF (filgrastim), GM- CSF (sargramostin)
Monoclonal antibodies - Monoclonal antibodies are agents which produced in the laboratory, that bind to cancer cells. When cancer-destroying agents are introduced into the body, they seek out the antibodies and kill the cancer cells. Monoclonal antibody agents do not destroy healthy cells.
E.g. Rituxan, Herceptin, Trastuzumab
Cytokine therapy - Cytokine therapy helps the immune system recognize and destroy cancerous cells by using proteins (cytokines). Cytokines are produced naturally in the body by the immune system, but can also be produced in the laboratory. Endothelial cells, macrophages, mast cells, lymphocytes, and fibroblasts are the cells in the immune system which produce cytokines. This therapy is used with advanced melanoma and with adjuvant therapy (therapy given after or in addition to the primary cancer treatment). Cytokine therapy reaches all parts of the body to kill cancer cells and prevent tumors from growing (8).
Vaccine therapy - This type is still an experimental biological therapy and the benefit of vaccine therapy has not yet been proven. With infectious diseases, vaccines are given before the disease develops. Cancer vaccines, however, are given after the disease develops, when the tumor is small. Scientists are testing the value of vaccines for melanoma and other cancers. Sometimes, vaccines are combined with other therapies such as cytokine therapy (6).
Gene therapy is an experimental treatment and introducing genetic material into a patient's cell to fight the disease is involved. Gene therapy methods that can improve a patient's immune response to cancer are still studied by researchers. For example, a gene may be inserted into an immune cell to enhance its ability to recognize and attack cancer cells. In another advance, cancer cells are injected with genes that cause the cancer cells to produce cytokines and stimulate the immune system. A number of clinical trials are currently studying in gene therapy and its potential application to the biological treatment of cancer (1).
Applications of biotherapy types
Advanced breast cancer- Three main biological therapies are used in patients who have advanced breast cancer; trastuzumab, bevacizumab, lapatinib (9). Many more biological therapies are expected to gain a license for the treatment of advanced breast cancer over next few years.
Trastuzumab and Bevacizumab are monoclonal anti bodies and Lapatinib is an oral agent which effect tumor growth. Currently, trastuzumab is the only one of these agents recommended by NICE for use in the NHS in England and Wales, for patients with advanced breast cancer, in combination with chemotherapy (9).
Non- Hodgkin's lymphoma- This is the most common hematologic cancer in adults.
Monoclonal antibody therapy is used to treat non- Hodgkin's lymphoma and Rituxan is the drug which was approved by the Food and Drug Administration (FDA) (10). The benefits of interleukin is continued to study with this type of lymphoma by researchers (11).
Bladder tumor / bladder cancer- Intravesical BCG treatment is one of the biological therapies widely used in bladder cancer (12). A fluid containing BCG, a weaken vaccine, is introduced into bladder through a thin catheter that has been passed through the urethra. Altered Mycobacterium is included in the attenuated vaccine and the Mycobacterium in the fluid stimulates the immune system to produce cancer-fighting substances (12).
The solution is held in the bladder for a few hours, and then drained. This treatment is repeated every week for six weeks and repeated at various times over several months or even longer in some cases.
Rheumatoid arthritis- Rheumatoid arthritis is a systemic autoimmune disease that affects approximately 1% of population (13). It is characterized by chronic inflammation in the synovial membrane of affected joints and eventually leads to loss of daily function due to chronic pain and fatigue. The greater part of patients also has corrosion of cartilage and bone in the affected joints that ultimately leads to eternal disability.
Rituximab provides significant improvements for patients with active rheumatoid arthritis. Rituximab is a monoclonal antibody and single short course of rituximab, either alone or in combination with cyclophosphamide or continuing methotrexate, provided patients in substantial improvements in disease symptoms (13).
Metastatic melanoma / renal cell cancer- Effective chemotherapies are not available for the patients with metastatic melanoma (14). Biologic therapies of cancer have been provided new oportunities for treatment of these patients. Interleukin-2 is administered intravenously to treat metastatic melanoma. Intrleukin-2 can cause antitumor therapeutic effects by altering host immune reactions and does not have direct effect on cancer cells (14).
Some biological therapies with their functions against diffferent cancers can be summarized as follows (4).
Tyrosin kinase inhibitor
Stromal cell tumor, chronic myeloid leukaemia
Tyrosin kinase inhibitor
Tyrosin kinase inhibitor
EGF tyrosin kinase inhibitor
Non- small- cell lung cancer, pancreatic cancer
Retinoid X receptor agonist
Cutaneous T- cell lymphoma
EGF tyrosin kinase inhibitor
Non- small cell lung cancer
Anti- EGF receptor
Anti-CD20 on B cells
EGF- epidermal growth factor, VEGF- vascular endothelial growth factor
The immune system is a complicated network of cells, tissues and organs that work together to defend the body against tackle by "foreign" or invaders. This network is one of the body's main defenses against infection and disease. These are primarily microbes- tiny organisms such as bacteria, parasites, and fungi that can cause infections (5).
The immune system includes different types of white blood cells - each with different way to fight against foreign or diseased cells, including cancer.
The immune system is included following cells;
Lymphocytes - lymphocytes are key elements in the production of immunity (8). Type of white blood cells and include B cells, T cells, and natural killer cells.
B cells - produce antibodies that attack other cells.
T cells - directly attack cancer cells themselves and signal other immune system cells to defend the body.
Natural killer cells - produce chemicals that bind to and kill foreign invaders in the body.
Phagocytes - Monocytes are the major type which swallow and digest foreign particles.
Two types of substances are secreted by these cells called antibodies and cytokines. Harmful substances are recognized and responded by antibodies, which are called antigens. Specific (helpful) antibodies match specific (foreign) antigens by locking together. Cytokines are proteins produced by specific immune system cells and can directly attack cancer cells. Cytokines are "messengers" that "communicate" with other cells (6).
SIDE EFFECTS OF BIOLOGICAL THERAPY.
Similarly other forms of cancer treatment, biological therapies can cause a number of side effects, which can vary widely from agent to agent and patient to patient and depend on the form of treatment.
Rashes or swelling may develop at the site where the biological therapy drug is injected. Several BRMs may cause flu-like symptoms including fever, chills, nausea, vomiting, fatigue, bone pain, muscle aches, and appetite loss.
The chills usually begin between two and six hours after drug administration and are marked by teeth chattering, shivers, and a pale complexion. The shivers cause the body temperature to rise, along with the pulse rate and the blood pressure.
Symptoms associated with interferon- alpha are; flue like symptoms such as fever, chills, gastrointestinal upset, body aches, and neuropsychiatric disorders such as insomnia, anxiety and depression. Similar side effects can be seen with interferon- beta other than neuropsychiatric disorders (15).
Interleukin-2 can cause side effects similar to the IFN-alpha and in addition to those symptoms; respiratory distress, anemia, capillary leak syndrome can occur. Il-11 can cause mild to moderate fluid retention, dysrhythmias, respiratory distress, and capillary leak syndrome (16). Toxicity is a common symptom with interleukins (4).
Reactions to monoclonal antibodies (mAB) are often caused by antibody-antigen interaction with consequent release of endogenous cytokines with or without supplement activation.
Fatigue is a very common side effect of biological therapy. For some patients, the feeling of tiredness may go away after the treatment has stopped; as well as for some patients, the fatigue can become chronic.
Some people may present allergic reactions to some drugs, including cough, wheezing, and skin rash. In extreme cases, fatal allergic reaction may occur.
Many biological agents have similar or overlapping side effects. Because of the overlapping symptoms it is difficult to determine whether the reaction is IgG- mediated, Ig E mediated, or cytokine mediated.
Due to the side effects of some drugs, many patients may experience confusion, disorientation, and depression. They may have trouble concentrating, performing simple calculations, or remembering things. These difficulties may interfere with their normal daily activities and ability to work. These side effects can be so severe that drug administration may be interrupted or the drug dose may have to be reduced.
Acute side effects associated with biological agents can occur at any time, during the infusion or can be delayed until after the patient has been discharged from the hospital or outpatient facility (15). This later phenomenon is particularly common with the subcutaneous biologics, some of which may be administered at home by the patient or a family member.
Even though studies of biological agents which are done in animals have shown no effect on fertility or destruction of the fetus, these studies cannot always predict the effects in humans. Pregnant women should receive these drugs only if clearly needed because the effects on a developing child are unknown.
Successful management of the side effects caused by biological therapies can be achieved by experienced oncologist with the cooperation of a well-informed patient. Accurate monitoring and prompt treatment are important components of dealing with the side effects.
Management of side effects
In the event of a reaction to an intravenous biological event, the first step is to stop infusion and assess the patient for airway, breathing, and circulation. Since it is difficult to determine the exact reaction because of overlapping symptoms of side effects, as mentioned above. When the symptoms are occurred, emergency treatments are necessary because cardiopulmonary collapse can be occurring with striking rapidity (15).
Mild reactions, such as nausea, vomiting, fever, and chills, may be managed by temporarily halting the infusion and treating the symptoms. Diphenhydramine and/or other antihistamines can be beneficial for symptoms of mild histamine release. Fevers may or may not respond to acetaminophen, and meperidine has been commonly used off-label for relief of rigors. If symptoms settle up, the infusion can then be continued at a downgraded rate.
Neupogen increases white blood cell counts and helps prevent infection in people who
Procrit, Epogen helps make red blood cells in people who have anemia.
Il-11, Interleukin-11 helps make platelets.
Biologic therapy has become a significant weapon for the treatment of a range of diseases. Because they can produce critical reactions and have a varying range of serious toxicities, nurses caring for patients receiving these agents must be familiar with patient-specific risk factors, general side effects, and strategies for preventing infusion reactions. The proper tools to manage reactions and moderate side effects must be available. Finally, as many of the newer agents are being used for nononcology indications and may be administered at home or in outpatient environments, we must ensure that patients and caregivers understand side effects that may occur in the absence of trained nursing staff (15).