Oncology Link to US NCI Introduction Cancer is a term used for diseases in which abnormal cells divide without control and are able to invade other tissues. Cancer cells can spread to other parts of the body through the blood and lymph systems. Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer that begins in melanocytes of the skin is called melanoma. Cancer types can be grouped into broader categories. The main categories of cancer are:
Oncology is a branch of medicine that specializes in the diagnosis and treatment of cancer. It includes medical oncology (the use of chemotherapy, hormone therapy, and other drugs to treat cancer), radiation oncology (the use of radiation therapy to treat cancer), and surgical oncology (the use of surgery and other procedures to treat cancer). Disease Description All cancers begin in cells, the body's basic unit of life. To understand cancer, it's helpful to know what happens when normal cells become cancer cells. The body is made up of many types of cells. These cells grow and divide in a controlled way to produce more cells as they are needed to keep the body healthy. When cells become old or damaged, they die and are replaced with new cells. However, sometimes this orderly process goes wrong. The genetic material (DNA) of a cell can become damaged or changed, producing mutations that affect normal cell growth and division. When this happens, cells do not die when they should and new cells form when the body does not need them. The extra cells may form a mass of tissue called a tumor. Not all tumors are cancerous; tumors can be benign or malignant. Benign tumors aren't cancerous. They can often be removed, and, in most cases, they do not come back. Cells in benign tumors do not spread to other parts of the body. Malignant tumors are cancerous. Cells in these tumors can invade nearby tissues and spread to other parts of the body. The spread of cancer from one part of the body to another is called metastasis. Some cancers do not form tumors. For example, leukemia is a cancer of the bone marrow and blood. Cancer Statistics Link to Cancer Research UK Cancer is a leading cause of disease worldwide and GLOBOCAN estimates that 12.7 million new cancer cases occurred worldwide in 2008.2 Lung (1.6 million, 12.7% of the total for men and women), female breast (1.4 million, 10.9% of the total for women), colorectal (1.2 million, 9.7% of the total for men and women) and stomach cancers (1 million, 7.8% of the total for men and women) were the most common, accounting for more than 40% of all cases diagnosed. Just five cancer sites –lung, female breast, colon-rectum, stomach and prostate – accounted for half (48%) of the world’s total cancer diagnoses in 2008 More information concerning cancer statistics for the most common cancer can be found in Cancer Research UK website (Cancer Research UK) Causes and Risk Factors Doctors often cannot explain why one person develops cancer and another does not. But research shows that certain risk factors increase the chance that a person will develop cancer. These are the most common risk factors for cancer:
Many of these risk factors can be avoided. Others, such as family history, cannot be avoided. People can help protect themselves by staying away from known risk factors whenever possible. Treatments The treatment plan depends mainly on the type of cancer and the stage of the disease. Doctors also consider the patient's age and general health. Often, the goal of treatment is to cure the cancer. In other cases, the goal is to control the disease or to reduce symptoms for as long as possible. The treatment plan may change over time. Most treatment plans include surgery, radiation therapy, or chemotherapy. Some involve hormone therapy or biological therapy. In addition, stem cell transplantation may be used so that a patient can receive very high doses of chemotherapy or radiation therapy. Some cancers respond best to a single type of treatment. Others may respond best to a combination of treatments. Treatments may work in a specific area (local therapy) or throughout the body (systemic therapy): Local therapy removes or destroys cancer in just one part of the body. Surgery to remove a tumor is local therapy. Radiation to shrink or destroy a tumor also is usually local therapy. Systemic therapy sends drugs or substances through the bloodstream to destroy cancer cells all over the body. It kills or slows the growth of cancer cells that may have spread beyond the original tumor. Chemotherapy, hormone therapy, and biological therapy are usually systemic therapy. Because cancer treatments often damage healthy cells and tissues, side effects are common. Side effects depend mainly on the type and extent of the treatment. Side effects may not be the same for each person, and they may change from one treatment session to the next. More information concerning type of treatment can be found in the US NCI Institute website Agency Guidelines FDA Link to FDA Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics 2007 The Guidance contain general regulatory requirements for efficacy with detailed description of endpoints and how they can be used in various clinical settings. Pros and Cons of the different endpoints are discussed. Details on the following topic are also provided:
The FDA has also undertake a project to evaluate potential endpoints for cancer drug approval. Endpoints were examined for the most common cancers, such as lung cancer, colon cancer, etc. For each cancer, FDA hold public workshops to identify important issues, and these issues have been discussed in meetings of the Oncologic Drugs Advisory Committee (ODAC). EMA Link to Guidelines on the evaluation of anticancer medicinal products in man The above guidelines provides guidance on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds. Supportive measures such as anti-emetics and haematopoietic growth factors, however, are covered by separate guidelines. The guidance of 2013 is a revised version of past versions where the focus was mainly the conventional cytotoxic compounds. The current version of the guidance cover also non-cytotoxic compounds and additional indication for exploratory studies. Moreover the guidance is also now completed by a set of specific appendices covering methodological aspects related to Progression Free Survival (PFS) and disease specific guidance. The appendix 1 Methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials [2] gives more details / suggestions concerning the following topics:
The appendix 2 for Confirmatory studies in Haematological Malignancies [3] gives specific indication for Chronic Myelogenoma Leukopenia (CML) and Myelodysplastic Syndromes (MDS) such as..... In the appendix 4 Condition Specific Guidance [4] additional details when conducting trial on NSCLC, Prostate and haematologicl malignancies, are also provided. Guidance for Paediatric Oncology are provided separately [5] The EMA is also planning to provide an additional appendix for Quality of Life/Patient Reported Outcome. For this reason in May 2012 a workshop was conducted to gather information / opinions from patients, industry and health technology assessment representative. A summary of the topic discussed was summarized in the documentb Report - Oncology Workshop Party Related Quality of Life (HRQoL) [6]. Clinical Trial Endpoints |