Go to MEDLINE so I can research my child’s cancer.

Information about commonly used treatments:

CHEMOTHERAPY

RADIATION

Today, you can read what medical doctors and scientists have written about treating specific cancers by accessing MEDLINE from your home computer.

MEDLINE is the National Library of Medicine's database of indexed journal citations and abstracts covering approximately 4,500 medical and scientific journals published in the United States and more than 70 other countries. MEDLINE includes references to articles indexed from 1966 to the present and new citations are added weekly. The database is available online through PubMed (a service of the National Library of Medicine).

To better understand the abstracts and articles you will find on MEDLINE, the following glossary and explanation of terms may be helpful.

Glossary of Some Cancer Terminology You May Encounter

Because there is no uniform cure for many cancers, especially pediatric cancers, most articles you will find will discuss the results of a clinical trial.

Clinical Trial - is a research study performed by physicians and other health professionals to help determine if a treatment (a medication, device, procedure, or method) is safe and effective. Every clinical trial is designed to answer a set of research questions. Participation in a clinical trial is voluntary. A patient who agrees to participate can choose to stop participation at any time.

Clinical trials generally have a variety of built-in safeguards to help protect the people who participate. These usually include:

• “Peer Review” of the clinical trial by experts chosen by the sponsoring organization (such as the National Cancer Institute, the Food and Drug Administration, or pharmaceutical company) for scientific merit, patient safety, and ethical considerations.
  
• Approval of the trial by the FDA.
  
• The hospital or clinic has a committee, the Institutional Review Board (IRB), which oversees all clinical trials in the healthcare facility. The IRB includes doctors, other health care providers, and members of the community. The IRB has the following functions:
  
  
  • Protect the rights and welfare of people who participate in clinical trials.
    
  • Approve the information to be presented and the manner of presentation to people who are deciding whether to participate in a clinical trial.
    
  • Obtain updates on the clinical trial’s progress such as information on any serious side effects that have taken place in the study.
    
    

Investigators – Clinical Trials are usually led by investigators. In the context of cancer, an investigator is usually a physician (i.e. oncologist). For research sponsored by companies, investigators are may be paid for their time and effort. This payment may be per patient enrolled on the study or through some other formula.

Protocol – The investigators who conduct a clinical trial follow a treatment plan. This treatment plan is called a “protocol.”

Sponsors – The Clinical Trial’s sponsor can be a pharmaceutical or a biotechnology company developing treatments they plan to market. Government agencies, foundations and groups dedicated to researching certain diseases can also sponsor clinical trials.

Clinical Trial Phases – Before a drug or treatment is FDA approved it usually goes through three stages – Phases I, II, and III.

• Phase I is designed to test the safety of a drug. During this phase, sometimes called the “dose finding stage,” the Maximum Tolerated Dose (MTD) of a new drug given by a particular schedule may be determined. The purpose of a Phase I Protocol is not to treat the cancer, but simply to determine if the administration of a drug is safe and what doses can be safely administered.
  
• Phase II is designed to see if the drug results in a response. (Responses are discussed below.)
  
• Phase III compares the new drug(s) or treatments to other drug(s) or treatments that are considered the standard treatments. The major goal of a Phase III Protocol is to prolong the cancer patient’s life.
  
• Phase IV may be performed after the FDA approves the drug or treatment. The purpose of a Phase IV trial is to find out how well the drug performs in a much larger number of patients.

Many pediatric cancer therapies are not FDA approved because they either have not completed the first three phases, the therapy has not been submitted for FDA approval, or the therapy was not approved after submission.

Response Rates – In gauging the success of a clinical trial, “response rates” are often used. The following terms are utilized to measure whether there was a response:

• Partial Response (PR) means the tumor decreased in size by at least 50% and there were no new lesions/tumors.
  
• Complete Response (CR) means all detectable cancer disappeared.
  
• Progressive Disease (PD) means the tumor increased in size by at least 25%.
  
• Stable Disease (SD) means there was no change in dimensions of a measurable tumor.

Evaluable Patients are those patients who completed a protocol and could be evaluated. Response rates may be based on the number of “evaluable patients.” Some children, however, may not be evaluable because they died before they completed the protocol.

Response Rate is Not a Survival Rate – Although the measurement of “responses” provides a convenient measure to oncologists, a response may be short-lived and a response rate is not equivalent to a survival rate. This is demonstrated by excerpts from two peer reviewed oncology articles.

“…Responses were short lived, with two patients relapsing while still receiving chemotherapy. Three of four very young children relapsed within 7 months of completing chemotherapy…”

- Gaze MN, et al., Combination chemotherapy for primitive neuroectodermal and other malignant brain tumours. Clin Oncol (R Coll Radiol) 1994; 6(2): 110-5

“Five children with recurrent medulloblastoma were treated with Vincristine, BCNU, Methotrexate and Dexamethasone. All five patients responded to therapy. Two of the patients are alive…”

- Duffner PK, et al., Combination chemotherapy in recurrent medulloblastoma. Cancer 1979 Jan; 43(1): 41-5.

 

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