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Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer

Methodology

The project's staff visited the two sites and asked the CAM providers to identify their best cases based on their belief that the patients benefited from the treatment. The staff screened these and additional patient files that were identified from the clinic records, based on the criteria for a best-case series established by the National Cancer Institute. In a 'best-case series,' cases are not selected randomly and are not representative of the 'average' or 'typical' case. Furthermore, there are no control cases that would facilitate a comparison of patient outcomes with and without the treatment in question. A best-case series relies on assumptions about patient outcomes in the absence of treatment, and consequently requires very rigorous documentation of the patient's clinical status. This information is then used by clinical experts to make judgments about outcomes in similar patients treated with the best available conventional therapy. This is the basis for conclusions regarding the potential efficacy of the treatment in question. Best-case series are useful to help identify therapies that have sufficient promise of efficacy to justify the time and resources necessary for more rigorous study, such as a clinical trial. For this study, the researchers used criteria developed by the Office of Cancer Complementary and Alternative Medicine (OCCAM), a part of the National Cancer Institute. These criteria require the following: Documentation of the diagnosis of cancer. The patient's cancer should be documented by obtaining tumor tissue and having it examined by a pathologist. The pathologist's report should be included in the case summary. Evaluation of the appropriate antitumor endpoint. The only reliable antitumor endpoint that can be documented in a best-case series is a demonstrable and reproducible reduction of tumor size. Tumor measurements are made before treatment, during treatment, and after treatment is complete. An objective response is considered to be a decrease of at least 50 percent in the area of the tumor (i.e., the cross product of the diameters) with no increase in size of any other lesions. The patient must not be receiving any other treatment for his/her cancer. To document an antitumor effect based upon individual patient histories, the patient must have a documented, measurable tumor just before the CAM modalities are given. While the CAM modalities themselves may have multiple components, they must not be given together with any other cancer treatments. A record of previous anti-cancer treatments. Documentation of sites of the cancer. At least one recurrent or metastatic cancer should be documented histologically. The date at which recurrence or metastatic disease was first noted should be provided. Description of the patient's general medical condition. The age, sex, and any other previous or concurrent illnesses or significant medical conditions should be carefully documented. Description of the treatment administered. The treatment that was felt to result in the antitumor response should be described.

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