Best-case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer

Published in: Evidence Report/Technology Assessment: no. 78 (Prepared by the Southern California/RAND Evidence-based Practice Center under contract No. 290-97-0001). AHRQ Publication No. 03-E029. Agency for Healthcare Research and Quality, Rockville, MD., Apr. 2003

Posted on RAND.org on December 31, 2002

by Paul G. Shekelle, Ian D. Coulter, Mary L. Hardy, Sally C. Morton, Joya T. Favreau, James Gagne, Adelaide Coulter, Sydne Newberry, Jay Udani, Beth Roth, Lara Hilton

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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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