UNLABELLED: Immunoaugmentative therapy (IAT) is an unconventional therapy used by thousands of cancer patients that has not been systematically evaluated for safety and efficacy. The authors evaluated the toxicity and effects of this therapy in a series of consecutively treated cancer patients. METHODS: A sample of 46 consecutive patients treated at the Immune Therapy Clinic in Playas, Mexico, from April to December 1989 were evaluated for adverse reactions, tumor response, quality of life and immune status over 12 weeks of IAT treatment. Patients' blood was tested for HIV and hepatitis B antibody before and after treatment. Histological confirmation of cancer and staging was obtained in all patients, and the results of follow-up radiological examinations were judged in a blinded fashion by independent diagnostic radiologists. RESULTS: There were no signs of toxicity (SWOG criteria) and no HIV or hepatitis B conversion attributable to IAT. None of the 46 patients showed tumor regression. Forty patients (87%) had disease progression, and 25 (55%) died within 6 months from disease progression. Thirty-five patients (76%) noticed a decline in their quality of life during IAT. Thirty-eight patients (83%) opted to continue with the IAT treatment, despite its lack of effectiveness. CONCLUSIONS: No indication of toxicity or effectiveness was found in an uncontrolled, consecutively selected series of 46 cancer patients undergoing IAT treatment. In addition, the therapy did not appear to contribute to improved quality of life in most patients. This study does not justify its continued use.
UNLABELLED: Immunoaugmentative therapy (IAT) is an unconventional therapy used by thousands of cancerpatients that has not been systematically evaluated for safety and efficacy. The authors evaluated the toxicity and effects of this therapy in a series of consecutively treated cancerpatients. METHODS: A sample of 46 consecutive patients treated at the Immune Therapy Clinic in Playas, Mexico, from April to December 1989 were evaluated for adverse reactions, tumor response, quality of life and immune status over 12 weeks of IAT treatment. Patients' blood was tested for HIV and hepatitis B antibody before and after treatment. Histological confirmation of cancer and staging was obtained in all patients, and the results of follow-up radiological examinations were judged in a blinded fashion by independent diagnostic radiologists. RESULTS: There were no signs of toxicity (SWOG criteria) and no HIV or hepatitis B conversion attributable to IAT. None of the 46 patients showed tumor regression. Forty patients (87%) had disease progression, and 25 (55%) died within 6 months from disease progression. Thirty-five patients (76%) noticed a decline in their quality of life during IAT. Thirty-eight patients (83%) opted to continue with the IAT treatment, despite its lack of effectiveness. CONCLUSIONS: No indication of toxicity or effectiveness was found in an uncontrolled, consecutively selected series of 46 cancerpatients undergoing IAT treatment. In addition, the therapy did not appear to contribute to improved quality of life in most patients. This study does not justify its continued use.