Clinical trials of transfer factor in malignancy.
Results of clinical trials of transfer factor therapy in various malignancies have been variable. In non randomized trials, about 300 patients have been evaluated, and clinical benefit has been reported in about 1/3 of the evaluable patients. Results of randomized studies are similarly varied. In some randomized trials, clinical benefits of increased disease free survival and prolonged survival have been claimed. In other studies, transfer factor has been reported to be of no clinical benefit. In a few studies, results suggest patients receiving transfer factor do not do as well as those receiving placebo, although these are only trends, and do not reach the level of statistical significance. There are a number of variables in the design of transfer factor trials, and review of the studies performed to date does not permit a determination of which, if any, of these variables is related to the therapeutic outcome. A variety of tumor types have been evaluated, and it is not clear which, if any, tumors respond to transfer factor. Similarly, the state of disease and prior and concomitant therapy vary widely in these trials and the impact of these variables is unclear. The source and dose of transfer factor also varies. In some studies, attempts have been made to select donors who might have cellular immune reactivity to the tumor being treated, whereas in other studies normal donors have been used. The rationale for the use of normal donors in that the clinical benefit of transfer factor may be related to the non specific immunopotentiating effects of this agent rather than the specific transfer of cellular immunity. Finally, the methods of preparation of transfer factor vary and the products used in various studies cannot be compared by standard biologic or biochemical tests currently available. This review of the literature regarding the clinical effort of transfer factor in malignancy leads to the conclusion that transfer factor might not be an effective therapy of cancer. If it does have efficacy in certain malignancies, it is unlikely that it will alone have dramatic effects in substantial numbers of patients. Perhaps transfer factor may have a role in tumor therapy as an adjuvant to other forms of therapy and as surgery, irradiation, or chemotherapy. In order for the proper evaluation of transfer factor in reproducible comparative studies, it will be necessary to have a standarized reproducible product which can be assessed by appropriate quality control procedures.(ABSTRACT TRUNCATED AT 250 WORDS)
Spitler
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Paul M. Aggelar Memorial Laboratory, Children's Hospital of San Francisco, California 94118.
Miller
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D001943:Breast Neoplasms / Q000628:therapy; D002277:Carcinoma / Q000628:therapy; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006689:Hodgkin Disease / Q000628:therapy; D006801:Humans; D008175:Lung Neoplasms / Q000628:therapy; D008297:Male; D008545:Melanoma / Q000628:therapy; D009303:Nasopharyngeal Neoplasms / Q000628:therapy; D009369:Neoplasms / Q000628:therapy*; D012516:Osteosarcoma / Q000628:therapy; D011897:Random Allocation; D014165:Transfer Factor / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000628:therapy
D014165:Transfer Factor