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Research: VICKERS and co-authors,
Listed in Issue 128
Abstract
VICKERS and co-authors, Integrative Medicine Service and Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA, have reviewed (15 references) trials of unconventional anticancer medicines.
Background
A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort combat the disease. These unconventional approaches include herbal medicines, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The aim of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer.
Methodology
MEDLINE 1966 to 2005 was searched for prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or non-clinical end points. Trial data were extracted by two reviewers using a standardized protocol.
Results
14,735 articles were found, of which 214, describing 198 different clinical trials, were included. 20 trials were phase I, 3 were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only 8 of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data.
Conclusion
Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies.
References
Vickers AJ, Kuo J, Cassileth BR. Unconventional anticancer agents: a systematic review of clinical trials. Journal of Clinical Oncology 24 (1): 136-140, Jan 1, 2006.
