The conventional approach for radiation protection is based on the ICRP's linear, no threshold (LNT) model of radiation carcinogenesis, which implies that ionizing radiation is always harmful, no matter how small the dose. But a different approach can be derived from the observed health effects of the serendipitous contamination of 1700 apartments in Taiwan with cobalt-60 (T(1/2) = 5.3 y). This experience indicates that chronic exposure of the whole body to low-dose-rate radiation, even accumulated to a high annual dose, may be beneficial to human health. Approximately 10,000 people occupied these buildings and received an average radiation dose of 0.4 Sv, unknowingly, during a 9-20 year period. They did not suffer a higher incidence of cancer mortality, as the LNT theory would predict. On the contrary, the incidence of cancer deaths in this population was greatly reduced-to about 3 per cent of the incidence of spontaneous cancer death in the general Taiwan public. In addition, the incidence of congenital malformations was also reduced--to about 7 per cent of the incidence in the general public. These observations appear to be compatible with the radiation hormesis model. Information about this Taiwan experience should be communicated to the public worldwide to help allay its fear of radiation and create a positive impression about important radiation applications. Expenditures of many billions of dollars in nuclear reactor operation could be saved and expansion of nuclear electricity generation could be facilitated. In addition, this knowledge would encourage further investigation and implementation of very important applications of total-body, low-dose irradiation to treat and cure many illnesses, including cancer. The findings of this study are such a departure from expectations, based on ICRP criteria, that we believe that they ought to be carefully reviewed by other, independent organizations and that population data not available to the authors be provided, so that a fully qualified epidemiologically-valid analysis can be made. Many of the confounding factors that limit other studies used to date, such as the A-bomb survivors, the Mayak workers and the Chernobyl evacuees, are not present in this population exposure. It should be one of the most important events on which to base radiation protection standards.
4604 Background: Results from the Phase III TARGETs study showed that sorafenib plus best supportive care (BSC) significantly prolonged progression-free survival (PFS) compared with BSC alone (p < 0.000001) in patients with advanced renal cell carcinoma (RCC). In addition, at a planned interim analysis, overall survival was numerically longer with sorafenib than BSC with a hazard ratio of 0.72. The objective of this study was to evaluate the cost-effectiveness of sorafenib + BSC versus BSC alone in advanced RCC from a US payer perspective. Methods: A Markov model was developed to project the lifetime survival and costs associated with sorafenib + BSC and BSC alone. The model tracked patients with advanced RCC through three disease states - PFS, progression, and death. Transition probabilities between disease states varied for each 3-month period and were obtained from the TARGETs study. Life-years gained were used as a measure of treatment effectiveness. Resource utilization included drug, administration, physician visits, monitoring, and adverse events. Costs and survival benefits were discounted annually at 3%. All costs were adjusted to 2004 US dollars. Scenario sensitivity analyses were conducted. Results: The lifetime per patient costs were $85,571 and $36,634 for sorafenib + BSC and BSC alone, respectively. The life-years gained were higher for sorafenib relative to BSC. The incremental cost-effectiveness ratio (ICER) of sorafenib + BSC versus BSC alone was $75,354 per life-year gained. The key drivers of the model results were survival after progression and PFS probabilities for both treatment groups. Sensitivity analyses showed that the model results were robust to variance in sorafenib and BSC treatment costs. Conclusions: The incremental cost-effectiveness ratio was within the established threshold that society is willing to pay (i.e., $50,000-$100,000). Therefore, sorafenib + BSC appears to be cost-effective in the management of advanced RCC. [Table: see text]
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