© 2005 Oxford University Press
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In Brief
Erlotinib May Be an Effective Treatment for Advanced Lung Cancer
Previously treated patients with advanced lung cancer may have a treatment option in erlotinib (Tarceva), according a recent study, which indicated that the drug may prolong survival for these patients.
In a randomized trial involving 731 patients with non–small-cell lung cancer (NSCLC), this study found that the group taking erlotinib survived an average of 6.7 months, compared with 4.7 months in the placebo group. Moreover, 31% of the 488 patients in the study treated with erlotinib were still living after 1 year, compared with 22% of the 243 in the placebo group.
Erlotinib works by interfering with the epidermal growth factor receptor (EGFR). The study, published in the July 14 issue of the New England Journal of Medicine, was accompanied by a second study that found that patients with genetic mutations affecting the expression of EGFR appeared to have a higher response rate to erlotinib. However, in terms of survival, there was no statistically significant difference between those with mutations and those without.
Cochrane Collaboration Publishes Two Systematic Reviews on Cancer
Two new systematic reviews from the Cochrane Collaboration, an international organization that evaluates medical research, focus on the effect of bisphosphonates on bone metastases and the relationship between calcium supplements and colorectal cancer.
Patients with painful breast cancer bone metastases may benefit from bisphosphonates, according to the first review published in the July issue of the Cochrane Library.
Researchers reviewed results from 19 randomized controlled trials that examined the benefits of bisphosphonates in terms of mortality and morbidity. In the 12 studies that looked at breast cancer patients with prior bone metastases, the researchers found that those taking the drug experienced 14%–48% fewer bone problems, depending on the particular study. However, in the six studies looking at patients without prior metastases, there was no benefit in terms of preventing new metastases or bone problems.
In the second systematic review from the Cochrane Collaboration, researchers concluded that, although calcium supplements may prevent the development of polyps that can lead to colon cancer, there is not enough evidence to support the theory that the mineral can actually prevent cancer.
The review evaluated two randomized clinical trials involving 1,346 patients with colon polyps. The patients were randomly assigned to take either daily calcium dietary supplements or a placebo. The Cochrane review found that after combining the studies, 28.7% patients in the control group developed additional polyps, compared with 23.7% assigned to the calcium group—a moderate statistically significant reduction, according to the authors.
The review authors concluded that, although calcium appeared to prevent polyps, this may not necessarily translate into preventing colorectal cancer.
FDA Accepts Modified Qualified Health Claim for Anticancer Benefit of Green Tea
The U.S. Food and Drug Administration has concluded that there is "very little credible evidence" that green tea reduces the risks of breast and prostate cancers and no evidence that green tea reduces the risk of any other type of cancer.
In January 2004, the FDA was petitioned to authorize a qualified health claim stating that daily consumption of green tea may reduce the risk of certain forms of cancer. In July 2005, after reviewing existing evidence, the FDA concluded that it is "highly unlikely" that green tea reduces the risk of breast or prostate cancers and that the evidence does not support qualified health claims for a reduced risk of any other type of cancer.
Manufacturers of products containing green tea will be allowed to use two FDA-approved statements regarding breast and prostate cancers that state that the evidence of an association is weak and that it is highly unlikely that green tea reduces the risk of either of the cancers. Manufacturers, however, will not be allowed to make any other claims about the anticancer benefits of green tea.
See also News, Vol. 96, No. 16, p. 1198, "FDA Reviews Expanded Claims on Health Benefits of Certain Foods."
FDA Commissioner Confirmed by Senate
The U.S. Senate confirmed Lester Crawford, D.V.M., as commissioner of the U.S. Food and Drug Administration on July 18 by a vote of 78–16.
Crawford has been acting commissioner since March 2004—succeeding Mark McClellan, M.D., Ph.D., who left to become head of the Centers for Medicare and Medicaid Services—and was nominated to be the permanent commissioner in February. His confirmation had been postponed for several months by concerns from some senators over recent FDA decisions.
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