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Patients and the FDA Push for More Tolerable Treatments
With an eye toward avoiding unnecessary side effects from treatments, the Food and Drug Administration (FDA) and patients are pushing drug companies and researchers to explore the impact of reducing the doses of cancer drugs. A Feb. 6 article by the Associated Press highlights the experiences of Jill Feldman, who has been living with lung cancer for 15 years and dealing with harsh side effects from her treatment. She worked with her doctors to continue treatment at a lower dose, but she and others want drug companies to study the effectiveness of lower doses in early clinical trials. Most early clinical trials focus on finding the maximum tolerable dose, a throwback from earlier days of drug development that looked at the highest possible doses of systemic treatments, such as chemotherapy, to wipe out cancer. However, patients and others wonder whether more-is-better is outdated in the era of new drugs like targeted therapies that focus on specific molecular characteristics of the tumor. The article cites a study where nearly half of patients in late-stage trials of 28 targeted therapy drugs needed to have their doses lowered. Treatment toxicities can cause the drug to be ineffective if patients can’t tolerate the regimens, experts noted. “We were pushing the dose as high as we could go. You get side effects and then you have to stop the drug to recover from the side effects and the tumor can grow,” said Patricia LoRusso, who leads drug discovery at Yale Cancer Center in New Haven, Connecticut, and is president-elect of the American Association for Cancer Research (AACR). (The AACR publishes Cancer Today.)
Learn More: Patricia LoRusso discusses an upcoming FDA-AACR workshop on cancer drug dosages in the AACR blog.
FDA Criticized for Still Allowing Cancer-causing Chemical in Hair Straighteners
Researchers and advocates are criticizing the Food and Drug Administration (FDA) for not banning formaldehyde, a chemical known to cause cancer, in beauty products such as hair straighteners. The FDA is tentatively scheduled to unveil a proposal to consider banning the chemical in hair-straightening products, according to a Feb. 8 report in KFF Health News, but advocates and scientists say the proposed regulation doesn’t go far enough and is coming too late. “The fact that formaldehyde is still allowed in hair care products is mind-blowing to me,” said Linda Birnbaum, a former director of the National Institute of Environmental Health Sciences and the National Toxicology Program. “I don’t know what we’re waiting for.” The ban would be a crucial public health step, but some researchers in the article note it doesn’t go nearly far enough to limit other chemicals in hair straighteners, including parabens and phthalates, that have been linked to cancer and other health conditions.
Men With Early-stage Prostate Cancer Should Consider Treatment Side Effects
Men with early-stage prostate cancer generally have a good prognosis, living long after their diagnosis. Whether they choose watchful waiting or immediate treatment, such as surgery or radiation, men typically have similar survival rates, according to a post published Feb. 6 in the National Institute of Health’s Research Matters blog, but different treatments are associated with different risks of adverse events. The post shared findings from a Jan. 23 JAMA study that followed men diagnosed with low-risk and high-risk localized prostate cancer between 2011 and 2012 for more than a decade. Among men with low-risk cancer, 14% of those who had surgery had trouble with leaking urine 10 years after treatment, compared with 4% of those who had radiation therapy and 10% of those who initially chose active surveillance. But 8% of men who had radiation reported serious bowel problems after 10 years compared with 3% of those who had surgery. For men with high-risk cancer, the study found no differences in sexual functioning between surgery and radiation therapy plus hormone therapy. Nearly one in four of those who had surgery reported urinary leakage after 10 years, compared with about one in ten who had radiation and hormone therapy. Bowel problems were reported in 7% of the men given radiation and hormone therapy and 2% to 5% of men who had surgery, the article notes.
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