Source: Journal of Clinical Oncology, March 21, 2011
A 10 year follow-up of women aged 50 and over with early breast cancer whose chemotherapy included Tamoxifen has been published in the Journal of Clinical Oncology. The study by researchers at Cancer Research UK touts the benefits of 5 years of Tamoxifen therapy.
Tamoxifen or NOLVADEX® (tamoxifen citrate) is Astra Zeneca’s nonsteroidal antiestrogen used to treat women with ductal breast cancer which may be metastatic. Tamoxifen itself has come under fire for being associated with an increased risk in uterine cancer, stroke and blood clots. Another known side effect of Tamoxifen is peripheral neuropathy or nerve disorder of the legs which can make walking painful and difficult.
The Cancer Research UK “Over 50s” trial compared women with early breast cancer who were prescribed Tamoxifen for 5 and 2 years, respectively. Of the patient’s in the study between 1987 and 1997, 3,449 patients age 50 to 81 years with operable breast cancer who had been taking 20 mg of tamoxifen for 2 years were randomly assigned to either stop or continue for an additional 3 years, if they were both alive (duh!) and recurrence free.
After this 10 year study, the following data were reported: There were 1,103 recurrences of breast cancer. 755 women died of their breast cancer. 621 women suffered cardiovascular events (ie. stroke). Of those, 236 women died.
For every 100 women who received tamoxifen for 5 years, there were 5.8 fewer recurrences, compared with those who received tamoxifen for 2 years. The risk of contralateral (in the opposite) breast cancer was significantly reduced (hazard ratio, 0.70; 95% CI, 0.48 to 1.00). Among women age 50 to 59 years, there was a 35% reduction in cardiovascular events and a 59% reduction in death as a result of a cardiovascular event. In older women, the effect was much smaller and not statistically significant.
The study concludes that taking tamoxifen for the recommended 5 years reduces the risk of recurrence or contralateral breast cancer 15 years after starting treatment. It also lowers the risk of cardiovascular disease and death as a result of a cardiovascular event, particularly among those age 50 to 59 years. The recommendations of the researchers are that women should, “Be encouraged to complete the full course.”
Post: David M. Schwadron, Esquire
Source: New York Times National Ed., 3/6/2011; US Food & Drug Administration
We previously reported on radiation errors with CT brain perfusion scans when they were widely reported in the summer of 2009 at Cedars-Sinai. Following reports at several other hospitals, the Food and Drug Administration conducted an investigation into why patients tested with this complex (and sparsely regulated) technology were being overradiated.
The Food and Drug Administration’s final report, issued Nov. 9, 2010, cited user error and recommended that manufacturers (including G.E.’s medical division) should do a better job of training and educating users and also the institution of controls to better warn technicians and operators when radiation levels are accidentally set too high.
The errors have continued to surface. A large West Virginia hospital, Cabell Huntington, overradiated patients suspected of having strokes with CT scans for more than a year after the FDA’s investigation.
A spokesman for G.E., who made the scanner, said a hospital technician had “manually increased” the radiation output to obtain a clearer picture, though that additional clarity was not necessary for diagnosis. G.E. said its machine did not malfunction, but it also said that technicians had subsequently received “refresher training.”A similar episode had happened the previous March.
Federal records indicate that Cabell knew of some of the overdoses for three months, but it did not disclose them publicly until The New York Times called the hospital for comment late last week. Within hours, the hospital issued a news release that was picked up by the local media. Charles Shumaker, a hospital spokesman, declined to say how many patients were overdosed, why the mistakes occurred or whether any hospital employees were disciplined as a result.
But Dr. Rebecca Smith-Bindman, a radiology professor who has testified before Congress about the need for more controls over CT scans, called the dosage report for one Huntington patient — provided to her by The Times — “grossly and unacceptably abnormal.”
One of those patients, a 36-year-old mother of two teenagers, lost large patches of hair in a band around her head. Her patient records indicate that she received at least 10x times the radiation she should have, according to her attorney.
David J. Brenner, who directs the Center for Radiological Research at Columbia University Medical Center, agrees that more needs to be done. “An underlying problem here,” he said, “is that there are almost no federal regulations controlling radiation exposure from medical X-ray scans, and it seems high time that we consider national legislation.”
Post: Gayle R. Lewis, Esquire
Parkinson’s Disease is a debilitating one, affecting 1 in every 500 people over the age of 50. It is linked with a shortage of the brain chemical dopamine and follows the death of important nerves cells. Parkinson’s Disease is both chronic (persists over a long period of time) and progressive (symptoms grow worse over time). Some people become severely disabled, while others experience only minor motor disruptions. Tremor is the major symptom for some patients and speech is often affected.
The current research was funded by the Michael J Fox Foundation for Parkinson’s Research (A former household face in television and movies) to find a cure for Parkinson’s which has affected him prematurely. The researchers have found that people who take ibuprofen on a regular basis have a lower risk of developing Parkinson’s disease. The study of more than 135,000 men and women regular users of ibuprofen are said to be 40% less likely to develop Parkinson’s Disease
Lead researcher Professor Alberto Ascherio, of the Harvard School of Public Health, said: “There is no cure for Parkinson’s disease, so the possibility that ibuprofen, an existing and relatively non-toxic drug, could help protect against the disease is captivating.”
It is thought that an inflammatory response in the brain might cause the death of nerve cells leading to Parkinson’s Disease. If correct, an anti-inflammatory medication could halt or slow the process. Further study is required and it is too early to say whether the benefits of taking the non steroidal anti-inflammatory (NSAID) drug outweigh the risk of side effects such as gastrointestinal bleeding, heart attack and stroke.
Post: David M. Schwadron, Esquire