Howard Waage ---- Editor
Where: Our meeting will be in the Bennett & Suzy Katz Cancer Resource Center on the 1st Floor of the
two-story redwood Education Building behind Santa Cruz Dominican Hospital.
When: Tuesday, June 30th, 2009 7:00 PM. For more information: Please call the Bennett
and Suzy Katz Cancer Resource Center at Dominican Hospital (831) 462-7770
Please feel free to contact any of the following steering committee members if you would like to volunteer or if you have any suggestions or questions.
Joe Ferrara 426-7724 Frank and Janet Schmetz 438 4781 Bill McDermott 423-8350 Howard Waage 688-0423
Michael & Julie Batz 724-2701 Tim Ryan 476-6550 Ron Locey 214-4338
Our website: http://www.scprostate.org Webmaster: Paul Johnson
Medical news can change often - one week, a new "breakthrough" is discovered, only to be disputed the next week. It is difficult to know what news to believe, and if a person should change a practice or specific habit. Finding answers to the following questions may help you better evaluate medical news.
1. Does the news story represent an entire area of research, or is it just reporting on one study? With some exceptions, news articles explaining only one study cannot adequately describe the risks or benefits of a new treatment or finding, nor do they examine the long-term effects of the research. Most doctors don't recommend changing your health habits based on one study. Talk with your doctor or a member of your health-care team if you have questions about a particular study.
2. How does this new information fit in with what is already known about the topic? Health-care professionals do not usually change their standard of care based on one study. Generally, it takes years of research results from many different studies performed at different institutions before there is enough evidence to adopt a new therapy. Researching new treatments is a process, and scientific papers are written at each step of the process. In short, the more evidence there is for something, the more likely it is to be true.
3. Where was the news article reported? Established news outlets, including national and large regional or local newspapers and network television stations, usually have science and medical reporters on staff. In general, these reporters are experienced in analyzing medical information and strive to cover the news as accurately as possible and put the information in context with previous research. Smaller news outlets may pick up stories after they have been run nationally. Although many of these outlets provide quality reporting, some of them may cut important information to save space or time.
4. If the news article is based on a research study, where was the study originally published? The most prestigious medical journals, including New England Journal of Medicine, Journal of the American Medical Association, The Lancet, Science, Journal of the National Cancer Institute, and Journal of Clinical Oncology, use a rigorous, peer-review process that requires articles submitted for publication to be reviewed by others working in the same field for accuracy, importance, and the ability to reproduce the results. However, just because the medical article was published in a leading journal doesn't mean you should assume the research changes standard practices.
5. Who were the research subjects, and what phase was the research? If the research was done with tissue cultures or animals, there is no reason to apply the findings to your daily life just yet. Tissue cultures and animals are used as models to better understand how a treatment may work, but they aren't reliable substitutes for how a treatment works in people. A research study involving people is called a clinical trial. There are distinct phases of clinical trials. The goal of a phase I clinical trial is to prove that a new drug or treatment, which has proven to be safe for use in animals, also may be given safely to humans. Doctors collect data on the dose, timing, and safety of the investigational therapy. People who participate in phase I clinical trials are often the first to receive a new therapy or a new combination of therapies. A phase II clinical trial is designed to provide more detailed information about the safety of the treatment. It focuses on determining whether the new treatment is effective for a specific cancer, such as shrinking a tumor or improving blood test results. The goal of a phase III clinical trial is to take a new treatment that has shown promising results when used to treat a small number of patients with a particular disease and compare it with the current standard of care for that specific disease. In this phase, data are gathered from larger numbers of patients to determine whether the new treatment is better and possibly less toxic than the current standard treatment. In summary, information from a phase III clinical trial is worth listening to, but results from a phase I and phase II clinical trial are preliminary.
6. What type of statistics does the news article report? Most research studies highlight relative risk rates, although absolute rates provide a clearer picture on the actual health risk. Absolute risk is the chance, usually measured as a percentage, that a person will develop a disease during a given time. Relative risk is a comparison of the risk in a group of people with a particular risk factor, and those who do not have that particular risk factor. Both relative risk and absolute risk are useful in understanding whether an individual's risk is higher or lower than the general population. However, most studies report relative risk, which makes the results seem more important than they are. Absolute risk rates are easier to interpret in terms of what the actual risk of exposure or benefit of treatment is. Learn more about risk and risk factors for cancer.
7. What type of health result does the news article report? The overall survival of people is the result of most interest in research studies. However, this may take quite some time to study, so researchers may use a substitute for this measurement, such as tumor response (whether the tumor shrinks in response to treatment) and disease-free survival (the length of time after treatment during which a person survives with no sign of the disease). When these substitute measurements are used, remember that positive findings may not translate into an actual improvement in overall survival. Also, a study may report on the statistical significance of a new treatment, although it may not be medically important. For example, a benefit of a new treatment may be statistically significant if it improves five-year survival from 50% to 51% in a large clinical trial. However, this statistical difference may not be a medically important difference if the new treatment causes severe side effects.
8. Other Tips: In addition to these questions, there are some warning signs that a news article may be overplaying a medical study. The use of the word "breakthrough." The process of scientific exploration usually happens in small steps, not giant leaps. Breakthroughs in medicine are rare. The study promises a magic bullet. Unfortunately, magic bullets are few and far between. The invention of penicillin to treat bacterial infections and the creation of the polio vaccine are examples of magic bullets. It is unlikely that a complex disease such as cancer, which is actually many different diseases, will be cured with a single treatment. The article is one-sided. A news article should be balanced and present the benefits and harms of the topic. A new cancer treatment rarely helps all patients. The best way to learn whether a cancer news story is relevant to you is to talk to your doctor or other member of your health-care team. He or she can help you put the new study in the context of your situation. Source: http://www.cancer.net
May 2, 2009 -Headline data from the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial was presented at the American Urological Association in Chicago, Illinois today. The study population was men between the ages of 50 and 75 who were at increased risk for prostate cancer with prostate specific antigen (PSA) levels between 2.5 and 10 ng/mL (men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL (men aged greater than 60 years). REDUCE achieved its primary endpoint and demonstrated that dutasteride significantly reduced the risk of all biopsy-detectable prostate cancer by 23% (p<0.0001) over four years. A total of 1516 cancers were seen, with 659 in the dutasteride arm and 857 in the placebo arm.
A key secondary endpoint was Gleason score at the time of diagnosis. The study endpoint showed no statistically significant difference in high grade tumours defined as Gleason scores 7-10 (233 out of 3406 patients or 6.8% for placebo, vs. 220 out of 3298 patients or 6.7% for dutasteride, p= 0.81) over the four year study period. In the Gleason scores 8-10, although a difference was seen over the four years, it was not statistically significant (19/3406 (0.6%) for placebo vs. 29/3298 (0.9%) for dutasteride, p=0.15).
The most common side effects reported, related to treatment, were erectile dysfunction (5.7% placebo vs. 9.0% dutasteride), decreased libido (1.6% placebo vs. 3.3% dutasteride), gynecomastia (1.0% placebo vs. 1.9% dutasteride). These adverse events are consistent with what has been previously reported in studies of dutasteride.
Further analysis will be included in the manuscript which will be prepared and submitted for publication in a peer review journal this year. Dutasteride is not approved or licensed to treat or reduce the risk of prostate cancer.
About the REDUCE trial: The REDUCE (REduction by DUtasteride of prostate Cancer Events) trial is a international, randomised, double-blind, placebo-controlled, parallel group study of the efficacy and safety of dutasteride, 0.5 mg administered daily for four years to reduce the risk of biopsy-detectable prostate cancer.
The study included 8121 men between 50 and 75 years of age, 4072 and 4049 subjects in the placebo arm and dutasteride arms respectively in the efficacy population. Men less than 60 years old were required to have a PSA of 2.5 - 10 ng/mL, and men greater than or equal to 60 years were required to have a PSA of 3 - 10 ng/mL+.
In order to ensure that the patients included in the efficacy population of the study were at an increased risk for prostate cancer, all study subjects had to have had a single, negative biopsy within the 6 months prior to enrollment, and a prostate volume ≤ 80 cc. The single negative biopsy was to limit the likelihood of having existing prostate cancer but also to ensure sufficiently increased risk for prostate cancer at trial entry, which would have been reduced if the patient had experienced multiple negative biopsies.
Dutasteride inhibits both type 1 and type 2 5-alpha reductase enzymes, which are responsible for converting testosterone to dihydrotestosterone (DHT), the most potent male hormone in the prostate.1 Basic science studies indicate that both types of the enzyme type 1 and type 2 are present in prostate tissue and that the type 1 form is increased in prostate cancer, including high grade cancer. Dutasteride is indicated for the treatment of moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It has been shown to improve urinary symptoms, reduce the risk of acute urinary retention (AUR), and the risk of BPH-related surgery.2
Newswise — 4/23/2009 Researchers at The Mount Sinai Medical Center in New York have found that, when it comes to worrying about the recurrence of prostate cancer, male patients worry less than their female spouses or partners. The study was presented today at the 30th annual meeting of the Society of Behavioral Medicine in Montreal.
In a study of 96 men and their spouses or partners, Michael Diefenbach, Ph.D., Associate Professor of Urology and Oncological Sciences at Mount Sinai School of Medicine, found that, at the time of prostate cancer diagnosis, the male patients described themselves as “moderately worried” about the chance of their disease recurring, while their female spouses and partners described themselves as “very much” worried.
“We know that illness perception and worries about cancer recurrence influence the emotional well-being of patients. But our studies show that this worry is actually a greater stress on spouses and partners. This research can help us develop programs to address the emotional health of the entire family unit,” said Dr. Diefenbach.
For both groups, the concern about recurrence decreased over the next 12 months, though it decreased more for the male patients than it did for their spouses and partners. This led to an even greater disparity after one year than what was observed at the time of diagnosis, with the men describing themselves as “a little bit” worried and their spouses and partners saying they were “moderately worried.”
The study also showed that men were less likely to worry about their cancer recurring if they believed that treatment options for their cancer would be effective, while their spouses’ and partners’ worries were generally unaffected by outside factors.
“For the male patients, the main driver of worry about cancer recurrence was whether they believed that effective treatment was available for their disease,” said Dr. Diefenbach. “But for their spouses and partners it was not possible to determine the main driver of worry, as their response was mainly an emotional one. The one factor we could really measure that affects the level of spouse and partner worry is age – in general, the older the spouse or partner, the more concerned they were about cancer recurrence.”
Dr. Diefenbach leads a federally funded research program that aims to improve treatment decision making, patient-physician communication and quality of life through innovative patient and family focused programs. He is also the developer of the Prostate Interactive Education System (PIES), a Web tool that helps prostate cancer patients weigh their treatment options. Source: http://www.newswise.com/p/articles/view/551565
UroToday.com - In the Lancet Oncology online edition, Dr. Andrew Vickers and collaborators report that prostate cancer (CaP) recurrence is significantly reduced with increasing surgical experience among urologists performing laparoscopic radical prostatectomy (LRP). The learning curve appears greater than that for open radical prostatectomy.
In open RP analysis, the probability of a cancer recurrence decreased after 250-350 cases. In this multicenter, international retrospective cohort all patients had LRP without use of robotic assistance. A total of 4,702 patients treated between 1998 and 2007 were eligible for analysis. These patients were treated by one of 29 surgeons with < 50 total lifetime LRPs performed by 12 surgeons (41%), 50-99 by 2 surgeons (7%), 100-249 by 10 surgeons (34%), and >250 by 5 surgeons (17%). The number of prior open RPs were also counted; 0 cases in 45% of the 29 surgeons, 1-10 in 10%, 11-99 in 17%, 100-249 in 17%, and >250 in 10% of the 29 surgeons.
Stratified by urologist experience, 30% of men were seen by a surgeon who had done less than 100 previous procedures, while half were seen by a surgeon with experience of more than 250 previous procedures. There was no correlation between surgeon experience and clinical variables, except for age with more experienced surgeons seeing slightly younger patients than less experienced surgeons. A total of 402 biochemical recurrences were recorded, for a 5-year recurrence-free probability of 82%. The risk of recurrence at 5 years decreased from 17% to 16% to 9% for a patient treated by a surgeon with 10, 250 and 750 previous LRPs, respectively. The risk difference between 10 and 750 procedures was 8%. Interestingly, surgeons with prior open RP experience had worse outcomes than surgeons with no prior open RP experience. For a surgeon with 100 previous open RPs, the relative risk increased at 5 years from 7.8% to 20.1%for an absolute risk difference of 12.3%.
Vickers AJ, Savage CJ, Hruza M, Tuerk I, Koenig P, Martínez-Piñeiro L, Janetschek G, Guillonneau B Lancet Oncol. 2009 May;10(5):475-80 Written by UroToday.com Contributing Editor Christopher P. Evans, MD,
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The Santa Cruz County Prostate Cancer Support Group does not endorse any provider, organization, product or individual. All medical decisions should be made with the advice and consultation of medical professionals.
Many THANKS to the American Cancer Society for assisting with the printing and mailing of this newsletter and the Katz Cancer Resource Center for allowing us to use their facility.