Older men treated for early prostate cancer live longer than those who are not
An observational study published in JAMA finds men who were treated 31 percent less likely to die
(PHILADELPHIA) – Recent findings from an observational study by researchers at the University of Pennsylvania School of Medicine suggest that men between 65 and 80 years of age who received treatment for early stage, localized prostate cancer lived significantly longer than men who did not receive treatment. The study will be published in the December 13th issue of the Journal of the American Medical Association.
Thanks to better cancer prevention education and the resulting wide-spread increase in using prostate-specific antigen (PSA) screenings, more men are being diagnosed with early-stage and low-or intermediate-grade prostate cancer. Studies have shown that the slow-developing nature of prostate cancer during its earliest stages makes treatment options, such as a radical prostatectomy (surgical removal of the prostate) and radiation therapy, controversial with unpredictable outcomes. Often, recently diagnosed men of this group were advised to just "watch and wait" to see how their situation progressed.
"For this study we looked back over the existing data of a large population of prostate cancer patients, aged 65 to 80, with small tumors that were at a low or intermediate risk of spreading," said senior author Katrina Armstrong, MD, MSCE, who worked on the study with colleagues from Penn's Abramson Cancer Center, Center for Clinical Epidemiology and Biostatistics, Leonard Davis Institute of Health and Economics, and Division of Internal Medicine, and Fox Chase Cancer Center. "After accounting for all their differences, we discovered that the men – who within six months of diagnosis underwent surgery or radiation therapy – were 31 percent less likely to die than those who did not undergo treatment during that time."
Researchers acquired the necessary data for this study from the Surveillance, Epidemiology, and End Results (SEER) Medicare database, a population-based cancer registry which encompasses approximately 14 percent of the US population. Data was included on 44,630 men, aged 65 to 80, who were diagnosed between 1991-1999, with prostate cancer and had survived more than a year after diagnosis. All patients were followed-up until death or December 31st, 2002, the end of the study. Of the 44,630 men, 32,022 (71.8 percent) were actively treated with either surgery or radiation therapy during the first six months after diagnosis. The remaining group of 12,608 (28.3 percent) were classified as having received "observation" and did not undergo surgery, radiation or hormonal therapy.
During the 12-years of follow-up, researchers found that the patients who received treatment had a 31 percent lower risk of death. In the observation-only group, 37 percent of the patients died whereas only 23.8 percent of those in the treatment group died.
Since this was not a randomized, controlled study but a retrospective analysis of existing data, the researches had to perform extensive statistical adjustments to account for study participants differences. Even with all these differences taken into account, there was still a significant improvement in the overall survival of those men who received active treatment. "This benefit was also seen across the board in all subgroups examined, including African-American men and older men aged 75-80 at diagnosis," added Armstrong. "However, as we summarized in the study, because observational data can never completely adjust for potential selection bias and confounding, our results must be validated by rigorous randomized controlled trials of elderly men with localized prostate cancer before the findings can be used to influence treatment decisions."
This study was funded by the Center for Population Health and Health Disparities at the University of Pennsylvania, Public Health Services Grant P50-CA105641.
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Contact: Olivia Fermano
Olivia.Fermano@uphs.upenn.edu
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University of
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Treating prostate cancer in elderly men associated with longer survival, compared to non-treatment
CHICAGO—New findings from an observational study suggest that elderly men who received treatment for localized prostate cancer survived significantly longer than men who did not receive treatment, according to a study in the December 13 issue of JAMA; however, the investigators emphasize the importance of validating these results in randomized trials.
The widespread adoption of prostate-specific antigen (PSA) screening has led to an increasing proportion of men being diagnosed with early-stage and low– or intermediate–grade prostate cancer. Studies have demonstrated the slow-developing nature of low- and intermediate-grade prostate cancer, making management options (observation, radiation therapy, and radical prostatectomy) controversial, with uncertain outcomes. This is also applies to men older than 65 years, because of a lack of information from randomized trials. When randomized controlled trial data are not available, observational studies can provide insight into important clinical questions, according to background information in the article
Yu-Ning Wong, M.D., of the Fox Chase Cancer Center, Philadelphia, and colleagues evaluated the association of active treatment (radiation or prostatectomy) vs. observation on overall survival in a large sample of elderly men treated for low– or intermediate–risk localized prostate cancer. The researchers used data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database, a population-based cancer registry encompassing approximately 14 percent of the U.S. population.
This study included data on 44,630 men age 65 to 80 years who were diagnosed between 1991-1999 with prostate cancer and who had survived more than a year past diagnosis. Patients were followed up until death or study end (December 31, 2002). Patients were classified as having received treatment (n = 32,022) if they had claims for radical prostatectomy or radiation therapy during the first 6 months after diagnosis. They were classified as having received observation (n = 12,608) if they did not have claims for radical prostatectomy radiation or hormonal therapy. Patients who received only hormonal therapy were excluded.
The researchers found that patients who received treatment had a 31 percent lower risk of death during the 12-years of follow-up. In the observation group, 4,643 patients died (37 percent) and 7,639 patients (23.8 percent) in the treatment group died. Active treatment was associated with a significant improvement in survival in the study overall. A benefit associated with treatment was seen in all subgroups examined, including older men (age 75-80 years at diagnosis), black men, and men with low-risk disease.
“In summary, even though prostate cancer commonly is considered an indolent
[slow to develop and painless] disease, this observational study suggests a
reduced risk of mortality associated with active treatment for low- and
intermediate-risk prostate cancer in the elderly Medicare population examined.
Because observational data can never be free of concerns about selection bias
and confounding, these results must be validated by rigorous randomized
controlled trials of elderly men with localized prostate cancer before the
findings can be used to inform treatment decisions,” the authors write.
(JAMA.
2006;296:2683-2693. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Media Advisory: To contact Yu-Ning Wong, M.D., call Karen Mallet at 215-728-2700. To contact editorial co-author Mark S. Litwin, M.D., M.P.H., call Kim Irwin at 310-206-2805.
EDITORIAL: TREATING OLDER MEN WITH PROSTATE CANCER — SURVIVAL (OR SELECTION) OF THE FITTEST?
In an accompanying editorial, Mark S. Litwin, M.D., M.P.H., and David C. Miller, M.D., M.P.H., of the University of California, Los Angeles, comment on the findings of Wong and colleagues.
“Improvement in the quality of care for men with prostate cancer may best be achieved not by treating more patients but by treating them more discerningly. Clinicians must remain steadfast in their efforts to reduce overtreatment and undertreatment by thoughtfully defining each patient’s unique balance between the natural history of prostate cancer and that individual patient’s life expectancy.”
“The reported association between treatment and improved survival for older
men with low- and intermediate-risk prostate cancer will be confirmed or refuted
by the results of ongoing randomized controlled trials … Until then,
physicians should apply these provocative findings judiciously and continue
their concerted efforts to help patients make informed treatment decisions based
not only on survival predictions but also on health status, functional concerns,
and—most importantly—personal preference,” they write.
(JAMA.
2006;296:2733-2734. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the editorial for additional information, including financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations@jama-archives.org.