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, 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.
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 JAMA/Archives Media Relations at 312/464-JAMA or e-mail mediarelations@jama-archives.org.
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