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The National Comprehensive Cancer Network (NCCN) has issued new practice guidelines for managing certain patients with prostate cancer. The guidelines now recommend active surveillance—without treatment—for men with “low-risk” tumors and a life expectancy <10 years and for those with “very low-risk” tumors whose life expectancy is <20 years. Bhupinder Mann, MD, from the NCI’s Division of Cancer Treatment and Diagnosis, said nearly half of the prostate cancer cases diagnosed in 2009 would likely fall under the NCCN’s definition of low risk (Table
). “Very low risk” is a new designation developed for the guideline revisions. It relies on modified Epstein criteria for clinically insignificant prostate cancer.
The NCCN says both categories of men for whom the guidelines recommend taking a watchful waiting approach should receive PSA testing at least every 6 months and an annual digital rectal examination. The NCCN guidelines require performing an initial needle biopsy. A second biopsy is optional for these patients, with the frequency dependent on how many cores were obtained during the first biopsy. In cases where at least 10 cores were obtained, the NCCN panel says a follow-up biopsy can be repeated within 18 months. If fewer than 10 cores were taken during the initial biopsy, a subsequent biopsy can be repeated within 6 months.
For men with low-risk tumors whose life expectancy is >10 years, the NCCN guidelines require a repeat biopsy as often as every 12 months. In addition, treatment options such as radiotherapy and radical prostatectomy should be considered.
James L. Mohler, MD, Roswell Park Cancer Institute, Buffalo, New York, chaired the NCCN panel that developed the new guideline recommendations. He said the panel based the guideline revisions on data published in 2009 from two large clinical trials that showed widespread prostate cancer screening contributed to significant over-diagnosis and overtreatment. Mohler said overtreatment leads to unnecessary suffering and expense.
The NCCN panel acknowledged that an active surveillance approach would lead to some men progressing to aggressive tumors that are more difficult to cure. Mohler estimated the risk of a “significant tumor grade increase” at approximately 5% and the risk of an increase in PSA levels at 16% to 25%. For patients whose disease progresses, the NCCN recommends pursuing more curative treatments, such as surgery or radiotherapy.
“Although the NCCN Guidelines Panel stresses the importance of considering active surveillance, ultimately this decision must be based on careful individualized weighting of a number of factors, including life expectancy, disease characteristics, general health condition, potential side effects of treatment, and patient preference,” Mohler said. “It is an option that needs to be thoroughly discussed with the patient and all of his physicians, which may include his urologist, radiation oncologist, medical oncologist, and primary care physician.” The new guidelines underscore the importance of establishing ways to identify at diagnosis which prostate cancer tumors are more likely to be aggressive and which patients would benefit from early treatment.
One concern in applying the new guidelines is how to estimate reliably someone’s life expectancy. On page PROS-A of the guidelines, the NCCN outlines the “Principles of Life Expectancy Estimation,” suggesting that physicians use the Social Security Administration tables at www.ssa.gov/OACT/ STAT/table4c6.html and adjust estimates based on an assessment of the patient’s overall health. For patients in the best quartile of health, add 50%; for those in the worst quartile, subtract 50%; and for those in the middle two quartiles of health, no adjustment is needed.
Experts at the upcoming Third Annual Interdisciplinary Prostate Cancer Congress on March 27 in New York City (see p. 10) plan to discuss the guideline revisions and how to apply them in clinical care. To see a list of all the changes, visit the NCCN Website at www. NCCN.org, and download a free PDF of the NCCN Clinical Practice Guidelines in Oncology Prostate Cancer, V.1.2010.