Surgery may be the preferred option for men younger than age 65 who are diagnosed with early-stage prostate cancer, according to extended follow-up from a randomized clinical trial. For several reasons, however, the findings may have limited applicability to men in the United States who are diagnosed with early-stage disease, several researchers said.
The results were published in the May 5 New England Journal of Medicine.
The clinical trial, conducted in Sweden, Finland, and Iceland, randomly assigned 695 men newly diagnosed with early-stage prostate cancer to immediate surgical removal of the prostate (radical prostatectomy) or watchful waiting, a less-intensive precursor to what today is typically called active surveillance. Among men younger than age 65, those who underwent immediate surgery had superior overall survival and prostate cancer-specific survival, and their risk of dying from prostate cancer was 51 percent lower than those in the watchful waiting group. (In the 15-year follow-up period, among men younger than 65, 28 men in the surgery group and 49 men in the watchful waiting group died from prostate cancer. The numbers of prostate cancer deaths for all men in the two groups were 55 and 81, respectively.)
Overall, about 15 men had to be treated to prevent one death, reported Dr. Anna Bill-Axelson of the University Hospital, Uppsala, and her colleagues. For men younger than 65, however, the number who needed to be treated to avoid one death was about seven.
The trial “has provided important evidence that effective treatment is both necessary and possible for many men with early-stage prostate cancer,” wrote Dr. Matthew R. Smith of the Massachusetts General Hospital Cancer Center in an accompanying editorial. But the findings, he cautioned, “may not be relevant for men with low-risk early-stage prostate cancers identified by PSA screening.” In the United States, the vast majority of early-stage prostate cancers are diagnosed by PSA screening, whereas only about 5 percent of cases in the Swedish trial were diagnosed in this manner.
Surgery and other common prostate cancer treatments can have serious side effects, including incontinence and erectile dysfunction, explained Dr. Barry Kramer, editor-in-chief of NCI’s Physician Data Query Screening and Prevention Editorial Board. “Because PSA screening can lead to the detection of a large number of tumors that wouldn’t have caused any medical problems in the absence of screening,” he continued, “the ratio of benefit to risk for immediate surgery can be quite different for men with PSA-detected cancers.”
In addition, the watchful waiting protocol used in the trial differs significantly from the more aggressive active surveillance protocol often used in the United States. Men in the watchful waiting arm of the trial were considered for treatment (with transurethral resection of the prostate) only if they had specific symptoms that suggested their disease was progressing.
In contrast, active surveillance programs in the United States can entail twice-yearly checkups that may include PSA testing and digital rectal exams, as well as annual or regular prostate biopsies. These may be followed by curative treatment with surgery or radiation if there is evidence of disease progression.
A recent observational study found that prostate cancer-specific survival rates in men with early-stage disease diagnosed via PSA screening who opted for active surveillance were nearly identical to those of men who opted for immediate treatment.
Results from a large, randomized U.S. trial, called PIVOT, comparing surgery with watchful waiting in men diagnosed with localized prostate cancer, are expected to be available sometime this year. Because the large majority of the men in the trial were diagnosed by PSA screening, the findings should be more applicable to current U.S. practice, Dr. Kramer said.
NCI Cancer Bulletin for May 17, 2011 - National Cancer Institute
N Engl J Med. 2011 May 5;364(18):1708-17.
Radical prostatectomy versus watchful waiting in early prostate cancer.
Bill-Axelson A, Holmberg L, Ruutu M, Garmo H, Stark JR, Busch C, Nordling S, Häggman M, Andersson SO, Bratell S, Spångberg A, Palmgren J, Steineck G, Adami HO, Johansson JE; SPCG-4 Investigators.
Collaborators (65)Adami, Johansson, Norlén, Andersson, Bill-Axelson, Bratell, Busch, Häggman, Johansson, Nordling, Ruutu, Spångberg, Adami, Bill-Axelson, Busch, Holmberg, Garmo, Johansson, Palmgren, Stark, Steineck, Bill-Axelson, Holmberg, Adami, Bill-Axelson, Garmo, Holmberg, Stark, Adami, Bill-Axelson, Bratell, Busch, Garmo, Holmberg, Johansson, Stark, Steineck, Adami, Bill-Axelson, Holmberg, Johansson, Steineck, Bill-Axelson, Holmberg, Johansson, Steineck, Busch, Nordling, Lindeborg T, Einarsson G, Ekman P, Wijkström H, Karlberg L, Hagberg G, Busch C, de la Torre M, Hamberg H, Lindgren A, Mavadati E, Gobén B, Pettersson I, Damberg JE, Lindgren A, Varenhorst E, Norlén BJ.
Source
Department of Urology, University Hospital, Uppsala, Sweden. anna.bill.axelson@akademiska.se
Abstract
BACKGROUND: In 2008, we reported that radical prostatectomy, as compared with watchful waiting, reduces the rate of death from prostate cancer. After an additional 3 years of follow-up, we now report estimated 15-year results.
METHODS: From October 1989 through February 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy. Follow-up was complete through December 2009, with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death. Relative risks, with 95% confidence intervals, were estimated with the use of a Cox proportional-hazards model.
RESULTS: During a median of 12.8 years, 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died (P=0.007). In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting, death was due to prostate cancer. This yielded a cumulative incidence of death from prostate cancer at 15 years of 14.6% and 20.7%, respectively (a difference of 6.1 percentage points; 95% confidence interval [CI], 0.2 to 12.0), and a relative risk with surgery of 0.62 (95% CI, 0.44 to 0.87; P=0.01). The survival benefit was similar before and after 9 years of follow-up, was observed also among men with low-risk prostate cancer, and was confined to men younger than 65 years of age. The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age. Among men who underwent radical prostatectomy, those with extracapsular tumor growth had a risk of death from prostate cancer that was 7 times that of men without extracapsular tumor growth (relative risk, 6.9; 95% CI, 2.6 to 18.4).
CONCLUSIONS: Radical prostatectomy was associated with a reduction in the rate of death from prostate cancer. Men with extracapsular tumor growth may benefit from adjuvant local or systemic treatment. (Funded by the Swedish Cancer Society and the National Institutes of Health.).
Comment in
N Engl J Med. 2011 May 5;364(18):1770-2.
PMID:21542742[PubMed - indexed for MEDLINE]
Radical prostatectomy versus watchful waiting in e... [N Engl J Med. 2011] - PubMed result
Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer — NEJM
Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer — NEJM
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