|Year : 2006 | Volume
| Issue : 1 | Page : 80-81
Radical prostatectomy versus watchful waiting in early prostate cancer
A Karthikeyan, J Chandra Singh, Nitin S Kekre
Department of Urology, Christian Medical College, Vellore - 632 004, Tamilnadu, India
Department of Urology, Christian Medical College, Vellore - 632 004, Tamilnadu
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Karthikeyan A, Singh J C, Kekre NS. Radical prostatectomy versus watchful waiting in early prostate cancer. Indian J Urol 2006;22:80-1
Bill-Axelson A, Holmberg L, Ruutu M, Haggman M, Andersson SO, Bratell S et al.Radical prostatectomy versus watchful waiting in early prostate cancer.N Engl J Med. 2005;352:1977-84.
| Summary|| |
Though prostate cancer is one of the most common cancers in men over the age of fifty, the treatment has been highly controversial, especially for localized prostate cancer. There were no randomized trials to demonstrate any survival benefit with aggressive management of localized prostate cancer. The authors investigated whether there is survival benefit with radical prostatectomy (RP), in a multicentric randomized control trial. 695 men with early prostate cancer were randomly assigned to radical prostatectomy, or watchful waiting (WW). After a median follow up of 8.2 years, they have reported the estimated 10 years results. Men with life expectancy less than 10 years, poorly differentiated cancers and those with second malignancy, were excluded. Well and moderately differentiated T1b, T1c, T2 cancers were included for the study. Men in the WW group received no initial treatment. For symptomatic local progression, transurethral resection in the WW group and hormonal treatment in the RP group, was recommended. Hormonal treatment was initiated for those with disseminated disease in both the groups. The end points were disease specific death, distant metastasis, local progression and death from any cause. Relative risk and difference in cumulative incidence with 95 percent confidence intervals, were used as measures of effect, for each end point. Relative risks were estimated from the Cox proportional hazards model. Disease-specific death and death from any cause, were calculated using low absolute risks.
During follow up, 30 men in the RP group and 50 men in the watchful waiting group, died of prostatic cancer ( P = 0.01). Fifty-three and fifty-six men died of other causes in the RP and WW group, respectively. In terms of death from any cause, 83 and 106 men died in the RP and WW group, respectively ( P =0.04). The difference in the cumulative incidence of death from prostate cancer increased between the two groups over time, from 2 percentage points, after 5 years of follow up to 5.3 percentage points, after 10 years in favour of RP. The cumulative incidence of distant metastasis was similar in the two groups during the first five years, but at 10 years of follow up, absolute risk reduction was 10.2 percentage points. The absolute risk reduction for local progression after 10 years of follow up was 25.1 percentage points ( P =<0.001). The cumulative incidence of death from any cause was similar in the two groups during the first five years, but at 10 years the absolute risk reduction was 5.0 percentage points ( P = 0.04).
| Comments|| |
This trial was conducted in a select group of patients to assess the survival benefit, with RP in men with localized prostate cancer. Various observational cohort studies have analyzed the survival rates among patients managed conservatively by WW., These studies were flawed by the lack of randomized trials and by the possibility of selection biases. Two long term observational studies,, suggested that patients with long life expectancy had a greater likehood of prostate cancer mortality, when managed conservatively. The results of this trial have provided concrete evidence in favour of RP. The authors found that the overall mortality is reduced with RP. Prostate cancer was diagnosed through screening in only 10% of patients. The results of this study therefore, cannot be generalized in men detected through PSA screening.
The 10 year's estimate showed that RP is associated with a moderate reduction in mortality, in absolute terms. The difference in mortality may increase with longer follow up, as median survival of men with distant metastasis is two to three years. The pitfall in this trial was that men in the WW group received hormonal treatment, when they developed metastasis. If these patients would have received hormonal treatment when they had local progression, the disease specific mortality might have been different. The survival benefit of RP in poorly differentiated tumors is unknown from this trial. If the results of this trial can be reproduced in other multicentric randomized trials, physicians can safely recommend RP for clinically detected localized prostate cancer. Until then, physicians must inform patients with prostate cancer about the various treatment options and the results of this trial can be of some help in decision making.
| References|| |
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