zurück Home	aktive Surveillance bei lokal begrenztem Prostata - Karzinom
Fragestellung	Kann mit einer aktiven Überwachung bei lokal begrenzten Prostatakarzinomen das gleiche Ergebnis erzielt werden wie bei einer primären Therapie?
Auswahl	low-risk prostate cancer or men: Gleason 6 or 3 + 4 = 7 >70 years with intermediate-risk disease
Patienten	450 observed median age = 70.3 years median follow-up = 6.8 years Gleason 6 (83%) or 3 + 4 = 7 (17%)
Überwachung	PSA was performed every 3 months for the first 2 years and then every 6 months thereafter for stable patients. A confirmatory biopsy was performed 6 to 12 months after the initial biopsy and every 3 to 4 years thereafter until age 80.
Beendigung der Überwachung	PSA doubling time of <2 years (from 1995 to 1999) and <3 years after 1999, b.histologic upgrade on repeat biopsy, or c.clinical progression defined as a biopsy confirmation of a prostate nodule on examination.
Ergebnisse	Ten-year overall survival and prostate cancer-specific survival were 68% and 97.2% Thirty percent of the patients were upgraded to higher risk and were offered therapy. Of the 117 patients treated based on upgraded risk who also had PSA follow-up, the PSA failure rate was 50%, representing 13% of all patients. A PSA doubling time of <3 years was associated with biochemical failure (odds ratio [OR] = 8.5; 95% confidence interval [CI] = 4.8-14.9; P<.0001) after definitive treatment, and clinical stage at initial diagnosis (OR = 2.0; 95% CI = 1.3-3.1; P=.0016) and baseline Gleason (OR = 1.8; 95% CI = 1.1-3.1; P=.0233) were associated with a patient eventually needing definitive treatment. Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012;367:203–213 Wilt et al (9) report on an effort to conduct a randomized trial of prostatectomy versus no treatment for patients ≤75 years with T1 or T2 disease and a PSA <50 ng/mL. The primary endpoint was all-cause mortality, and the secondary endpoint was prostate cancer-specific mortality. The planned number of study subjects was 2000. Because of poor accrual, however, they revised the number to 740, which they calculated would permit a 91% chance of detecting a 25% reduction in the primary endpoint. They were able to enroll 731 men from 1994 to 2002. Of the 364 assigned to treatment, only 311 (85.4%) received some type of attempted definite therapy (281 prostatectomy, 14 external beam radiation, 9 brachytherapy, 6 aborted prostatectomy due to positive lymph nodes, and 1 unspecified radiation). Of the 367 assigned to observation, only 292 (79.6%) received observation; the rest had attempted definitive therapy (36 prostatectomy, 1 aborted prostatectomy, 29 radiation, 8 brachytherapy, and 1 cryotherapy). The all-cause mortality for the treatment arm versus observation arm was 47.0% versus 49.9% (HR = 0.88; 95% CI = 0.71-1.08; P=.22). The prostate cancer-specific mortality for treatment versus observation was 5.8% versus 8.4% (HR = 0.63; 95% CI = 0.36-1.09; P=.09). There was a significant difference in the rate of bone metastases in the treatment arm of 4.7% versus 10.6% in the observation arm (HR = 0.40; 95% CI = 0.22-0.70; P<.0001). Comment: Although this trial does not directly address the question of PSA screening, it does offer insight into the effect of upfront treatment versus no treatment or delayed treatment for patients with screen-detected prostate cancer. Most have dismissed the trial as insignificant due to the poor accrual and significant crossover. Despite the crossover, the rate of metastatic disease in the treated arm was much lower than in the control arm. This reinforces the idea that treating screened patients helps reduce the metastatic burden in the population even if there is no measurable effect on survival.
Quelle	1.) Klotz L, Zhang L, Lam A, et al.: Clinical results of long-term follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol 2010;28:126–131

Impressum                           Zuletzt geändert am 22.09.2012 19:45