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ARO 96-02, AUO AP09/95 |
| Fragestellung |
Kann eine postoperative Bestrahlung bei
T3-Prostata - Tumoren ohne nachweisbaren PSA-Spiegel das Ergebnis verbessern? |
| Ergebnis |
Eine postoperative Bestrahlung bei T3-Tumoren
reduziert das Risiko eines biochemischen Rezidivs. |
| 5a ohne PSA-Rezidiv |
mit RT |
ohne RT |
p |
| 72% |
54% |
0,0015 |
Prognosefaktoren |
Gleason >6, praeoperatives PSA, Stadium, Resektionsränder |
| Behandlungs-Arm |
radikale Prostatektomie und Nachbestrahlung |
| Kontrollarm |
radikale Prostatektomie ohne Bestrahlung |
Einschluss |
- 307 Männer
- pT3 pNo
- postoperativ kein PSA nachweisbar
|
| Quelle |
1.) Wiegel T, et al.:
Phase III postoperative adjuvant radiotherapy after
radical prostatectomy
compared with radical prostaectomy alone in pT3 prostatic cancer with
postoperative undetectable prostate-specific antigen.
ARO 96-02 / AUO AP
09/95.
JCO 27(2009): 2924-30
2.) Wiegel T, et al.:
Adjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year
follow-up of the ARO 96-02/AUO AP 09/95 trial.
Eur Urol 2014;66:243-50.
Doi: 10.1016/j.eururo.2014.03.011.
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DESIGN, SETTING, AND PARTICIPANTS: After RP, 388 patients with pT3 pN0
prostate cancer (PCa) were randomized to WS or three-dimensional conformal
ART with 60 Gy. The present analysis focuses on intent-to-treat patients who
achieved an undetectable prostate-specific antigen after RP (ITT2
population)--that is, 159 WS plus 148 ART men. OUTCOME MEASUREMENTS AND
STATISTICAL ANALYSIS: The primary end point of the study was
progression-free survival (PFS) (events: biochemical recurrence, clinical
recurrence, or death). Outcomes were compared by log-rank test. Cox
regression analysis served to identify variables influencing the course of
disease. RESULTS AND LIMITATIONS: The median follow-up was 111 mo for ART
and 113 mo for WS. At 10 yr, PFS was 56% for ART and 35% for WS (p<0.0001).
In pT3b and R1 patients, the rates for WS even dropped to 28% and 27%,
respectively. Of all 307 ITT2 patients, 15 died from PCa, and 28 died for
other or unknown reasons. Neither metastasis-free survival nor overall
survival was significantly improved by ART. However, the study was
underpowered for these end points. The worst late sequelae in the ART cohort
were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2
cases of rectum toxicity. No grade 4 events occurred.
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