| zurück Home | AIO-GC-0121/SAKK 01/18 - Studie | |||||||||
| allgemeines | Gemeinschaftsprojekt der Schweizer Arbeitsgemeinschaft für klinische Krebsforschung und der GTCSC (BRD) | |||||||||
| Fragestellung | De-Eskalation beim Seminom IIA/B möglich? | |||||||||
| Ergebnis | Studie rekrutiert noch. | |||||||||
Prognosefaktoren |
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| Therapie |
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Einschluss |
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Zentren |
Berlin-Buch, Berlin am U rban, UKE, Hamburg Altona | |||||||||
Teil von |
Tumoren endokriner Organe | Hoden-Karzinom | urologische Tumoren | Onkologie | ||||||
| Quelle |
1.) , et al.: |
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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