[Preliminary results for EORTC trial 22911: radical prostatectomy followed by postoperative radiotherapy in prostate cancers with a high risk of progression].
OBJECTIVE
Local failure after radiotherapy can arise with cancer extending beyond the capsule and/or involvement of seminal vesicles or positive surgical margins.


METHODS
After undergoing radical prostatectomy 1005 patients were randomly assigned (1999-2001) to a wait and see policy or an immediate postoperative irradiation (60 Gy delivered over 6 weeks); eligible patients had pN0 M0 tumors and one or more pathological risk factors mentioned above. The main end-point was 5-year biochemical progression free survival.


RESULTS
After a median follow-up of 5-year biochemical progression free survival was significantly improved in the irradiated group (74%, 98% CI: 68.7-79.3 vs 52.6%, 98% CI: 46.6-58.5; P<0.0001) Clinical progression free survival was also significantly improved (P<0.0009). The cumulative rate of loco-regional failure was also significantly improved (P<0.0009). Grade 2 or 3 late effects were significantly more frequent in the postoperative irradiation group (P=0.0005), but severe toxicity (grade 3 or higher) were rare with a 5-year rate of 2.6% in the wait-and-see group and 4.2% in the postoperative irradiation group (P=0.07).


CONCLUSIONS
Immediate external irradiation after radical prostatectomy improves biochemical progression free survival and local control in patients with positive surgical margin or pT3 prostate cancer who are at high risk of progression. Further follow-up is needed to assess the impact on overall survival.
Bolla
M
M
Département de Cancérologie-Radiothérapie, CHU de Grenoble, Hôpital Albert-Michallon, BP 217, 38043, Grenoble Cedex 09, France. Mbolla@chu-grenoble.fr
Van Poppel
H
H
Collette
L
L
D000368:Aged; D003131:Combined Modality Therapy; D018450:Disease Progression; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011182:Postoperative Care; D011467:Prostate / Q000473:pathology; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D011879:Radiotherapy Dosage; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors; D017211:Treatment Failure