Postoperative radiotherapy 61 Adjuvant radiotherapy ART

The results of three large phase III trials, which evaluated the merits of adjuvant versus expectant management in postoperative patients with positive surgical margins and/or pT3 disease, were reported.

EORTC 22911 confirmed the value of ART, which reduced the risk of biochemical failure and prolongs the time to clinical progression [117]. Patients eligible for this study had pT2-3N0M0 tumors and one or more pathologic risk factors (extracapsular extension (ECE), positive surgical margins (PSM), seminal vesicles invasion (SVI)). After a median follow-up of 5 years, biochemical and clinical progression-free survivals were significantly improved in the radiotherapy group (P < 0.0001 and P = 0.0009, respectively). The rate of local regional failure was also lower in the radiotherapy group (P = 0.07). Severe toxicity (grade 3 or higher) was similar, being 2.6% versus 4.2% at 5 years in the postoperative radiotherapy group (P = 0.07).

SWOG 8794 randomly assigned 473 node-negative patients initially treated with radical prostectomy, but found to have either PSM or pT3 (ECE and/or SVI) disease to ART or observation [118]. ART consisted of 60 to 64 Gy. ART resulted in an improvement in metastasis-free and overall survival compared with deferred therapy (HR 0.71; P = 0.016 and HR 0.72; P = 0.023, respectively). Although adverse effects were more common with radiotherapy versus observation, by 5 years there were no differences in health-related QOL, and a subset analysis suggests that earlier treatment is better than delayed treatment [119].

From the German Cancer Society, ARO 96-02/AU0 AP 09/95 randomized 385 patients with pT3 or PSM to either ART (60Gy in 2 Gy fractions) or observation [120]. Although this study had the short median follow-up of 40 months, ART significantly improved progression-free survival (P < 0.0001) with a low incidence of late complications from radiotherapy.

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