Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911)

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• 作者：Prof Michel Bolla ; MD^a ; ^{mbolla@chu-grenoble.fr} ; Prof Hein van Poppel ; MD^b ; Prof Bertrand Tombal ; MD^d ; Kris Vekemans ; MD^f ; Luigi Da Pozzo ; MD^g ; Theo M de Reijke ; PhD^h ; Antony Verbaeys ; MD^j ; Prof Jean-Franç ; ois Bosset ; MD^k ; Prof Roland van Velthoven ; MD^l ; Prof Marc Colombel ; MD^m ; Cees van de Beek ; MDⁿ ; Paul Verhagen ; PhD^o ; Alphonsus van den Bergh ; PhD^p ; Cora Sternberg ; MD^q ; Prof Thomas Gasser ; MD^r ; Geertjan van Tienhoven ; MDⁱ ; Prof Pierre Scalliet ; MD^e ; Prof Karin Haustermans ; MD^c ; Laurence Collette ; PhD^s ; for the European Organisation for Research ; Treatment of Cancer ; Radiation Oncology ; Genito-Urinary Groups
• 刊名：The Lancet
• 出版年：2012
• 出版时间：8-14 December, 2012
• 年：2012
• 卷：380
• 期：9858
• 页码：2018-2027
• 全文大小：381 K

文摘

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Summary

Background

We report the long-term results of a trial of immediate postoperative irradiation versus a wait-and-see policy in patients with prostate cancer extending beyond the prostate, to confirm whether previously reported progression-free survival was sustained.

Methods

This randomised, phase 3, controlled trial recruited patients aged 75 years or younger with untreated cT0-3 prostate cancer (WHO performance status 0 or 1) from 37 institutions across Europe. Eligible patients were randomly assigned centrally (1:1) to postoperative irradiation (60 Gy of conventional irradiation to the surgical bed for 6 weeks) or to a wait-and-see policy until biochemical progression (increase in prostate-specific antigen >0¡¤2 ¦Ìg/L confirmed twice at least 2 weeks apart). We analysed the primary endpoint, biochemical progression-free survival, by intention to treat (two-sided test for difference at ¦Á=0.05, adjusted for one interim analysis) and did exploratory analyses of heterogeneity of effect. This trial is registered with , number .

Findings

1005 patients were randomly assigned to a wait-and-see policy (n=503) or postoperative irradiation (n=502) and were followed up for a median of 10¡¤6 years (range 2 months to 16¡¤6 years). Postoperative irradiation significantly improved biochemical progression-free survival compared with the wait-and-see policy (198 [39¡¤4 % ] of 502 patients in postoperative irradiation group vs 311 [61¡¤8 % ] of 503 patients in wait-and-see group had biochemical or clinical progression or died; HR 0¡¤49 [95 % CI 0¡¤41-0¡¤59]; p<0¡¤0001). Late adverse effects (any type of any grade) were more frequent in the postoperative irradiation group than in the wait-and-see group (10 year cumulative incidence 70¡¤8 % [66¡¤6-75¡¤0] vs 59¡¤7 % [55¡¤3-64¡¤1]; p=0.001).

Interpretation

Results at median follow-up of 10¡¤6 years show that conventional postoperative irradiation significantly improves biochemical progression-free survival and local control compared with a wait-and-see policy, supporting results at 5 year follow-up; however, improvements in clinical progression-free survival were not maintained. Exploratory analyses suggest that postoperative irradiation might improve clinical progression-free survival in patients younger than 70 years and in those with positive surgical margins, but could have a detrimental effect in patients aged 70 years or older.

Funding

Ligue Nationale contre le Cancer (Comit¨¦ de l'Is¨¨re, Grenoble, France) and the European Organisation for Research and Treatment of Cancer (EORTC) Charitable Trust.