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M. Wirth Department of Urology, Technical University of Dresden

M. Wirth Department of Urology, Technical University of Dresden. Adjuvant or Salvage Radiotherapy after Radical Prostatectomy. Adjuvant or Salvage Radiotherapy after Radical Prostatectomy: Background. PSA-relapse after RPE in locally advanced PCa (n=2091).

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M. Wirth Department of Urology, Technical University of Dresden

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  1. M. Wirth Department of Urology, Technical University of Dresden • Adjuvant or Salvage Radiotherapy after Radical Prostatectomy

  2. Adjuvant or Salvage Radiotherapy after Radical Prostatectomy: Background

  3. PSA-relapse after RPE in locally advanced PCa (n=2091) % PSA-relapse (0.2 ng/ml) after 10 years 100 80 60 preop. PSA 40 20+ ng/ml 20 10.1-20 ng/ml 4.1-10 ng/ml 0-4 ng/ml 0 6- 4+3 8-10 3+4 Gleason-Score Han, Partin et al., J Urol 2003

  4. extracapsular: 82 % organconfined: 18 % cT3: MSKCC-Nomogramm: pT Stage Exampel: cT3, PSA 10 ng/ml, Gleason 4+4=8 Ohori, Kattan et al., J Urol 2004

  5. extracapsular: 50 % organconfined: 50 % cT3:MSKCC-Nomogramm:pT-Stage Exampel: cT3, PSA 10 ng/ml, Gleason 3+3=6 Ohori, Kattan et al., J Urol 2004

  6. Adjuvant or Salvage Radiotherapy after Margin Positive Radical Prostatectomy • Patients with R1 after RPE are at an increased risk of biochemical, local and distant failure [1]. • With R1, the risk of biochemical recurrence may supersede 50 % after 10-years [2]. • The associated 10-year local recurrence rate accounts for narrowly 30 % [2]. 1 EAU guidelines 2008; 2 Pfitzenmaier et al., BJU Int 2008

  7. Adjuvant Radiotherapy vs. Wait-and-see after Radical Prostatectomy

  8. Wait-and-see vs. immediate postoperative radiotherapy - EORTC trial 22911 (n=1005) • randomised controlled trial • pT3 or positive margins, pN0 • age < 76 years, WHO perf. status 0-1 • wait-and-see (n=503) vs. irradition (60 Gy) within 16 w. after RPE (n=502) • Bolla et al., Lancet 2005

  9. wait-and-see vs. immediate postoperative radiotherapy - EORTC trial 22911 (n=1005) • age 65 y. (61-69) • PSA: 12.4 ng/ml (7.2-20.3) • PSA: 3 weeks after RPE, before RTX0.2 (0.0-0.3) • median FU 5 y. • biochemical and clinical progression free survival significantly improved after ART • overall survival with trend towards improvement after ART, but not (yet?) significant • Bolla et al., Lancet 2005

  10. EORTC trial 22911 (n=1005)clinical progression free survival Clinical progression-free survival • Bolla et al., Lancet 2005

  11. EORTC trial 22911 (n=1005)biochemical progression free survival PSA progression-free survival • Bolla et al., Lancet 2005

  12. EORTC trial 22911 (n=1005) cumulative incidence of locoreg. failure local progression-free survival • Bolla et al., Lancet 2005

  13. Patients who benefit from immediate postoperative RT – EORTC trial 22911 (n=1005) Van der Kwast, JCO 2007

  14. Patients who benefit from immediate postoperative RT – EORTC trial 22911 (n=1005) Margins ECE SV Gleason Postop. PSA Van der Kwast, JCO 2007

  15. Patients who benefit from immediate postoperative RT – EORTC trial 22911 (n=1005) Van der Kwast, JCO 2007

  16. Patients who benefit from immediate postoperative RT – EORTC trial 22911 (n=1005) control arm Van der Kwast, JCO 2007

  17. Patients who benefit from immediate postoperative RT – EORTC trial 22911 (n=1005) immediate postoperative radiation Van der Kwast, JCO 2007

  18. EORTC trial 22911 (n=1005)cumulative incidence of late complications Late complications • Bolla et al., Lancet 2005

  19. Adjuvant RTX for T3N0M0 PCA – randomised SWOG trial 8794 (n=425) • Randomised controlled trial • clinical T1/T2 preoperatively • pT3 or positive margins, N0 M0 • WHO perf. status 0-2 • Wait-and-see (n=211) vs. Irradition (60-64 Gy, n=214) • Thompson et al., J Urol 2009

  20. 100 80 60 Percentage 40 20 0 Adjuvant RT in pT3 PCA (randomised study SWOG 8794, n=425) Thompson et al., JAMA 2006

  21. Adjuvant RTX for T3N0M0 PCA – randomised SWOG trial 8794 (n=425) Overall survival p=0.023 • Thompson et al., J Urol 2009

  22. Adjuvant RTX for T3N0M0 PCA – randomised SWOG trial 8794 (n=425) Metastatic-free survival p=0.016 • Thompson et al., J Urol 2009

  23. Adjuvant RTX for T3N0M0 PCA – randomised SWOG trial 8794 (n=425) Metastatic-free survival, PSA < / > 0.2 p=0.03 • Thompson et al., J Urol 2009

  24. Adjuvant RTX for T3N0M0 PCA – randomised SWOG trial 8794 (n=425) Summary • Thompson et al., J Urol 2009

  25. Adjuvant radiotherapy after RPE (ARO 96-02 / AUO AP 09/95, pT3R0-1, PSA 0, n=108) % PSA recurrence after 4 years 100 p<0.0001, hazard ratio 0.4 80 60 81 % 40 60 % 20 0 adjuvant RT (60 Gy)no adjuvant RT Wiegel et al., ASCO 2005 [in press as full article: J Clin Oncol 2009]

  26. RPE with and without adjuvant RT in pT3-PCA Bottke and Wiegel, Urol Int 2007

  27. Adjuvant radiotherapy following radical prostatectomy for pathologic T3 or margin-positive prostate cancer A systematic review and meta-analysis Survival Biochemical progression Morgan et al., Radiother Oncol 2008

  28. Salvage Radiotherapy vs. Observation at PSA Failure after Radical Prostatectomy

  29. PCA specific survival following salvage RTX vs observation after RPE – survival • no salvage treatment (n=397) vs. salvage radiotherapy (n=160) vs. salvage radiotherapy + HT (n=78) • significant increase of PC-specific survival for both SRT (HR 0.32, p<0.001) and SRT+HT (HR 0.34, p=0.003) • improvement limited to patients with - PSA-doubling time < 6 month - SRT within 2 y. after recurrence • Trock et al., JAMA 2009

  30. PCA specific survival following salvage RTX vs. observation after RPE – survival PCA specific survival • Trock et al., JAMA 2009

  31. PSA failure following salvage radiotherapy – CaPSURE data (retrospective study, n=194) Macdonald et al., Urol Oncol 2008

  32. Radiotherapy at biochemical recurrence after RPE(retrospective study, n=162) No biochemical recurrence Wiegel et al., IJROBP 2008

  33. Radiotherapy at biochemical recurrence after RPE(retrospective study, n=162) No biochemical recurrence Wiegel et al., IJROBP 2008

  34. Radiotherapy at biochemical recurrence after RPE(retrospective study, n=162) No biochemical recurrence Wiegel et al., IJROBP 2008

  35. Salvage RTX at PSA progression: long-term efficacy Literature review 35-54 % Bottke and Wiegel, Urologe 2008

  36. Arguments pro delayed radiotherapy for positive surgical margins • Questionable survival advantage for immediate adjuvant RTX • Sparing of side effects and costs in about 50 % of patients • Improved risk stratification by monitoring of PSA value and PSA kinetics • High rate of disease control with timely applied salvage therapy

  37. Adjuvant vs. Salvage Radiotherapy after Radical Prostatectomy

  38. Adjuvant vs. Salvage Radiotherapy Matched-control analysis (n=192) Five-year freedom from biochemical failure from end of RT Trabulsi et al., Urology 2008

  39. Adjuvant vs. Salvage Radiotherapy Matched-control analysis (n=192) Five-year freedom from biochemical failure from end of surgery Trabulsi et al., Urology 2008

  40. Adjuvant and Salvage RTX after RPE Biochemical failure free survival Adjuvant RT Salvage RT n=410 Jereczek-Fossa, IntJRadOncol 2008

  41. Adjuvant and Salvage RTX after RPE Grade 2 or greater rectal and urinary toxicity n=410 Adjuvant RT Salvage RT Jereczek-Fossa, IntJRadOncol 2008

  42. Adjuvant and Salvage RTX after RPE Biochemical failure free survival • Taylor et al., IntJRadOncBiolPhys 2003

  43. Adjuvant and Salvage RTX after RPE Biochemical failure free survival • Taylor et al., IntJRadOncBiolPhys 2003 Adjuvant RT

  44. Adjuvant and Salvage RTX after RPE Biochemical failure free survival • Taylor et al., IntJRadOncBiolPhys 2003 Salvage RT +/- adj. androgen ablation

  45. Adjuvant RTX for pN+ disease?

  46. Conclusions: This study is the first to report a significant protective role for adjuvant RT in BCR-free survival and CSS of node-positive patients. Da Pozzo et al., Eur Urol 2009

  47. Adjuvant RTX for pN+ disease (retrospective study, n=250) No biochemical failure Da Pozzo et al., Eur Urol 2009

  48. Adjuvant RTX for pN+ disease (retrospective study, n=250) PCA-specific survival Da Pozzo et al., Eur Urol 2009

  49. RT for PSA-Recurrence after RPE: Dosage?(n=122) No new PSA-recurrence p<0.0001 0 3 6y King et al. IJROBP 2008

  50. odds-ratio for secondary malignancy 2 1.5 1.89 (1.85-1.95) 1 0.5 0 PCA, RT PCA, no RT RT in prostate cancer induces secondary malignancies (n=130.375 vs. 375.235) ! Chamie et al., AUA 2008 #393

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