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Reviewer: Dr Lori Wood Date posted: June 21, 2007

Concomitant and adjuvant androgen deprivation (ADT) with external beam irradiation (RT) for locally advanced prostate cancer: 6 months versus 3 years ADT – Results of the randomized EORTC Phase III trial 22961 Authors: Bolla et al, ASCO 2007. Abstract: 5014. Reviewer: Dr Lori Wood

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Reviewer: Dr Lori Wood Date posted: June 21, 2007

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  1. Concomitant and adjuvant androgen deprivation (ADT) with external beam irradiation (RT) for locally advanced prostate cancer: 6 months versus 3 years ADT – Results of the randomized EORTC Phase III trial 22961Authors: Bolla et al, ASCO 2007.Abstract: 5014 Reviewer: Dr Lori Wood Date posted: June 21, 2007

  2. Treatment A: ADT x 30 months Locally advanced prostate cancer T1c-T2b N1-2 or T2c-T4 N0-2 M0 PSA  150 WHO PS  2 (n=1117) Pelvic EBRT + 6 months ADT (n=970) Treatment B: No further ADT

  3. RESULTS *Primary objective: non-inferior OS; median follow-up 7 years. SADT: short term ADT, LADT: long term ADT

  4. STUDY COMMENTARY • All patients were treated with ADT for 6 months (combined androgen blockade) along with external beam radiotherapy and then randomized to either 30 further months of ADT (LHRH agonist monotherapy) or no further ADT. • The study was designed to show non-inferiority between short-term and-long term ADT. • The study was stopped at a preplanned interim analysis. • Long-term ADT significantly increased 5-year biochemical PFS (78.3% vs 58.9%), 5-year clinical PFS (81.8% vs 68.9%) and 5-year overall survival (85.3% vs 80.6%) in this patient population. • This study’s conclusions support the previous EORTC study published by Bolla et al (NEJM 1997, Lancet 2002) showing a benefit with 3 years of ADT in patients with locally advanced prostate cancer treated with external beam radiotherapy.

  5. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • In this prostate cancer patient population with T1c to N+ disease, patients treated with pelvic external beam RT, 3 years of ADT should be an option after a thorough discussion regarding acute and long- term side effects of ADT. • This study further supports a practice that has already been used by many radiation oncologists for patients with locally advanced prostate cancer based on the previous EORTC data published by Bolla et al. • In Canada, many radiation oncologists would consider monotherapy vs combined androgen blockade (CAB) to be the standard of care and may not use CAB for the initial 6 months as was done in this study.

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