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

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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

Date posted: June 21, 2007

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Treatment A:

ADT x 30 months

Treatment B:

No further ADT

Locally advancedprostate cancer

T1c-T2b N1-2 orT2c-T4 N0-2M0PSA 150WHO PS 2

(n=1117)

Pelvic EBRT+ 6 months ADT

(n=970)

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RESULTS

SADT

(n=483)

LADT

(n=487)HR p-value

5-y OS 80.6% 85.3% 1.43 (1.04-1.98) p=0.0191

5-y Biochemical Failure PFS

58.9% 78.3% 2.29 (1.81-2.90) p0.0001

5-y Clinical PFS 68.9% 81.8% 1.93 (1.49-2.51) p0.0001

QOL

(EORTC QLQ30)= = NS

*Primary objective: non-inferior OS; median follow-up 7 years.

SADT: short term ADT, LADT: long term ADT

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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.

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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.