www.OncologyEducation.ca
Intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP),
(NCIC-CTG PR.3)
Authors: Warde PR et al, ASCO 2010Abstract: CRA4504Reviewed by: Dr. Lori WoodDate posted: Jun 18 2010
www.OncologyEducation.ca
Thank you for downloading this update. Please feel free to use it for educational purposes.
Please acknowledge OncologyEducation.ca and Dr. Wood when using these slides.
www.OncologyEducation.ca
R
Treatment A: Androgen Deprivation Therapy (ADT) (Orchiectomy or LHRHa Continuous)N=602
Treatment B: ADT plus:Radiation (45 Gy/25 # to Pelvis and 20-24 Gy/10-12 # to Prostate)N=603
STUDY DESIGN
- High-risk, localized PCa - predominately T3/T4- Primary outcome: - overall survival- Statistics: - N=1200 - Goal: 10% improvement with target HR 0.76
www.OncologyEducation.ca
STUDY RATIONALE
• Designed in 1993• Emerging data:
– RT alone in high-risk prostate cancer was disappointing– Addition of ADT improved results– It was unclear if the benefit was from ADT and what the added
benefit of local RT was– MRC PR02 (1992)
• RT vs. orchiectomy vs. combination– Closed due to poor accrual– No evidence of survival benefit with RT
• Therefore the question was: Does local RT in addition to ADT improve OS in high-risk localized prostate cancer?
www.OncologyEducation.ca
RESULTS
ADT ADT/RT HR P value
Overall Survival at 7 Years
66% 74% 0.77 p=0.0331
Disease Specific Survival at 7 Years
90% 79% 0.57 p=0.001
- Results from second planned interim analysis with median follow-up of 6 years
www.OncologyEducation.ca
STUDY COMMENTARY
• The addition of radiation therapy to ADT in high-risk prostate cancer overall survival (74% vs. 66% at 7 years) disease specific survival (90% vs. 79% at 7 years)
• No significant increase in late toxicity• Relevance to 2010
– Capcure Database showed a significant amount of ADT was used alone as primary therapy
• 1990-1994: 36.7%• 2004-2007: 45.5%
– Significant variation in current therapy
• In these high risk patients, ADT and RT should be considered standard of care and not ADT alone
www.OncologyEducation.ca
BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS
• Canadian led study• If non-surgical option chosen which is the case in most
high-risk patients, the standard of care should be the combination of ADT and RT
• However:– The survival benefit may not be seen until after ~ 4 years which
needs to be taken into account in patients who have other significant co-morbidities
– There are toxicities of ADT and RT that need to be taken into account
– Optimal duration of ADT still unknown– Unknown if there would be an even greater benefit of RT if given
with current RT doses (vs. those in 1995)
