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Addition of radiation to ADT improved OS in locally advanced prostate cancer
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Combined treatment with androgen deprivation therapy plus radiation therapy for men with locally advanced prostate cancer improved OS compared with androgen deprivation therapy alone, according to the interim analysis of a randomized study.
Between 1995 and 2005, researchers enrolled 1,205 men with locally advanced (T3 or T4) prostate cancer (n=1,057); or organ-confined disease (T2) with either a PSA concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25).
Patients were randomly assigned to receive lifelong androgen deprivation therapy (ADT) plus radiotherapy or ADT alone.
At this interim analysis, median follow-up was 6 years. By that time, 320 patients had died.
Those patients assigned combined radiation and ADT had improved OS (HR=0.77; 95% CI, 0.61-0.98). At 7 years, OS was 74% for the combination group vs. 66% for the group assigned ADT alone.
Grade-3 or higher adverse events were uncommon in both groups. However, some patients on radiation had grade-1 and grade-2 gastrointestinal toxicity.
In an accompanying editorial, Matthew R. Cooperburg, MD, an assistant professor in the department of urology at the University of California, San Francisco, wrote: “This study has provided the strongest evidence to date that androgen deprivation therapy alone for men with high-risk prostate cancer is not adequate. These patients require an aggressive, multimodal approach incorporating prostate-directed local therapy. However, the crucial question — whether the optimum initial strategy should include radiation combined with androgen deprivation therapy, or surgery followed by selective radiation on the basis of pathological findings and early biochemical outcomes — is still open. The definitive answer will only come through trials of men with high-risk disease randomly assigned to receive surgery or radiation as an initial treatment.”
For more information:
- Warde P. Lancet. 2011;doi:10.1016/S0140-6736(11)61095-7.
The manuscript of Warde and colleagues provides additional data supporting the use of irradiation in patients with locally advanced prostate cancer; as reported by others, PFS, survival and prostate cancer-specific survival are improved among such patients if ADT is employed. This study also illustrates the many questions that remain in the care of such patients. Eighty percent had tumors that were Gleason 7 or less, and 80% were aged older than 65 years. How many such patients were in situations where no therapy might be justified? Also, we still struggle in estimating treatment outcome based on historical data or “experience.” At the inception of this study (about 1994), the 10-year survival of T3N0M0 patients treated with ADT only was estimated to be 35%. In 2002, based on interim analysis, this estimate was revised to 57%. In this report, 10-year survival is projected to be about 57%, but median follow-up is 6 years and about 10% have been followed for 2 years. The continued analysis of this study of Warde et al is critical to allow us to understand the real outcome of our “standard” therapies. As pointed out in the accompanying editorial by Cooperburg, the toxicity of irradiation added to ADT in this setting requires further delineation as our tools to make this assessment in large-scale trials are somewhat blunt.
– Donald L. Trump, MD
HemOnc Today Editorial Board member
Disclosure: Dr. Trump reports no relevant financial disclosures.