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Short-term ADT improved OS, disease-specific survival
Jones CU. N Engl J Med. 2011;365:107-118.
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A 4-month course of androgen deprivation therapy before and after radiotherapy was associated with significantly better disease-specific mortality and OS for some patients with prostate adenocarcinoma, according to results from an international phase 3 study.
From 1994 to 2001, researchers randomly assigned 1,979 eligible patients with stage T1b, T1c, T2a or T2b prostate adenocarcinoma and a PSA level of 20 ng/mL or less to radiotherapy alone (n=992) or radiotherapy with androgen deprivation therapy (ADT) starting 2 months before radiotherapy (n=987).
Patients assigned to ADT received 250 mg oral flutamide three times a day and either monthly subcutaneous 3.6 mg goserelin or intramuscular 7.5 mg leuprolide for 4 months. Radiotherapy began after 2 months of ADT
Patients received a total dose of 66.6 Gy in daily 1.8 Gy fractions.
At a median follow-up of roughly 9 years, 10-year OS was 57% in the radiotherapy-alone group (HR=1.17; 95% CI, 1.01-1.35) and 62% in the ADT group. Ten-year disease-specific mortality was 8% in the radiotherapy-alone group vs. 4% in the combined-therapy group (HR=1.87; 95% CI, 1.27-2.74). The 10-year cumulative incidence of non-prostate cancer death was 37% in the radiotherapy group and 34% in the ADT group.
The 10-year rate of biochemical failure was 41% in the radiotherapy-alone group compared with 26% in the ADT group (HR=1.74; 95% CI, 1.48-2.04), and the 10-year cumulative incidence of distant metastases was 8% in the radiotherapy-alone group and 6% in the ADT group (HR=1.45; 95% CI, 1.03-2.06).
This paper proves something we've known for years: hormonal therapy benefits men with intermediate-risk prostate cancer, and short-course ADT is beneficial for these patients. Unfortunately, in prostate cancer it takes about 10 years to accrue meaningful data - this trial was started many years ago and the world has changed. The radiation dose of 66.6 Gy would not be the appropriate dose now. Today, we would administer 75.6 Gy and some argue that hormonal therapy is beneficial in this kind of trial is because the radiation dose is too low. The ongoing RTOG 0815 trial is looking at hormonal therapy with higher doses of radiation to see if this benefit remains true in the modern age. For low-risk patients, this paper showed no benefit with hormone therapy, and four months of ADT probably isn't enough for high-risk patients. The benefit was largely restricted to intermediate-risk patients.
- Sean P. Collins, MD, PhD
Head of the Prostate Cyberknife Program,
Lombardi Comprehensive Cancer Center, Washington, DC
Disclosures: Dr. Collins reported no relevant financial disclosures.
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