Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: Long-term results of RTOG 8610

Purpose Radiation Therapy Oncology Group ( RTOG) 8610 was the first phase III randomized trial to evaluate neoadjuvant androgen deprivation therapy ( ADT) in combination with external-beam radiotherapy ( EBRT) in men with locally advanced prostate cancer. This report summarizes long-term follow-up results. Materials and Methods Between 1987 and 1991, 456 assessable patients ( median age, 70 years) were enrolled. Eligible patients had bulky ( 5 x 5 cm) tumors ( T2-4) with or without pelvic lymph node involvement according to the 1988 American Joint Committee on Cancer TNM staging system. Patients received combined ADT that consisted of goserelin 3.6 mg every 4 weeks and flutamide 250 mg tid for 2 months before and concurrent with EBRT, or they received EBRT alone. Study end points included overall survival ( OS), disease-specific mortality ( DSM), distant metastasis ( DM), disease-free survival ( DFS), and biochemical failure ( BF). Results Ten-year OS estimates ( 43% v 34%) and median survival times ( 8.7 v 7.3 years) favored ADT and EBRT, respectively; however, these differences did not reach statistical significance ( P =.12). There was a statistically significant improvement in 10-year DSM ( 23% v 36%; P =.01), DM ( 35% v 47%; P =.006), DFS ( 11% v 3%; P <.0001), and BF ( 65% v 80%; P <.0001) with the addition of ADT, but no differences were observed in the risk of fatal cardiac events. Conclusion The addition of 4 months of ADT to EBRT appears to have a dramatic impact on clinically meaningful end points in men with locally advanced disease with no statistically significant impact on the risk of fatal cardiac events.