title: Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer.
abstract: OBJECTIVE
  To report the long-term results of a randomized radiotherapy dose escalation trial for prostate cancer.
  
  
  METHODS
  From 1993 to 1998, a total of 301 patients with stage T1b to T3 prostate cancer were accrued to a randomized external beam dose escalation trial using 70 Gy versus 78 Gy. The median follow-up is now 8.7 years. Kaplan-Meier analysis was used to compute rates of prostate-specific antigen (PSA) failure (nadir + 2), clinical failure, distant metastasis, disease-specific, and overall survival as well as complication rates at 8 years post-treatment.
  
  
  RESULTS
  For all patients, freedom from biochemical or clinical failure (FFF) was superior for the 78-Gy arm, 78%, as compared with 59% for the 70-Gy arm (p = 0.004, and an even greater benefit was seen in patients with initial PSA >10 ng/ml (78% vs. 39%, p = 0.001). The clinical failure rate was significantly reduced in the 78-Gy arm as well (7% vs. 15%, p = 0.014). Twice as many patients either died of prostate cancer or are currently alive with cancer in the 70-Gy arm. Gastrointestinal toxicity of grade 2 or greater occurred twice as often in the high dose patients (26% vs. 13%), although genitourinary toxicity of grade 2 or greater was less (13% vs. 8%) and not statistically significantly different. Dose-volume histogram analysis showed that the complication rate could be significantly decreased by reducing the amount of treated rectum.
  
  
  CONCLUSIONS
  Modest escalation in radiotherapy dose improved freedom from biochemical and clinical progression with the largest benefit in prostate cancer patients with PSA >10 ng/ml.
authors.affiliation: Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. dakuban@mdanderson.org
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Kuban
authors.forename: Susan L
authors.initials: SL
authors.lastname: Tucker
authors.forename: Lei
authors.initials: L
authors.lastname: Dong
authors.forename: George
authors.initials: G
authors.lastname: Starkschall
authors.forename: Eugene H
authors.initials: EH
authors.lastname: Huang
authors.forename: M Rex
authors.initials: MR
authors.lastname: Cheung
authors.forename: Andrew K
authors.initials: AK
authors.lastname: Lee
authors.forename: Alan
authors.initials: A
authors.lastname: Pollack
mesh_terms: D005500:Follow-Up Studies; D041981:Gastrointestinal Tract / Q000528:radiation effects; D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D016019:Survival Analysis; D017211:Treatment Failure
chemical_list: D017430:Prostate-Specific Antigen