title: Hyperthermia combined with radiation in treatment of locally advanced prostate cancer is associated with a favourable toxicity profile.
abstract: OBJECTIVE
  Hyperthermia is used to treat several pelvic tumours. An important step in establishing a broader role for hyperthermia in treatment of prostate cancer is verification of an acceptable toxicity profile. In this report, short- and long-term toxicity profiles of a completed phase II trial of transrectal ultrasound hyperthermia combined with radiation in treatment of locally advanced prostate cancer are presented.
  
  
  METHODS
  Thirty-seven patients enrolled on a phase II study of external beam radiation +/- androgen suppression with two transrectal ultrasound hyperthermia treatments were assessed for short- and long-term toxicity. Prostatic and anterior rectal wall temperatures were monitored. Rectal wall temperatures were limited to 40 degrees C (19 patients), 41 degrees C (three patients) and 42 degrees C (15 patients). Univariate logistic regression was used to estimate the log hazard of developing NCI CTC Grade 2 toxicity based on temperature parameters. Hazard ratios, 95% confidence intervals, p-values for statistical significance of each parameter and proportion of variability explained for each of the parameters were calculated.
  
  
  RESULTS
  Median follow-up was 42 months. Both short- and long-term GI toxicity were limited to grade 2 or less. Acute grade 2 proctitis was greater for patients with allowable rectal wall temperature of >40 degrees C. Eleven of 18 patients in this group had acute grade 2 proctitis vs three of 19 patients with rectal wall temperatures limited to 40 degrees C (p = 0.004). Long-term grade 2 GI and GU toxicity occurred in 5% and 19% of patients. No late grade 3 or greater toxicity occurred. Late GI and GU toxicity were not associated with the allowable rectal wall temperature.
  
  
  CONCLUSIONS
  Transrectal ultrasound hyperthermia combined with radiation for treatment of advanced clinically localized prostate cancer is safe and well tolerated.
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. mhurwitz@lroc.harvard.edu
authors.forename: Mark D
authors.initials: MD
authors.lastname: Hurwitz
authors.forename: Irving D
authors.initials: ID
authors.lastname: Kaplan
authors.forename: Jorgen L
authors.initials: JL
authors.lastname: Hansen
authors.forename: Savina
authors.initials: S
authors.lastname: Prokopios-Davos
authors.forename: George P
authors.initials: GP
authors.lastname: Topulos
authors.forename: Kenneth
authors.initials: K
authors.lastname: Wishnow
authors.forename: Judith
authors.initials: J
authors.lastname: Manola
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Bornstein
authors.forename: Kullervo
authors.initials: K
authors.lastname: Hynynen
mesh_terms: D000368:Aged; D003131:Combined Modality Therapy; D006801:Humans; D006979:Hyperthermia, Induced / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000532:radiotherapy* / Q000628:therapy*; D020266:Radiotherapy, Conformal / Q000009:adverse effects; D012007:Rectum; D014464:Ultrasonic Therapy / Q000009:adverse effects / Q000379:methods