title: Acute gastrointestinal, genitourinary, and dermatological toxicity during dose-escalated 3D-conformal radiation therapy (3DCRT) using an intrarectal balloon for prostate gland localization and immobilization.
abstract: OBJECTIVE
  We determined the acute gastrointestinal (GI), genitourinary (GU), and dermatologic (D) toxicity during dose-escalated three-dimensional conformal radiation therapy (3DCRT). A modified intrarectal balloon (Medrad) was used for prostate gland localization and immobilization.
  
  
  METHODS
  Forty-six men with clinical category T1c to T3a, and at least one high-risk feature (PSA >10, Gleason > or =7, or MRI evidence of extracapsular extension or seminal vesical invasion) comprised the study cohort. Treatment consisted of hormonal therapy and 4-field 3DCRT using an intrarectal balloon for the initial 15 of 40 treatments. Planning treatment volume dose was 72 Gy (95% normalization). A Mantel-Haenzel Chi-square test compared the distribution of GU, GI, and D symptoms at baseline and at end of treatment (EOT).
  
  
  RESULTS
  There was no significant difference between the 2 time points in the proportion of patients with bowel symptoms (p = 0.73), tenesmus (p = 0.27), nocturia (p = 1.00), or GU urgency (p = 0.40). However, there was a significant decrease in GU frequency (70% vs. 50%, p = 0.46) as a result of medical interventions and a significant increase in hemorrhoidal irritation (4% vs. 20%, p = 0.02) and anal cutaneous skin reaction (0% vs. 70%, p < 0.001). By 3 months after EOT compared to baseline, there was no significant difference in the proportion of patients experiencing hemorrhoidal bleeding (4% vs. 8%, p = 0.52), requiring intervention for hemorrhoidal symptoms (7% vs. 5%, p = 0.8), or experiencing persistent anal cutaneous skin reaction (0% vs. 3%, p = 0.31).
  
  
  CONCLUSIONS
  Dose-escalated 3DCRT using an intrarectal balloon for prostate localization and immobilization was well tolerated. Acute GU, GI, and D symptoms resolved with standard dietary or medical interventions by the EOT or shortly thereafter.
authors.affiliation: Joint Center for Radiation Therapy, Brigham and Women's Hospital and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02115, USA. rwoel@lroc.harvard.edu
authors.forename: Rosemonde
authors.initials: R
authors.lastname: Woel
authors.forename: Clair
authors.initials: C
authors.lastname: Beard
authors.forename: Ming-Hui
authors.initials: MH
authors.lastname: Chen
authors.forename: Mark
authors.initials: M
authors.lastname: Hurwitz
authors.forename: Marian
authors.initials: M
authors.lastname: Loffredo
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McMahon
authors.forename: Jane
authors.initials: J
authors.lastname: Ching
authors.forename: Lynn
authors.initials: L
authors.lastname: Lopes
authors.forename: Anthony V
authors.initials: AV
authors.lastname: D'Amico
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal; D002404:Catheterization / Q000379:methods; D003672:Defecation / Q000528:radiation effects*; D041981:Gastrointestinal Tract / Q000528:radiation effects; D006484:Hemorrhoids / Q000209:etiology*; D006801:Humans; D007103:Immobilization / Q000379:methods; D008297:Male; D008875:Middle Aged; D011467:Prostate; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011788:Quality of Life; D011829:Radiation Dosage; D011832:Radiation Injuries / Q000209:etiology*; D011855:Radiodermatitis / Q000209:etiology*; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000009:adverse effects* / Q000379:methods; D014555:Urination Disorders / Q000209:etiology*; D014566:Urogenital System / Q000528:radiation effects