title: Acute and late urinary toxicity following radiation in men with an intact prostate gland or after a radical prostatectomy: A secondary analysis of RTOG 94-08 and 96-01.
abstract: To estimate the contribution of the prostate gland and prostatic urethral inflammation to urinary symptoms after radiation therapy for prostate cancer, we performed a secondary analysis of urinary toxicity after primary radiation to an intact prostate vs. postprostatectomy radiation to the prostatic fossa in protocols RTOG 94-08 and 96-01, respectively.
  
  
  
  Patients randomized to the radiation-alone arms (without hormone therapy) of the 2 trials were evaluated, including 104 men receiving primary prostate radiation to 68.4Gy on RTOG 94-08 and 371 men receiving 64.8Gy to the prostatic fossa on RTOG 96-01. Acute and late urinary toxicity were scored prospectively by RTOG scales. Chi-square test/logistic regression and cumulative incidence approach/Fine-Gray regression model were used for analyses of acute and late toxicity, respectively.
  
  
  
  Grade≥2 acute urinary toxicity was significantly higher after primary prostatic radiation compared with postprostatectomy radiation (30.8% vs. 14.0%; P<0.001), but acute grade≥3 toxicity did not differ (3.8% vs. 2.7%; P = 0.54). After adjusting for age, primary radiation resulted in significantly higher grade≥2 acute urinary toxicity (odds ratio = 3.72; 95% CI: 1.65-8.37; P = 0.02). With median follow-up of 7.1 years, late urinary toxicity was not significantly different with primary vs. postprostatectomy radiation (5-year grade≥2: 16.7% vs. 18.3%; P = 0.65; grade≥3: 6.0% vs. 3.3%; P = 0.24).
  
  
  
  Primary radiation to an intact prostate resulted in higher grade≥2 acute urinary toxicity than radiation to the prostatic fossa, with no difference in late urinary toxicity. Thus, a proportion of acute urinary toxicity in men with an intact prostate may be attributable to inflammation of the prostatic gland or urethra.
authors.affiliation: Harvard Radiation Oncology Program, Dana Farber/Brigham and Women׳s/Cancer Center, Boston, MA.
authors.forename: Raymond H
authors.initials: RH
authors.lastname: Mak
authors.affiliation: NRG Oncology Statistics and Data Management Center, Philadelphia, PA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Hunt
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
authors.forename: Jason A
authors.initials: JA
authors.lastname: Efstathiou
authors.affiliation: Department of Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
authors.forename: Niall M
authors.initials: NM
authors.lastname: Heney
authors.affiliation: Sutter Cancer Research Consortium, Roseville, CA.
authors.forename: Christopher U
authors.initials: CU
authors.lastname: Jones
authors.affiliation: Division of Radiation Oncology, Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Himu R
authors.initials: HR
authors.lastname: Lukka
authors.affiliation: Department of Radiation Oncology, CHUM-Hospital Notre-Dame, Montreal, Québec, Canada.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Bahary
authors.affiliation: Division of Radiation Oncology, Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Malti
authors.initials: M
authors.lastname: Patel
authors.affiliation: Division of Radiation Oncology, Tom Baker Cancer Centre, Calgary, Alberta, Canada.
authors.forename: Alexander
authors.initials: A
authors.lastname: Balogh
authors.affiliation: Department of Nuclear Medicine and Radiobiology, Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Québec, Canada.
authors.forename: Abdenour
authors.initials: A
authors.lastname: Nabid
authors.affiliation: Sutter Cancer Research Consortium, Roseville, CA.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Leibenhaut
authors.affiliation: Department of Radiation Oncology, University of Michigan Health System-Cancer Center, Ann Arbor, MI.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Hamstra
authors.affiliation: Southeast Cancer Control Consortium, Inc., CCOP, Winston-Salem, NC.
authors.forename: Kevin S
authors.initials: KS
authors.lastname: Roof
authors.affiliation: Intermountain Medical Center, Murray, UT.
authors.forename: Robert
authors.initials: R
authors.lastname: Jeffrey Lee
authors.affiliation: Department of Radiation Oncology, Froedtert and the Medical College of Wisconsin, Milwaukee, WI.
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Gore
authors.affiliation: Department of Radiation Oncology, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA.
authors.forename: Howard M
authors.initials: HM
authors.lastname: Sandler
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA. Electronic address: wshipley@partners.org.
authors.forename: William U
authors.initials: WU
authors.lastname: Shipley
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000528:radiation effects; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000532:radiotherapy* / Q000601:surgery; D011832:Radiation Injuries / Q000209:etiology*; D011878:Radiotherapy / Q000009:adverse effects*; D012720:Severity of Illness Index; D013997:Time Factors; D014521:Urethra / Q000528:radiation effects; D014570:Urologic Diseases / Q000209:etiology*
keywords: Postprostatectomy radiation; Primary prostate cancer radiation therapy; Urinary toxicity