title: Acute and late toxicity in a randomized trial of conventional versus hypofractionated three-dimensional conformal radiotherapy for prostate cancer.
abstract: OBJECTIVE
  To compare the toxicity between hypofractionation vs. conventional fractionation schedules in patients with high-risk prostate cancer.
  
  
  METHODS
  Between January 2003 and December 2007, 168 patients were randomized to receive either hypofractionated (62 Gy in 20 fractions within 5 weeks, 4 fractions/wk) or conventionally fractionated (80 Gy in 40 fractions within 8 weeks) three-dimensional conformal radiotherapy to the prostate and seminal vesicles. All patients had undergone a 9-month course of total androgen deprivation, with radiotherapy starting 2 months after initiation of the total androgen deprivation.
  
  
  RESULTS
  The median follow-up was 32 and 35 months in the hypofractionation and conventional fractionation arms, respectively. For the patients developing acute toxicity, no difference between the two fractionation groups was found in either severity or duration of gastrointestinal or genitourinary toxicity. Also, no difference was found in the incidence and severity of late gastrointestinal and genitourinary toxicity between the two treatment schedules, with a 3-year rate of Grade 2 or greater toxicity of 17% and 16% for the hypofractionation arm and 14% and 11% for the conventional fractionation arm, respectively. A statistically significant correlation between acute and late gastrointestinal toxicity was found only in the conventional fractionation group.
  
  
  CONCLUSIONS
  Our findings suggest that the hypofractionation regimen used in our study is safe, with only a slight, nonsignificant increase in tolerable and temporary acute toxicity compared with the conventional fractionation schedule. The severity and frequency of late complications was equivalent between the two treatment groups.
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy. arcangeli.gio@gmail.com
authors.forename: Giorgio
authors.initials: G
authors.lastname: Arcangeli
authors.forename: Jack
authors.initials: J
authors.lastname: Fowler
authors.forename: Sara
authors.initials: S
authors.lastname: Gomellini
authors.forename: Stefano
authors.initials: S
authors.lastname: Arcangeli
authors.forename: Biancamaria
authors.initials: B
authors.lastname: Saracino
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Petrongari
authors.forename: Marcello
authors.initials: M
authors.lastname: Benassi
authors.forename: Lidia
authors.initials: L
authors.lastname: Strigari
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D019583:Dose Fractionation, Radiation; D005500:Follow-Up Studies; D041981:Gastrointestinal Tract / Q000528:radiation effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000528:radiation effects; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000009:adverse effects* / Q000379:methods; D012669:Seminal Vesicles / Q000528:radiation effects; D013997:Time Factors; D014566:Urogenital System / Q000528:radiation effects