title: Phase I/II trial of docetaxel and concurrent radiation therapy in localized high risk prostate cancer (AGUSG 03-10).
abstract: OBJECTIVE
  A Phase I/II trial was conducted to assess the radiosensitizer docetaxel administered weekly (20 mg/m(2)) with concurrent intensity modulated radiation therapy (72 Gy at 1.8 Gy/fraction) in high risk prostate cancer.
  
  
  METHODS
  Patients with high risk prostate cancer (clinical stage > or = T3; Gleason score 8, 9, or 10; Gleason score 7 and PSA > 10) received IMRT (Clinac 600 CD with 6 MV photons and sliding window technique) and concurrent weekly docetaxel (20 mg/m(2)) as a continuous 30 minute infusion for 8 weeks. Patients desirous of concurrent androgen suppression were not excluded.
  
  
  RESULTS
  Twenty men (median age: 64 years; range, 50-78 years) were enrolled in the chemoradiation protocol. Three patients experienced treatment interruptions: dehydration requiring inpatient hydration (n = 2); NSAID induced GI bleed (n = 1). An additional patient required outpatient hydration (<24 hours) with no treatment interruption. Overall, the most frequently observed toxicities were grade 2 diarrhea (40%), grade 2 fatigue (40%), grade 2 urinary frequency (35%), taste aversion (20%), grade 2 constipation (20%), and rectal bleeding (15%). No significant hematologic toxicity (grades 2-4) was encountered among the 20 patients. Although the follow-up interval was relatively short, no significant subacute gastrointestinal toxicities have been observed. At a median follow-up duration of 11.7 months, 17 patients were free of biochemical disease recurrence, and all patients are alive.
  
  
  CONCLUSIONS
  The radiosensitizer docetaxel administered weekly (20 mg/m(2)) with concurrent IMRT is well tolerated with acceptable toxicity. Early oncologic outcomes in this challenging patient cohort are encouraging.
authors.affiliation: Section of Urology, Saint Peter's Cancer Care Center, Albany, NY 12208, USA. perrotmi@yahoo.com
authors.forename: Michael
authors.initials: M
authors.lastname: Perrotti
authors.forename: Todd
authors.initials: T
authors.lastname: Doyle
authors.forename: Parvesh
authors.initials: P
authors.lastname: Kumar
authors.forename: Daryl
authors.initials: D
authors.lastname: McLeod
authors.forename: William
authors.initials: W
authors.lastname: Badger
authors.forename: Susan
authors.initials: S
authors.lastname: Prater
authors.forename: Michael
authors.initials: M
authors.lastname: Moran
authors.forename: Stuart
authors.initials: S
authors.lastname: Rosenberg
authors.forename: Cora
authors.initials: C
authors.lastname: Bonatsos
authors.forename: Carrie
authors.initials: C
authors.lastname: Kreitner
authors.forename: Ralf
authors.initials: R
authors.lastname: Kiehl
authors.forename: Theodore
authors.initials: T
authors.lastname: Chang
authors.forename: Michael
authors.initials: M
authors.lastname: Kolodziej
mesh_terms: D000368:Aged; D003131:Combined Modality Therapy / Q000009:adverse effects; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D012307:Risk Factors; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; D000077143:Docetaxel