title: Patient-reported quality of life during radiation treatment for localized prostate cancer: results from a prospective phase II trial.
abstract: Study Type--Therapy (cohort) Level of Evidence 2a. What's known on the subject? and What does the study add? Patient-reported quality of life (QoL) in prostate cancer is recognized as an important outcome, and has been shown in multiple studies to capture the incidence and timing of patient symptoms more accurately than physician-graded toxicity reports. Although the long-term QoL after completing radiation therapy (RT) has been previously studied, patient experience during RT is not well described in the literature. The present study collected patient-reported QoL during RT in a prospective phase II clinical trial. The study describes in detail the time course and severity of gastrointestinal and genitourinary symptoms during radiation, providing clinically useful information for patients and physicians considering RT during the treatment decision-making process.
  
  
  OBJECTIVE
  • To evaluate data collected from a phase II trial to describe the time course and trajectory of patient-reported acute urinary and bowel symptom development during radiation therapy (RT) for prostate cancer.
  
  
  METHODS
  • In all, 100 patients with intermediate- or high-risk prostate cancer received 72 Gy of RT to the prostate and seminal vesicles, with 6 months of concurrent androgen deprivation therapy; a rectal balloon was used for prostate immobilization. • Patients completed the validated Prostate Cancer Symptom Indices questionnaire every 1-2 weeks, reporting urinary and bowel symptoms on a four- or five-point Likert scale. • A score of ≥ 3 in a symptom is associated with clinically meaningful distress. Cumulative incidence of each symptom is reported. Bonferroni corrections of P values were used to adjust for multiple comparisons.
  
  
  RESULTS
  • Urinary symptoms were frequent at baseline and worsened during treatment. By the end of RT, 28-50% of patients developed clinically meaningful obstructive and irritative urinary symptoms. • Acute bowel symptoms were less frequent. Each bowel symptom increased in frequency by 9-26% from baseline to end of RT. • Urinary incontinence was rare. • Overall, symptom burden at the end of treatment was modest.
  
  
  CONCLUSIONS
  • Urinary symptoms were common during RT, and bowel symptoms were less frequent. • These results inform patients and physicians during the decision-making process about potential patient quality of life experiences during RT, and also provide a benchmark for comparative effectiveness studies against newer treatments and technologies.
authors.affiliation: Department of Radiation Oncology and Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC 27599-7512, USA. ronald_chen@med.unc.edu
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Chen
authors.forename: Yuanye
authors.initials: Y
authors.lastname: Zhang
authors.forename: Ming-Hui
authors.initials: MH
authors.lastname: Chen
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McMahon
authors.forename: Marian
authors.initials: M
authors.lastname: Loffredo
authors.forename: Carol P
authors.initials: CP
authors.lastname: McPherson
authors.forename: Angela U
authors.initials: AU
authors.lastname: Nguyen
authors.forename: Paul L
authors.initials: PL
authors.lastname: Nguyen
authors.forename: Anthony V
authors.initials: AV
authors.lastname: D'Amico
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D000368:Aged; D000369:Aged, 80 and over; D003967:Diarrhea / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009093:Mucus; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology / Q000523:psychology / Q000532:radiotherapy*; D011788:Quality of Life; D011878:Radiotherapy / Q000009:adverse effects; D012002:Rectal Diseases / Q000209:etiology*; D014555:Urination Disorders / Q000209:etiology*