title: Unanticipated frequency and consequences of regimen-related diarrhea in patients being treated with radiation or chemoradiation regimens for cancers of the head and neck or lung.
abstract: OBJECTIVE
  To better understand the indirect effects of standard courses of radiation therapy (RT) on distant tissue toxicity, we evaluated the frequency, course, and health and economic burden of regimen-related diarrhea in a large, multinational group of patients who were being treated for cancers of the head and neck (HNC) or lung (NSCLC).
  
  
  METHODS
  In this exploratory, prospective study, 284 patients being treated for HNC and 60 being treated for NSCLC were stratified into four cohorts to evaluate the effect of radiation alone and radiation plus concomitant chemotherapy (CRT) on radiation-induced diarrhea (RID). RID was assessed daily throughout RT using a patient-reported five-point categorical scale. Health and resource use outcomes were evaluated at least weekly during radiation.
  
  
  RESULTS
  Moderate to severe RID was reported in all groups and was worse among patient being treated with concomitant chemoradiation (CRT). Whereas 29 % of patients treated with radiation only developed RID, the incidence was 42 % among CRT-treated patients. Tumor site did not impact the rate of RID, but did impact the rate of development and was more acute in patients being treated for NSCLC than for HNC. Patients with significant RID had worse health and resource use outcomes than did patients without RID regardless of the form of treatment. G-tube placement, weight loss, unplanned office visits, and in-patient days were adversely affected by RID. Not surprisingly, patients treated with CRT had poorer health and resource outcomes than RT only patients, even in the absence of RID.
  
  
  CONCLUSIONS
  In addition to local tissue toxicities, our results suggest that focal radiation may also be associated with significant distant tissue-centric injury here represented by RID. While these changes were seen with radiation alone, the addition of chemotherapy increased the incidence and burden of illness. RID adversely impacted resource use. This unanticipated finding supports the hypothesis that focal radiation therapy results in pathobiological changes that extend beyond the radiation field and which can produce distant changes.
authors.affiliation: Brigham and Women's Hospital and the Dana-Farber Cancer Institute, Boston, MA, USA, ssonis@partners.org.
authors.forename: Stephen
authors.initials: S
authors.lastname: Sonis
authors.forename: Linda
authors.initials: L
authors.lastname: Elting
authors.forename: Dorothy
authors.initials: D
authors.lastname: Keefe
authors.forename: Hoang
authors.initials: H
authors.lastname: Nguyen
authors.forename: Steven
authors.initials: S
authors.lastname: Grunberg
authors.forename: Pamela
authors.initials: P
authors.lastname: Randolph-Jackson
authors.forename: Michael
authors.initials: M
authors.lastname: Brennan
mesh_terms: D000368:Aged; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D002985:Clinical Protocols; D003967:Diarrhea / Q000209:etiology / Q000517:prevention & control; D005260:Female; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D058958:Organs at Risk; D011446:Prospective Studies; D011832:Radiation Injuries / Q000209:etiology / Q000517:prevention & control; D011879:Radiotherapy Dosage / Q000592:standards; D061106:Radiotherapy Setup Errors / Q000009:adverse effects / Q000517:prevention & control; D016896:Treatment Outcome; D014481:United States