title: Multicenter, phase III trial comparing selenium supplementation with observation in gynecologic radiation oncology: follow-up analysis of the survival data 6 years after cessation of randomization.
abstract: OBJECTIVE
  In 2010, we reported that selenium (Se) supplementation during radiation therapy (RT) is effective for increasing blood Se levels in Se-deficient cervical and uterine cancer patients, and reduced the number of episodes and severity of RT-induced diarrhea. In the current study, we examine whether of Se supplementation during adjuvant RT affects long-term survival of these patients.
  
  
  METHODS
  Former patients were identified and questioned with respect to their health and well-being.
  
  
  RESULTS
  A total of 81 patients were randomized in the initial supplementation study, 39 of whom received Se (selenium group, SeG) and 42 of whom served as controls (control group, CG). When former patients were reidentified after a median follow-up of 70 months (range = 0-136), the actuarial 10-year disease-free survival rate in the SeG was 80.1% compared to 83.2% in the CG (P = .65), and the actuarial 10-year overall survival rate of patients in the SeG was 55.3% compared to 42.7% in the CG (P = .09).
  
  
  CONCLUSIONS
  Our extended follow-up analysis demonstrates that Se supplementation had no influence on the effectiveness of the anticancer irradiation therapy and did not negatively affect patients' long-term survival. In view of its positive effects on RT-induced diarrhea, we consider Se supplementation to be a meaningful and beneficial adjuvant treatment in Se-deficient cervical and uterine cancer patients while undergoing pelvic radiation therapy.
authors.affiliation: Lippe Hospital, Lemgo, Germany Marien Hospital Herne, Ruhr University, Bochum, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Muecke
authors.affiliation: Franziskus Hospital, Bielefeld, Germany strahlenklinik@web.de.
authors.forename: Oliver
authors.initials: O
authors.lastname: Micke
authors.affiliation: Charité, Berlin, Germany.
authors.forename: Lutz
authors.initials: L
authors.lastname: Schomburg
authors.affiliation: Municipal Hospital, Erfurt, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Glatzel
authors.affiliation: Municipal Hospital, Weiden, Germany.
authors.forename: Berthold
authors.initials: B
authors.lastname: Reichl
authors.affiliation: St. Anna Hospital, Herne, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Kisters
authors.affiliation: Lippe Hospital, Lemgo, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schaefer
authors.affiliation: Working Group Integrative Oncology, German Cancer Society, Berlin, Germany.
authors.forename: Jutta
authors.initials: J
authors.lastname: Huebner
authors.affiliation: University, Muenster, Germany.
authors.forename: Hans T
authors.initials: HT
authors.lastname: Eich
authors.affiliation: Marien Hospital Herne, Ruhr University, Bochum, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Fakhrian
authors.affiliation: Marien Hospital Herne, Ruhr University, Bochum, Germany.
authors.forename: Irenaeus A
authors.initials: IA
authors.lastname: Adamietz
authors.affiliation: Suedharz Hospital, Nordhausen, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Buentzel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003967:Diarrhea / Q000209:etiology / Q000517:prevention & control; D019587:Dietary Supplements; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011832:Radiation Injuries / Q000517:prevention & control; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D012643:Selenium / Q000097:blood* / Q000172:deficiency; D018038:Sodium Selenite / Q000627:therapeutic use*; D015996:Survival Rate; D013997:Time Factors; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D014594:Uterine Neoplasms / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D012643:Selenium; D018038:Sodium Selenite
keywords: disease-free survival; gynecologic radiation oncology; long-term data; overall survival; selenium supplementation