title: HDR brachytherapy combined with interstitial hyperthermia in locally advanced cervical cancer patients initially treated with concomitant radiochemotherapy--a phase III study.
abstract: OBJECTIVE
  The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer.
  
  
  METHODS
  After radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II-III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45min before and during the HDR BT.
  
  
  RESULTS
  The median follow-up time was 45months (range 3-72months). An effect of hyperthermia was not detected for disease-free survival (DFS) (log-rank test: p=0.178) or for local control (LC) (p=0.991). According to Cox's analysis, HT did not significantly influence failure or interactions with potential prognostic factors for LC or DFS. Statistical differences were not observed for the distribution of early and late complications between the HT and non HT groups.
  
  
  CONCLUSIONS
  ISHT is well-tolerated and does not affect treatment-related early or late complications. Improvements in DFS and LC were not observed following the addition of ISHT to ISBT.
authors.affiliation: Department of Brachytherapy, The Maria Skłodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Zolciak-Siwinska
authors.forename: Norbert
authors.initials: N
authors.lastname: Piotrkowicz
authors.forename: Joanna
authors.initials: J
authors.lastname: Jonska-Gmyrek
authors.forename: Maria
authors.initials: M
authors.lastname: Nicke-Psikuta
authors.forename: Wojciech
authors.initials: W
authors.lastname: Michalski
authors.forename: Maryla
authors.initials: M
authors.lastname: Kawczyńska
authors.forename: Michał
authors.initials: M
authors.lastname: Bijok
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Bujko
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy; D059248:Chemoradiotherapy; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced; D008875:Middle Aged; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011879:Radiotherapy Dosage; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*
keywords: Cervical cancer; HDR brachytherapy; Interstitial hyperthermia; Side effects