title: Combined proton beam radiotherapy and transpupillary thermotherapy for large uveal melanomas: a randomized study of 151 patients.
abstract: BACKGROUND
  Exudation from the tumour scar and glaucoma can be major problems after proton beam irradiation of uveal melanoma and can sometimes lead to secondary enucleation. We conducted a randomized study to determine whether systematic transpupillary thermotherapy (TTT) after proton beam radiotherapy could have a beneficial effect.
  
  
  METHODS
  Between February 1999 and April 2003, all the patients treated by proton beam radiotherapy for uveal melanomas >/=7 mm thick or >/=15 mm in diameter were included in this study after giving their informed consent. One half of the patients received proton beam radiotherapy alone (60 Gy in 4 fractions) and the other half received the same dose of proton beam radiotherapy followed by TTT at 1, 6 and 12 months. All the information concerning the initial tumour parameters, treatments and follow-up was recorded and a statistical analysis was performed.
  
  
  RESULTS
  We randomized 151 patients. The median follow-up was 38 months. The 2 groups of patients were similar in terms of age, gender and tumour characteristics. The patients treated with TTT showed a greater reduction of tumour thickness (p = 0.06), less retinal detachment at the latest follow-up (p = 0.14) and a lower secondary enucleation rate (p = 0.02).
  
  
  CONCLUSIONS
  The present study is the first randomized analysis to demonstrate a significant decrease in the secondary enucleation rate in patients treated with TTT after proton beam radiotherapy. Further studies should be performed to determine whether TTT could be beneficial to smaller tumours and to define its optimal dose.
authors.affiliation: Institut Curie, Paris, France. laurence.desjardins@curie.net
authors.forename: L
authors.initials: L
authors.lastname: Desjardins
authors.forename: L
authors.initials: L
authors.lastname: Lumbroso-Le Rouic
authors.forename: C
authors.initials: C
authors.lastname: Levy-Gabriel
authors.forename: R
authors.initials: R
authors.lastname: Dendale
authors.forename: S
authors.initials: S
authors.lastname: Delacroix
authors.forename: C
authors.initials: C
authors.lastname: Nauraye
authors.forename: M
authors.initials: M
authors.lastname: Estève
authors.forename: C
authors.initials: C
authors.lastname: Plancher
authors.forename: B
authors.initials: B
authors.lastname: Asselain
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003037:Cobalt Radioisotopes / Q000627:therapeutic use; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D015353:Eye Enucleation / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced; D008297:Male; D008545:Melanoma / Q000532:radiotherapy* / Q000628:therapy; D008875:Middle Aged; D011680:Pupil; D011867:Radioisotope Teletherapy; D012163:Retinal Detachment / Q000517:prevention & control; D016896:Treatment Outcome; D014604:Uveal Neoplasms / Q000532:radiotherapy* / Q000628:therapy
chemical_list: D003037:Cobalt Radioisotopes