title: Long-term Results of the UCSF-LBNL Randomized Trial: Charged Particle With Helium Ion Versus Iodine-125 Plaque Therapy for Choroidal and Ciliary Body Melanoma.
abstract: OBJECTIVE
  Relevant clinical data are needed given the increasing national interest in charged particle radiation therapy (CPT) programs. Here we report long-term outcomes from the only randomized, stratified trial comparing CPT with iodine-125 plaque therapy for choroidal and ciliary body melanoma.
  
  
  METHODS
  From 1985 to 1991, 184 patients met eligibility criteria and were randomized to receive particle (86 patients) or plaque therapy (98 patients). Patients were stratified by tumor diameter, thickness, distance to disc/fovea, anterior extension, and visual acuity. Tumors close to the optic disc were included. Local tumor control, as well as eye preservation, metastases due to melanoma, and survival were evaluated.
  
  
  RESULTS
  Median follow-up times for particle and plaque arm patients were 14.6 years and 12.3 years, respectively (P=.22), and for those alive at last follow-up, 18.5 and 16.5 years, respectively (P=.81). Local control (LC) for particle versus plaque treatment was 100% versus 84% at 5 years, and 98% versus 79% at 12 years, respectively (log rank: P=.0006). If patients with tumors close to the disc (<2 mm) were excluded, CPT still resulted in significantly improved LC: 100% versus 90% at 5 years and 98% versus 86% at 12 years, respectively (log rank: P=.048). Enucleation rate was lower after CPT: 11% versus 22% at 5 years and 17% versus 37% at 12 years, respectively (log rank: P=.01). Using Cox regression model, likelihood ratio test, treatment was the most important predictor of LC (P=.0002) and eye preservation (P=.01). CPT was a significant predictor of prolonged disease-free survival (log rank: P=.001).
  
  
  CONCLUSIONS
  Particle therapy resulted in significantly improved local control, eye preservation, and disease-free survival as confirmed by long-term outcomes from the only randomized study available to date comparing radiation modalities in choroidal and ciliary body melanoma.
authors.affiliation: Department of Radiation Oncology, University of California-San Francisco, San Francisco, California. Electronic address: Kavita.mishra@ucsf.edu.
authors.forename: Kavita K
authors.initials: KK
authors.lastname: Mishra
authors.affiliation: Department of Radiation Oncology, University of California-San Francisco, San Francisco, California; Lawrence Berkeley National Laboratory, Berkeley, California.
authors.forename: Jeanne M
authors.initials: JM
authors.lastname: Quivey
authors.affiliation: Department of Radiation Oncology, University of California-San Francisco, San Francisco, California; Lawrence Berkeley National Laboratory, Berkeley, California.
authors.forename: Inder K
authors.initials: IK
authors.lastname: Daftari
authors.affiliation: Department of Radiation Oncology, University of California-San Francisco, San Francisco, California.
authors.forename: Vivian
authors.initials: V
authors.lastname: Weinberg
authors.affiliation: The Tumori Foundation, San Francisco, California.
authors.forename: Tia B
authors.initials: TB
authors.lastname: Cole
authors.affiliation: Department of Radiation Oncology, University of California-San Francisco, San Francisco, California.
authors.forename: Kishan
authors.initials: K
authors.lastname: Patel
authors.affiliation: Department of Radiation Oncology, University of California-San Francisco, San Francisco, California; Lawrence Berkeley National Laboratory, Berkeley, California.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Castro
authors.affiliation: Department of Radiation Oncology, University of California-San Francisco, San Francisco, California; Lawrence Berkeley National Laboratory, Berkeley, California.
authors.forename: Theodore L
authors.initials: TL
authors.lastname: Phillips
authors.affiliation: The Tumori Foundation, San Francisco, California; Department of Ophthalmology, University of California-San Francisco, San Francisco, California; Department of Ophthalmology, Stanford University, Palo Alto, California.
authors.forename: Devron H
authors.initials: DH
authors.lastname: Char
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000379:methods; D002830:Choroid Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D002924:Ciliary Body / Q000473:pathology; D018572:Disease-Free Survival; D015353:Eye Enucleation / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006371:Helium / Q000627:therapeutic use*; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008875:Middle Aged; D059351:Organ Sparing Treatments; D011879:Radiotherapy Dosage; D013997:Time Factors; D014604:Uveal Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D055815:Young Adult
chemical_list: D007457:Iodine Radioisotopes; D006371:Helium