title: Phase II study of proton beam therapy as a nonsurgical approach for mucosal melanoma of the nasal cavity or para-nasal sinuses.
abstract: OBJECTIVE
  The aim of this phase II study was to assess the clinical benefit of proton beam therapy for mucosal melanoma of the nasal cavity and para-nasal sinuses.
  
  
  METHODS
  N0M0 mucosal melanoma of the nasal cavity and para-nasal sinuses were enrolled. Proton therapy was delivered three times per week with a planned total dose of 60 GyE in 15 fractions. Primary endpoint was local control rate at 1 year after treatment. Based on the results of a pilot study, the local control rate was estimated at 75%.
  
  
  RESULTS
  Thirty-two patients were enrolled from June 2008 through October 2012. Patient characteristics were as follows: median age 73 years (range, 36-89 years); male/female ratio, 12/20; and T stage 3/4, 11/21. Local control rate at 1 year was 75.8% (95% CI: 63.8-92.4%). With a median follow-up period of 36.4 months, 3-year overall survival rate was 46.1%. The most frequent pattern of first failure was distant metastasis. The main cause of death was cancer death due to distant metastases (93.3%).
  
  
  CONCLUSIONS
  Proton beam therapy showed sufficient local control benefits for mucosal melanoma as an alternative treatment of surgery.
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital East, Japan. Electronic address: szenda@east.ncc.go.jp.
authors.forename: Sadamoto
authors.initials: S
authors.lastname: Zenda
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital East, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Akimoto
authors.affiliation: Department of Radiation Oncology & Proton Medical Research Center, United States.
authors.forename: Masashi
authors.initials: M
authors.lastname: Mizumoto
authors.affiliation: Head and Neck Surgery, National Cancer Center Hospital East, Japan.
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Hayashi
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital East, Japan.
authors.forename: Satoko
authors.initials: S
authors.lastname: Arahira
authors.affiliation: Department of Radiation Oncology & Proton Medical Research Center, United States.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Okumura
authors.affiliation: Department of Radiation Oncology & Proton Medical Research Center, United States.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Sakurai
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008545:Melanoma / Q000532:radiotherapy*; D008875:Middle Aged; D009296:Nasal Cavity; D009297:Nasal Mucosa / Q000528:radiation effects*; D009669:Nose Neoplasms / Q000532:radiotherapy*; D010255:Paranasal Sinus Neoplasms / Q000532:radiotherapy; D010256:Paranasal Sinuses; D010865:Pilot Projects; D011446:Prospective Studies; D061766:Proton Therapy; D015996:Survival Rate; D016896:Treatment Outcome
keywords: Head and neck cancer; Mucosal melanoma; Nasal cavity; Proton beam therapy; Rare disease