Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2015
Phase II study of proton beam therapy as a nonsurgical approach for mucosal melanoma of the nasal cavity or para-nasal sinuses.
Клиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Zenda Sadamoto, Akimoto Tetsuo, Mizumoto Masashi, Hayashi Ryuichi, Arahira Satoko, Okumura Toshiyuki, Sakurai Hideyuki
Аннотация
PURPOSE: 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.
MATERIALS AND 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.
MATERIALS AND 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.