title: Results of a phase II study of Short-course Accelerated Radiation Therapy (SHARON) for multiple brain metastases.
abstract: OBJECTIVE
  To assess the effectiveness of a SHort-course Accelerated RadiatiON therapy (SHARON) in the treatment of patients with multiple brain metastases.
  
  
  METHODS
  A phase II clinical trial was designed. Eligibility criteria included patients with at least 3 brain metastases or metastatic disease in >3 organ systems, and Eastern Cooperative Oncology Group performance status of ≤3. Fifty patients were treated with whole brain radiotherapy at 18 Gy (4.5 Gy per fraction) in 2 days with a twice daily fractionation. The primary endpoint was the assessment of efficacy in terms of overall survival.
  
  
  RESULTS
  Characteristics of the 50 enrolled patients were: male/female: 24/26; median age: 65 years (range, 45 to 80 y). Eastern Cooperative Oncology Group performance status was <3 in 42 patients (84%). Nineteen patients (38%) were considered to have recursive partitioning analysis class 3 disease. Grade 1-2 acute neurological (46%) and skin (24%) toxicities were recorded. Three patients (6%) experienced neurological grade 3 acute toxicity. With a median follow-up time of 6 months (range, 1 to 18 mo) 2 skin grade 1 late toxicities has been observed. Seventeen of 27 symptomatic patients showed an improvement or resolution of baseline symptoms (overall palliative response rate: 63.0%; 95% confidence interval, 36.6%-82.4%).Two-month overall survival was 86% (median survival time=7 mo).
  
  
  CONCLUSIONS
  Short-course accelerated whole brain radiotherapy of 18 Gy in twice daily fractions for 2 consecutive days is tolerated and effective in terms of symptom relief and median survival time. These results justify a phase III comparison against the standard-of-care in this patient population (30 Gy in 10 fractions).
authors.affiliation: *Department of Radiation Oncology †Medical Physics Unit ‡Department of Palliative Therapies, Fondazione di Ricerca e Cura "Giovanni Paolo II," Università Cattolica del S. Cuore ∥Department of Oncology Regional, A. Cardarelli Hospital, Campobasso ¶Madre Teresa di Calcutta Hospice, Larino #Department of Neurological Sciences, Istituto Neurologico Mediterraneo Neuromed, Istituto di Ricovero e Cura a Carattere Scientifico, Pozzilli **Department of Radiation Oncology, "San Francesco" Hospital, Nuoro ‡‡Department of Radiotherapy, Università Cattolica del S. Cuore, Roma, Italy §Department of Radiation Oncology, The Lacks Cancer Center Saint Mary's Health Care, Grand Rapids, MI ††Department of Radiotherapy, Black Lion Hospital, Addis Ababa, Ethiopia.
authors.forename: Luciana
authors.initials: L
authors.lastname: Caravatta
authors.forename: Francesco
authors.initials: F
authors.lastname: Deodato
authors.forename: Marica
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authors.lastname: Ferro
authors.forename: Gabriella
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authors.lastname: Macchia
authors.forename: Mariangela
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authors.lastname: Massaccesi
authors.forename: Savino
authors.initials: S
authors.lastname: Cilla
authors.forename: Rosa
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authors.lastname: Tambaro
authors.forename: Samantha
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authors.lastname: Mignogna
authors.forename: Gilbert D A
authors.initials: GD
authors.lastname: Padula
authors.forename: Michela
authors.initials: M
authors.lastname: Musacchio
authors.forename: Mariano
authors.initials: M
authors.lastname: Flocco
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Cantore
authors.forename: Andrea
authors.initials: A
authors.lastname: Scapati
authors.forename: Solomon
authors.initials: S
authors.lastname: Bogale
authors.forename: Mario
authors.initials: M
authors.lastname: Balducci
authors.forename: Vincenzo
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authors.lastname: Valentini
authors.forename: Numa
authors.initials: N
authors.lastname: Cellini
authors.forename: Alessio G
authors.initials: AG
authors.lastname: Morganti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001932:Brain Neoplasms / Q000532:radiotherapy* / Q000556:secondary; D002277:Carcinoma / Q000532:radiotherapy* / Q000556:secondary; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000473:pathology*; D011832:Radiation Injuries / Q000209:etiology; D011855:Radiodermatitis / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome