Short-course regimen of palliative radiotherapy in complicated bone metastases: a phase i–ii study (SHARON Project)

Francesco Cellini, Vincenzo Valentini, Francesco Deodato, Jenny Capuccini, Eleonora Farina, Milly Buwenge, Domenico Genovesi, Luciana Caravatta, Nam P. Nguyen, Silvia Cammelli, Tigeneh Wondemagegnhu, A. F. M. Kamal Uddin, Mostafà Aziz Sumon, Alessio G. Morganti

Risultato della ricerca: Contributo in rivistaArticolo in rivista

6 Citazioni (Scopus)

Abstract

Metastases with soft tissues invasion, impending fractures or spinal cord compression (complicated bone metastases) represent a common clinical problem in advanced cancers and frequently lead to deterioration of patients’ quality of life (QoL). A phase I–II study was planned to define the maximum tolerated dose (MTD) of a short-course radiotherapy (RT) and its efficacy in palliation of complicated bone metastases. A phase I trial was designed with three dose-escalation steps: 16, 18, and 20 Gy. Total dose at each level was delivered in 2 days, twice daily. Eligibility criteria were painful complicated bone metastases and ECOG performance status ≤ 3. The presence of acute toxicity ≥ Grade 3 (RTOG scale) was considered the dose limiting toxicity. The MTD was used to plan a phase II trial with pain response as the primary outcome. Pain was recorded using a Visual Analogic Scale (VAS), and QoL using CLAS scales. Forty-five patients were enrolled in this trial. In phase I no Grade ≥ 2 acute toxicities were recorded. Thus 20 Gy was established as MTD. In phase II, with a median follow-up of 4 months, rates of complete symptom remission, partial response, no symptomatic change, and symptoms progression were 32.0%, 52.0%, 8.0%, and 8.0%, respectively. This RT protocol tested in our study is effective and tolerable with comparable results to traditional RT treatments delivered in 5–10 daily fractions.
Lingua originaleEnglish
pagine (da-a)605-611
Numero di pagine7
RivistaCLINICAL & EXPERIMENTAL METASTASIS
Volume35
DOI
Stato di pubblicazionePubblicato - 2018

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Bone Neoplasms
  • Cancer Pain
  • Complicated bone metastases
  • Dose-Response Relationship, Radiation
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pain
  • Palliative Care
  • Palliative care
  • Quality of life
  • Radiotherapy

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