Hypofractionated radiotherapy for complicated bone metastases in patients with poor performance status: a phase II international trial



To evaluate the efficacy and safety of hypofractionated radiotherapy (16 Gy in 2 fractions, 1 week apart) in patients with complicated bone metastases and poor performance status.


A prospective single-arm phase II clinical trial was conducted from July 2014 to May 2016. The primary endpoint was pain response as defined in the International Consensus on Palliative Radiotherapy Endpoints. Secondary endpoints included quality of life as measured by quality of life questionnaire (QLQ) PAL-15 and QLQ-BM22 European Organisation for Research and Treatment of Cancer guidelines, pain flare, adverse events, re-irradiation, and skeletal complications.


Fifty patients were enrolled. There were 23 men with a median age of 58 years (range 26-86). Of the 50 patients, 38 had an extraosseous soft tissue component, 18 needed postsurgical radiation, 3 had neuropathic pain, and 3 had an impending fracture in a weight-bearing bone. At 2 months, 33 patients were alive (66%). Four (12.5%) had a complete response and 12 (37.5%) had a partial response. A statistically significant improvement was seen in the functional interference (p = 0.01) and psychosocial aspects (p = 0.03) of the BM22. No patient had spinal cord compression. One patient required surgery for pathologic fracture, and another re-irradiation.


Hypofractionated radiotherapy (16 Gy in 2 fractions of 8 Gy 1 week apart) achieved satisfactory pain relief and safety results in patients with complicated bone metastases and poor performance status.

Post author correction




Mauricio F. Silva, Gustavo N. Marta, Felipe P.C. Lisboa, Guilherme Watte, Fabio Trippa, Ernesto Maranzano, Neiro W. da Motta, Marko Popovic, Tuan Ha, Bryan Burmeister, Edward Chow

Article History


Financial support: No financial support was received for this submission.
Conflict of interest: None of the authors has conflict of interest with this submission.

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  •  Radiation Oncology Unit, Hospital de Caridade Astrogildo de Azevedo, Santa Maria, Rio Grande do Sul - Brazil
  •  Radiation Oncology Department, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Rio Grande do Sul - Brazil
  •  Radiation Oncology Department, Hospital Sírio-Libanês, São Paulo - Brazil
  •  Department of Radiology and Oncology of University of São Paulo, Instituto do Câncer do Estado de São Paulo (ICESP), Faculdade de Medicina da Universidade de São Paulo, São Paulo - Brazil
  •  Radiology Department, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, Merseyside - United Kingdom
  •  Radiation Oncology Department, “S. Maria” Hospital, Terni - Italy
  •  Radiation Oncology Department, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto - Canada
  •  Radiation Oncology Centres, Fraser Coast, Queensland - Australia
  •  Radiation Oncology Department, Princess Alexandra Hospital, Brisbane, Queensland - Australia

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