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

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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.

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Author information

Author notes

  1. Francesco Deodato and Alessio G. Morganti have contributed equally to this work.

Authors and Affiliations

  1. Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine – DIMES, S. Orsola-Malpighi Hospital, University of Bologna, Via Massarenti 9, 40138, Bologna, Italy

    Jenny Capuccini, Eleonora Farina, Milly Buwenge, Silvia Cammelli & Alessio G. Morganti

  2. Radiotherapy Unit, Department of Oncology, “Giovanni Paolo II” Foundation, Catholic University of Sacred Heart, Largo Agostino Gemelli 1, 86100, Campobasso, Italy

    Gabriella Macchia & Francesco Deodato

  3. Department of Radiation Oncology, SS. Annunziata Hospital, G. D’Annunzio University of Chieti, V. dei Vestini, 66100, Chieti, Italy

    Domenico Genovesi & Luciana Caravatta

  4. Department of Radiation Oncology, Howard University College of Medicine, 520 W St NW, Washington, DC, 20059, USA

    Nam P. Nguyen

  5. Medical Physics Unit, Fondazione “Giovanni Paolo II”, Catholic University of Sacred Heart, Largo Agostino Gemelli 1, 86100, Campobasso, Italy

    Savino Cilla

  6. Department of Radiotherapy, Black Lion Hospital, Zambia St, Addis-Ababa, Ethiopia

    Tigeneh Wondemagegnhu

  7. Department of Radiation Oncology, United Hospital Limited, Plot 15, Road 71, Gulshan, Dhaka, 1212, Bangladesh

    A. F. M. Kamal Uddin

  8. Clinical Oncology, Kurmitola General Hospital, Tongi Diversion Rd, Dhaka, 1206, Bangladesh

    Mostafà Aziz Sumon

  9. Department of Radiotherapy, “A. Gemelli” Hospital, Catholic University, Largo Agostino Gemelli 8, 00168, Rome, Italy

    Francesco Cellini & Vincenzo Valentini

Authors
  1. Jenny Capuccini
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  2. Gabriella Macchia
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  3. Eleonora Farina
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  4. Milly Buwenge
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  5. Domenico Genovesi
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  6. Luciana Caravatta
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  7. Nam P. Nguyen
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  8. Silvia Cammelli
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  9. Savino Cilla
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  10. Tigeneh Wondemagegnhu
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  11. A. F. M. Kamal Uddin
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  12. Mostafà Aziz Sumon
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  13. Francesco Cellini
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  14. Vincenzo Valentini
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  15. Francesco Deodato
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  16. Alessio G. Morganti
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Corresponding author

Correspondence to Eleonora Farina.

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The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the local Ethics Committee. The study is registered in an international public registry (ClinicalTrials.gov: NCT03455231).

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Informed consent was obtained from all individual participants included in the study.

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This article does not contain any studies with animals performed by any of the authors.

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Capuccini, J., Macchia, G., Farina, E. et al. Short-course regimen of palliative radiotherapy in complicated bone metastases: a phase i–ii study (SHARON Project). Clin Exp Metastasis 35, 605–611 (2018). https://doi.org/10.1007/s10585-018-9931-9

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  • DOI: https://doi.org/10.1007/s10585-018-9931-9

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