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Conventionally fractionated radiotherapy versus CyberKnife hypofractionated radiotherapy for painful vertebral haemangiomas – A randomized clinical trial

  • Marcin Miszczyk
    Correspondence
    Corresponding author. III Klinika Radioterapii i Chemioterapii, ul. Wybrzeże Armii Krajowej 15, 44-100 Gliwice, Poland.
    Affiliations
    IIIrd Radiotherapy and Chemotherapy Department, M. Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
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  • Aleksandra Napieralska
    Affiliations
    Radiotherapy Department, M. Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
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  • Grzegorz Woźniak
    Affiliations
    Radiotherapy Department, M. Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
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  • Małgorzata Kraszkiewicz
    Affiliations
    Radiotherapy Department, M. Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
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  • Michał Gola
    Affiliations
    Radiology and Diagnostic Imaging Department, M. Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
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  • Michał Kalemba
    Affiliations
    Department of Nuclear Medicine and Endocrine Oncology, M. Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
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  • Grzegorz Głowacki
    Affiliations
    Radiotherapy Department, M. Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
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  • Bartłomiej Tomasik
    Affiliations
    Department of Oncology and Radiotherapy, Faculty of Medicine, Medical University of Gdańsk, Poland
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  • Magdalena Kocot-Kępska
    Affiliations
    Department of Pain Research and Treatment, Jagiellonian University Medical College, Krakow, Poland
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  • Author Footnotes
    1 The trial was designed and led by prof. Leszek Miszczyk. Due to his tragic death in May 2021, he was not able to finish the manuscript in person. However, we believe that he would accept this analysis which we prepared, and would like for him to remain among the authors of the publication, just as he will remain in our memory.
    Leszek Miszczyk
    Footnotes
    1 The trial was designed and led by prof. Leszek Miszczyk. Due to his tragic death in May 2021, he was not able to finish the manuscript in person. However, we believe that he would accept this analysis which we prepared, and would like for him to remain among the authors of the publication, just as he will remain in our memory.
    Affiliations
    IIIrd Radiotherapy and Chemotherapy Department, M. Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
    Search for articles by this author
  • Author Footnotes
    1 The trial was designed and led by prof. Leszek Miszczyk. Due to his tragic death in May 2021, he was not able to finish the manuscript in person. However, we believe that he would accept this analysis which we prepared, and would like for him to remain among the authors of the publication, just as he will remain in our memory.
Published:September 19, 2022DOI:https://doi.org/10.1016/j.radonc.2022.09.008

      Highlights

      • Five fractions hypofractionated radiotherapy for painful haemangiomas is safe and effective.
      • The delivery of 25 Gy in 5 fractions is associated with improved subjective pain relief at two years compared to 36 Gy in 18 fractions.
      • Hypofractionation significantly reduces the number of necessary hospital visits and overall treatment time.

      Abstract

      Background and purpose

      The outcomes of conventional radiotherapy for painful vertebral haemangiomas have been improved through dose escalation at the expense of overall treatment time. We hypothesized that with the aid of precise hypofractionated radiotherapy, it is possible to safely deliver a similar biological equivalent dose over a significantly shorter course of treatment with a comparable efficacy and safety.

      Materials and methods

      In this prospective, single-institution unblinded randomized clinical trial (NCT02332408) patients with painful vertebral haemangiomas were allocated one-to-one either to 25 Gy delivered in five fractions (CK) or conventionally fractionated radiotherapy up to 36 Gy (conv.). The main endpoint was pain relief at two years, measured on a subjective and numerical scale (NRS).

      Results

      The trial was finished yielding 74 evaluable patients, including 38 in the CK arm. Adverse events were infrequent and the treatment was well tolerated. The overall treatment time was significantly shorter in the CK arm (median of 13 days vs 25 days). At two years, more than half of the patients reported improvement (46; 62.2 %) , in 21 cases the pain symptoms were stable (28.4 %), and in seven cases worse (9.5 %). There were significantly more patients reporting improvement in the CK arm (73.7 % vs 50 %; p = 0.036). The median decrease in NRS was 4 (IQR 1–5) or 59 % (IQR 20–86 %), and the difference between arms was not statistically significant.

      Conclusion

      Five fractions hypofractionated radiotherapy for painful vertebral haemangiomas up to a total dose of 25 Gy is a safe treatment modality, significantly shorter compared to conventional fractionation, and possibly more effective.

      Keywords

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