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01-10-2018 | Research Paper

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

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

Published in: Clinical & Experimental Metastasis | Issue 7/2018

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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Title: Short-course regimen of palliative radiotherapy in complicated bone metastases: a phase i–ii study (SHARON Project)
Authors: Jenny Capuccini
Gabriella Macchia
Eleonora Farina
Milly Buwenge
Domenico Genovesi
Luciana Caravatta
Nam P. Nguyen
Silvia Cammelli
Savino Cilla
Tigeneh Wondemagegnhu
A. F. M. Kamal Uddin
Mostafà Aziz Sumon
Francesco Cellini
Vincenzo Valentini
Francesco Deodato
Alessio G. Morganti
Publication date: 01-10-2018
Publisher: Springer Netherlands
Published in: Clinical & Experimental Metastasis / Issue 7/2018
Print ISSN: 0262-0898
Electronic ISSN: 1573-7276
DOI: https://doi.org/10.1007/s10585-018-9931-9

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