ESTRO 2023

Session Item

Saturday

May 13

09:00 - 10:00

Business Suite 1-2

Palliative radiotherapy & SBRT

Chair: Nicolaus Andratschke, Switzerland

Session Type: Poster Discussion

Track: Clinical

Journey:

Final results of a randomized trial on accelerated radiotherapy in bone metastases (NCT03503682)

Alice Zamagni, Italy

Presentation Number: PD-0063

Abstract

Abstract Title:

Final results of a randomized trial on accelerated radiotherapy in bone metastases (NCT03503682)

Authors:

Alice Zamagni¹, Giambattista Siepe², Silvia Bisello^1,2, Erica Scirocco^3,2, Filippo Candoli^1,2, Francesco Deodato^4,5, Gabriella Macchia⁴, Francesco Fiorica⁶, Eleonora Farina⁷, Savino Cilla⁸, Ilario Ammendolia², Luciana Caravatta⁹, Claudio Malizia¹⁰, Silvia Cammelli^1,2, Francesco Cellini^5,11, Alessio G. Morganti^3,2

¹Department of Experimental Diagnostic and Specialty Medicine – DIMES, University of Bologna, Bologna, Italy; ²Radiation Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; ³Department of Experimental Diagnostic and Specialty Medicine – DIMES , University of Bologna, Bologna, Italy; ⁴Radiation Oncology Unit, Gemelli Molise Hospital – Università Cattolica del Sacro Cuore, Campobasso, Italy; ⁵Istituto di Radiologia, Università Cattolica del Sacro Cuore, Roma, Italy; ⁶Department of Radiation Oncology and Nuclear Medicine, AULSS 9 Scaligera, Verona, Italy; ⁷Department of Radiation Oncology, Sant'Anna University Hospital of Ferrara, Ferrara, Italy; ⁸Medical Physics Unit, Gemelli Molise Hospital – Università Cattolica del Sacro Cuore, Campobasso, Italy; ⁹Department of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Chieti, Italy; ¹⁰Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; ¹¹Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, 10. Fondazione Policlinico Universitario "A. Gemelli" Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Roma, Italy

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Purpose or Objective

SHARON BONE is a phase III randomized controlled multicenter trial aiming to demonstrate non-inferior symptoms relief of hypofractionated accelerated palliative radiotherapy (RT; 20 Gy in 4 fractions twice a day) versus a standard RT regimen (30 Gy in 10 daily fractions), in painfully complicated bone metastases.

Material and Methods

SHARON BONE involved 4 Italian RT units. Patients (pts) aged at least 18 years with ECOG PS ≤ 3 candidates for palliative RT on painfully complicated bone metastases were eligible. We randomly allocated pts to either 30 Gy in 10 daily fractions (over two weeks), or 20 Gy in 4 fractions twice a day (in two consecutive days). Allocation was not masked because of the nature of the intervention. The primary endpoint was pain relief one month after treatment. Pain relief, toxicities, and Quality of Life questionnaires were also assessed at 2, 3, 6, and 12 months after RT. This trial is registered at clinicaltrials.gov (NCT03503682).

Results

Between February 2018 and December 2021, 83 pts were enrolled (30 Gy: 41; 20 Gy: 42). Pts characteristics are summarized in Table 1. Five patients on the standard RT schedule versus none in the experimental arm did not complete RT. Moreover, due to early death, the primary endpoint was not evaluable in 5 pts (1 and 4 pts from the standard and experimental arm, respectively). Overall, the primary endpoint was evaluable for 73 pts (35 and 38 pts for standard and experimental arms respectively). Complete pain response (NRS=0) at 1 month was 22.9% and 28.9% in the 30 and 20 Gy arms, respectively (p: NS). The overall pain response rates (complete plus partial) were 82.9% and 86.8% in the 30 and 20 Gy arms, respectively (p: NS). Both treatments were well tolerated, with 12.2% and 4.8% pts experiencing G≥2 toxicity in standard and experimental arms, respectively. In the 30 Gy arm, two vertebral fractures were recorded.

Conclusion

20 Gy in 4 fractions twice a day is non-inferior to the standard 30 Gy in 10 fractions for pain relief in complicated bone metastases, and it is at least as safe in terms of acute toxicity, with a lower rate of RT definitive interruptions.