1. Clin Exp Metastasis. 2018 Aug 18. doi: 10.1007/s10585-018-9931-9.

[Epub ahead of

print]

Short-course regimen of palliative radiotherapy in complicated bone metastases: a

phase i-ii study (SHARON Project).

Capuccini J(1), Macchia G(2), Farina E(3), Buwenge M(1), Genovesi D(4), Caravatta
L(4), Nguyen NP(5), Cammelli S(1), Cilla S(6), Wondemagegnhu T(7), Uddin AFMK(8),
Aziz Sumon M(9), Cellini F(10), Valentini V(10), Deodato F(2), Morganti AG(1).

Author information:
(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.
(2)Radiotherapy Unit, Department of Oncology, "Giovanni Paolo II" Foundation,
Catholic University of Sacred Heart, Largo Agostino Gemelli 1, 86100, Campobasso,
Italy.
(3)Radiation Oncology Center, Department of Experimental, Diagnostic and
Specialty Medicine - DIMES, S. Orsola-Malpighi Hospital, University of Bologna,
Via Massarenti 9, 40138, Bologna, Italy. efarina.rt@gmail.com.
(4)Department of Radiation Oncology, SS. Annunziata Hospital, G. D'Annunzio
University of Chieti, V. dei Vestini, 66100, Chieti, Italy.
(5)Department of Radiation Oncology, Howard University College of Medicine, 520 W
St NW, Washington, DC, 20059, USA.
(6)Medical Physics Unit, Fondazione "Giovanni Paolo II", Catholic University of
Sacred Heart, Largo Agostino Gemelli 1, 86100, Campobasso, Italy.
(7)Department of Radiotherapy, Black Lion Hospital, Zambia St, Addis-Ababa,
Ethiopia.
(8)Department of Radiation Oncology, United Hospital Limited, Plot 15, Road 71,
Gulshan, Dhaka, 1212, Bangladesh.
(9)Clinical Oncology, Kurmitola General Hospital, Tongi Diversion Rd, Dhaka,
1206, Bangladesh.
(10)Department of Radiotherapy, "A. Gemelli" Hospital, Catholic University, Largo
Agostino Gemelli 8, 00168, Rome, Italy.

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.

DOI: 10.1007/s10585-018-9931-9
PMID: 30121938