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Observational Study
. 2024 Sep 24;65(5):701-711.
doi: 10.1093/jrr/rrae060.

Multi-institutional prospective observational study of radiotherapy for metastatic bone tumor

Hideyuki Harada  1 , Naoto Shikama  2 , Akifumi Notsu  3 , Hiroki Shirato  4 , Kazunari Yamada  5 , Haruka Uezono  6 , Yutaro Koide  7 , Hikaru Kubota  8 , Takuya Yamazaki  9 , Kei Ito  10 , Joichi Heianna  11 , Yukinori Okada  12 , Ayako Tonari  13 , Norio Katoh  14 , Hitoshi Wada  15 , Yasuo Ejima  16 , Kayo Yoshida  17 , Takashi Kosugi  18 , Shigeo Takahashi  19 , Takafumi Komiyama  20 , Nobue Uchida  21 , Misako Miwa  22 , Miho Watanabe  23 , Hisayasu Nagakura  24 , Hiroko Ikeda  25 , Tetsuo Saito  26 , Isao Asakawa  27 , Takeo Takahashi  28 , Naoyuki Shigematsu  17
Affiliations
Observational Study

Multi-institutional prospective observational study of radiotherapy for metastatic bone tumor

Hideyuki Harada et al. J Radiat Res. .

Abstract

Purpose of this study is to evaluate patient characteristics, treatments and outcomes in bone metastasis radiotherapy practice. Patients for whom radiotherapy for bone metastasis was planned at 26 institutions in Japan between December 2020 and March 2021 were consecutively registered in this prospective, observational study. Study measures included patient characteristics, pain relief, skeletal-related events (SREs), overall survival and incidence of radiation-related adverse events. Pain was evaluated using a numerical rating scale (NRS) from 0 to 10. Irradiated dose was analyzed by the biologically effective dose (BED) assuming α/β = 10. Overall, 232 patients were registered; 224 patients and 302 lesions were fully analyzed. Eastern Cooperative Oncology Group Performance Status was 0/1/2/3/4 in 23%/38%/22%/13%/4%; 59% of patients had spinal metastases and 84% had painful lesions (NRS ≥ 2). BED was <20 Gy (in 27%), 20-30 Gy (24%), 30-40 Gy (36%) and ≥ 40 Gy (13%); 9% of patients were treated by stereotactic body radiotherapy. Grade 3 adverse events occurred in 4% and no grade 4-5 toxicity was reported. Pain relief was achieved in 52% at 2 months. BED is not related to pain relief. The cumulative incidence of SREs was 6.5% (95% confidence interval (CI) 3.1-9.9) at 6 months; no factors were significantly associated with SREs. With spinal lesions, 18% of patients were not ambulatory at baseline and 50% of evaluable patients in this group could walk at 2 months. The 6-month overall survival rate was 70.2% (95% CI 64.2-76.9%). In conclusion, we report real-world details of radiotherapy in bone metastasis.

Keywords: SRE; bone metastasis; pain relief; prospective study; radiotherapy.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Hideyuki Harada received honoraria from Astrazeneca, Accuray, Chugai pharmaceutical, Takeda pharmaceutical, MSD, Eizai pharmaceutical, Phizer, Brainlab, Hitachi, Novartis, Guerbet Japan, GE Healthcare, Nihon Medi-Physics and Taiho pharmaceutical outside this work. Naoto Shikama reports research grants from Chiyoda Technol, Boston Scientific, and Elekta during the conduct of this study. Yukinori Okada received lecture fee from PDRadiopharma Inc outside this work.

Figures

Fig. 1
Fig. 1
NRS score of pain at the region treated with radiation therapy. The bars represent mean and its 95% CI. (a) Pain scores in patients who were evaluable before treatment and at 2 and 6 months after initiation of the radiation therapy. (b) Pain score in patients who were evaluable 6 months after initiation of the radiation therapy. CI = confidence interval.
Fig. 2
Fig. 2
Cumulative probability of SREs. SREs = skeletal-related events (spinal cord paralysis, pathological fracture, surgery at the irradiated site or re-irradiation).
Fig. 3
Fig. 3
(a) Overall survival. (b) Overall survival by performance status. PS = Eastern Cooperative Oncology Group Performance Status.
See this image and copyright information in PMC

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