Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases
Purpose: Stereotactic body radiation therapy (SBRT) is an effective treatment approach for spinal metastases. However, local recurrence may occur. This prospective phase 2 trial evaluated whether SBRT with dose escalation in the gross tumor volume through simultaneous integrated boost (SIB–SBRT) can...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-06-01
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| Series: | Advances in Radiation Oncology |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S245210942500048X |
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| author | Takamasa Mitsuyoshi, MD, PhD Peter J. K. Tokuda, MD Yumi Kokubo, MD Takahiro Iwai, MD Hiroyuki Inoo, MD Ryo Ashida, MD, PhD Ryosuke Nasada, MS Mikiko Yamashita, PhD Hiroaki Tanabe, MS Shigeki Arizono, MD, PhD Toshiyuki Imagumbai, MD Masaki Kokubo, MD, PhD |
| author_facet | Takamasa Mitsuyoshi, MD, PhD Peter J. K. Tokuda, MD Yumi Kokubo, MD Takahiro Iwai, MD Hiroyuki Inoo, MD Ryo Ashida, MD, PhD Ryosuke Nasada, MS Mikiko Yamashita, PhD Hiroaki Tanabe, MS Shigeki Arizono, MD, PhD Toshiyuki Imagumbai, MD Masaki Kokubo, MD, PhD |
| author_sort | Takamasa Mitsuyoshi, MD, PhD |
| collection | DOAJ |
| description | Purpose: Stereotactic body radiation therapy (SBRT) is an effective treatment approach for spinal metastases. However, local recurrence may occur. This prospective phase 2 trial evaluated whether SBRT with dose escalation in the gross tumor volume through simultaneous integrated boost (SIB–SBRT) can improve local control (LC) without increasing adverse events (AEs). Methods and Materials: Eligible patients aged ≥ 20 years with spinal metastases and a life expectancy of > 1 year received SIB–SBRT in 5 fractions over 1 week. The prescribed dose was 30 Gy to the planning target volume for evaluation and an escalated dose of 40 to 45 Gy to the gross tumor volume through SIB. Neurologic examinations and magnetic resonance imaging were performed at 3-, 6-, and 12-month follow-up and every 6 months thereafter. The primary endpoint was the 1-year LC rate. The secondary endpoints included overall survival and AEs, such as vertebral compression fractures (VCFs). Results: A total of 25 patients with 28 vertebral segments from September 2020 to March 2023 were enrolled in this study. The median follow-up was 26.2 months, and 24 segments in 21 patients were followed up for >1 year. The 1- and 2-year LC rates were 100.0% and 95.0%, respectively. Local recurrence developed in only 1 patient at 18 months. The 1- and 2-year overall survival rates were 92.0% and 72.8%, respectively. Six patients developed VCFs (3 cases each of grades 1 and 2), with 1- and 2-year cumulative incidence rates of 3.6% and 15.6%, respectively. No radiation myelopathy or other grade ≥ 2 AEs occurred, except for 1 case of grade 2 pain. Conclusions: Dose-escalated SIB–SBRT for spinal metastases demonstrates excellent LC with acceptable toxicity, supporting the need for a larger comparative trial. |
| format | Article |
| id | doaj-art-7f68467b545f4bf191a62e7113f5a7e2 |
| institution | DOAJ |
| issn | 2452-1094 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Advances in Radiation Oncology |
| spelling | doaj-art-7f68467b545f4bf191a62e7113f5a7e22025-08-20T03:14:08ZengElsevierAdvances in Radiation Oncology2452-10942025-06-0110610176010.1016/j.adro.2025.101760Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal MetastasesTakamasa Mitsuyoshi, MD, PhD0Peter J. K. Tokuda, MD1Yumi Kokubo, MD2Takahiro Iwai, MD3Hiroyuki Inoo, MD4Ryo Ashida, MD, PhD5Ryosuke Nasada, MS6Mikiko Yamashita, PhD7Hiroaki Tanabe, MS8Shigeki Arizono, MD, PhD9Toshiyuki Imagumbai, MD10Masaki Kokubo, MD, PhD11Department of Radiation Oncology, Kobe City Medical Center General Hospital, Kobe, Japan; Corresponding author: Takamasa Mitsuyoshi, MD, PhDDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, Kobe, Japan; Department of Radiation Oncology and Image-applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, JapanDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, Kobe, JapanDepartment of Radiation Oncology and Image-applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, JapanDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, Kobe, JapanDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, Kobe, JapanDepartment of Radiological Technology, Kobe City Medical Center General Hospital, Kobe, Japan; Department of Radiological Technology, Kobe City Medical Center West Hospital, Kobe, JapanDepartment of Radiological Technology, Kobe City Medical Center General Hospital, Kobe, JapanDepartment of Radiological Technology, Kobe City Medical Center General Hospital, Kobe, JapanDepartment of Diagnostic Radiology, Kobe City Medical Center General Hospital, Kobe, JapanDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, Kobe, Japan; Department of Radiation Oncology, Medical Research Institute Kitano Hospital, Osaka, JapanDepartment of Radiation Oncology, Kobe City Medical Center General Hospital, Kobe, JapanPurpose: Stereotactic body radiation therapy (SBRT) is an effective treatment approach for spinal metastases. However, local recurrence may occur. This prospective phase 2 trial evaluated whether SBRT with dose escalation in the gross tumor volume through simultaneous integrated boost (SIB–SBRT) can improve local control (LC) without increasing adverse events (AEs). Methods and Materials: Eligible patients aged ≥ 20 years with spinal metastases and a life expectancy of > 1 year received SIB–SBRT in 5 fractions over 1 week. The prescribed dose was 30 Gy to the planning target volume for evaluation and an escalated dose of 40 to 45 Gy to the gross tumor volume through SIB. Neurologic examinations and magnetic resonance imaging were performed at 3-, 6-, and 12-month follow-up and every 6 months thereafter. The primary endpoint was the 1-year LC rate. The secondary endpoints included overall survival and AEs, such as vertebral compression fractures (VCFs). Results: A total of 25 patients with 28 vertebral segments from September 2020 to March 2023 were enrolled in this study. The median follow-up was 26.2 months, and 24 segments in 21 patients were followed up for >1 year. The 1- and 2-year LC rates were 100.0% and 95.0%, respectively. Local recurrence developed in only 1 patient at 18 months. The 1- and 2-year overall survival rates were 92.0% and 72.8%, respectively. Six patients developed VCFs (3 cases each of grades 1 and 2), with 1- and 2-year cumulative incidence rates of 3.6% and 15.6%, respectively. No radiation myelopathy or other grade ≥ 2 AEs occurred, except for 1 case of grade 2 pain. Conclusions: Dose-escalated SIB–SBRT for spinal metastases demonstrates excellent LC with acceptable toxicity, supporting the need for a larger comparative trial.http://www.sciencedirect.com/science/article/pii/S245210942500048X |
| spellingShingle | Takamasa Mitsuyoshi, MD, PhD Peter J. K. Tokuda, MD Yumi Kokubo, MD Takahiro Iwai, MD Hiroyuki Inoo, MD Ryo Ashida, MD, PhD Ryosuke Nasada, MS Mikiko Yamashita, PhD Hiroaki Tanabe, MS Shigeki Arizono, MD, PhD Toshiyuki Imagumbai, MD Masaki Kokubo, MD, PhD Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases Advances in Radiation Oncology |
| title | Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases |
| title_full | Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases |
| title_fullStr | Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases |
| title_full_unstemmed | Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases |
| title_short | Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases |
| title_sort | phase 2 trial of stereotactic body radiation therapy with dose escalation using simultaneous integrated boost for spinal metastases |
| url | http://www.sciencedirect.com/science/article/pii/S245210942500048X |
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