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Aim: We aimed to verify the therapeutic efficacy and safety of stereotactic body radiotherapy (SBRT) for previously untreated initial small hepatocellular carcinoma (HCC) in a multicenter, retrospective study. Methods: Patients who underwent SBRT for HCC at the Japanese Society of Clinical Oncology (JCOG) member hospitals in Japan between July 2013 and December 2017 and met the following eligibility criteria were included: (1) initial HCC; (2) ≤3 nodules, ≤5 cm in diameter; (3) Child–Pugh score of A or B; and (4) unsuitability for or refusal of standard treatment. We analyzed the overall survival, recurrence‐free survival, and cumulative incidence of local recurrence rate, and adverse events directly related to SBRT. Results: Seventy‐three patients with 79 lesions from 14 hospitals were analyzed. The median age was 77 years (range: 50–89 years), and the median tumor size was 23 mm (range: 6–50 mm). The median radiation dose was 40 Gy (range: 35–60 Gy) in five fractions (range: 4–8). The median follow‐up period was 45 months (range: 0–103 months). The 3‐year overall survival, recurrence‐free survival, and cumulative incidence of local recurrence rates were 69.9% (95% CI: 58.7%–81%), 57.9% (95% CI: 45.2%–70.5%), and 20.0% (95% CI: 11.2%–30.5%), respectively. Four cases (5.5%) of adverse events of grade 3 or higher were reported: three cases of grade 3 and one case of grade 4 (duodenal ulcer). No grade 5 toxicities were observed. Conclusion: SBRT is a promising treatment modality, particularly for small HCCs, as they are not suitable for standard treatment. [ABSTRACT FROM AUTHOR]

Bone metastases are often associated with pain and can occur in various types of cancer, significantly affecting patients' quality of life. Despite the high response rates to initial conventional radiotherapy in patients with painful spinal metastases, recurrence and inadequate response still occur. Thus, the development of a highly effective strategy for pain recurrence is crucial to improving the quality of life in patients with advanced metastatic cancer. This randomized phase III trial aims to confirm the superiority of re-irradiation with stereotactic body radiotherapy (24 Gy in 2 fractions) over conventional radiotherapy (8 Gy in a single fraction) in achieving a complete pain response at 12 weeks in patients with previously irradiated painful spinal metastases. A total of 158 patients from 33 hospitals will be enrolled in Japan over 3.5 years. This trial has been registered in the Japan Registry of Clinical Trials as jRCTs1030240172 (https://jrct.niph.go.jp/latest-detail/jRCT1030240172)., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.)

Aim: CyberKnife is the most advanced form of stereotactic body radiotherapy (SBRT) system that uses a robotic arm to deliver highly focused beams of radiation; however, a limitation is that it only irradiates from ceiling to floor direction. In patients with posterior lungs tumour who are positioned supine, normal lung tissue may suffer undesirable radiation injuries. This study compares the treatment planning between the prone set-up and the supine set-up for lung cancer in CyberKnife SBRT to decrease normal lung dose to avoid radiation side effects. Materials and methods: A human phantom was used to generate 108 plans (54 for prone and 54 for supine) using the CyberKnife planning platform. The supine and prone plans were compared in terms of the dosimetric characteristics, delivery efficiency and plan efficiency. Results: For posterior targets, the area of low-dose exposure to normal lungs was smaller in the prone set-up than in the supine set-up. V10 of the lungs was 7·53% and 10·47% (p < 0·001) in the anterior region, and 10·78% and 8·03% (p < 0·001) in the posterior region in the supine and prone set-up plans, respectively. Conclusions: The comparison between the prone set-up and the supine set-up was investigated with regard to target coverage and dose to organs at risk. Our results may be deployed in CyberKnife treatment planning to monitor normal tissue dose by considering patient positioning. This may assist in the design of better treatment plans and prevention of symptomatic radiation pneumonitis in lung cancer patients. [ABSTRACT FROM AUTHOR]

Background This study aimed to evaluate stereotactic body radiation therapy ( SBRT) in patients with stage I non-small cell lung cancer ( NSCLC) in terms of radiation-induced changes and computed tomography ( CT) features of local recurrence by 18F-fluorodeoxyglucose positron emission tomography (18 F- FDG-PET). Methods From January 2006 to December 2012, 81 patients with NSCLC received SBRT. Follow-up consisted of non-contrast enhanced CT scans performed before and every four months after SBRT. In addition, 18F- FDG-PET/ CT was conducted before SBRT for each patient, and one year later for each case suspected of recurrence. The CT findings were classified into two categories: mass-like fibrosis and others. The mass-like fibrosis category was subdivided into two patterns: mass-like consolidation (with air bronchogram) and mass-like opacity. Results Six patients had histologically confirmed local recurrence, including 83% (5/6) with mass-like opacity pattern and one case of modified conventional pattern ( P = 0.02). In contrast, the non-recurrent group exhibited only 7% (5/75) with mass-like opacity and 13% (10/75) with mass-like consolidation pattern. Five patients with local recurrence presented with the mass-like opacity pattern, compared with 33% of patients (5/15) from the non-recurrent group ( P = 0.01) and showed an increase in maximum diameter at ≥12 months after SBRT. The recurrent group also had a significantly higher standardized uptake value ( SUVmax) than the non-recurrent group ( P < 0.001), with all values >5 (range: 5.7-25.4). Conclusion The following characteristics of mass-like fibrosis should be considered indicators of local recurrence after SBRT: opacity pattern, increasing maximum diameter, and SUVmax > 5. [ABSTRACT FROM AUTHOR]

Background and aims Stereotactic body radiotherapy (SBRT) is a relatively new treatment for liver tumor. The outcomes of SBRT for liver tumor unfit for ablation and surgical resection were evaluated. Methods Liver tumor patients treated with SBRT in seven Japanese institutions were studied retrospectively. Patients given SBRT for liver tumor between 2004 and 2012 were collected. Patients treated with SBRT preceded by trans-arterial chemoembolization (TACE) were eligible. Seventy-nine patients with hepatocellular carcinoma (HCC) and 51 patients with metastatic liver tumor were collected. The median biologically effective dose (BED) (α/β = 10 Gy) was 96.3 Gy for patients with HCC and 105.6 Gy with metastatic liver tumor. Results The median follow-up time was 475.5 days in patients with HCC and 212.5 days with metastatic liver tumor. The 2-year local control rate (LCR) for HCC and metastatic liver tumor was 74.8% ± 6.3% and 64.2 ± 9.5% (p = 0.44). The LCR was not different between BED10 ≥ 100 Gy and < 100 Gy (p = 0.61). The LCR was significantly different between maximum tumor diameter > 30 mm vs. ≤ 30 mm (64% vs. 85%, p = 0.040) in all 130 patients. No grade 3 laboratory toxicities in the acute, sub-acute and chronic phases were observed. Conclusions There was no difference in local control after SBRT in the range of median BED10 around 100 Gy for between HCC and metastatic liver tumor. SBRT is safe and might be an alternative method to resection and ablation. Summary There was no difference in local control after SBRT in the range of median BED10 around 100 Gy for between HCC and metastatic liver tumor and SBRT is safe and might be an alternative method to resection and ablation. [ABSTRACT FROM AUTHOR]

Carbon-ion radiotherapy (CIRT) for clinical stage I non-small-cell lung cancer (NSCLC) is used as an advanced medical treatment regimen in Japan. Carbon-ion radiotherapy reportedly aids in achieving excellent treatment outcomes, despite its high medical cost. We aimed to compare CIRT with stereotactic body radiotherapy (SBRT) in terms of cost-effectiveness for treating clinical stage I NSCLC. Data of patients with clinical stage I NSCLC treated with CIRT or SBRT at Gunma University between 2010 and 2015 were analyzed. The CIRT and SBRT groups included 62 and 27 patients, respectively. After propensity-score matching, both groups comprised 15 patients. Life year (LY) was used as an indicator of outcome. The CIRT technical fee was 3 140 000 JPY. There was no technical fee for the second CIRT carried out on the same organ within 2 years. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the incremental cost by the incremental LY for 5 years after treatment. Sensitivity analysis was applied to evaluate the impact of LY or costs of each group on ICER. The ICERs were 7 491 017 JPY/LY and 3 708 330 JPY/LY for all patients and matched patients, respectively. Hospitalization and examination costs were significantly higher in the CIRT group, and the impact of the CIRT technical costs was smaller than other costs and LY. Carbon-ion radiotherapy is a cost-effective treatment approach. However, our findings suggest that reducing excessive costs by considering the validity and necessity of examinations and hospitalizations would make CIRT a more cost-effective approach., (© 2021 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.)

There is dearth of data regarding the long-term survival outcomes of salvage surgery after stereotactic body radiotherapy for early-stage non-small-cell lung cancer, as previous studies have included a short follow-up period. There is also scarce information on the management of re-relapse in previous studies. This study examined the long-term survival outcomes of patients who underwent salvage surgery for isolated local relapse (LR). We reviewed consecutive patients who underwent salvage surgery for isolated LR after stereotactic body radiotherapy for early-stage non-small-cell lung cancer between 1999 and 2015. All patients were followed up until death or at least 5 years from salvage surgery. Twelve patients were included for analysis. The median follow-up from isolated LR was 62.4 (range: 14.3-152.1) months. The 5-year overall survival rate was 58.3%, updated from 79.5% in our previous report. During the interim, new re-relapses did not occur, whereas there were 5 additional deaths. The median survival after re-relapse was 32.6 months. Our follow-up report confirmed that our patient selection for salvage surgery appeared to be appropriate and that long-term follow-up is required to assess the outcomes of patients undergoing salvage surgery. Long-term follow-up would provide detailed information on late re-relapses, treatment and outcomes of re-relapses and mortality from any causes., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Cancer-specific death (CSD) and non-cancer-specific death (non-CSD) after stereotactic body radiotherapy (SBRT) for pulmonary oligometastases have not been studied in detail. The aim of this study was to determine the cumulative incidences of CSD and non-CSD and to reveal prognostic factors. Data from a large survey of SBRT for pulmonary oligometastases were used for analyses, and patients with unknown cause of death were excluded from current analyses. CSD was primary cancer death and non-CSD was non-primary cancer death including a series of cancer treatment-related deaths. Cumulative incidences were calculated using the Kaplan-Meier method and a stratified Cox regression model was used for multivariate analyses (MVA). Fifty-two patients with an unknown death were excluded and a total of 1326 patients was selected. CSD and non-CSD occurred in 375 and 109 patients, respectively. The median OS period was 53.2 months and the cumulative incidences of 1-, 3-, and 5-year CSD vs. non-CSD rates were 6.5% vs. 2.3%, 29.5% vs. 8.6%, and 41.2% vs. 11.0%, respectively. In MVA, the incidence of CSD was related to performance status (1 vs. 0; p < 0.001, 2-3 vs. 0; p = 0.011), oligometastatic state (sync-oligometastases vs. oligo-recurrence, p = 0.026) and maximum tumor diameter (p = 0.009), and the incidence of non-CSD was related to age (p = 0.001), sex (p = 0.030), performance status (2-3 vs. 0; p = 0.002), and irradiated tumor-located lung lobe (left lower lobe vs. other lobes, p = 0.036). CSD was main cause of death, but non-CSD was not rare after SBRT. Prognostic factors for CSD and non-CSD were different, and an understanding of the factors would help in treatment., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Objective: We compared outcomes after surgery or stereotactic body radiotherapy (SBRT) among patients with metachronous primary lung cancer (MPLC)., Methods: Patients with MPLC were treated with either surgery (2008-2018) or SBRT (2010-2018). We used propensity score matching (PSM) to reduce bias from various clinicopathological factors. MPLC was defined by the Martini and Melamed criteria., Results: Of 77 patients, 51 underwent surgery and 26 received SBRT. Most median clinicopathological characteristics did not significantly differ between the surgery and SBRT groups (male sex: 67% vs 65%; age: 73 vs 77 years; time after first surgery: 6.2 vs 4.7 years; lobectomy as first procedure: 82% vs 85%; second tumor size: 11 vs 12 mm; clinical stage I: 96% vs 100%; CEA: 2.9 vs 3.0 ng/ml). However, the surgery group had significantly more ipsilateral second tumors (n = 71, 58%, P = 0.003), better performance status (P = 0.03), and preserved lung function (P = 0.02). Surgery, thus, tended to be selected for patients with good physical function and for the MPLC in the contralateral side. Five-year overall survival did not significantly differ between the surgery and SBRT groups, either before PSM (86.5% vs 65.8%, P = 0.24, log-rank) or after PSM (100% vs 84.4%, P = 0.73)., Conclusions: Surgery and SBRT for MPLC patients are safe and feasible treatments with similar outcomes. However, this finding should be verified by a random controlled trial with a larger study cohort.

Background: Stereotactic ablative radiotherapy (SABR) is an emerging therapy for primary renal cell carcinoma. The authors assessed safety, efficacy, and survival in a multi-institutional setting. Outcomes between single-fraction and multifraction SABR were compared., Methods: Individual patient data sets from 9 International Radiosurgery Oncology Consortium for Kidney institutions across Germany, Australia, the United States, Canada, and Japan were pooled. Toxicities were recorded using Common Terminology Criteria for Adverse Events, version 4.0. Patient, tumor, and treatment characteristics were stratified according to the number of radiotherapy fractions (single vs multiple). Survival outcomes were examined using Kaplan-Meier estimates and Cox proportional-hazards regression., Results: Of 223 patients, 118 received single-fraction SABR, and 105 received multifraction SABR. The mean patient age was 72 years, and 69.5% of patients were men. There were 83 patients with grade 1 and 2 toxicity (35.6%) and 3 with grade 3 and 4 toxicities (1.3%). The rates of local control, cancer-specific survival, and progression-free survival were 97.8%, 95.7%, and 77.4%, respectively, at 2 years; and they were 97.8%, 91.9%, and 65.4%, respectively, at 4 years. On multivariable analysis, tumors with a larger maximum dimension and the receipt of multifraction SABR were associated with poorer progression-free survival (hazard ratio, 1.16 [P < .01] and 1.13 [P = .02], respectively) and poorer cancer-specific survival (hazard ratio, 1.28 [P < .01] and 1.33 [P = .01], respectively). There were no differences in local failure between the single-fraction cohort (n = 1) and the multifraction cohort (n = 2; P = .60). The mean ( ± standard deviation) estimated glomerular filtration rate at baseline was 59.9 ± 21.9 mL per minute, and it decreased by 5.5 ± 13.3 mL per minute (P < .01)., Conclusions: SABR is well tolerated and locally effective for treating patients who have primary renal cell carcinoma and has an acceptable impact on renal function. An interesting observation is that patients who receive single-fraction SABR appear to be less likely to progress distantly or to die of cancer. Cancer 2018;124:934-42. © 2017 American Cancer Society., (© 2017 American Cancer Society.)

Stereotactic body radiotherapy (SBRT) is a relatively new treatment for liver tumor. Outcomes of SBRT for liver tumors unsuitable for ablation or surgical resection were evaluated. A total of 79 patients treated with SBRT for primary hepatocellular carcinoma (HCC) between 2004 and 2012 in six Japanese institutions were studied retrospectively. Patients treated with SBRT preceded by trans-arterial chemoembolization were eligible. Their median age was 73 years, 76% were males, and their Child-Pugh scores were Grades A (85%) and B (11%) before SBRT. The median biologically effective dose (α/β = 10 Gy) was 96.3 Gy. The median follow-up time was 21.0 months for surviving patients. The 2-year overall survival (OS), progression-free survival (PFS), and distant metastasis-free survival were 53%, 40% and 76%, respectively. Sex and serum PIVKA-II values were significant predictive factors for OS. Hypovascular or hypervascular types of HCC, sex and clinical stage were significant predictive factors for PFS. The 2-year PFS was 66% in Stage I vs 18% in Stages II-III. Multivariate analysis indicated that clinical stage was the only significant predictive factor for PFS. No Grade 3 laboratory toxicities in the acute, sub-acute, and chronic phases were observed. PFS after SBRT for liver tumor was satisfactory, especially for Stage I HCC, even though these patients were unsuitable for resection and ablation. SBRT is safe and might be an alternative to resection and ablation., (© The Author 2015. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.)

The purpose of this study was to analyze the dosimetry and investigate the clinical outcomes of radiation-induced rib fractures (RIRFs) after stereotactic body radiotherapy (SBRT). A total of 126 patients with Stage I primary lung cancer treated with SBRT, who had undergone follow-up computed tomography (CT) at least 12 months after SBRT and who had no previous overlapping radiation exposure were included in the study. We used the Mantel-Haenszel method and multiple logistic regression analysis to compare risk factors. We analyzed D(0.5 cm(3)) (minimum absolute dose received by a 0.5-cm(3) volume) and identified each rib that received a biologically effective dose (BED) (BED3, using the linear-quadratic (LQ) formulation assuming an α/β = 3) of at least 50 Gy. Of the 126 patients, 46 (37%) suffered a total of 77 RIRFs. The median interval from SBRT to RIRF detection was 15 months (range, 3-56 months). The 3-year cumulative probabilities were 45% (95% CI, 34-56%) and 3% (95% CI, 0-6%), for Grades 1 and 2 RIRFs, respectively. Multivariate analysis showed that tumor location was a statistically significant risk factor for the development of Grade 1 RIRFs. Of the 77 RIRFs, 71 (92%) developed in the true ribs (ribs 1-7), and the remaining six developed in the false ribs (ribs 8-12). The BED3 associated with 10% and 50% probabilities of RIRF were 55 and 210 Gy to the true ribs and 240 and 260 Gy to the false ribs. We conclude that RIRFs develop more frequently in true ribs than in false ribs., (© The Author 2014. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.)