Two prospective phase II trials were designed to assess the efficacy and safety of image-guided proton therapy (IGPT) for either medically inoperable or operable stage I non-small cell lung cancer (NSCLC). The present study reports the interim results of these trials. Fifty-five patients with histologically confirmed stage I NSCLC (IA in 33 patients and IB in 22 patients; inoperable in 21 patients and operable in 34 patients) who received IGPT between July 2013 and February 2017 were analyzed. The median patient age was 71 years (range: 48–88 years). IGPT with fiducial metallic marker matching was performed for suitable patients, and a respiratory gating method for motion management was used for all treatments. Peripherally located tumors were treated with 66 Gy relative biological effectiveness equivalents (Gy(RBE)) in 10 fractions (n = 49) and centrally located tumors were treated with 72.6 Gy(RBE) in 22 fractions (n = 6). Treatment associated toxicities were evaluated using Common Toxicity Criteria for Adverse Events (v.4.0). Median follow-up was 35 months (range: 12–54 months) for survivors. For all patients, the 3-year overall survival, progression-free survival, and local control rates were 87% (95% confidence interval: 73–94%), 74% (58–85%), and 96% (83–99%), respectively. Fiducial marker matching was used in 39 patients (71%). Grade 2 toxicities observed were radiation pneumonitis in 5 patients (9%), rib fracture in 2 (4%), and chest wall pain in 5 (9%). There were no grade 3 or higher acute or late toxicities. IGPT appears to be effective and well tolerated for all patients with stage I NSCLC. Lung-001, 13–02-09 (9), registered 11 June 2013 and Lung-002, 13–02-10 (10), registered 11 June 2013.

This study retrospectively investigated the efficacy and safety of image-guided proton therapy (IGPT) for elderly (≥80 years old) hepatocellular carcinoma (HCC) patients. Proton therapy was performed using respiratory-gated and image-guided techniques. Seventy-one elderly HCC patients were treated using IGPT. The Child–Pugh score was A5 in 49 patients, A6 in 15, and B7-9 in 7. Forty-seven patients with a peripherally located tumor were administered 66 gray relative biological effectiveness (GyRBE) in 10 fractions, whereas 24 with a centrally located tumor received 72.6 GyRBE in 22 fractions. The median follow-up period of surviving patients was 33 months (range: 9–68). Two-year overall survival (OS) and local control (LC) rates estimated by the Kaplan–Meier method were 76% (95% confidence interval: 66–87%) and 88% (80–97%), respectively. According to the Common Terminology Criteria for Adverse Events version 4.0, no grade 2 or higher radiation-induced liver disease was observed, and only 1 patient developed grade 3 dermatitis. The quality of life score (European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 version 3.0, QLQ-HCC18, and SF-36) did not change after 1 year, except for the three-mental component summary (SF-36, improvement). IGPT is a safe and effective treatment for HCC in elderly patients.

We retrospectively evaluated the three-year patient-reported quality of life (QOL) after moderately hypofractionated proton therapy (MHPT) for localized prostate cancer in comparison with that after normofractionated PT (NFPT) using the Expanded Prostate Cancer Index Composite-50. Patients who received MHPT (60–63 Gy (relative biological effectiveness equivalents; RBE)/20–21 fractions) (n = 343) or NFPT (74–78 Gy (RBE)/37–39 fractions) (n = 296) between 2013 and 2016 were analyzed. The minimum clinically important difference (MCID) threshold was defined as one-half of a standard deviation of the baseline value. The median follow-up was 56 months and 83% completed questionnaires at 36 months. Clinically meaningful score deterioration was observed in the urinary domain at 1 month in both groups and in the sexual domain at 6–36 months in the NFPT group, but not observed in the bowel domain. At 36 months, the mean score change for urinary summary was −0.3 (MHPT) and −1.6 points (NFPT), and that for bowel summary was +0.1 and −2.0 points; the proportion of patients with MCID was 21% and 24% for urinary summary and 18% and 29% for bowel summary. Overall, MHPT had small negative impacts on QOL over three years, and the QOL after MHPT and NFPT was similar.

Optimal management for locally confined unresectable trunk soft tissue sarcomas (STS) has not been established, and the role of radiotherapy remains unclear. We evaluated clinical outcomes and quality of life (QOL) after definitive proton therapy (PT). We conducted a retrospective and single-institution review of patients with unresectable trunk STS treated with definitive PT, drawn from a prospective registry. Endpoints included overall survival (OS), local control (LC), progression-free survival (PFS), toxicity, and QOL. Thirty-three patients were included. Median age was 61 years (range, 19–85). PT was most commonly delivered as 70.2 Gy (RBE) in 26 fractions (58%) or 60.8 Gy (RBE) in 16 fractions (30%). Spot scanning technique was used in 26 patients (79%). The most common histological subtype was dedifferentiated liposarcoma (42%). Median follow-up was 27 months (41.5 months for survivors). Three-year OS, LC, and PFS rates were 51% (95% CI: 31–68%), 81% (60–92%), and 39% (23–55%), respectively; median OS was 39 months. Gross tumor volume ≥300 cm³ was associated with worse OS (p = 0.03). No grade ≥3 toxicities were observed. QOL was generally maintained, and the global health status showed no clinically significant deterioration. Reports on PT for this disease are scarce. Our findings suggest that PT is a safe and effective treatment option for unresectable trunk STS. Given its favorable safety profile and dosimetric advantages, PT is well suited for multidisciplinary treatment strategies and should be actively considered for these patients.

Background and purpose: Optimal management for locally confined unresectable trunk soft tissue sarcomas (STS) has not been established, and the role of radiotherapy remains unclear. We evaluated clinical outcomes and quality of life (QOL) after definitive proton therapy (PT).Materials and methods: We conducted a retrospective and single-institution review of patients with unresectable trunk STS treated with definitive PT, drawn from a prospective registry. Endpoints included overall survival (OS), local control (LC), progression-free survival (PFS), toxicity, and QOL.Results: Thirty-three patients were included. Median age was 61 years (range, 19－85). PT was most commonly delivered as 70.2 Gy (RBE) in 26 fractions (58%) or 60.8 Gy (RBE) in 16 fractions (30%). Spot scanning technique was used in 26 patients (79%). The most common histological subtype was dedifferentiated liposarcoma (42%). Median follow-up was 27 months (41.5 months for survivors). Three-year OS, LC, and PFS rates were 51% (95% CI: 31－68%), 81% (60－92%), and 39% (23－55%), respectively; median OS was 39 months. Gross tumor volume ≥300 cm3 was associated with worse OS (p = 0.03). No grade ≥3 toxicities were observed. QOL was generally maintained, and the global health status showed no clinically significant deterioration.Conclusion: Reports on PT for this disease are scarce. Our findings suggest that PT is a safe and effective treatment option for unresectable trunk STS. Given its favorable safety profile and dosimetric advantages, PT is well suited for multidisciplinary treatment strategies and should be actively considered for these patients.