Clinical effectiveness of combined whole body hyperthermia and external beam radiation therapy (EBRT) versus EBRT alone in patients with painful bony metastases: A phase III clinical trial study.

PURPOSE: To evaluate the response rate, pain relief duration, and time it took for pain to decline or resolve after radiation therapy (RT) with or without fever-range Whole Body Hyperthermia (WBH) in bony metastatic patients with mainly primary tumor of prostate and breast cancer leading to bone pain. MATERIALS & METHODS: Bony metastatic patients with pain score ≥4 on the Brief Pain Inventory (BPI) underwent RT of 30 Gy in 10 fractions in combination with WBH with nursing care under medical supervision versus RT-alone. WBH application time was 3-4 h in three fractions with at least 48-h intervals. All patients were stratified primary site, breast or prostate cancer vs others, BPI score, and exclusion criteria. The primary endpoint was complete response (CR) (BPI equal to zero with no increase of analgesics) within two months of follow-up. RESULTS: Based on this study, the RT-alone group showed the worst pain. The study was terminated after the enrollment of a total of 61 patients, 5 years after the first enrollment (April 2016 to February 2021). Finally, the CR rate in RT + WBH revealed the most significant difference with RT-alone, 47.4% versus 5.3% respectively within 2 months post-treatment (P-value <0.05). The time of complete pain relief was 10 days for RT + WBH, while the endpoint was not reached during the RT-alone arm. Pain progression or stable disease was observed in half of the patients in RT-alone group within 4 weeks after treatment. However, this score was near zero in RT + WBHT patients in two months post-treatment. CONCLUSIONS: WBH plus RT showed significant increases in pain relief and shorter response time in comparison with RT-alone for patients with bone metastatic lesions.

Combination treatment with transarterial chemoembolization, radiotherapy, and hyperthermia (CERT) for hepatocellular carcinoma with portal vein tumor thrombosis: Final results of a prospective phase II trial.

BACKGROUND & AIMS: This study was designed to evaluate the efficacy and safety of combination transarterial chemoembolization (TACE) followed by radiotherapy (RT) and hyperthermia (CERT) in hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT). METHODS: This single-institution, single-arm, prospective phase II study was performed from October 2013 to February 2016. The objective response rate (ORR) was evaluated at 3 months after CERT completion, and overall ORR was the primary end point. RESULTS: During the study period, 69 of 77 patients who consented to participate underwent at least one session of hyperthermia and RT. More than half of the patients (39, 56.5%) complained of severe hyperthermia-related pain. The overall ORR was 43.5% (30/69), and the ORR of the RT target area was 69.6% (48/69). Liver function status was not significantly affected by CERT. Overall survival, local progression-free survival, and progression-free survival of all enrolled patients at 2 years was 62.9%, 47.6%, and 14.3%, respectively. CONCLUSIONS: An overall ORR of 43.5% was observed after CERT, but a promising ORR of 69.6% was achieved in the RT target area. Toxicities related to CERT were manageable, and pain intolerance to hyperthermia was the main obstacle to treatment maintenance.