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.

Assessing the out-of-field dose calculation accuracy by eclipse treatment planning system in sliding window IMRT of prostate cancer patients.

AIM: The objective of this study was to evaluate out-of-field dose distribution calculation accuracy by the Anisotropic Analytical Algorithm (AAA), version 13.0.26, in Eclipse TPS, (Varian Medical Systems, Palo Alto, Ca, USA) for sliding window IMRT delivery technique in prostate cancer patients. MATERIALS AND METHODS: Prostate IMRT plans with nine coplanar were calculated with the AAA Eclipse treatment planning system. To assess the accuracy of dose calculation predicted by the Eclipse in normal tissue and OARs located out of radiation field areas, including the rectum, bladder, right and left head of the femur, absolute organ dose value, and dose distribution were measured using the Delta4+ IMRT phantom. RESULTS: In the out-of-field areas, underestimation of -0.66% in organs near the field edge to -39.63% in organs far from the field edge (2.5 and 7.3 cm respectively) occurred in the TPS calculations. The percentage of dose deviation for the femoral heads was 95.7 on average while for the organ closer to the target (rectum) it was 79.81. CONCLUSIONS: AAA dosimetry algorithm (used in Eclipse TPS) showed poor dose calculation in areas beyond the treatment fields border where underestimation varies with the distance from the field edges. A significant underestimation was found for the AAA algorithm in the sliding window IMRT technique (P-value > 0.05).