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Targeting Accuracy Considerations for Simultaneous Tumor Treating Fields Antimitotic Therapy During Robotic Hypofractionated Radiation Therapy.

ABSTRACT: Purpose: Tumor treating fields (TTFields) is a novel antimitotic treatment that was first proven effective for glioblastoma multiforme, now with trials for several extracranial indications underway. Several studies focused on concurrent TTFields therapy with radiation in the same time period, but were not given simultaneously. This study evaluates the targeting accuracy of simultaneous radiation therapy while TTFields arrays are in place and powered on, ensuring that radiation does not interfere with TTFields and TTFields does not interfere with radiation. This is one of several options to enable TTFields to begin several weeks sooner, and opens potential for synergistic effects of combined therapy. Methods: TTFields arrays were attached to a warm saline water bath and salt was added until the TTFields generator reached the maximal 2000 mA peak-to-peak current. A ball cube phantom containing 2 orthogonal films surrounded by fiducials was placed in the water phantom, CT scanned, and a radiation treatment plan with 58 isocentric beams was created using a 3 cm circular collimator. Fiducial tracking was used to deliver radiation, the films were scanned, and end-to-end targeting error was measured with vendor-supplied software. In addition, radiation effects on electric fields generated by the TTFields system were assessed by examining logfiles generated from the field generator. Results: With TTFields arrays in place and powered on, the robotic radiosurgery system achieved a final targeting result of 0.47 mm, which was well within the submillimeter specification. No discernible effects on TTFields current output beyond 0.3% were observed in the logfiles when the radiation beam pulsed on and off. Conclusion: A robotic radiosurgery system was used to verify that radiation targeting was not adversely affected when the TTFields arrays were in place and the TTFields delivery device was powered on. In addition, this study verified that radiation delivered simultaneously with TTFields did not interfere with the generation of the electric fields.

SUBMITTER: Biswas S

PROVIDER: S-EPMC8504228 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background Little is known about the effectiveness of hypofractionated radiation therapy (HFRT) or stereotactic body radiation therapy (SBRT) for the treatment of patients with oligometastatic (OM) or oligoprogressive (OP) thymic malignancies. Methods We retrospectively reviewed Stage IV patients with OM or OP thymic malignancies treated with HFRT or SBRT between 2009–2021. We defined OM as 5 or fewer sites of metastatic disease and OP as 5 or fewer sites of metastatic disease increasing in radiological size at the time of radiation. Analysis of local failure (LF, defined as failure within a treated lesion) and distant failure (DF, defined as failure outside the treated lesion) was done at the treatment course level using univariate analysis Fine-Gray regression adjusted for clustering. Analysis of overall survival (OS) and progression-free survival (PFS) was done at the patient level utilizing only the first course of treatment for each patient. Results Our analysis included 50 patients with 92 treatment courses. Patients had thymoma (50%), thymic carcinoma (TC, 40%), or atypical thymic carcinoid (ATC, 10%). The median biologic effective dose (BED) was 51 Gy (range, 38–106 Gy). With a median follow-up of 36 months, the median OS and PFS were 50 and 6.5 months, respectively. Patients with TC or ATC had significantly worse PFS than those with thymoma [hazard ratio (HR) 2.37; 95% confidence interval (CI): 1.18–4.76, P=0.013], but similar OS (P=0.55) and LF (P=0.729). Treated thymoma lesions had a lower hazard of DF than TC/ATC lesions, but this was not statistically significant (HR 0.59; 95% CI: 0.34–1.03, P=0.065). Lesions treated to a BED higher than 60 Gy had lower hazards of LF and DF, although this was not statistically significant (HR 0.29; 95% CI: 0.05–1.68, P=0.166 and HR 0.58; 95% CI: 0.3–1.1, P=0.096, respectively). Conclusions In our analysis, patients with TC or ATC had worse PFS than those with thymoma. Treated thymoma and TC/ATC lesions had similar hazards of LF, indicating similar radiation sensitivity in thymic lesions regardless of histology. There was a trend towards increased local control with higher BED regimens, but this did not reach statistical significance. Overall, our analysis points to the need for clinical trials on HFRT/SBRT for the treatment of these rare malignancies.

Project description:PurposeThis phase 1 trial aimed to identify the maximally tolerated hypofractionated dose schedule for postoperative radiation therapy (PORT) after radical prostatectomy. Secondary objectives included biochemical control and quality of life (QoL) measures.Methods and materialsPatients were treated on 1 of 3 dose levels (DLs): 56.4 Gy in 20 fractions (DL1), 51.2 Gy in 15 fractions (DL2), and 44.2 Gy in 10 fractions (DL3). Treatment was delivered to the prostate bed without pelvic nodal irradiation. Dose escalation followed a standard 3 + 3 design with an expansion for 6 additional patients at the maximally tolerated hypofractionated dose schedule. Acute dose-limiting toxicity (DLT) was defined as grade 3 toxicity lasting >4 days within 21 days of PORT completion; late DLT was defined as grade 4 gastrointestinal (GI) or genitourinary (GU) toxicity.ResultsBetween January 2018 and August 2019, 15 patients underwent radiation treatment: 3 on DL1, 3 on DL2, and 9 on DL3. The median follow-up was 24 months. There were no DLTs, and the maximally tolerated hypofractionated dose schedule was identified as DL3. Two of the 15 patients (13.3%) experienced biochemical failure (prostate-specific antigen >0.1). Ten of 15 patients (67%) had grade 2+ acute toxicities, consisting of transient GI toxicities. Three patients experienced late grade 2+ GI toxicity, and 5 patients experienced late grade 2+ GU toxicity. Late grade 3 GU toxicity occurred in 2 patients. There were no grade 4+ acute or late toxicities. There were no significant differences in GI measures of QoL, however, there was an increase in GU symptoms and corresponding decrease in GU QoL between 12 and 24 months.ConclusionsThe maximum tolerated hypofractionated dose schedule for hypofractionated PORT to the prostate bed was determined to be 44.2 Gy in 10 daily fractions. The most frequent clinically significant toxicities were late grade 2+ GU toxicities, which corresponded to a worsening of late GU QoL.

Project description:PURPOSE:Treatment strategies in palliation of pediatric cancer remain a significant challenge. In this study, we aimed to assess the efficacy and safety of a short course of hypofractionated radiation therapy (RT) for metastatic or recurrent childhood tumors. METHODS AND MATERIALS:A total of 104 lesions in 62 pediatric patients with metastatic or recurrent cancer were treated with a short hypofractionation schedule (>1 but ?5 fractions; ?3 Gy per fraction) between 2007 and 2017 in our institution. The primary endpoint was local control (LC). Other endpoints included treatment response, overall survival, progression-free survival, and toxicity. Toxicities were assessed using the Common Terminology Criteria for Adverse Events v.4.0. RESULTS:The most common histologies were neuroblastoma, comprising 50 of the 104 lesions (48.1%); osteosarcoma, 17 lesions (16.4%); and Ewing sarcoma, 13 lesions (12.5%). A median total dose of 24 Gy was delivered in a median of 5 fractions. Of 104 lesions, 26 (25.0%) were treated with stereotactic body radiation therapy, 24 (23.1%) with intensity modulated RT, and 48 (46.2%) with 2-dimensional RT or 3-dimensional conformal RT. A complete or partial response was observed in 63 (60.6%) of lesions, and stable disease was observed in 34 (32.7%). At a median follow-up of 8.7 months, 21 local failures occurred (20.2%). The 1- and 2-year LC rates were 74% and 68%, respectively. LC was better for tumors without previous irradiation (83% vs 57% with previous RT; P = .004). LC rates did not differ between RT techniques or total biologically effective dose with ?/? ratio of 10 (BED10) (?30 vs >30 Gy). At the time of analysis, 38 deaths in the cohort of 62 patients (61.3%) were recorded. The 1-year progression-free survival and overall survival rates were 31% and 44%, respectively. Incidence of any grade ?3 toxicity was 6.7% (7 of 104). No grade 5 events occurred. CONCLUSIONS:A short hypofractionation scheme yields effective disease control and treatment response with a favorable side effect profile. Select pediatric patients with symptomatic metastases or recurrent disease can be considered for a short course of palliative RT.

Project description:ImportanceHypofractionated radiation therapy (RT) for prostate cancer has been associated with greater acute grade 2 gastrointestinal (GI) toxic effects compared with conventionally fractionated RT.ObjectiveTo evaluate whether a hyaluronic acid rectal spacer could (1) improve rectal dosimetry and (2) affect acute grade 2 or higher GI toxic effects for hypofractionated RT.Design, setting, and participantsThis randomized clinical trial was conducted from March 2020 to June 2021 among 12 centers within the US, Australia, and Spain, with a 6-month follow-up. Adult patients with biopsy-proven, T1 to T2 prostate cancer with a Gleason score 7 or less and prostate-specific antigen level of 20 ng/mL or less (to convert to μg/L, multiply by 1) were blinded to the treatment arms. Of the 260 consented patients, 201 patients (77.3%) were randomized (2:1) to the presence or absence of the spacer. Patients were stratified by intended 4-month androgen deprivation therapy use and erectile quality.Main outcomes and measuresFor the primary outcome, we hypothesized that more than 70% of patients in the spacer group would achieve a 25% or greater reduction in the rectal volume receiving 54 Gy (V54). For the secondary outcome, we hypothesized that the spacer group would have noninferior acute (within 3 months) grade 2 or higher GI toxic effects compared with the control group, with a margin of 10%.ResultsOf the 201 randomized patients, 8 (4.0%) were Asian, 26 (12.9%) Black, 42 (20.9%) Hispanic or Latino, and 153 (76.1%) White; the mean (SD) age for the spacer group was 68.6 (7.2) years and 68.4 (7.3) years for the control group. For the primary outcome, 131 of 133 (98.5%; 95% CI, 94.7%-99.8%) patients in the spacer group experienced a 25% or greater reduction in rectum V54, which was greater than the minimally acceptable 70% (P < .001). The mean (SD) reduction was 85.0% (20.9%). For the secondary outcome, 4 of 136 patients (2.9%) in the spacer group and 9 of 65 patients (13.8%) in the control group experienced acute grade 2 or higher GI toxic effects (difference, -10.9%; 95% 1-sided upper confidence limit, -3.5; P = .01).Conclusions and relevanceThe trial results suggest that rectal spacing with hyaluronic acid improved rectal dosimetry and reduced acute grade 2 or higher GI toxic effects. Rectal spacing should potentially be considered for minimizing the risk of acute grade 2 or higher toxic effects for hypofractionated RT.Trial registrationClinicalTrials.gov Identifier: NCT04189913.

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Targeting Accuracy Considerations for Simultaneous Tumor Treating Fields Antimitotic Therapy During Robotic Hypofractionated Radiation Therapy.

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