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1.5T Magnetic Resonance-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer: Preliminary Clinical Results of Clinician- and Patient-Reported Outcomes.

ABSTRACT: Magnetic resonance-guided stereotactic body radiotherapy (MRgSBRT) offers the potential for achieving better prostate cancer (PC) treatment outcomes. This study reports the preliminary clinical results of 1.5T MRgSBRT in localized PC, based on both clinician-reported outcome measurement (CROM) and patient-reported outcome measurement (PROM). Fifty-one consecutive localized PC patients were prospectively enrolled with a median follow-up of 199 days. MRgSBRT was delivered in five fractions of 7.25-8 Gy with daily online adaptation. Clinician-reported gastrointestinal (GI) and genitourinary (GU) adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE) Scale v. 5.0 were assessed. The Expanded Prostate Cancer Index Composite Questionnaire was collected at baseline, 1 month, and every 3 months thereafter. Serial prostate-specific antigen measurements were longitudinally recorded. The maximum cumulative clinician-reported grade ≥ 2 acute GU and GI toxicities were 11.8% (6/51) and 2.0% (1/51), respectively, while grade ≥ 2 subacute GU and GI toxicities were 2.3% (1/43) each. Patient-reported urinary, bowel, and hormonal domain summary scores were reduced at 1 month, then gradually returned to baseline levels, with the exception of the sexual domain. Domain-specific subscale scores showed similar longitudinal changes. All patients had early post-MRgSBRT biochemical responses. The finding of low toxicity supports the accumulation of clinical evidence for 1.5T MRgSBRT in localized PC.

SUBMITTER: Poon DMC

PROVIDER: S-EPMC8508440 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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1.5T Magnetic Resonance-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer: Preliminary Clinical Results of Clinician- and Patient-Reported Outcomes.

Poon Darren M C DMC Yuan Jing J Wong Oi-Lei OL Yang Bin B Chiu Sin-Ting ST Cheung Kin-Yin KY Chiu George G Yu Siu-Ki SK

Cancers 20210928 19

<h4>Background</h4>Magnetic resonance-guided stereotactic body radiotherapy (MRgSBRT) offers the potential for achieving better prostate cancer (PC) treatment outcomes. This study reports the preliminary clinical results of 1.5T MRgSBRT in localized PC, based on both clinician-reported outcome measurement (CROM) and patient-reported outcome measurement (PROM).<h4>Methods</h4>Fifty-one consecutive localized PC patients were prospectively enrolled with a median follow-up of 199 days. MRgSBRT was d ...[more]

PMID: 34638348

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Project description:Purpose/objectiveStereotactic body radiation therapy (SBRT) has emerged as a valid treatment alternative for non-resectable liver metastases or hepatocellular carcinomas (HCC). Magnetic resonance (MR) guided SBRT has a high potential of further improving treatment quality, allowing for higher, tumoricidal irradiation doses whilst simultaneously sparing organs at risk. However, data on treatment outcome and patient acceptance is still limited.Material/methodsWe performed a subgroup analysis of an ongoing prospective observational study comprising patients with liver metastases or HCC. Patients were treated with ablative MR-guided SBRT at the MRIdian Linac in the Department of Radiation Oncology at Heidelberg University Hospital between January 2019 and February 2020. Local control (LC) and overall survival (OS) analysis was performed using the Kaplan-Meier method. An in-house designed patient-reported outcome questionnaire was used to measure patients' experience with the MR-Linac treatment. Toxicity was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v. 5.0).ResultsTwenty patients (with n = 18 metastases; n = 2 HCC) received MR-guided SBRT for in total 26 malignant liver lesions. Median biologically effective dose (BED at α/β = 10) was 105.0 Gy (range: 67.2-112.5 Gy) and median planning target volume was 57.20 ml (range: 17.4-445.0 ml). Median treatment time was 39.0 min (range: 26.0-67.0 min). At 1-year, LC was 88.1% and OS was 84.0%. Grade I° gastrointestinal toxicity °occurred in 30.0% and grade II° in 5.0% of the patients with no grade III° or higher toxicity. Overall treatment experience was rated positively, with items scoring MR-Linac staff's performance and items concerning the breath hold process being among the top positively rated elements. Worst scored items were treatment duration, positioning and low temperature.ConclusionMR-guided SBRT of liver tumors is a well-tolerated and well-accepted treatment modality. Initial results are promising with excellent local control and only mildest toxicity. However, prospective studies are warranted to truly assess the potential of MR-guided liver SBRT and to identify which patients profit most from this new versatile technology.

Project description:ObjectiveUsing moderate or ultra-hypofractionation, which is also known as stereotactic body radiotherapy (SBRT) for treatment of localized prostate cancer patients has been increased. We present our preliminary results on the clinical utilization of MRI-guided adaptive radiotherapy (MRgRT) for prostate cancer patients with the workflow, dosimetric parameters, toxicities and prostate-specific antigen (PSA) response.Methods50 prostate cancer patients treated with ultra-hypofractionation were included in the study. Treatment was performed with intensity-modulated radiation therapy (step and shoot) technique and daily plan adaptation using MRgRT. The SBRT consisted of 36.25 Gy in 5 fractions with a 7.25 Gy fraction size. The time for workflow steps was documented. Patients were followed for the acute and late toxicities and PSA response.ResultsThe median follow-up for our cohort was 10 months (range between 3 and 29 months). The median age was 73.5 years (range between 50 and 84 years). MRgRT was well tolerated by all patients. Acute genitourinary (GU) toxicity rate of Grade 1 and Grade 2 was 28 and 36%, respectively. Only 6% of patients had acute Grade 1 gastrointestinal (GI) toxicity and there was no Grade ≥ 2 GI toxicity. To date, late Grade 1 GU toxicity was experienced by 24% of patients, 2% of patients experienced Grade 2 GU toxicity and 6% of patients reported Grade 2 GI toxicity. Due to the short follow-up, PSA nadir has not been reached yet in our cohort.ConclusionIn conclusion, MRgRT represents a new method for delivering SBRT with markerless soft tissue visualization, online adaptive planning and real-time tracking. Our study suggests that ultra-hypofractionation has an acceptable acute and very low late toxicity profile.Advances in knowledgeMRgRT represents a new markerless method for delivering SBRT for localized prostate cancer providing online adaptive planning and real-time tracking and acute and late toxicity profile is acceptable.

Project description:PurposeTo report acute and late bowel, urinary, and sexual dysfunction patient-reported outcome measures, among patients with localized prostate cancer who underwent stereotactic magnetic resonance-guided daily adaptive radiation therapy (SMART).Methods and materialsAll patients who completed a baseline 12-item Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events questionnaire, before undergoing SMART with 36.25 Gy in 5 fractions, were subsequently followed up with the same graded questionnaire at set time points. Latest prostate-specific antigen levels were recorded. The percentage of patients who reported no change from their baseline adverse event (AE) or reported a new ≥ "frequent or almost constant" or "severe grade or higher" AE grade during follow-up was calculated. The maximum 12-item Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events grade for each item was recorded for each patient. The percentage of toxicity levels for each separate AE item at set time points was calculated.ResultsThe total number of patients was 69 with a median follow-up of 27 months. Median age of the cohort was 73 years (range, 54-85 years). The median pretreatment prostate-specific antigen level, T stage, and Gleason score were 7.5 mmol/L (range, 4.5-32 mmol/L), T2b (range, T2-T3b), and 7 (3 + 4; range, 6-9), respectively. No patient had biochemical failure during follow-up. Regarding bowel symptoms, >80% of men reported no change from baseline toxicity during follow-up. New ≥ frequent or almost constant diarrhea was reported in 9% of patients. "Almost constant" diarrhea peaked at 1 month but was absent at >33 months. Regarding urinary symptoms, increased urinary urgency was the most common complaint (39%). Twenty percent of men reported new ≥ frequent or almost constant urinary urgency incidence peaking at 1 month but absent at >33 months. New "severe" sexual dysfunction was seen in 26% of patients and was persistent at >33 months.ConclusionsOur study is one the largest patient-reported outcomes study after prostate SMART. It shows acceptable levels of toxicity even up to 2 years after treatment.

Project description:BackgroundLung stereotactic body radiotherapy (SBRT) has proven an effective treatment for medically inoperable lung tumors, even for (ultra-)central tumors. Recently, there has been growing interest in radiation-induced cardiac toxicity in lung radiotherapy. More specifically, dose to cardiac (sub-)structures (CS) was found to correlate with survival after radiotherapy.PurposeOur goal is first, to investigate the percentage of patients who require CS sparing in an magnetic resonance imaging guided lung SBRT workflow, and second, to quantify how successful implementation of cardiac sparing would be.MethodsThe patient cohort consists of 34 patients with stage II-IV lung cancer who were treated with SBRT between 2017 and 2020. A mid-position computed tomography (CT) image was used to create treatment plans for the 1.5 T Unity MR-linac (Elekta AB, Stockholm, Sweden) following clinical templates. Under guidance of a cardio-thoracic radiologist, 11 CS were contoured manually for each patient. Dose constraints for five CS were extracted from the literature. Patients were stratified according to their need for cardiac sparing depending on the CS dose in their non-CS constrained MR-linac treatment plans. Cardiac sparing treatment plans (CSPs) were then created and dosimetrically compared with their non-CS constrained treatment plan counterparts. CSPs complied with the departmental constraints and were considered successful when fulfilling all CS constraints, and partially successful if some CS constraints could be fulfilled. Predictors for the need for and feasibility of cardiac sparing were explored, specifically planning target volume (PTV) size, cranio-caudal (CC) distance, 3D distance, and in-field overlap volume histograms (iOVH).Results47% of the patients (16 out of 34) were in need of cardiac sparing. A successful CSP could be created for 62.5% (10 out of 16) of these patients. Partially successful CSPs still complied with two to four CS constraints. No significant difference in dose to organs at risk (OARs) or targets was identified between CSPs and the corresponding non-CS constrained MR-linac plans. The need for cardiac sparing was found to correlate with distance in the CC direction between target and all of the individual CS (Mann-Whitney U-test p-values <10-6 ). iOVHs revealed that complying with dose constraints for CS is primarily determined by in-plane distance and secondarily by PTV size.ConclusionWe demonstrated that CS can be successfully spared in lung SBRT on the MR-linac for most of this patient cohort, without compromising doses to the tumor or to other OARs. CC distance between the target and CS can be used to predict the need for cardiac sparing. iOVHs, in combination with PTV size, can be used to predict if cardiac sparing will be successful for all constrained CS except the left ventricle.

Project description:ImportanceMagnetic resonance imaging (MRI) guidance offers multiple theoretical advantages in the context of stereotactic body radiotherapy (SBRT) for prostate cancer. However, to our knowledge, these advantages have yet to be demonstrated in a randomized clinical trial.ObjectiveTo determine whether aggressive margin reduction with MRI guidance significantly reduces acute grade 2 or greater genitourinary (GU) toxic effects after prostate SBRT compared with computed tomography (CT) guidance.Design, setting, and participantsThis phase 3 randomized clinical trial (MRI-Guided Stereotactic Body Radiotherapy for Prostate Cancer [MIRAGE]) enrolled men aged 18 years or older who were receiving SBRT for clinically localized prostate adenocarcinoma at a single center between May 5, 2020, and October 1, 2021. Data were analyzed from January 15, 2021, through May 15, 2022. All patients had 3 months or more of follow-up.InterventionsPatients were randomized 1:1 to SBRT with CT guidance (control arm) or MRI guidance. Planning margins of 4 mm (CT arm) and 2 mm (MRI arm) were used to deliver 40 Gy in 5 fractions.Main outcomes and measuresThe primary end point was the incidence of acute (≤90 days after SBRT) grade 2 or greater GU toxic effects (using Common Terminology Criteria for Adverse Events, version 4.03 [CTCAE v4.03]). Secondary outcomes included CTCAE v4.03-based gastrointestinal toxic effects and International Prostate Symptom Score (IPSS)-based and Expanded Prostate Cancer Index Composite-26 (EPIC-26)-based outcomes.ResultsBetween May 2020 and October 2021, 156 patients were randomized: 77 to CT (median age, 71 years [IQR, 67-77 years]) and 79 to MRI (median age, 71 years [IQR, 68-75 years]). A prespecified interim futility analysis conducted after 100 patients reached 90 or more days after SBRT was performed October 1, 2021, with the sample size reestimated to 154 patients. Thus, the trial was closed to accrual early. The incidence of acute grade 2 or greater GU toxic effects was significantly lower with MRI vs CT guidance (24.4% [95% CI, 15.4%-35.4%] vs 43.4% [95% CI, 32.1%-55.3%]; P = .01), as was the incidence of acute grade 2 or greater gastrointestinal toxic effects (0.0% [95% CI, 0.0%-4.6%] vs 10.5% [95% CI, 4.7%-19.7%]; P = .003). Magnetic resonance imaging guidance was associated with a significantly smaller percentage of patients with a 15-point or greater increase in IPSS at 1 month (6.8% [5 of 72] vs 19.4% [14 of 74]; P = .01) and a significantly reduced percentage of patients with a clinically significant (≥12-point) decrease in EPIC-26 bowel scores (25.0% [17 of 68] vs 50.0% [34 of 68]; P = .001) at 1 month.Conclusions and relevanceIn this randomized clinical trial, compared with CT-guidance, MRI-guided SBRT significantly reduced both moderate acute physician-scored toxic effects and decrements in patient-reported quality of life. Longer-term follow-up will confirm whether these notable benefits persist.Trial registrationClinicalTrials.gov Identifier: NCT04384770.

Dataset Information

1.5T Magnetic Resonance-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer: Preliminary Clinical Results of Clinician- and Patient-Reported Outcomes.

Publications

1.5T Magnetic Resonance-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer: Preliminary Clinical Results of Clinician- and Patient-Reported Outcomes.

Similar Datasets

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