PURPOSE: ARTO (ClinicalTrials.gov identifier: NCT03449719 ) is a multicenter, phase II randomized clinical trial testing the benefit of adding stereotactic body radiation therapy (SBRT) to abiraterone acetate and prednisone (AAP) in patients with oligometastatic castrate-resistant prostate cancer (CRPC). MATERIALS AND METHODS: All patients were affected by oligometastatic CRPC as defined as three or less nonvisceral metastatic lesions. Patients were randomly assigned 1:1 to receive either AAP alone (control arm) or AAP with concomitant SBRT to all the sites of disease (experimental arm). Primary end point was the rate of biochemical response (BR), defined as a prostate-specific antigen (PSA) decrease ≥50% from baseline measured at 6 months from treatment start. Complete BR (CBR), defined as PSA < 0.2 ng/mL at 6 months from treatment, and progression-free survival (PFS) were secondary end points. RESULTS: One hundred and fifty-seven patients were enrolled between January 2019 and September 2022. BR was detected in 79.6% of patients (92% v 68.3% in the experimental v control arm, respectively), with an odds ratio (OR) of 5.34 (95% CI, 2.05 to 13.88; P = .001) in favor of the experimental arm. CBR was detected in 38.8% of patients (56% v 23.2% in the experimental v control arm, respectively), with an OR of 4.22 (95% CI, 2.12 to 8.38; P < .001). SBRT yielded a significant PFS improvement, with a hazard ratio for progression of 0.35 (95% CI, 0.21 to 0.57; P < .001) in the experimental versus control arm. CONCLUSION: The trial reached its primary end point of biochemical control and PFS, suggesting a clinical advantage for SBRT in addition to first-line AAP treatment in patients with metastatic castration-resistant prostate cancer.
The role of consolidation radiotherapy (RT) for bulky lesions is controversial in patients with advanced-stage Hodgkin lymphoma who achieve complete metabolic response (CMR) after doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD)–based chemotherapy. We present the final results of the Fondazione Italiana Linfomi HD0801 trial, which investigated the potential benefit of RT in that setting. In this phase 3 randomized study, patients with a bulky lesion at baseline (a mass with largest diameter ≥5 cm) who have CMR after 2 and 6 ABVD cycles were randomly assigned 1:1 to RT vs observation (OBS) with a primary endpoint of event-free survival (EFS) at 2 years. The sample size was calculated estimating an EFS improvement for RT of 20% (from 60% to 80%). The secondary end point was progression-free survival (PFS). One hundred sixteen patients met the inclusion criteria and were randomly assigned to RT or OBS. Intention-to-treat (ITT) analysis showed a 2-year EFS of 87.8% vs 85.8% for RT vs OBS (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.6-3.5; P = .34). At 2 years, ITT-PFS was 91.3% vs 85.8% (HR, 1.2; 95% CI, 0.5-3; P = .7). Patients in CMR randomly assigned to OBS had a good outcome, and the primary end point of a 20% benefit in EFS for RT was not met. However, the sample size was underpowered to detect a benefit of 10% or less, keeping open the question of a potential, more limited role of RT in this setting. This trial was registered at www.clinicaltrials.gov as #NCT00784537.
Purpose: This retrospective work aims to evaluate the possible impact on intra‐ and inter‐observer variability, contouring time, and contour accuracy of introducing a pelvis computed tomography (CT) auto‐segmentation tool in radiotherapy planning workflow.Methods: Tests were carried out on five structures (bladder, rectum, pelvic lymph‐nodes, and femoral heads) of six previously treated subjects, enrolling five radiation oncologists (ROs) to manually re‐contour and edit auto‐contours generated with a male pelvis CT atlas created with the commercial software MIM MAESTRO. The ROs first delineated manual contours (M). Then they modified the auto‐contours, producing automatic‐modified (AM) contours. The procedure was repeated to evaluate intra‐observer variability, producing M1, M2, AM1, and AM2 contour sets (each comprising 5 structures × 6 test patients × 5 ROs = 150 contours), for a total of 600 contours. Potential time savings was evaluated by comparing contouring and editing times. Structure contours were compared to a reference standard by means of Dice similarity coefficient (DSC) and mean distance to agreement (MDA), to assess intra‐ and inter‐observer variability. To exclude any automation bias, ROs evaluated both M and AM sets as “clinically acceptable” or “to be corrected” in a blind test.Results: Comparing AM to M sets, a significant reduction of both inter‐observer variability (p < 0.001) and contouring time (‐45% whole pelvis, p < 0.001) was obtained. Intra‐observer variability reduction was significant only for bladder and femoral heads (p < 0.001). The statistical test showed no significant bias.Conclusion: Our atlas‐based workflow proved to be effective for clinical practice as it can improve contour reproducibility and generate time savings. Based on these findings, institutions are encouraged to implement their auto‐segmentation method.
Objective:To evaluate the prognostic role of both interim fluorine-18 fludeoxyglucose positron emission tomography (i-18F-FDG-PET) and end-of-chemotherapy fluorine-18 fludeoxyglucose positron emission tomography (eoc-18F-FDG-PET) in patients with early-stage Hodgkin lymphoma (HL).Methods:We screened 257 patients with early-stage HL treated with combined modality therapy between March 2003 and July 2011. All were staged using fluorine-18 fludeoxyglucose positron emission tomography (18F-FDG-PET) before chemotherapy and after two doxorubicin, bleomycin, vinblastine and dacarbazine cycles (i-18F-FDG-PET); 165 patients were also evaluated by 18F-FDG-PET at the end of chemotherapy (eoc-18F-FDG-PET).Results:After revision, 85% of patients were negative for i-18F-FDG-PET and 15% were positive. After eoc-18F-FDG-PET revision, 23 patients had a positive scan. The median follow-up was 56 months. The 5-year overall survival (OS) and progression-free survival (PFS) for the whole cohort were 97.5% and 95.6%, respectiv...