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The purpose of the reported study was to investigate the value of cone-beam computed tomography (CBCT)-based radiomics for risk stratification and prediction of biochemical relapse in prostate cancer. The study population consisted of 31 prostate cancer patients. Radiomics features were extracted from weekly CBCT scans performed for verifying treatment position. From the data, logistic-regression models were learned for establishing tumor stage, Gleason score, level of prostate-specific antigen, and risk stratification, and for predicting biochemical recurrence. Performance of the learned models was assessed using the area under the receiver operating characteristic curve (AUC-ROC) or the area under the precision-recall curve (AUC-PRC). Results suggest that the histogram-based Energy and Kurtosis features and the shape-based feature representing the standard deviation of the maximum diameter of the prostate gland during treatment are predictive of biochemical relapse and indicative of patients at high risk. Our results suggest the usefulness of CBCT-based radiomics for treatment definition in prostate cancer.

353 Background: Pre-clinical and retrospective clinical data support an interaction of metformin (MET) and radiotherapy. Thus, MET may represent a cost-effective means to improve radiotherapy outcomes. We sought to investigate whether MET increases time to progression (TTP) when combined with salvage radiation therapy (SRT) in men with recurrent prostate cancer after radical prostatectomy (RP). Methods: Non-diabetic men with biochemical recurrence after RP were enrolled into an open label, randomized, phase 2 study in 17 hospitals in Switzerland, France, and Germany. The randomization (1:1) was stratified by Gleason score ( 0.5 vs ≤ 0.5 ng/mL), ADT use, and evidence of local recurrence. Following randomization, patients received either prostate bed SRT (70Gy) or prostate bed SRT (70Gy) + MET. MET 850mg PO QD was given for 4 weeks before SRT, then 850mg PO QD for 48 weeks. The primary endpoint was TTP. Secondary endpoints were progression-free survival, undetectable PSA under normal testosterone levels, 50% PSA response, clinical progression-free survival, time to further systemic therapy, prostate cancer-specific survival, overall survival, and adverse events (AE). The trial design was powered for a HR 0.65 with planned enrollment of 170 patients. The trial was prematurely closed by the sponsor due to financial reasons. Data is reported after patients reached a minimum follow-up of 12 months after SRT and corresponds to the final analysis. Results: A total of 111 patients were randomized (106 evaluable) between 10/2017 and 11/2020. The median PSA at randomization was 0.3 ng/mL (range, 0.03-1.5 ng/mL), 19 patients (17.9%) had Gleason ≥8, 54 (50.9%) pT3 disease, and 50 (47.2%) positive surgical margins. Twenty-four patients (22.6%) used short-term ADT. Trial arms were well balanced. At a median follow-up of 27.1 months (95% CI: 26.7-27.8), a total of 16 progression events occurred. The median TTP was not reached in either treatment arm. The hazard ratio adjusted by stratification factors was 1.25 (95% CI: 0.40-3.94; one-sided 80% CI: 2.05; log-rank p=0.62). Two-year TTP was 89% (95% CI: 76%-96%) in the SRT arm vs 82% (95% CI: 67%-91%) in the SRT + MET arm. No statistically significant differences were found for the secondary endpoints. Most common AE during treatment was grade 1-2 diarrhea (24.1% SRT vs 54.6% SRT + MET). Grade 2 and 3 AE (gastrointestinal and/or urinary) were 25.9% and 3.7% with SRT vs 34.5% and 7.3% with SRT + MET (p=0.41 and p=0.68), respectively. Conclusions: Adding MET to SRT did not result in a significant improvement in TTP in non-diabetic men with recurrent prostate cancer post-RP. Because of early trial closure and fewer than expected events, the trial may have been underpowered for this endpoint. Additional correlative studies will be pursued. Clinical trial information: NCT02945813 .

383 Background: The clinical role of germline testing (GT) for prostate cancer (PC) is rapidly increasing due to the growing implications of precision medicine in metastatic disease, where genetic results can address eligibility for novel targeted treatments. Thus, ESMO and NCCN guidelines recommend GT for all metastatic PC individuals, whereas American testing criteria are more broad and include family history and other tumor features, such as high-risk disease, or intraductal or cribriform histology. Methods: We have retrospectively collected and analyzed clinical and genetic features of men with PC who underwent single-gene or multi-gene GT at some Swiss Institutions with expertise in hereditary cancers from July 2018 until October 2022. All patients (pts) have given written informed consent for research. Results: 109 men with PC underwent GT and received pre- and post-test counseling. Of these, 54 (50%) were metastatic, 34 (31%) had high-risk localized disease according to NCCN criteria, 7 (6%) presented cribriform or intraductal histology. A significant family history, as defined by current NCCN guidelines, was found in 79 (72%). 67 (61%) had no pathogenic (P) or likely pathogenic (LP) variants; 25 (23%) had a variant of unknown significance (VUS); 17 (16%) were found to have a P/LP variant in the following genes: BRCA2 (8), ATM (4), BRIP1 (1), FANCA (1), NBN (1), POT1 (1), TP53 (1). Among these 17 pts, the median age at diagnosis was 66 (45-80), 10 had metastatic disease, 5 had high-risk localized disease, 14 had a family history and 5 had a personal history of another cancer. Only 6 pts were

Https://coronavirus.jhu.edu/map.html. Accessed: 8 Sep 2020 Filippi AR, Russi E, Magrini SM et al (2020) Covid-19 outbreak in northern Italy: first practical indications for radiotherapy departments. Int J Radiat Oncol Biol Phys. https://doi.org/10.1016/j.ijrobp.2020.03.007 Article PubMed PubMed Central Google Scholar https://www.corona-data.ch/. Accessed: 8 Sep 2020 Baumann M, Krause M, Overgaard J et al (2016) Radiation oncology in the era of precision medicine. Nat Rev Cancer 16:234–249 CAS Article Google Scholar Meattini I, Franco P, Belgioia L et al (2020) Radiation therapy during the coronavirus disease 2019 (covid-19) pandemic in Italy: a view of the nation’s young oncologists. ESMO Open. https://doi.org/10.1136/esmoopen-2020-000779 Article PubMed PubMed Central Google Scholar Guckenberger M, Belka C, Bezjak A et al (2020) Practice recommendations for lung cancer radiotherapy during the covid-19 pandemic: An ESTRO-ASTRO consensus statement. Radiother Oncol. https://doi.org/10.1016/j.radonc.2020.04.001 Article PubMed PubMed Central Google Scholar Slotman BJ, Ricardi U, Lievens Y (2020) Radiotherapy in a time of crisis, ESTRO Presidents’ statement Google Scholar Sack C, Sack H, Willich N, Popp W (2020) Evaluation of the time required for overhead tasks performed by physicians, medical physicists, and technicians in radiation oncology institutions The DEGRO-QUIRO study. Strahlenther Onkol 191:113–124 Article Google Scholar Achard V, Tsoutsou P, Zilli T (2020) Radiotherapy in the time of the Coronavirus pandemic: when less is better. Int J Radiat Oncol Biol Phys. https://doi.org/10.1016/j.ijrobp.2020.03.008 Article PubMed PubMed Central Google Scholar Thomson D, Palma D, Guckenberger M et al (2020) Practice recommendations for risk-adapted head and neck cancer radiotherapy during the covid-19 pandemic: An ASTRO-ESTRO consensus statement. Int J Radiat Oncol Biol Phys. https://doi.org/10.1016/j.ijrobp.2020.04.016 Article PubMed PubMed Central Google Scholar Download references Radiation Oncology Clinic, Oncology Institute of Southern Switzerland (IOSI), Bellinzona-Lugano, Via Gallino, 6500, Bellinzona, Switzerland Dr. Letizia Deantonio MD, Davide Bosetti MD, Simona Cima MD, Francesco Martucci MD, Giulia Borgonovo MD, Gianluca Di Bella MD, Gianfranco Angelo Pesce MD, Mariacarla Valli MD & Antonella Richetti MD You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar You can also search for this author in PubMed Google Scholar Correspondence to Dr. Letizia Deantonio MD. L. Deantonio, D. Bosetti, S. Cima, F. Martucci, G. Borgonovo, G. Di Bella, G.A. Pesce, M. Valli and A. Richetti declare that they have no known competing interests. Reprints and Permissions Deantonio, L., Bosetti, D., Cima, S. et al. #Stayathome: Smart working for radiation oncologists during the corona pandemic. Strahlenther Onkol (2020). https://doi.org/10.1007/s00066-020-01683-z Download citation Received: 28 May 2020 Accepted: 24 August 2020 Published: 18 September 2020 DOI: https://doi.org/10.1007/s00066-020-01683-z

194 Background: Salvage radiotherapy (RT) is often utilized in case of biochemical progression after radical prostatectomy (RP). Here we report the outcomes of the European SAKK 09/10 randomized phase 3 trial with the aim to compare effectiveness and tolerability of conventional vs. dose-intensified salvage RT. Methods: SAKK 09/10 is an open-label, multicenter, randomized phase 3 trial performed in 24 centers in Switzerland, Germany and Belgium. Men with biochemical progression (two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises) after RP with a PSA nadir of ≤ 0.4 ng/mL, with a PSA ≤ 2 ng/mL at randomization and without clinical evidence of macroscopic disease were recruited. Patients were randomly assigned to either conventional dose RT (64 Gy in 32 fractions) or dose-intensified RT (70 Gy in 35 fractions) directed to the prostate bed. Three-dimensional conformal RTor intensity-modulated RT/rotational techniques were used. The primary endpoint was freedom from biochemical progression (PSA ≥ 0.4 ng/mL and rising). Secondary endpoints included clinical progression-free survival, time to hormonal treatment, overall survival, acute and late toxicity (according to the NCI CTCAE v4.0) and quality of life (according to the EORTC QLQ-C30 and PR25). The trial was registered under NCT01272050 in clinicaltrials.gov. Results: Between 02/2011 and 04/2014, 350 patients were randomly assigned to 64 Gy (n = 175) or 70 Gy (n = 175), of whom 344 aged between 48 to 75 years were assessable for the intention-to-treat population. The median PSA at randomization was 0.3 ng/mL (range, 0.03-1.61 ng/mL). At the time of data cutoff (July 3, 2020), the median follow-up was 6.2 years (IQR 5.5-7.2) and a total of 138 biochemical progression events occurred. The estimated freedom from biochemical progression rate at 6 years was 62.3% (95% CI 54.2-69.4%) and 61.3% (95% CI 53.4-68.3%) for the 64 Gy and the 70 Gy arm, respectively, and the hazard ratio adjusted by stratification factors was 1.14 (95% CI 0.82-1.60; log-rank p = 0.44). No significant difference was found for clinical progression-free survival, time to hormonal treatment and overall survival between the two arms, respectively. Late grade 2 and 3 genitourinary toxicity was observed in 35 (21.2%) and 13 (7.9%) patients treated with 64 Gy, and in 46 (26.3%) and 7 (4%) patients with 70 Gy (p = 0.81). Lategrade 2 and 3 gastrointestinal toxicity was observed in 12 (7.3%) and 7 (4.2%) patients with 64 Gy, and in 35 (20%) and 4 (2.3%) patients with 70 Gy(p = 0.009). Quality of life data will be presented. Conclusions: Dose-intensified salvage RT to the prostate bed was not superior to conventional dose RT. However, dose-intensified salvage RT was associated with higher frequencies of late grade ≥ 2 gastrointestinal toxicity. Clinical trial information: NCT01272050.

To evaluate acute and late skin/subcutaneous toxicities and radiation-induced lung fibrosis (RILF) in patients treated with adjuvant radiotherapy (RT) for synchronous bilateral breast cancers (SBBC), after conservative surgery. Twenty-five patients were treated with volumetric-modulated arc therapy (VMAT/RapidArc®) on both breasts, and checked clinically for detecting RT toxicities during and after treatment. A high-resolution computed tomography (HRCT) was performed, for detecting RILF during follow-up. We registered acute Grade-1 skin toxicity in 18 patients (72%), while six patients (24%) experienced Grade-2 toxicity. No breath symptoms were reported during and after RT. Late Grade-1 subcutaneous toxicity and late Grade-2 skin toxicity were registered in four patients (16%) and one patient (4%), respectively, at a mean follow-up of 36 months. Grade-1 RILF was detected in six patients (30%). The median volume of fibrosis area was 6.5 cc (range 1.3–21.5 cc). The partial volumes receiving a specified dose (V20, V30, V40, and V50) in patients who developed lung fibrosis were significantly bigger than who did not (p