Publications by authors named "Stefano Maria Magrini"

93 Publications

The NIPRO Study: An Observational, Retrospective, Multicenter Study on the Safety of the Radiotherapy and Immunotherapy Combination for Advanced-Stage NSCLC.

Clin Lung Cancer 2021 Feb 16. Epub 2021 Feb 16.

Radiotherapy Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.

Introduction: In this observational, retrospective, multicenter study, we aimed to assess the safety of the combination of local metastasis-directed radiotherapy (RT) and immunotherapy (IT) in a cohort of advanced non-small-cell lung cancer (aNSCLC) patients.

Material And Methods: We collected clinical data of aNSCLC patients who received concomitant RT and anti-PD-1/PD-L1 inhibitors in seven Italian centers from September 2015 to June 2019. Concomitant RT was defined as delivered ≤4 weeks before or after the first or last administration of immunotherapy, or within two consecutive cycles of ICI. All adverse events apparently related to RT and/or IT were graded according to the Common Terminology Criteria for Adverse Events, version 4.0, and reported in terms of incidence and severity as immune related or RT related, or combined.

Results: We analyzed the clinical charts of 187 patients. Median follow-up time was 23 months, and median overall survival was 16.5 months (range, 3-162). Thirteen patients developed pure RT-related side effects, and 43 patients (23.9%) developed immune-related side effects. No additive toxic effects were observed. A case of grade 5 pulmonary toxicity was recorded as a possible consequence of a combined effect.

Conclusion: This analysis suggests that the combination of concomitant RT and anti-PD-1/PD-L1 agents is safe, and the two toxicity profiles are independent.
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http://dx.doi.org/10.1016/j.cllc.2021.02.005DOI Listing
February 2021

Changes in body composition and lipid profile in prostate cancer patients without bone metastases given Degarelix treatment: the BLADE prospective cohort study.

Prostate Cancer Prostatic Dis 2021 Mar 15. Epub 2021 Mar 15.

Medical Oncology Unit, Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, Brescia, Italy.

Background: Luteinizing hormone-releasing hormone (LHRH)-agonists in prostate cancer (PCa) patients induce sarcopenic obesity. The effect of LHRH-antagonist on body composition has never been explored. We evaluated changes in fat (FBM) and lean body mass (LBM) in PCa patients undergoing Degarelix.

Methods: This is a single-center prospective study, enrolling 29 non-metastatic PCa patients eligible to LHRH-antagonist from 2017 to 2019. All patients received monthly subcutaneous injection of Degarelix for 12 months. Changes in FBM and LBM between baseline and 12-month Degarelix, as measured by dual-energy x-ray absorptiometry, were the co-primary endpoints. Secondary endpoints were changes in serum lipids, glucose profile and follicle-stimulating hormone (FSH). Appendicular lean mass index (ALMI) and ALMI/FBM ratio were assessed as post-hoc analyses. Linear mixed models with random intercept tested for estimated least squared means differences (EMD).

Results: FBM significantly increased after 12 months (EMD +2920.7, +13.8%, p < 0.001), whereas LBM remained stable (EMD -187.1, -0.3%, p = 0.8). No differences occurred in lipid profile. Glycated hemoglobin significantly increased and serum FSH significantly decreased. A significant inverse relationship was found between serum FSH and ALMI/FBM ratio after 12 month (r = -0.44, p = 0.02).

Conclusions: The BLADE study prospectively evaluated changes in body composition after LHRH-antagonist. LHRH-antagonist therapy is associated to an increased risk of obesity and diabetes, but lean body mass and serum lipids are not affected. This may represent an additional evidence supporting the reduced cardiovascular risk associated with LHRH-antagonist. The role of FSH in influencing sarcopenic obesity in PCa after androgen deprivation deserves to be further explored.
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http://dx.doi.org/10.1038/s41391-021-00345-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7958940PMC
March 2021

Caveolin-1 promotes radioresistance in rhabdomyosarcoma through increased oxidative stress protection and DNA repair.

Cancer Lett 2021 May 18;505:1-12. Epub 2021 Feb 18.

Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy. Electronic address:

The aim of this work was to investigate whether Caveolin-1 (Cav-1), a membrane scaffolding protein widely implicated in cancer, may play a role in radiation response in rhabdomyosarcoma (RMS), a pediatric soft tissue tumor. For this purpose, we employed human RD cells in which Cav-1 expression was stably increased via gene transfection. After radiation treatment, we observed that Cav-1 limited cell cycle arrest in the G2/M phase and enhanced resistance to cell senescence and apoptosis via reduction of p21, p16 and Caspase-3 cleavage. After radiotherapy, Cav-1-mediated cell radioresistance was characterized by low accumulation of H2AX foci, as confirmed by Comet assay, marked neutralization of reactive oxygen species (ROS) and enhanced DNA repair via activation of ATM, Ku70/80 complex and DNA-PK. We found that Cav-1-overexpressing RD cells, already under basal conditions, had higher glutathione (GSH) content and greater catalase expression, which conferred protection against acute treatment with hydrogen peroxide. Furthermore, pre-treatment of Cav-1-overexpressing cells with PP2 or LY294002 compounds restored the sensitivity to radiation treatment, indicating a role for Src-kinases and Akt pathways in Cav-1-mediated radioresistance. These findings were confirmed using radioresistant RD and RH30 lines generated by hypofractionated radiotherapy protocol, which showed marked increase of Cav-1, catalase and Akt, and sensitivity to PP2 and LY294002 treatment. In conclusion, these data suggest that concerted activity of Cav-1 and catalase, in cooperation with activation of Src-kinase and Akt pathways, may represent a network of vital mechanisms that allow irradiated RMS cells to evade cell death induced by oxidative stress and DNA damage.
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http://dx.doi.org/10.1016/j.canlet.2021.02.005DOI Listing
May 2021

Treatment of muscle-invasive bladder cancer in patients without comorbidities and fit for surgery: Trimodality therapy vs radical cystectomy. Development of GRADE (Grades of Recommendation, Assessment, Development and Evaluation) recommendation by the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Crit Rev Oncol Hematol 2021 Mar 22;159:103235. Epub 2021 Jan 22.

Radiation Oncology, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.

Aim: To compare trimodality therapy (TMT) versus radical cystectomy (RC) and develop GRADE (Grades of Recommendation, Assessment, Development and Evaluation) Recommendation by the Italian Association of Radiotherapy and Clinical Oncology (AIRO) for treatment of muscle-invasive bladder cancer (MIBC).

Material And Methods: Prospective and retrospective studies comparing TMT and RC for MIBC patients were included. Qualitative and quantitative evaluation of evidence was made.

Results: Ten studies were included in the analysis. Pooled analysis showed salvage cystectomy and pathological complete response rates after TMT of 12 % and 72-77.5 %, respectively. Pooled rates of G3-G4 GU toxicity and serious toxicity rate were 18 vs 3% and 45 vs 29 % for patients undergoing TMT vs RC, respectively. The panel assessed a substantial equivalence in terms of OS and CSS at 5 years between TMT and RC.

Conclusions: TMT could be suggested as an alternative treatment to RC in non-metastatic MIBC patients, deemed fit for surgery.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103235DOI Listing
March 2021

INTERACTS (INTErventional Radiotherapy ACtive Teaching School) consensus conference on sarcoma interventional radiotherapy (brachytherapy) endorsed by AIRO (Italian Association of Radiotherapy and Clinical Oncology).

J Contemp Brachytherapy 2020 Aug 21;12(4):397-404. Epub 2020 Aug 21.

Radiotherapy Department, University of Florence, Florence, Italy.

Purpose: To report the results of INTERACTS (INTErventional Radiotherapy ACtive Teaching School) consensus conference on sarcoma interventional radiotherapy (brachytherapy).

Material And Methods: An international board of multidisciplinary experts was invited to a consensus conference on the state-of-the-art of sarcoma interventional oncology during the 9 Rome INTER-MEETING (INTERventional Radiotherapy Multidisciplinary Meeting), proposing 3 statements for each one speech. At the end of each lecture, the entire group of experts was invited to vote with an electronic device. The preliminary results were presented and discussed at the end of the meeting, during a dedicated session. After the meeting, a survey was distributed within the consensus conference board to share and definitively vote the statements.

Results: All the invited authors of the consensus conference board completed the final survey. All the 38 statements received more than 70% of agreement, 31 statements (82%) obtained an agreement of level higher or equal to 90%, 6 statements (15.8%) received an agreement level between 80% and 90%, and 1 statement (2.6%) had less than 80% of agreement.

Conclusions: The consensus conference demonstrated that interventional radiotherapy must be considered by a multidisciplinary management of patients affected by sarcoma.
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http://dx.doi.org/10.5114/jcb.2020.98120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7690224PMC
August 2020

Radiotherapy for the treatment of solitary plasmacytoma: 7-year outcomes by a mono-institutional experience.

J Cancer Res Clin Oncol 2020 Nov 17. Epub 2020 Nov 17.

Department of Radiation Oncology, Brescia University, Piazza Spedali Civili,1, 25100, Brescia, Italy.

Objectives: Solitary plasmacytoma (SP) is characterized by a single mass of clonal plasma cells. Definitive RT can result in long-term local control of the SP. Due to the small number of patients and narrow range of doses, phase III randomized trials are lacking. The aim of this study is to further support the potential use of RT for the treatment of SP.

Methods: Clinical data of all patients treated for SP at our Institution between 1992 and 2018 were reviewed. A total of 42 consecutive patients were analyzed.

Results: The median follow-up was 84.8 months. Radiation dose did not differ significantly as a function of sex, type of SP (solitary bone plasmacytoma or as extramedullary plasmacytoma), tumor size; conversely differs significantly as a function of age (p = 0.04). The 5y-OS and 10y-OS were, respectively, 96 and 91%. Local recurrences developed in 21.4% of patients (9/42). 16 patients progressed to MM (38.1%). The 5y-progression to MM free survival (PMFS) and the 10y-PMFS were, respectively, 68.6 and 61.9%.

Conclusions: Our data confirm that good results are achievable with RT to treat SP, but they don't allow defining a dose-effect correlation; therefore, it remains uncertain which is the most effective dose and whether lower doses can guarantee adequate disease control.
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http://dx.doi.org/10.1007/s00432-020-03452-yDOI Listing
November 2020

Back to (new) normality-A CODRAL/AIRO-L survey on cancer radiotherapy in Lombardy during Italian COVID-19 phase 2.

Med Oncol 2020 Nov 4;37(11):108. Epub 2020 Nov 4.

Radiotherapy Unit, ASST Ospedale Niguarda, Milano, Italy.

Background: Italy experienced one of the world's severest COVID-19 outbreak, with Lombardy being the most afflicted region. However, the imposed safety measures allowed to flatten the epidemic curve and hence to ease the restrictions and inaugurate, on the 4th of May 2020, the Italian phase (P) 2 of the pandemic. The present survey study, endorsed by CODRAL and AIRO-L, aimed to assess how radiotherapy (RT) departments in Lombardy have dealt with the recovery.

Materials And Methods: A questionnaire dealing with the management of pandemic was developed online and sent to all CODRAL Directors on the 10th of June 2020. Answers were collected in full anonymity one week after.

Results: All the 33 contacted RT facilities (100%) responded to the survey. Despite the scale of the pandemic, during P1 14 (42.4%) centres managed to safely continue the activity (≤ 10% reduction). During P2, 10 (30.3%) centres fully recovered and 14 (42.4%) reported an increase. Nonetheless, 6 (18.2%) declared no changes and, interestingly, 3 (9.1%) reduced activities. Overall, 21 centres (63.6%) reported suspected or positive cases within healthcare workforce since the beginning of the pandemic. Staff units were quarantined in 19 (57.6%) and 6 (18.2%) centres throughout P1 and P2, respectively. In the two phases, about two thirds centres registered positive or suspected cases amongst patients.

Conclusion: The study revealed a particular attention to anti-contagion measures and a return to normal or even higher clinical workload in most RT centres in Lombardy, necessary to carry out current and previously deferred treatments.
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http://dx.doi.org/10.1007/s12032-020-01434-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7641253PMC
November 2020

Metastasis-directed Therapy (SBRT) Guided by PET-CT F-CHOLINE Versus PET-CT Ga-PSMA in Castration-sensitive Oligorecurrent Prostate Cancer: A Comparative Analysis of Effectiveness.

Clin Genitourin Cancer 2020 Aug 6. Epub 2020 Aug 6.

Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy; Radiation Oncology Unit, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.

Background: The present analysis aims to compare the impact of 18F-fluorocholine (F-choline) and gallium-68 prostate-specific membrane antigen (Ga-PSMA) positron emission tomography (PET)-computed tomography (CT)-guided metastases-directed therapies (MDTs) in patients with castration-sensitive oligorecurrent prostate cancer (PC).

Materials And Methods: Inclusion criteria were: (1) histologically proven prostate adenocarcinoma; (2) evidence of biochemical relapse after primary tumor treatment; (3) ≤ 3 hypermetabolic oligorecurrent lesions detected by F-choline or Ga-PSMA PET-CT; (4) PET-CT imaging performed in a single nuclear medicine department; (5) patients treated with upfront stereotactic body radiotherapy (SBRT) without hormone therapy; and (6) SBRT delivered with a dose per fraction ≥ 5 Gy. In the case of oligoprogression (≤ 3 lesions outside the previous RT field) after MTD, a further course of SBRT was proposed; otherwise, androgen deprivation therapy (ADT) was administered.

Results: A total of 118 lesions in 88 patients were analyzed. Forty-four (50%) patients underwent Ga-PSMA PET-guided SBRT, and the remaining underwent choline PET-based SBRT. The median follow-up was 25 months (range, 5-87 months) for the entire cohort. Overall survival and local control were both 100%. Distant progression occurred in 48 (54.5%) patients, for a median distant progression-free survival of 22.8 months (range, 14.4-28.8 months). The median pre-SBRT prostate-specific antigen was 2.04 ng/mL in the choline PET cohort and 0.58 ng/mL in the PSMA-PET arm. Disease-free survival rates were 63.6% and 34%, respectively, in the Ga-PSMA and choline PET group (P = .06). The ADT administration rate was higher after choline-PET-guided SBRT (P = .00) owing to the higher incidence of polymetastatic disease after first-course SBRT compared with Ga-PSMA-based SBRT.

Conclusion: In the setting of oligorecurrent castration-sensitive PC, PSMA-PET-guided SBRT produced a higher rate of ADT-free patients when compared with the F-choline-PET cohort. Randomized trials are advocated.
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http://dx.doi.org/10.1016/j.clgc.2020.08.002DOI Listing
August 2020

PROACTA: a survey on the actual attitude of the Italian radiation oncologists in the management and prescription of hormonal therapy in prostate cancer patients.

Radiol Med 2021 Mar 27;126(3):460-465. Epub 2020 Aug 27.

Advanced Radiation Oncology Department, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar-Verona, Italy.

Aim: To investigate the actual attitude of Radiation Oncologists in the prescription of hormonal therapy in prostate cancer (PC) with or without Radiation Therapy (RT).

Materials And Methods: In 2019, a survey named Prescription of Radiation Oncologists ACtual Attitude including 18 items was sent to all Italian Radiation Oncologists of the Italian Association of Radiotherapy and Clinical Oncology. The first 4 items were about the Radiation Oncology Centers characteristics and years of practice of the respondents. The remaining 14 items concerned the setting in which hormone therapy was prescribed in PC patients (radical, postprostatectomy/oligometastatic state), the kind of drug, the choice modality (Multidisciplinary Group/autonomy decision) and other factors.

Results: A total of 127 questionnaires were returned, mainly by Northern Italy Radiation Oncology Centres (44.9%), and by experienced Radiation Oncologists (78%), who declared to prescribe independently hormone therapy in 85.8% of cases. The Androgen deprivation therapy (ADT) prescription in castration naive PC was made independently by 56.7% of respondents and associated with radical RT, postoperative or salvage RT according to various risk factors. In castration-sensitive oligorecurrent PC, the majority (51.2%) administered ADT only if local ablative treatment was not feasible, while in metastatic castration resistant disease novel hormone therapy use was established in almost half of cases within multidisciplinary board. Radiation Oncologists could prescribe these drugs independently in 64% of cases.

Conclusion: Our survey established the prescription attitude of ADT and new hormonal agents (abiraterone, enzalutamide, apalutamide) by Italian Radiation Oncologists and highlighted the importance of expertise in global PC management.
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http://dx.doi.org/10.1007/s11547-020-01264-1DOI Listing
March 2021

Head and neck radiotherapy amid the COVID-19 pandemic: practice recommendations of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Med Oncol 2020 Aug 17;37(10):85. Epub 2020 Aug 17.

Department of Radiotherapy, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Management of patients with head and neck cancers (HNCs) is challenging for the Radiation Oncologist, especially in the COVID-19 era. The Italian Society of Radiotherapy and Clinical Oncology (AIRO) identified the need of practice recommendations on logistic issues, treatment delivery and healthcare personnel's protection in a time of limited resources. A panel of 15 national experts on HNCs completed a modified Delphi process. A five-point Likert scale was used; the chosen cut-offs for strong agreement and agreement were 75% and 66%, respectively. Items were organized into two sections: (1) general recommendations (10 items) and (2) special recommendations (45 items), detailing a set of procedures to be applied to all specific phases of the Radiation Oncology workflow. The distribution of facilities across the country was as follows: 47% Northern, 33% Central and 20% Southern regions. There was agreement or strong agreement across the majority (93%) of proposed items including treatment strategies, use of personal protection devices, set-up modifications and follow-up re-scheduling. Guaranteeing treatment delivery for HNC patients is well-recognized in Radiation Oncology. Our recommendations provide a flexible tool for management both in the pandemic and post-pandemic phase of the COVID-19 outbreak.
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http://dx.doi.org/10.1007/s12032-020-01409-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7430932PMC
August 2020

A single-center retrospective safety analysis of cyclin-dependent kinase 4/6 inhibitors concurrent with radiation therapy in metastatic breast cancer patients.

Sci Rep 2020 08 12;10(1):13589. Epub 2020 Aug 12.

Department of Radiation Oncology, Brescia University, Piazzale Spedali Civili, 1, 25123, Brescia, Italy.

Cyclin dependent kinases 4/6 (CDK4/6) inhibitors gained an essential role in the treatment of metastatic breast cancer. Nevertheless, data regarding their use in combination with radiotherapy are still scarce. We performed a retrospective preliminary analysis of breast cancer patients treated at our Center with palliative radiation therapy and concurrent CDK4/6 inhibitors. Toxicities were measured according to CTCAE 4.0, local response according to RECIST 1.1 or PERCIST 1.0 and pain control using verbal numeric scale. 18 patients (32 treated sites) were identified; 50% received palbociclib, 33.3% ribociclib and 16.7% abemacliclib. Acute non-hematologic toxicity was fair, with the only exception of a patient who developed G3 ileitis. During 3 months following RT, 61.1% of patients developed G 3-4 neutropenia; nevertheless no patient required permanent suspension of treatment. Pain control was complete in 88.2% of patients three months after radiotherapy; 94.4% of patients achieved and maintained local control of disease. Radiotherapy concomitant to CDK4/6 inhibitors is feasible and characterized by a fair toxicity profile, with isolated episodes of high-grade reversible intestinal toxicity. Rate of G 3-4 neutropenia was comparable with that measured for CDK4/6 inhibitors alone. Promising results were reported in terms of pain relief and local control of disease.
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http://dx.doi.org/10.1038/s41598-020-70430-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423932PMC
August 2020

Two months of radiation oncology in the heart of Italian "red zone" during COVID-19 pandemic: paving a safe path over thin ice.

Radiat Oncol 2020 Aug 10;15(1):191. Epub 2020 Aug 10.

Department of Radiation Oncology, Brescia University, Università degli Studi di Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy.

Background: Coronavirus Disease 2019 (COVID-19) pandemic had an overwhelming impact on healthcare worldwide. Outstandingly, the aftermath on neoplastic patients is still largely unknown, and only isolated cases of COVID-19 during radiotherapy have been published. We will report the two-months experience of our Department, set in Lombardy "red-zone".

Methods: Data of 402 cancer patients undergoing active treatment from February 24 to April 24, 2020 were retrospectively reviewed; several indicators of the Department functioning were also analyzed.

Results: Dedicated measures allowed an overall limited reduction of the workload. Decrease of radiotherapy treatment number reached 17%, while the number of administration of systemic treatment and follow up evaluations kept constant. Conversely, new treatment planning faced substantial decline. Considering the patients, infection rate was 3.23% (13/402) and mortality 1.24% (5/402). Median age of COVID-19 patients was 69.7 years, the large majority were male and smokers (84.6%); lung cancer was the most common tumor type (61.5%), 84.6% of subjects were stage III-IV and 92.3% had comorbidities. Remarkably, 92.3% of the cases were detected before March 24. Globally, only 2.5% of ongoing treatments were suspended due to suspect or confirmed COVID-19 and 46.2% of positive patients carried on radiotherapy without interruption. Considering only the last month, infection rate among patients undergoing treatment precipitated to 0.43% (1/232) and no new contagions were reported within our staff.

Conclusions: Although mortality rate in COVID-19 cancer patients is elevated, our results support the feasibility and safety of continuing anticancer treatment during SARS-Cov-2 pandemic by endorsing consistent preventive measures.
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http://dx.doi.org/10.1186/s13014-020-01631-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7416803PMC
August 2020

How radical prostatectomy procedures have changed over the last 10 years in Italy: a comparative analysis based on more than 1500 patients participating in the MIRROR-SIU/LUNA and the Pros-IT CNR study.

World J Urol 2020 Aug 1. Epub 2020 Aug 1.

Aging Branch, National Research Council (CNR), Neuroscience Institute, Padua, Italy.

Purpose: Therapeutic strategies for prostate cancer (PCa) have been evolving dramatically worldwide. The current article reports on the evolution of surgical management strategies for PCa in Italy.

Methods: The data from two independent Italian multicenter projects, the MIRROR-SIU/LUNA (started in 2007, holding data of 890 patients) and the Pros-IT-CNR project (started in 2014, with data of 692 patients), were compared. Differences in patients' characteristics were evaluated. Multivariable logistic regression models were used to identify characteristics associated with robot-assisted (RA) procedure, nerve sparing (NS) approach, and lymph node dissection (LND).

Results: The two cohorts did not differ in terms of age and prostate-specific antigen (PSA) levels at biopsy. Patients enrolled in the Pros-IT-CNR project more frequently were submitted to RA (58.8% vs 27.6%, p < 0.001) and NS prostatectomy (58.4% vs. 52.9%, p = 0.04), but received LND less frequently (47.7% vs. 76.7%, p < 0.001), as compared to the MIRROR-SIU/LUNA patients. At multivariate logistic models, Lower Gleason Scores (GS) and PSA levels were significantly associated with RA prostatectomy in both cohorts. As for the MIRROR-SIU/LUNA data, clinical T-stage was a predictor for NS (OR = 0.07 for T3, T4) and LND (OR = 2.41 for T2) procedures. As for Pros-IT CNR data, GS ≥ (4 + 3) and positive cancer cores ≥ 50% were decisive factors both for NS (OR 0.29 and 0.30) and LND (OR 7.53 and 2.31) strategies.

Conclusions: PCa management has changed over the last decade in Italian centers: RA and NS procedures without LND have become the methods of choice to treat newly medium-high risk diagnosed PCa.
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http://dx.doi.org/10.1007/s00345-020-03350-5DOI Listing
August 2020

Non-metastatic ductal adenocarcinoma of the prostate: pattern of care from an uro-oncology multidisciplinary group.

World J Urol 2020 Jun 26. Epub 2020 Jun 26.

Urology Unit, Department of Medical and Surgical Specialties, Radiological Science and Public Health, ASST Spedali Civili of Brescia, University of Brescia, Brescia, Italy.

Purpose: To retrospectively review our 20 year experience of multidisciplinary management of non-metastatic ductal prostate cancer (dPC), a rare but aggressive histological subtype of prostate cancer whose optimal therapeutic approach is still controversial.

Methods: Histologically confirmed dPC patients undergoing primary, curative treatment [radical prostatectomy (RP), external beam radiotherapy (EBRT), and androgen deprivation therapy (ADT)] were included, and percentage of ductal and acinar pattern within prostate samples were derived. Survival outcomes were assessed using the subdistribution hazard ratio (SHR) and Fine-and-Gray model.

Results: From January 1997 to December 2016, 81 non-metastatic dPC fitted selection criteria. Compared to surgery alone, SHR for progression-free survival and cancer-specific mortality were 2.8 (95% CI 0.6-13.3) and 1.3 (95% CI 0.1-16.2) for exclusive EBRT, 2.7 (95% CI 0.6-13.0) and 6.5 (95% CI 0.6-69.8) for adjuvant EBRT, 4.9 (95% CI 0.7-35.5) and 5.8 (95% CI 0.5-65.6) for salvage EBRT post-prostatectomy recurrence, and 3.2 (95% CI 0.7-14.0) and 3.9 (95% CI 0.3-44.1) for primary ADT (P = 0.558; P = 0.181), respectively. Comparing multimodal treatment and monotherapy confirmed the above trends. Local recurrence more typically occurred in pure dPC patients, mixed histology more frequently produced metastatic spread (29.6% relapse in total, P = 0.026).

Conclusion: Albeit some limitations affected the study, our findings support the role of local treatment to achieve better disease control and improve quality of life. Different behavior, with typical local growth in pure dPC, higher distant metastatization in the mixed form, might influence treatment response. Given its poor prognosis, we recommend multidisciplinary management of dPC.
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http://dx.doi.org/10.1007/s00345-020-03315-8DOI Listing
June 2020

Short fractionation radiotherapy for early prostate cancer in the time of COVID-19: long-term excellent outcomes from a multicenter Italian trial suggest a larger adoption in clinical practice.

Radiol Med 2021 Jan 15;126(1):142-146. Epub 2020 May 15.

Radiation Oncology Department, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Introduction: To evaluate stereotactic body radiotherapy (SBRT) in low-risk Prostate Cancer patients as preferred treatment option in emergency health conditions.

Materials And Methods: From April 2013 to September 2015, 28 patients with low-risk prostate cancer were prospectively enrolled. The SBRT prescribed dose was 36.25 Gy in 5 fractions, twice a week. Primary endpoints were acute and late toxicity. Secondary endpoints were biochemical recurrence free survival (bRFS) and overall survival.

Results: Median follow-up was 65.5 months (range 52-81). No acute G3 or G4 toxicity was recorded. Acute G1 or G2 genitourinary (GU) toxicity occurred in 43% and acute G1-G2 gastrointestinal (GI) toxicity in 14%. Late G1 and G3 GU toxicity in 18% and 3.5%, respectively. The G3 toxicity was not directly attributable to radiotherapy. Late G1 GI toxicity occurred in 18%. 5yy bRFS was 96.5% (95% CI 82.3-99.4%).

Conclusions: Stereotactic body radiotherapy for early prostate cancer reported safe toxicity profile and a good clinical outcome at the median follow-up of 5 years. It may be an useful option if radiotherapy is required in emergency medical conditions.
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http://dx.doi.org/10.1007/s11547-020-01216-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227177PMC
January 2021

COVID-19 outbreak and cancer radiotherapy disruption in Italy: Survey endorsed by the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Radiother Oncol 2020 08 12;149:89-93. Epub 2020 May 12.

Radiation Oncology Division, Oncology and Speciality Medicine Department, San Camillo-Forlanini Hospital, Roma, Italy; President of AIRO (Italian Association of Radiotherapy and Clinical Oncology), Italy.

Italy experienced one of the world's deadliest COVID-19 outbreaks and healthcare systems had to instantly reorganise activity. The Italian Radiation Oncology Departments adapted numerous solutions to minimize the disruptions. Information technologies, treatment prioritization and implementation of hypofractionation and protection procedures allowed balancing between cancer patient care and patient/healthcare workers safety.
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http://dx.doi.org/10.1016/j.radonc.2020.04.061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7215158PMC
August 2020

In reply to Simcock et al.

Clin Transl Radiat Oncol 2020 Jul 1;23:65. Epub 2020 Apr 1.

Radiation Oncology Department, Ospedali Civili Hospital and Brescia University, Brescia, Italy.

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http://dx.doi.org/10.1016/j.ctro.2020.03.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7118646PMC
July 2020

Letter from Italy: First practical indications for radiation therapy departments during COVID-19 outbreak.

Int J Radiat Oncol Biol Phys 2020 07 19;107(3):597-599. Epub 2020 Mar 19.

Department of Radiation Oncology, IRCCS Ospedale Policlinico San Martino and Department of Health Science, University of Genoa, Italy.

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http://dx.doi.org/10.1016/j.ijrobp.2020.03.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141469PMC
July 2020

Can brachytherapy be properly considered in the clinical practice? Trilogy project: The vision of the AIRO (Italian Association of Radiotherapy and Clinical Oncology) Interventional Radiotherapy study group.

J Contemp Brachytherapy 2020 Feb 28;12(1):84-89. Epub 2020 Feb 28.

Radiation Oncology Department, Spedali Civili Hospital and Brescia University, Brescia, Italy.

Purpose: Brachytherapy (BT, interventional radiotherapy - IRT) is a kind of radiation therapy, in which the radioactive source is placed nearby or even inside the cancer itself. Even though this kind of radiation therapy appears effective and valuable, BT has been facing a slow but progressive decline over the past decades in Europe, particularly in Italy. Aims of this study were to identify the practical and theoretical reasons why BT is facing a slow decline in Italy, and to define a vision of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) and a strategy about this emerged issues.

Material And Methods: A programmatic path divided into three steps like a trilogy was launched by AIRO Interventional Radiotherapy study group. The study group performed an initial data collection to highlight both the clinical and the educational topics and problems through specific surveys. After having analyzed the results of the surveys and shared a vision about the emerged issues, a specific strategy was adopted.

Results: Four relevant domains were identified and for each ones, a strategy has been discussed and defined. This manuscript shows in detail the individual actions defined (accomplished or in progress).

Conclusions: The AIRO vision implies that specific strategic interventions must be carried out in the field of national guidelines, education, research, and communication with patients and colleagues of other specialties in an interdisciplinary setting.
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http://dx.doi.org/10.5114/jcb.2020.92765DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7073336PMC
February 2020

Cetuximab and Radiation Therapy Versus Cisplatin and Radiation Therapy for Locally Advanced Head and Neck Cancer: Long-Term Survival and Toxicity Outcomes of a Randomized Phase 2 Trial.

Int J Radiat Oncol Biol Phys 2020 07 14;107(3):469-477. Epub 2020 Mar 14.

Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.

Purpose: This study describes the long-term survival and toxicity outcomes of a multicenter randomized phase 2 trial comparing radiation therapy (RT) plus cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced head and neck cancer (LASCCHN).

Methods And Materials: Between January 2011 and August 2014, 70 patients were enrolled and randomized to receive RT plus weekly CDDP (40 mg/m) or CTX (250 mg/m plus a loading dose of 400 mg/m). This updated series focuses on late toxicities (graded by using Common Terminology Criteria for Adverse Events version 4.0) and long-term survival outcomes in terms of local control, overall survival, cancer-specific survival, and metastasis-free survival (MFS). A supplementary analysis based on human papilloma virus (HPV) status was also performed.

Results: No statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss). In the CDDP arm and the CTX arm, 5-year local control rates were 67% and 48%; 5-year MFS rates were 83% and 97%; 5-year overall survival rates were 61% and 52%; and 5-year cancer-specific survival rates were 70% and 59%, respectively. None of these differences reached statistical significance. A subgroup analysis by HPV status and anatomic subsites revealed that in HPV+ oropharyngeal carcinoma, better survival was obtained in the CDDP arm (although statistical tests were not performed owing to the small sample size). Conversely, no statistically significant differences were observed in HPV- oropharyngeal carcinoma and other anatomic subsites, except for the confirmed better MFS rates of the CTX arm.

Conclusions: Long-term results are in line with current literature suggesting that RT + CTX is inferior to RT + CDDP for the definitive treatment of LASCCHN. However, if not as an alternative to CDDP, CTX might still play a role in LASCCHN, particularly in HPV- cases.
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http://dx.doi.org/10.1016/j.ijrobp.2020.02.637DOI Listing
July 2020

HAPPY - Humanity Assurance Protocol in interventional radiotheraPY (brachytherapy) - an AIRO Interventional Radiotherapy Study Group project.

J Contemp Brachytherapy 2019 Dec 25;11(6):510-515. Epub 2019 Dec 25.

UOC Radioterapia Oncologica, Dipartimento di Diagnostica per immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Purpose: Interventional procedures may produce emotional distress, particularly in interventional radiotherapy (IRT, brachytherapy - BT). This work would like to propose a series of recommendationsinterventions to guarantee a human approach in order to favor the psychological well-being of the patient during interventional radiotherapy.

Material And Methods: Thirty patients affected by gynecological cancer and treated with endovaginal high-dose-rate IRT (HDR-IRT) were selected from January to March 2019. A specific Multiprofessional Task Group (MTG) was defined in order to analyze the needs of patients. Each component of the task group spoke with the patients to examine their needs and to investigate their fears and perception. The results of the MTG were subjected to evaluation by an Expert Team (ET) of 4 physicians from 4 different institutions for a final evaluation. Both teams discussed the patient's needs to generate a list of necessary interventions to fulfill every single need in order to obtain their inner well-being. Another team (Master Team - MT) performed an independent check.

Results: All patients suggest that the main issue is the "lack of information and fear of the unknown". The fear of feeling pain was a significant source of concern, sadness, and vulnerability for the majority of the patients (76.6%). All patients do not appreciate the use of the word "bunker" to describe the treatment place. In 33.3% of patients the word "brachytherapy" (often unknown) determines insecurity while the term "interventional radiotherapy" reassures. Ninety percent of patients preferred to perform the external genital depilation at home and 80% of them would like the bladder catheter to be placed immediately before the procedure. MTG and ET defined nine "HAPPY recommendations". The MT approved the protocol without changes.

Conclusions: The aim of the present paper was to produce a protocol consisting in intervention that could improve the internal serendipity and emotional state of patients who underwent HDR-IRT.
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http://dx.doi.org/10.5114/jcb.2019.91222DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6964336PMC
December 2019

Radiosurgery and fractionated stereotactic radiotherapy in oligometastatic/oligoprogressive non-small cell lung cancer patients: Results of a multi-institutional series of 198 patients treated with "curative" intent.

Lung Cancer 2020 03 3;141:1-8. Epub 2020 Jan 3.

Department of Radiotherapy, Ospedale di Circolo e Fondazione Macchi, ASST dei Sette Laghi, Varese, Italy.

Objectives: stereotactic radiosurgery (SRS) and fractionated stereotactic radiotherapy (FSRT) are a therapeutic option for Oligometastatic/Oligoprogressive (OM/OP) NSCLC. This retrospective multicentre analysis aims to analyse clinical outcomes and treatment related toxicity of patients treated to all sites of know disease with SRS and/or FSRT for OM/OP NSCLC in 8 Italian radiation oncology centres.

Materials And Methods: From January 2016 to January 2017 198 OM/OP NSCLC patients (pts) were treated in 8 Centres. Inclusion criteria were as follows: 1-5 lesions at onset or after previous systemic treatment; Pts must have all metastatic lesions treated. Endpoints analysed were local progression free survival (LPFS); out-of-field recurrence free survival (OFPS); progression free survival (PFS); overall survival (OS). Time to New systemic Therapy free survival (TNT) and toxicity were also analysed.

Results: At the time of radiotherapy, 119 pts (60 %) were treated for a single lesion, 49 (25 %) for 2 lesions, 30 (15 %) for 3-5 metastases. Total number of lesions treated was 333: 204 brain, 68 lung, 24 bone, 16 nodal, 12 adrenal, 8 liver and 1 soft tissue. 83/198 pts (41.8 %) had the primary tumour controlled at the time of the SRT. After a median follow-up of 18 months, median OS and PFS were 29.6 months and 10.6 months, respectively. One year LPFS and OPFS were 90 % and 47 %, respectively. Median TNT was 10 months. At univariate analysis factors associated with better OS were PS 0-1; controlled primary tumour, 1-2 lesions; extracranial metastasis. Multivariate analysis confirmed number of lesions <3 and extracranial metastasis to be related with better survival (Relative Risk 0.4 and 0.41, respectively). Two cases of death possibly related to brain radionecrosis were observed.

Conclusion: OM/OP NSCLC pts treated with an ablative SRT to all metastatic sites have fair outcomes with acceptable toxicity. Better results might be achieved in case of low disease burden and extracranial possibly when primary tumour is controlled.
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http://dx.doi.org/10.1016/j.lungcan.2019.12.019DOI Listing
March 2020

Treatment paths for localised prostate cancer in Italy: The results of a multidisciplinary, observational, prospective study (Pros-IT CNR).

PLoS One 2019 1;14(11):e0224151. Epub 2019 Nov 1.

Radiation Oncology Department, University and Spedali Civili Hospital, Brescia, Italy.

Background: There are several treatments available to newly diagnosed prostate cancer (PCA) patients. Although surgery and radiotherapy (RT) with or without androgen deprivation therapy (ADT) are widely adopted treatment options for localized PCA together with active surveillance (AS), there is no consensus nor randomised trials on treatment selection, prospective quality of life (QOL), along with toxicity outcomes and according to treatment modality in the Italian population. The current study aimed to describe clinical-therapeutic features and QOL at PCA diagnosis, according to different treatment patterns in a large prospective, Italian population, enrolled in the Pros-IT CNR study.

Methods: The Pros-IT CNR is an on-going national, multicenter, observational, prospective study on patients affected by PCA who have been referred by 97 Italian Urology, Radiation Oncology and Medical Oncology facilities participating in the project. The possible relationships between the treatment patterns reported in the 6 month follow-up case report form and patients' features at diagnosis were evaluated using exploratory multiple correspondence analysis (MCA) and other data analysis method.

Results: At diagnosis, surgery and AS patients were significantly younger, had fewer comorbidities, lower PSA levels and Gleason Score (GS) values; they were also diagnosed at an earlier stage of disease with respect to the RT or ADT patients who showed significantly worse QoL scores at the time of diagnosis.

Conclusions: An analysis of the data collected at baseline and 6 months later uncovered substantial differences in ages, comorbidities, clinical and QOL features in the various treatment groups. These findings do not fully reflect the current PCA treatment guidelines and suggest the need for a multidisciplinary consensus guideline to ameliorate both the counselling and treatments of PCA patients.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224151PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824566PMC
March 2020

The role of palliative interventional radiotherapy (brachytherapy) in esophageal cancer: An AIRO (Italian Association of Radiotherapy and Clinical Oncology) systematic review focused on dysphagia-free survival.

Brachytherapy 2020 Jan - Feb;19(1):104-110. Epub 2019 Oct 18.

Fondazione Policlinico Universitario "A. Gemelli" IRCCS, UOC Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Roma, Italy.

Purpose: The aim of this review was to examine efficacy of palliative interventional radiotherapy (IRT) in esophageal cancer compared with other treatment in terms of dysphagia-free survival (DyFS) and safety.

Methods And Material: A systematic research using PubMed, Scopus, and Cochrane library was performed to identify full articles evaluating the efficacy of IRT as palliation in patients with esophageal cancer. ClinicalTrials.gov was searched for ongoing or recently completed trials, and PROSPERO was searched for ongoing or recently completed systematic reviews. We analyzed only clinical study as full text of patients with symptomatic esophageal cancer treated with IRT alone or in combination with other treatment. Conference paper, survey, letter, editorial, book chapter, and review were excluded. Time restriction (1990-2018) as concerns the years of the publication was considered. The primary outcome was the duration of dysphagia relief (DyFS) after brachytherapy vs. other treatment (external-beam radiotherapy, photodynamic therapy, argon plasma coagulation, stent, and laser) during followup. Secondary outcomes included overall survival and adverse event rates.

Results: The literature search resulted in 554 articles. Sixty-six articles were assessed via full text for eligibility. Of these, 59 articles were excluded for various reasons, leaving seven randomized studies. The number of evaluated patients was 905 patients, and median age was 70.5 years. In the IRT group, the median DyFS was 99 days, the most relevant G3-G4 toxicity were fistula development and stenosis reported, respectively, in 8.3% and 12.2%; the overall median survival was 175.5 days.

Conclusion: In conclusion, we provided evidence-based support that IRT is an effective and safe treatment option; therefore, its underuse is no longer justified.
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http://dx.doi.org/10.1016/j.brachy.2019.09.005DOI Listing
September 2020

Cetuximab and Radiation Therapy in Head and Neck Cancer.

Int J Radiat Oncol Biol Phys 2019 11;105(3):678-679

Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.

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http://dx.doi.org/10.1016/j.ijrobp.2019.07.025DOI Listing
November 2019