Publications by authors named "Alessio Giuseppe Morganti"

75 Publications

Immunotherapy and radiotherapy in melanoma: a multidisciplinary comprehensive review.

Hum Vaccin Immunother 2021 Apr 13:1-8. Epub 2021 Apr 13.

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

Melanoma is an extremely aggressive tumor and is considered to be an extremely immunogenic tumor because compared to other cancers it usually presents a well-expressed lymphoid infiltration. The aim of this paper is to perform a multidisciplinary comprehensive review of the evidence available about the combination of radiotherapy and immunotherapy for melanoma. Radiation, in fact, can increase tumor antigens visibility and promote priming of T cells but can also exert immunosuppressive action on tumor microenvironment. Combining radiotherapy with immunotherapy provides an opportunity to increase immunostimulatory potential of radiation. We therefore provide the latest clinical evidence about radiobiological rationale, radiotherapy techniques, timing, and role both in advanced and systemic disease (with a special focus on ocular melanoma and brain, liver, and bone metastases) with a particular attention also in geriatric patients. The combination of immunotherapy and radiotherapy seems to be a safe therapeutic option, supported by a clear biological rationale, even though the available data confirm that radiotherapy is employed more for metastatic than for non-metastatic disease. Such a combination shows promising results in terms of survival outcomes; however, further studies, hopefully prospective, are needed to confirm such evidence.
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http://dx.doi.org/10.1080/21645515.2021.1903827DOI Listing
April 2021

Challenges in lung and heart avoidance for postmastectomy breast cancer radiotherapy: Is automated planning the answer?

Med Dosim 2021 Apr 6. Epub 2021 Apr 6.

Radiation Oncology Unit, Gemelli Molise Hospital, Università Cattolica del Sacro Cuore, Campobasso, Italy; Istituto di Radiologia, Università Cattolica del Sacro Cuore, Rome, Italy.

Postmastectomy radiotherapy (PMRT) has been shown to improve the overall survival for invasive breast cancer patients. However, it represents a challenging treatment geometry and individualized planning strategies with complex field arrangements are usually adopted to decrease radiotoxicity to heart and lungs. Automated treatment planning has the potential to improve plan quality consistency and planning efficiency. Herein, we describe the application of the Pinnacle Autoplanning engine as a valuable technological resource able to allow the treatment of challenging patients theoretically unfit for radiotherapy for major cardiac and pulmonary comorbidities. Treatment was planned for three left-sided chest wall and regional lymph-nodes postmastectomy breast cancer patients. A deep inspiration breath-hold (DIBH) technique was used aiming to reduce the OARs irradiation. Three manually generated plans (hybrid-IMRT (HMRT), hybrid-VMAT (HVMAT) and full VMAT (MP-VMAT) and a fully automated plan created by the Autoplanning engine (AP-VMAT) were optimized in order to ensure a safe radiation therapy to the patients. The plans were evaluated based on planning target volumes (PTVs) coverage, dose homogeneity index (HI), conformity index (CN), dose to organs at risk (OARs) and normal tissue complication probabilities (NTCPs) of pericarditis, long term mortality and pneumonitis. Despite the use of deep moderated breath-hold, all human-driven plans failed to reach the stringent dose objectives for OARs. All plans provided an optimal coverage for chest wall and lymph-nodal area. AP-VMAT delivered the lowest mean dose to the heart (3.4 to 4.9 Gy) and ipsilateral lung (7.5 to 12.5 Gy) reporting the lowest NTCP for pneumonitis (<1%), confirming the only chance to comply the dose objectives. Moreover, AP-VMAT reported a decrease of the integral dose, which was lower by about 4-8% with respect to manual plans. AP-VMAT plan resulted in up to 58% increase of MUs with respect to manual plans, suggesting a more pronounced fluence modulation and plan complexity. A major difference was found for the planning time which was reduced to less than 30 minutes by using the Auto-Planning module. With improved planning quality and efficiency, Auto-planning is an effective tool to enable high-quality plans in challenging postmastectomy breast cancer radiotherapy.
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http://dx.doi.org/10.1016/j.meddos.2021.03.002DOI Listing
April 2021

Treatment Volume, Dose Prescription and Delivery Techniques for Dose-intensification in Rectal Cancer: A National Survey.

Anticancer Res 2021 Apr;41(4):1985-1995

Radiation Oncology Unit, "SS Annunziata" Hospital, "G. D'Annunzio" University, Chieti, Italy.

Background/aim: The aim of the study was to investigate boost volume definition, doses, and delivery techniques for rectal cancer dose intensification.

Patients And Methods: An online survey was made on 25 items (characteristics, simulation, imaging, volumes, doses, planning and treatment).

Results: Thirty-eight radiation oncologists joined the study. Twenty-one delivered long-course radiotherapy with dose intensification. Boost volume was delineated on diagnostic magnetic resonance imaging (MRI) in 18 centres (85.7%), and computed tomography (CT) and/or positron emission tomography-CT in 9 (42.8%); 16 centres (76.2%) performed co-registration with CT-simulation. Boost dose was delivered on gross tumor volume in 10 centres (47.6%) and on clinical target volume in 11 (52.4%). The most common total dose was 54-55 Gy (71.4%), with moderate hypofractionation (85.7%). Intensity-modulated radiotherapy (IMRT) was used in all centres, with simultaneous integrated boost in 17 (80.8%) and image-guidance in 18 (85.7%).

Conclusion: A high quality of treatment using dose escalation can be inferred by widespread multidisciplinary discussion, MRI-based treatment volume delineation, and radiation delivery relying on IMRT with accurate image-guided radiation therapy protocols.
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http://dx.doi.org/10.21873/anticanres.14966DOI Listing
April 2021

Post-Operative Accelerated-Hypofractionated Chemoradiation With Volumetric Modulated Arc Therapy and Simultaneous Integrated Boost in Glioblastoma: A Phase I Study (ISIDE-BT-2).

Front Oncol 2020 22;10:626400. Epub 2021 Feb 22.

Radiation Oncology Unit, Gemelli Molise Hospital - Università Cattolica del Sacro Cuore, Campobasso, Italy.

Background: Glioblastoma Multiforme (GBM) is the most common primary brain cancer and one of the most lethal tumors. Theoretically, modern radiotherapy (RT) techniques allow dose-escalation due to the reduced irradiation of healthy tissues. This study aimed to define the adjuvant maximum tolerated dose (MTD) using volumetric modulated arc RT with simultaneous integrated boost (VMAT-SIB) plus standard dose temozolomide (TMZ) in GBM.

Methods: A Phase I clinical trial was performed in operated GBM patients using VMAT-SIB technique with progressively increased total dose. RT was delivered in 25 fractions (5 weeks) to two planning target volumes (PTVs) defined by adding a 5-mm margin to the clinical target volumes (CTVs). The CTV was the tumor bed plus the MRI enhancing residual lesion with 10-mm margin. The CTV was the CTV plus 20-mm margin. Only PTV dose was escalated (planned dose levels: 72.5, 75, 77.5, 80, 82.5, 85 Gy), while PTV dose remained unchanged (45 Gy/1.8 Gy). Concurrent and sequential TMZ was prescribed according to the EORTC/NCIC protocol. Dose-limiting toxicities (DLTs) were defined as any G ≥ 3 non-hematological acute toxicity or any G ≥ 4 acute hematological toxicities (RTOG scale) or any G ≥ 2 late toxicities (RTOG-EORTC scale).

Results: Thirty-seven patients (M/F: 21/16; median age: 59 years; median follow-up: 12 months) were enrolled and treated as follows: 6 patients (72.5 Gy), 10 patients (75 Gy), 10 patients (77.5 Gy), 9 patients (80 Gy), 2 patients (82.5 Gy), and 0 patients (85 Gy). Eleven patients (29.7%) had G1-2 acute neurological toxicity, while 3 patients (8.1%) showed G ≥ 3 acute neurological toxicities at 77.5 Gy, 80 Gy, and 82.5 Gy levels, respectively. Since two DLTs (G3 neurological: 1 patient and G5 hematological toxicity: 1 patient) were observed at 82.5 Gy level, the trial was closed and the 80 Gy dose-level was defined as the MTD. Two asymptomatic histologically proven radionecrosis were recorded.

Conclusions: According to the results of this Phase I trial, 80 Gy in 25 fractions accelerated hypofractionated RT is the MTD using VMAT-SIB plus standard dose TMZ in resected GBM.
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http://dx.doi.org/10.3389/fonc.2020.626400DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937791PMC
February 2021

Proton therapy: A therapeutic opportunity for aggressive pediatric meningioma.

Pediatr Blood Cancer 2021 May 7;68(5):e28919. Epub 2021 Mar 7.

Department of Pediatrics, University of Bologna, Bologna, Italy.

Meningiomas are an extremely rare histology among pediatric brain tumors, and there is a shortage of literature on their management. Proton therapy is currently used safely and effectively for many types of both pediatric and adult cancer, and its main advantage is the sparing of healthy tissues from radiation, which could translate in the reduction of late side effects. We review the literature on radiotherapy and proton therapy for pediatric meningiomas and report clinical outcomes for two aggressive pediatric meningiomas we treated with protons. Proton therapy might be a safe and effective therapeutic option for this rare subgroup of tumors.
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http://dx.doi.org/10.1002/pbc.28919DOI Listing
May 2021

Electrochemotherapy in Kaposi sarcoma: A systematic review.

Mol Clin Oncol 2021 Apr 8;14(4):64. Epub 2021 Feb 8.

Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, I-40138 Bologna, Italy.

Kaposi sarcoma (KS) is a rare angioproliferative disorder, which is usually associated with human herpesvirus-8 infection. Electrochemotherapy (ECT) may be an option in the treatment of KS skin lesions due to the high response rate noted in neoplastic lesions of different histological types. The aim of the present systematic review was to analyse the available evidence on using ECT in the treatment of KS skin lesions. Tumor response, local control and toxicity were analyzed. In the three included studies, the complete response rate was 65-100% and the overall response rate in all studies was 100%. The treatment was well tolerated with mild and transient toxicity. However, further studies are required to fully analyze long-term disease control and to compare ECT with other local therapies used for KS.
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http://dx.doi.org/10.3892/mco.2021.2226DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7890459PMC
April 2021

The Role of Radiotherapy in Orbital Pseudotumor: A Systematic Review of Literature.

Ocul Immunol Inflamm 2021 Feb 9:1-6. Epub 2021 Feb 9.

U.O.C. Oncologia Oculare, Dipartimento di Scienze dell'Invecchiamento, Neurologiche, Ortopediche e della Testa Collo, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy.

: Orbital pseudotumor (or pseudotumor orbitae) is a benign entity, also known as idiopathic orbital inflammatory syndrome (IOIS), which encompasses a wide range of non-tumoral, space occupying lesions of the orbit. In selected cases of refractory disease or presence of side effects or even comorbidities that limit systemic therapies, radiotherapy could play a role in the management because it has been demonstrated that irradiation is effective in suppressing the inflammatory process. : A systematic review of the literature about the main scientific databases was launched and the time interval included all published articles present in the databases from their inception until September 2020. : We were able to identify 19 studies eligible for inclusion in this review from 1978 to 2018. Overall the data of 241 patients were collected and are presented in this systematic review. The response rate varied between 74% and 100% with a median recurrence rate of 10%. The median total dose was 20 Gy whereas the mean total dose was 21 Gy with a range from 4 to 36 Gy. Regarding the fractionation, 2 Gy/fraction daily was the most widely used. : Radiotherapy seemed to achieve good response rates however, in most of the studies, inclusion criteria and outcome parameters are not uniform and therefore the results are difficult to compare. Often important parameters such as chronic pain and permanent functional deficits are not assessed in the outcome. Therefore, prospective studies, with good cohort characteristics and a clear definition of the outcome, are required.
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http://dx.doi.org/10.1080/09273948.2020.1871493DOI Listing
February 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

Electrochemotherapy of skin metastases from breast cancer: a systematic review.

Clin Exp Metastasis 2021 Feb 12;38(1):1-10. Epub 2020 Nov 12.

Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna S. Orsola-Malpighi Hospital, Via Massarenti 9, 40138, Bologna, Italy.

Skin metastases occur in 5-30% of breast cancer (BC) patients. Standard treatments include systemic therapies (chemotherapy, endocrine therapy, and immunotherapy) and local treatments (surgery and radiotherapy). Electrochemotherapy (ECT) could be another option in this setting based on preclinical and clinical studies. Aim of this review was to analyze the available evidence on ECT in skin metastases from BC. Studies reporting on ECT in skin metastases from BC were included in this review. Studies not reporting toxicity or tumor response or not reporting results separately from other primary cancers were excluded. The search was based on Medline, Scopus, and The Cochrane Library databases. Eleven studies including 464 patients were analyzed. ECT was performed using intravenous/intratumoral bleomycin (10 studies) or intratumoral cisplatin (one study). Complete and overall pooled response rates were 46.2% (CI 33.2-59.4 and 74.6% (CI 60.6-86.4) in studies reporting results on a per patient basis and 61.9% (CI 53.8-69.6) and 86.9% (CI 80.0-92.6) in studies reporting results on a per lesion basis, respectively. Worse response rates in larger lesions were observed in three studies. The incidence of toxicity was heterogeneous but adverse events were mild and manageable in all studies. One- and 3-year local progression-free survival was 86.2% and 81.0% in two studies, respectively. ECT is tolerable and effective in terms of response in BC skin metastases especially in less advanced lesions. Further studies are justified to compare ECT with other treatments in this setting.
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http://dx.doi.org/10.1007/s10585-020-10063-xDOI Listing
February 2021

Advanced head and neck cancer in older adults: Results of a short course accelerated radiotherapy trial.

J Geriatr Oncol 2021 Apr 21;12(3):441-445. Epub 2020 Oct 21.

Radiation Oncology Unit, Gemelli Molise Hospital, Catholic University of Sacred Heart, Largo A. Gemelli 1, 86100 Campobasso, Italy; Istituto di Radiologia, Catholic University of Sacred Heart, 00168 Rome, Italy.

Objectives: To assess the feasibility and safety of a repeated SHort course Accelerated RadiatiON therapy (SHARON) regimen in the palliative setting of Head and Neck (H&N) cancer in older adults.

Material And Methods: Patients with histological confirmed H&N cancers, age ≥ 80 years, expected survival >3 months, and Eastern Cooperative Oncology Group (ECOG) performance status of ≤3 were enrolled. Patients were treated in cohorts of six patients: a total dose of 20 Gy was delivered in 2 consecutive days with a twice-daily fractionation (5 Gy per fraction) and at least 8-h interval. If no Grade 3 toxicity was registered, a second enrollment started with another cohort of six patients to whom were administered two cycles (total dose of 40 Gy). The primary endpoint was to evaluate the feasibility of the two cycles of treatment. Secondary endpoints were evaluation of symptoms control rate, symptoms-free survival (SFS), and Quality of Life (QoL) scores.

Results: Seventeen consecutive patients (median age: 85 years) were treated. Nine patients were treated with one cycle and 8 patients with two cycles. No G3 toxicity was reported in either cohort. With a median follow-up time of 4 months, 3-month SFS in the first and second cohorts was 83.3%, and 87.5%, respectively. The overall palliative response rate was 88%. Among 13 patients reporting pain, 8 (61.5%) showed an improvement or resolution of their pain.

Conclusion: Repeated short course accelerated radiotherapy in a palliative setting of H&N cancers is safe and well-tolerated in older adults.
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http://dx.doi.org/10.1016/j.jgo.2020.10.006DOI Listing
April 2021

Skin toxicity following radiotherapy in patients with breast carcinoma: is anthocyanin supplementation beneficial?

Clin Nutr 2020 Oct 6. Epub 2020 Oct 6.

Department of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli, IS, Italy. Electronic address:

Background: The EU-supported ATHENA project stems from a previous study suggesting that moderate wine consumption reduced the side-effects of radiotherapy (RT) in breast cancer patients, an effect possibly due to non-alcoholic anthocyanin fractions of wine.

Objective: To evaluate the role of anthocyanins on RT skin side effects in breast cancer patients.

Methods: Randomized, controlled, double-blind clinical trial. Patients were assigned to an intensity modulated radiation therapy (IMRT) either for three or five weeks, then randomized to receive three times a day a water-soluble anthocyanin (125 mg)-rich extract of corn cob or a placebo. Supplementation started one week before till the end of RT. Skin characteristics were detected by a standardized, non-invasive Cutometer® dual-MPA580, providing quantitative indices of skin maximal distensibility (R0), elasticity (R2, R5, R7) and viscoelasticity (R6); a Mexameter® MX18 probe evaluated the skin erythema (Er) and melanin (M). Measures were performed before (T0), at the end of RT and of supplementation (T1), and 1, 6 and 12 months after RT (T2-T4). Acute and late skin toxicity were scored according to the RTOG/EORTG scale. Selected biomarkers were measured at T0 and T1.

Results: 193 patients previously assigned to 3- or 5-week RT schedules were randomized to either anthocyanin (97) or placebo (96) supplementation. RT induced changes in skin parameters: R0, R2, R5 and R7 decreased, while R6 increased; the changes in R0 and R6 continued in the same direction up to one year, while the others recovered towards basal values; Er and M peaked at T1 and T2, respectively, and returned to basal values at T4. Comparable skin changes were apparent in anthocyanin and placebo groups. A moderate RT-induced increase in total and HDL cholesterol and triglycerides was prevented by anthocyanins.

Conclusions: Anthocyanin supplementation did not prevent RT-induced local skin toxicity. The supplementation was well tolerated and safe.
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http://dx.doi.org/10.1016/j.clnu.2020.09.030DOI Listing
October 2020

An Analysis of Clinical, Surgical, Pathological and Molecular Characteristics of Endometrial Cancer According to Mismatch Repair Status. A Multidisciplinary Approach.

Int J Mol Sci 2020 Sep 29;21(19). Epub 2020 Sep 29.

Gynecologic Oncology Unit, Azienda Ospedaliero-Universitaria Policlinico di Sant'Orsola, 40138 Bologna, Italy.

Since 2016, our hospital has applied tumor testing with immunohistochemistry (IHC) in endometrial cancer in order to detect mutations of mismatch repair genes (MMR). All cases with MMR deficiency proteins expression are sent for genetic testing, except those with protein deficiency, in which case genetic testing is performed if negative for promoter hypermethylation. The primary aim of this study was to investigate the ability of our algorithm to identify Lynch syndrome (LS). The Secondary aims were to investigate the relationship between MMR status and clinicopathological features and prognosis of primary endometrial cancer (EC). From January 2016 to December 2018, 239 patients with EC were retrospectively analyzed and subdivided according to MMR status. Patients were divided in three groups: MMR proficient, LS and Lynch-like cancer (LLC). LS was characterized by a lower age and BMI, more use of contraceptive and less use of hormonal replacement therapy, nulliparity and a trend versus a better prognosis. LLC appeared more related to MMR proficient than LS and exhibited a more aggressive behavior. Our multidisciplinary approach permitted a correct diagnosis of germline mutation in patients with newly diagnosis EC and it confirmed clinicopathologic and prognostic characteristics of LS.
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http://dx.doi.org/10.3390/ijms21197188DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7582893PMC
September 2020

Hypofractionated sequential radiotherapy boost: a promising strategy in inoperable locally advanced pancreatic cancer patients.

J Cancer Res Clin Oncol 2021 Mar 1;147(3):661-667. Epub 2020 Oct 1.

Università Cattolica del Sacro Cuore, Roma, Italy.

Purpose: To investigate the potential benefits of a hypofractionated radiotherapy boost (HRB) after chemotherapy (CT) and concomitant chemoradiotherapy (CRT) in locally advanced pancreatic cancer (LAPC) patients. Primary endpoints were early and late toxicity, local control (LC) and pain-free progression (PFP) assessment. Two-years overall survival (OS), metastasis-free survival (MFS) and disease-free survival (DFS) were secondary endpoints.

Materials And Methods: Patients (pts) affected by unresectable non-metastatic LAPC, previously treated with CT and CRT in upfront or sandwich setting, were selected for sequential HRB. Total prescribed dose was 30 Gy in 5 fractions (fr) to pancreatic primary lesion. Dose de-escalation was allowed in case of failure in respecting organs at risk constraints. Early and late toxicity were assessed according to CTCAE v.4.0 classification. The Kersh-Hazra scale was used for pain assessment. Local Control, PFP, MFS and DFS were calculated from the date of HRB to the date of relapse or the date of the last follow-up.

Results: Thirty-one pts affected by unresectable, non-metastatic LAPC were consecutively enrolled from November 2004 to October 2019. All pts completed the planned HRB. Total delivered dose varied according to duodenal dose constraint: 20 Gy in 5 fr (N: 6; 19.4%), 20 Gy in 4 fr (N: 5; 16.2%), 25 Gy in 5 fr (N: 18; 58.0%) and 30 Gy in 6 fr (N: 2; 6.4%). Early and late toxicity were assessed in all pts: no Grade 3 or 4 acute gastrointestinal toxicity and no late gastrointestinal complications occurred. Median LC was 19 months (range 1-156) and 1- and 2-year PFP were 85% and 62.7%, respectively (median 28 months; range 2-139). According to the Kersh-Hazra scale, four pts had a Grade 3 and four pts had a Grade 1 abdominal pain before HRB. At the last follow-up only 3/31 pts had residual Grade 1 abdominal pain.Median MFS was 18 months (range 1-139). The 2-year OS after HRB was 57.4%, while 2-year OS from diagnosis was 77.3%.

Conclusion: Treatment intensification with hypofractionated radiotherapy boost is well tolerated in pts affected by unresectable LAPC previously treated with CT/CRT. Its rates of local and pain control are encouraging, supporting its introduction in clinical practice. Timing, schedule and dose of HRB need to be further investigated to personalize therapy and optimize clinical advantages.
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http://dx.doi.org/10.1007/s00432-020-03411-7DOI Listing
March 2021

Stereotactic body radiotherapy vs conventionally fractionated chemoradiation in locally advanced pancreatic cancer: A multicenter case-control study (PAULA-1).

Cancer Med 2020 11 10;9(21):7879-7887. Epub 2020 Sep 10.

Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.

Conventionally fractionated chemoradiation (CRT) or chemotherapy (CHT) are considered as standard options in locally advanced pancreatic cancer (LAPC) while stereotactic body radiotherapy (SBRT) is an emerging treatment in this setting. The aim of this study was to compare two cohorts of LAPC patients treated with SBRT ± CHT vs CRT ± CHT in terms of local control (LC), distant metastases-free survival (DMFS), progression-free survival (PFS), overall survival (OS), and toxicity. Eighty patients were included. Patients in the two cohorts were matched according to: age ≤/>65 years, tumor diameter (two cut-offs:
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http://dx.doi.org/10.1002/cam4.3330DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643643PMC
November 2020

Basics and Frontiers on Pancreatic Cancer for Radiation Oncology: Target Delineation, SBRT, SIB technique, MRgRT, Particle Therapy, Immunotherapy and Clinical Guidelines.

Cancers (Basel) 2020 Jun 29;12(7). Epub 2020 Jun 29.

Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, 40138 Bologna, Italy.

Pancreatic cancer represents a modern oncological urgency. Its management is aimed to both distal and local disease control. Resectability is the cornerstone of treatment aim. It influences the clinical presentation's definitions as up-front resectable, borderline resectable and locally advanced (unresectable). The main treatment categories are neoadjuvant (preoperative), definitive and adjuvant (postoperative). This review will focus on i) the current indications by the available national and international guidelines; ii) the current standard indications for target volume delineation in radiotherapy (RT); iii) the emerging modern technologies (including particle therapy and Magnetic Resonance [MR]-guided-RT); iv) stereotactic body radiotherapy (SBRT), as the most promising technical delivery application of RT in this framework; v) a particularly promising dose delivery technique called simultaneous integrated boost (SIB); and vi) a multimodal integration opportunity: the combination of RT with immunotherapy.
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http://dx.doi.org/10.3390/cancers12071729DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7407382PMC
June 2020

Results of a Phase I-II Study on Laser Therapy for Vaginal Side Effects after Radiotherapy for Cancer of Uterine Cervix or Endometrium.

Cancers (Basel) 2020 Jun 21;12(6). Epub 2020 Jun 21.

Gynecologic Oncology Unit, Sant'Orsola-Malpighi Hospital, 40138 Bologna, Italy.

Women who have previously received radiotherapy (RT) for gynecologic cancer often suffer from vaginal fibrosis and stenosis. The success of "non-ablative" laser therapy for postmenopausal vaginal atrophy has led to the idea of testing the laser in patients submitted to RT. In this prospective observational study, we selected patients who underwent pelvic RT followed by vaginal laser treatment. We scheduled three treatment sessions (at T0-T1-T2) and three controls (at T1-T2-T3) one month apart. The follow-up (at T4) was carried out six months after the last treatment. Vaginal Health Index (VHI) and vaginal length were evaluated. Sexual function was assessed through Female Sexual Function Index (FSFI). Overall, 43 patients with severe vaginal shortening, atrophy and stenosis was enrolled and treated with intravaginal non-ablative CO laser. We observed a progressive increase in vaginal length of 9% ( = 0.03) at T2 and 28% ( < 0.0001) at T3; effects were maintained at T4 ( < 0.0001). After the first application VHI showed a significant improvement of 57% at T3 ( < 0.0001). The results were maintained at T4 ( < 0.0001). No changes were found in FSFI. All procedures were well tolerated. In conclusion, laser therapy improved vaginal length and VHI in women undergoing pelvic RT; prospective studies are needed.
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http://dx.doi.org/10.3390/cancers12061639DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352893PMC
June 2020

Intraluminal Brachytherapy in Unresectable Extrahepatic Biliary Duct Cancer: An Italian Pooled Analysis.

Anticancer Res 2020 Jun;40(6):3417-3421

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

Background/aim: To evaluate the outcome of patients with unresectable extrahepatic cholangiocarcinoma (CC) treated with external-beam radiotherapy (EBRT) and concurrent chemotherapy (CT) with or without intraluminal brachytherapy (ILBT) boost or with definitive ILBT.

Patients And Methods: A pooled analysis of patients with non-metastatic unresectable CC was performed. They were treated in three different institution with EBRT plus CT with or without an ILBT boost. Some patients received only ILBT with curative dose.

Results: Seventy-three patients were included in the analysis. Thirty-nine patients (53%) received EBRT treatment with ILBT boost (18 patients with CT during EBRT), while 28 patients (38%) were treated with EBRT (CT in 26 patients) and 6 patients (8.2%) with definitive ILBT (2 patients with CT). CT was administered including either the use of gemcitabine or 5-fluorouracil. With a median follow-up of 16 month (range=1-94 months), median overall survival (OS) was 16 months. Overall median LC was 16 months and patients who underwent ILBT had a better local control (LC) (p=0.018).

Conclusion: The role of ILBT in unresectable CC is not yet supported by robust evidence in the literature. However, within this limit, preliminary results seem to suggest an improved local control in patients treated with ILBT, almost comparable to the ones of standard chemo-radiotherapy (CRT).
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http://dx.doi.org/10.21873/anticanres.14326DOI Listing
June 2020

Multidisciplinary personalized approach in the management of vulvar cancer - the Vul.Can Team experience.

Int J Gynecol Cancer 2020 07 30;30(7):932-938. Epub 2020 May 30.

Unità Operativa di Radioterapia, Gemelli Molise Hospital, Campobasso, Molise, Italy.

Introduction: Multidisciplinary treatment strategy involving adjuvant radiotherapy for advanced vulvar cancer could be useful in offering the best personalized clinical approach. In 2013, the VULvar CANcer Multi-Disciplinary Team (Vul.Can MDT) was set up in our institution, in order to share knowledge and expertise, high-quality diagnosis, and evidence-based decision making in the context of personalized medicine. The aim of this observational study was to report on our series of vulvar cancer patients managed postoperatively with radiotherapy within the framework of a formal multidisciplinary tumor board.

Methods: Coupling surgical and oncological international guidelines with "case-by-case" discussions, a multi-specialist consensus was progressively reached and internal recommendations were developed and introduced in the daily routine. Data from vulvar cancer patients who underwent primary surgery and adjuvant radiotherapy throughout a 5-year period were retrospectively collected. Actuarial local control was the primary endpoint, while secondary end-points were acute and late toxicities, disease-free survival, and overall survival. Toxicity was evaluated according to the Common Toxicity Criteria Adverse Event v 4.0 scale.

Results: The analysis included 35 patients with squamous vulvar cancer treated with adjuvant radiotherapy±chemotherapy, from April 2013 to September 2017. Median age was 70 years (range 18-87), all patients underwent surgery followed by concomitant chemoradiation (45.7%) or radiotherapy alone (54.3%). The median prophylactic dose on lymphatic drainage was 45 Gy, while positive nodes and perineal area received 51.2 Gy and 52.6 Gy, respectively. Chemotherapy involved the cisplatin-based regimen (45.7%)±5-fluorouracil (37.1%). Median follow-up was 32 months (range 6-72): the 24-months local control, disease-free survival, and actuarial overall survival rates were 88.6%, 82.0%, and 91.0%, respectively. Low rates of severe acute (12%) and late (3%) toxicities occurred.

Discussion: The outcomes of this series support the benefit of a multidisciplinary personalized approach in the management of vulvar cancer.
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http://dx.doi.org/10.1136/ijgc-2020-001465DOI Listing
July 2020

Magnetic Resonance Imaging Derived Biomarkers of IDH Mutation Status and Overall Survival in Grade III Astrocytomas.

Diagnostics (Basel) 2020 Apr 23;10(4). Epub 2020 Apr 23.

Neuroradiology Unit, S. Chiara Hospital, Trento, Largo Medaglie d'oro 9, 38122 Trento, Italy.

The evaluation of the isocitrate dehydrogenase (IDH) mutation status in the glioma decision-making process has diagnostic, prognostic and therapeutic implications. The aim of this study was to evaluate whether conventional magnetic resonance imaging (MRI) and apparent diffusion coefficient (ADC) can noninvasively predict the most common IDH mutational status (R132H) in GIII-astrocytomas and the overall survival (OS). Hence, twenty-two patients (9-F, 13-M) with a histological diagnosis of GIII-astrocytoma and evaluation of IDH-mutation status (12-wild type, 10-mutant) were retrospectively evaluated. Imaging studies were reviewed for the morphological feature and mean ADC values (ADCm). Statistics included a Fisher's exact test, Student's -test, Spearman's Test and receiver operating characteristic analysis. A ≤ 0.05 value was considered statistically significant for all the tests. A younger age and a frontal location were more likely related to mutational status. IDH-wild type (Wt) exhibited a slight enhancement ( = 0.039). The ADCm values in IDH-mutant (Mut) patients were higher than those of IDH-Wt patients ( < 0.0004). The value of ADC ≥ 0.99 × 10 mm/s emerged as a "cut-off" to differentiate the mutation state. In the overall group, a positive relationship between the ADCm values and OS was detected ( = 0.003; r = 0.62). Adding quantitative measures of ADC values to conventional MR imaging could be used routinely as a noninvasive marker of specific molecular patterns.
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http://dx.doi.org/10.3390/diagnostics10040247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236014PMC
April 2020

Clinical aspects of mCRPC management in patients treated with radium-223.

Sci Rep 2020 04 21;10(1):6681. Epub 2020 Apr 21.

Radiation Oncology Center, S. Orsola-Malpighi Hospital, Bologna, Italy.

Bone is the most common site of metastasis in metastatic castration-resistant prostate cancer (mCRPC), which is associated with pain and skeletal events. Radium-223 dichloride (Xofigo) is an alpha-emitting radioactive isotope that can specifically target bone lesions. Herein, we report the results of a retrospective analysis that documents our experience in the use of radium-223. Data from 63 patients (pts) with mCRPC who underwent radium-223 treatment from December 2015 to September 2017 were collected. Radium-223 (55 kBq/kg) was administered every 4 weeks for up to 6 cycles. The primary endpoint was OS. Radium-223 was administered as first line therapy in 11 pts, as second line in 19 pts, as third line in 16 pts and in successive lines in 17 pts; 42 pts out of 63 (67%) completed all six cycles. Within one month after the end of 6 cycles of radium-223, 15 pts out of 42 (35.7%) had achieved PR, 11 pts out of 42 (26.2%) had SD and 14 pts out of 42 (33.3%) had PD. Levels of pain decreased with progressive cycles of radium-223. After a minimum follow-up of 2 months and a maximum of 43 months, median OS was 15 months and median PFS was 8 months. The most frequent radium-223 related toxicity was low grade haematologic toxicity, predominantly G1-G2, that occurred halfway through treatment in about 75% of pts. The favourable results reported herein confirm that radium-223 can be considered well tolerated and effective in mCRPC, and is associated with significant decreases in pain.
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http://dx.doi.org/10.1038/s41598-020-63302-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7174360PMC
April 2020

A Large, Multicenter, Retrospective Study on Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Ovarian Cancer (MITO RT1 Study): A Collaboration of MITO, AIRO GYN, and MaNGO Groups.

Oncologist 2020 02 10;25(2):e311-e320. Epub 2019 Oct 10.

Fondazione Policlinico Universitario A. Gemelli, IRCCS, Unità Operativa Complessa Ginecologia Oncologica, Dipartimento per la Salute della Donna e del Bambino e della Salute Pubblica, Roma, Italy.

Background: Recent studies have reported improvement of outcomes (progression-free survival, overall survival, and prolongation of androgen deprivation treatment-free survival) with stereotactic body radiotherapy (SBRT) in non-small cell lung cancer and prostate cancer. The aim of this retrospective, multicenter study (MITO RT-01) was to define activity and safety of SBRT in a very large, real-world data set of patients with metastatic, persistent, and recurrent ovarian cancer (MPR-OC).

Materials And Methods: The endpoints of the study were the rate of complete response (CR) to SBRT and the 24-month actuarial local control (LC) rate on "per-lesion" basis. The secondary endpoints were acute and late toxicities and the 24-month actuarial late toxicity-free survival. Objective response rate (ORR) included CR and partial response (PR). Clinical benefit (CB) included ORR and stable disease (SD). Toxicity was evaluated by the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) and Common Terminology Criteria for Adverse Events (CTCAE) scales, according to center policy. Logistic and Cox regression were used for the uni- and multivariate analysis of factors predicting clinical CR and actuarial outcomes.

Results: CR, PR, and SD were observed in 291 (65.2%), 106 (23.8%), and 33 (7.4%) lesions, giving a rate of CB of 96.4%. Patient aged ≤60 years, planning target volume (PTV) ≤18 cm , lymph node disease, and biologically effective dose α/β10 > 70 Gy were associated with higher chance of CR in the multivariate analysis. With a median follow-up of 22 months (range, 3-120), the 24-month actuarial LC rate was 81.9%. Achievement of CR and total dose >25 Gy were associated with better LC rate in the multivariate analysis. Mild toxicity was experienced in 54 (20.7%) patients; of 63 side effects, 48 were grade 1, and 15 were grade 2. The 24-month late toxicity-free survival rate was 95.1%.

Conclusions: This study confirms the activity and safety of SBRT in patients with MPR-OC and identifies clinical and treatment parameters able to predict CR and LC rate.

Implications For Practice: This study aimed to define activity and safety of stereotactic body radiotherapy (SBRT) in a very large, real life data set of patients with metastatic, persistent, recurrent ovarian cancer (MPR-OC). Patient age <60 years, PTV <18 cm , lymph node disease, and biologically effective dose α/β10 >70 Gy were associated with higher chance of complete response (CR). Achievement of CR and total dose >25 Gy were associated with better local control (LC) rate. Mild toxicity was experienced in 20.7% of patients. In conclusion, this study confirms the activity and safety of SBRT in MPR-OC patients and identifies clinical and treatment parameters able to predict CR and LC rate.
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http://dx.doi.org/10.1634/theoncologist.2019-0309DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7011643PMC
February 2020

The VEGF gene polymorphism in glioblastoma may be a new prognostic marker of overall survival.

J BUON 2019 Nov-Dec;24(6):2475-2482

Clinic for Radiotherapy, Oncology Institute of Vojvodina, Sremska Kamenica, Serbia.

Purpose: Glioblastoma (GBM) is the most aggressive primary brain tumor. Vascular endothelial growth factor (VEGF) gene polymorphisms and overexpression are involved in high-grade malignant gliomas. The aim of this study was to assess the distribution of +405C>G VEGF gene polymorphism in patients diagnosed by glioblastoma and to test its association with the overall survival (OS).

Methods: Patients diagnosed for glioblastoma were randomly selected, and follow-up was conducted for a minimum of 36 months. Tissue paraffin embedded GBM samples were subjected for the VEGF polymorphism detection. The associations of the observed genotypes and clinical data were evaluated.

Results: The most frequent single nucleotide polymorphism (SNP) variant was G (72.58%). The GG genotype was proved to have statistically significant longer OS and patient status (alive/dead) compared to CC and CG genotypes (p=0.022 and 0.005, respectively).

Conclusion: Our results indicate that +405C>G VEGF gene polymorphism may be used as prognostic genetic marker of OS in GBM patients.
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June 2020

Pain REduction with bone metastases STereotactic radiotherapy (PREST): A phase III randomized multicentric trial.

Trials 2019 Oct 28;20(1):609. Epub 2019 Oct 28.

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

Background: Palliative antalgic treatments represent an issue for clinical management and a challenge for scientific research. Radiotherapy (RT) plays a central role. Techniques such as stereotactic body radiotherapy (SBRT) were largely investigated in several phase 2 studies with good symptom response, becoming widely adopted. However, evidence from randomized, direct comparison of RT and SBRT is still lacking.

Methods/design: The PREST trial was designed as an interventional study without medicinal treatment. It is a phase 3, open-label, multicentric trial randomized 1:1. Inclusion criteria include painful spinal bone metastases presenting with a pain level > 4 (or > 1 if being treated with an analgesic) on the Numeric Rating Scale (NRS); expected intermediate/high prognosis (greater than 6 months) according to the Mizumoto prognostic score; low spine instability neoplastic score (SINS) sores (< 7); magnetic resonance imaging (MRI) assessment of the bulky lesion. Patients will be assigned to either standard conventional radiotherapy involving 4 Gy × 5 fractions (fx) to the whole involved vertebra or SBRT by intensity modulated radiotherapy with simultaneous integrated boost (IMRT-SIB) involving 7 Gy × 3 fx to the whole involved vertebra + 10 Gy × 3 fx on the macroscopic lesion (gross tumor volume (GTV)). In the experimental arm, the GTV will be contoured by registration with baseline MRI.

Discussion: The primary endpoint is overall pain reduction, defined in terms of variation between baseline and 3-month evaluation; pain will be measured using the NRS. Secondary endpoints include pain control duration; retreatment rates (after a minimum interval of 1 month); local control assessed with RECIST criteria; symptom progression free survival; progression-free survival; overall survival; and quality of life (at 0, 30, and 90 days). Accrual of 330 lesions is planned. The experimental arm is expected to have an improvement in overall pain response rates of 15% with respect to the standard arm (60% according to Chow et al. (Int J Radiat Oncol Biol Phys. 82(5):1730-7, 2012)).

Trial Registration: ClinicalTrials.gov, NCT03597984 . Registered on July 2018.
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http://dx.doi.org/10.1186/s13063-019-3676-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6816218PMC
October 2019

Interventional radiotherapy (brachytherapy) for squamous cell carcinoma of the nasal vestibule: a multidisciplinary systematic review.

Eur J Dermatol 2019 Aug;29(4):417-421

Interdisciplinary Brachytherapy Unit, University of Lübeck/UKSH, Lübeck, Germany.

Surgery is the first-line therapy for treatment of cutaneous squamous cell carcinoma (cSCC), and interventional radiotherapy is recommended when surgery is not feasible, contraindicated, or refused by the patient. To provide a multidisciplinary systematic review of the role of interventional radiotherapy for the treatment of cSCC of the nasal vestibule. A systematic search was performed; primary outcomes were tumour local control and overall survival. Acute toxicity, late toxicity, and functional cosmetic results, regardless of the scoring systems used, were secondary outcomes. After full-text review of the 92 papers initially identified, we included only 10 papers in the review; no randomized controlled trials or prospective studies were identified. Five studies reported five-year local control, with rates ranging between 69% and 97%. A high level of heterogeneity was observed regarding the methods used to assess treatment-related toxicity. Interventional radiotherapy may be considered for lesions specifically arising from the area of the nasal vestibule. A multidisciplinary approach might help to select cases that are potential candidates for conservative treatment according to the tumour and the patient's features.
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http://dx.doi.org/10.1684/ejd.2019.3599DOI Listing
August 2019

Importance of the correct assessment of bone fractures in the clinical management of metastatic castration-resistant prostate cancer treated with radium-223: A case report.

Mol Clin Oncol 2019 Jul 6;11(1):63-66. Epub 2019 May 6.

Radiation Oncology Center, S. Orsola-Malpighi Hospital, I-40138 Bologna, Italy.

Patients who undergo radium-223 treatment for metastatic castration-resistant prostate cancer (mCRPC) generally have a long history of androgen deprivation therapy and/or steroid therapy, which leads to bone loss and causes osteoporosis. Notably, Osteoporosis in combination with metastatic bone disease increases the risk of bone fracture. An 84-year-old man with multi-metastatic bone CRPC underwent six administrations of intravenous radium-223, which induced a good biochemical and clinical response. However, two months following the treatment, the patient reported acute pain localized to the lumbar spine mimicking bone progression disease and presented with stable prostate-specific antigen levels. A prostate-specific membrane antigen-positron emission tomography scan showed no tracer uptake in that site, whereas a magnetic resonance imaging scan and subsequent vertebral biopsy confirmed the absence of cancer progression and showed the presence of vertebral crushing of L4-L5, which was probably due to an osteoporotic process. The patient had never received bisphosphonate therapy and refused it during α-emitting therapy with radium-223. The osteoporotic process, in association with metastatic bone disease, more easily leads to bone fractures that have an important impact on performance status, quality of life and prognosis quoad vitam in patients with advanced prostate cancer. Use of bisphosphonates or anti-RANKL antibody appears to be effective in improving bone mineral density. Notably, patients with multi-metastatic bone disease who undergo radium-223 therapy should be treated in conjunction with anti-osteoporotic therapy (bisphosphonates or anti-RANKL antibody) and adequate calcium and vitamin D supplementation. Early recognition and differentiation of osteoporotic processes when determining the progression of cancer-associated bone disease is crucial in evaluating the response to radium-223 therapy and, consequently, for further therapeutic decision making.
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http://dx.doi.org/10.3892/mco.2019.1852DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6535633PMC
July 2019

Palliative Electrochemotherapy in Vulvar Carcinoma: Preliminary Results of the ELECHTRA (Electrochemotherapy Vulvar Cancer) Multicenter Study.

Cancers (Basel) 2019 May 12;11(5). Epub 2019 May 12.

Oncologic Gynaecology Unit, Department Medical and Surgical Sciences (DIMEC), S. Orsola-Malpighi Hospital, University of Bologna, Via Massarenti 13, 40138 Bologna, Italy.

Vulvar cancer (VC) is a rare disease of which recurrence poses management problems due to patients' advanced age and comorbidities, and to the localization of the disease. Palliative treatments, allowing local disease control in patients previously treated with multimodal therapies or with comorbidities, are lacking. In this study we tested electrochemotherapy (ECT) on recurrent VC refractory to standard therapies to assess the tumor response and to define the selection criteria for patient's candidate to ECT. This is a multicenter observational study carried out in five Italian centers. Data about patients and tumor characteristics, treatment, toxicity, and clinical response were recorded. In all procedures, intravenous bleomycin was administered according to European Standard Operative Procedure ECT (ESOPE) guidelines. Sixty-one patients, with a median age 79 years (range: 39-85) and mainly affected by squamous cellular carcinoma (91.8%), were treated with ECT. No serious adverse events were reported. Patients were discharged after three days (median, range: 0-8 days). Two months after ECT, the clinical response rate was 83.6% and was not related to age, body mass index, International Federation of Gynecology and Obstetrics (FIGO) stage, number of treated nodules, or previous treatments. ECT is a safe procedure with a favorable cost-effectiveness ratio and should be considered as a treatment option for local disease control in patients unsuitable for standard therapies.
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http://dx.doi.org/10.3390/cancers11050657DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6562538PMC
May 2019

The INTERACT Trial: Long-term results of a randomised trial on preoperative capecitabine-based radiochemotherapy intensified by concomitant boost or oxaliplatin, for cT2 (distal)-cT3 rectal cancer.

Radiother Oncol 2019 05 7;134:110-118. Epub 2019 Feb 7.

Radiation Oncology Department, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy.

Background And Purpose: Capecitabine-based radiochemotherapy (cbRCT) is standard for preoperative long-course radiochemotherapy of locally advanced rectal cancer. This prospective, parallel-group, randomised controlled trial investigated two intensification regimens. cT4 lesions were excluded.

Primary Objective: pathological outcome (TRG 1-2) among arms.

Materials And Methods: Low-located cT2N0-2M0, cT3N0-2M0 (up to 12 cm from anal verge) presentations were treated with cbRCT randomly intensified by either radiotherapy boost (Xelac arm) or multidrug concomitant chemotherapy (Xelox arm). Xelac: concomitant boost to bulky site (45 Gy/1.8 Gy/die, 5 sessions/week to the pelvis, +10 Gy at 1 Gy twice/week to the bulky) plus concurrent capecitabine (1650 mg/mq/die). Xelox: 45 Gy to the pelvis + 5.4 Gy/1.8 Gy/die, 5 sessions/week to the bulky site + concurrent capecitabine (1300 mg/mq/die) and oxaliplatin (130 mg/mq on days 1,19,38). Surgery was planned 7-9 weeks after radiochemotherapy.

Results: From June 2005 to September 2013, 534 patients were analysed: 280 in Xelac, 254 in Xelox arm. Xelox arm presented higher G ≥ 3 haematologic (p = 0.01) and neurologic toxicity (p < 0.001). Overall, 98.5% patients received curative surgery. The tumour regression grade distribution did not differ between arms (p = 0.102). TRG 1+2 rate significantly differed: Xelac arm 61.7% vs. Xelox 52.3% (p = 0.039). Pathological complete response (ypT0N0) rates were 24.4 and 23.8%, respectively (p non-significant). Median follow-up:5.62 years. Five-year disease-free survival rate were 74.7% (Xelac) and 73.8% (Xelox), respectively (p = 0.444). Five-year overall survival rate were 80.4% (Xelac) and 85.5% (Xelox), respectively (p = 0.155).

Conclusion: Xelac arm significantly obtained higher TRG1-2 rates. No differences were found about clinical outcome. Because of efficacy on TRG, inferior toxicity and good compliance, Xelac schedules or similar radiotherapy dose intensification schemes could be considered as reference treatments for cT3 lesions.
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http://dx.doi.org/10.1016/j.radonc.2018.11.023DOI Listing
May 2019

Current state of interventional radiotherapy (brachytherapy) education in Italy: results of the INTERACTS survey.

J Contemp Brachytherapy 2019 Feb 28;11(1):48-53. Epub 2019 Feb 28.

AIRO President; Chairman, Radiation Oncology Section, National College of Professors of Radiology, Radiotherapy and Nuclear Medicine; Head, Radiation Oncology Department, Spedali Civili Hospital and Brescia University, Brescia, Italy.

Purpose: Increased complexity of interventional radiotherapy (brachytherapy - BT) treatment planning and quality control procedures has led to the need of a specific training. However, the details of the features of BT learning objectives and their distribution in the training paths of the Italian Radiation Oncology Schools are not known. This paper aims to provide the actual 'state-of-the-art' of BT education in Italy and to stimulate the debate on this issue.

Material And Methods: All the Italian radiation oncology schools' directors (SD) were involved in a web survey, which included questions on the teaching of BT, considering also the 2011 ESTRO core curriculum criteria. The survey preliminary results were discussed at the 8 Rome INTER-MEETING (INTERventional Radiotherapy Multidisciplinary Meeting), June 24, 2017. The present paper describes the final results of the survey and possible future teaching strategies resulting from the discussion.

Results: A total of 23 SDs answered the survey. The results evidenced a wide heterogeneity in the learning activities available to trainees in BT across the country. While theoretical knowledge is adequately and homogeneously transmitted to trainees, the types of practice to which they are exposed varies significantly among different schools.

Conclusions: This survey proves the need for an improvement of practical BT education in Italy and the advisability of a national BT education programme networking schools of different Universities. Beside the organization of national/international courses for BT practical teaching, Universities may also establish post-specialization courses ('second level' Masters) to allow professionals (already certified in radiation oncology) to acquire more advanced BT knowledge.
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http://dx.doi.org/10.5114/jcb.2019.83137DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6431105PMC
February 2019