Publications by authors named "Renzo Corvò"

123 Publications

Impact of Gastrointestinal Side Effects on Patients' Reported Quality of Life Trajectories after Radiotherapy for Prostate Cancer: Data from the Prospective, Observational Pros-IT CNR Study.

Cancers (Basel) 2021 Mar 23;13(6). Epub 2021 Mar 23.

Radiation Oncology Department, University and Spedali Civili Hospital, 25123 Brescia, Italy.

Radiotherapy (RT) represents an important therapeutic option for the treatment of localized prostate cancer. The aim of the current study is to examine trajectories in patients' reported quality of life (QoL) aspects related to bowel function and bother, considering data from the PROState cancer monitoring in ITaly from the National Research Council (Pros-IT CNR) study, analyzed with growth mixture models. Data for patients who underwent RT, either associated or not associated with androgen deprivation therapy, were considered. QoL outcomes were assessed over a 2-year period from the diagnosis, using the Italian version of the University of California Los Angeles-Prostate Cancer Index (Italian-UCLA-PCI). Three trajectories were identified for the bowel function; having three or more comorbidities and the use of 3D-CRT technique for RT were associated with the worst trajectory (OR = 3.80, 95% CI 2.04-7.08; OR = 2.17, 95% CI 1.22-3.87, respectively). Two trajectories were identified for the bowel bother scores; diabetes and the non-Image guided RT method were associated with being in the worst bowel bother trajectory group (OR = 1.69, 95% CI 1.06-2.67; OR = 2.57, 95% CI 1.70-3.86, respectively). The findings from this study suggest that the absence of comorbidities and the use of intensity modulated RT techniques with image guidance are related with a better tolerance to RT in terms of bowel side effects.
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http://dx.doi.org/10.3390/cancers13061479DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8004900PMC
March 2021

Adjuvant radiotherapy and radioiodine treatment for locally advanced differentiated thyroid cancer: systematic review and meta-analysis.

Tumori 2021 Mar 16:300891621996817. Epub 2021 Mar 16.

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

Background: Treatment for locally advanced differentiated thyroid cancer is surgery followed by radioiodine while the role of adjuvant external beam radiotherapy (EBRT) is debated.

Methods: The panel of the Italian Association of Radiotherapy and Clinical Oncology developed a clinical recommendation on the addition of EBRT to radioiodine after surgery for locally advanced differentiated thyroid cancer by using the Grades of Recommendation, Assessment, Development, and Evaluation methodology and the Evidence to Decision framework. A systematic review with meta-analysis about this topic was conducted with a focus on outcome of benefits and toxicity.

Results: Locoregional control was improved by EBRT while no considerable toxicity impact was reported.

Conclusion: The panel judged uncertain the benefit/harms balance; final recommendation was conditional both for EBRT + radioiodine and radioiodine alone in the adjuvant setting.
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http://dx.doi.org/10.1177/0300891621996817DOI Listing
March 2021

The Prognostic Value of the New Combined Hemo-Eosinophil Inflammation Index (HEI Index): A Multicenter Analysis of Anal Cancer Patients Treated with Concurrent Chemo-Radiation.

Cancers (Basel) 2021 Feb 7;13(4). Epub 2021 Feb 7.

Department of Oncology, IRCCS San Raffaele Scientific Institute Hospital, 20019 Milan, Italy.

Anal squamous cell carcinoma (SCC) is a rare tumor, and bio-humoral predictors of response to chemo-radiation (CT-RT) are lacking. We developed a prognostic score system based on laboratory inflammation parameters. We investigated the correlation between baseline clinical and laboratory variables and disease-free (DFS) and overall (OS) survival in anal SCC patients treated with CT-RT in five institutions. The bio-humoral parameters of significance were included in a new scoring system, which was tested with other significant variables in a Cox's proportional hazard model. A total of 308 patients was included. We devised a prognostic model by combining baseline hemoglobin level, SII, and eosinophil count: the Hemo-Eosinophils Inflammation (HEI) Index. We stratified patients according to the HEI index into low- and high-risk groups. Median DFS for low-risk patients was not reached, and it was found to be 79.5 months for high-risk cases (Hazard Ratio 3.22; 95% CI: 2.04-5.10; < 0.0001). Following adjustment for clinical covariates found significant at univariate analysis, multivariate analysis confirmed the HEI index as an independent prognostic factor for DFS and OS. The HEI index was shown to be a prognostic parameter for DFS and OS in anal cancer patients treated with CT-RT. An external validation of the HEI index is mandatory for its use in clinical practice.
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http://dx.doi.org/10.3390/cancers13040671DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914854PMC
February 2021

Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group.

Radiother Oncol 2021 Mar 27;156:281-293. Epub 2021 Jan 27.

Cleveland Clinic Foundation, OH, USA; Institut Saint Catherine, France.

Background And Purpose: The Meta-Analysis of Chemotherapy in squamous cell Head and Neck Cancer (MACH-NC) demonstrated that concomitant chemotherapy (CT) improved overall survival (OS) in patients without distant metastasis. We report the updated results.

Materials And Methods: Published or unpublished randomized trials including patients with non-metastatic carcinoma randomized between 1965 and 2016 and comparing curative loco-regional treatment (LRT) to LRT + CT or adding another timing of CT to LRT + CT (main question), or comparing induction CT + radiotherapy to radiotherapy + concomitant (or alternating) CT (secondary question) were eligible. Individual patient data were collected and combined using a fixed-effect model. OS was the main endpoint.

Results: For the main question, 101 trials (18951 patients, median follow-up of 6.5 years) were analyzed. For both questions, there were 16 new (2767 patients) and 11 updated trials. Around 90% of the patients had stage III or IV disease. Interaction between treatment effect on OS and the timing of CT was significant (p < 0.0001), the benefit being limited to concomitant CT (HR: 0.83, 95%CI [0.79; 0.86]; 5(10)-year absolute benefit of 6.5% (3.6%)). Efficacy decreased as patients age increased (p_trend = 0.03). OS was not increased by the addition of induction (HR = 0.96 [0.90; 1.01]) or adjuvant CT (1.02 [0.92; 1.13]). Efficacy of induction CT decreased with poorer performance status (p_trend = 0.03). For the secondary question, eight trials (1214 patients) confirmed the superiority of concomitant CT on OS (HR = 0.84 [0.74; 0.95], p = 0.005).

Conclusion: The update of MACH-NC confirms the benefit and superiority of the addition of concomitant CT for non-metastatic head and neck cancer.
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http://dx.doi.org/10.1016/j.radonc.2021.01.013DOI Listing
March 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

Prediction of Response in Head and Neck Tumor: Focus on Main Hot Topics in Research.

Front Oncol 2020 8;10:604965. Epub 2021 Jan 8.

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

Radiation therapy is a cornerstone in the treatment of head and neck cancer patients; actually, their management is based on clinical and radiological staging with all patients at the same stage treated in the same way. Recently the increasing knowledge in molecular characterization of head and neck cancer opens the way for a more tailored treatment. Patient outcomes could be improved by a personalized radiotherapy beyond technological and anatomical precision. Several tumor markers are under evaluation to understand their possible prognostic or predictive value. In this paper we discuss those markers specific for evaluate response to radiation therapy in head and neck cancer for a shift toward a biological personalization of radiotherapy.
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http://dx.doi.org/10.3389/fonc.2020.604965DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821385PMC
January 2021

Loco-regional adjuvant radiation therapy in breast cancer patients with positive axillary lymph-nodes at diagnosis (CN2) undergoing preoperative chemotherapy and with complete pathological lymph-nodes response. Development of GRADE (Grades of recommendation, assessment, Development and Evaluation) recommendation by the Italian Association of radiation therapy and Clinical Oncology (AIRO).

Breast 2021 Feb 2;55:119-127. Epub 2021 Jan 2.

Radiotherapy, Dipartimento di Biomedicina e Prevenzione, Università Degli Studi di Roma Tor Vergata, Rome, Italy.

Objective: To perform a meta-analysis to determine the effect of loco-regional radiation therapy (RT) compared to no loco-regional RT for operated patients in clinical stage cN2 breast cancer at diagnosis and ypN0 after preoperative chemotherapy (PST).

Material And Methods: Eligible studies were identified through a systematic search of the medical literature performed independently by two researchers using a validated search strategy. An electronic search of Medline via PubMed and Embase (Breast cancer AND preoperative chemotherapy AND radiation therapy) was conducted with no language or publication status restrictions. The effect of loco-regional RT on overall (OS), disease free (DFS), loco-regional recurrence-free (LRRFS) survival and local recurrence was evaluated. An electronic search of Medline via PubMed and Embase (Toxicity AND radiation therapy breast cancer AND preoperative therapy; toxicity AND breast surgery AND preoperative chemotherapy) was conducted for outcomes of harm: major acute and late skin toxicity, lymphedema and cardiac events.

Results: Of 333 studies identified, 4 retrospective studies reporting on a total of 1107 patients were included in the meta-analysis. Six and 3 reported data of acute and late skin toxicity, while 2 studies provided information on cardiac events. Pooled results showed no difference in terms of hazard ratio for loco-regional RT versus no loco-regional RT [hazard ratio (HR) = 0.82, 95% confidence interval (CI) 0.63-1.68]. Loco-regional RT was associated with an OS benefit in the subgroup analysis: IIIB-C (loco-regional RT 79.3% vs no loco-regional RT 71.2%, p = 0.027) and T3-T4 (loco-regional RT 82.6% vs no loco-regional RT 76.6%, p = 0.025). No difference was shown in terms of 5-year DFS (loco-regional RT 91.2% vs no loco-regional RT 83%, p = 0.441) and LRRFS (loco-regional RT 98.1% vs no loco-regional RT 92.3%, p = 0.148). There was no significant difference between the groups in terms of acute and late skin toxicities, lymphedema and cardiac events.

Conclusions: Because of the limitations due to the small number of studies and heterogeneity in the analysis, the present study does not allow to draw any definitive conclusion, highlighting the need for well-controlled trials to determine the effect of loco-regional RT in patients with cN2 having a pathological complete response in the axillary nodes after preoperative chemotherapy.
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http://dx.doi.org/10.1016/j.breast.2020.12.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7808946PMC
February 2021

Health-related quality of life 24-month after prostate cancer diagnosis: an update from the Pros-IT CNR prospective observational study.

Minerva Urol Nefrol 2021 Jan 13. Epub 2021 Jan 13.

Urology Unit, Azienda Socio-Sanitaria Territoriale Lariana, Sant'Anna Hospital, Como, Italy.

Background: This study analyzes patient health-related quality of life (QoL) 24-month after prostate cancer (PCa) diagnosis within the PROState cancer monitoring in ITaly from the National Research Council (Pros-IT CNR) study.

Methods: Pros-IT CNR is an ongoing, longitudinal and observational study, considering a convenience sample of patients enrolled at PCa diagnosis and followed at 6, 12, 24, 36, 48 and 60 months from the diagnosis. Patients were grouped according to the treatment received: nerve sparing radical prostatectomy (NSRP), non-nerve sparing radical prostatectomy (NNSRP), radiotherapy (RT), radiotherapy plus androgen deprivation (RT plus ADT) and active surveillance (AS). QoL was measured through the Italian versions of SF-12 and UCLA-PCI questionnaires at diagnosis and at 6-12 and 24-month. The minimal clinically important difference (MCID) was defined as half a standard deviation of the baseline domain.

Results: Overall, 1 537 patients were included in the study. The decline in urinary function exceeded the MCID at each timepoint only in the NSRP and NNSRP groups (at 24 months -14.7, p<0.001 and - 19.7, p<0.001, respectively). The decline in bowel function exceeded the MCID only in the RT (-9.1, p=0.02) and RT plus ADT groups at 12 months (-10.3, p=0.001); after 24 months, most patients seem to recover their bowel complaints. The decline in sexual function exceeded the MCID at each timepoint in the NNSRP, NSRP and RT plus ADT groups (at 6 months -28.7, p<0.001, -37.8, p<0.001, -20.4, p<0.001, respectively).

Conclusions: Although all the treatments were relatively well-tolerated over the 24 month period following PCa diagnosis, each had a different impact on QoL.
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http://dx.doi.org/10.23736/S0393-2249.20.04032-1DOI Listing
January 2021

How Can Imaging Help the Radiation Oncologist in Multiple Myeloma Treatment.

Medicina (Kaunas) 2020 Dec 28;57(1). Epub 2020 Dec 28.

Health Science Department (DISSAL), University of Genoa, 16132 Genoa, Italy.

Multiple myeloma is an incurable malignant tumor of plasma cells of the bone marrow; most patients present a disseminated disease with important bone involvement. Even though a chemotherapy-based approach is the major treatment, radiotherapy often has a supportive role for symptom relief but also a radical role for patients with indolent disease or localized forms. In both cases imaging is the basis for treatment planning and for correct patient classification. This paper aims to describe and summarize how radiation oncologists could use imaging information to personalize the treatment for each patient.
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http://dx.doi.org/10.3390/medicina57010020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7823586PMC
December 2020

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

The waiting time for prostate cancer treatment in Italy: analysis from the Pros-IT CNR study.

Minerva Urol Nefrol 2020 Nov 17. Epub 2020 Nov 17.

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

Background: Prostate cancer (PCa) is the second most common neoplasm in male patients. To date, there's no certain indication about the maximum waiting time (WT) acceptable for treatment beginning and the impact on oncological and functional outcomes has not been well established.

Methods: Data from the National Research Council PCa monitoring multicenter project in Italy (Pros-IT CNR) were prospectively collected and analyzed. WT was defined as the time from the bioptical diagnosis of PCa to the first treatment received. Patients were divided in two groups, using a time frame of 90 days. Quality of life was measured through the Italian version of the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) and of the Short-Form Health Survey (SF-12). The occurrence of upgrading, upstaging, presence of lymph node metastasis and positive surgical margins at the final histopathological diagnosis, and PSA at 12 months follow-up were evaluated.

Results: The overall median WT was 93 days. The logistic multivariable model confirmed that age, being resident in Southern regions of Italy and T staging at diagnosis were significantly associated with a WT >90 days. At 6 months from diagnosis the mean SF-12 score for the emotionalpsychological component was significantly lower in WT ≥ 90 days group (p=0.0428). Among patients treated with surgical approach, no significant differences in oncological outcomes were found in the two groups.

Conclusions: In our study age, clinical T stage and provenance from Southern regions of Italy are associated with a WT > 90 days. WT might have no impact on functional and oncological outcome.
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http://dx.doi.org/10.23736/S0393-2249.20.03925-9DOI Listing
November 2020

To a new normal in radiation oncology: looking back and planning forward.

Tumori 2020 Dec 12;106(6):440-444. Epub 2020 Oct 12.

National Center of Oncological Hadrontherapy (Fondazione CNAO), Pavia, Italy.

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http://dx.doi.org/10.1177/0300891620962197DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727020PMC
December 2020

Italian consensus conference on management of uterine sarcomas on behalf of S.I.G.O. (Societa' italiana di Ginecologia E Ostetricia).

Eur J Cancer 2020 11 29;139:149-168. Epub 2020 Sep 29.

Fondazione Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology Unit, Roma, Italy; Universita' Cattolica Del Sacro Cuore, Roma, Italy.

Background: Uterine sarcomas are very rare tumours with different histotypes, molecular features and clinical outcomes; therefore, it is difficult to carry out prospective clinical trials, and this often results in heterogeneous management of patients in the clinical practice.

Aim: We planned to set up an Italian consensus conference on these diseases in order to provide recommendations on treatments and quality of care in our country.

Results: Early-stage uterine sarcomas are managed by hysterectomy + bilateral salpingo-oophorectomy according to menopausal status and histology; lymphadenectomy is not indicated in patients without bulky nodes, and morcellation must be avoided. The postoperative management is represented by observation, even though chemotherapy can be considered in some high-risk patients. In early-stage low-grade endometrial stromal sarcoma and adenosarcomas without sarcomatous overgrowth, hormonal adjuvant treatment can be offered based on hormone receptor expression. In selected cases, external beam radiotherapy ± brachytherapy can be considered to increase local control only. Patients with advanced disease involving the abdomen can be offered primary chemotherapy (or hormonal therapy in the case of low-grade endometrial stromal sarcoma and adenosarcoma without sarcomatous overgrowth), even if potentially resectable in the absence of residual disease in order to test the chemosensitivity (or hormonosensitivity); debulking surgery can be considered in patients with clinical and radiological response. Chemotherapy is based on anthracyclines ± ifosfamide or dacarbazine. Palliative radiotherapy can be offered for symptom control, and stereotactic radiotherapy can be used for up to five isolated metastatic lesions.

Conclusions: Treatment of uterine sarcoma should be centralised at referral centres and managed in a multidisciplinary setting.
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http://dx.doi.org/10.1016/j.ejca.2020.08.016DOI Listing
November 2020

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

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

Practice recommendations for risk-adapted head and neck cancer radiotherapy during the COVID-19 pandemic: An ASTRO-ESTRO consensus statement.

Radiother Oncol 2020 10 27;151:314-321. Epub 2020 Jul 27.

Department of Radiation Oncology, University of California San Francisco, San Francisco, California. Electronic address:

Purpose: Because of the unprecedented disruption of health care services caused by the COVID-19 pandemic, the American Society of Radiation Oncology (ASTRO) and the European Society for Radiotherapy and Oncology (ESTRO) identified an urgent need to issue practice recommendations for radiation oncologists treating head and neck cancer (HNC) in a time of limited resources and heightened risk for patients and staff.

Methods And Materials: A panel of international experts from ASTRO, ESTRO, and select Asia-Pacific countries completed a modified rapid Delphi process. Topics and questions were presented to the group, and subsequent questions were developed from iterative feedback. Each survey was open online for 24 hours, and successive rounds started within 24 hours of the previous round. The chosen cutoffs for strong agreement (≥80%) and agreement (≥66%) were extrapolated from the RAND methodology. Two pandemic scenarios, early (risk mitigation) and late (severely reduced radiation therapy resources), were evaluated. The panel developed treatment recommendations for 5 HNC cases.

Results: In total, 29 of 31 of those invited (94%) accepted, and after a replacement 30 of 30 completed all 3 surveys (100% response rate). There was agreement or strong agreement across a number of practice areas, including treatment prioritization, whether to delay initiation or interrupt radiation therapy for intercurrent SARS-CoV-2 infection, approaches to treatment (radiation dose-fractionation schedules and use of chemotherapy in each pandemic scenario), management of surgical cases in event of operating room closures, and recommended adjustments to outpatient clinic appointments and supportive care.

Conclusions: This urgent practice recommendation was issued in the knowledge of the very difficult circumstances in which our patients find themselves at present, navigating strained health care systems functioning with limited resources and at heightened risk to their health during the COVID-19 pandemic. The aim of this consensus statement is to ensure high-quality HNC treatments continue, to save lives and for symptomatic benefit.
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http://dx.doi.org/10.1016/j.radonc.2020.04.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7384409PMC
October 2020

Phase III Randomized Study of Induction Chemotherapy Followed by Definitive Radiotherapy + Cetuximab Versus Chemoradiotherapy in Squamous Cell Carcinoma of Head and Neck: The INTERCEPTOR-GONO Study (NCT00999700).

Oncology 2020 6;98(11):763-770. Epub 2020 Jul 6.

Statistic Unit, Genova University, Genova, Italy.

Objectives: Induction chemotherapy followed by cetuximab and RT (IBRT) (Arm A) was compared to cisplatin/RT (CRT) (Arm B) in a randomized phase III study.

Patients And Methods: Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible. Arm A (IBRT): 3 TPF induction followed by cetuximab-RT (equivalent daily dose 2 Gy up to 70 Gy); Arm B: 3 cisplatin concurrent with the same RT scheduling. Due to slow accrual and incomplete data collection a futility analysis was performed.

Results: 236/282 patients were evaluable. Therefore, no formal analyses can be made between the two arms. OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms. Neutropenia and skin toxicity were significantly worse in Arm A and body weight loss was significantly worse in Arm B. Compliance with the planned drug administration was higher in Arm B (p = 0.0008).

Conclusion: The study suggests that IBRT and CRT have similar efficacy, activity and toxicity.
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http://dx.doi.org/10.1159/000507733DOI Listing
November 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

Practice Recommendations for Risk-Adapted Head and Neck Cancer Radiation Therapy During the COVID-19 Pandemic: An ASTRO-ESTRO Consensus Statement.

Int J Radiat Oncol Biol Phys 2020 07 14;107(4):618-627. Epub 2020 Apr 14.

Department of Radiation Oncology, University of California San Francisco, San Francisco, California. Electronic address:

Purpose: Because of the unprecedented disruption of health care services caused by the COVID-19 pandemic, the American Society of Radiation Oncology (ASTRO) and the European Society for Radiotherapy and Oncology (ESTRO) identified an urgent need to issue practice recommendations for radiation oncologists treating head and neck cancer (HNC) in a time of limited resources and heightened risk for patients and staff.

Methods And Materials: A panel of international experts from ASTRO, ESTRO, and select Asia-Pacific countries completed a modified rapid Delphi process. Topics and questions were presented to the group, and subsequent questions were developed from iterative feedback. Each survey was open online for 24 hours, and successive rounds started within 24 hours of the previous round. The chosen cutoffs for strong agreement (≥80%) and agreement (≥66%) were extrapolated from the RAND methodology. Two pandemic scenarios, early (risk mitigation) and late (severely reduced radiation therapy resources), were evaluated. The panel developed treatment recommendations for 5 HNC cases.

Results: In total, 29 of 31 of those invited (94%) accepted, and after a replacement 30 of 30 completed all 3 surveys (100% response rate). There was agreement or strong agreement across a number of practice areas, including treatment prioritization, whether to delay initiation or interrupt radiation therapy for intercurrent SARS-CoV-2 infection, approaches to treatment (radiation dose-fractionation schedules and use of chemotherapy in each pandemic scenario), management of surgical cases in event of operating room closures, and recommended adjustments to outpatient clinic appointments and supportive care.

Conclusions: This urgent practice recommendation was issued in the knowledge of the very difficult circumstances in which our patients find themselves at present, navigating strained health care systems functioning with limited resources and at heightened risk to their health during the COVID-19 pandemic. The aim of this consensus statement is to ensure high-quality HNC treatments continue, to save lives and for symptomatic benefit.
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http://dx.doi.org/10.1016/j.ijrobp.2020.04.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7194855PMC
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

Overview of potential determinants of radical prostatectomy versus radiation therapy in management of clinically localized prostate cancer: results from an Italian, prospective, observational study (the Pros-IT CNR study).

Minerva Urol Nefrol 2020 Oct 7;72(5):595-604. Epub 2020 Jan 7.

Aging Branch, Neuroscience Institute, Section of Padua, National Research Council of Italy, Padua, Italy.

Background: We assessed patients and tumor characteristics, as well as health-related quality of life (HRQoL) items, associated with curative intent treatment decision-making in clinically localized prostate cancer (PCa) patients.

Methods: Clinically localized PCa treated with either radical prostatectomy (RP) or radiation therapy (RT) within 12 months from diagnosis were abstracted from The PROState cancer monitoring in ITaly, from the National Research Council (Pros-IT CNR) database. Multivariable logistic regression (MLR) models predicting RT vs. RP were fitted, after adjustment for HRQoL items, patients and tumor characteristics.

Results: Of 1041 patients, 631 (60.2%) were treated with RP and 410 (39.8%) with RT. Relative to RT, RP patients were younger age (mean age 64.5±6.6 vs. 71.4±4.9, P<0.001) and had higher rates of D'Amico low-intermediate risk groups (31.8 vs. 21.9% low, 46.3% vs. 43.5% intermediate and 21.9% vs. 34.6% high risk, P<0.001). Overall, 93.2% of RP patients were enrolled by urologists and 82.7% of RT patients by radiation oncologists. RP patients had generally higher means values of HRQoL items. In MLR models, higher RT rates were independently associated with more advanced age (odds ratio [OR] 6.14, P<0.001) and BMI≥30 kg/m2 (OR 1.78, P<0.001). Conversely, lower rates of RT were independently associated with married (OR 0.55, P=0.01) and worker status (OR 0.52, P=0.004), enrollment in academic centers (OR 0.59, P=0.005) and higher physical composite score (OR 0.88, P=0.03) and baseline sexual function items (OR 0.92, P<0.001).

Conclusions: Most patients with clinically localized prostate cancer undergoing definitive treatment at Italian institutions receive RP instead of RT. Moreover, those who are younger, married, working, as well as those with better physical and sexual function are more likely to undergo surgery.
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http://dx.doi.org/10.23736/S0393-2249.19.03637-3DOI Listing
October 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