Publications by authors named "Pierluigi Bonomo"

102 Publications

Survival and toxicity of weekly cisplatin chemoradiotherapy versus three-weekly cisplatin chemoradiotherapy for head and neck cancer: a systematic review and meta-analysis endorsed by the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Crit Rev Oncol Hematol 2021 Apr 29:103345. Epub 2021 Apr 29.

Department of Radiation Oncology, Policlinico S. Gerardo and University of Milan "Bicocca", Milano, Italy.

Purpose: To evaluate efficacy and toxicity of weekly cisplatin chemoradiotherapy versus three-weekly cisplatin chemoradiotherapy and identify differences in clinical outcomes and severe toxicity rate.

Methods: PICOS/PRISMA methods were used to identify studies on PubMed, EMBASE and Cochrane Library, 2005-2019.

Results: Six randomized clinical trials (554 patients) were identified. Weekly cisplatin was not associated with significant overall survival (HR 1.13, 95% CI 0.84-1.51) and progression-free survival (HR 1.23, 95%CI 0.91-1.65) improvement compared with three-weekly regimen. Severe acute toxicity (RR 0.95), treatment compliance to chemotherapy (RR 1.67) and radiotherapy (RR 0.61) were similar between regimens.

Conclusion: Weekly cisplatin is not associated with better clinical outcomes compared to three-weekly cisplatin. Three-weekly cisplatin chemoradiotherapy should be considered the standard approach in the management of locally advanced head and neck cancer. Methodologically robust RCTs designs are needed to improve the quality of evidence. Differences on long-term toxicity and cost-effectiveness remain to be tested.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103345DOI Listing
April 2021

Impact of COVID-19 on workload burden of a complex radiotherapy facility.

Radiol Med 2021 May 1;126(5):717-721. Epub 2021 Mar 1.

Department of Biomedical, Experimental and Clinical Sciences "Mario Serio", University of Florence, Florence, Italy.

Background And Purpose: COVID-19 constitutes a worldwide threat, prompting Italian Government to implement specific measures on March 8, 2020, to protect patients and health workers from disease transmission. The impact of preventive measures on daily activity of a radiotherapy facility may hamper the ability to fulfill normal workload burden. Thus, we assessed the number of delivered treatments in a specific observation period after the adoption of preventive measures (since March 11 to April 24, 2020) and compared it with the corresponding period of the year 2019.

Materials And Methods: Overall number of delivered fractions was related to actual time of platform daily activity and reported as a ratio between number of delivered fractions and activity hours (Fr/Hrs). Fr/Hrs were calculated and compared for two different periods of time, March 11-April 24, 2019 (Fr/Hrs1), and March 11-April 24, 2020 (Fr/Hrs2).

Results: Fr/Hrs1 and Fr/Hrs2 were 2.66 and 2.54 for year 2019 and 2020, respectively, for a Fr/Hrs of 1.07 (95% CI 1.03-1.12, p = 0.0005). Fr/Hrs1 was significantly higher than Fr/Hrs2 for Sli and Precise, with Fr/Hrs of 1.92 (95% CI 1.66-2.23, p < 0.0001) and 1.11 (95% CI 1.03-1.2, p = 0.003), respectively. No significant difference was reported for Synergy and Cyberknife with Fr/Hrs of 0.99 (95% CI 0.91-1.08, p = 0.8) and 0.9 (95% CI 0.77-1.06, p = 0.2), respectively. Fr/Hrs1 was significantly lower than Fr/Hrs2 for Tomotherapy, with Fr/Hrs of 0.88 (95% CI 0.8-0.96, p = 0.007).

Conclusion: Preventive measures did not influence workload burden performed. Automation in treatment delivery seems to compensate effectively for health workers number reduction.
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http://dx.doi.org/10.1007/s11547-021-01338-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917169PMC
May 2021

Texture analysis in the characterization of parotid salivary gland lesions: A study on MR diffusion weighted imaging.

Eur J Radiol 2021 Mar 7;136:109529. Epub 2021 Jan 7.

Department of Experimental and Clinical Biomedical Sciences, Radiodiagnostic Unit n. 2, University of Florence - Azienda Ospedaliero-Universitaria Careggi, Largo Brambilla 3, 50134, Florence, Italy. Electronic address:

Background And Purpose: Parotid lesions show overlaps of morphological findings, apparent diffusion coefficient (ADC) values and types of time/intensity curve. This research aimed to evaluate the role of diffusion weighted imaging texture analysis in differentiating between benign and malignant parotid lesions and in characterizing pleomorphic adenoma (PA), Warthin tumor (WT), epithelial malignancy (EM), and lymphoma (LY).

Methods: Texture analysis of 54 parotid lesions (19 PA, 14 WT, 14 EM, and 7 LY) was performed on ADC map images. An ANOVA test was used to estimate both the difference between benign and malignant lesions and the texture feature differences among PA, WT, EM, and LY. A P-value≤0.01 was considered to be statistically significant. A cut-off value defined by ROC curve analysis was found for each statistically significant texture parameter. The diagnostic accuracy was obtained for each texture parameter with AUC ≥ 0.5. The agreement between each texture parameter and histology was calculated using the Cohen's kappa coefficient.

Results: The mean kappa values were 0.61, 0.34, 0.26, 0.17, and 0.48 for LY, EM, WT, PA, and benign vs. malignant lesions respectively. Long zone emphasis cut-off values >1.870 indicated EM with an accuracy of 81 % and values >2.630 revealed LY with an accuracy of 93 %. Long run emphasis values >1.050 and >1.070 indicated EM and LY with a diagnostic accuracy of 79% and 93% respectively.

Conclusions: Long zone emphasis and long run emphasis texture parameters allowed the identification of LY and the differentiation between benign and malignant lesions. WT and PA were not accurately recognized.
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http://dx.doi.org/10.1016/j.ejrad.2021.109529DOI Listing
March 2021

The impact of the COVID-19 outbreak on supportive care for oral mucositis: current concepts and practice.

Support Care Cancer 2021 May 4;29(5):2255-2258. Epub 2021 Jan 4.

Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, ASST Spedali Civili, University of Brescia, Brescia, Italy.

The outbreak of coronavirus disease 2019 (COVID-19) markedly affected the way healthcare professionals approach patients with cancer worldwide, not only in terms of therapeutic decision-making but also in terms of supportive care. With the rapid appearance of signs and symptoms and the need of close re-assessment, standard management of oral mucositis has been challenged by physical distancing and limited resources due to the global crisis. Building on the clinical experience developed during the acute phase by members of the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO), the implications of COVID-19 on the prevention, assessment, and treatment of mucositis are critically reported. Inspired by the restructuring of supportive care measures in response to the pandemic, suggestions for new models of approaching acute side effects are also discussed.
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http://dx.doi.org/10.1007/s00520-020-05966-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779243PMC
May 2021

1.5 T MR-linac planning study to compare two different strategies of rectal boost irradiation.

Clin Transl Radiat Oncol 2021 Jan 3;26:86-91. Epub 2020 Dec 3.

Department of Radiation Oncology, University Hospital and Medical Faculty, Eberhard Karls University, Tübingen, Germany.

Purpose: To compare treatment plans of two different rectal boost strategies: up-front versus adaptive boost at the 1.5 T MR-Linac.

Methods: Patients with locally advanced rectal cancer (LARC) underwent standard neoadjuvant radiochemotherapy with 50.4 Gy in 28 fractions. T2-weighted MRI prior and after the treatment session were acquired to contour gross tumor volumes (GTVs) and organs at risk (OARs). The datasets were used to simulate four different boost strategies (all with 15 Gy/5 fractions in addition to 50.4 Gy): up-front boost (5 daily fractions in the first week of treatment) and an adaptive boost (one boost fraction per week). Both strategies were planned using standard and reduced PTV margins. Intra-fraction motion was assessed by pre- and post-treatment MRI-based contours.

Results: Five patients were included and a total of 44 MRI sets were evaluated. The median PTV volumes of the adaptive boost were significantly smaller than for the up-front boost (81.4 cm vs 44.4 cm for PTV with standard margins; 31.2 cm vs 15 cm for PTV with reduced margins; p = 0.031). With reduced margins the rectum was significantly better spared with an adaptive boost rather than with an up-front boost: V60Gy and V65Gy were 41.2% and 24.8% compared with 59% and 29.9%, respectively (p = 0.031). Median GTV intra-fractional motion was 2 mm (range 0-8 mm).

Conclusions: The data suggest that the adaptive boost strategy exploiting tumor-shrinkage and reduced margin might result in better sparing of rectum and anal canal. Individual margin assessment, motion management and real-time adaptive radiotherapy appear attractive applications of the 1.5 T MR-Linac for further testing of individualized and safe dose escalation in patients with rectal cancer.
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http://dx.doi.org/10.1016/j.ctro.2020.11.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732969PMC
January 2021

Metastatic salivary gland carcinoma: A role for stereotactic body radiation therapy? A study of AIRO-Head and Neck working group.

Oral Dis 2020 Dec 15. Epub 2020 Dec 15.

Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.

Objectives: The role of radiotherapy (RT) for oligometastases is currently established in different oncological settings but data on salivary gland cancer (SGC) are lacking. We evaluated the role of RT in oligometastatic SGC patients, focusing on stereotactic body radiation therapy (SBRT).

Materials And Methods: We performed a retrospective, multicentric study of oligometastatic SGC treated with palliative RT or SBRT. Endpoints included response evaluation and local control (LC).

Results: Between 2006 and 2016, 64 patients were collected from 9 Italian Cancer Centers, on behalf of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) Head and Neck Working Group. 37 patients (57.8%) were suffering from adenoid cystic carcinoma (ACC) and 27 patients (42.2%) had non-ACC. Thirty-four patients underwent palliative RT (53,1%), and 30 received SBRT (46,9%). Most common metastatic sites were bone for palliative RT and lung for SBRT. Among patients treated with SBRT, an objective response or a stability was observed in all treated lesions. After a median follow-up of 29.2 months (range 2.3-117.1), LC at 12 months was 57.5% for patients treated with SBRT and was higher in ACC subgroup.

Conclusion: We confirmed the potential role of SBRT in the management of oligometastatic SGC patients to control limited burden of disease considering the absence of effective systemic therapies.
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http://dx.doi.org/10.1111/odi.13755DOI Listing
December 2020

Local treatment for relapsing glioblastoma: A decision-making tree for choosing between reirradiation and second surgery.

Crit Rev Oncol Hematol 2021 Jan 28;157:103184. Epub 2020 Nov 28.

Azienda Ospedaliera Universitaria Careggi, Radiotherapy Unit, Oncology Department, University of Florence, Florence, Italy.

In case of circumscribed recurrent glioblastoma (rec-GBM), a second surgery (Re-S) and reirradiation (Re-RT) are local strategies to consider. The aim is to provide an algorithm to use in the daily clinical practice. The first step is to consider the life expectancy in order to establish whether the patient should be a candidate for active treatment. In case of a relatively good life expectancy (>3 months) and a confirmed circumscribed disease(i.e. without multiple lesions that are in different lobes/hemispheres), the next step is the assessment of the prognostic factors for local treatments. Based on the existing prognostic score systems, patients who should be excluded from local treatments may be identified; based on the validated prognostic factors, one or the other local treatment may be preferred. The last point is the estimation of expected toxicity, considering patient-related, tumor-related and treatment-related factors impacting on side effects. Lastly, patients with very good prognostic factors may be considered for receiving a combined treatment.
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http://dx.doi.org/10.1016/j.critrevonc.2020.103184DOI Listing
January 2021

Assessing Preferences in Patients with Head and Neck Squamous Cell Carcinoma: Phase I and II of Questionnaire Development.

Cancers (Basel) 2020 Nov 30;12(12). Epub 2020 Nov 30.

Medical Oncology Unit, ASST Spedali Civili di Brescia and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, 25123 Brescia, Italy.

Shared-decision making for head and neck squamous cell carcinoma (HNSCC) is challenged by the difficulty to integrate the patient perception of value within the framework of a multidisciplinary team approach. The aim of this study was to develop a questionnaire to assess the preferences of HNSCC patients with respect to the disease trajectory, expected treatment, and toxicities. In accordance with the standardized EORTC Quality of Life Group's methodology for the development of quality of life modules, a phase 1-2 study was envisaged. Following a systematic review of the literature, a consolidated list of 28 issues was administered through a semi-structured interview to 111 patients from 7 institutions in 5 countries. Overall, "cure of disease", "survival", and "trusting in health care professionals" were the 3 most common priorities, being chosen by 87.3%, 73.6% and 59.1% of patients, respectively. When assessing the correlation with the treatment subgroup, the issue of "being thoroughly and sincerely informed about treatments' efficacy and survival expectation" was highly prevalent in an independent manner (71.4%, 75% and 90% of patients in the follow-up, palliative and curative subgroups, respectively). Based on prespecified scoring criteria, a 24-item list was generated. Pending clinical applicability, further testing and validation of the questionnaire are warranted.
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http://dx.doi.org/10.3390/cancers12123577DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760305PMC
November 2020

Application of Radiomics for the Prediction of Radiation-Induced Toxicity in the IMRT Era: Current State-of-the-Art.

Front Oncol 2020 6;10:1708. Epub 2020 Oct 6.

Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.

Normal tissue complication probability (NTCP) models that were formulated in the Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC) are one of the pillars in support of everyday's clinical radiation oncology. Because of steady therapeutic refinements and the availability of cutting-edge technical solutions, the ceiling of organs-at-risk-sparing has been reached for photon-based intensity modulated radiotherapy (IMRT). The possibility to capture heterogeneity of patients and tissues in the prediction of toxicity is still an unmet need in modern radiation therapy. Potentially, a major step towards a wider therapeutic index could be obtained from refined assessment of radiation-induced morbidity at an individual level. The rising integration of quantitative imaging and machine learning applications into radiation oncology workflow offers an unprecedented opportunity to further explore the biologic interplay underlying the normal tissue response to radiation. Based on these premises, in this review we focused on the current-state-of-the-art on the use of radiomics for the prediction of toxicity in the field of head and neck, lung, breast and prostate radiotherapy.
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http://dx.doi.org/10.3389/fonc.2020.01708DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7574641PMC
October 2020

A snapshot on radiotherapy for head and neck cancer patients during the COVID-19 pandemic: a survey of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) head and neck working group.

Radiol Med 2021 Feb 6;126(2):343-347. Epub 2020 Oct 6.

National Center of Oncological Hadrontherapy (Fondazione CNAO), Strada Campeggi, 53, 27100, Pavia, Italy.

Objectives: The objective of the paper was to assess real-life experience in the management of head and neck cancer (HNC) patients during the COVID-19 pandemic in radiotherapy departments and to evaluate the variability in terms of adherence to American Society of Radiation Oncology (ASTRO) and European Society for Radiotherapy and Oncology (ESTRO) recommendations.

Materials And Methods: In May 2020, an anonymous 30-question online survey, comparing acute phase of outbreak and pre-COVID-19 period, was conducted. Two sections exploited changes in general management of HNC patients and different HNC primary tumors, addressing specific statements from ASTRO ESTRO consensus statement as well.

Results: Eighty-eight questionnaires were included in the demographic/clinical workflow analysis, and 64 were analyzed for treatment management. Forty-eight percent of radiotherapy departments became part of oncologic hubs. First consultations reduced, and patients were addressed to other centers in 33.8 and 18.3% of cases, respectively. Telematic consultations were used in 50% of follow-up visits and 73.9% of multidisciplinary tumor board discussions. There were no practical changes in the management of patients affected by different primitive HNCs. Hypofractionation was not favored over conventional schedules.

Conclusions: Compared to pre-COVID era, the clinical workflow was highly re-organized, whereas there were no consistent changes in RT indications and schedules.
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http://dx.doi.org/10.1007/s11547-020-01296-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538045PMC
February 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

Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial.

J Clin Oncol 2020 12 24;38(35):4175-4183. Epub 2020 Aug 24.

University of Florence, Florence, Italy.

Purpose: To report the long-term results of external-beam accelerated partial-breast irradiation (APBI) intensity-modulated radiation therapy (IMRT) Florence phase III trial comparing whole-breast irradiation (WBI) to APBI in early-stage breast cancer.

Patients And Methods: The primary end point was to determine the 5-year difference in ipsilateral breast tumor recurrence (IBTR) between 30 Gy in 5 once-daily fractions (APBI arm) and 50 Gy in 25 fractions with a tumor bed boost (WBI arm) after breast-conserving surgery.

Results: Five hundred twenty patients, more than 90% of whom had characteristics associated with low recurrence risk, were randomly assigned (WBI, n = 260; APBI, n = 260) between 2005 and 2013. Median follow-up was 10.7 years. The 10-year cumulative incidence of IBTR was 2.5% (n = 6) in the WBI and 3.7% (n = 9) in the APBI arm (hazard ratio [HR], 1.56; 95% CI, 0.55 to 4.37; = .40). Overall survival at 10 years was 91.9% in both arms (HR, 0.95; 95% CI, 0.50 to 1.79; = .86). Breast cancer-specific survival at 10 years was 96.7% in the WBI and 97.8% in the APBI arm (HR, 0.65; 95% CI, 0.21 to 1.99; = .45). The APBI arm showed significantly less acute toxicity ( = .0001) and late toxicity ( = .0001) and improved cosmetic outcome as evaluated by both physician ( = .0001) and patient ( = .0001).

Conclusion: The 10-year cumulative IBTR incidence in early breast cancer treated with external APBI using IMRT technique in 5 once-daily fractions is low and not different from that after WBI. Acute and late treatment-related toxicity and cosmesis outcomes were significantly in favor of APBI.
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http://dx.doi.org/10.1200/JCO.20.00650DOI Listing
December 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

Moderately accelerated intensity-modulated radiation therapy using simultaneous integrated boost: Practical reasons or evidence-based choice? A critical appraisal of literature.

Head Neck 2020 11 6;42(11):3405-3414. Epub 2020 Aug 6.

Radiotherapy 2 Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Concurrent chemo-radiotherapy is the non-surgical mainstay of treatment for locally advanced head and neck squamous cell carcinoma (HNSCC). The following aspects have emerged as fundamental components of the combined approach: first, intensity modulated radiotherapy (IMRT) is the minimum standard technical requirement, with level 1 evidence in support of its reduction of late treatment-induced morbidity in comparison with 3D conformal radiotherapy. Second, cisplatin-based chemotherapy is the preferred systemic agent to be associated with radiation, with 100 mg/m every 3 weeks deemed as the reference schedule. Because of significant progress in irradiation techniques achieved in last 15 years, the optimal fractionation schedule in modern radiation era remains controversial, especially for locally advanced disease. The purpose of this work was to perform a critical review on the value of moderately accelerated IMRT using simultaneous-integrated boost (SIB) in HNSCC, aiming to provide insights on current clinical practice and directions for future research.
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http://dx.doi.org/10.1002/hed.26400DOI Listing
November 2020

Stereotactic reirradiation for local failure of brain metastases following previous radiosurgery: Systematic review and meta-analysis.

Crit Rev Oncol Hematol 2020 Sep 2;153:103043. Epub 2020 Jul 2.

Radiotherapy Department, University of Florence, Florence, Italy.

Introduction: Local failure (LF) following stereotactic radiosurgery (SRS) of brain metastases (BM) may be treated with a second course of SRS (SRS2), though this procedure may increase the risk of symptomatic radionecrosis (RN).

Methods: A literature search was conducted according to PRISMA to identify studies reporting LF, overall survival (OS) and RN rates following SRS2. Meta-analysis was performed to identify predictors of RN.

Results: Analysis included 11 studies (335 patients,389 metastases). Pooled 1-year LF was 24 %(CI95 % 19-30 %): heterogeneity was acceptable (I2 = 21.4 %). Median pooled OS was 14 months (Confidence Interval 95 %, CI95 % 8.8-22.0 months). Cumulative crude RN rate was 13 % (95 %CI 8 %-19 %), with acceptable heterogeneity (I2 = 40.3 %). Subgroup analysis showed higher RN incidence in studies with median patient age ≥59 years (13 % [95 %CI 8 %-19 %] vs 7 %[95 %CI 3 %-12 %], p = 0.004) and lower incidence following prior Whole Brain Radiotherapy (WBRT, 19 %[95 %CI 13 %-25 %] vs 7%[95 %CI 3 %-13 %], p = 0.004).

Conclusions: SRS2 is an effective strategy for in-site recurrence of BM previously treated with SRS.
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http://dx.doi.org/10.1016/j.critrevonc.2020.103043DOI Listing
September 2020

Letter to "Medial lingual lymph node metastasis in carcinoma of the tongue".

Auris Nasus Larynx 2020 12 21;47(6):1091-1092. Epub 2020 Jun 21.

Unit of Radiation Oncology, University of Brescia, ASST Spedali Civili of Brescia, Brescia, Italy.

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http://dx.doi.org/10.1016/j.anl.2020.05.023DOI Listing
December 2020

T1 Glottic Cancer: Does Anterior Commissure Involvement Worsen Prognosis?

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

Department of Otorhinolaryngology, Maxillofacial and Thyroid Surgery, Fondazione IRCCS, National Cancer Institute of Milan, University of Milan, 20122 Milan, Italy.

Radiotherapy (RT) and transoral laser microsurgery (TLM) represent the main treatment modalities for early glottic carcinoma. Local failure is notoriously more frequent in T1b glottic cancer in comparison to T1a and T2 tumors. In this scenario, the role of anterior commissure (AC) involvement is still controversial. The aim of the present study was therefore to determine its potential prognostic power in worsening patients' survival and outcomes. We categorized different tumor glottic fold locations with respect to the involvement of one (T1a) or both vocal cords, with or without AC involvement. We analyzed a retrospective cohort of 74 patients affected by Stage I glottic cancer, treated between 2011 and 2018 by TLM or RT at a single academic institution. There were 22 T1a (30%) and 52 T1b (70%) cases. The median follow-up period was 30 months (mean, 32.09 ± 18.738 months; range, 12-79). Three-year overall survival (OS), disease-specific survival (DSS), recurrence-free survival (RFS), and laryngectomy-free survival (LFS) were compared according to tumor location, extension, and cT category. According to both uni- and multivariate analyses, an increased risk for recurrence in T1b with AC involvement and T1a tumors was 7.31 and 9.45 times, respectively (-values of 0.054 and 0.030, respectively). Among the 17 recurrences, T1b with AC involvement experienced 15 tumor relapses (88.2%), thus significantly affecting both the RFS and LFS in comparison to the other two tumor subcategories (T1a, = 0.028 and T1b without AC involvement, = 0.043). The deteriorating prognosis in the presence of AC involvement likely reflects the need to power the hazard consistency and discrimination of the T1b category when associated with such a risk factor, thus deserving an independent T category.
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http://dx.doi.org/10.3390/cancers12061485DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352716PMC
June 2020

Dose prescription in SBRT for early-stage non-small cell lung cancer: are we all speaking the same language?

Tumori 2020 Jun 9:300891620929425. Epub 2020 Jun 9.

Radiation Oncology, Santa Croce e Carle Hospital, Cuneo, Italy.

Introduction: Stereotactic body radiation therapy is increasingly used in the treatment of early-stage lung cancers. Guidelines provide indications regarding the constraints to the organs at risk (OARs) and the minimum coverage of the planning target volume but do not suggest optimal dose distribution. Data on dose distribution from the different published series are not comparable due to different prescription modalities and reported dose parameters.

Methods: We conducted a review of the published data on dose prescription, focusing on the role of homogeneity on local tumor control, and present suggestions on how to specify and report the prescriptions to permit comparisons between studies or between cases from different centers.

Conclusions: To identify the dose-prescription modality that better correlates with oncologic outcomes, future studies should guarantee a close uniformity of dose distribution between cases and complete dose parameters reporting for treatment volumes and OARs.
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http://dx.doi.org/10.1177/0300891620929425DOI Listing
June 2020

Biomarkers in wound drainage fluids of head and neck squamous cell carcinoma patients receiving neck dissection: A pilot study.

Clin Transl Radiat Oncol 2020 Jul 23;23:60-64. Epub 2020 Apr 23.

Unit of Otorhinolaryngology - Head and Neck Surgery, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.

Aim: In a pilot prospective study, we aimed to test the feasibility and report on the preliminary results on the expression of molecular biomarkers in wound drainage fluids (WDFs) of operated head and neck squamous cell carcinoma (HNSCC) patients.

Material And Methods: Nineteen patients undergoing primary tumor resection with en-block neck dissection were enrolled. In postoperative days 1-3, the expression of several biomarkers in WDFs was measured using enzyme-linked immunosorbent assay (ELISA) kits and correlated with clinical and histopathologic features.

Results: The expression of stromal cell-derived factor 1 (CXCL-12) was significantly increased in WDFs in presence of lymph node metastases, extranodal extension (ENE), and in case of close resection margins. In addition, Osteopontin expression was significantly increased in presence of ENE, whereas transforming growth factor beta (TGF-β) detection was significantly reduced. At multivariate analysis, CXCL-2 levels in both day 1 and 3 post-surgery were the only factor which retained significance in the prediction of close surgical margins (p = 0.028 and 0.025 for day 1 and day 3, respectively). Both CXCL-2 and Ostepontin assays were significantly correlated with ENE (p = 0.018 and 0.035 for day 1; 0.052 and 0.025 for day 3, respectively) whereas TGF- β expression was significant at day 1 only (p = 0.038).

Conclusions: Our pilot study showed that WDFs could qualify as a potential source of relevant postoperative information. Further studies are needed to confirm the prognostic impact of CXCL-12, Osteopontin and TGF-β expressed in WDFs on the personalized management of HNSCC.
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http://dx.doi.org/10.1016/j.ctro.2020.04.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7231969PMC
July 2020

Re-irradiation for oligoprogression under Nivolumab in recurrent head and neck squamous cell carcinoma: A case report.

Clin Transl Radiat Oncol 2020 Jul 17;23:16-19. Epub 2020 Apr 17.

Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.

Immune checkpoint inhibitors (ICIs) represent a recently introduced class of agents active in head and neck squamous cell carcinoma (HNSCC). For a subgroup of patients with recurrent or metastatic disease, long-term benefit can be achieved: maintaining a sustained response to immunotherapy is therefore a critical factor for its efficacy at an individual level. In analogy to targeted agents, a limited pattern of progression, or "oligoprogression", can occur. For locally recurrent HNSCC, the potential biologic interplay between the efficacy of ICIs and the design of radiation fields chosen for primary treatment is currently unknown. Here, we report on a patient who presented two subsequent oligoprogressions successfully treated with re-irradiation without interrupting Nivolumab. Both oligoprogressive lesions developed in previously unirradiated areas. We hypothesize the existence of a synergistic effect with optimal spatial cooperation between ICIs and re-irradiation for oligoprogressive disease under immunotherapy.
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http://dx.doi.org/10.1016/j.ctro.2020.04.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186263PMC
July 2020

Dosimetric Predictors of Acute and Chronic Alopecia in Primary Brain Cancer Patients Treated With Volumetric Modulated Arc Therapy.

Front Oncol 2020 8;10:467. Epub 2020 Apr 8.

Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Florence, Italy.

To determine dose constraints that correlate with alopecia in patients treated with photon-based Volumetric Modulated Arc Therapy (VMAT) for primary brain tumors. During the treatment planning process, the scalp was drawn as a region of interest. Dose received by 0.1 cc (D), mean dose (D), absolute volumes receiving different doses (V, V, V, V, V, V, and V) were registered for the scalp. Alopecia was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Receiver operating characteristics (ROC) curve analysis was used to identify parameters associated with hair-loss. One-hundred and one patients were included in this observational study. At the end of radiotherapy (RT), 5 patients did not develop alopecia (D scalp 3.1 Gy). The scalp of the patients with G1 ( = 11) and G2 ( = 85) alopecia received D of 10.6 Gy and 11.8 Gy, respectively. At ROC analysis, V ≥ 5.2 cc were the strongest predictors of acute alopecia risk. Chronic hair-loss assessment was available for 74 patients: median time to recovery from G2 alopecia was 5, 9 months. The actuarial rate of hair regrowth was 98.1% at 18 months after the end of RT. At ROC analysis, V ≥2.2 cc were the strongest predictors of chronic G2-alopecia risk. V, V, and D were shown to be independent variables according to correlation coefficient r. V and V were the strongest predictors for acute and chronic G2 hair-loss, respectively. The low-dose bath typical of VMAT corresponds to large areas of acute but transient alopecia. However, the steep dose gradient of VMAT allows to reduce the areas of the scalp that receive higher doses, minimizing the risk of permanent alopecia. The application of our dosimetric findings for the scalp may help in reducing the alopecia risk and also in estimating the probability of hair-loss during patient counseling before starting radiotherapy.
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http://dx.doi.org/10.3389/fonc.2020.00467DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7156544PMC
April 2020

Automated planning through robust templates and multicriterial optimization for lung VMAT SBRT of lung lesions.

J Appl Clin Med Phys 2020 Jun 10;21(6):114-120. Epub 2020 Apr 10.

Careggi University Hospital, Medical Physic Unit, Florence, Italy.

Purpose: To develop and validate a robust template for VMAT SBRT of lung lesions, using the multicriterial optimization (MCO) of a commercial treatment planning system.

Methods: The template was established and refined on 10 lung SBRT patients planned for 55 Gy/5 fr. To improve gradient and conformity a ring structure around the planning target volume (PTV) was set in the list of objectives. Ideal fluence optimization was conducted giving priority to organs at risk (OARs) and using the MCO, which further pushes OARs doses. Segmentation was conducted giving priority to PTV coverage. Two different templates were produced with different degrees of modulation, by setting the Fluence Smoothing parameter to Medium (MFS) and High (HFS). Each template was applied on 20 further patients. Automatic and manual plans were compared in terms of dosimetric parameters, delivery time, and complexity. Statistical significance of differences was evaluated using paired two-sided Wilcoxon signed-rank test.

Results: No statistically significant differences in PTV coverage and maximum dose were observed, while an improvement was observed in gradient and conformity. A general improvement in dose to OARs was seen, which resulted to be significant for chest wall V , total lung V , and spinal cord D . MFS plans are characterized by a higher modulation and longer delivery time than manual plans. HFS plans have a modulation and a delivery time comparable to manual plans, but still present an advantage in terms of gradient.

Conclusion: The automation of the planning process for lung SBRT using robust templates and MCO was demonstrated to be feasible and more efficient.
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http://dx.doi.org/10.1002/acm2.12872DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7324702PMC
June 2020

Outcome and prognostic factors for older patients undergoing radiosurgery for brain metastases.

J Geriatr Oncol 2020 09 4;11(7):1103-1107. Epub 2020 Apr 4.

Azienda Ospedaliero Universitaria Careggi, University of Florence, Radiation Oncology Unit, Florence, Italy.

Purpose: Older patients with brain metastases (BM) are often excluded from clinical trials. The aim of our study was to investigate the outcomes following Gamma Knife radiosurgery (GKRS) in young old (65-74 years) and very old (≥75 years) patients with BM.

Methods: Between October 2012 and October 2018, we treated 89 patients aged ≥65 years with GKRS. Patients were divided in two group: young old (YO) and very old (VO) patients. At baseline G8, Graded Prognostic Assessment (DS-GPA) and Basic Score for Brain Metastases (BSBM) were assessed for all patients. Survival analysis was estimated using the Kaplan-Meier (KM) method. Cox regression model was used to investigate the influence of significant factors on KM.

Results: Median age at the time of GKRS was 72.2 years (range 65-87). A mean of 2.52 lesions were treated per patient (range 1-14). Median overall survival (OS) for YO and VO patients was 14.2 and 15.7 months, respectively. At univariate analysis, there were no significant differences in OS between the two age groups. A high BSBM (p ≤ .0001) and a high DS-GPA score (p = .0069) were associated with longer survival. A low DS-GPA score was the most powerful independent factor for predicting short survival (HR 1.76, 95% CI 1.25-2.46, p = .001) at multivariate analysis.

Conclusion: GKRS is a safe approach to treat BM in elderly patients. DS-GPA score represents an important prognostic factor for survival in elderly patients undergoing GKRS.
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http://dx.doi.org/10.1016/j.jgo.2020.03.009DOI Listing
September 2020

De-intensification for HPV positive oropharyngeal cancer: and yet it moves!: 2019 in review.

Clin Transl Radiat Oncol 2020 May 7;22:40-43. Epub 2020 Mar 7.

Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.

In the last decade, the recognition of the strongly positive prognostic impact of human papilloma virus (HPV) infection on the natural history of squamous cell carcinoma of the oropharynx has reshaped the historical monolithic view of a "one-size-fits-all approach" for head and neck cancer. Unlike their HPV negative counterparts, patients affected by HPV positive oropharyngeal cancer are usually in their prime with a low burden of comorbidities: most importantly, they are less likely to die for their disease, for second primary tumors or for intercurrent mortality. On these grounds, the scientific community was confronted with a pragmatic question: can the morbidity induced by standard concurrent chemo-radiotherapy be reduced without compromising efficacy? Worldwide, several prospective studies were launched, with the common aim to look for alternative treatment paradigms in the frame of de-intensification. This mini-review focuses on three new important trials published in 2019 and discusses their potential implications for clinical practice in the management of patients with HPV positive oropharyngeal cancer.
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http://dx.doi.org/10.1016/j.ctro.2020.03.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7078121PMC
May 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

Reply to Yamazaki et al (HED-19-525.R1).

Head Neck 2020 08 9;42(8):2219-2220. Epub 2020 Mar 9.

Institute for Cancer Research, Prevention, and Clinical Network (ISPRO), Cancer Risk Factors and Lifestyle Epidemiology Unit, Florence, Italy.

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http://dx.doi.org/10.1002/hed.26113DOI Listing
August 2020

Higher Biologically Effective Dose Predicts Survival in SBRT of Pancreatic Cancer: A Multicentric Analysis (PAULA-1).

Anticancer Res 2020 Jan;40(1):465-472

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

Aim: The purpose of the present multicentric study was to review stereotactic body radiotherapy (SBRT) with or without chemotherapy (CHT) experience in locally advanced pancreatic cancer (LAPC). Endpoints were overall survival (OS), local control (LC), and distant metastasis-free survival (DMFS). Several parameters' impact on these outcomes was assessed.

Materials And Methods: Fifty-six patients with LAPC undergoing SBRT+/-CHT were included. SBRT median BED was 48.0 Gy (range=28.0-78.7). Survival curves were calculated by Kaplan-Meier method. A Cox regression model was fitted.

Results: At a median follow-up of 15.0 months, 2-year OS, LC, DMFS were: 33.8% 55.4%, and 22.9%, respectively. Patients treated with BED≥48 Gy showed improved OS (p=0.020) and LC (p=0.024). At multivariate analysis, BED≥48 Gy was significantly associated to both higher OS (p=0.042) and LC (p=0.045), while post-SBRT CHT improved DMFS (p=0.003).

Conclusion: SBRT proved to be tolerable and effective in LAPC. Moreover, BED≥48 Gy was significantly correlated with improved OS and LC.
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http://dx.doi.org/10.21873/anticanres.13975DOI Listing
January 2020

Analysis of skin dose distribution for the prediction of severe radiation dermatitis in head and neck squamous cell carcinoma patients treated with concurrent chemo-radiotherapy.

Head Neck 2020 02 4;42(2):244-253. Epub 2019 Nov 4.

Cancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research, Prevention, and Clinical Network (ISPRO), Florence, Italy.

Background: We investigated whether the pattern of intensity-modulated radiotherapy (IMRT) dose distribution to the skin can be correlated with the development of G3/G4 radiation dermatitis (RD).

Methods: A frequency-matched cohort analysis was perfomed on patients treated with IMRT and concurrent cisplatin or cetuximab. Risk ratios were obtained by fitting Poisson regression models.

Results: The incidence of G3/G4 RD was 41.1% in 90 patients included (50% vs 36.6% in the cetuximab and cisplatin cohorts, respectively). In multivariate analysis, PS ≥ 1 and weight loss at RT completion >10 kg were the only factors that retained significance. The best dosimetric predictive accuracy was provided by 19.9 cc and 5.8 cc of skin ring 2 mm V50 and V60, respectively (AUC: 0.61 for both).

Conclusion: Along with clinical factors, the pattern of dose distribution to a ring structure localized 2 mm below the patient's surface may help predict the development of severe RD.
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http://dx.doi.org/10.1002/hed.25997DOI Listing
February 2020

Radiation-induced nausea and vomiting in head and neck cancer: Is it something worth considering in the intensity modulated radiotherapy era? "A narrative review".

Head Neck 2020 01 21;42(1):131-137. Epub 2019 Oct 21.

Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.

Radiation therapy is one of the cornerstones in the treatment of head and neck squamous cell carcinomas (HNSCC), alone or in combination with chemotherapy or surgery. Technological advances which occurred over the last few decades have increased the efficacy of radiotherapy (RT), particularly, intensity-modulated RT (IMRT). IMRT can deliver treatments on complex tumoral targets with dose escalation while sparing organs at risk; anyway IMRT deposits dose in unpredictable patterns outside of the target volume with the purpose of improving conformality. Radiation-induced nausea and vomiting (RINV) is a frequent albeit neglected side effect of RT that can lead to delays in treatment with serious consequences on cure rates. According to several guidelines (MASCC 2016, NCCN 2018), RT for HNSCC has traditionally been regarded as a low emetic risk treatment. Nevertheless, several works suggest that IMRT could increase RINV. Further studies are needed to define the exact incidence and the detailed pathophysiology of RINV in patients with HNSCC treated with state of art IMRT techniques, with and without concurrent chemotherapy.
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http://dx.doi.org/10.1002/hed.25982DOI Listing
January 2020

Quality Assessment in Supportive Care in Head and Neck Cancer.

Front Oncol 2019 18;9:926. Epub 2019 Sep 18.

Medical Oncology Unit, Department of Medical Oncology, ASST Spedali Civili di Brescia, Brescia, Italy.

Quality assessment is a key issue in every clinical intervention, to be periodically performed so to measure the adherence to standard and to possibly implement strategies to improve its performance. This topic is rarely discussed for what concerns supportive care; however, it is necessary to verify the quality of the supportive measures; "supportive care makes excellent cancer care possible," as stated by the Multinational Association of Supportive Care in Cancer (MASCC). In this regard, the quality of supportive care in head and neck cancer patients is a crucial topic, both to allow administration of treatments according to planned dose intensity or surgical indications and to maintain or improve patients' quality of life. This paper aims to provide insight on state of the art supportive care and its future developments for locally advanced and recurrent/metastatic head and neck cancer, with a focus on quality assessment in relation to surgery, radiotherapy, and systemic therapy.
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http://dx.doi.org/10.3389/fonc.2019.00926DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6759470PMC
September 2019