Publications by authors named "Paolo Bossi"

183 Publications

The role of benzydamine in prevention and treatment of chemoradiotherapy-induced mucositis.

Support Care Cancer 2021 Mar 1. Epub 2021 Mar 1.

Centre de Haute Energie, Nice, France.

Purpose: To discuss the role of benzydamine in the prevention and treatment of radiation-induced oral mucositis (OM) in head and neck (H&N) cancer patients. This document represents an expert opinion paper on indications and key-role aspects in OM pathogenesis, prevention and treatment.

Oral Mucositis: OM represents a common side effect of chemotherapy (CHT) and radiotherapy (RT). It consists in a painful erythema involving the oral cavity mucosa, which may progress to ulceration. Five biologically dynamic phases are considered crucial in mucositis: "initiation, signalling, amplification, ulceration and healing". Oral environment and microbiota are fundamental in mucositis development being involved in susceptibility to infections and in ulceration consequences. Different agents against mucositis have been studied and the use of benzydamine is strongly supported in literature. The Multinational Association of Supportive Care in Cancer and International Society for Oral Oncology (MASCC/ISOO) guidelines recommend its use for the prevention of OM in H&N patients undergoing RT and RT/CHT.

Benzydamine: Benzydamine is a local anti-inflammatory drug with analgesic properties. It can decrease TNF-α, IL-1β and prostaglandin synthesis, also inhibiting leukocyte-endothelial interactions, neutrophil degranulation, vasodilation and vascular permeability. Literature agrees on the beneficial effects of benzydamine in preventing and reducing oral mucositis severity in H&N cancer patients undergoing RT/CHT.

Conclusions: Mucositis represents a major concern in H&N cancer patients and a clinical and economical issue. A multimodal and multidisciplinary approach is needed for its management. International guidelines recommend benzydamine for OM prevention and treatment in H&N cancer patients, but further "real world" trials should be designed.
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http://dx.doi.org/10.1007/s00520-021-06048-5DOI Listing
March 2021

Prognosis and management of recurrent and/or metastatic head and neck adenoid cystic carcinoma.

Oral Oncol 2021 Feb 9;115:105213. Epub 2021 Feb 9.

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

Adenoid cystic carcinoma (ACC) is a rare tumor, usually arising in the salivary gland, accounting for 1% of all head and neck cancers. ACC may have a long-term poor prognosis, as about 40% of radically treated patients will recur locoregionally and up to 60% will develop distant metastasis. Factors influencing risk of recurrence have been well studied, but few data exist about prognostic factors in Recurrent/Metastatic (RM) setting. Moreover, treatment of RM ACC is often a challenge for clinicians, in the context of a rare disease, which may have an indolent clinical behavior or less frequently a quicker growth and with a paucity of available clinical trials. This review critically analyzes pathological and molecular prognostic factors in RM ACC and make an overview on actual therapeutic choices and future direction of therapy. Recognized prognostic factors in RM ACC are the presence and site of distant metastasis (lung vs other), the presence of nodal metastasis and of extranodal extension, skull base recurrence, disease free interval, lymphovascular invasion, solid histotypes and grading of disease, and the presence of mutation of NOTCH1 family, PI3K, and TP53. Due to disappointing results with chemotherapy, new approaches are under study, also on the basis of biomolecular research. Ongoing clinical trials are evaluating treatment targeting MYB and NOTCH1 alterations, immunotherapy or combination of targeted treatments and immune checkpoint inhibitors.
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http://dx.doi.org/10.1016/j.oraloncology.2021.105213DOI Listing
February 2021

M. D. Anderson symptom inventory head neck (MDASI-HN) questionnaire: Italian language psychometric validation in head and neck cancer patients treated with radiotherapy ± systemic therapy - A study of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Oral Oncol 2021 Feb 4;115:105189. Epub 2021 Feb 4.

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

Purpose: Head and neck cancer (HNC) patients are likely to develop severe side effects, which may persist long after the end of treatment and may be responsible for decrease patient's quality of life. The M.D. Anderson Symptom Inventory- Head and Neck Module (MDASI-HN) is a questionnaire developed to detect patient's symptom burden. To conduct an Italian language psychometric validation of MDASI-HN among Italian HNC patients on behalf of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) Head and Neck Working Group.

Method And Materials: To assess construct validity, it was performed a confirmatory factor analysis (CFA) with both a five-factor solution and three-factor solution, which were compared by a chi-square difference test. The concurrent validity was evaluated by the correlation with EORTC QLQ-C30 and HN35, and it was also assessed known-group validity. The internal consistency was tested using Cronbach's alpha coefficient.

Results: In total 166 patients (71.7% male) were included in the study, most of patients (56.2%) had an oropharynx cancer and received definitive chemoradiotherapy (51.2%). The chi-square difference test was significant and indicated that the five-factor solution fits the data better than the other one. Regarding CFA, all items had a significant saturation with their respective factors; besides, significant and strong correlations were found among factors. Most of the correlations between MDASI-HN factors and EORTC QLQ-C30 and HN35 were significant. It was found a good internal consistency.

Conclusion: The MDASI-HN is a valid, short, and easy patient-reported outcome questionnaire which would be useful and efficient in clinical setting.
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http://dx.doi.org/10.1016/j.oraloncology.2021.105189DOI Listing
February 2021

Sinonasal cancer encroaching the orbit: Ablation or preservation?

Oral Oncol 2021 Mar 28;114:105185. Epub 2021 Jan 28.

Section of Otorhinolaryngology - Head and Neck Surgery, Department of Neurosciences, University of Padua - "Azienda Ospedaliera di Padova", Padua, Italy.

Background: Encroachment on the orbital cavity represents a challenge in the management of sinonasal cancer. Criteria guiding orbital preservation lack univocal consensus. Stage of orbital involvement is best assessed through magnetic resonance imaging (MRI).

Methods: Patients affected by orbit-encroaching sinonasal cancer with available preoperative MRI, receiving surgery-based treatment at the University of Brescia between May 2005 and October 2018 were included. All cases were reviewed by expert radiologists and pathologists. Diagnostic performance of MRI was calculated using pathological information as reference. Survival analysis was performed.

Results: The study included 123 patients. The orbit was abutted in 53 (43.1%) patients, whereas orbital invasion reached the periorbit in 18 (14.6%), extraconal fat and/or medial lacrimal sac in 29 (23.6%), extrinsic ocular muscles in 7 (5.7%), intraconal compartment in 4 (3.3%), and orbital apex in 12 (9.8%). Seventy-six (61.8%) patients received orbit-sparing surgery, 47 (38.2%) underwent orbital ablation (OA). Accuracy of MRI in detecting involvement by cancer was ≥80.0% for the orbital wall, extraconal fat, and muscles, and <80.0% for the periorbit and intraconal compartment. Previous surgery, neoadjuvant chemotherapy, and perineural invasion decreased MRI accuracy. Age, histology, tumor grade, pT category, N status, perineural invasion, orbital invasion stage, and need for OA were found to affect prognosis. Five-year orbital dysfunction-free survival was 92.8%.

Conclusion: Conservative management of sinonasal cancers encroaching the orbit is feasible. MRI is essential to preoperatively stage orbital invasion, yet with some limitation. Given the dismal prognosis despite aggressive surgery, neoadjuvant non-surgical therapies should be considered in patients requiring OA.
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http://dx.doi.org/10.1016/j.oraloncology.2021.105185DOI Listing
March 2021

Peripherally or centrally inserted central catheters: what is the best vascular access device for cancer patients?

Support Care Cancer 2021 Jan 29. Epub 2021 Jan 29.

Medical Oncology, Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.

Choosing the appropriate vascular access device is a pivotal step to guarantee vessel health and preservation in cancer patients. The first turning point is the determination of the need for central venous catheters (CVCs) followed by the selection of the CVC that will complete the prescribed treatment while minimizing complications and satisfying patients' needs and expectations. Peripherally inserted central catheters (PICCs) have steadily grown over the years as an alternative to centrally inserted central catheters and totally implantable catheters based on several advantages including avoidance of placement-associated mechanical complications, easier transitions from hospital to intermediate care settings and home, but also increase in healthcare expenditure, supportive reimbursement policies, and ability to train existing staff. Notwithstanding PICCs have been perceived for a long time as associated with fewer complications, reduced costs, and higher patients' satisfaction compared to other CVCs, recent evidence has raised concerns about their safety profile without any benefits for longer-term costs neither for patients' satisfaction. This commentary offers a comprehensive overview on PICC-related (1) complications, (2) costs, and (3) patients' satisfaction to help healthcare professionals in the choice of the vascular device during their clinical practice. Based on the most recent literature, we finally suggested that the choice of the CVC should depend on the clinical situation with totally implantable catheters being the preferred device for patients who need intermittent long-term and high-dose chemotherapy, while PICCs may be a better choice for patients who need short-term chemotherapy or continuous short-term supportive therapy.
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http://dx.doi.org/10.1007/s00520-021-06032-zDOI Listing
January 2021

Advanced lung cancer inflammation index and its prognostic value in HPV-negative head and neck squamous cell carcinoma: a multicentre study.

Support Care Cancer 2021 Jan 29. Epub 2021 Jan 29.

Department of Neurosciences, Section of Otolaryngology, University of Padova, Treviso, Italy.

Purpose: The aim of this study is to evaluate the prognostic value of pre-treatment advanced lung cancer inflammation index (ALI) in patients with HPV-negative HNSCC undergoing up-front surgical treatment.

Methods: The present multi-centre, retrospective study was performed in a consecutive cohort of patients who underwent upfront surgery with or without adjuvant (chemo)-radiotherapy for head and neck squamous cell carcinoma (HNSCC). Patients were stratified by ALI, and survival outcomes were compared between groups. In addition, the prognostic value of ALI was compared with two other indices, the prognostic nutritional index (PNI) and systemic inflammatory index (SIM).

Results: Two hundred twenty-three patients met the inclusion criteria (151 male and 72 female). Overall and progression-free survival were significantly predicted by ALI < 20.4 (HR 3.23, CI 1.51-6.90 for PFS and HR 3.41, CI 1.47-7.91 for OS). Similarly, PNI < 40.5 (HR = 2.43, 95% CI: 1.31-4.51 for PFS and HR = 2.40, 95% CI: 1.19-4.82 for OS) and SIM > 2.5 (HR = 2.51, 95% CI: 1.23-5.10 for PFS and HR = 2.60, 95% CI: 1.19-5.67 for OS) were found to be significant predictors. Among the three indices, ALI < 20.4 identified the patients with the worst 5-year outcomes. Moreover, patients with a combination of low PNI and low ALI resulted to be a better predictor of progression (HR = 5.26, 95% CI: 2.01-13.73) and death (HR = 5.68, 95% CI: 1.92-16.79) than low ALI and low PNI considered alone.

Conclusions: Our results support the use of pre-treatment ALI, an easily measurable inflammatory/nutritional index, in daily clinical practice to improve prognostic stratification in surgically treated HPV-negative HNSCC.
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http://dx.doi.org/10.1007/s00520-020-05979-9DOI Listing
January 2021

Genome-wide study of salivary miRNAs identifies miR-423-5p as promising diagnostic and prognostic biomarker in oral squamous cell carcinoma.

Theranostics 2021 1;11(6):2987-2999. Epub 2021 Jan 1.

'Angelo Nocivelli' Institute of Molecular Medicine, University of Brescia and ASST Spedali Civili di Brescia, Brescia, Italy.

Survival rates of oral squamous cell carcinoma (OSCC) remained substantially unchanged over the last decades; thus, additional prognostic tools are strongly needed. Salivary miRNAs have emerged as excellent non-invasive cancer biomarker candidates, but their association with OSCC prognosis has not been investigated yet. In this study, we analyzed global salivary miRNA expression in OSCC patients and healthy controls, with the aim to define its diagnostic and prognostic potential. Saliva was collected from patients with newly diagnosed untreated primary OSCC and healthy controls. Global profiling of salivary miRNAs was carried out through a microarray approach, while signature validation was performed by quantitative real-time PCR (RT-qPCR). A stringent statistical approach for microarray and RT-qPCR data normalization was applied. The diagnostic performance of miRNAs and their correlation with OSCC prognosis were comprehensively analyzed. In total, 25 miRNAs emerged as differentially expressed between OSCC patients and healthy controls and, among them, seven were significantly associated with disease-free survival (DFS). miR-106b-5p, miR-423-5p and miR-193b-3p were expressed at high levels in saliva of OSCC patients and their combination displays the best diagnostic performance (ROC - AUC = 0.98). Moreover, high expression of miR-423-5p was an independent predictor of poor DFS, when included in multivariate survival analysis with the number of positive lymph nodes - the only significant clinical prognosticator. Finally, we observed a significant decrease in miR-423-5p expression in matched post-operative saliva samples, suggesting its potential cancer-specific origin. Salivary miRNAs identified in our cohort of patients show to be accurate in OSCC detection and to effectively stratify patients according to their likelihood of relapse. These results, if validated in an independent set of patients, could be particularly promising for screening/follow-up of high-risk populations and useful for preoperative prognostic assessment.
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http://dx.doi.org/10.7150/thno.45157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806472PMC
January 2021

The appropriate use of circulating EBV-DNA in nasopharyngeal carcinoma: Comprehensive clinical practice guidelines evaluation.

Oral Oncol 2021 Mar 11;114:105128. Epub 2021 Jan 11.

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

Background: In EBV-related nasopharyngeal carcinoma (NPC), quantitative determination of circulating EBV-DNA (cEBV-DNA) can potentially be applied as disease marker. The aim of the study was to investigate if the clinical utility of cEBV-DNA is established in clinical practice guidelines and if recommendations are provided to standardize the quantitative cEBV-DNA determination.

Methods: A systematic literature search for NPC guidelines published since 2011 was performed. Information for cEBV-DNA detection method and use in clinical practice was synthesized in consecutive steps of increasing simplification.

Results: From 570 titles and abstracts identified by the search, 16 guidelines were included. The selected documents were further clustered as either being based on a systematic literature revision to generate recommendations (4/16) or not (12/16). cEBV-DNA was evaluated in only one guideline based on a systematic revision and in 8 guidelines without systematic revision. Half of available guidelines provide recommendation for its clinical use. Methodological issues on cEBV-DNA determination are discussed by 31% of guidelines, without providing any recommendation on method standardization.

Conclusions: Due to its prognostic value, cEBV-DNA is suggested in the pre-treatment work-up and in the follow-up. Guideline producers need to take into more consideration methodological aspects impacting the actual reliability and generalizability of laboratory results.
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http://dx.doi.org/10.1016/j.oraloncology.2020.105128DOI Listing
March 2021

Oral potentially malignant disorders: new insights for future treatment.

Curr Opin Otolaryngol Head Neck Surg 2021 Apr;29(2):138-142

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

Purpose Of Review: The purpose of this review is to define the issues regarding oral potentially malignant disorders (OPMDs) and provide an overview of currently available treatments and ongoing clinical trials for future opportunities.

Recent Findings: Nowadays, the treatment of choice of OPMD is surgery, whose role in preventing malignant transformation is however limited because of the high rate of recurrence and field cancerization. There have been several attempts of combining systemic therapies with surgery to reduce risk of malignant transformation. The identification of biomarkers that could predict malignant transformation is crucial in better tailoring the risk profile and possible therapeutic approaches.

Summary: Loss of heterozygosity remains the most predictive marker of malignant transformation; however, role of specific microRNA and OPMD immune infiltration are emerging as potential biomarkers. Given the failure of previous trials with various chemopreventive strategies, new strategies should be defined to address the issue of systemic prevention of malignant transformation. Recent updates about immune infiltration and the immune-equilibrium concept for OPMD could shed light into new preventive approaches.
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http://dx.doi.org/10.1097/MOO.0000000000000695DOI Listing
April 2021

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

Support Care Cancer 2021 Jan 4. 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
January 2021

Brain metastasis in head and neck squamous cell carcinoma after immune check point inhibitors treatment.

Oral Oncol 2020 Dec 31:105138. Epub 2020 Dec 31.

Medical Oncology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health University of Brescia, ASST-Spedali Civili, Brescia, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.oraloncology.2020.105138DOI Listing
December 2020

Defining the needs of patients with recurrent and/or metastatic head and neck cancer: An expert opinion.

Crit Rev Oncol Hematol 2021 Jan 13;157:103200. Epub 2020 Dec 13.

Medical Oncology, Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, ASST Spedali Civili, 25123, Brescia, Italy. Electronic address:

The clinical and biological heterogeneity of head and neck cancer (HNC) is paralleled by a plethora of different symptoms that affect the patient's quality of life. These symptoms include, for instance, pain, fatigue, nutritional issues, airways obstruction, voice alterations and psychological distress. In addition, patients with HNC are prone to a high risk of infection, and may also suffer from acute complications, such as hypercalcemia, spine compression by bone metastasis or bleeding. Prolonging survival is also an inherent expectation for all patients. Addressing the above needs is crucial in all patients with HNC, and especially in those with recurrent and/or metastatic (RM) disease. However, research on how to address patients' needs in RM-HNC remains scarce. This paper defines patients' needs for RM HNC and presents an Expert Opinion on how to address them, proposing also some lines of research.
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http://dx.doi.org/10.1016/j.critrevonc.2020.103200DOI Listing
January 2021

Patients with locally advanced and metastatic cutaneous squamous cell carcinoma treated with immunotherapy in the era of COVID-19: stop or go? Data from five Italian referral cancer centers.

Ther Adv Med Oncol 2020 20;12:1758835920977002. Epub 2020 Nov 20.

Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, Milan, Italy.

Since the end of 2019, global healthcare systems have been dealing with the COVID-19 pandemic. In oncology, the biggest questions concern interaction of COVID-19 with pre-existing cancer disease and with systemic anticancer treatments. With regards to immunotherapy, there is uncertainty about its effect in the context of COVID-19 in terms of probability and course of viral infection. Herein, we retrospectively report data of patients with advanced cutaneous squamous cell carcinoma (cSCC) treated with immunotherapy at five Italian referral cancer centers during the pandemic. cSCC is a disease poorly represented in the literature, typically affecting fragile, elderly patients, with multiple comorbidities and often immunosuppressed. Overall, 54 patients were identified, most of them coming from Lombardy and Piedmont, the two regions hit hardest by COVID in Italy. In most cases, our choice was to continue treatment, reserving temporary interruptions only to patients considered particularly at risk for age and comorbidity. A total of 9% of patients developed new-onset symptoms or had chest radiological assessment potentially related to COVID-19. Nasopharyngeal swabs were collected in all suspicious cases and two hospitalized patients were found to be positive. In conclusion, the outbreak of COVID-19 is a major worldwide health concern. Our data indicate that COVID-19 mortality in patients with cancer may be principally driven by advancing age, the presence of other comorbidities, and other cancer-related conditions (i.e. hospitalization). Our data further suggests the safety of continued use of PD-1 blockade during the COVID-19 pandemic (obviously implementing all the safety measures in the hospital environment) also considering the possible negative effects of a prolonged suspension on the course of the tumor evolution. We think it is useful to collect and report case studies coming from reference centers, because they can represent helpful examples for the scientific community of clinical management of patients affected by cancer in this difficult period and guide further research.
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http://dx.doi.org/10.1177/1758835920977002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7684275PMC
November 2020

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

MASCC/ISOO clinical practice guidelines for the management of mucositis: sub-analysis of current interventions for the management of oral mucositis in pediatric cancer patients.

Support Care Cancer 2020 Nov 6. Epub 2020 Nov 6.

Division of Oral Medicine, Eastman Institute for Oral Health, University of Rochester Medical Center, Rochester, NY, USA.

Objective: The aim of this sub-analysis was to highlight the MASCC/ISOO clinical practice guidelines for the management of oral mucositis (OM) in pediatric patients and to present unique considerations in this patient population.

Methods: This sub-analysis of the pediatric patient population is based on the systematic review conducted by the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISSO) published in 2019/2020. Studies were scored and assigned a level of evidence based on previously published criteria. Data regarding adverse effects and compliance was collected from the original publications.

Results: A total of 45 papers were included and assessed in this sub-analysis, including 21 randomized controlled trials (RCTs). Chewing gum was demonstrated to be not effective in preventing OM in pediatric cancer patients in 2 RCTs. The efficacy of all other interventions could not be determined based on the available literature.

Conclusion: There is limited or conflicting evidence about interventions for the management of OM in pediatric cancer patients, except for chewing gum which was ineffective for prevention. Therefore, currently, data from adult studies may need to be extrapolated for the management of pediatric patients. Honey and photobiomodulation therapy in this patient population had encouraging potential. Implementation of a basic oral care protocol is advised amid lack of high level of evidence studies.
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http://dx.doi.org/10.1007/s00520-020-05803-4DOI Listing
November 2020

Role of IMRT/VMAT-Based Dose and Volume Parameters in Predicting 5-Year Local Control and Survival in Nasopharyngeal Cancer Patients.

Front Oncol 2020 24;10:518110. Epub 2020 Sep 24.

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

This study aimed to look into the relationship between intensity-modulated-radiotherapy (IMRT)- or volumetric-modulated-arc-therapy (VMAT)-based dose-volume parameters and 5-year outcome for a consecutive series of non-metastatic nasopharyngeal cancer (NPC) patients (pts) treated in a single institution in a non-endemic area in order to identify potential prognostic factors. A retrospective analysis of consecutive non-metastatic NPC pts treated curatively with IMRT or VMAT and chemotherapy (CHT) between 2004 and 2014 was conducted. One patient was in stage I (0.7%), and 24 pts (17.5%) were in stage II, 38 pts (27.7%) in stage III, 29 pts (21.2%) in stage IVA, and 45 pts (32.8%) in stage IVB. Five pts (3.6%) received radiotherapy (RT) alone. Of the remaining 132 pts (96.4%), 30 pts (21.9%) received CHT concomitant to RT, and 102 pts (74.4%) were treated with induction CHT followed by RT-CHT. IMRT was given with standard fractionation at a total dose of 70 Gy. Clinical outcomes investigated in the study were local control (LC), disease-free survival (DFS), and overall survival (OS). Kaplan-Meier (KM) analysis was performed for the outcomes considering dose and coverage parameters, staging, and RT technique. Overall, 137 pts were eligible for this retrospective analysis. With a median follow-up of 70 months (range 12-143), actuarial rates at 5 years were LC 90.4, DFS 77.2, and OS 82.8%. For this preliminary study, T stage was dichotomized as T1, T2, T3 vs. T4. At 5 years, the group T1-T2-T3 reported an LC of 93%, a DFS of 79%, and an OS of 88%, whereas T4 pts reported LC, DFS, and OS, respectively, of 56, 50, and 78%. Pts with V95% > 95.5% had better LC ( = 0.006). Pts with D99% > 63.8 Gy had better LC ( = 0.034) and OS ( = 0.005). The threshold value of 43.2 cm of GTVT was prognostic for LC ( = 0.016). To predict the risk of local recurrence at 5 years, we constructed a nomogram which combined GTVT with D99% relative to HRPTV. We demonstrated the prognostic value of some dose-volume parameters, although in a retrospective series, this is potentially useful to improve planning procedure. In addition, for the first time in a non-endemic area, a threshold value of GTVT, prognostic for LC, has been confirmed.
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http://dx.doi.org/10.3389/fonc.2020.518110DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7541899PMC
September 2020

Baseline MRI-Radiomics Can Predict Overall Survival in Non-Endemic EBV-Related Nasopharyngeal Carcinoma Patients.

Cancers (Basel) 2020 Oct 13;12(10). Epub 2020 Oct 13.

Radiotherapy 2 Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 20133 Milan, Italy.

Advanced stage nasopharyngeal cancer (NPC) shows highly variable treatment outcomes, suggesting the need for independent prognostic factors. This study aims at developing a magnetic resonance imaging (MRI)-based radiomic signature as a prognostic marker for different clinical endpoints in NPC patients from non-endemic areas. A total 136 patients with advanced NPC and available MRI imaging (T1-weighted and T2-weighted) were selected. For each patient, 2144 radiomic features were extracted from the main tumor and largest lymph node. A multivariate Cox regression model was trained on a subset of features to obtain a radiomic signature for overall survival (OS), which was also applied for the prognosis of other clinical endpoints. Validation was performed using 10-fold cross-validation. The added prognostic value of the radiomic features to clinical features and volume was also evaluated. The radiomics-based signature had good prognostic power for OS and loco-regional recurrence-free survival (LRFS), with C-index of 0.68 and 0.72, respectively. In all the cases, the addition of radiomics to clinical features improved the prognostic performance. Radiomic features can provide independent prognostic information in NPC patients from non-endemic areas.
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http://dx.doi.org/10.3390/cancers12102958DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7601980PMC
October 2020

The Spread of SARS-CoV-2 Infection Among the Medical Oncology Staff of ASST Spedali Civili of Brescia: Efficacy of Preventive Measures.

Front Oncol 2020 18;10:1574. Epub 2020 Aug 18.

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

Patients with cancer are at a higher risk of developing serious disease-related complications in case of contracting SARS-CoV-2. Oncology units should implement all possible preventive measures to reduce the risk of viral transmission by healthcare professionals (HCPs) to patients. We conducted a surveillance for SARS-CoV-2 infection among the staff members of the Medical Oncology Unit of ASST Spedali Civili in Brescia, one of the Italian areas most affected by the SARS-CoV-2 pandemic. The aim of this study was to demonstrate whether the recommended preventive measures, promptly implemented by the unit, have been effective in reducing the spread of the virus among the HCPs. Between February 24 and May 19, 2020, SARS-CoV-2 infection was detected in 10 out of 76 healthy HCPs (13%). Six of them developed a symptomatic disease, leading to home quarantine, and four remained asymptomatic. The infection was revealed when a serology test was performed on all staff members of the unit. In seven HCPs, in which it was possible to trace the person-to-person infection, the contagion occurred as a result of unprotected contacts or partially protected with surgical masks. In particular, four asymptomatic HCPs did not stop working, but a widespread outbreak in the unit was avoided. Adherence to the recommended preventive strategies, in particular, wearing of surgical masks by both the HCPs and the patients, is effective in reducing and preventing the viral spread.
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http://dx.doi.org/10.3389/fonc.2020.01574DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462005PMC
August 2020

A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients.

Radiat Oncol 2020 Aug 13;15(1):193. Epub 2020 Aug 13.

Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.

Background: This study was an open-label, 2-arms, monocentric, randomized clinical trial comparing Xonrid®, a topical medical device, versus standard of care (SOC) in preventing and treating acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT).

Methods: Eligible HNC and BC patients were randomized 1:1 to receive Xonrid® + SOC or SOC during RT. Patients were instructed to apply Xonrid® on the irradiated area three times daily, starting on the first day of RT and until 2 weeks after RT completion or until the development of grade ≥ 3 skin toxicity. The primary endpoint was to evaluate the proportion of patients who developed an ARD grade < 2 at the 5th week in both groups. Secondary endpoints were median time to grade 2 (G2) skin toxicity onset; changes in skin erythema and pigmentation and trans-epidermal water loss (TEWL); patient-reported skin symptoms. All patients were evaluated at baseline, weekly during RT and 2 weeks after treatment completion. The evaluation included: clinical toxicity assessment; reflectance spectrometry (RS) and TEWL examination; measurement of patients' quality of life (QoL) through Skindex-16 questionnaire.

Results: Eighty patients (40 for each cancer site) were enrolled between June 2017 and July 2018. Groups were well balanced for population characteristics. All BC patients underwent 3-Dimensional Conformal RT (3D-CRT) whereas HNC patients underwent Volumetric-Modulated Arc Therapy (VMAT). At week 5 the proportion of BC patients who did not exhibit G2 ARD was higher in Xonrid® + SOC group (p = 0.091). In the same group the onset time of G2 ARD was significantly longer than in SOC-alone group (p < 0.0491). For HNC groups there was a similar trend, but it did not reach statistical significance. For both cancer sites, patients' QoL, measured by the Skindex-16 score, was always lower in the Xonrid® + SOC group.

Conclusion: Despite the failure to achieve the primary endpoint, this study suggests that Xonrid® may represent a valid medical device in the prevention and treatment of ARD at least in BC patients, delaying time to develop skin toxicity and reducing the proportion of patients who experienced G2 ARD during RT treatment and 2 weeks later.

Trial Registration: The study was approved by the Ethical Committee of Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (INT 52/14 - NCT02261181 ). Registered on ClinicalTrial.gov on 21st August 2017.
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http://dx.doi.org/10.1186/s13014-020-01633-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427075PMC
August 2020

MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy.

Cancer 2020 Oct 28;126(19):4423-4431. Epub 2020 Jul 28.

Medical Oncology Department, University of Brescia, Brescia, Italy.

Background: Mucositis is a significant toxicity of cancer therapy with numerous systemic sequelae. The goal of this systematic review was to update the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for the management of mucositis.

Methods: The literature was reviewed systematically to identify interventions for mucositis. Studies were rated according to the presence of major and minor flaws according to previously published criteria. The body of evidence for each intervention and in each treatment setting was assigned a level of evidence based on previously published criteria. Guidelines were developed based on the level of evidence, with 3 possible guideline determinations: recommendation, suggestion, or no guideline possible.

Results: The guideline covers evidence from 1197 publications related to oral or gastrointestinal mucositis. Thirteen new guidelines were developed for or against the use of various interventions in specific treatment settings, and 11 previous guidelines were confirmed after aa review of new evidence. Thirteen previously established guidelines were carried over because there was no new evidence for these interventions.

Conclusions: The updated MASCC/ISOO Clinical Practice Guidelines for mucositis provide professional health caregivers with a clinical setting-specific, evidence-based tool to help with the management of mucositis in patients who have cancer.
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http://dx.doi.org/10.1002/cncr.33100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540329PMC
October 2020

Gene Expression Clustering and Selected Head and Neck Cancer Gene Signatures Highlight Risk Probability Differences in Oral Premalignant Lesions.

Cells 2020 08 3;9(8). Epub 2020 Aug 3.

Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, ASST Spedali Civili, 25123 Brescia, Italy.

Background: Oral premalignant lesions (OPLs) represent the most common oral precancerous conditions. One of the major challenges in this field is the identification of OPLs at higher risk for oral squamous cell cancer (OSCC) development, by discovering molecular pathways deregulated in the early steps of malignant transformation. Analysis of deregulated levels of single genes and pathways has been successfully applied to head and neck squamous cell cancers (HNSCC) and OSCC with prognostic/predictive implications. Exploiting the availability of gene expression profile and clinical follow-up information of a well-characterized cohort of OPL patients, we aim to dissect tissue OPL gene expression to identify molecular clusters/signatures associated with oral cancer free survival (OCFS).

Materials And Methods: The gene expression data of 86 OPL patients were challenged with: an HNSCC specific 6 molecular subtypes model (Immune related: HPV related, Defense Response and Immunoreactive; Mesenchymal, Hypoxia and Classical); one OSCC-specific signature (13 genes); two metabolism-related signatures (3 genes and signatures raised from 6 metabolic pathways associated with prognosis in HNSCC and OSCC, respectively); a hypoxia gene signature. The molecular stratification and high versus low expression of the signatures were correlated with OCFS by Kaplan-Meier analyses. The association of gene expression profiles among the tested biological models and clinical covariates was tested through variance partition analysis.

Results: Patients with Mesenchymal, Hypoxia and Classical clusters showed an higher risk of malignant transformation in comparison with immune-related ones (log-rank test, = 0.0052) and they expressed four enriched hallmarks: "TGF beta signaling" "angiogenesis", "unfolded protein response", "apical junction". Overall, 54 cases entered in the immune related clusters, while the remaining 32 cases belonged to the other clusters. No other signatures showed association with OCFS. Our variance partition analysis proved that clinical and molecular features are able to explain only 21% of gene expression data variability, while the remaining 79% refers to residuals independent of known parameters.

Conclusions: Applying the existing signatures derived from HNSCC to OPL, we identified only a protective effect for immune-related signatures. Other gene expression profiles derived from overt cancers were not able to identify the risk of malignant transformation, possibly because they are linked to later stages of cancer progression. The availability of a new well-characterized set of OPL patients and further research is needed to improve the identification of adequate prognosticators in OPLs.
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http://dx.doi.org/10.3390/cells9081828DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7466020PMC
August 2020

The 8th TNM classification for oral squamous cell carcinoma: What is gained, what is lost, and what is missing.

Oral Oncol 2020 12 1;111:104937. Epub 2020 Aug 1.

Section of Otorhinolaryngology - Head and Neck Surgery, Department of Neurosciences, University of Padua, Padua, Italy.

Objectives: The 8th TNM edition remarkably changed the classification of T and N categories for oral squamous cell carcinoma (OSCC). The present study aims at evaluating the improvement in prognostic power compared to the 7th edition, pros and cons of the modifications, and parameters deserving consideration for further implementations.

Materials And Methods: All OSCCs treated with upfront surgery at our institution between 2002 and 2017 were included. Demographics, clinical-pathological and treatment variables were retrieved. All tumors were classified according to both the 7th and 8th TNM edition, and patients were grouped according to the shift in T category and stage. Survivals were calculated with the Kaplan-Meier method. Univariate and multivariate analysis were carried out. Receiver Operating Characteristics (ROC) curve analyses were performed to find the best cut-off of DOI (in patients with DOI > 10 mm) and number of involved nodes (in positive neck patients).

Results: 244 patients were included. T, N categories, and stage changed in 59.2%, 20.5%, and 49.1% patients, respectively; 41.5% of patients were upstaged. The new T classification well depicted prognosis according to OS. Five-year overall (OS), disease-specific, recurrence-free (RFS) survivals were 60.5%, 70.9%, 59.8%, respectively. According to ROC curves, DOI > 20 mm and 4 positive nodes were the best cutoffs for OS and RFS.

Conclusion: The novelties introduced in 8th TNM edition were positive. DOI > 20 mm for T4 definition and number of positive nodes (0, <4, 4 or more) for N classification emerged as the most urgent factors to be implemented.
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http://dx.doi.org/10.1016/j.oraloncology.2020.104937DOI Listing
December 2020

The Evolving Role of Systemic Therapy in the Primary Treatment of Sinonasal Cancer.

Adv Otorhinolaryngol 2020 30;84:78-86. Epub 2020 Jul 30.

Unit of Oncology, University of Brescia, Brescia, Italy.

The inclusion of systemic therapy in the multimodal approach of locally advanced sinonasal cancers, at least in some selected histologies, may improve locoregional control and reduce the frequency of distant metastasis, allowing longer survival. Response to induction chemotherapy is a strong prognostic factor for a patient's outcome and it may improve disease control by surgery and radiation. Concurrent chemoradiation aims at increasing locoregional control in squamous cell cancer of the head and neck; this is particularly important in sinonasal cancers, with a risk of local relapse of about 30%. Selected histologies may benefit from specific drug combinations, according to varying chemosensitivity. Intestinal-type adenocarcinoma carrying a functional p53 protein may be treated with preoperative cisplatin, 5-fluorouracil, and leucovorin. Sinonasal undifferentiated carcinoma is a chemosensitive disease, where the multimodal approach is necessary to counterbalance the severe prognosis. Sinonasal neuroendocrine carcinoma and olfactory neuroblastoma may benefit from systemic treatments, but their added value has not been so clearly defined yet. Multimodality trials are ongoing to test the activity of induction chemotherapy followed by locoregional curative treatment. A deeper knowledge of the molecular deregulations of these diseases could help in identifying targeted therapies.
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http://dx.doi.org/10.1159/000457927DOI Listing
July 2020

Future Perspectives in the Management of Tumors of the Anterior Skull Base.

Adv Otorhinolaryngol 2020 30;84:246-250. Epub 2020 Jul 30.

Unit of Otorhinolaryngology - Head and Neck Surgery, University of Brescia, Brescia, Italy,

In the coming years, further developments can be expected in the field of diagnosis and management of tumors involving the anterior skull base, and especially malignant tumors of the sinonasal tract, which account for the majority of lesions affecting this anatomic area. Advances in genomics and radiomics will undoubtedly lead to better profiling of tumor biology, with consequent refinement of treatment according to the principles of precision medicine. Similarly, the continuous evolution of morphologic and metabolic imaging will improve the accuracy of pretreatment staging and posttreatment surveillance. Finally, the relentless development of technology in complementary fields (i.e., bioengineering, regenerative medicine, robotics, navigation systems, optical imaging) will refine the safety and accuracy of surgery. As a consequence of these innovations, all healthcare professionals involved in the management of anterior skull base tumors need to consolidate their multidisciplinary efforts for improving the patient's quality of life and survival outcomes. In tandem, hospital administrators and politicians should understand the essential importance of limiting the treatment of these pathologies to "centers of excellence," ensuring an adequate workload and appropriate human and technological resources.
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http://dx.doi.org/10.1159/000457943DOI Listing
July 2020

Treatment Options for Recurrent Anterior Skull Base Tumors.

Adv Otorhinolaryngol 2020 30;84:231-245. Epub 2020 Jul 30.

Section of Otorhinolaryngology - Head and Neck Surgery, Department of Neurosciences, University of Padua, Padua, Italy.

Malignancies of the anterior skull base are rare and recur in 40-80% of treated cases, varying with substantial variance according to histology, stage at primary diagnosis, and other factors. Most recurrences manifest within 2-5 years after primary treatment, but some histologies can relapse even decades after the first presentation. Management of recurrent anterior skull base tumors is challenging and a wide variety of treatment options are available. Similar to the primary setting, surgery is the mainstay of treatment. However, only few patients are likely to be suitable for salvage surgery after restaging. In this scenario, non-surgical options such as re-irradiation with photon or heavy particles may play a role, although the potential toxicity and benefits of treatment needs to be considered on a case-by-case basis. Moreover, stereotactic technologies are emerging as an adjunct valuable tool to minimize side effects. Chemotherapy is acquiring a relevant role in the primary treatment of sinonasal malignant lesions involving the anterior skull base in the neoadjuvant setting or in combination with radiotherapy, but evidence of its efficacy in the treatment of the recurrent/metastatic disease is very limited. The specific drugs employed vary considerably and need to be paralleled with the biology of the different histologies.
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http://dx.doi.org/10.1159/000457942DOI Listing
July 2020

Value and Quality of Care in Head and Neck Oncology.

Curr Oncol Rep 2020 Jul 10;22(9):92. Epub 2020 Jul 10.

International Head and Neck Scientific Group, Padua, Italy.

Purpose Of Review: The concept of value-based health care (VBHC) was articulated more than a decade ago. However, its clinical implementation remains an on-going process and a particularly demanding one for the domain of head and neck cancer (HNC). These cancers often present with fast growing tumors in functionally and cosmetically sensitive sites and afflict patients with differing circumstances and comorbidity. Moreover, the various treatment modalities and protocols have different effects on functional outcomes. Hence, the interpretation of what constitutes VBHC in head and neck oncology remains challenging.

Recent Findings: This monograph reviews developments in specific aspects of VBHC for HNC patients, including establishment of registries and quality indices (such as infrastructure, process, and outcome indicators). It emphasizes the importance of the multidisciplinary team, "time to treatment intervals," and adherence to guidelines. The discussion addresses major indicators including survival, quality of life and functional outcomes, and adverse events. Also, strengths and weaknesses of nomograms, prognostic and decision models, and variation of care warrant attention. Health care professionals, together with patients, must properly define quality and relevant outcomes, both for the individual patient as well as the HNC population. It is essential to capture and organize the relevant data so that they can be analyzed and the results used to improve both outcomes and value.
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http://dx.doi.org/10.1007/s11912-020-00952-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351804PMC
July 2020

Prognostic nomogram in patients with metastatic adenoid cystic carcinoma of the salivary glands.

Eur J Cancer 2020 09 3;136:35-42. Epub 2020 Jul 3.

Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Italy.

Background: Distant metastases in adenoid cystic carcinoma (ACC) are common. There is no consensus on the management of metastatic disease because no therapeutic approach has demonstrated improvement in overall survival (OS) and because of prolonged life expectancy. The aim of this study is to build and validate a prognostic nomogram for metastatic ACC patients.

Methods: The study end-point was OS, measured from the date of first metastatic presentation to death/last follow-up. A retrospective analysis including metastatic ACC patients was performed to build the prognostic nomogram at the INT (Milan, Italy). The model was validated on an independent cohort of patients with similar characteristics treated at Leuven (Belgium). Outcome data and covariates were modelled by resorting to a random forest method. This machine-learning approach was used to guide and benchmark the subsequent use of more conventional modelling methods. Cox model performance was assessed in terms of discrimination (Harrell's c-index).

Results: Two hundred ninety-eight patients with metastatic ACC (testing set 259 INT, validation set 39 Leuven) were studied. Akaike Information Criterion-based backward selection yielded a 5-factor model showing a bias-corrected c-index of 0.730. Five independent prognostic factors were found: gender, disease-free interval and presence of lung, liver or bone metastases. Nomogram discrimination in the validation series was c = 0.701.

Conclusion: This retrospective analysis allowed the building of an externally validated prognostic nomogram. This tool might help clinicians to discriminate patients requiring prompt management from who can benefit from a 'watchful waiting'. In addition, the nomogram might be useful to stratify patients in clinical trials.
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http://dx.doi.org/10.1016/j.ejca.2020.05.013DOI Listing
September 2020

A randomized, double-blind, placebo controlled, phase II study to evaluate the efficacy of ginseng in reducing fatigue in patients treated for head and neck cancer.

J Cancer Res Clin Oncol 2020 Oct 2;146(10):2479-2487. Epub 2020 Jul 2.

Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.

Purpose: Fatigue is a distressing symptom in head & neck cancer patients before during and at the end of curative therapy. Pharmacologic and not pharmacologic treatments have been proposed with scarce or no evidence of efficacy. The aim of the study is to evaluate the efficacy of American ginseng in respect to placebo in reducing fatigue in patients treated for head and neck cancer with curative intent.

Methods: Thirty-two patients who had completed oncological treatment for a primary Head & neck tumor for at least 1 year and had a global fatigue score > 4 by means of Brief Fatigue Inventory (BFI) were randomized to receive 1000 mg of American ginseng or placebo per day for 8 weeks with the aim to assess their efficacy. Changes in fatigue scores in the 2 subgroups of patients before and after the treatment with American ginseng or placebo, were assessed by the BFI at baseline and at the end of week 8.

Results: The mean of the mean values of the BFI measured at 8 weeks (end of treatment) was 4.6 in the Ginseng arm and 3.4 in the Placebo arm (p = ns). Mean comparison showed a tendency to statistical significance only for the single item on interference with general activity (p = 0.06), with better performance for placebo. The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire.

Conclusion: The present data shows that American ginseng has insufficient evidence to be recommended for Cancer Related Fatigue (CRF) in post treatment HNC survivors.
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http://dx.doi.org/10.1007/s00432-020-03300-zDOI Listing
October 2020

Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study.

Future Oncol 2020 Jun 6;16(16):1091-1100. Epub 2020 May 6.

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Naples, Italy.

To assess safety and efficacy of vismodegib in the Italian cohort from the SafeTy Events in VIsmodEgib study. Data from Italian patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC were analyzed. Among 182 Italian patients, adverse events occurred with similar incidence to the overall population. Overall response rate was 67.1% in laBCC, 20% in metastatic BCC; complete response rate was 33.1% overall and 37.4% in laBCC. Median time to response was 2 months in complete responders versus 3.6 months overall. Quality of life improved from baseline. In the Italian cohort of STEVIE, vismodegib showed a safety profile consistent with the whole population; older age did not affect safety or efficacy. NCT01367665.
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http://dx.doi.org/10.2217/fon-2019-0664DOI Listing
June 2020

Precision medicine in rare tumors and the need for multicenter trials and international collaboratives: Sinonasal cancer as paradigm.

Oral Oncol 2020 10 25;109:104737. Epub 2020 Apr 25.

Department of Translational Research and of New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.

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http://dx.doi.org/10.1016/j.oraloncology.2020.104737DOI Listing
October 2020