Publications by authors named "Isacco Desideri"

99 Publications

The impact of modern radiotherapy on radiation-induced late sequelae: Focus on early-stage mediastinal classical Hodgkin Lymphoma. A critical review by the Young Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Crit Rev Oncol Hematol 2021 Apr 20;161:103326. Epub 2021 Apr 20.

Department of Radiation Oncology, University of Florence, Florence, Italy.

Introduction: The historically feared radiation-induced secondary cancers and cardiac toxicities observed among mediastinal classical Hodgkin Lymphoma (cHL) patients may still negatively burden the benefit of radiotherapy among long-term survivors. Modern radiotherapy (RT) delivery techniques, including intensity-modulated RT (IMRT) and deep inspiration breath-hold (DIBH) solutions, are drastically changing this scenario. Results of a literature overview are reported and discussed in this paper.

Materials And Methods: Key references were derived from a PubMed query. Hand searching and clinicaltrials.gov were also used.

Results: This paper contains a narrative report and a critical discussion of organs-at-risk dose-volume metrics linked with radiation-induced toxicities in cHL patients.

Conclusions: The scenario of early-stage cHL presents long-life expectancies, thus the goal of treatment should aim at maintaining high cure rates and limiting the onset of late complications. Further evaluations of dosimetric measures and clinical outcomes are warranted to identify patients at higher risk to target treatment tailoring.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103326DOI Listing
April 2021

Validation of a secondary dose check tool against Monte Carlo and analytical clinical dose calculation algorithms in VMAT.

J Appl Clin Med Phys 2021 Apr 18;22(4):52-62. Epub 2021 Mar 18.

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

Purpose: Patient-specific quality assurance (QA) is very important in radiotherapy, especially for patients with highly conformed treatment plans like VMAT plans. Traditional QA protocols for these plans are time-consuming reducing considerably the time available for patient treatments. In this work, a new MC-based secondary dose check software (SciMoCa) is evaluated and benchmarked against well-established TPS (Monaco and Pinnacle ) by means of treatment plans and dose measurements.

Methods: Fifty VMAT plans have been computed using same calculation parameters with SciMoCa and the two primary TPSs. Plans were validated with measurements performed with a 3D diode detector (ArcCHECK) by translating patient plans to phantom geometry. Calculation accuracy was assessed by measuring point dose differences and gamma passing rates (GPR) from a 3D gamma analysis with 3%-2 mm criteria. Comparison between SciMoCa and primary TPS calculations was made using the same estimators and using both patient and phantom geometry plans.

Results: TPS and SciMoCa calculations were found to be in very good agreement with validation measurements with average point dose differences of 0.7 ± 1.7% and -0.2 ± 1.6% for SciMoCa and two TPSs, respectively. Comparison between SciMoCa calculations and the two primary TPS plans did not show any statistically significant difference with average point dose differences compatible with zero within error for both patient and phantom geometry plans and GPR (98.0 ± 3.0% and 99.0 ± 3.0% respectively) well in excess of the typical clinical tolerance threshold.

Conclusion: This work presents results obtained with a significantly larger sample than other similar analyses and, to the authors' knowledge, compares SciMoCa with a MC-based TPS for the first time. Results show that a MC-based secondary patient-specific QA is a clinically viable, reliable, and promising technique, that potentially allows significant time saving that can be used for patient treatment and a per-plan basis QA that effectively complements traditional commissioning and calibration protocols.
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http://dx.doi.org/10.1002/acm2.13209DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8035572PMC
April 2021

COVID-19 and radiotherapy: impact on work and personal life of Lombardy residents during first lockdown, survey endorsed by AIRO Young.

Tumori 2021 Mar 17:3008916211000826. Epub 2021 Mar 17.

Division of Radiation Oncology, IEO, European Institute of Oncology, IRCCS, Milan, Italy.

Aim: Since 20 February 2020, Lombardy has been one of the most affected areas worldwide by the coronavirus disease 2019 (COVID-19) pandemic. The aim of this study is to evaluate work and psychological impact of COVID-19 on Lombardy radiation therapy (RT) residents in the first 3 months of the outbreak (first lockdown).

Methods: An online questionnaire (22 multiple choice questions) via Microsoft Forms was administered on 30 May 2020 to RT residents.

Results: Nineteen Lombardy RT residents responded to the survey. Nineteen percent of residents underwent a nasal swab and 11% were quarantined. Seventeen residents (89%) reported an increase in workload. Twelve residents (63%) did not find any difference in terms of work distress; worsening was highlighted in 5 cases (26%). The majority has never considered the possibility of stopping work due to excessive stress (89%). Almost all the residents experienced self- or relative-referred apprehension (95%). Ninety-five percent reported having missed extra-work social relationships. Most of the sample noted worsening sleep quality and difficulty concentrating (69%). No residents requested psychological support, even if provided by the hospital.

Conclusion: Overall, the residents adapted to the new workplace scenario, although some health risks and well-being challenges have been reported. An extension of the survey to all Italian RT residents endorsed by Italian Association of Radiotherapy and Clinical Oncology "Young AIRO" will allow an evaluation of COVID-19 impact on a national level. A second survey is planned to underline differences between the first lockdown and the current situation of the pandemic.
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http://dx.doi.org/10.1177/03008916211000826DOI Listing
March 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

Results of a survey on elderly head and neck cancer patients on behalf of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Acta Otorhinolaryngol Ital 2020 Dec;40(6):405-409

Department of Radiation Oncology, University Hospital of Pisa, Italy.

Objective: Over the years, evidence-based data and technical improvements have consolidated the central role of radiation therapy (RT) in head and neck cancer (HNC) treatment, even in the elderly. This survey aimed to describe the management of the elderly HNC patients among Italian Radiation Oncology Departments (RODs) and provide possible suggestions for improvement.

Methods: An online survey based on 43 questions was sent to RODs via email. For each RODs, a radiation oncologist with expertise in HNC was invited to answer questions addressing his/her demographic data, ROD multidisciplinary unit (MU) organisation and ROD management policy in elderly HNC patients.

Results: In total, 68 RODs answered, representing centres located in 16 Italian regions. MU was considered the core of HNC patient management in almost all the entire country. However, in many RODs, there was minimal access to a routinely comprehensive geriatric assessment at diagnosis. Most treatments were reported by respondents as curative (89% on average) and the preferred treatment technique was intensity modulated radiation therapy (IMRT). A considerable variation between RODs was found for RT target volumes. There was a relation between the specialist's years of experience and type of concomitant systemic therapy prescribed.

Conclusions: Substantial differences in elderly HNC management have been found, especially concerning patient clinical evaluation and target volume delineation. This survey shows the necessity to design a prospective national trial to provide a uniform treatment strategy and define an effective patient-centred approach.
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http://dx.doi.org/10.14639/0392-100X-N0618DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7889254PMC
December 2020

Radiation treatment for adult rare cancers: Oldest and newest indication.

Crit Rev Oncol Hematol 2021 Mar 27;159:103228. Epub 2021 Jan 27.

Radiation Oncology Department, Azienda Ospedaliera San Camillo-Forlanini, Roma, Italy.

Aim: Aim of this analysis is to review the role of RT in the management of several rare tumors for adult patients.

Methods: Collection data regarding RT and rare tumors was made by Pubmed.

Results: For mucosal melanomas, RT is prescribed, being associated with lower local recurrence rate. For trachea tumors, RT was used as adjuvant or salvage treatment for unresectable disease. For pNET, RT can be a suitable option for post-surgical or unresectable/borderline. For bronchopulmonary neuroendocrine tumors the role of adjuvant treatments is uncertain. For hepatobiliary and ovarian malignancy, stereotactic body RT (SBRT) is a promising approach. For soft tissue sarcoma, perioperative treatments are indicated, and a growing role of SBRT in oligometastatic disease is recognized. For endocrine tumors, adjuvant RT has demonstrated benefits through reducing recurrence risk.

Conclusion: The radiotherapy is a frequent indication in adult rare cancers; thus the role of Radiation Oncologist must not be neglected.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103228DOI Listing
March 2021

Integrating stereotactic body radiation therapy (SBRT) and systemic treatments in oligoprogressive prostate cancer: new evidence from the literature.

Clin Exp Metastasis 2021 Apr 20;38(2):227-230. Epub 2021 Jan 20.

Radiation Oncology Unit - Oncology Department, Azienda Ospedaliero Universitaria Careggi, Viale Morgagni 85, 50134, Florence, Italy.

Recent findings from literature evidenced that metastatic prostate cancer often shows heterogeneous response to therapy, with persistent sensibility to systemic treatments after biochemical, clinical, or radiographic progression. This highlights the advantage of integrated approaches in which local ablative treatments (e.g., stereotactic body radiation therapy) could prolong clinical benefit of systemic therapies beyond oligo-progression. Of course, development of predictive biomarker could be helpful in order to select patients who could much benefit from this treatment strategy. Circulating tumor cell detection and analysis could also have a crucial role in this field. A joint effort of two prospective ongoing trials (ARTO, clinical.gov identifier NCT03449719 and PRIMERA, clinical.gov identifier NCT04188275) might help to improve criteria to select patients in whom a local ablative approach might confer significant benefit. In this commentary, we summarized recent data from literature to support this thesis.
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http://dx.doi.org/10.1007/s10585-021-10072-4DOI Listing
April 2021

Charlson comorbidity index and G8 in older old adult(≥80 years) hepatocellular carcinoma patients treated with stereotactic body radiotherapy.

J Geriatr Oncol 2021 Jan 15. Epub 2021 Jan 15.

Humanitas Clinical and Research Center, IRCSS, Radiotherapy and Radiosurgery Department, Rozzano, Italy; Radiotherapy Department, University of Florence, Florence, Italy.

Introduction: Hepatocellular Carcinoma (HCC) is characterized, in Western countries, by higher incidence and mortality rates in the older adult population. In frail patients, limited therapeutic resources are available due to limited expected benefit concerning the risk of treatment-related toxicity. The aim of our study is to evaluate the role of Stereotactic Body Radiotherapy (SBRT) in the clinical management of older old adults (age ≥ 80 years) HCC patients and to identify predictors of efficacy and toxicity.

Material And Methods: Clinical and treatment-related data of older old adults HCC patients treated with SBRT at our institution were retrospectively reviewed. Statistical analysis was carried out to identify variables correlated with impaired outcome and toxicity.

Results: Forty-two patients were included, accounting for 63 treated tumors. Median age was 85 (range 80-91) years. Median Charlson Comorbidity Index (CCI) and G8 scores were 10 (range 7-16) and 11 (range 8-14), respectively. SBRT was administered to a median BED10 of 103 Gy10. Median follow-up interval was 11 (range 3-40) months. Two years Local Control (LC), Progression-Free Survival (PFS), and Overall Survival (OS) were 93%, 31%, and 43%, respectively. Acute toxicity occurred in 28% (n = 13) of treatments. A G8 score > 10 was associated with improved survival (p = 0.045), while a CCI ≥10 was correlated with increased acute toxicity (p = 0.021).

Conclusions: SBRT is a safe and effective option in older old adults HCC patients. A comprehensive geriatric assessment (CGA) is advised before treatment decisions to select optimal candidates for SBRT.
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http://dx.doi.org/10.1016/j.jgo.2021.01.001DOI Listing
January 2021

Regorafenib in glioblastoma recurrence: A case report.

Cancer Treat Res Commun 2021 10;26:100263. Epub 2020 Dec 10.

Azienda Ospedaliero-Universitaria Careggi, Radiation Oncology Unit, Florence, Italy.

GBM (glioblastoma multiforme) is the most common and aggressive brain tumor. To date, treatment options for glioblastoma recurrence are lacking. Recently, REGOMA trial showed the superiority of regorafenib to lomustine in patients with first glioblastoma recurrence. We report an excellent response to three months treatment with regorafenib, in a patient who presented a rapid progression after the end of post operative radio-chemotherapy and after only one cycle of adjuvant TMZ (Temozolomide).
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http://dx.doi.org/10.1016/j.ctarc.2020.100263DOI 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

Methodological approach to create an atlas using a commercial auto-contouring software.

J Appl Clin Med Phys 2020 Dec 25;21(12):219-230. Epub 2020 Nov 25.

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

Purpose: The aim of this work was to establish a methodological approach for creation and optimization of an atlas for auto-contouring, using the commercial software MIM MAESTRO (MIM Software Inc. Cleveland OH).

Methods: A computed tomography (CT) male pelvis atlas was created and optimized to evaluate how different tools and options impact on the accuracy of automatic segmentation. Pelvic lymph nodes (PLN), rectum, bladder, and femurs of 55 subjects were reviewed for consistency by a senior consultant radiation oncologist with 15 yr of experience. Several atlas and workflow options were tuned to optimize the accuracy of auto-contours. The deformable image registration (DIR), the finalization method, the k number of atlas best matching subjects, and several post-processing options were studied. To test our atlas performances, automatic and reference manual contours of 20 test subjects were statistically compared based on dice similarity coefficient (DSC) and mean distance to agreement (MDA) indices. The effect of field of view (FOV) reduction on auto-contouring time was also investigated.

Results: With the optimized atlas and workflow, DSC and MDA median values of bladder, rectum, PLN, and femurs were 0.91 and 1.6 mm, 0.85 and 1.6 mm, 0.85 and 1.8 mm, and 0.96 and 0.5 mm, respectively. Auto-contouring time was more than halved by strictly cropping the FOV of the subject to be contoured to the pelvic region.

Conclusion: A statistically significant improvement of auto-contours accuracy was obtained using our atlas and optimized workflow instead of the MIM Software pelvic atlas.
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http://dx.doi.org/10.1002/acm2.13093DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769405PMC
December 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

Impact of COVID-19 on patient-doctor interaction in a complex radiation therapy facility.

Support Care Cancer 2021 Jun 2;29(6):2931-2937. Epub 2020 Oct 2.

Department of Biomedical, Experimental, and Clinical Sciences "Mario Serio", University of Florence, Viale Morgagni 85, 50134, Florence, Italy.

Purpose: In the last months, Italy faced a COVID-19 emergency and implemented preventive measures in order to protect patients and healthcare providers from a disease outbreak. The pandemic control strategies impacted patient experience directly. Questionnaires evaluating patients reported measures (PREMs) may assess critical issues and represent a helpful tool to measure the patient perception of healthcare service. Our aim was to prospectively assess patient satisfaction about doctor-patient interaction in a high-volume radiation therapy and oncology center during the COVID-19 pandemic.

Methods: Cancer patients receiving either systemic and/or radiation treatment underwent a survey. Two validated questionnaires (EORTC QLQ-C30, FACIT-TS-G version 1) and 14 specific questions evaluating patients' perception of COVID-19 measures were administered.

Results: One hundred twenty-five patients admitted to our department from 1-30 April 2020 completed the questionnaires. The majority (66.4%) of patients were women and the most common disease was breast cancer (40%). The average Global Health Status (GHS) of EORTC QLQ-C30 was 61.67. Emotional functioning, social, and cognitive domains obtained scores of 75.48, 80.13, and 84.67, respectively. FACIT-TS-G results revealed 120 patients rated the treatments effective and 108 patients thought the side effects were the same as expected or better. Most (89.6%) rated their treatment good, very good, or excellent. Concerning COVID-19-related questions, patients reported overall very good level of information.

Conclusions: Despite the introduction of strict COVID-19 control measures, there was a high level of cancer outpatient satisfaction. The satisfaction levels may influence compliance, continuity of treatments, and patient-doctor communication, impacting the quality of clinical care in the next phases of the pandemic.
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http://dx.doi.org/10.1007/s00520-020-05793-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531068PMC
June 2021

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

Clinical outcomes and secondary glaucoma after gamma-knife radiosurgery and Ruthenium-106 brachytherapy for uveal melanoma: a single institution experience.

Melanoma Res 2021 02;31(1):38-48

Eye Clinic, Neuromuscular and Sense Organs Department.

We retrospectively analyzed data from records of 48 patients (48 eyes) treated with gamma-knife (n = 18) or Ruthenium-106 brachytherapy (n = 30) for uveal melanoma, in our Ocular Oncology Unit between December 2013 and September 2019, with the aim to evaluate treatment outcomes, and incidence and risk factors for secondary glaucoma. Patients demographics and tumor characteristics at diagnosis were recorded. Follow-up data were collected regarding local tumor control, treatment complications, enucleation need, metastases occurrence and survival status. The median follow-up period was 33.7 months in the gamma-knife group and 26.2 months in the brachytherapy group. The mean tumor thickness, the largest basal diameter and the tumor volume were significantly higher in the gamma-knife group than in the brachytherapy group. The local tumor control rate was 100% in the brachytherapy group and 77.8% in the gamma-knife group. In the gamma-knife group, six patients were enucleated, no patient treated with brachytherapy underwent enucleation. The overall survival rate was 96.7% in the brachytherapy group and 94.44% in the gamma-knife group. Secondary glaucoma occurred in 10 patients after gamma-knife and in one patient after brachytherapy: it should be emphasized that larger lesions were treated with gamma-knife, whereas smaller tumors were selected for brachytherapy. We found a significative correlation of tumor thickness (P value = 0.043) and volume (P value = 0.040) with secondary glaucoma occurrence after gamma-knife treatment. Moreover, secondary glaucoma significantly correlated with radiation retinopathy in the gamma-knife group (P value = 0.009). This study shows preliminary clinical results that could be useful for further studies with more patients and longer follow-up.
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http://dx.doi.org/10.1097/CMR.0000000000000689DOI Listing
February 2021

Exclusive endocrine therapy or partial breast irradiation for women aged ≥70  years with luminal A-like early stage breast cancer (NCT04134598 - EUROPA): Proof of concept of a randomized controlled trial comparing health related quality of life by patient reported outcome measures.

J Geriatr Oncol 2021 Mar 29;12(2):182-189. Epub 2020 Jul 29.

Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Azienda Ospedaliero Universitaria Careggi, Florence, Italy.

Background: Postoperative radiation therapy after breast conserving surgery in the older adult population is a matter of debate; although radiation therapy was shown to benefit these patients concerning local disease control, the absolute benefit was small and potentially negligible. Partial breast irradiation has been introduced as an alternative treatment approach for low-risk patients. Older adult patients with early breast cancer constitute a unique population with regards to prognosis and potential comorbidities, thus minimizing treatment to maintain health-related quality of life (HRQoL) without compromising survival is extremely important. Estimates of the patient's risk of benefit and/or harm with treatment should be performed together with an assessment of baseline comorbidities, life expectancy, and care preferences. Published data suggest that radiation therapy or endocrine therapy alone resulted in excellent disease control in older women with early breast cancer, and that the combination of both treatments has less incremental benefit than expected. Conversely, the toxicity profile of endocrine therapy is well known, often significantly impacting long term HRQoL of these potentially frail patients.

Methods: Patients older than 70  years receiving breast conserving surgery with T1N0, Luminal A-like tumors will be randomized to receive partial breast irradiation-alone or endocrine therapy-alone. The main objectives are to determine patient reported outcome measures in terms of HRQoL, as assessed by the EORTC QLQ-C30 using the global health status of patients, and to demonstrate a non-inferior local control rate between arms. Secondary endpoints are represented by individual scales from QLQ-C30 and module QLQ-BR45 scores; ELD14 questionnaire; geriatric COre DatasEt assessment; distant control rate, adverse events rates, breast cancer specific, and overall survival.

Discussion: The EUROPA trial is a new randomized trial focused on older adults (≥70  years) affected by good prognosis primary breast cancer. Our assumption is that postoperative radiation therapy-alone avoids the long-term toxicity of endocrine therapy and favorably impacts on HRQoL in this population. In the current report we present the trial's background and methods, focusing on perspectives in the field of precision medicine.

Trial Registration: The trial is registered with ClinicalTrial.gov Identifier NCT04134598 / EUROPA trial.
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http://dx.doi.org/10.1016/j.jgo.2020.07.013DOI Listing
March 2021

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

Cyclin-Dependent Kinase 4/6 Inhibitors Combined With Radiotherapy for Patients With Metastatic Breast Cancer.

Clin Breast Cancer 2020 12 26;20(6):495-502. Epub 2020 May 26.

Department of Experimental and Clinical Biomedical Sciences "M. Serio," University of Florence, Florence, Italy; Oncology Department, Radiation Oncology Unit, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.

Background: The cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) represent the standard treatment for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. Data about the balance between efficacy and toxicity of combined palliative radiotherapy (RT) and CDK4/6 inhibition are lacking.

Patients And Methods: We undertook a review of 46 patients with metastatic breast cancer on systemic treatment with CDK4/6i who underwent 62 metastases-directed RT. Clinical, laboratory, and RT treatment planning data were collected. Statistical analyses included Student t test, paired sample t test, and logistic regression modeling.

Results: Thirty patients (65.2%) received palbociclib, 15 (32.6%) received ribociclib, and one patient received abemaciclib (2.2%). Median total prescribed RT dose was 20 Gy (range, 8-63 Gy). Sites of RT were bone (n = 50; 80.7%), visceral (n = 7; 11.3%), or brain metastases (n = 3; 4.8%), as well as primary tumor of the breast (n = 2; 3.2%). Overall, the rates of grade 3 or higher adverse events (AEs) were 6.5%, 4.3%, 15.2%, and 23.9% before the start of RT, during RT, 2 and 6 weeks after RT completion, respectively. We found no correlation between dose distribution to organs at risk and the development of AEs. The local control rates for the entire cohort were 98% at 6 months and 90% at 12 months. Overall, pain relief (complete or partial) was experienced by 80% (24/30) of patients who initially reported pain at the treated metastatic site.

Conclusion: We observed a modest increase in the rates of grade 3 or higher AEs after combined RT and CDK4/6i, with maintained efficacy of concomitant RT.
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http://dx.doi.org/10.1016/j.clbc.2020.05.013DOI Listing
December 2020

Recent advances in de-intensification of radiotherapy in elderly cancer patients.

F1000Res 2020 27;9. Epub 2020 May 27.

Department of Experimental and Clinical Biomedical Sciences Biochemistry, Radiotherapy Unit, University of Florence, Florence, Italy.

Cancer in the elderly remains an evolving issue and a health challenge. Several improvements in the radiotherapy field allow the delivery of higher doses/fractions with a safe toxicity profile, permitting the reduction of radiation treatment protocols in the elderly. Regarding breast, prostate, and lung cancer, the under-representation of older patients in clinical trials limits the extension of treatment recommendations to elderly patients in routine clinical practice. Among the feasible alternatives to standard whole breast radiotherapy (WBRT) in older patients are shorter courses using higher hypofractionation (HF) and accelerated partial breast irradiation (APBI). The boost continues to be used in women at high risk of local recurrence but is less widely accepted for women at lower risk and patients over 70 years of age. Regarding prostate cancer, there are no published studies with a focus on the elderly. Current management decisions are based on life expectancy and geriatric assessment. Regimens of HF and ultra-HF protocols are feasible strategies for older patients. Several prospective non-randomized studies have documented the safe delivery of ultra-HF for patients with localized prostate cancer, and multiple phase III trials and meta-analyses have confirmed that the HF regimen should be offered with similar acute toxicity regardless of patient age and comorbidity. A recent pooled analysis from two randomized trials comparing surgery to stereotactic body radiation therapy (SBRT) in older adult patients with early stage non-small cell lung cancer did show comparable outcomes between surgery and SBRT. Elderly cancer patients are significantly under-represented in all clinical trials. Thus, the inclusion of older patients in clinical studies should be strongly encouraged to strengthen the evidence base for this age group. We suggest that the creation of oncogeriatric coordination units may promote individualized care protocols, avoid overtreatment with aggressive and unrecommended therapies, and support de-escalating treatment in elderly cancer patients.
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http://dx.doi.org/10.12688/f1000research.21151.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255897PMC
July 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

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

Caring for older patients with cancer during the COVID-19 pandemic: A Young International Society of Geriatric Oncology (SIOG) global perspective.

J Geriatr Oncol 2020 09 10;11(7):1175-1181. Epub 2020 May 10.

Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Seccion XVI, 14080, Tlalpan, Mexico City, Mexico. Electronic address:

The ongoing coronavirus disease 2019 (COVID-19) pandemic has affected millions of people in over 180 territories, causing a significant impact on healthcare systems globally. Older adults, as well as people living with cancer, appear to be particularly vulnerable to COVID-19 related morbidity and mortality, which means that older adults with cancer are an especially high-risk population. This has led to significant changes in the way geriatric oncologists provide care to older patients, including the implementation of novel methods for clinical visits, interruptions or delays in procedures, and modification of therapeutic strategies, both in the curative and palliative settings. In this manuscript, we provide a global overview of the perspectives of geriatric oncology providers from countries across Europe, America, and Asia, regarding the adaptive strategies utilized to continue providing high quality care for older patients with cancer during the COVID-19 pandemic. Through these perspectives, we attempt to show that, although each country and setting has specific issues, we all face similar challenges when providing care for our older patients with cancer during these difficult times.
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http://dx.doi.org/10.1016/j.jgo.2020.05.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7252080PMC
September 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

Thermal Ablation versus SBRT in liver tumours: pros and cons.

Med Oncol 2020 Apr 29;37(6):52. Epub 2020 Apr 29.

Radiotherapy Department, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.

Non-surgical locally ablative treatments for primary liver cancer and liver metastases represent an effective therapeutic choice when surgery cannot be performed or is not indicated. Thermal ablative employing electric currents or electromagnetic fields have historically played an important role in this setting. Radiotherapy, in the last decades, due to a series of important technological development, has become an attractive option for the treatment of liver tumours, especially with the introduction of Stereotactic Body Radiotherapy. Published literature so far evidenced both for radiotherapy and thermal ablative techniques a benefit in terms of local control and other oncological outcomes; however, no direct prospective comparison between the two techniques have been published so far. The aim of this review is to summarize the technical and clinical implications of these treatment modalities and to identify criteria to allocate patients to one or another option in consideration of the expected efficacy. The main features and critical aspects of both thermoablative techniques and external beam radiation will also be covered in the present paper.
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http://dx.doi.org/10.1007/s12032-020-01377-7DOI Listing
April 2020

Artificial Intelligence in radiotherapy: state of the art and future directions.

Med Oncol 2020 Apr 22;37(6):50. Epub 2020 Apr 22.

Radiotherapy Department, University of Florence, Florence, Italy.

Recent advances in computing capability allowed the development of sophisticated predictive models to assess complex relationships within observational data, described as Artificial Intelligence. Medicine is one of the several fields of application and Radiation oncology could benefit from these approaches, particularly in patients' medical records, imaging, baseline pathology, planning or instrumental data. Artificial Intelligence systems could simplify many steps of the complex workflow of radiotherapy such as segmentation, planning or delivery. However, Artificial Intelligence could be considered as a "black box" in which human operator may only understand input and output predictions and its application to the clinical practice remains a challenge. The low transparency of the overall system is questionable from manifold points of view (ethical included). Given the complexity of this issue, we collected the basic definitions to help the clinician to understand current literature, and overviewed experiences regarding implementation of AI within radiotherapy clinical workflow, aiming to describe this field from the clinician perspective.
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http://dx.doi.org/10.1007/s12032-020-01374-wDOI Listing
April 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

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

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