Publications by authors named "Fabiola Paiar"

98 Publications

[F]FMCH PET/CT biomarkers and similarity analysis to refine the definition of oligometastatic prostate cancer.

EJNMMI Res 2021 Nov 27;11(1):119. Epub 2021 Nov 27.

Nuclear Medicine, Department of Translational Research and Advanced Technology in Medicine and Surgery University of Pisa, Pisa University Hospital, Via Roma 67, 56123, Pisa, Italy.

Background: The role of image-derived biomarkers in recurrent oligometastatic Prostate Cancer (PCa) is unexplored. This paper aimed to evaluate [F]FMCH PET/CT radiomic analysis in patients with recurrent PCa after primary radical therapy. Specifically, we tested intra-patient lesions similarity in oligometastatic and plurimetastatic PCa, comparing the two most used definitions of oligometastatic disease.

Methods: PCa patients eligible for [F]FMCH PET/CT presenting biochemical failure after first-line curative treatments were invited to participate in this prospective observational trial. PET/CT images of 92 patients were visually and quantitatively analyzed. Each patient was classified as oligometastatic or plurimetastatic according to the total number of detected lesions (up to 3 and up to 5 or > 3 and > 5, respectively). Univariate and intra-patient lesions' similarity analysis were performed.

Results: [F]FMCH PET/CT identified 370 lesions, anatomically classified as regional lymph nodes and distant metastases. Thirty-eight and 54 patients were designed oligometastatic and plurimetastatic, respectively, using a 3-lesion threshold. The number of oligometastic scaled up to 60 patients (thus 32 plurimetastatic patients) with a 5-lesion threshold. Similarity analysis showed high lesions' heterogeneity. Grouping patients according to the number of metastases, patients with oligometastatic PCa defined with a 5-lesion threshold presented lesions heterogeneity comparable to plurimetastic patients. Lesions within patients having a limited tumor burden as defined by three lesions were characterized by less heterogeneity.

Conclusions: We found a comparable heterogeneity between patients with up to five lesions and plurimetastic patients, while patients with up to three lesions were less heterogeneous than plurimetastatic patients, featuring different cells phenotypes in the two groups. Our results supported the use of a 3-lesion threshold to define oligometastatic PCa.
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http://dx.doi.org/10.1186/s13550-021-00858-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8627538PMC
November 2021

Adjuvant Radiotherapy in Patients With Pancreatic Adenocarcinoma. Is It Still Appealing in Clinical Trials? A Meta-analysis and Review of the Literature.

Anticancer Res 2021 Oct;41(10):4697-4704

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

Aim: Pancreatic adenocarcinoma is a life-threatening disease with a rising frequency and the fourth leading cause of cancer death. This review aimed to assess the impact of postoperative radiotherapy through a meta-analysis of prospective randomized studies.

Materials And Methods: Six studies met the inclusion criteria and were analyzed to calculate the cumulative risk of death (hazard ratio) in patients affected by pancreatic cancer treated with or without radiotherapy. Higgins' index was used to determine heterogeneity in between-study variability and, subsequently, the random-effects model was applied according to DerSimonian and Laird.

Results: Eight hundred and thirty-seven patients were analyzed (418 in the control arm and 419 in the treatment one), the hazard ratio for death after randomization was 0.92 (p=0.560, 95% confidence interval=0.70-1.22). When scrutinizing these studies, only one out of six showed a statistically significant benefit due to the addition of radiotherapy in the postoperative setting.

Conclusion: We conclude that the use of adjuvant radiotherapy is not beneficial in treating all patients affected by pancreatic cancer but only for a subset of cases with potential residual local disease.
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http://dx.doi.org/10.21873/anticanres.15283DOI Listing
October 2021

Impact of recurrence pattern in patients undergoing a second surgery for recurrent glioblastoma.

Acta Neurol Belg 2021 Aug 16. Epub 2021 Aug 16.

Radiation Oncology Unit, Pisa University Hospital, Via Roma 67, 56123, Pisa, Italy.

The impact of different patterns of glioblastoma (GBM) recurrence has not yet been fully established in patients suitable for a second surgery. Through the present observational study carried out at Pisa University Hospital, we aimed to investigate how different patterns of GBM failure influence second surgery outcomes. Overall survival (OS) and post-recurrence survival (PRS) were assessed according to clinical characteristics, including pattern of recurrence, in a prospective cohort of recurrent GBM patients. Survival curves were calculated using the Kaplan-Meier method and the log-rank test was applied to evaluate the differences between curves. Patients with local recurrence had better OS than patients with non-local one, 24.1 versus 18.2 months, respectively [P = 0.015, HR = 1.856 (1.130-3.050)]. The second surgery conferred an advantage in OS respect to non-operated patients, however, this advantage was more evident in patients with local recurrence [P = 0.002 with HR 0.212 (95% CI 0.081-0.552) and P = 0.029 with HR = 0.522 (95% CI 0.291-0.936), respectively]. The recurrence pattern can influence the outcome of patients with recurrent GBM suitable for a second surgery.
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http://dx.doi.org/10.1007/s13760-021-01765-4DOI Listing
August 2021

MRI-based radiomics: promise for locally advanced cervical cancer treated with a tailored integrated therapeutic approach.

Tumori 2021 Jul 8:3008916211014274. Epub 2021 Jul 8.

Department of New Technologies and Translational Research, Division of Radiation Oncology, University of Pisa, Pisa, Italy.

Objective: To assess prognostic factors by analyzing clinical and radiomic data of patients with locally advanced cervical cancer (LACC) treated with definitive concurrent cisplatin-based chemoradiotherapy (CCRT) using magnetic resonance imaging (MRI).

Methods: We analyzed radiomic features from MRI in 60 women with FIGO (International Federation of Gynecology and Obstetrics) stage IB2-IVA cervical cancer who underwent definitive CCRT 45-50.4 Gy (in 25-28 fractions). Thirty-nine (65.0%) received EBRT sequential boost (4-20 Gy) on primary tumor site and 56 (93.3%) received high-dose-rate brachytherapy boost (6-28 Gy) (daily fractions of 5-7 Gy). Moreover, 71.7% of patients received dose-dense neoadjuvant chemotherapy for 6 cycles. The gross tumor volume was defined on T2-weighted sequences and 29 features were extracted from each MRI performed before and after CCRT, using dedicated software, and their prognostic value was correlated with clinical information.

Results: In univariate analysis, age ⩾60 years and FIGO stage IB2-IIB had significantly better progression-free survival (PFS) ( = 0.022 and = 0.009, respectively). There was a trend for significance for worse overall survival (OS) in patients with positive nodes ( = 0.062). In multivariate analysis, only age ⩾60 years and FIGO stage IB2-IIB reached significantly better PFS ( = 0.020 and = 0.053, respectively). In radiomic dataset, in multivariate analysis, pregray level p75 was significantly associated with PFS ( = 0.047), pre-D3D value with OS ( = 0.049), and preinformation measure of correlation value with local control ( = 0.031).

Conclusion: The combination of clinical and radiomics features can provide information to predict behavior and prognosis of LACC and to make more accurate treatment decisions.
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http://dx.doi.org/10.1177/03008916211014274DOI Listing
July 2021

Surgical outcome and molecular pattern characterization of recurrent glioblastoma multiforme: A single-center retrospective series.

Clin Neurol Neurosurg 2021 08 8;207:106735. Epub 2021 Jun 8.

Department of Neurosurgery, Azienda Ospedaliera Universitaria Pisana (AOUP), Pisa, Italy; Department of Translational Research and of New Surgical and Medical Technologies, University of Pisa, Pisa, Italy.

Objective: Despite recent advances in diagnosis and treatment of the disease, the prognosis of patients with glioblastoma multiforme (GBM) remains poor. While the value of molecular pattern profiles at first diagnosis has been demonstrated, only few studies have examined these biomarkers at the time of recurrence. The aim of this study was to explore the impact of extent of resection at repeated craniotomy on overall survival (OS) of patients with recurrent GBM. In addition, we investigated the molecular pattern profiles at first and second surgery to evaluate possible temporal evolution of these patterns and to assess the effect of these modifications on OS.

Methods: We conducted a retrospective cohort study of 63 patients (mean age 59.2 years) surgically treated at least two times for recurrent GBM between 2006 and 2020.

Results: Median OS and progression-free survival (PFS) were 22 months (range 2-168 months) and 10 months (range 1-96 months), respectively. The OS following gross-total resection (GTR) at recurrence for patients with initial GTR (GTR/GTR) was significantly increased (42.6 months) compared with sub-total resection (STR) at reoperation after initial GTR (GTR/STR) (19 months) and with GTR at reoperation after initial STR (STR/GTR) (17 months) (p = 0.0004). Overall surgical morbidity resulted 12.7% and 11.1% at first and at second surgery, respectively. Changes in genetic profiles between first and second surgery of 1p/19q co-deletion, MGMT promoter methylation and p53 mutations occurred in 5.6%, 1.9% and 9.3% of cases, respectively. MGMT promoter methylation appeared to affect OS in univariate analysis at first (p = 0.038) and second surgery (p = 0.107), whereas p53 mutation appeared to affect OS only at second surgery (p = 0.01). In a multivariate analysis female sex (HR = 0.322, 95% CI 0.147-0.705; p = 0.005), PFS (HR = 0.959, 95% CI 0.934-0.986; p = 0.003), GTR at first and second surgery (HR = 0.195, 95% CI 0.091-0.419; p < 0.0001) and adjuvant chemotherapy at recurrence (HR = 0.407, 95% CI 0.206-0.809; p = 0.01) were associated with longer OS.

Conclusions: This study confirmed the role of extent of resection (EOR) at first and at recurrence as a significant predictor of outcome in patients with recurrent GBM. In addition, this study highlighted the concept of a dynamic evolution of GBM genome after initial surgical resection, supporting the need of further studies to investigate the clinical and therapeutic implications of the changes in genetic profiles after initial surgery.
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http://dx.doi.org/10.1016/j.clineuro.2021.106735DOI Listing
August 2021

DICOM-MIABIS integration model for biobanks: a use case of the EU PRIMAGE project.

Eur Radiol Exp 2021 May 12;5(1):20. Epub 2021 May 12.

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

PRIMAGE is a European Commission-financed project dealing with medical imaging and artificial intelligence aiming to create an imaging biobank in oncology. The project includes a task dedicated to the interoperability between imaging and standard biobanks. We aim at linking Digital imaging and Communications in Medicine (DICOM) metadata to the Minimum Information About BIobank data Sharing (MIABIS) standard of biobanking. A very first integration model based on the fusion of the two existing standards, MIABIS and DICOM, has been developed. The fundamental method was that of expanding the MIABIS core to the imaging field, adding DICOM metadata derived from CT scans of 18 paediatric patients with neuroblastoma. The model was developed with the relational database management system Structured Query Language. The integration data model has been built as an Entity Relationship Diagram, commonly used to organise data within databases. Five additional entities have been linked to the "Image Collection" subcategory in order to include the imaging metadata more specific to the particular type of data: Body Part Examined, Modality Information, Dataset Type, Image Analysis, and Registration Parameters. The model is a starting point for the expansion of MIABIS with further DICOM metadata, enabling the inclusion of imaging data in biorepositories.
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http://dx.doi.org/10.1186/s41747-021-00214-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8113005PMC
May 2021

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

Crit Rev Oncol Hematol 2021 Jun 29;162:103345. Epub 2021 Apr 29.

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

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

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

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

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

High-dose-rate brachytherapy for non-melanoma skin cancer using tailored custom moulds - a single-centre experience.

Contemp Oncol (Pozn) 2021 24;25(1):12-16. Epub 2021 Mar 24.

Division of Radiation Oncology, University of Pisa, Pisa, Italy.

Aim Of The Study: The aim of this retrospective study was to analyse tumour control, toxicity, and aesthetic outcome of patients affected by non-melanoma skin cancer (NMSC) treated with 192 Ir high-dose-rate (HDR)-brachytherapy (BT) at the Division of Radiotherapy, University of Pisa.

Material And Methods: From January 2014 to December 2019 we treated 37 patients (median age 79 years; range 31-91 years) affected by NMSC, with the following histological subtypes: 62.2% basal cell carcinoma and 37.8% squamous cell carcinoma. We analysed 40 lesions with a depth ≤ 5 mm, located in 40.0% scalp, 17.5% nose, 25.0% face, and 17.5% ear, all treated with 192 Ir-based HDR-BT, using tailored custom moulds, with a median of 5 catheters (range, 1-9) spaced 1 cm apart. The most common fractionation scheme was 40 Gy in 8 daily fractions; the biological effective dose was 60 Gy.

Results: The median follow-up was 25 months (range, 3-70 months). The 2-year local control rate was 90%. Common terminology criteria for adverse event (CTCAE vs. 5.0) G1 toxicities were dermatitis (52%), pain (25%), and ulceration (22%). The only G2 acute toxicities were dermatitis and ulceration. The most common G1 late toxicities were fibrosis (17%), atrophy (15%), and hypopigmentation (12%). No G3 or higher acute or late toxicity was reported. Excellent cosmetic results were observed in 65.0% of the lesions; only 1 case (2.5%) reported a poor cosmetic result.

Conclusions: Surface mould HDR-BT is a safe, effective, and well tolerated treatment modality for NMSC and can be considered a good alternative, especially for elderly patients who are often unfit for surgery.
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http://dx.doi.org/10.5114/wo.2021.104688DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8063903PMC
March 2021

Association of XRCC3 rs1799794 polymorphism with survival of glioblastoma multiforme patients treated with combined radio-chemotherapy.

Invest New Drugs 2021 08 8;39(4):1159-1165. Epub 2021 Feb 8.

Radiation Oncology Unit, Pisa University Hospital, Via Roma 67, 56123, Pisa, Italy.

This study reports the results of a monocentric prospective analysis conducted with the aim of evaluating the impact of XRCC1 rs25487, XRCC3 rs861539, XRCC3 rs1799794, RAD51 rs1801320 and GSTP-1 rs1695 single nucleotide polymorphisms (SNP) on patients with high-grade glioma treated with concomitant radio-chemotherapy. From October 2010 to August 2019, a total of 75 patients aged ≥18 years, with histological diagnosis of high-grade glioma, isocitrate dehydrogenase (IDH) 1/2 wild type and treated with radio-chemotherapy and sequential chemotherapy with temozolomide (TMZ) were prospectively recruited. The local ethic committee approved this study (Comitato Etico di Area Vasta Nord Ovest [CEAVNO]; protocol 3304/2011). After a median follow up of 25 months (range: 7-98 months), median progression-free survival (PFS) and overall survival (OS) were 11 months (CI95%: 8-14 months) and 18 months (CI95%: 15-21 months), respectively. In univariate and multivariate Cox regression analysis, a statistically significant association with PFS and OS was found with XRCC3 rs1799794 SNP. The study suggests that XRCC3 rs1799794 SNP can be associated with different PFS and OS in glioblastoma patients treated with radio-chemotherapy.
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http://dx.doi.org/10.1007/s10637-021-01075-9DOI Listing
August 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

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 04 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
April 2021

Radiotherapy in the COVID-19 Pandemic Era.

In Vivo 2020 Nov-Dec;34(6):3731-3734

Department of Radiation Oncology, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.

Background/aim: In 2020, because of coronavirus pandemic, medical activities changed. The aim of this report is to compare the volumes of Pisa radiotherapy activities from March 9 to May 31, 2020, with the same period in 2019.

Patients And Methods: We analyzed the activity of our Unit to evaluate how logistics changes, related to the COVID-19 epidemic, impacted on volumes of radiotherapy (RT) activity and on the number of cases of COVID-19 infections observed in healthcare professionals and patients.

Results: The total number of first-time visits between March-May 2020 was reduced by 18%, probably due to delays in diagnosis and histological tests as well as the temporary closure of the operating rooms. None of the healthcare professionals and only two patients contracted the infection.

Conclusion: We were able to treat all patients referred to our hospital and we were able to reduce risk of infection for both our patients and healthcare staff, guaranteeing continuum of care for our oncological patients.
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http://dx.doi.org/10.21873/invivo.12222DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811622PMC
November 2020

Brain metastases from primary colorectal cancer: is radiosurgery an effective treatment approach? Results of a multicenter study of the radiation and clinical oncology Italian association (AIRO).

Br J Radiol 2020 Dec 22;93(1116):20200951. Epub 2020 Oct 22.

Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Hospital-IRCCS, Rozzano (MI), Italy.

Objectives: The prognosis of brain metastatic colorectal cancer patients (BMCRC) is poor. Several local treatments have been used, but the optimal treatment choice remains an unresolved issue. We evaluated the clinical outcomes of a large series of BMCRC patients treated in several Italian centers using stereotactic radiosurgery (SRS).

Methods: 185 BMCRC patients for a total of 262 lesions treated were evaluated. Treatments included surgery followed by post-operative SRS to the resection cavity, and SRS, either single-fraction, then hypofractionated SRS (HSRS). Outcomes was measured in terms of local control (LC), toxicities, brain distant failure (BDF), and overall survival (OS). Prognostic factors influencing survival were assed too.

Results: The median follow-up time was 33 months (range 3-183 months). Surgery plus SRS have been performed in 28 (10.7%) cases, SRS in 141 (53.8%), and HSRS in 93 (35.5%). 77 (41.6%) patients received systemic therapy. The main total dose and fractionation used were 24 Gy in single fraction or 24 Gy in three daily fractions. Local recurrence occurred in 32 (17.3%) patients. Median, 6 months,1-year-LC were 86 months (95%CI 36-86), 87.2% ± 2.8, 77.8% ± 4.1. Median,6 months,1-year-BDF were 23 months (95%CI 9-44), 66.4% ± 3.9, 55.3% ± 4.5. Median,6 months,1-year-OS were 7 months (95% CI 6-9), 52.7% ± 3.6, 33% ± 3.5. No severe neurological toxicity occurred. Stage at diagnosis, Karnofsky Performance Status (KPS), presence and number of extracranial metastases, and disease-specific-graded-prognostic-assessment (DS-GPA) score were observed as conditioning survival.

Conclusion: SRS/HSRS have proven to be an effective local treatment for BMCRC. A careful evaluation of prognostic factors as well as a multidisciplinary evaluation is a valid aid to manage the optimal therapeutic strategy for CTC patients with BMs.

Advances In Knowledge: The prognosis of BMCRC is poor. Several local treatments was used, but optimal treatment choice remains undefined. Radiosurgery has proven to be an effective local treatment for BMCRC. A careful evaluation of prognostic factors and a multidisciplinary evaluation needed.
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http://dx.doi.org/10.1259/bjr.20200951DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716018PMC
December 2020

Incorporating dose-volume histogram parameters of swallowing organs at risk in a videofluoroscopy-based predictive model of radiation-induced dysphagia after head and neck cancer intensity-modulated radiation therapy.

Strahlenther Onkol 2021 Mar 9;197(3):209-218. Epub 2020 Oct 9.

Department of Radiation Oncology, University Hospital S. Chiara, Via Roma 55, 56100, Pisa, Italy.

Purpose: To develop a videofluoroscopy-based predictive model of radiation-induced dysphagia (RID) by incorporating DVH parameters of swallowing organs at risk (SWOARs) in a machine learning analysis.

Methods: Videofluoroscopy (VF) was performed to assess the penetration-aspiration score (P/A) at baseline and at 6 and 12 months after RT. An RID predictive model was developed using dose to nine SWOARs and P/A-VF data at 6 and 12 months after treatment. A total of 72 dosimetric features for each patient were extracted from DVH and analyzed with linear support vector machine classification (SVC), logistic regression classification (LRC), and random forest classification (RFC).

Results: 38 patients were evaluable. The relevance of SWOARs DVH features emerged both at 6 months (AUC 0.82 with SVC; 0.80 with LRC; and 0.83 with RFC) and at 12 months (AUC 0.85 with SVC; 0.82 with LRC; and 0.94 with RFC). The SWOARs and the corresponding features with the highest relevance at 6 months resulted as the base of tongue (V65 and D), the superior (D) and medium constrictor muscle (V45, V55; V65; D; D; D and D), and the parotid glands (D and D). On the contrary, the features with the highest relevance at 12 months were the medium (V55; D and D) and inferior constrictor muscles (V55, V65 D and D), the glottis (V55 and D), the cricopharyngeal muscle (D), and the cervical esophagus (D).

Conclusion: We trained and cross-validated an RID predictive model with high discriminative ability at both 6 and 12 months after RT. We expect to improve the predictive power of this model by enlarging the number of training datasets.
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http://dx.doi.org/10.1007/s00066-020-01697-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892680PMC
March 2021

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

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

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

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

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

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

Conclusions: Compared to pre-COVID era, the clinical workflow was highly re-organized, whereas there were no consistent changes in RT indications and schedules.
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http://dx.doi.org/10.1007/s11547-020-01296-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538045PMC
February 2021

Bipolar Disorder Treatments and Ovarian Cancer: A Systematic Review.

Clin Neuropsychiatry 2020 Oct;17(5):300-313

Department of Surgical Pathology, Medical, Molecular and Critical Area, University of Pisa, 57 Via Roma, Pisa, Italy.

Objective: We reviewed literature on drugs for bipolar disorders (BD), utilized in ovarian cancer (OC).

Method: We adhered to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines in completion of this systematic review.

Results: We identified 73 papers. Thirty-two studies were finally included. BD is rarely diagnosed in OC patients. Limited finding from case reports is available. Drugs used to treat BD (mainly lithium and valproic acid) have been extensively studied in add-on to chemotherapy for treatment-resistant OC cells or in animal models, with promising results in vitro but not in vivo.

Conclusions: The clinical underestimation of BD in OC has leaded to the almost complete absence of evidences for a soundly based clinical guidance in this field. There is a urgent need for a systematic multi-disciplinary approach to OC.
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http://dx.doi.org/10.36131/cnfioritieditore20200508DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8629050PMC
October 2020

Head and neck radiotherapy amid the COVID-19 pandemic: practice recommendations of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Med Oncol 2020 Aug 17;37(10):85. Epub 2020 Aug 17.

Department of Radiotherapy, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Management of patients with head and neck cancers (HNCs) is challenging for the Radiation Oncologist, especially in the COVID-19 era. The Italian Society of Radiotherapy and Clinical Oncology (AIRO) identified the need of practice recommendations on logistic issues, treatment delivery and healthcare personnel's protection in a time of limited resources. A panel of 15 national experts on HNCs completed a modified Delphi process. A five-point Likert scale was used; the chosen cut-offs for strong agreement and agreement were 75% and 66%, respectively. Items were organized into two sections: (1) general recommendations (10 items) and (2) special recommendations (45 items), detailing a set of procedures to be applied to all specific phases of the Radiation Oncology workflow. The distribution of facilities across the country was as follows: 47% Northern, 33% Central and 20% Southern regions. There was agreement or strong agreement across the majority (93%) of proposed items including treatment strategies, use of personal protection devices, set-up modifications and follow-up re-scheduling. Guaranteeing treatment delivery for HNC patients is well-recognized in Radiation Oncology. Our recommendations provide a flexible tool for management both in the pandemic and post-pandemic phase of the COVID-19 outbreak.
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http://dx.doi.org/10.1007/s12032-020-01409-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7430932PMC
August 2020

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

Angiosarcomaafteradjuvantradiotherapy in high-risksquamouscell carcinoma of the vulva: a case report.

Prz Menopauzalny 2019 Dec 15;18(4):230-232. Epub 2020 Jan 15.

Department of New Technologies and TranslationalResearch, Division of RadiationOncology, University of Pisa, Pisa, Italy.

Squamous cell carcinoma of the vulva represents 3-5% of gynecological cancers. The incidence is higher in postmenopausal patients; the mean age of women with vulvar cancer is between 64 and 70 years. Radiotherapy plays an increasing role in the treatment of high-risk squamous cell carcinoma of the vulva; associated with surgery it significantly improves prognosis but is also associated with serious late side-effects, such as secondary malignancies. We describe a case of a 75-year-old woman who underwent deep total vulvectomy with inguinal-femoral lymphadenectomy for high-risk, keratinizing variant HPV-negative, squamous cell carcinoma of the vulva, followed by adjuvant concomitant chemo-radiotherapy, at the University Hospital of Pisa in February 2013. Five years later she developed a very large angiosarcoma in the right abdominal wall, at the edge of the previous radiotherapy field, and underwent radical surgery. After four months, she developed bone metastasis of angiosarcoma, also treated with surgery. This experience shows that the use of new technologies allows the delivery of high doses of radiotherapy, significantly correlated with a better prognosis, but also associated with fortunately rare morbidity, such as radiation-induced angiosarcoma. Due to the presence of long, mostly post-menopausal survivors among irradiated patients, screening for second malignancies must be developed for selected high-risk survivor groups.
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http://dx.doi.org/10.5114/pm.2019.93114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045357PMC
December 2019

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

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

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

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

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

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

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

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

Vismodegibfor the treatment of radiation-induced basal cell carcinoma - a case report and brief literature study.

Contemp Oncol (Pozn) 2019 30;23(4):251-253. Epub 2019 Dec 30.

Department of Translational Medicine, Division of Radiation Oncology, University of Pisa, Pisa, Italy.

Vismodegib is playing an increasing role in the treatment of locally advanced or metastatic basal cell carcinoma (BCC) that is not a candidate for surgery or radiotherapy, and also in radiation-induced BCC. A 22-year-old man with a history of Hodgkin lymphoma, nodular sclerosis stage IIA, from October 1994 to February 1995 treated with 25 mg/m doxorubicin, 10 IU/m bleomycin, 6 mg/m vinblastine, and 375 mg/m dacarbazine for four cycles, followed byconformal beam radiotherapy (EBRT) on laterocervical, supraclavear, and mediastinal nodes up to a total dose of 30 Gy and following EBRT boost on mediastinal nodes up to a dose of 10 Gy. Subsequently, the patient underwent conformal EBRT on lomboaortic nodes up to total dose of 30 Gy at the University Hospital of Pisa until May 1995. There was no evidence of disease, until March 2012 when the patient developed severalBCCs, occurring in the field of prior radiation, treated with local excisions. No mutations of Hedgehog (Hh) pathway or other genes were found and nevoid basal cell carcinoma syndrome was not diagnosed. In February 2018, the patient began therapy with vismodegib at standard dose of 150 mgorally daily and was treated for 10 months, with low adverse events and with pathological complete response of disease until July 2019. This experience shows that there are, however very few, BCCs not associated with genetic disorders. Vismodegib seems to be an effective and safe therapeutic approach also for radiation-related BCCs, associated with relatively low toxicity.
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http://dx.doi.org/10.5114/wo.2019.91540DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6978755PMC
December 2019

Squamous cell carcinoma (SCC) of the Pyriform sinus with multiple metachronous brain metastases, a case report.

Radiat Oncol 2020 Jan 20;15(1):18. Epub 2020 Jan 20.

Department of Radiotherapy, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

Background: Distant Metastases from Head and Neck Squamous cell carcinomas are uncommon (9-11%) and they are usually found in the lung and less frequently in the liver, kidney and adrenals. Central nervous system (CNS) metastases are extremely rare (2-8%), and they are described mainly in patients who already have extracranial metastases. So there's scarcity of data about their optimal management .

Methods And Results: A patient presented CNS metastases after having been successfully treated with induction chemotherapy and definitive radiotherapy for a pyriform sinus carcinoma. The patient's work up, treatment and outcome are described.

Conclusions: CNS metastases from Head and Neck carcinomas are exceptionally rare. Nevertheless, clinicians should be alert of neurological symptoms in these patients, in order to set up a timely assessment and treatment. Secondarily, given the rarity of this condition, additional research on this topic is warranted in order to improve therapeutic strategies and outcomes of such patients.
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http://dx.doi.org/10.1186/s13014-020-1472-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6971903PMC
January 2020

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

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

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

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

[F]Fluorocholine PET/CT-guided stereotactic body radiotherapy in patients with recurrent oligometastatic prostate cancer.

Eur J Nucl Med Mol Imaging 2020 01 16;47(1):185-191. Epub 2019 Oct 16.

Nuclear Medicine, Pisa University Hospital, Via Roma 67, 56123, Pisa, Italy.

Background: In the last years, functional imaging has given a significant contribution to the clinical decision-making of biochemically relapsed prostate cancer (PCa). Hereby, we present a prospective study aiming to validate the role of [F]Fluoro-Methyl Choline ([F]FMCH) PET/CT in the selection of PCa patients suitable for stereotactic body radiotherapy (SBRT).

Methods: Patients with biochemical recurrence limited up to three lesions revealed by [F]FMCH PET/CT were enrolled in the present study and treated with SBRT on all active lesions. Systemic therapy-free survival since the [F]FMCH PET/CT was considered as the primary endpoint.

Results: Forty-six patients were evaluated, and a total of 67 lesions were treated. After a median follow-up of 28.9 months, systemic therapy was started in 30 patients (65.2%) and median systemic therapy-free survival was 39.1 months (95% CI 6.5-68.6); 6, 12, and 24-month ratios were 93.5%, 73.9%, and 63.1%, respectively. At univariate Cox regression analysis, Delta PSA demonstrated an impact on systemic therapy-free survival (p < 0.001).

Conclusions: Based on our findings, [F]FMCH PET/CT can identify oligometastatic prostate cancer patients suitable for SBRT, resulting in a systemic therapy-free survival of 39.1 months.
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http://dx.doi.org/10.1007/s00259-019-04482-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6885020PMC
January 2020

A multicenter real-world study of bevacizumab in heavily pretreated malignant gliomas: clinical benefit is a plausible end point?

Future Oncol 2019 May 12;15(15):1717-1727. Epub 2019 Apr 12.

Neuroncology Unit, IRCCS Regina Elena National Cancer Institute, via Elio Chianesi 53 00144, Rome, Italy.

This multicenter, retrospective study evaluates the clinical benefit (CB) of bevacizumab, alone or in combination, in recurrent gliomas (RG).  The CB was measured as a reduction of corticosteroid dosage and an improvement ≥20 points in the Karnofsky Performance Status lasting ≥3 months. We collected data of 197 RG patients. A CB was observed in 120, patients without significant differences between patients treated with bevacizumab alone or in combination. The rate of patients who achieved a CB and free from progression at 1 year was 21.5 versus 1.4% in patients who did not report CB. The majority of RG patients treated with bevacizumab reported CB. Moreover, patients with CB showed improved survival.
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http://dx.doi.org/10.2217/fon-2018-0826DOI Listing
May 2019

Patterns of Failures and Clinical Outcome of Patients with Early-Stage, High-Risk, Node-Negative Endometrial Cancer Treated with Surgery Followed by Adjuvant Platinum-Based Chemotherapy and Vaginal Brachytherapy.

Oncology 2019 22;96(5):235-241. Epub 2019 Mar 22.

Department of Experimental and Clinical Medicine, Division of Gynecology and Obstetrics, University of Pisa, Pisa, Italy.

Objective: To assess the clinical outcome of patients with high-risk early-stage endometrial cancer and negative pelvic nodes who received adjuvant platinum-based chemotherapy plus vaginal brachytherapy (VBT).

Methods: This investigation assessed 80 patients who underwent hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for stage Ib-II, grade 2-3 endometrioid (n = 43) or stage Ia-II nonendometrioid (n = 37) endometrial cancer.

Results: Five-year local control rate, 5-year disease-free survival, and 5-year overall survival were 97, 87, and 97%, respectively, for endometrioid carcinoma, and 66, 50, and 72%, respectively, for nonendometrioid carcinoma.

Conclusions: This retrospective study appears to show that adjuvant platinum-based chemotherapy plus VBT achieve very good results in endometrioid carcinoma. This combined treatment seems to be less effective in nonendometrioid carcinoma.
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http://dx.doi.org/10.1159/000492430DOI Listing
May 2019

Metastasis-directed stereotactic radiotherapy for oligoprogressive castration-resistant prostate cancer: a multicenter study.

World J Urol 2019 Dec 11;37(12):2631-2637. Epub 2019 Mar 11.

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

Purpose: Herein, we report the clinical outcomes of a multicenter study evaluating the role of SBRT in a cohort of patients affected by oligoprogressive castration-resistant prostate cancer (CRPC).

Materials And Methods: This is a retrospective multicenter observational study including eleven centers. Inclusion criteria of the current study were: (a) Karnofsky performance status > 80, (b) histologically proven diagnosis of PC, (c) 1-5 oligoprogressive metastases, defined as progressive disease at bone or nodes levels (detected by means of choline PET/CT or CT plus bone scan) during ADT, (d) serum testosterone level under 50 ng/ml during ADT, (e) controlled primary tumor, (f) patients treated with SBRT with a dose of at least 5 Gy per fraction to a biologically effective dose (BED) of at least 80 Gy using an alpha-to-beta ratio of 3 Gy, (g) at least 6 months of follow-up post-SBRT.

Results: Eighty-six patients for a total of 117 lesions were treated with SBRT. The median follow-up was 30.7 months (range 4-91 months). The median new metastasis-free survival after SBRT was 12.3 months (95% CI 5.5-19.1 months). One- and two-year distant progression-free survival was 52.3% and 33.7%, respectively. Twenty-six out of 86 patients underwent a second course of SBRT due to further oligoprogressive disease: This resulted in a median systemic treatment-free survival of 21.8 months (95% CI 17.8-25.8 months). One-year systemic treatment-free survival was 72.1%.

Conclusion: SBRT appears to be a promising approach in oligoprogressive castration-resistant prostate cancer. Further investigations are warranted.
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http://dx.doi.org/10.1007/s00345-019-02717-7DOI Listing
December 2019

Definitive radiotherapy for recurrent vulvar carcinoma after primary surgery: a two-institutional Italian experience.

Tumori 2019 Jun 21;105(3):225-230. Epub 2019 Feb 21.

1 Department of Translational Medicine, Division of Radiation Oncology, University of Pisa, Italy.

Objective: To assess the clinical outcome of patients treated with radiotherapy (RT) for recurrent squamous cell carcinoma of the vulva after primary surgery.

Methods: Fifty-six patients developed recurrent disease after surgery, consisting of deep total vulvectomy with inguino-femoral lymphadenectomy in 44 (78.6%) and deep partial vulvectomy with inguino-femoral lymphadenectomy in 12 (21.4%). All patients underwent RT at the Divisions of Radiotherapy, University of Pisa and ASST Cremona, between 1992 and 2016. Forty-three patients (76.8%) underwent external beam RT and 13 (23.2%) were treated with exclusive high-dose rate brachytherapy.

Results: Five-year progression-free survival (PFS) and overall survival (OS) were 19% and 43%, respectively. Primary tumor size ⩽4 cm, early FIGO stage, and negative lymph node status were significantly associated with better PFS ( = .005, = .020 and = .036, respectively) and OS ( < .0001, = .023 and = .008, respectively). Patients with more than 1 positive lymph node at primary surgery had significantly worse PFS ( = .028) and OS ( = .001). Patients with local recurrence had significantly better PFS and OS ( = .022, = .002, respectively). RT total dose >54 Gy was associated with a lower risk of recurrence.

Conclusions: Primary tumor size, FIGO stage, nodal status, and site of recurrent disease were significant predictors of clinical outcome in patients treated with RT for recurrent squamous cell carcinoma of the vulva.
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http://dx.doi.org/10.1177/0300891618811279DOI Listing
June 2019
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