Publications by authors named "Viola Salvestrini"

11 Publications

  • Page 1 of 1

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

The NIPRO Study: An Observational, Retrospective, Multicenter Study on the Safety of the Radiotherapy and Immunotherapy Combination for Advanced-Stage NSCLC.

Clin Lung Cancer 2021 Feb 16. Epub 2021 Feb 16.

Radiotherapy Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.

Introduction: In this observational, retrospective, multicenter study, we aimed to assess the safety of the combination of local metastasis-directed radiotherapy (RT) and immunotherapy (IT) in a cohort of advanced non-small-cell lung cancer (aNSCLC) patients.

Material And Methods: We collected clinical data of aNSCLC patients who received concomitant RT and anti-PD-1/PD-L1 inhibitors in seven Italian centers from September 2015 to June 2019. Concomitant RT was defined as delivered ≤4 weeks before or after the first or last administration of immunotherapy, or within two consecutive cycles of ICI. All adverse events apparently related to RT and/or IT were graded according to the Common Terminology Criteria for Adverse Events, version 4.0, and reported in terms of incidence and severity as immune related or RT related, or combined.

Results: We analyzed the clinical charts of 187 patients. Median follow-up time was 23 months, and median overall survival was 16.5 months (range, 3-162). Thirteen patients developed pure RT-related side effects, and 43 patients (23.9%) developed immune-related side effects. No additive toxic effects were observed. A case of grade 5 pulmonary toxicity was recorded as a possible consequence of a combined effect.

Conclusion: This analysis suggests that the combination of concomitant RT and anti-PD-1/PD-L1 agents is safe, and the two toxicity profiles are independent.
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http://dx.doi.org/10.1016/j.cllc.2021.02.005DOI Listing
February 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

The role of postoperative radiotherapy for thymomas: a multicentric retrospective evaluation from three Italian centers and review of the literature.

J Thorac Dis 2020 Dec;12(12):7518-7530

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

Background: Thymoma is a rare mediastinal neoplasia. Surgery is the backbone of the treatment, but the role of postoperative radiotherapy (PORT) remains controversial. We aimed to obtain data on survival and safety in patients treated with PORT in three different Italian institutions.

Methods: We retrospectively analyzed 183 consecutive patients who underwent surgery from 1981 to 2015. According to the Masaoka-Koga staging system, 39.3%, 32.7%, 18.6% and 9.8% patients were in stage I, II, III and IV of disease, respectively. PORT was indicated in 114 patients (62.3%), while 69 subjects underwent surgery alone. Complete resection was obtained in 68 patients who underwent PORT. Adverse events (AEs) were graded according to CTCAE v4.0. We analyzed the recent literature to describe the current reports on PORT for resected thymoma.

Results: Mean follow-up was 130 months (range, 3-417 months). Overall survival (OS) at 1-, 5- and 10-year from surgery was 98.3%, 90.2% and 69.7% respectively. One-, 5- and 10-year disease specific survival (DSS) was 98.9%, 92.3% and 89.8% respectively. Disease free survival (DFS) at 1, 5 and 10 years from surgery was 96.7%, 88.3% and 82.8% respectively. Univariate analysis showed that complete resection, cell histology A-AB-B1 and stages I-II were significant predictors of better DSS and DFS. Multivariate analysis showed that sex, R0 margins and WHO histology was independent prognostic factors. Among patients treated with PORT, a trend towards better OS was evident with Masaoka stage I-II (P=0.09). Patients with R0 margins treated with PORT showed better OS and DSS (P=0.05). No differences in DSS for performance status (P=0.70), WHO histology (P=0.19), paraneoplastic syndrome (P=0.23) and surgical procedure (P=0.53) were evident. Patients treated with PORT had a higher level of acute AEs compared to surgery alone, but none of these was graded ≥3.

Conclusions: Our results confirmed that patients with incompletely resected thymoma had the worst OS and DSS. High grade acute toxicity was not different between PORT and surgery alone. Other trials reported a significant benefit in OS, DSS and DFS in stage IIb-IV thymoma treated with PORT.
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http://dx.doi.org/10.21037/jtd-2019-thym-09DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7797870PMC
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

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

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

Hypofractionated whole breast irradiation after conservative surgery for patients aged less than 60 years: a multi-centre comparative study.

Acta Oncol 2020 Feb 25;59(2):188-195. Epub 2019 Nov 25.

Department of Radiation Oncology, Ewha Womans University College of Medicine, Seoul, Republic of Korea.

For decades, conventional fractionated whole breast irradiation (CF-WBI) was used after breast conserving surgery (BCS). Pivotal phase-3 trials on hypofractionated-WBI (HF-WBI) showed its non-inferiority as compared to CF-WBI. However, younger patients are often not treated with HF-WBI. The aim of this multi-centre comparative study is to confirm the safety of HF-WBI in a real-life series of younger patients. Between 2010 and 2016, a total of 786 patients aged less than 60 years old with early-stage breast cancer were treated with postoperative WBI after BCS in three breast cancer centres: 340 underwent HF-WBI while 446 were treated with CF-WBI. Acute toxicity was evaluated at the end of WBI. Late toxicity was evaluated at 6, 12, 24 and 36 months. At univariate logistic analysis, hypofractionation showed a significant protective effect in terms of acute oedema, acute wet desquamation, chronic oedema, chronic erythema/pigmentation and breast fibrosis. At multivariate logistic analysis, hypofractionation was an independent significant factor for acute oedema, acute wet desquamation, and chronic oedema. There were not differences in tumour-related outcomes. HF-WBI showed significantly improved outcomes in terms of acute skin oedema, wet desquamation and chronic skin oedema. HF-WBI after BCS should be strongly encouraged to replace CF-WBI independently of age.
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http://dx.doi.org/10.1080/0284186X.2019.1695061DOI Listing
February 2020

Clinical outcome of stereotactic body radiotherapy for lung-only oligometastatic head and neck squamous cell carcinoma: Is the deferral of systemic therapy a potential goal?

Oral Oncol 2019 06 8;93:1-7. Epub 2019 Apr 8.

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

Objectives: Oligometastatic head and neck squamous cell carcinoma (HNSCC) is a rare entity with no evidence-based treatment recommendations available to support the use of local ablative therapies. The aim of our study was to report on the clinical benefit of stereotactic body radiotherapy (SBRT) for patients with lung-only oligometastases, defined by the presence of 1 to 5 pulmonary lesions.

Material And Methods: SBRT was applied in case of single lesions deemed amenable to local treatment only ("de novo" pattern) or after first line chemotherapy at time of disease oligoprogression ("induced" pattern). To assess the potential deferral of systemic therapy in both time points, we analyzed time to progression (TTP) defined as the time from the last day of SBRT to disease progression or death from any cause. Cox regression analysis was performed to identify predictive factors of better outcome.

Results: Twenty-seven patients were retrospectively evaluated. The majority (81.5%) had HPV negative disease and a "de novo" oligometastatic pattern (78.6%). The median maximum lesion diameter and target size were 1.5 cm and 22.7 cc, respectively. At a median follow-up of 22 months (range 6-73), the median TTP was 10 months (95% CI: 9.5-21.1), with 1- and 2-year rates of 56.2% and 35%, respectively. The objective response rate at 3 months after SBRT was 75%. At multivariate analysis baseline T3/T4 stage had a HR for worse outcome of 5.38 (p = 0.033). Acute toxicity was minimal (G1/G2 of 14.8%).

Conclusion: In properly selected oligometastatic patients, SBRT has potential for sustained deferral of systemic treatment.
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http://dx.doi.org/10.1016/j.oraloncology.2019.04.006DOI Listing
June 2019

Phase 2 placebo-controlled, single-blind trial to evaluate the impact of oral ibandronate on bone mineral density in osteopenic breast cancer patients receiving adjuvant aromatase inhibitors: 5-year results of the single-centre BONADIUV trial.

Eur J Cancer 2019 02 14;108:100-110. Epub 2019 Jan 14.

Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi, Department of Biomedical, Experimental, and Clinical Sciences, University of Florence, Florence, Italy. Electronic address:

Aim: We present the final results of the BONADIUV trial, a single-blind, randomised, placebo-controlled phase 2 study to evaluate the impact of ibandronate treatment on bone mineral density (BMD) in osteopenic women taking aromatase inhibitors (AI).

Patients And Methods: Between 2011 and 2014, 171 osteopenic patients were randomised in a 1:1 ratio to receive either placebo or oral monthly ibandronate (150 mg). Treatment duration was 2 years, with 6-month evaluation. Primary end-point was the 2-year lumbar spine (LS) and total hip (TH) T-score mean differences as measure of BMD variation. Secondary analyses of survival outcomes have been performed at a 5-year median follow-up. CLINICALTRIALS.

Gov Identifier: NCT02616744.

Results: Median age of study population was 60.2 years (range 44-75). At the database cut-off time, the median follow-up was 63.3 months (range 2.7-87.3). No difference in terms of T-score was shown at baseline between arms both for TH (P = 0.61) and LS (P = 0.96). At 2-year follow up, the mean change was statistically significant in favour of ibandronate arm both at TH (P = 0.0002) and LS (P < 0.0001). No significant difference in terms of adverse events was observed between arms. At a median follow-up of 63.3 months (range 2.7-87.3), the overall survival (OS) rate was 97.5% in the placebo group and 93.0% in the ibandronate arm (P = 0.19). The invasive disease-free survival (iDFS) rates did not differ between groups (P = 0.42).

Conclusions: Ibandronate compared to placebo improved BMD change in osteopenic women treated with adjuvant AI. Five-year survival analyses showed no difference between arms in terms of OS and iDFS rates.
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http://dx.doi.org/10.1016/j.ejca.2018.12.005DOI Listing
February 2019