Publications by authors named "Gianluca Ingrosso"

50 Publications

Personalization in Modern Radiation Oncology: Methods, Results and Pitfalls. Personalized Interventions and Breast Cancer.

Front Oncol 2021 18;11:616042. Epub 2021 Mar 18.

Radiation Oncology Section, University of Perugia and Perugia General Hospital, Perugia, Italy.

Breast cancer, the most frequent malignancy in women worldwide, is a heterogeneous group of diseases, characterized by distinct molecular aberrations. In precision medicine, radiation oncology for breast cancer aims at tailoring treatment according to tumor biology and each patient's clinical features and genetics. Although systemic therapies are personalized according to molecular sub-type [i.e. endocrine therapy for receptor-positive disease and anti-human epidermal growth factor receptor 2 (HER2) therapy for HER2-positive disease] and multi-gene assays, personalized radiation therapy has yet to be adopted in the clinical setting. Currently, attempts are being made to identify prognostic and/or predictive factors, biomarkers, signatures that could lead to personalized treatment in order to select appropriate patients who might, or might not, benefit from radiation therapy or whose radiation therapy might be escalated or de-escalated in dosages and volumes. This overview focuses on what has been achieved to date in personalized post-operative radiation therapy and individual patient radiosensitivity assessments by means of tumor sub-types and genetics.
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http://dx.doi.org/10.3389/fonc.2021.616042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012886PMC
March 2021

Haploidentical age-adapted myeloablative transplant and regulatory and effector T cells for acute myeloid leukemia.

Blood Adv 2021 Mar;5(5):1199-1208

Division of Hematology and Clinical Immunology, Department of Medicine, University of Perugia, Perugia, Italy.

Allogeneic hematopoietic stem cell transplantation (HSCT) is the most effective treatment in eradicating high-risk acute myeloid leukemia (AML). Here, we present data from a novel HLA-haploidentical HSCT protocol that addressed the 2 remaining major unmet medical needs: leukemia relapse and chronic graft-versus-host disease (cGVHD). Fifty AML patients were enrolled in the study. The conditioning regimen included total body irradiation for patients up to age 50 years and total marrow/lymphoid irradiation for patients age 51 to 65 years. Irradiation was followed by thiotepa, fludarabine, and cyclophosphamide. Patients received an infusion of 2 × 106/kg donor regulatory T cells on day -4 followed by 1 × 106/kg donor conventional T cells on day -1 and a mean of 10.7 × 106 ± 3.4 × 106/kgpurified CD34+ hematopoietic progenitor cells on day 0. No pharmacological GVHD prophylaxis was administered posttransplantation. Patients achieved full donor-type engraftment. Fifteen patients developed grade ≥2 acute GVHD (aGVHD). Twelve of the 15 patients with aGVHD were alive and no longer receiving immunosuppressive therapy. Moderate/severe cGVHD occurred in only 1 patient. Nonrelapse mortality occurred in 10 patients. Only 2 patients relapsed. Consequently, at a median follow-up of 29 months, the probability of moderate/severe cGVHD/relapse-free survival was 75% (95% confidence interval, 71%-78%). A novel HLA-haploidentical HSCT strategy that combines an age-adapted myeloablative conditioning regimen with regulatory and conventional T-cell adoptive immunotherapy resulted in an unprecedented cGVHD/relapse-free survival rate in 50 AML patients with a median age of 53 years. This trial was registered with the Umbria Region Institutional Review Board Public Registry as identification code 02/14 and public registry #2384/14 and at www.clinicaltrials.gov as #NCT03977103.
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http://dx.doi.org/10.1182/bloodadvances.2020003739DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7948281PMC
March 2021

Management of prostate cancer radiotherapy during the COVID-19 pandemic: A necessary paradigm change.

Cancer Treat Res Commun 2021 Feb 6;27:100331. Epub 2021 Feb 6.

RadiationOncology Unit, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.

Purpose: To adapt the management of prostate malignancy in response to the COVID-19 pandemic.

Methods: In according to the recommendations of the European Association of Urology, we have developed practical additional document on the treatment of prostate cancer.

Results: Low-Risk Group Watchful Waiting should be offered to patients >75 years old, with a limited life expectancy and unfit for local treatment. In Active Surveillance (AS) patients re-biopsy, PSA evaluation and visits should be deferred for up to 6 months, preferring non-invasive multiparametric-MRI. The active treatment should be delayed for 6-12 months. Intermediate-Risk Group AS should be offered in favorable-risk patients. Short-course neoadjuvant androgen deprivation therapy (ADT) combined with ultra-hypo-fractionation radiotherapy should be used in unfavorable-risk patients. High-Risk Group Neoadjuvant ADT combined with moderate hypofractionation should be preferred. Whole-pelvis irradiation should be offered to patients with positive lymph nodes in locally advanced setting. ADT should be initiated if PSA doubling time is < 12 months in radio-recurrent patients, as well as in low priority/low volume of metastatic hormone sensitive prostate cancer. If radiotherapy cannot be delayed, hypo-fractionated regimens should be preferred. In high priority class metastatic disease, treatment with androgen receptor-targeted agents should be offered. When palliative radiotherapy for painful bone metastasis is required, single fraction of 8 Gy should be offered.

Conclusions: In Covid-19 Era, the challenge should concern a correct management of the oncologic patient, reducing the risk of spreading the virus without worsening tumor prognosis.
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http://dx.doi.org/10.1016/j.ctarc.2021.100331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7864785PMC
February 2021

Stereotactic body radiotherapy (SBRT) in combination with drugs in metastatic kidney cancer: A systematic review.

Crit Rev Oncol Hematol 2021 Mar 2;159:103242. Epub 2021 Feb 2.

Radiation Oncology, A.O.U. Careggi, University of Florence, Largo Brambilla, 3, 50134 Florence, Italy. Electronic address:

Objective: To conduct a systematic review and meta-analysis of the role of SBRTdrug combination in patients affected by mRCC and associated oncologic outcomes and toxicity profiles.

Evidence Acquisition: We performed a critical review of the Pubmed, Medline, and Embase databases from January 1, 2000 through April 30, 2020 according to the Preferred Reporting Items and Meta-Analyses statement. To assess the overall quality of the literature reviewed, we used a modified Delphi tool.

Evidence Synthesis: A total of 6 studies were included, corresponding to a cohort of 216 patients. Tyrosine Kinases Inhibitors were the most widely used drugs in combination with SBRT, being administered in 93% patients. No study reported an increase of radiation-induced toxicity.

Conclusions: SBRT resulted to be safe, without increase in terms of drugs-related adverse events in this setting. Moreover, this approach showed promising clinical outcomes in terms of LC and OS.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103242DOI Listing
March 2021

Health-related quality of life 24-month after prostate cancer diagnosis: an update from the Pros-IT CNR prospective observational study.

Minerva Urol Nefrol 2021 Jan 13. Epub 2021 Jan 13.

Urology Unit, Azienda Socio-Sanitaria Territoriale Lariana, Sant'Anna Hospital, Como, Italy.

Background: This study analyzes patient health-related quality of life (QoL) 24-month after prostate cancer (PCa) diagnosis within the PROState cancer monitoring in ITaly from the National Research Council (Pros-IT CNR) study.

Methods: Pros-IT CNR is an ongoing, longitudinal and observational study, considering a convenience sample of patients enrolled at PCa diagnosis and followed at 6, 12, 24, 36, 48 and 60 months from the diagnosis. Patients were grouped according to the treatment received: nerve sparing radical prostatectomy (NSRP), non-nerve sparing radical prostatectomy (NNSRP), radiotherapy (RT), radiotherapy plus androgen deprivation (RT plus ADT) and active surveillance (AS). QoL was measured through the Italian versions of SF-12 and UCLA-PCI questionnaires at diagnosis and at 6-12 and 24-month. The minimal clinically important difference (MCID) was defined as half a standard deviation of the baseline domain.

Results: Overall, 1 537 patients were included in the study. The decline in urinary function exceeded the MCID at each timepoint only in the NSRP and NNSRP groups (at 24 months -14.7, p<0.001 and - 19.7, p<0.001, respectively). The decline in bowel function exceeded the MCID only in the RT (-9.1, p=0.02) and RT plus ADT groups at 12 months (-10.3, p=0.001); after 24 months, most patients seem to recover their bowel complaints. The decline in sexual function exceeded the MCID at each timepoint in the NNSRP, NSRP and RT plus ADT groups (at 6 months -28.7, p<0.001, -37.8, p<0.001, -20.4, p<0.001, respectively).

Conclusions: Although all the treatments were relatively well-tolerated over the 24 month period following PCa diagnosis, each had a different impact on QoL.
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http://dx.doi.org/10.23736/S0393-2249.20.04032-1DOI Listing
January 2021

Stereotactic body radiotherapy for adrenal oligometastasis in lung cancer patients.

Br J Radiol 2020 Nov 2;93(1115):20200645. Epub 2020 Sep 2.

Radiotherapy Oncology Centre, "S. Maria" Hospital, Terni, Italy.

Objective: To report our experience on stereotactic body radiotherapy (SBRT) in adrenal metastases from lung cancer.

Methods: 37 oligometastatic lung cancer patients with 38 adrenal metastases submitted to SBRT were retrospectively analyzed. SBRT was delivered by volumetric modulated arc therapy (VMAT) or helical tomotherapy (HT). Primary study end point was local recurrence-free survival (LR-FS) and secondary end points were distant-progression free survival (d-PFS) and overall survival (OS).

Results: Median age was 67 years and primary tumor was non-small-cell lung cancer in 27 (73%) and small-cell lung cancer in 10 (27%) patients. Adrenal metastases were in the left side in 66% cases. Median prescribed dose was 30 Gy in 5 fractions for a median biologically equivalent dose (α/β ratio 10  Gy, BED10) of 48 Gy. Most patients (62%) were submitted to SBRT alone, while the others (38%) received chemo-, immune- or target- therapies. Median follow-up was 10.5 months, median OS 16 months and median d-PFS 3 months. 27 (70%) patients obtained a local control with a median LR-FS of 32 months. LR-FS was significantly related to BED10 with a better LC with BED10 ≥72 Gy, 1- and 2 year LR-FS rates were 54.1±11.6% and 45±12.7%  100 and 100% for BED ≤59.5 Gy and BED ≥72 Gy, respectively ( = 0.05). There was no severe toxicity.

Conclusion: SBRT was effective and safe in lung cancer adrenal metastases. A dose-response relationship was found between BED10 72 Gy and better local control. No significant toxicity was registered thanks to the respect of dose constraints and suspension of chemo- and target-therapies.

Advances In Knowledge: SBRT with a BED10 72 Gy is an effective treatment for adrenal oligometastatic lung cancer patients.
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http://dx.doi.org/10.1259/bjr.20200645DOI Listing
November 2020

Stereotactic Radiotherapy for Brain Metastases: Imaging Tools and Dosimetric Predictive Factors for Radionecrosis.

J Pers Med 2020 Jul 4;10(3). Epub 2020 Jul 4.

Radiation Oncology Section, Department of Surgical and Biomedical Science, University of Perugia, 6100 Perugia, Italy.

Radionecrosis (RN) is the most important side effect after stereotactic radiotherapy (SRT) for brain metastases, with a reported incidence ranging from 3% to 24%. To date, there are no unanimously accepted criteria for iconographic diagnosis of RN, as well as no definitive dose-constraints correlated with the onset of this late effect. We reviewed the current literature and gave an overview report on imaging options for the diagnosis of RN and on dosimetric parameters correlated with the onset of RN. We performed a PubMed literature search according to the preferred reporting items and meta-analysis (PRISMA) guidelines, and identified articles published within the last ten years, up to 31 December 2019. When analyzing data on diagnostic tools, perfusion magnetic resonance imaging (MRI) seems to be very useful allowing evaluation of the blood flow in the lesion using the relative cerebral blood volume (rCBV) and blood vessel integrity using relative peak weight (rPH). It is necessary to combine morphological with functional imaging in order to match information about lesion morphology, metabolism and blood-flow. Eventually, serial imaging follow-up is needed. Regarding dosimetric parameters, in radiosurgery (SRS) V12 < 8 cm and V10 < 10.5 cm of normal brain are the most reliable prognostic factors, whereas in hypo-fractionated stereotactic radiotherapy (HSRT) V18 and V21 are considered the main predictive independent risk factors of RN.
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http://dx.doi.org/10.3390/jpm10030059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7565332PMC
July 2020

Radiotherapy in the era of COVID-19.

Expert Rev Anticancer Ther 2020 08 7;20(8):625-627. Epub 2020 Jul 7.

Radiation Oncology Section, Department of Surgical and Biomedical Science, University of Perugia , Perugia, Italy.

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http://dx.doi.org/10.1080/14737140.2020.1785290DOI Listing
August 2020

Radiotherapy treatment volumes for oligorecurrent nodal prostate cancer: a systematic review.

Acta Oncol 2020 Oct 13;59(10):1224-1234. Epub 2020 Jun 13.

Department of Radiation Oncology, Geneva University Hospital, Geneva, Switzerland.

Background: Radiotherapy is an emerging treatment strategy for nodal oligorecurrent prostate cancer (PCa) patients. However, large heterogeneities exist in the RT regimens used, with series reporting the use of elective nodal radiotherapy (ENRT) strategies and others the delivery of focal treatments to the relapsing nodes with Stereotactic Body Radiotherapy (SBRT). In this systematic review of the literature we compared the oncological outcomes and toxicity of the different RT regimens for nodal oligorecurrent PCa patients, with the aim of defining the optimal RT target volume in this setting.

Methods: We performed a systemic search on the Pubmed database to identify articles reporting on the use of ENRT or SBRT for oligometastatic PCa with nodal recurrence.

Results: Twenty-two articles were analyzed, including four prospective phase II trials (3 with SBRT and 1 with ENRT). Focal SBRT, delivered with an involved node, involved site, and involved field modality, was the most commonly used strategy with 2-year progression-free survival (PFS) rates ranging from 16 to 58% and a very low toxicity profile. Improved PFS rates were observed with ENRT strategies (52-80% at 3 years) compared to focal SBRT, despite a slightly higher toxicity rate. One ongoing randomized phase II trial is comparing both modalities in patients with nodal oligorecurrent PCa.

Conclusions: With a large variability in patterns of practice, the optimal RT strategy remains to be determined in the setting of nodal oligorecurrent PCa. Ongoing randomized trials and advances in translational research will help to shed light on the best management for these patients. .
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http://dx.doi.org/10.1080/0284186X.2020.1775291DOI Listing
October 2020

Pulmonary function in stereotactic body radiotherapy with helical tomotherapy for primary and metastatic lung lesions.

Radiol Med 2021 Jan 15;126(1):163-169. Epub 2020 May 15.

Radiation Oncology Unit, University of Perugia and Perugia General Hospital, Perugia, Italia.

Aims: This retrospective study reports outcomes after stereotactic body radiation therapy (SBRT) as delivered by helical tomotherapy (HT) for lung lesions. It promotes a dose escalation program.

Methods: Histological and/or radiological findings and/or case histories identified 41 primary and 15 metastatic lesions. Thirty patients received 40 Gy in 5 fractions (BED 72 Gy) and 26 50 Gy in 5 fractions (BED 100Gy). Primary end point was lung toxicity. Secondary end points were respiratory function, local control and local progression-free survival.

Results: Acute toxicity developed in 18/56 patients and late toxicity in 8/54. Median FEV-1 variations versus baseline were - 0.5% (range - 16 to + 43%) at 6 months and - 4.00% (range - 42 to + 18%) at 24 months. Median DLCO variations versus baseline were - 1% (range - 38 to + 36%) at 6 months and - 12.2% (range - 48 to + 11%) at 24 months. At 6 months, a significant positive correlation emerged between FEV-1 change and KPS (p = 0.047). At 24 months, a significant negative correlation emerged between FEV-1 change and the ipsilateral lung V5 (p = 0.006). A low baseline DLCO correlated with more marked DLCO worsening at 6 months (p = 0.012). At 24 months, DLCO worsening correlated significantly with the median contralateral lung dose (p = 0.003). At the last checkup, 23 patients were in complete remission, 16 were in partial remission, 5 had stable disease, and 7 were in relapse. Median follow-up was 12 months (range 5-56).

Conclusions: In patients with lung disease, SBRT, as delivered by HT, was well tolerated and provided good local control.
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http://dx.doi.org/10.1007/s11547-020-01223-wDOI Listing
January 2021

High-resolution microultrasound imaging for bladder cancer: the birth of a new diagnostic tool?

Transl Androl Urol 2019 Dec;8(Suppl 5):S505-S506

Radiation Oncology Section, Department of Surgical and Biomedical Science, University of Perugia and Perugia General Hospital, Perugia, Italy.

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http://dx.doi.org/10.21037/tau.2019.08.20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6989852PMC
December 2019

Helical tomotherapy re-irradiation for patients affected by local radiorecurrent prostate cancer.

Rep Pract Oncol Radiother 2020 Mar-Apr;25(2):157-162. Epub 2020 Jan 22.

Radiation Oncology Section, Department of Surgical and Biomedical Science, University of Perugia, Italy.

Background: Salvage re-irradiation in patients affected by radiorecurrent prostate cancer might be a valid as well as challenging treatment option. The aim of this study was to evaluate feasibility and toxicity of salvage external beam radiotherapy (EBRT) re-treatment in patients affected by radiorecurrent prostate cancer within the prostate gland or the prostate bed.

Materials And Methods: 15 patients underwent EBRT re-treatment using helical tomotherapy (HT), with daily Megavolt computed tomography image-guidance. We registered toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Biochemical relapse was defined as a PSA increase > 20% compared with the pre-EBRT re-treatment value. Survival curves were calculated using the Kaplan-Meier method.

Results: All patients received a total dose of 50 Gy (25 × 2 Gy), and 7 (46.6%) had concomitant androgen deprivation therapy (median duration of 12 months). With a median follow-up of 40.9 months, the 2-year and 4-year biochemical relapse-free survival were 55% and 35%, respectively. Acute and late genito-urinary (GU) toxicity ≥2 were recorded in 4 (26.6%) and 5 (33.3%) patients, respectively, and the 4-year late GU toxicity was 30%. Acute gastrointestinal toxicity ≥2 was recorded in 2 (13.3%) cases, whereas no patient experienced late toxicity.

Conclusions: Despite the inherent bias of a retrospective analysis, our long-term results showed a low toxicity profile with a relatively low rate of biochemical control for HT re-treatment in patients affected by local radiorecurrent prostate cancer. Prospective trials are needed to investigate the role of EBRT in this setting.
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http://dx.doi.org/10.1016/j.rpor.2020.01.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6994272PMC
January 2020

Radiotherapy for papillary tumor of the pineal region: A systematic review of the literature.

Clin Neurol Neurosurg 2020 03 21;190:105646. Epub 2019 Dec 21.

Radioterapia Oncologica, Dipartimento di Scienze Chirurgiche e Biomediche, Università degli Studi di Perugia, ospedale S. Maria della Misericordia, S. Andrea delle Fratte, 06156 Perugia, Italy.

Papillary tumor of the pineal region (PTPR) is a rare neuroepithelial brain tumor, characterized by a high risk of local recurrence (greater than 70 % at 6 years). The aim of our study was to review the available literature on radiotherapy for PTPR in order to evaluate timings, schedules, outcomes and toxicities of this treatment modality. In our review, 72.4 % (84) of the patients diagnosed with PTPR received radiation therapy. There is heterogeneity in the dose prescription, ranging from 45 Gy (25 × 1.8 Gy) to 60 Gy (30 × 2 Gy) for 3D Conformal Radiation Therapy and from 12 Gy to 36 Gy for Stereotactic Radiosurgery. Being considered as a grade II or III tumor, PTPR should receive higher total radiation dose in the adjuvant setting. Our analysis showed a very limited treatment-related toxicity with an expected 10-y OS of 72.5 %. At 5-years from the diagnosis, about 60 % of the patients experienced a local recurrence, whereas at 10 years the rate is higher than 80 %. In the literature, conflicting data about radiotherapy for PTPR are reported, in particular regarding disease progression. Although radiotherapy represents a fundamental treatment in the management of PTPR, prospective studies are required to better define its impact on overall survival and progression-free survival.
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http://dx.doi.org/10.1016/j.clineuro.2019.105646DOI Listing
March 2020

Physician And Patient Barriers To Radiotherapy Service Access: Treatment Referral Implications.

Cancer Manag Res 2019 7;11:8829-8833. Epub 2019 Oct 7.

Radiation Oncology Section, Department of Surgical and Biomedical Sciences, University of Perugia and Perugia General Hospital, Perugia, Italy.

Radiotherapy is one of the mainstays of cancer treatment, and about 60% of cancer patients receive this type of treatment during their course of treatment. An evident gap between optimal and actual radiotherapy utilization proportions has recently been reported, which has been ascribed to lack of referral to radiation oncology. There are many factors influencing the radiotherapy referral, including patient anxiety about toxicity, wrong perception of efficacy and side effects by physicians and patients, insufficient knowledge of referral process. These factors, defined as barriers can be categorized in health system barriers, physician and patient barriers. In the present brief narrative review, we discussed barriers to radiotherapy referral focusing on physician and patient barriers.
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http://dx.doi.org/10.2147/CMAR.S168941DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789154PMC
October 2019

Prostate Cancer Recurrence in Kidney Transplant Recipient 15 Years After Radical Prostatectomy: A Case Report.

Transplant Proc 2019 Nov 10;51(9):2995-2997. Epub 2019 Oct 10.

Department of Hepatobiliary Surgery and Transplant Unit, Tor Vergata University of Rome, Italy.

Incidence of malignant tumors in kidney transplant recipients is higher than nontransplanted population due to many factors, such as immunosuppression therapy and complex donor-recipient interaction. Genitourinary malignancies have been reported as the second most common malignancy in kidney transplant recipients. In this regard, prostate cancer is the most common neoplasm. Herein, we describe a rare case of prostate cancer recurrence after 15 years in a patient who underwent kidney transplant after radical prostatectomy.
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http://dx.doi.org/10.1016/j.transproceed.2019.04.098DOI Listing
November 2019

Whole breast external beam radiotherapy in elderly patients affected by left-sided early breast cancer: a dosimetric comparison between two simple free-breathing techniques.

Aging Clin Exp Res 2020 Jul 19;32(7):1335-1341. Epub 2019 Aug 19.

Radiotherapy Unit, Department of Oncology and Hematology, Tor Vergata General Hospital, Rome, Italy.

Background: Elderly breast cancer patients are frequently affected by significant comorbidities that make sophisticated radiotherapy treatments particularly challenging.

Aims: We dosimetrically analyzed two different simple free-breathing external beam radiotherapy (EBRT) techniques for the hypofractionated treatment of the left breast in elderly patients with a low compliance, to compare target coverage, and heart and left anterior descending coronary artery (LADCA) sparing.

Methods: We developed radiation plans for 24 elderly patients using 3D conformal (3DCRT) field-in-field tangential technique and intensity-modulated (IMRT) tangential beam technique. Dose-Volume-Histograms (DVHs) were used to provide a quantitative comparison between plans.

Results: The median breast volume was 645 cm. IMRT and 3DCRT plans comparison demonstrated no significant differences in terms of organ sparing for the heart. Regarding LADCA, mean dose (10.3 ± 9.5 Gy vs 11.9 ± 9.6 Gy, p = 0.0003), maximum dose (26.1 ± 16.1 Gy vs 29.1 ± 16.1 Gy, p = 0.004) and V (21.5% ± 26.9% vs 25.0% ± 27.2%, p = 0.002) significantly decreased using IMRT compared with 3DCRT. IMRT plans showed a better target coverage compared with 3DCRT (0.91 ± 0.05 vs 0.93 ± 0.04, p = 0.05).

Discussion: Comparing the two different EBRT techniques, we demonstrated few, although substantial, dosimetric differences in terms of doses to the organs at risk characterized by a statistically significant dose reduction of LADCA in the IMRT plans.

Conclusions: Elderly patients with a low compliance to treatment might benefit from 3DCRT with field-in-field tangential arrangement or from a simple IMRT approach. IMRT should be preferred.
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http://dx.doi.org/10.1007/s40520-019-01312-5DOI Listing
July 2020

Nonsurgical Salvage Local Therapies for Radiorecurrent Prostate Cancer: A Systematic Review and Meta-analysis.

Eur Urol Oncol 2020 04 24;3(2):183-197. Epub 2019 Jan 24.

Department of Radiation Oncology, A.O.U. Careggi, University of Florence, Florence, Italy.

Context: Different nonsurgical therapeutic strategies can be adopted for intraprostatic relapse of prostate cancer after primary radiotherapy, including re-irradiation (with brachytherapy [BT] or external beam radiotherapy [EBRT]), high-intensity focused ultrasound (HIFU), and cryotherapy. The main issues to consider when choosing nonsurgical salvage local therapies are local tumor control and significant genitourinary toxicity.

Objective: To conduct a systematic review and meta-analysis of the role of nonsurgical salvage modalities in patients with radiorecurrent prostate cancer and associated clinical outcomes and toxicity profiles.

Evidence Acquisition: We performed a critical review of the Medline, Scopus, and ClinicalKey databases from January 1, 2000 through February 1, 2018 according to the Preferred Reporting Items and Meta-Analyses statement. To assess the overall quality of the literature reviewed, we used a modified Delphi tool for case-series studies.

Evidence Synthesis: A total of 64 case-series studies were included, corresponding to a cohort of 5585 patients. The modified Delphi checklist evidenced high methodological quality overall (mean quality score of 80.6%). Biochemical control rates were lowest for patients treated with HIFU (58%, 95% confidence interval [CI] 47-68%) and highest for patients treated with BT (69%, 95% CI 62-76%) and EBRT (69%, 95% CI 53-83%). The lowest prevalence of incontinence was for patients treated with BT (3%, 95% CI 0-6%; I=63.4%) and the highest was among patients treated with HIFU (28%, 95% CI 19-38%; I=89.7%).

Conclusions: Nonsurgical therapeutic options, especially BT, showed good outcomes in terms of biochemical control and tolerability in the local recurrence setting.

Patient Summary: The current analysis demonstrated that nonsurgical salvage local therapies offer a chance of a curative local approach in radiorecurrent prostate cancer. However, high-quality data from prospective trials are needed to validate long-term outcomes from nonsurgical strategies for the treatment of intraprostatic recurrence after previous radiotherapy.
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http://dx.doi.org/10.1016/j.euo.2018.12.011DOI Listing
April 2020

Metastasis-directed Therapy in Treating Nodal Oligorecurrent Prostate Cancer: A Multi-institutional Analysis Comparing the Outcome and Toxicity of Stereotactic Body Radiotherapy and Elective Nodal Radiotherapy.

Eur Urol 2019 12 20;76(6):732-739. Epub 2019 Jul 20.

Department of Radiation Oncology and Experimental Cancer Research, Ghent University, Ghent, Belgium.

Background: Stereotactic body radiotherapy (SBRT) and elective nodal radiotherapy (ENRT) are being investigated as metastasis-directed treatments in oligorecurrent prostate cancer (PC); however, comparative data are still lacking.

Objective: To compare outcome and toxicity between both treatments. Primary endpoint was metastasis-free survival, adjusted for selected variables (aMFS).

Design, Setting, And Participants: This was a multi-institutional, retrospective analysis of 506 (SBRT: 309, ENRT: 197) patients with hormone-sensitive nodal oligorecurrent PC (five or fewer lymph nodes (LNs; N1/M1a), treated between 2004 and 2017. Median follow-up was 36 mo (interquartile range 23-56).

Intervention: SBRT was defined as a minimum of 5 Gy per fraction to each lesion with a maximum of 10 fractions. ENRT was defined as a minimum dose of 45 Gy in up to 25 fractions to the elective nodes, with or without a simultaneous boost to the suspicious node(s). The choice of radiotherapy (RT) was at the discretion of the treating physician, with treatments being unbalanced over the centers.

Outcome Measurements And Statistical Analysis: In total, 506 patients from 15 different treatment centers were included. Primary treatment was radical prostatectomy, RT, or their combination. Nodal recurrences were detected by positron emission tomography/computer tomography (97%) or conventional imaging (3%). Descriptive statistics was used to summarize patient characteristics.

Results And Limitations: ENRT was associated with fewer nodal recurrences compared with SBRT (p < 0.001). In a multivariable analysis, patients with one LN at recurrence had longer aMFS after ENRT (hazard ratio: 0.50, 95% confidence interval 0.30-0.85, p = 0.009). Late toxicity was higher after ENRT compared with that after SBRT (16% vs. 5%, p < 0.01). Limitations include higher use of hormone therapy in the ENRT cohort and nonstandardized follow-up.

Conclusions: ENRT reduces the number of nodal recurrences as compared with SBRT, however at higher toxicity. Our findings hypothesize that ENRT should be preferred to SBRT in the treatment of nodal oligorecurrences. This hypothesis needs to be evaluated in a randomized trial.

Patient Summary: This study investigated the difference between stereotactic and elective nodal radiotherapy in treating limited nodal metastatic prostate cancer. Nodal relapse was less frequent following elective nodal radiotherapy than following stereotactic body radiotherapy, and thus elective nodal radiotherapy might be the preferred treatment.
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http://dx.doi.org/10.1016/j.eururo.2019.07.009DOI Listing
December 2019

Consensus statements on ablative radiotherapy for oligometastatic prostate cancer: A position paper of Italian Association of Radiotherapy and Clinical Oncology (AIRO).

Crit Rev Oncol Hematol 2019 Jun 1;138:24-28. Epub 2019 Apr 1.

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

Oligometastatic prostate cancer comprises a wide spectrum of conditions, ranging from de novo oligometastatic cancer at diagnosis to oligometastatic castration-resistant disease, which are distinct entities in terms of biology and prognosis. In order to clarify and standardize the clinical role of ablative radiotherapy in oligometastatic prostate cancer, the Italian Association of Radiotherapy and Clinical Oncology (AIRO) formed an expert panel to review the current literature and develop a formal consensus. Oligometastatic prostate cancer was defined as the presence of up to three metastatic lesions involving bones or nodes outside pelvis. Thereafter, four clinical scenarios were explored: metastatic castration-sensitive disease at diagnosis and after primary treatment, and metastatic castration-resistant disease at diagnosis and during treatment, where the role of ablative radiotherapy was defined either in conjunction with systemic therapy or as the only treatment in selected cases. This paper summarizes the current literature about these issues and the proposed recommendations.
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http://dx.doi.org/10.1016/j.critrevonc.2019.03.014DOI Listing
June 2019

Combining abiraterone and radiotherapy in metastatic castration-resistant prostate cancer: a review of current evidence.

Tumori 2019 Aug 25;105(4):277-281. Epub 2019 Mar 25.

4 Department of Radiation Oncology, Policlinico Tor Vergata, University of Rome, Rome, Italy.

Prostate cancer is the second most frequent cancer worldwide, with a very high rate of progression despite treatment. The most aggressive form of the disease is known as castration-resistant prostate cancer, which carries a poor prognosis. We reviewed available literature regarding the combination of abiraterone acetate antihormonal drug and ablative radiation therapy for the treatment of metastatic castration-resistant prostate cancer. This dual treatment may enhance the effects of second-line hormonal therapy, as radiotherapy renders cancer cells more prone to immune-mediated cytotoxicity. Moreover, radiotherapy exerts its effect both on directly irradiated cells and on other distant tissues, with an abscopal effect, already demonstrated in other solid tumors. This combination treatment is safe and effective, with few adverse events. Moreover, it is of paramount importance in patients with oligoprogression of the primary disease, when current guidelines recommend continuing abiraterone treatment. Ablative radiation therapy is a noninvasive, nontoxic treatment with very high efficacy on local tumor growth control. In the available literature, the combination of radiation therapy and abiraterone acetate has prolonged both overall survival and progression-free survival, with a positive impact also on locoregional recurrence and distant metastases.
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http://dx.doi.org/10.1177/0300891619839282DOI Listing
August 2019

Interfraction prostate displacement during image-guided radiotherapy using intraprostatic fiducial markers and a cone-beam computed tomography system: A volumetric off-line analysis in relation to the variations of rectal and bladder volumes.

J Cancer Res Ther 2019 Mar;15(Supplement):S69-S75

Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology and Radiotherapy, Tor Vergata General Hospital, Rome, Italy.

Purpose: Prostate motion during the radiotherapy course is an important issue. This study investigated the inter-fraction prostate motion in controlled rectal filling condition.

Methods: 10 prostate cancer patients underwent image-guided radiotherapy (IGRT) using a cone-beam computed tomography (CBCT) system, after the insertion of fiducial markers (FMs). The planning CT was the reference CT (CTref) used to estimate the reference intermarker distances, and CBCTs were used for off-line comparison with CTref. We evaluated the influence of rectal and bladder volume on prostate shifts. We calculated the required planning target volume (PTV) margins in this patient population.

Results: 120 CBCTs were analyzed. Mean prostate displacements (± SD) along the 3 axes (x, y, z) averaged over the 10 patients, were: 0.90 ± 0.84 mm in x, 0.00 ± 2.07 mm in y, -0.80 ± 1.28 mm in z. There is a statistically significant anti-correlation between prostate displacements and: bladder volume variations (P < 0.001) in the y-axis, and rectal volume variations (P < 0.05) in the z-axis. PTV margins obtained for the directions x, y and z are respectively 2.5, 5.6 and 3.9 mm.

Conclusion: IGRT in reproducible empty rectum condition allow a high reduction of daily treatment uncertainties.
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http://dx.doi.org/10.4103/jcrt.JCRT_463_17DOI Listing
March 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

The impact of ionizing irradiation on liver detoxifying enzymes. A re-investigation.

Cell Death Discov 2019 8;5:66. Epub 2019 Feb 8.

1Department of Chemical Sciences and Technologies, University of Rome "Tor Vergata", Rome, Italy.

By looking at many studies describing the impact of ionizing irradiations in living mice on a few key detoxifying enzymes like catalase, superoxide dismutase, glutathione peroxidase, glutathione reductase and glutathione transferase, we noted conflicting evidences: almost all papers finalized to demonstrate the protective effects of natural or synthetic drugs against the damage by irradiations, described also a relevant inactivation of these enzymes in the absence of these compounds. Conversely, no inactivation and even enhanced activity has been noted under similar irradiation modality in all studies supporting the "adaptive response". Motivated by these curious discrepancies, we performed irradiation experiments on living mice, explanted mouse livers and liver homogenates observing that, in all conditions the activity of all these enzymes remained almost unchanged except for a slight increase found in explanted livers. Our results put a question about many previous scientific reports in this field.
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http://dx.doi.org/10.1038/s41420-019-0148-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6368569PMC
February 2019

Oligometastatic prostate cancer: The game is afoot.

Cancer Treat Rev 2019 Feb 17;73:84-90. Epub 2019 Jan 17.

Radiation Oncology, Ghent University Hospital, Ghent, Belgium.

Oligometastatic prostate cancer represents an intermediate state between a localized tumor and widespread metastatic disease. Its specific clinical features suggest the existence of a distinct biology which still needs to be elucidated. New imaging techniques like prostate specific membrane antigen (PSMA) PET scans have shown to perform well in the staging and restaging of this category of patients, at different phases of disease evolution. Despite limited prospective evidence, metastasis-directed therapies (MDT) are emerging as valid treatment options able to postpone systemic therapies and probably improve survival outcome. The aim of this review is to shed light on the clinical scenario of prostate cancer patients with limited metastatic disease burden and highlight the role of MDT strategies in this setting.
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http://dx.doi.org/10.1016/j.ctrv.2019.01.005DOI Listing
February 2019

Current therapeutic options in metastatic castration-resistant prostate cancer.

Semin Oncol 2018 10 30;45(5-6):303-315. Epub 2018 Oct 30.

Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology and Radiotherapy, Tor Vergata General Hospital, Rome, Italy.

Background: The tumors of many patients with prostate cancer eventually become refractory to androgen deprivation therapy with progression to metastatic castration-resistant disease. Significant advances in the treatment of metastatic castration-resistant prostate cancer (mCRPC) have been made in recent years, and new treatment strategies have recently been made available. The aim of this report was to schematically review all the approved pharmacologic treatment options for patients with mCRPC through 2018, analyzing the efficacy and possible side effects of each therapy to assist clinicians in reaching an appropriate treatment decision. New biomarkers potentially of aid in the choice of treatment in this setting are also briefly reviewed.

Methods: We performed a literature search of clinical trials of new drugs and treatments for patients diagnosed with mCRPC published through 2018.

Results: Two new hormonal drugs, abiraterone acetate and enzalutamide have been approved by FDA in 2011 and 2012, respectively for the treatment of patients with mCRPC and have undergone extensive testing. While these treatments have shown a benefit in progression-free and overall survival, the appropriate sequencing must still be determined so that treatment decisions can be made based on their specific clinical profile. Cabazitaxel has been shown to be an efficient therapeutic option in a postdocetaxel setting, while its role in chemotherapy-naïve patients must still be determined. Sipuleucel-T and radium-223 have been studied in patients without visceral metastases and have achieved overall survival benefits with good safety profiles. The feasibility and efficacy of combinations of new treatments with other known therapies such as chemotherapy are currently under investigation.

Conclusions: Drug development efforts continue to attempt to prolong survival and improve quality of life in the mCRPC setting, with several therapeutic options available. Ongoing and future trials are needed to further assess the efficacy and safety of these new drugs and their interactions, along with the most appropriate sequencing.
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http://dx.doi.org/10.1053/j.seminoncol.2018.10.001DOI Listing
October 2018

Endoscopic Intravesical Fibrin Glue Application in the Treatment of Refractory Hemorrhagic Radiation Cystitis: A Single Cohort Pilot Study.

J Endourol 2019 02;33(2):93-98

4 Urology Unit, Department of Experimental Medicine and Surgery, Tor Vergata University of Rome, Rome, Italy.

Objective: To evaluate the clinical value of endoscopic fibrin glue (FG) application therapy in treating hemorrhagic radiation cystitis (HRC).

Patients And Methods: This is a single-cohort, prospective pilot study. We collected data from patients with HRC who were treated at our urology unit from May 2014 to December 2016. Patients with grade ≥2 HRC for whom conventional therapy and transurethral endoscopic electrocoagulation had failed were treated with endoscopic intravesical FG. The mean follow-up was 26.2 ± 9.78 months. Our analysis included data on patient demographics, pelvic malignancies, radiotherapy regimens, total dose of radiation received, time of onset and severity of hematuria, and previous intravesical management. Following FG intervention, patients' clinical status was defined as: (1) clinical response; absence of dysuria, urgency, and frequency; discontinuation of analgesic medication; and Foley catheter removal, but with ongoing hematuria grade <2; (2) complete response, clinical response, and no further hematuria; or (3) no response, no clinical response, and sustained hematuria.

Results: A total of 20 patients (12 women and 8 men; mean age, 69 ± 7.5 years) were treated with 12 mL FG intravesically, using endoscopic application. Of the 20 patients, 16 (80%) had a complete response and 4 (20%) had a clinical response. In the case of four patients (20%), treatment was carried out twice. Mean hospital stay was 6 ± 2.5 days. The intervention showed good tolerability in all patients. No major adverse events were reported. Bladder spasms were the only minor adverse events reported in six patients (30%).

Conclusion: Application of FG is an effective, practical, affordable, and repeatable procedure for the treatment of grade ≥2 HRC.
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http://dx.doi.org/10.1089/end.2018.0028DOI Listing
February 2019

Volumetric image-guided conformal radiotherapy for localized prostate cancer: Analysis of dosimetric and clinical factors affecting acute and late toxicity.

Rep Pract Oncol Radiother 2018 Sep-Oct;23(5):315-321. Epub 2018 Aug 13.

Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology and Radiotherapy, Tor Vergata General Hospital, Rome, Italy.

Aim: To identify factors influencing toxicity in patients affected by localized prostate cancer treated with conformal image-guided radiotherapy.

Background: Image guidance in combination with conformal techniques is the standard of care in localized prostate cancer, but factors affecting toxicity are still under investigation.

Materials And Methods: 294 patients were analyzed. Median age at diagnosis was 71 year. 76 Gy (38 × 2 Gy) were delivered to the target volume. We used the test to analyse associations between toxicity and dosimetric and clinical parameters. Multivariate analysis was performed using binary logistic regression. Kaplan-Meier method was used for survival analysis.

Results: Median follow-up was 62.9 months. Acute grade ≥2 gastro-intestinal toxicity (GI) was 12.1%. Acute genito-urinary (GU) toxicity of grade ≥2 was 33.9%. Actuarial 4 and 5 years late grade ≥2 GI was 3% and 4%, respectively. Four and 5-year late grade ≥2 GU toxicity was 6% and 10%. At multivariate analysis for acute toxicity rectal was correlated with GI toxicity ( = 0.01, HR 2.73 CI 1.19-6.26), and smoking habit with GU toxicity ( < 0.01, HR 2.50 CI 1.51-4.14). For late toxicity, rectal was correlated with gastro-intestinal toxicity ( = 0.04, HR 4.76 CI 1.07-21.13), and pre-radiotherapy urinary symptoms with genito-urinary toxicity ( = 0.01, HR 2.84 CI 1.29-6.22).

Discussion: Conformal image-guided radiotherapy shows low rates of toxicity. Smoking should be avoided during radiotherapy. Besides the evaluation of high doses received by the organs at risk, individual factors, such as co-morbidities and lifestyle choices, have an impact on normal-tissue complication risk.
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http://dx.doi.org/10.1016/j.rpor.2018.07.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097402PMC
August 2018

Oligorecurrent prostate cancer limited to lymph nodes: getting our ducks in a row : Nodal oligorecurrent prostate cancer.

World J Urol 2019 Dec 11;37(12):2607-2613. Epub 2018 May 11.

Department of Radiotherapy, Tor Vergata General Hospital, Viale Oxford 81, 00133, Rome, Italy.

Purpose: Oligorecurrent prostate cancer with exclusive nodal involvement represents a common state of disease, amenable to local therapy. New radio-labeled tracers have enriched the possibility of cancer detection and treatment. In this review, we aim to illustrate the main nuclear medicine diagnostic options and the role of radiotherapy in this setting of patients.

Methods: We performed a PubMed search referring to the PRISMA guidelines to analyze the performance of PSMA- and choline-PET in detecting oligorecurrence limited to lymph nodes, and to review the main studies supporting either ablative stereotactic body radiotherapy or regional lymph node irradiation in this clinical setting.

Results: PSMA-PET has shown higher efficacy in the diagnosis of nodal lesions if compared with choline-PET. More specifically, for PSA ≤ 2 ng/ml, the median detection rate of choline-PET ranges from 19.5 to 44.5%, whereas PSMA ranges from 51.5 to 74%. SBRT achieves high local control rates positively affecting progression-free survival (PFS), with androgen deprivation therapy (ADT)-free survival ranging from 25 to 44 months and with low toxicity rates (0-15%). Prophylactic nodal irradiation shows 3-year PFS rates ranging from 62 to 75%, but with a potential higher risk of toxicity. However, the chosen treatment option needs to be tailored on the single patient.

Conclusions: Newer PET/CT radio-labeled tracers have increased disease detection in oligorecurrent prostate cancer patients. Growing evidence of their impact on metastasis-directed therapy encourages the use of the most advanced radiotherapy techniques in the clinical management of such patients.
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http://dx.doi.org/10.1007/s00345-018-2322-7DOI Listing
December 2019

Oligometastatic cancer in elderly patients: the "blitzkrieg" radiotherapy approach : SBRT in oligometastatic elderly patients.

Aging Clin Exp Res 2019 Jan 29;31(1):109-114. Epub 2018 Mar 29.

Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology and Radiotherapy, Tor Vergata General Hospital, Viale Oxford 81, 00133, Rome, Italy.

Aims: To retrospectively evaluate the outcome of stereotactic body radiation therapy (SBRT) in the treatment of elderly patients affected by isolated body metastasis from different primitive tumors.

Methods: 70 patients with isolated body metastasis were treated. Median age at diagnosis was 75 years (IQR 69-80). The most common SBRT fractionation scheme was 5 × 7 Gy (total dose 35 Gy). The primary endpoints were Local Control (LC) and Toxicity. Secondary endpoints were Overall Survival (OS) and Disease-Specific Survival (DSS). Response to radiotherapy was assessed according to RECIST criteria v1.1. Toxicity was registered according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. We performed survival analysis with the Kaplan-Meier method. The correlation between time actuarial incidence and clinical parameters was studied.

Results: Median follow-up was 26.5 months. 44 patients (62.8%) were alive at the time of analysis, while 22 (31.4%) died because of the disease. Local control at 2 and 3 years was 87%. The 2-year OS and DSS were 84 and 71%, respectively, while the 3-year values were 57 and 62%. PFS at 2 and 3 years was 41 and 25%, respectively. On univariate analysis, KPS ≥ 90 is statistically correlated with improved OS and DSS (p < 0.05). Acute toxicity of grade ≥ 2 occurred in 4 (5.7%) patients, while late toxicity ≥ 2 was recorded in 6 (8.6%) patients.

Conclusions: Ablative Radiotherapy represents a safe, effective, and minimally invasive treatment modality for elderly oligometastatic patients who are judged unfit for systemic therapy.
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http://dx.doi.org/10.1007/s40520-018-0937-6DOI Listing
January 2019