Publications by authors named "Salvatore Grisanti"

251 Publications

Supportive therapies in patients with advanced adrenocortical carcinoma submitted to standard EDP-M regimen.

Endocrine 2022 May 14. Epub 2022 May 14.

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

Purpose: The management of patients with advanced/metastatic adrenocortical carcinoma (ACC) is challenging, EDP-M (etoposide, doxorubicin, cisplatin combined with mitotane) is the standard regimen. However, it is quite toxic, so an adequate supportive therapy is crucial to reduce as much as possible the side effects and maintain the dose intensity of cytotoxic agents.

Methods: We describe the main side effects of the EDP-M scheme and the best way to manage them based on the experience of the Medical Oncology Unit of the Spedali Civili of Brescia. We also deal with the administration of EDP-M in specific frail patients, such as those with huge disease extent and poor performance status (PS) and those with mild renal insufficiency.

Results: In patients with hormone secreting ACC the rapid control of Cushing syndrome using adrenal steroidogenesis inhibitors such as metyrapone or osilodrostat is mandatory before starting EDP-M. Primary prophylaxis of neutropenia with Granulocyte-Colony Stimulating Factors is crucial and should be introduced at the first chemotherapy cycle. Possible mitotane induced hypoadrenalism should be always considered in case of persistent nausea and vomiting and asthenia in the interval between one cycle to another. In case of poor PS. A 24 h continuous infusion schedule of cisplatin could be an initial option in patients with poor PS as well as to reduce the risk of nefrotoxocity in patients with mild renal impairment.

Conclusion: A careful and accurate supportive care is essential to mitigate EDP-M side effects as much as possible and avoid that, due to toxicity, patients have to reduce doses and or postpone cytotoxic treatment with a negative impact on efficacy of this chemotherapy regimen.
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http://dx.doi.org/10.1007/s12020-022-03075-yDOI Listing
May 2022

Taste alterations during neo/adjuvant chemotherapy and subsequent follow-up in breast cancer patients: a prospective single-center clinical study.

Support Care Cancer 2022 May 11. Epub 2022 May 11.

Medical Oncology Department, ASST Spedali Civili of Brescia, Brescia, Italy.

Purpose: Dysgeusia and taste alterations (TAs) are side effects of cytotoxic chemotherapy and affect patients' quality of life; however, the prevalence, types, and duration of TAs and their potential relationship with other clinical disturbances are not well-described. Our primary aim was to prospectively evaluate the characteristics of TAs in early breast cancer (EBC) patients during (neo)adjuvant chemotherapy and up to 1 year after its completion.

Methods: From April 2014 to June 2018, 182 EBC patients entered the study and received (neo)adjuvant chemotherapy, mostly with taxane and anthracycline-containing regimens (65% of cases). A dietitian performed TAs assessment through the Common Terminology Criteria for Adverse Event v4.0 (CTCAE) and the Chemotherapy-induced Taste Alteration Scale (CiTAS) questionnaire during chemotherapy and follow-up according to defined time points: at baseline (T0, before starting chemotherapy); at the first follow-up visit, (T1, 2 months after starting chemotherapy); at the final follow-up visit (T2, 1 week after completing chemotherapy); after that, every 3 months up to 12 months.

Results: Dysgeusia was reported by 69.8% of patients at T1 and declined subsequently; salty flavor distortion was the most frequently reported TA (51.6% of cases). CiTAS was significantly different between T0 and T2 (p < 0.001). Dysgeusia occurred more frequently in patients reporting nausea, mucositis, diarrhea, and appetite modification.

Conclusions: TAs are common but transient during chemotherapy and occurred frequently with other distressing gastrointestinal side effects. The assessment of these side effects is crucial in managing EBC patients during (neo)adjuvant chemotherapy.
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http://dx.doi.org/10.1007/s00520-022-07091-6DOI Listing
May 2022

Ovarian Strumal Carcinoid: Case Report, Systematic Literature Review and Pooled Analysis.

Front Endocrinol (Lausanne) 2022 21;13:871210. Epub 2022 Apr 21.

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

Background: Ovarian strumal carcinoid is a rare tumor in which thyroid (struma) and carcinoid components coexist. The disease is generally considered to be a borderline malignancy, however, cases with metastatic disease have been described. No data in the literature are available to guide diagnosis and therapy.

Methods: We performed a pooled analysis and a systematic review of histopathological-confirmed strumal carcinoid cases published in the literature using the following keywords: "strumal carcinoid of the ovary", "strumal carcinoid case report". A case of strumal carcinoid tumor diagnosed and followed-up at the Medical Oncology Unit of Spedali Civili (Brescia, Italy) was also described and included.

Results: Sixty-six eligible publications were identified, providing data from one hundred and seventeen patients, plus a case diagnosed at our institution. At presentation, among the eighty-eight patients with symptomatic disease, 37% of patients suffered from abdominal distention and 49% from pain due to a growing abdominal tumor mass, 37% from constipation (peptide YY was analyzed in only nine of them, resulting above the physiologic range). Surgery was the primary therapy in 99% of the patients. Three patients had metastatic disease at diagnosis and five patients underwent recurrence after radical surgery. Histology at disease recurrence concerned the thyroid component in two patients, the carcinoid component in two patients, both histologies in one patient. Median disease-free survival and overall survival in this series were not attained.

Conclusion: Strumal carcinoid of the ovary generally presents a benign behavior and surgery is curative in most cases. However, a small group of patients with this disease can undergo disease recurrence due to both the thyroid and the neuroendocrine (carcinoid) components. A follow-up in radically operated patients is therefore needed, particularly in those with a voluminous disease at diagnosis.
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http://dx.doi.org/10.3389/fendo.2022.871210DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9069053PMC
May 2022

[Transparent Depiction of Case Reports Linked to COVID-19 and its Vaccination - a Temporal Coincidence].

Klin Monbl Augenheilkd 2022 Apr 14. Epub 2022 Apr 14.

Klinik für Augenheilkunde, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Deutschland.

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http://dx.doi.org/10.1055/a-1775-8405DOI Listing
April 2022

COVID-19 Sequelae and the Host Pro-Inflammatory Response: An Analysis From the OnCovid Registry.

J Natl Cancer Inst 2022 Apr 13. Epub 2022 Apr 13.

Division of Haematology, Department of Translational Medicine, University of Piemonte Orientale and Maggiore della Carità Hospital, Novara, Italy.

Background: 15% of patients with cancer experience symptomatic sequelae, which impair post COVID-19 outcomes. In this study we investigated whether a pro-inflammatory status is associated with the development of COVID-19 sequelae.

Methods: OnCovid recruited 2795 consecutive patients, diagnosed with SARS-CoV-2 infection between 27/02/2020-14/02/2021. This analysis focused on COVID-19 survivors who underwent a clinical re-assessment after the exclusion of patients with haematological malignancies. We evaluated the association of inflammatory markers collected at COVID-19 diagnosis with sequelae, considering the impact of prior systemic anticancer therapy (SACT).

Results: Out of 1339 patients eligible, 203 experienced at least one sequela (15.2%). Median baseline C-reactive protein (CRP, 77.5 mg/L vs 22.2 mg/L, p<.001), lactate dehydrogenase (LDH, 310 UI/L vs 274 UI/L, p=.028) and neutrophil-to-lymphocyte ratio (NLR, 6.0 vs 4.3, p=.001) were statistically significantly higher among patients who experienced sequelae, while no association were reported for platelet-to-lymphocyte ratio (PLR) and the OnCovid Inflammatory Score (OIS), which includes albumin and lymphocytes. The widest Area under the ROC curve was reported for baseline CRP (AUC 0.66,95%CI:0.63-0.69), followed by the NLR (AUC0.58,95%CI:0.55-0.61) and LDH (AUC=0.57,95%CI:0.52-0.61). Using a fixed categorical multivariable analysis high CRP (OR 2.56,95%CI:1.67-3.91) and NLR (OR 1.45,95%CI:1.01-2.10) were confirmed to be statistically significantly associated with an increased risk of sequelae. Exposure to chemotherapy was associated with a decreased risk of sequelae (OR 0.57,95%CI:0.36-0.91), while no associations with immune checkpoint inhibitors, endocrine therapy, and other types of SACT were found.

Conclusions: Although the association between inflammatory status, recent chemotherapy and sequelae warrants further investigations, our findings suggest that a deranged pro-inflammatory reaction at COVID-19 diagnosis may predict for sequelae development.
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http://dx.doi.org/10.1093/jnci/djac057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9047221PMC
April 2022

Protein Profiling of WERI-RB1 and Etoposide-Resistant WERI-ETOR Reveals New Insights into Topoisomerase Inhibitor Resistance in Retinoblastoma.

Int J Mol Sci 2022 Apr 6;23(7). Epub 2022 Apr 6.

Department of Cell Morphology and Molecular Neurobiology, Faculty of Biology and Biotechnology, Ruhr-University Bochum, Universitaetsstraße 150, 44780 Bochum, Germany.

Chemotherapy resistance is one of the reasons for eye loss in patients with retinoblastoma (RB). RB chemotherapy resistance has been studied in different cell culture models, such as WERI-RB1. In addition, chemotherapy-resistant RB subclones, such as the etoposide-resistant WERI-ETOR cell line have been established to improve the understanding of chemotherapy resistance in RB. The objective of this study was to characterize cell line models of an etoposide-sensitive WERI-RB1 and its etoposide-resistant subclone, WERI-ETOR, by proteomic analysis. Subsequently, quantitative proteomics data served for correlation analysis with known drug perturbation profiles. Methodically, WERI-RB1 and WERI-ETOR were cultured, and prepared for quantitative mass spectrometry (MS). This was carried out in a data-independent acquisition (DIA) mode. The raw SWATH (sequential window acquisition of all theoretical mass spectra) files were processed using neural networks in a library-free mode along with machine-learning algorithms. Pathway-enrichment analysis was performed using the REACTOME-pathway resource, and correlated to the molecular signature database (MSigDB) hallmark gene set collections for functional annotation. Furthermore, a drug-connectivity analysis using the L1000 database was carried out to associate the mechanism of action (MOA) for different anticancer reagents to WERI-RB1/WERI-ETOR signatures. A total of 4756 proteins were identified across all samples, showing a distinct clustering between the groups. Of these proteins, 64 were significantly altered (q < 0.05 & log2FC |>2|, 22 higher in WERI-ETOR). Pathway analysis revealed the "retinoid metabolism and transport" pathway as an enriched metabolic pathway in WERI-ETOR cells, while the "sphingolipid de novo biosynthesis" pathway was identified in the WERI-RB1 cell line. In addition, this study revealed similar protein signatures of topoisomerase inhibitors in WERI-ETOR cells as well as ATPase inhibitors, acetylcholine receptor antagonists, and vascular endothelial growth factor receptor (VEGFR) inhibitors in the WERI-RB1 cell line. In this study, WERI-RB1 and WERI-ETOR were analyzed as a cell line model for chemotherapy resistance in RB using data-independent MS. Analysis of the global proteome identified activation of "sphingolipid de novo biosynthesis" in WERI-RB1, and revealed future potential treatment options for etoposide resistance in RB.
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http://dx.doi.org/10.3390/ijms23074058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9000009PMC
April 2022

Letter to the editor from Berruti et al: "Cytoreductive Surgery of the Primary Tumor in Metastatic Adrenocortical Carcinoma: Impact on Patients' Survival".

J Clin Endocrinol Metab 2022 Mar 18. Epub 2022 Mar 18.

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

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http://dx.doi.org/10.1210/clinem/dgac169DOI Listing
March 2022

Modeling the Prognostic Impact of Circulating Tumor Cells Enumeration in Metastatic Breast Cancer for Clinical Trial Design Simulation.

Oncologist 2022 Mar 12. Epub 2022 Mar 12.

Department of Medical Oncology, Centro di Riferimento Oncologico (CRO), IRCCS, 33081 Aviano (PN), Italy.

Despite the strong prognostic stratification of circulating tumor cells (CTCs) enumeration in metastatic breast cancer (MBC), current clinical trials usually do not include a baseline CTCs in their design. This study aimed to generate a classifier for CTCs prognostic simulation in existing datasets for hypothesis generation in patients with MBC. A K-nearest neighbor machine learning algorithm was trained on a pooled dataset comprising 2436 individual MBC patients from the European Pooled Analysis Consortium and the MD Anderson Cancer Center to identify patients likely to have CTCs ≥ 5/7 mL blood (StageIVaggressive vs StageIVindolent). The model had a 65.1% accuracy and its prognostic impact resulted in a hazard ratio (HR) of 1.89 (Simulatedaggressive vs Simulatedindolent  P < .001), similar to patients with actual CTCs enumeration (HR 2.76; P < .001). The classifier's performance was then tested on an independent retrospective database comprising 446 consecutive hormone receptor (HR)-positive HER2-negative MBC patients. The model further stratified clinical subgroups usually considered prognostically homogeneous such as patients with bone-only or liver metastases. Bone-only disease classified as Simulatedaggressive had a significantly worse overall survival (OS; P < .0001), while patients with liver metastases classified as Simulatedindolent had a significantly better prognosis (P < .0001). Consistent results were observed for patients who had undergone CTCs enumeration in the pooled population. The differential prognostic impact of endocrine- (ET) and chemotherapy (CT) was explored across the simulated subgroups. No significant differences were observed between ET and CT in the overall population, both in terms of progression-free survival (PFS) and OS. In contrast, a statistically significant difference, favoring CT over ET was observed among Simulatedaggressive patients (HR: 0.62; P = .030 and HR: 0.60; P = .037, respectively, for PFS and OS).
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http://dx.doi.org/10.1093/oncolo/oyac045DOI Listing
March 2022

[Acute Central Serous Chorioretinopathy Following Immunisation with SARS-CoV-2 mRNA Vaccine?]

Klin Monbl Augenheilkd 2022 Feb 21. Epub 2022 Feb 21.

Klinik für Augenheilkunde, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Deutschland.

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http://dx.doi.org/10.1055/a-1697-5429DOI Listing
February 2022

Is adjuvant immunotherapy effective in patients with urothelial cancer?

Minerva Urol Nephrol 2022 Jun 11;74(3):252-254. Epub 2022 Feb 11.

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

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http://dx.doi.org/10.23736/S2724-6051.22.04841-8DOI Listing
June 2022

Lutetium-177-PSMA-617 for Prostate Cancer.

N Engl J Med 2021 Dec;385(26):2495

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia, Italy

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http://dx.doi.org/10.1056/NEJMc2116647DOI Listing
December 2021

Myeloid Leukemia Involvement or Intraocular Inflammation? Histopathological Examination of a Fibrinous Anterior Chamber Membrane.

Klin Monbl Augenheilkd 2021 Dec 20. Epub 2021 Dec 20.

Department of Ophthalmology, Universitätsklinikum Schleswig Holstein - Campus Lübeck, Lübeck, Germany.

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http://dx.doi.org/10.1055/a-1583-9672DOI Listing
December 2021

Progression of Vertebral Fractures in Patients with Adrenocortical Carcinoma Undergoing Mitotane Therapy.

J Clin Endocrinol Metab 2022 Apr;107(5):e2167-e2176

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

Context: Patients with adrenocortical carcinoma (ACC) are frequently on mitotane therapy for a long time period. The drug exerts adrenolytic activity requiring glucocorticoid supplementation, which can be potentially detrimental for bone.

Objective: To explore whether mitotane with/without chemotherapy is associated with an increased proportion of morphometric vertebral fractures (VFs) in ACC patients. Secondary objectives were proportion of patients with VF progression, or worsening of the spinal deformity index (SDI) during mitotane therapy; and to explore predictive factors of VF progression and a prognostic role of VF progression.

Methods: Multicenter, retrospective cohort study of patients with ACC who received mitotane alone or in association to chemotherapy, recruited from January 2010 to January 2020 in 2 reference centers in Italy and France.

Results: A significant increase in the frequency of VFs before and after mitotane therapy was seen both in Italian (28.3% vs 47.8%, P = .04) and French (17.8% vs 35.6%, P = .04) series. VF progression was observed in 39.1%, and 28.9% of patients, respectively. Baseline VFs and increased patient body mass index, but not the dose of cortisol supplementation, showed an independent association with VF progression at multivariate analysis. Among the 72 advanced ACC patients, progression of VFs was associated with a poorer survival.

Conclusion: The administration of mitotane with/without chemotherapy in ACC patients impairs bone health independently from cortisol supplementation. Appropriate preventive measures to decrease the fracture risk should be implemented in these patients.
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http://dx.doi.org/10.1210/clinem/dgab899DOI Listing
April 2022

Ribociclib Cytotoxicity Alone or Combined With Progesterone and/or Mitotane in in Vitro Adrenocortical Carcinoma Cells.

Endocrinology 2022 02;163(2)

Section of Pharmacology, Department of Molecular and Translational Medicine, University of Brescia, Brescia, 25123, Italy.

Mitotane is the only approved drug for treating adrenocortical carcinoma (ACC). The regimen added to mitotane is chemotherapy with etoposide, doxorubicin, and cisplatin. This pharmacological approach, however, has a limited efficacy and significant toxicity. Target-therapy agents represent a new promising approach to cancer therapy. Among these, a preeminent role is played by agents that interfere with cell-cycle progression, such as CDK4/6-inhibitors. Here, we investigate whether ribociclib could induce a cytotoxic effect both in ACC cell line and patient-derived primary cell cultures, alone or in combined settings. Cell viability was determined by 3-(4,5-dimethyl-2-thiazol)-2,5-diphenyl-2H-tetrazolium bromide assay, whereas cell proliferation was evaluated by direct count. Binary combination experiments were performed using Chou and Talalay method. Gene expression was analyzed by quantitative RT-PCR, whereas protein expression was evaluated by immunofluorescence. A double staining assay revealed that ribociclib induced a prevalent apoptotic cell death. Cell-cycle analysis was performed to evaluate the effect of ribociclib treatment on cell-cycle progression in ACC cell models. Our results indicate that ribociclib was cytotoxic and reduced the cell proliferation rate. The effect on cell viability was enhanced when ribociclib was combined with progesterone and/or mitotane. The effect of ribociclib on cell-cycle progression revealed a drug-induced cell accumulation in G2 phase. The positive relationship underlined by our results between ribociclib, progesterone, and mitotane strengthen the clinical potential of this combination.
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http://dx.doi.org/10.1210/endocr/bqab248DOI Listing
February 2022

Specific Autoantibodies in Neovascular Age-Related Macular Degeneration: Evaluation of Morphological and Functional Progression over Five Years.

J Pers Med 2021 Nov 16;11(11). Epub 2021 Nov 16.

Department of Ophthalmology, University Hospital Schleswig-Holstein, University of Lübeck, 23562 Lübeck, Germany.

(1) Background: Altered levels of autoantibodies (aab) and their networks have been identified as biomarkers for various diseases. Neovascular age-related macular degeneration (nAMD) is a leading cause for central vision loss worldwide with highly variable inter- and intraindividual disease courses. Certain aab networks could help in daily routine to identify patients with a high disease activity who need to be visited and treated more regularly. (2) Methods: We analyzed levels of aab against Angiotensin II receptor type 1 (AT1-receptor), Protease-activated receptors (PAR1), vascular endothelial growth factor (VEGF) -A, VEGF-B, and VEGF-receptor 2 in sera of 164 nAMD patients. In a follow-up period of five years, we evaluated changes in functional and morphological characteristics. Using correlation analyses, multiple regression models, and receiver operator characteristics, we assessed whether the five aab have a clinical significance as biomarkers that correspond to the clinical properties. (3) Results: Neither the analyzed aab individually nor taken together as a network showed statistically significant results that would allow us to draw conclusions on the clinical five-year course in nAMD patients. (4) Conclusions: The five aab that we analyzed do not correspond to the clinical five-year course of nAMD patients. However, larger, prospective studies should reevaluate different and more aab to gain deeper insights.
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http://dx.doi.org/10.3390/jpm11111207DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8624782PMC
November 2021

Rare Case of Bilateral Diffuse Uveal Melanocytic Proliferation with Dermal and Mucosal Hyperpigmentations.

Diagnostics (Basel) 2021 Nov 5;11(11). Epub 2021 Nov 5.

Department of Ophthalmology, University of Lübeck, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, 23538 Lübeck, Germany.

Purpose: The demonstration of a rare case of bilateral diffuse uveal melanocytic proliferation (BDUMP) due to a lung carcinoma with unusual dermal lesions.

Case Description: A 76-year-old man with painless bilateral vision loss revealed leopard or giraffe spot chorioretinopathy and bilateral serous retinal detachment. Ultrasound biomicroscopy revealed uveal swelling expanding into the anterior chamber angle. Dermal and mucosal lesions were present on the lip, breast, groin, scrotum, and penis. Screening analyses revealed a non-small cell lung carcinoma.

Conclusions: The diagnosis of BDUMP, a rare paraneoplastic syndrome, was made. The ophthalmological diagnosis led to screening investigations and revealed the underlying malignant disease. Uncommonly, multiple dermal and mucosal lesions could be detected and were analyzed histopathologically.
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http://dx.doi.org/10.3390/diagnostics11112052DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8619430PMC
November 2021

Time-Dependent COVID-19 Mortality in Patients With Cancer: An Updated Analysis of the OnCovid Registry.

JAMA Oncol 2022 01;8(1):114-122

Translational Oncology and Urology Research, School of Cancer and Pharmaceutical Sciences, King's College London, London, United Kingdom.

Importance: Whether the severity and mortality of COVID-19 in patients with cancer have improved in terms of disease management and capacity is yet to be defined.

Objective: To test whether severity and mortality from COVID-19 among patients with cancer have improved during the course of the pandemic.

Design, Setting, And Participants: OnCovid is a European registry that collects data on consecutive patients with solid or hematologic cancer and COVID-19. This multicenter case series study included real-world data from 35 institutions across 6 countries (UK, Italy, Spain, France, Belgium, and Germany). This update included patients diagnosed between February 27, 2020, and February, 14, 2021. Inclusion criteria were confirmed diagnosis of SARS-CoV-2 infection and a history of solid or hematologic cancer.

Exposures: SARS-CoV-2 infection.

Main Outcomes And Measures: Deaths were differentiated at 14 days and 3 months as the 2 landmark end points. Patient characteristics and outcomes were compared by stratifying patients across 5 phases (February to March 2020, April to June 2020, July to September 2020, October to December 2020, and January to February 2021) and across 2 major outbreaks (February to June 2020 and July 2020 to February 2021).

Results: At data cutoff, 2795 consecutive patients were included, with 2634 patients eligible for analysis (median [IQR] age, 68 [18-77] years ; 52.8% men). Eligible patients demonstrated significant time-dependent improvement in 14-day case-fatality rate (CFR) with estimates of 29.8% (95% CI, 0.26-0.33) for February to March 2020; 20.3% (95% CI, 0.17-0.23) for April to June 2020; 12.5% (95% CI, 0.06-22.90) for July to September 2020; 17.2% (95% CI, 0.15-0.21) for October to December 2020; and 14.5% (95% CI, 0.09-0.21) for January to February 2021 (all P < .001) across the predefined phases. Compared with the second major outbreak, patients diagnosed in the first outbreak were more likely to be 65 years or older (974 of 1626 [60.3%] vs 564 of 1008 [56.1%]; P = .03), have at least 2 comorbidities (793 of 1626 [48.8%] vs 427 of 1008 [42.4%]; P = .001), and have advanced tumors (708 of 1626 [46.4%] vs 536 of 1008 [56.1%]; P < .001). Complications of COVID-19 were more likely to be seen (738 of 1626 [45.4%] vs 342 of 1008 [33.9%]; P < .001) and require hospitalization (969 of 1626 [59.8%] vs 418 of 1008 [42.1%]; P < .001) and anti-COVID-19 therapy (1004 of 1626 [61.7%] vs 501 of 1008 [49.7%]; P < .001) during the first major outbreak. The 14-day CFRs for the first and second major outbreaks were 25.6% (95% CI, 0.23-0.28) vs 16.2% (95% CI, 0.13-0.19; P < .001), respectively. After adjusting for country, sex, age, comorbidities, tumor stage and status, anti-COVID-19 and anticancer therapy, and COVID-19 complications, patients diagnosed in the first outbreak had an increased risk of death at 14 days (hazard ratio [HR], 1.85; 95% CI, 1.47-2.32) and 3 months (HR, 1.28; 95% CI, 1.08-1.51) compared with those diagnosed in the second outbreak.

Conclusions And Relevance: The findings of this registry-based study suggest that mortality in patients with cancer diagnosed with COVID-19 has improved in Europe; this improvement may be associated with earlier diagnosis, improved management, and dynamic changes in community transmission over time.
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http://dx.doi.org/10.1001/jamaoncol.2021.6199DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8777559PMC
January 2022

Is BMI a reliable prognostic parameter in metastatic prostate cancer patients?

Prostate Cancer Prostatic Dis 2021 Nov 22. Epub 2021 Nov 22.

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

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http://dx.doi.org/10.1038/s41391-021-00474-6DOI Listing
November 2021

[Benign Tumors of the Eyelid].

Klin Monbl Augenheilkd 2022 Jan 19;239(1):111-130. Epub 2021 Nov 19.

Benign tumors of the eyelids are manifold. They can severely impair the anatomical unit of upper and lower eyelid, which basically serves to protect the eyeball. Furthermore, they can induce reduction of visual acuity or cause a subjectively more or less strong aesthetic disturbance of appearance. Patients may visit the ophthalmologist by themselves or referred by a dermatologist or a general practitioner. Therefore, knowledge of the clinical signs and symptoms of benign tumors are mandatory to discriminate against malign tumors or to identify possible associated disease. In this article, the incidence, clinic, risk factors, symptomatology, histopathologic features, and probabilities of malignant transformation and recurrence of the most common benign eyelid tumors are presented. Objective of this article is to illustrate when to do further work-up to rule out systemic disease and when to do biopsy to rule out malignancy. Finally, the publication is giving an outlook on the use of artificial intelligence to diagnose lid tumors in the future.
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http://dx.doi.org/10.1055/a-1671-0923DOI Listing
January 2022

Nasopharyngeal cancer in non-endemic areas: Impact of treatment intensity within a large retrospective multicentre cohort.

Eur J Cancer 2021 12 11;159:194-204. Epub 2021 Nov 11.

Radiotherapy 2 Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. Electronic address:

Aim: Recommendations for managing patients with nasopharyngeal carcinoma (NPC) in non-endemic areas are largely derived from studies conducted in endemic areas. We analysed the impact of treatment approaches on survival in non-endemic areas.

Methods: In an international, multicentre, retrospective study, we analyse consecutive patients with NPC diagnosed between 2004 and 2017 in 36 hospitals from 11 countries. Treatment was categorised as non-intensive (NIT), including radiotherapy alone or concomitant chemoradiotherapy (cCRT), and intensive (IT) including cCRT preceded by and/or followed by chemotherapy (CT). The impact of IT on overall survival (OS) and disease-free survival (DFS) was adjusted for all the available potential confounders.

Results: Overall, 1021 and 1113 patients were eligible for overall survival (OS) and disease-free survival (DFS) analyses, respectively; 501 and 554 with Epstein Barr-encoded RNA (EBER) status available. In the whole group, 5-year OS was 84% and DFS 65%. The use of NIT was associated with a risk of death or recurrence 1.37 times higher than patients receiving IT. Patients submitted to NIT and induction CT + concurrent concomitant chemo and three-dimensional Conformal Radiation Therapy (3DCRT) had a risk of death or recurrence 1.5 and 1.7 times higher than patients treated with induction CT + cCRT with intensity-modulated radiotherapy (IMRT), respectively. The IT had no impact on OS in neither patients with EBER+ nor in patients with EBER-; IT showed better DFS in EBER+ but not in patients with EBER-.

Conclusions: In low-incidence areas, patients with NPC treated with induction CT followed by concurrent IMRT cCRT achieved the highest DFS rate. The benefit of IT on DFS was restricted to patients with EBER+, suggesting that additional therapy offers no advantages in EBER- cases.
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http://dx.doi.org/10.1016/j.ejca.2021.09.005DOI Listing
December 2021

Prevalence and impact of COVID-19 sequelae on treatment and survival of patients with cancer who recovered from SARS-CoV-2 infection: evidence from the OnCovid retrospective, multicentre registry study.

Lancet Oncol 2021 12 3;22(12):1669-1680. Epub 2021 Nov 3.

Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.

Background: The medium-term and long-term impact of COVID-19 in patients with cancer is not yet known. In this study, we aimed to describe the prevalence of COVID-19 sequelae and their impact on the survival of patients with cancer. We also aimed to describe patterns of resumption and modifications of systemic anti-cancer therapy following recovery from SARS-CoV-2 infection.

Methods: OnCovid is an active European registry study enrolling consecutive patients aged 18 years or older with a history of solid or haematological malignancy and who had a diagnosis of RT-PCR confirmed SARS-CoV-2 infection. For this retrospective study, patients were enrolled from 35 institutions across Belgium, France, Germany, Italy, Spain, and the UK. Patients who were diagnosed with SARS-CoV-2 infection between Feb 27, 2020, and Feb 14, 2021, and entered into the registry at the point of data lock (March 1, 2021), were eligible for analysis. The present analysis was focused on COVID-19 survivors who underwent clinical reassessment at each participating institution. We documented prevalence of COVID-19 sequelae and described factors associated with their development and their association with post-COVID-19 survival, which was defined as the interval from post-COVID-19 reassessment to the patients' death or last follow-up. We also evaluated resumption of systemic anti-cancer therapy in patients treated within 4 weeks of COVID-19 diagnosis. The OnCovid study is registered in ClinicalTrials.gov, NCT04393974.

Findings: 2795 patients diagnosed with SARS-CoV-2 infection between Feb 27, 2020, and Feb 14, 2021, were entered into the study by the time of the data lock on March 1, 2021. After the exclusion of ineligible patients, the final study population consisted of 2634 patients. 1557 COVID-19 survivors underwent a formal clinical reassessment after a median of 22·1 months (IQR 8·4-57·8) from cancer diagnosis and 44 days (28-329) from COVID-19 diagnosis. 234 (15·0%) patients reported COVID-19 sequelae, including respiratory symptoms (116 [49·6%]) and residual fatigue (96 [41·0%]). Sequelae were more common in men (vs women; p=0·041), patients aged 65 years or older (vs other age groups; p=0·048), patients with two or more comorbidities (vs one or none; p=0·0006), and patients with a history of smoking (vs no smoking history; p=0·0004). Sequelae were associated with hospitalisation for COVID-19 (p<0·0001), complicated COVID-19 (p<0·0001), and COVID-19 therapy (p=0·0002). With a median post-COVID-19 follow-up of 128 days (95% CI 113-148), COVID-19 sequelae were associated with an increased risk of death (hazard ratio [HR] 1·80 [95% CI 1·18-2·75]) after adjusting for time to post-COVID-19 reassessment, sex, age, comorbidity burden, tumour characteristics, anticancer therapy, and COVID-19 severity. Among 466 patients on systemic anti-cancer therapy, 70 (15·0%) permanently discontinued therapy, and 178 (38·2%) resumed treatment with a dose or regimen adjustment. Permanent treatment discontinuations were independently associated with an increased risk of death (HR 3·53 [95% CI 1·45-8·59]), but dose or regimen adjustments were not (0·84 [0·35-2·02]).

Interpretation: Sequelae post-COVID-19 affect up to 15% of patients with cancer and adversely affect survival and oncological outcomes after recovery. Adjustments to systemic anti-cancer therapy can be safely pursued in treatment-eligible patients.

Funding: National Institute for Health Research Imperial Biomedical Research Centre and the Cancer Treatment and Research Trust.
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http://dx.doi.org/10.1016/S1470-2045(21)00573-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8565932PMC
December 2021

Accurate Triage of Oncological Patients for Safely Continuing Cancer Therapy During the SARS-CoV-2 Pandemic.

Front Oncol 2021 14;11:707346. Epub 2021 Oct 14.

Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia at the Azienda Socio Sanitaria Territoriale (ASST)-Spedali Civili, Brescia, Italy.

Objective: To evaluate the efficacy of clinical triage of oncological patients for safe continuation of cancer therapy implemented during the first SARS-CoV-2 outbreak.

Methods: Between 25 February and 21 April 2020, patients attending the Medical Oncology Unit, Spedali Civili Hospital, Brescia (Italy) for cancer therapy underwent triage to identify those with no signs and symptoms suspicious for SARS-CoV-2 infection in which antineoplastic treatment could be continued as scheduled. Triage questions investigated common symptoms (e.g., fever, cough, dyspnea, anosmia, dysgeusia, headache, nasal congestion, conjunctival congestion, sore throat, diarrhea, nausea and vomiting); body temperature and pulse oximetry were also recorded. All patients were followed-up for overt SARS-CoV-2 through to 18 May 2020.

Results: Overall, 1180 patients (median age 65 years) underwent triage during the study period. The most frequent primary malignances were breast (32%), gastrointestinal (18%), and lung (16.5%) cancer. Thirty-one (2.5%) presented with clinically evident SARS-CoV-2 infection and tested positive on nasopharyngeal swab testing and/or radiological imaging. Triage identified 69 (6%) grey zone patients with symptoms suspicious for SARS-CoV-2; 5 (7.2%) subsequently developed symptomatic disease. Neither the symptomatic nor the grey zone patients received their scheduled treatment; instead, they were referred for hospitalization or home quarantine.

Conclusion: Triage of oncological patients at our Unit provided for safe continuation of scheduled cancer treatment in 91.5% of patients during the initial SARS-CoV-2 outbreak.
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http://dx.doi.org/10.3389/fonc.2021.707346DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8552044PMC
October 2021

Epidermal Growth Factor Is Increased in Conjunctival Malignant Melanoma.

In Vivo 2021 Nov-Dec;35(6):3603-3612

Experimental Eye Research Institute, University Eye Hospital, Ruhr-University Bochum, Bochum, Germany.

Background/aim: Conjunctival malignant melanoma (CMM) is a rare, but very aggressive tumor with a high metastasis rate. Not much is known about the CMM metastasis mechanisms. So far, epidermal growth factor (EGF) and its receptor (EGF-R) as well as macrophages and matrix metalloproteinase 9 (MMP-9) have been reported to lead to metastasis by epithelial-mesenchymal-transition and tumor migration in different solid tumors. Therefore, we evaluated whether EGF and EGF-R, CD68 and MMP-9 are altered in CMM samples in comparison to conjunctival nevi and healthy conjunctiva.

Patients And Methods: EGF, EGF-R, the macrophage marker CD68 and MMP-9 expression were analyzed in human conjunctival melanoma (CMM, n=16), human conjunctival nevi (n=13) and disease-free human conjunctiva (controls, n=14) by immunohistology. Staining of each sample was evaluated using a standardized score ranging from negative (0) to triple positive (3). The groups were then compared by ANOVA, followed by Tukey's post-hoc test.

Results: A statistically significant increase of EGF was seen in CMM samples in comparison to conjunctival nevi (p=0.03). In contrast, no statistically significant differences in EGF-R expression were noted between the three groups. A statistically significant increase of CD68 was only seen in conjunctival nevi compared to controls (p=0.04). MMP-9 expression was similar in all groups.

Conclusion: In CMM, the study data demonstrated an up-regulation of EGF in comparison to conjunctival nevi. Hence, EGF might promote proliferation of CMM cells and induce the epithelial-mesenchymal transition. Therefore, our data suggest that an interplay between EGF and CMM might have a critical role in the developing CMM tumors and metastasis.
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http://dx.doi.org/10.21873/invivo.12666DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8627743PMC
October 2021

Molecular genotyping of adrenocortical carcinoma: a systematic analysis of published literature 2019-2021.

Curr Opin Oncol 2022 01;34(1):19-28

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

Purpose Of Review: comprehensive molecular characterization of adrenocortical carcinoma (ACC) through next-generation sequencing and bioinformatics analyses is expanding the number of targets with potential prognostic and therapeutic value. We performed a critical review of recent published literature on genotyping of ACC.

Recent Findings: 423 studies were published between 2019 and 2021. After manual curation we summarized selected evidence in two thematic areas: germline deoxyribonucleic acid (DNA) variations, genomic alterations and prognosis.

Summary: the evolving genomic landscape of ACC requires target validation in terms of prognostic and predictive value within scientific consortia. Although the existing multiple driver genes are difficult targets in the perspective of precision oncology, alterations in DNA damage repair genes or in promoter hypermethylation could open new venues for repurposing of existing drugs in ACC.
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http://dx.doi.org/10.1097/CCO.0000000000000799DOI Listing
January 2022

Results From the German Fungal Keratitis Registry: Significant Differences Between Cases With and Without a History of Contact Lens Use.

Cornea 2021 Nov;40(11):1453-1461

Department of Ophthalmology, University Hospital Düsseldorf, Germany.

Purpose: Fungal keratitis (FK) is a serious ophthalmic disease with a potentially devastating outcome that seems to be increasing in recent years. The use of contact lenses (CLs) was evaluated as a risk factor for FK to determine possible differences in course and outcome.

Methods: Data from 173 cases reported in the German FK registry until August 2019 were evaluated regarding CL behavior, other ophthalmological and general risk factors, age, sex, identified pathogens, conservative and surgical therapy, visual acuity, and findings at admission and follow-up.

Results: One hundred seventy-four eyes from 173 patients between 2000 and 2019 were included [64.4% women, median age 54 (39; 72) years]; 49.7% wore CL, of which 81.3% were soft CL, and 50.3% had no history of contact lens use (NCL). CL users were significantly more often women and otherwise healthy (CL: 80.2% vs. NCL: 48.9%; P < 0.0001). The spectrum of pathogens among CL users showed a significantly higher proportion of infections with filamentous pathogens, in particular Fusarium sp. (total filament: CL 69.8% vs. NCL 27.3%; P = 0.0001; Fusarium sp.: CL 50.0% vs. NCL 14.8%; P < 0.0001). Overall, 54.6% required keratoplasty and 8.6% enucleation.

Conclusions: CLS are the most important risk factor for FK in Germany. With CLs, typically, the infection is caused by molds, and patients are comparably younger and otherwise healthy. Often, extensive surgery is needed. To evaluate changes in the pathogen and resistance spectrum and to further monitor possible CL-related risk factors, a consistent collection of data remains paramount.
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http://dx.doi.org/10.1097/ICO.0000000000002705DOI Listing
November 2021

Efficacy of Immune Checkpoint Inhibitors in Rare Tumours: A Systematic Review.

Front Immunol 2021 20;12:720748. Epub 2021 Sep 20.

Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Azienda Socio Sanitaria Territoriale (ASST) Spedali Civili of Brescia, Brescia, Italy.

Background: Rare cancers, as defined by the European Union, occur in fewer than 15 out of 100,000 people each year. The International Rare Cancer Consortium defines rare cancer incidence as less than six per 100,000 per year. There is a growing number of reports of the efficacy of immune checkpoint inhibitor (ICI) therapy in patients with rare tumours, and hence, we conducted a comprehensive review to summarise and analyse the available literature.

Methods: A literature search of PubMed was performed on January 31, 2021, using the following ICI names as keywords: ipilimumab, tremelimumab, cemiplimab, nivolumab, pembrolizumab, avelumab, atezolizumab, and durvalumab. Studies on patients with rare tumours who were being treated with ICIs were included. We plotted the overall response rate against the corresponding median survival across a variety of cancer types using linear regression.

Results: From 1,255 publications retrieved during the primary search, 62 publications were selected (with a total of 4,620 patients). Only four were randomised trials. A minority were first-line studies, while the remaining were studies in which ICIs were delivered as salvage therapy in pretreated patients. There was a good correlation between response rate and overall survival (Spearman R >0.9) in skin cancers, mesothelioma, and sarcomas.

Conclusions: Treatment of advanced-stage rare tumours with ICI therapy was found to be associated with significant activity in some orphan diseases (e.g., Merkel cell carcinoma) and hepatocellular carcinoma. Several ongoing prospective clinical trials will expand the knowledge on the safety and efficacy of ICI therapy in patients with these rare cancers.
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http://dx.doi.org/10.3389/fimmu.2021.720748DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8488393PMC
December 2021

Different management of adrenocortical carcinoma in children compared to adults: is it time to share guidelines?

Endocrine 2021 12 24;74(3):475-477. Epub 2021 Sep 24.

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

Pediatric and adult adrenocortical carcinomas differ in many respects but treatment is often similar in both age groups. The Journal of Clinical Oncology recently published the results of a risk-stratified single-arm interventional trial conducted by the Children's Oncology Group in which 77 patients were treated in three different interventional cohorts. In this Point of View paper we comment on the treatment strategies adopted within the ARAR0332 trial in terms of surgery approach, duration of adjuvant therapies, and palliative chemotherapy. We focus on the differences in the treatment of pediatric ACC patients compared to the ESE/ENSAT and ESMO guidelines released in 2018 for adult patients. For example, patients in stratum 3 and 4 received 8 (instead of 6) cycles of EDP chemotherapy but 8 months (instead of 24) of mitotane adjuvant therapy. Bearing clearly in the mind that pediatric and adult ACC patients represent different settings, we wonder whether there could be some areas of intervention overlapping to constitute a continuum of disease across ages. Thus, pediatric and adult cohoperative groups should be encouraged to collaborate in order to reach common guidelines for the treatment of such a rare disease.
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http://dx.doi.org/10.1007/s12020-021-02874-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8571231PMC
December 2021

Establishment of a Robust and Simple Corneal Organ Culture Model to Monitor Wound Healing.

J Clin Med 2021 Aug 6;10(16). Epub 2021 Aug 6.

Department of Ophthalmology, University of Luebeck, Ratzeburger Allee 160, 23538 Luebeck, Germany.

The use of in vitro systems to investigate the process of corneal wound healing offers the opportunity to reduce animal pain inflicted during in vivo experimentation. This study aimed to establish an easy-to-handle ex vivo organ culture model with porcine corneas for the evaluation and modulation of epithelial wound healing. Cultured free-floating cornea disks with a punch defect were observed by stereomicroscopic photo documentation. We analysed the effects of different cell culture media and investigated the impact of different wound sizes as well as the role of the limbus. Modulation of the wound healing process was carried out with the cytostatic agent Mitomycin C. The wound area calculation revealed that after three days over 90% of the lesion was healed. As analysed with TUNEL and lactate dehydrogenase assay, the culture conditions were cell protecting and preserved the viability of the corneal tissue. Wound healing rates differ dependent on the culture medium used. Mitomycin C hampered wound healing in a concentration-dependent manner. The porcine cornea ex vivo culture ideally mimics the in vivo situation and allows investigations of cellular behaviour in the course of wound healing. The effect of substances can be studied, as we have documented for a mitosis inhibitor. This model might aid in toxicological studies as well as in the evaluation of drug efficacy and could offer a platform for therapeutic approaches based on regenerative medicine.
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http://dx.doi.org/10.3390/jcm10163486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8397146PMC
August 2021

[Treatment and management of orbital tumors].

Ophthalmologe 2021 Oct 18;118(10):1004-1011. Epub 2021 Aug 18.

Klinik für Augenheilkunde, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Deutschland.

Background: There are various options for the conservative treatment of the most frequent orbital tumors. These can delay, complement or be superior to the surgical approach, which is often prone to complications.

Objective: This article gives a summary of the possible treatment options for the most common orbital tumors in childhood and adulthood.

Methods: A literature search was carried out and the possible treatment pathways are presented.

Results: 1. Frequent orbital tumors in childhood: a systemic treatment with noncardioselective beta blockers is the primary treatment for capillary orbital hemangiomas. In cases of no response, steroids, interferon alpha or cyclophosphamide are treatment options. Observation is a possible option for smaller dermoid cysts, in cases of progression excision can become necessary. Symptomatic optic nerve gliomas can also be observed and in cases of progression treated with chemotherapy, mTOR/MEK inhibitors or radiotherapy (children > 5 years). Rhabdomyosarcomas are biopsied and subsequently treated by radiotherapy and chemotherapy. 2. Frequent orbital tumors in adulthood: asymptomatic cases of cavernous hemangiomas of the orbit can just be observed. Symptomatic hemangiomas can be surgically excised or treated with radiotherapy. For meningiomas of the optic nerve sheath radiotherapy is a very effective treatment. Surgical excision should be reserved for cases with no prognosis of visual acuity. There is also the option to treat with antiprogesterone. Orbital lymphomas with purely orbital involvement can be treated with radiotherapy, chemotherapy or the application of rituximab.

Conclusion: There are now very effective conservative treatment options for many orbital tumors. In some cases a surgical procedure can be avoided and a good visual function can be retained.
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http://dx.doi.org/10.1007/s00347-021-01471-9DOI Listing
October 2021

[Retinal tumors in adults: Part 2 nonvascular tumors of retina and retinal pigment epithelium].

Ophthalmologe 2021 Nov 29;118(11):1153-1160. Epub 2021 Jul 29.

Klinik für Augenheilkunde, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Deutschland.

Retinal tumors are a heterogeneous group of congenital and acquired lesions. In the second part of the article retinocytic and glial cell tumors of the retina, tumors of the retinal pigment epithelium, malignant tumors, such as lymphomas and metastases are presented. In benign and malignant tumors visual symptoms, such as exudative retinal detachment occur, which often lead to irreversible visual impairments. Because visual symptoms are often a manifestation of systemic diseases, the ophthalmologist plays an important role in the accurate and early diagnosis of retinal tumors. This article reviews the most important clinical and diagnostic features of retinal tumors in adults, the systemic associations and the literature on currently available treatment strategies.
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http://dx.doi.org/10.1007/s00347-021-01446-wDOI Listing
November 2021
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