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Dataset related to article "Linac-based stereotactic body radiation therapy for low and intermediate-risk prostate cancer : Long-term results and factors predictive for outcome and toxicity"

This record contains raw data related to article “Linac-based stereotactic body radiation therapy for low and intermediate-risk prostate cancer : Long-term results and factors predictive for outcome and toxicity" Introduction: Stereotactic body radiation therapy (SBRT) is considered an effective and safe treatment in patients with low- and intermediate-risk prostate cancer (PC). However, due to a lack of long-term follow-up and late toxicity data, this treatment is not universally accepted. The present study aimed to evaluate outcome and early and late toxicity in a cohort of patients with low- and intermediate-risk PC treated prospectively with linear accelerator (linac)-based SBRT. Patients and methods: Patients with low- or intermediate-risk (NCCN criteria) PC were included. All patients received linac-based SBRT to 35 Gy in 5 fractions delivered on alternate days. Endpoints were toxicity, biochemical relapse-free survival (BRFS), metastatic progression-free survival (mPFS), and overall survival (OS). Results: From 2012 to 2018, 178 patients were treated. Median baseline prostate-specific antigen (iPSA) was 6.37 ng/ml (range 1.78-20). Previous transurethral resection of the prostate (TURP) was present in 23 (12.9%) patients. Median follow-up was 58.9 months (range 9.7-89.9). BRFS rates at 1, 3, and 5 years were 98.3 (95% confidence interval, CI, 94.7-99.4%), 94.4 (95%CI 89.4-97), and 91.6% (95%CI 85.4-95.2), respectively. In univariate analysis, performance status (PS), iPSA, and nadir PSA (nPSA) were correlated with BRFS. In multivariable analysis iPSA and nPSA remained significant. BRFS rates at 5 years were 94.9% (95%CI 86.8-98) for International Society of Urological Pathology (ISUP) grade group 1, 93.2% (95%CI 80.5-97.7) for ISUP group 2, and 74.8% (95%CI 47.1-89.5) for ISUP group 3. At 1, 3, and 5 years, mPFS rates were 98.8 (95%CI 95.5-99.7), 96.2 (95%CI 91.9-98.3), and 92.9% (95%CI 87.2-96.2), respectively; OS rates were 100, 97.2 (95%CI 92.9-98.9), and 95.1% (95%CI 90-97.6), respectively. One (0.56%) case of grade 3 acute genitourinary (GU), one case of acute gastrointestinal (GI), and one case of grade 3 late GU toxicity were observed. GI toxicity positively correlated with prostate volume. Conclusion: At long-term follow-up, linac-based SBRT continues to be a valid option for the management localized PC. Biochemical control remains high at 5 years, albeit with some concerns regarding the optimal schedule for unfavorable intermediate-risk PC. Considering the excellent prognosis, patient selection is crucial for prevention of severe late toxicity.

Dataset related to article "Assessing the role of Stereotactic Body Radiation Therapy in a large cohort of patients with lymph node oligometastases: Does it affect systemic treatment's intensification?"

This record contains raw data related to article “Assessing the role of Stereotactic Body Radiation Therapy in a large cohort of patients with lymph node oligometastases: Does it affect systemic treatment's intensification?" Background and purpose: Lymph nodes (LN) are common site of oligometastases and stereotactic body radiation therapy (SBRT) represents an effective ablative treatment. Aim of this study was to analyze a large cohort of nodal oligometastases treated with SBRT to identify impact on systemic therapy intensification, pattern of recurrence, and predictive factors. Materials and methods: We included patients with a maximum of 5 oligometastases. Concomitant treatments were allowed. Patients were treated with Volumetric Modulated Arc Therapy (VMAT) and end points were local control of treated metastases (LC), locoregional nodal control (LRNC), distant nodal control (DNC), distant metastases free survival (DMFS), overall survival (OS) and freedom from treatment intensification (FFTI). Results: 418 LN were treated in 278 patients with 327 SBRT treatments. Patients were more commonly affected by colorectal (20.9%) and prostate cancer (17.99%). Most represented schedule was 45 Gy in 6 fractions, with a median BED10 of 78.75 Gy. After median follow-up of 15.1 months, LC at 1 and 2 years were 87.2% and 76.8%, respectively. Prostate primary tumor, small volume, oligorecurrence, and BED10 ≥75 Gy were associated with higher LC. One and 2 years FFTI were 82.8% and 74.5%; in patients reporting intensification of systemic therapy, median time was 8.43 months, while for patients who repeated SBRT, median FFTI was 14.6 months. Rates of LRNC at 1 and 2 years were 70.9% and 57.6%, and DNC were 82.0% and 77.9%. Conclusion: With the present analysis, we confirmed on a large cohort the benefit from SBRT on lymph node oligometastases in multidisciplinary management. Combination of SBRT with new systemic therapies, including immunotherapy and targeted therapy, should be investigated to reduce the risk of progression out of the field of irradiation.

Dataset related to article "Risk calculator for prediction of treatment‐related urethroplasty failure in patients with penile urethral strictur"es

This record contains data related to the paper: Risk calculator for prediction of treatment‐related urethroplasty failure in patients with penile urethral strictures. Purpose: To design a dedicated risk calculator for patients with penile urethra stricture who are scheduled to urethroplasty that might be used to counsel patients according to their pre-operative risk of failure. Methods: Patients treated with penile urethroplasty at our center (1994–2018) were included in the study. Patients received 1-stage or staged penile urethroplasty. Patients with failed hypospadias repair, lichen sclerosus or incomplete clinical records were excluded. Treatment failure was defined as any required postoperative instrumentation, including dilation. Univariable Cox regression identified predictors of post-operative treatment failure and Kaplan–Meier analysis plotted the failure-free survival rates according to such predictors. Multivariable Cox regression-based risk calculator was generated to predict the risk of treatment failure at 10 years after surgery. Results: 261 patients met the inclusion criteria. Median follow-up was 113 months. Out of 216 patients, 201 (77%) were classified as success and 60 (23%) failures. Former smoker (hazard ratio [HR] 2.12, p = 0.025), instrumentation-derived stricture (HR 2.55, p = 0.006), and use of grafts (HR 1.83, p = 0.037) were predictors of treatment failure. Model-derived probabilities showed that the 10-year risk of treatment failure varied from 5.8 to 41.1% according to patient’s characteristics. Conclusions: Long-term prognosis in patients who underwent penile urethroplasty is uncertain. To date, our risk-calculator represents the first tool that might help physicians to predict the risk of treatment failure at 10 years. According to our model, such risk is largely influenced by the etiology of the stricture, the use of graft, and patient’s smoking habits.

Dataset related to article "Patient‐reported outcomes for typical single cheek harvesting vs atypical lingual, labial or bilateral cheeks harvesting: a single‐center analysis of more than 800 patients"

This record contains data of the paper: Patient‐reported outcomes for typical single cheek harvesting vs atypical lingual, labial or bilateral cheeks harvesting: a single‐center analysis of more than 800 patients. Purpose The optimal harvesting site for oral grafting in patients with urethral strictures remain controversial, with no study investigating morbidity on large scale. We aimed to compare typical single cheek harvesting vs atypical lingual, labial or bilateral cheeks harvesting in terms of complications and patient-reported outcomes. Methods Within 827 patients treated at our referral center with oral graft urethroplasty, we compared typical vs atypical harvesting techniques. A self-administered, semiquantitative, non-validated questionnaire assessed early (10 days) and late (4 months) postoperative complications and patient-reported outcomes. A semiquantitative score was calculated according to patient responses, and it was used to assess early (6 questions) and late (13 questions) patient dissatisfaction status. Patients were defined early and/or late dissatisfied when they scored ≥ 7 and ≥ 10 at the early or late questionnaires, respectively. Results Between 1998 and 2019, our patients predominantly received typical single cheek harvesting (89% vs 11%), with + 1.5% increase rate per year (p < 0.001). Early and late dissatisfied patients were, respectively, 170 (23%) vs 39 (44%) and 59 (8%) vs 16 (18%) in the typical vs atypical groups. Atypical harvesting was associated with higher rates of early (Odds ratio [OR]: 2.34; 95% Confidence interval [CI] 1.44–3.75; p = 0.001) and late (OR: 2.37; 95%CI 1.22–4.42; p = 0.008) postoperative dissatisfaction. Conclusions Typical single cheek harvesting was the preferred surgical option at our center and it was associated with negligible early and late rates of complications and patient’s dissatisfaction. Conversely, atypical lingual, labial or bilateral cheeks harvesting was associated with higher complications and frequent patient dissatisfaction.

Dataset related to article "Phase II trial of high dose stereotactic body radiation therapy for lymph node oligometastases"

This record contains raw data related to article "Phase II trial of high dose stereotactic body radiation therapy for lymph node oligometastases" Lymph nodes are common sites of oligometastases for several primaries. Stereotactic body radiation therapy (SBRT) represents an effective treatment but no consensus exists regarding dose and fractionation. Aim of this trial was to evaluate safety and efficacy of high-dose SBRT. We included patients with 1 to 3 lymph node metastases. Primary end-point was safety, while secondary end-points were in-field local control (LC), out-field lymph nodal progression free survival (LPFS), distant metastasis free survival (DMFS), progression free survival (PFS) and overall survival (OS). 64 lesions in 52 patients were treated from 2015 to 2019. Most common primary tumor was genitourinary cancer (75%), in particular prostate cancer (65.4%). With a median follow-up of 24.4 months (range 3-49), treatment was very well tolerated, with only 4 (7.7%) patients reporting acute side effects, all classified as grade 1, in the form of pain, fatigue, nocturia and dysuria. No toxicity ≥ grade 2 were reported. Rates of LC at 1, 2 and 3 years were 97.9%, 82.1% and 82.1%. Male sex (HR 0.12, p value 0.014) was associated with improved LC. LPFS at 1, 2 and 3 years were 69.6%, 49.6% and 46.1%, respectively, and DMFS was 81.74%, 67.5% and 58.5%, respectively. Presence of lesions in other organs was correlated with inferior DMFS (HR 3.82, p = 0.042). PFS at 1, 2 and 3 years were 67.4%, 42.4% and 31.86%, respectively. OS at 1, 2 and 3 years were 97.3%, 94.2%, 84%, respectively and significantly correlated with in-field recurrence (HR 8.72, p = 0.000). Our prospective trial confirms safety and efficacy of SBRT in the management of lymph node metastases. Registered Clinical trial <a href="http://clinicaltrials.gov/show/NCT02570399">NCT02570399</a>.

Dataset related to article "Thyrotoxicosis in patients with COVID-19: the THYRCOV study"

This record contains data related to article "Thyrotoxicosis in patients with COVID-19: the THYRCOV study" Abstract Objective: This study assessed thyroid function in patients affected by the coronavirus disease-19 (COVID-19), based on the hypothesis that the cytokine storm associated with COVID-19 may influence thyroid function and/or the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may directly act on thyroid cells, such as previously demonstrated for SARS-CoV-1 infection. Design and methods: This single-center study was retrospective and consisted in evaluating thyroid function tests and serum interleukin-6 (IL-6) values in 287 consecutive patients (193 males, median age: 66 years, range: 27-92) hospitalized for COVID-19 in non-intensive care units. Results: Fifty-eight patients (20.2%) were found with thyrotoxicosis (overt in 31 cases), 15 (5.2%) with hypothyroidism (overt in only 2 cases), and 214 (74.6%) with normal thyroid function. Serum thyrotropin (TSH) values were inversely correlated with age of patients (rho -0.27; P < 0.001) and IL-6 (rho -0.41; P < 0.001). In the multivariate analysis, thyrotoxicosis resulted to be significantly associated with higher IL-6 (odds ratio: 3.25, 95% confidence interval: 1.97-5.36; P < 0.001), whereas the association with age of patients was lost (P = 0.09). Conclusions: This study provides first evidence that COVID-19 may be associated with high risk of thyrotoxicosis in relationship with systemic immune activation induced by the SARS-CoV-2 infection.

Dataset related to article "TNM 8th edition in thyroid cancer staging: is there an improvement in predicting recurrence?"

This record contains data related to article "TNM 8th edition in thyroid cancer staging: is there an improvement in predicting recurrence?" Abstract TNM 8th edition introduces changes in the staging of patients with differentiated thyroid carcinoma (DTC). This study aims at assessing the value of TNM 8th edition in predicting response to therapy and structural recurrence of DTC. Four hundred and eighty DTC patients were retrospectively evaluated by 7th and 8th editions of TNM staging system in relationship with risk stratification, response to therapy and recurrence of disease as defined by 2015 ATA guidelines. As compared to the 7th edition, TNM 8th led to downstage 136 patients (28.3%), with 97.5% of patients falling into lower stages (I-II) and only 2.5% remaining in higher stages (III-IV) (P < 0.001). Patients who were downstaged in stages I-II by TNM 8th were classified more frequently at intermediate-high risk (P < 0.001), had more frequently structural incomplete response to therapy (P = 0.009) and had higher risk of structural recurrence (P = 0.002) as compared to patients who were in the same TNM stages but were not downstaged. Specifically, the risk of structural recurrence was significantly higher in patients in whom the downstaging was induced by changes in tumour classification (hazard ratio (HR) 6.18, 95% CI 2.20-17.40; P = 0.001) but not in those who were downstaged for the increase in age cut-off (HR 2.80, 95% CI 0.86-9.19; P = 0.09). In conclusion, TNM 8th edition did not show reliability in predicting aggressiveness of DTC. In fact, the downstaging of DTC patients especially when performed due to changes in tumour classification may overlook patients predisposed to structural recurrence, potentially causing uncertainty in the therapeutic decision-making at the time of disease's diagnosis.

Dataset related to article "Secondary hyperparathyroidism and thoracic vertebral fractures in heart failure middle-aged patients: a 3-year prospective study"

This record contains data related to article "Secondary hyperparathyroidism and thoracic vertebral fractures in heart failure middle-aged patients: a 3-year prospective study" Abstract Purpose: Vertebral fractures (VFs) were described in elderly patients with heart failure (HF) whereas their prevalence and determinants in younger HF patients are still unknown. This study aimed at assessing whether secondary hyperparathyroidism (SHPT) may influence the risk of VFs in middle-aged patients with HF. Methods: 84 patients (44 males, median age 48.5 years, range 43-65) with HF were prospectively evaluated at the baseline and after 36-month follow-up for bone mineral density (BMD) and VFs by quantitative morphometry on chest X-rays. Serum PTH, calcium, 25-hydroxyvitamin D and 24-h-urinary calcium were evaluated at the baseline and every 6-12 months during the study period. Results: At baseline, SHPT, hypovitaminosis D and VFs were found in 43 patients (51.2%), 73 patients (86.9%) and 29 patients (34.5%), respectively. SHPT was associated with VFs at baseline [inverse probability-weighted (ipw) odds ratio (OR) 12.2, p < 0.001]. Patients were treated with vitamin D3 alone (56%), vitamin D3 plus calcium carbonate (21.4%), calcitriol alone (4.8%), bisphosphonates plus vitamin D3 (8.3%) or a combination of bisphosphonates, vitamin D3 and calcium carbonate (9.5%). At the end of follow-up, hypovitaminosis D was corrected in all patients, whereas 19/84 patients (22.6%) had persistent SHPT. During the follow-up, 16 patients developed incident VFs which resulted to be associated with baseline SHPT (ipw OR 55.7, p < 0.001), even after adjusting from BMD change from baseline to follow-up (ipw OR 46.4, p < 0.001). Conclusions: This study provides a first evidence that SHPT may be a risk factor for VFs in middle-aged patients with HF.

Dataset related to article "Morphometric vertebral fractures in patients with castration-resistant prostate cancer undergoing treatment with radium-223: a longitudinal study in the real-life clinical practice"

This record contains data related to article "Morphometric vertebral fractures in patients with castration-resistant prostate cancer undergoing treatment with radium-223: a longitudinal study in the real-life clinical practice" Abstract Purpose: Radium-223 was associated with high incidence of non-vertebral fractures in patients with castration-resistant prostate cancer (CRPC). However, it is still unclear whether radium-223 may induce skeletal fragility regardless of other therapies for CRPC. We aimed at evaluating the prevalence, incidence, and determinants of vertebral fractures (VFs), i.e., the most frequent complication of skeletal fragility, in CRCP patients undergoing radium-223 therapy in the real-life clinical practice. Methods: We retrospectively reviewed 49 CRPC patients with symptomatic bone metastases treated with radium-223. Patients received median number of four radium-223 doses (range: 2-6) and were followed-up for a median period of 11 months (range: 6-44). VFs were assessed by a quantitative morphometry using lateral images of spine 11C-Choline PET/CT, excluding from the analysis the vertebral bodies affected by bone metastases. Results: Before radium-223 administration, 24 patients (49%) had VFs significantly associated with duration of androgen deprivation therapy (ADT; odds ratio 1.29) and previous abiraterone therapy (odds ratio 3.80). During radium-223 therapy, incident VFs occurred in 25% of patients, in relationship with prevalent VFs (hazard ratio 6.89) and change in serum total alkaline phosphatase values (hazard ratio 0.97), whereas the correlations with ADT and abiraterone therapy were lost. Noteworthy, the risk of VFs did not correlate with the therapeutic end points of radium-223. Conclusions: This study provides a first evidence that in real-life clinical practice, radium-223 therapy may induce skeletal fragility with high risk of VFs, likely by inhibition of bone formation and independently of ADT and abiraterone therapy.

Dataset related to article "Stereotactic body radiotherapy in the management of oligometastatic and recurrent biliary tract cancer: single-institution analysis of outcome and toxicity"

This record contains raw data related to article “Stereotactic body radiotherapy in the management of oligometastatic and recurrent biliary tract cancer: single-institution analysis of outcome and toxicity" Introduction: Biliary tract cancers (BTC) are rare malignancies arising from biliary system. Systemic therapy is the cornerstone for stage IV disease, with poor overall survival (OS). Evidence is lacking about safety and efficacy of local ablative treatments, such as surgery and stereotactic body radiotherapy (SBRT) in the context of metastatic BTC (mBTC). Materials and methods: We retrospectively analyzed clinical outcomes for a cohort of mBTC patients treated with SBRT for oligometastatic disease. Inclusion criteria were 1-5 distant metastases; SBRT with a dose/fraction of a least 5 Gy to a biological effective dose (BED) of at least 40 Gy considering an α/β of 10 Gy. Analyzed outcomes included local control (LC), distant progression-free survival (DPFS), PFS, and OS. Results: 51 patients meeting the inclusion criteria. Primary tumor sites were intrahepatic cholangiocarcinoma (35%), extrahepatic cholangiocarcinoma (31%), ampullary adenocarcinoma (20%), gallbladder adenocarcinoma (14%). 21 patients were treated on liver lesions, 17 on nodal metastasis, 5 patients on lung lesions, 4 patients on recurrence along the extrahepatic bile duct. After a median follow-up of 14 months median OS was 13.7 months, 1- and 2-year OS were 58% and 41%, respectively. Node and lung as metastatic sites were associated with a longer OS (p < 0.001). Median LC was 26.8 months, and intrahepatic cholangiocarcinoma was associated with longer LC (p = 0.036). Median DPFS was 11 months, with 1- and 2-year DPFS of 48% and 27.8%, respectively. Ten patients reported grade 1-2 toxicity and 2 cases of acute G3 biliary obstruction. Conclusions: Stereotactic body radiotherapy (SBRT) is feasible in the context of mBTC. OS and PFS results are promising, considering that our patients were heavily pre-treated with systemic therapy. Patients with nodal or lung relapse have better prognosis. Distant relapses remain the main pattern of failure, but treatment of all metastatic sites seems to improve DMFS.

restrictedAug 2020View details →

Dataset related to article: "Time Course of Autonomic Symptoms in Postural Orthostatic Tachycardia Syndrome (POTS) Patients: Two-Year Follow-Up Results

This record contains data related to article "Time Course of Autonomic Symptoms in Postural Orthostatic Tachycardia Syndrome (POTS) Patients: Two-Year Follow-Up Results" Postural orthostatic tachycardia syndrome (POTS) is a multifactorial condition capable of chronically reducing the quality of life and the work ability of patients. The study aim was to assess the burden of autonomic symptoms in a cohort of POTS patients over 2 years. Patients’ clinical profiles were assessed by the 31-item Composite Autonomic Symptom Score questionnaire (COMPASS 31) and a visual analog scale (VAS). One-way ANOVA for repeated measures followed by Dunnett’s post-hoc test were used to compare symptoms at baseline and at 1 and 2 years. Out of 42 enrolled patients, 25 had a 1-year follow-up and 12 had a 2-year follow-up. At baseline, the reported burden of autonomic symptoms was high (overall COMPASS 31 = 49.9 14.3 /100). Main complaints were related to orthostatic intolerance according to both COMPASS 31 and VAS. Fourteen patients were rendered inactive because of symptoms. At 1-year follow-up, a statistically significant improvement in pupillomotor function and overall score was detected by the COMPASS 31. These findings were confirmed at 2 years, together with a significant reduction in quality of life impairment, assessed by VAS. However, these improvements did not change patients’ occupational status. Awareness of POTS diagnosis, patient monitoring, and tailored therapies can help to improve patients’ condition.

Dataset related to the article "Presence of SARS-CoV-2 nucleoprotein in cardiac tissues of donors negative to COVID-19 molecular tests"

This record contains raw data related to the article “Presence of SARS-CoV-2 nucleoprotein in cardiac tissues of donors negative to COVID-19 molecular tests”   Abstract Background: COVID-19 outbreak caused detrimental effects on essential medical services as organ and tissue donation. Lombardy, one of the most active Italian region in organ/tissue procurement, has been strongly affected by the COVID-19 pandemic. To date, data concerning the risk of SARS-CoV-2 transmission after tissue transplantation are controversial. Here we aim to evaluate the presence/absence of SARS-CoV-2 in different cardiac tissues eligible for transplantation obtained from Lombard donors. Methods and Results: We used cardiovascular tissues from eight donors potentially suitable for pulmonary valve transplantation. All donor subjects involved in the study were negative for the SARS-CoV-2 RNA molecular tests (qRT-PCR and chip-based digital PCR) in NPS and/or BAL. None of the 8 donors included in this study revealed viral genome SARS-CoV-2 presence. However, the evaluation of protein content of pulmonary vein wall (PVW) tissue revealed in all donors variable levels of SARS-CoV-2 nucleoprotein signal. Conclusion: Our study demonstrated for the first time, to the best of our knowledge, that, viral nucleoprotein but not viral RNA was present in the tissue bank examined specimens, suggesting caution and in-depth investigations on implantable tissue specimens collected during COVID-19 pandemic period.

Dataset related to article "Post-biopsy cell-free DNA from blood: an open window on primary prostate cancer genetics and biology"

This record contains data related to article "Post-biopsy cell-free DNA from blood: an open window on primary prostate cancer genetics and biology". Circulating cell-free DNA (ccfDNA), released from normal and cancerous cells, is a promising biomarker for cancer detection as in neoplastic patients it is enriched in tumor-derived DNA (ctDNA). ctDNA contains cancer-specific mutations and epigenetic modifications, which can have diagnostic/prognostic value. However, in primary tumors, and in particular in localized prostate cancer (PCa), the fraction of ctDNA is very low and conventional strategies to study ccfDNA are unsuccessful. Here we demonstrate that prostate biopsy, by causing multiple injuries to the organ, leads to a significant increase in plasma concentration of ccfDNA (P<0.0024) in primary PCa patients. By calculating the minor allele fraction at patient-specific somatic mutations pre- and post-biopsy, we show that ctDNA is significantly enriched (from 3.9 to 164 fold) after biopsy, representing a transient “molecular window” to access and analyze ctDNA. Moreover, we show that newly released ccfDNA contains a larger fraction of di-, tri- and multi-nucleosome associated DNA fragments. This feature could be exploited to further enrich prostate-derived ccfDNA and to analyze epigenetic markers. Our data represent a proof-of-concept that liquid tumor profiling from peripheral blood performed just after the biopsy procedure can open a “valuable molecular metastatic window” giving access to the tumor genetic asset, thus providing an opportunity for early cancer detection and individual genomic profiling in the view of PCa precision medicine.

Dataset related to the article:"Generation of the Becker muscular dystrophy patient derived induced pluripotent stem cell line carrying the DMD splicing mutation c.1705-8 T>C."

This record contains raw data related to the article: "Generation of the Becker muscular dystrophy patient derived induced pluripotent stem cell line carrying the DMD splicing mutation c.1705-8 T>C." Abstract: Becker Muscular dystrophy (BMD) is an X-linked syndrome characterized by progressive muscle weakness. BMD is generally less severe than Duchenne Muscular Dystrophy. BMD is caused by mutations in the dystrophin gene that normally give rise to the production of a truncated but partially functional dystrophin protein. We generated an induced pluripotent cell line from dermal fibroblasts of a BMD patient carrying a splice mutation in the dystrophin gene (c.1705-8 T>C). The iPSC cellline displayed the characteristic pluripotent-like morphology, expressed pluripotency markers, differentiated into cells of the three germ layers and had a normal karyotype.

Dataset related to article "The human factor: does the operator performing the embryo transfer significantly impact the cycle outcome?"

This record contains data related to article “The human factor: does the operator performing the embryo transfer significantly impact the cycle outcome?”.   Abstract Study question: Is Ongoing Pregnancy Rate (OPR) operator-dependent, and can experience improve embryo transfer efficiency? Summary answer: OPR is influenced by the operators who perform the embryo transfer (ET), and experience does not assure proficiency for everyone. What is known already: ET remains the critical step in assisted reproduction. Although many other factors such as embryo quality and uterine receptivity impact embryo implantation, the proper ET technique is clearly an operator-dependent variable and as such it should be objectively standardized. Study design, size, duration: Retrospective comparative analysis including all fresh ETs performed between January 1996 and December 2016 at the Humanitas Fertility Center after IVF-ICSI cycles. Participants/materials, setting, methods: IVF/ICSI fresh ETs performed by 32 operators, 19 824 cycles in all, were analyzed. All transfers consisting of freehand insertion of a preloaded soft catheter into the uterine cavity under transabdominal ultrasound guidance were considered. Two different statistical analyses were performed. First, a logistic regression model with a random intercept for the operator was used to estimate the heterogeneity of the rate of success among operators, accounting for woman age, FSH, number of oocytes retrieved, fertilization rate, year of the procedure, number and stage of transferred embryos and operator's experience. Second, the relationship between experience and pregnancy rate was estimated separately for each operator by logistic regression, and operator-specific results were combined and compared in a random-effects meta-analysis. In both analyses, the operator's experience at time t was measured in terms of number of embryo transfers performed before t. Main results and the role of chance: The heterogeneity among operators was highly significant (P value <0.001) and explained 44.5% of the total variability. The odds ratio of success of the worst operator in respect to the mean was equal to 0.84. For the best operator, the odds ratio of success was equal to 1.13 in respect to the mean. Based on the meta-analysis of the relationship between operator's experience and success rate, it resulted that, on average, the operators' performance did not improve with additional transfers. Limitations, reasons for caution: At our center, operators become independent for ET's after performing between 30 and 50 transfers under supervision. It is also possible that other relevant factors, such as embryologists on duty for the ET, have not been included in the present analysis and this may represent a potential bias. Among these, it should be mentioned that the embryologists on duty for the ET were not taken into consideration. Wider implications of the findings: Continued performance analysis and the use of a digital simulator could help operators to test their expertise over time and either correct poor performance or avoid doing transfers. Study funding/competing interest(s): None. Trial registration number: <a href="http://clinicaltrials.gov/show/NCT03561129">NCT03561129</a>.

Dataset related to the article-Fenretinide treatment accelerates atherosclerosis development in apoE‐deficient mice in spite of beneficial metabolic effects

This record contains raw data related to the article "Fenretinide treatment accelerates atherosclerosis development in apoE‐deficient mice in spite of beneficial metabolic effects" Abstract Background and Purpose Fenretinide, a synthetic retinoid derivative first investigated for cancer prevention and treatment, has been shown to ameliorate glucose tolerance, improve plasma lipid profile and reduce body fat mass. These effects, together with its ability to inhibit ceramide synthesis, suggest that fenretinide may have an anti‐atherosclerotic action. Experimental Approach To this aim, nine‐week‐old apoE‐knockout (EKO) female mice were fed for twelve weeks a Western diet, without (control) or with (0.1% w/w) fenretinide. As a reference, wild‐type (WT) mice were treated similarly. Growth and metabolic parameters were monitored throughout the study. Atherosclerosis development was evaluated in the aorta and at the aortic sinus. Blood and lymphoid organs were further characterized with thorough cytological/histological and immunocytofluorimetric analyses. Key Results Fenretinide treatment significantly lowered body weight, glucose levels and plasma levels of total cholesterol, triglycerides, and phospholipids. In the liver, fenretinide remarkably reduced hepatic glycogenosis and steatosis driven by the Western diet. Treated spleens were abnormally enlarged, with severe follicular atrophy and massive extramedullary haematopoiesis. Severe renal hemosiderin deposition was observed in treated EKO mice. Treatment resulted in a threefold increase of total leukocytes (WT and EKO) and raised the activated/resting monocyte ratio in EKO mice. Finally, atherosclerosis development was markedly increased at the aortic arch, thoracic and abdominal aorta of fenretinide‐treated mice. Conclusions and Implications We provide the first evidence that, despite beneficial metabolic effects, fenretinide treatment may enhance the development of atherosclerosis.

restrictedFeb 2021View details →

Dataset related to article "Metastatic salivary gland carcinoma: A role for stereotactic body radiation therapy? A study of AIRO-Head and Neck working group"

This record contains raw data related to article "Metastatic salivary gland carcinoma: A role for stereotactic body radiation therapy? A study of AIRO-Head and Neck working group" Objectives: The role of radiotherapy (RT) for oligometastases is currently established in different oncological settings but data on salivary gland cancer (SGC) are lacking. We evaluated the role of RT in oligometastatic SGC patients, focusing on stereotactic body radiation therapy (SBRT). Materials and methods: We performed a retrospective, multicentric study of oligometastatic SGC treated with palliative RT or SBRT. Endpoints included response evaluation and local control (LC). Results: Between 2006 and 2016, 64 patients were collected from 9 Italian Cancer Centers, on behalf of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) Head and Neck Working Group. 37 patients (57.8%) were suffering from adenoid cystic carcinoma (ACC) and 27 patients (42.2%) had non-ACC. Thirty-four patients underwent palliative RT (53,1%), and 30 received SBRT (46,9%). Most common metastatic sites were bone for palliative RT and lung for SBRT. Among patients treated with SBRT, an objective response or a stability was observed in all treated lesions. After a median follow-up of 29.2 months (range 2.3-117.1), LC at 12 months was 57.5% for patients treated with SBRT and was higher in ACC subgroup. Conclusion: We confirmed the potential role of SBRT in the management of oligometastatic SGC patients to control limited burden of disease considering the absence of effective systemic therapies.

restrictedSep 2020View details →

Dataset related to article "Brain metastases from primary colorectal cancer: is radiosurgery an effective treatment approach? Results of a multicenter study of the radiation and clinicaloncology Italian association (AIRO)"

This record contains raw data related to article “Brain metastases from primary colorectal cancer: is radiosurgery an effective treatment approach? Results of a multicenter study of the radiation and clinicaloncology Italian association (AIRO)" Objectives: The prognosis of brain metastatic colorectal cancer patients (BMCRC) is poor. Several local treatments have been used, but the optimal treatment choice remains an unresolved issue. We evaluated the clinical outcomes of a large series of BMCRC patients treated in several Italian centers using stereotactic radiosurgery (SRS). Conclusion: SRS/HSRS have proven to be an effective local treatment for BMCRC. A careful evaluation of prognostic factors as well as a multidisciplinary evaluation is a valid aid to manage the optimal therapeutic strategy for CTC patients with BMs.

restrictedFeb 2021View details →

Dataset related to article "The 70-year-old newly diagnosed glioblastoma patients are older thanthe 65-year-old? Outcome evaluation of the two categories in a matchedcase control study with propensity score balancing"

This record contains raw data related to article “The 70-year-old newly diagnosed glioblastoma patients are older thanthe 65-year-old? Outcome evaluation of the two categories in a matchedcase control study with propensity score balancing" Background: The standard of care for elderly, newly-diagnosed glioblastoma patients consists, if feasible, of surgical resection followed by a short course of radiation therapy (RT) with concomitant and adjuvant temozolomide chemotherapy (TMZCHT). To date, the literature lacks of consistence in the definition of elderly, if older than 65 years, or 70 years. Aim of this study was to explore whether differences exist between these two cohorts, comparing outcomes using a propensity score matched analysis (PSM). Conclusions: The PSM analyses showed a similar outcome in 65–69-year old patients compared to older ones notwithstanding a more burdensome RT schedule. Hypofractionated RT treatment has to be considered also in this group of younger elderly, newly-diagnosed GBM patients.

Dataset related to article "Twenty-one year experience with intrauterine inseminations after controlled ovarian stimulation with gonadotropins: maternal age is the only prognostic factor for success."

This record contains data related to article "Twenty-one year experience with intrauterine inseminations after controlled ovarian stimulation with gonadotropins: maternal age is the only prognostic factor for success.". Abstract Purpose: To report our experience on homologous intrauterine insemination (IUI) with gonadotropin controlled ovarian stimulation (COS) cycles and to examine different variables which could predict IUI success. Materials and methods: This is a retrospective analysis of IUIs performed between January 1997 and December 2017. A total of 7359 COS IUI's procedures (2901 couples) were reviewed. Clinical pregnancy, live birth rate and age, body mass index (BMI), smoking habit, duration of infertility, sperm characteristics before and after treatment (total motile count, morphology, and vitality), day 3 FSH, total gonadotropin dose, and number of follicles were assessed by multivariate logistic regression analysis, and data were expressed as odds ratio (OR). Results: The mean female age at the time of COS was 35.10 ± 3.93 years. The most common single infertility diagnoses were unexplained infertility (53.55%), mild male factor (19.69%), and anovulation (10.95%). The total progressive motile sperm count (TPMC) was > 1 × 106/ml (mean 1.34 ± 1.08 × 106/ml). The clinical pregnancy rate was 9.38%, and the live birth rate was 7.19% per cycle. Twin pregnancies were 12.17%. Cumulative pregnancy was 21.89% and cumulative live birth rate was 17.58% per couple. Clinical pregnancy and live birth rates were significantly associated with female age [OR 0.97 (95% CI 0.95-0.99) and 0.95 (95% CI 0.93-0.97), respectively] and day 3 FSH [OR 0.91 (95% CI 0.87-0.94) e 0.90 (95% CI 0.87-0.94), respectively]. Conclusions: Clinical pregnancy rate and live birth rates after COS-IUIs were significantly influenced by female age and FSH levels. Trial registration: Clinical trial registration number: <a href="http://clinicaltrials.gov/show/NCT03836118">NCT03836118</a>. Conflict of interest statement The authors declare that they have no conflict of interest.