Orsola-Malpighi Hospital Research Articles

Diagnostic accuracy of cardiac computed tomography and 18F-fluorodeoxyglucose with positron emission tomography/computed tomography in cardiac masses

Abstract Background Understanding the nature of cardiac masses represents a challenge for clinicians in order to select the appropriate therapeutic strategies. The diagnostic accuracy of cardiac computed tomography (CT) and 18F-fluorodeoxyglucose (18F-FDG) with positron emission tomography/CT (PET/CT) in identifying the nature of cardiac masses has not been evaluated before in a large population. Purpose To assess the diagnostic value of CT and 18F-FDG PET/CT in defining the nature of cardiac masses, integrating morphologic features and metabolic activity. Methods Out of 223 we selected a final cohort 60 patients which underwent cardiac CT scan and 18F-FDG PET/CT. All masses had histological certain, apart from thrombi, in which was defined radiologic resolution after adequate anticoagulant treatment. For each mass, eight morphologic CT signs and standardized uptake value (SUVmax, SUVmean), metabolic tumour volume (MTV) and total lesion glycolysis (TLG) in 18F-FDG PET, were evaluated. Results Twenty patients had benign cardiac masses and 40 patients malignant cardiac masses. Irregular tumour margins, pericardial effusion, invasions, solid nature of the mass, mass diameter, TC contrast up-take and pre-contrast characteristics were strongly associated with the malignant nature of cardiac masses (p<0.001). Additionally, the presence of at least four CT signs was able to discriminate malignancies, withsensitivity of 95% and specificity of 95% (AUC=0.988, 95% CI 0.969–1). The mean value of SUVmax, SUVmean, MTV and TLG was significantly higher in malignant cardiac masses than in benign lesions (p<0.001). ROC curve for diagnostic accuracy of 18F-FDG PET/CT parameters in detecting malignant lesions showed an excellent performance of SUV (AUC=0.948, 95% CI 0.891–1), MTV (AUC=0.928, 95% CI 0.841–1) and TLG (AUC=0.961, 95% CI 0.902–1). Conclusions In patients with cardiac masses, cardiac computed tomography and 18F-FDG PET/CT findings provide independent and incremental prognostic information regarding their nature. A systematic use of CT and 18F-FDG PET/CT is therefore useful for diagnostic and therapeutic purposes. PET-CT evaluation of cardiac masses Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): S. Orsola Malpighi Hospital, University of Bologna

Lung ultrasound features predict admission to the neonatal intensive care unit in infants with transient neonatal tachypnoea or respiratory distress syndrome born by caesarean section

We aimed to evaluate the reliability of lung ultrasound (LU) to predict admission to the neonatal intensive care unit (NICU) for transient neonatal tachypnoea or respiratory distress syndrome in infants born by caesarean section (CS). A prospective, observational, single-centre study was performed in the delivery room and NICU of Sant’Orsola-Malpighi Hospital in Bologna, Italy. Term and late-preterm infants born by CS were included. LU was performed at 30’ and 4 h after birth. LU appearance was graded according to a previously validated three-point scoring system (3P-LUS: type-1, white lung; type-2, black/white lung; type-3, normal lung). Full LUS was also calculated. One hundred infants were enrolled, and seven were admitted to the NICU. The 5 infants with bilateral type-1 lung at birth were all admitted to the NICU. Infants with type-2 and/or type-3 lung were unlikely to be admitted to the NICU. Mean full-LUS was 17 in infants admitted to the NICU, and 8 in infants not admitted. In two separate binary logistic regression models, both the 3P- and the full LUS proved to be independently associated with NICU admission (OR [95% CI] 0.001 [0.000–0.058], P = .001, and 2.890 [1.472–5.672], P = .002, respectively). The ROC analysis for the 3P-LUS yielded an AUC of 0.942 (95%CI, 0.876–0.979; P<.001), while ROC analysis for the full LUS yielded an AUC of 0.978 (95%CI, 0.926–0.997; P<.001). The AUCs for the two LU scores were not significantly different (p = .261).Conclusion: the 3P-LUS performed 30 min after birth proved to be a reliable tool to identify, among term and late preterm infants born to CS, those who will require NICU admission for transient neonatal tachypnoea or respiratory distress syndrome.What is known• Lung ultrasound (LU) has become an attractive diagnostic tool in neonatal settings, and guidelines on point-of-care LU in the neonatal intensive care unit (NICU) have been recently issued.• LU is currently used for diagnosing several neonatal respiratory morbidities and has been also proposed for predicting further intervention, such as NICU admission, need for surfactant treatment or mechanical ventilation in preterm infants.What is new• LU performed 30′ after birth and evaluated through a simple three-point scoring system represents a reliable tool to identify, among term and late preterm infants born to caesarean section, those with transient neonatal tachypnoea or respiratory distress syndrome who will require NICU admission.• LU performed in the neonatal period confirms its potential role in ameliorating routine neonatal clinical management.

Acute acquired concomitant esotropia associated with myopia: is the condition related to any binocular function failure?

To evaluate the sensory motor state, accommodation, and accommodative convergence to accommodation ratio (AC/A) in a cohort of non-amblyopic myopes with acquired concomitant esotropia (Bielschowsky esotropia (BE)). Refraction, near and far deviation, fusional amplitude (FA), near point of accommodation (NPA), AC/A (gradient method), and stereopsis were measured in a cohort of 26 patients (25 phakic and 1 pseudophakic, age: 14-60years) with BE, prospectively recruited from January to September 2019 at St. Orsola-Malpighi Hospital, Bologna, Italy. The Pearson's correlation coefficient was used to correlate distance with near deviation, distance with near divergence FA and angle of deviation with FA (statistical significance: p values < 0.05). Myopia range was 0-17.5 diopters (D) spherical equivalent (mean: 4.4D). A positive correlation resulted between distance (mean: 23.7 prism diopters/PD, range: 4-40PD) and near (mean: 23.7PD, range: 2-45PD) deviation (p < 0.00001) and between distance (mean: 12.6PD, range 0-34PD) and near (mean: 17.0PD, range 3-36PD) divergence FA (p < 0.00001). A non-significant correlation resulted between angle of deviation and divergent FA at near (p = 0.07) and distance (p = 0.13) fixation. NPA was within normal limits for age. AC/C ratio range was 0-8 (mean: 3). Twenty-three patients showed Randot stereopsis. BE shows high variability in the age of onset, degree of associated myopia, AC/A, and divergent FA. A little stronger near divergent FA can justify the better compensation at near fixation. These results show that uncorrected myopia, accommodation, and divergence paralysis do not concur with the genesis of BE.

Activation studies for the decommissioning of PET cyclotron bunkers by means of Monte Carlo simulations

During the operational life of a PET cyclotron, the concrete walls of the vault are activated by secondary neutrons. For the dismantling of such accelerator facilities, a considerable amount of low level solid radioactive waste has to be characterized and disposed. To decrease future dismantling costs and complexity, the amount of radioactive waste has to been prospectively evaluated in the design phase, then confirmed at the time of planning decommissioning. In this work, the Monte Carlo code Fluka was used for the assessment of the activation of the bunkers of two different facilities: the 16.5 MeV GE PETtrace at S. Orsola-Malpighi Hospital in Bologna and the 18 MeV IBA Cyclone 18/18 HC at the Bern University Hospital (Inselspital). The simulations were validated by means of experimental measurements performed in our previous works: non-destructive, in field measurements using a portable CZT detector were performed in Bologna; while core drilling samples were extracted from the bunker and measured in laboratory with an HPGe detector in Bern. The activity of the most important radionuclides in the concrete walls of the bunker, namely Eu-152, Mn-54, Co-60, Sc-46, Zn-65 and Cs-134 resulted within the range of 0.01 – 2 Bq/g. The consistency between Monte Carlo results and experimental measurements was within a factor 2 - 3 for most radionuclides, except for Eu-152, Sc-46, Zn-65. The activity concentrations estimated at each position considered exceeds the clearance levels of the new Directive 2013/59/Euratom.The results of this work demonstrate that Monte Carlo simulations based on FLUKA are adequate to assess the residual activation levels, a fundamental information to foresee, plan and optimize the decommissioning of a cyclotron based PET centers.

Percutaneous radiofrequency ablation in intrahepatic cholangiocarcinoma: a retrospective single-center experience

Background & aims Very few data are available in literature about the role of radiofrequency ablation (RFA) in intrahepatic cholangiocarcinoma (ICC) and previous studies are mainly case reports and case series on a very small number of patients and nodules. In this study, we aimed to evaluate effectiveness and safety of RFA for the treatment of unresectable ICC. Methods This is a retrospective observational cohort study comprising all consecutive patients treated with RFA for unresectable ICC at Policlinico Sant’Orsola Malpighi Hospital, Bologna, Italy. Primary endpoint was Local Tumor Progression-Free Survival (LTPFS) while Overall Survival (OS) was also assessed as secondary endpoint. Results From January 2014 to June 2019, 29 patients with 117 nodules underwent RFA. Technique effectiveness 1 month after RFA was 92.3%; median LTPFS was 9.27 months. Univariate analysis and multivariate analysis showed that LTPFS was significantly related to tumor size ≥20 mm. At a median follow up of 39.9 months, median OS from the date of RFA was 27.5 months, with an OS of 89%, 45% and 11% at 1, 2 and 4 years, respectively. Number of overall lesions and the sum of their diameter at the moment of the first RFA significantly affected OS in multivariate analysis. Minor and major complication rates were 14% and 7%, respectively. Conclusion Tumor size ≥20 mm was associated with lower LTPFS, representing a potential useful threshold value. A careful evaluation of tumor burden appears as a crucial element in choosing the best therapeutic strategy in unresectable ICC.

Potentially actionable mutations in intrahepatic cholangiocarcinoma

Abstract Background Intrahepatic cholangiocarcinoma (iCCA) is a liver neoplasm with few treatment options and a dismal prognosis. To date, the only curative option remains the surgery. New insights concerning its molecular pathogenesis and genetic heterogeneity are recently coming to light and are promising to widen the treatment landscape. Methods We evaluated data of the first 39 patients with iCCA included in the “Next Generation Sequencing in Intrahepatic Cholangiocarcinoma” study (EtherBil study, NCT02184871) from May 2014 to Dec 2017. For each patient enrolled, we performed whole exome sequencing (“WES)” on fresh frozen tumor tissue and peripheral blood DNA. All variants that were unique in the tumor sample were called as somatic. We used OncoKB ( http://oncokb.org/ ) to define the clinical actionability of the somatic mutation identified (Chakravarty D. et al. JCO Precision Oncology 2017). Results A total of 33 actionable/potentially actionable mutations were identified in 17 genes. IDH1 (5/39, 12.8%), FGFR2 (4/39, 10.2%), IDH2 (3/39, 7.6%), KRAS (3/39, 7.6%), PIK3CA (3/39, 7.6%), NF1 (3/39, 7.6%) were the genes with the higher frequency of actionable/potentially actionable mutations. Remarkably, 20 out of 39 patients (51.2%) harbored at least one potentially actionable mutation. Furthermore, 2 out of 39 tumors were found to be ultra-hypermutated hypermutated (≥100 Mut/Mb). The MSI-H/MMRd phenotype in the latter was confirmed by PCR and MLH1, PMS2, MSH2, and MSH6IHC immunohistochemistry. Conclusions Given the limited armory currently available in advanced unresectable iCCA patients, these data can be helpful to consolidate new understanding aimed at opening up future treatment options. Finally, we report the data of MSI-H/MMRd prevalence in our iCCA series having regard to the new insight on the immunotherapy in this subgroup of patients. Clinical trial identification NCT02184871; First posted: July 9, 2014. Legal entity responsible for the study Sant’Orsola-Malpighi Hospital. Funding Programma Strategico Uni-Regione Innovations in Onco-Hepatology and Onco-Haematology (WP3-1MED3BRA-BRANDI, WP4-1MED3BRA-BRANDI). Disclosure All authors have declared no conflicts of interest.

Rectal screening for carbapenemase-producing Enterobacteriaceae: a proposed workflow

ObjectivesActive screening is a crucial element for the prevention of carbapenemase-producing Enterobacteriaceae (CPE) transmission in healthcare settings. Here we propose a culture-based protocol for rectal swab CPE screening that combines CPE detection with identification of the carbapenemase type. MethodsThe workflow integrates an automatic digital analysis of selective chromogenic media (WASPLab®; Copan), with subsequent rapid tests for the confirmation of carbapenemase production [i.e. detection of Klebsiella pneumoniae carbapenemase (KPC)-specific peak by matrix-assisted laser desorption/ionisation time-of-flight mass spectrometry (MALDI-TOF/MS) or a multiplex immunochromatographic assay identifying the five commonest carbapenemase types]. To evaluate the performance of this protocol in depth, data for 21 162 rectal swabs submitted for CPE screening to the Microbiology Unit of S. Orsola-Malpighi Hospital (Bologna, Italy) were analysed. ResultsConsidering its ability to correctly segregate plates with/without Enterobacteriaceae, WASPLab Image Analysis Software showed globally a sensitivity and specificity of 100% and 79.4%, respectively. Of the plates with bacterial growth (n = 901), 693 (76.9%) were found to be positive for CPE by MALDI-TOF/MS (KPC-specific peak for K. pneumoniae) or by immunochromatographic assay. Only 2.8% (16/570) of KPC-positive K. pneumoniae strains were missed by the specific MALDI-TOF/MS algorithm, being detected by the immunochromatographic assay. The mean turnaround time needed from sample arrival to the final report ranged between 18 and 24 h, representing a significant time saving compared with manual reading. ConclusionThis workflow proved to be fast and reliable, being particularly suitable for areas endemic for KPC-producing K. pneumoniae and for high-throughput laboratories.

The Role Of Effective Radiation Therapist-Patient Communication In Alleviating Treatment-Related Pain And Procedural Discomfort During Radiotherapy.

PurposeManaging radiotherapy (RT)-induced pain is essential for reducing the likelihood of treatment interruption and improving the chance of tumor control. The current study aimed to examine the role of radiation therapist (RTTs) interaction and effective information communication in modulating patients’ experiences of pain and discomfort during RT.MethodsParticipants were 91 cancer patients undergoing RT for the first time referred to the Radiotherapy Unit of Sant’Orsola-Malpighi Hospital in Bologna, Italy. Patient-reported outcome measures included patient satisfaction with the quality of the relationship and the information received by the RTTs, assessed by the Communication with RTTs — Shortened, scale, and pain and discomfort experienced during RT, assessed through two VAS scales. Attitudes toward RT were also assessed. All measures were collected as patients were approximately halfway through the overall RT duration (on average at the end of the 12th session).ResultsPatient satisfaction with RTT relationships and treatment-information communication was significantly related to RT-induced pain intensity and patient attitudes toward RT. The more satisfied patients were with RTT interactions and communication, the more positive their attitudes were toward RT and the lower the pain intensity experienced during treatment.ConclusionClinical implications can be drawn in terms of highlighting the need for RTTs to be mindful of their technical and supportive role in delivery of patient care and in structuring treatment information content in a way that contrasts potential nocebo effects related to patients' negative expectations about RT. The findings support the idea that RTTs may benefit from training interventions and structured education sessions with a focus on interpersonal skills and patient-centered communication.

Pharyngeal Chlamydia and gonorrhea: a hidden problem.

In this study we assessed the prevalence and predictors of pharyngeal infections due to Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in a cohort of patients attending an STI Clinic. From January 2016 to September 2018, 893 patients attending the STI Clinic of St Orsola-Malpighi Hospital (Bologna, Italy) and reporting unprotected oral sex were enrolled. A pharyngeal swab for the molecular detection of CT and NG was collected from each patient. Positive CT samples were further genotyped by an omp1 gene PCR. A total of 134 cases of gonorrhea (15%) and 34 chlamydial infections (3.8%) were detected in the pharyngeal site, with no significant differences between males (all men who have sex with men [MSM]) and females. More than 90% of the infections were completely asymptomatic, suggesting that symptoms were not predictors of a pharyngeal infection ( P = 0.7). On the contrary, a history of sexual contacts with a partner positive for CT and/or NG ( P &lt; 0.0001), HIV positivity ( P = 0.01), and the presence of concurrent genital and/or rectal infections ( P &lt; 0.0001) were significantly associated with CT/NG pharyngeal infections. Pharyngeal lymphogranuloma venereum cases were rare (prevalence: 0.4%), asymptomatic, and only found in MSM. Better knowledge about pharyngeal CT/NG infections could help to set up effective strategies for their prevention.

Pathological ASXL1 Mutations and Protein Variants Impair Neural Crest Development.

SummaryThe neural crest (NC) gives rise to a multitude of fetal tissues, and its misregulation is implicated in congenital malformations. Here, we investigated molecular mechanisms pertaining to NC-related symptoms in Bohring-Opitz syndrome (BOS), a developmental disorder linked to mutations in the Polycomb group factor Additional sex combs-like 1 (ASXL1). Genetically edited human pluripotent stem cell lines that were differentiated to NC progenitors and then xenotransplanted into chicken embryos demonstrated an impairment of NC delamination and emigration. Molecular analysis showed that ASXL1 mutations correlated with reduced activation of the transcription factor ZIC1 and the NC gene regulatory network. These findings were supported by differentiation experiments using BOS patient-derived induced pluripotent stem cell lines. Expression of truncated ASXL1 isoforms (amino acids 1–900) recapitulated the NC phenotypes in vitro and in ovo, raising the possibility that truncated ASXL1 variants contribute to BOS pathology. Collectively, we expand the understanding of truncated ASXL1 in BOS and in the human NC.

Activation studies of a PET cyclotron bunker

During the operational life of a PET Cyclotron, the concrete walls of its vault are activated by secondary neutrons. For this reason when considering dismantling of such accelerators, a considerable amount of low level solid radioactive waste has to be characterized and disposed. To decrease future dismantling costs, the amount of radioactive waste has to be evaluated in advance to define an optimum decommissioning strategy. Aim of this work is to develop methodologies for the preliminary assessment of activation induced in a bunker via experimental measurements. Two different facilities were studied and different approaches were adopted: non-destructive, in field measurements using a portable CZT detector were performed in the bunker of a 16.5 MeV GE PETtrace (S. Orsola-Malpighi Hospital of Bologna); while core drilling samples were extracted from the bunker of an 18 MeV IBA Cyclone 18 H C (Inselspital in Bern) and measured in laboratory with an HPGe detector. The principal long-lived radionuclides found in concrete were Eu-152, Mn-54, Co-60, Sc-46, Cs-134 with activity concentrations comprised between 0.01 and 0.6 Bq/g. In all performed measurements the total activity concentration exceed the clearance level of Directive (2013)/59/Euratom. Considering a hypothetical decommissiong of the two facilities, the amount of low lever radioactive waste estimated was about 93 m3 in the case of S. Orsola-Malpighi, while about 58 m3 for Insespital facility. Both the methodologies have proved to be adequate for the purposes.

Determinants of troponin T and I elevation in old patients without acute coronary syndrome

Cardiac troponins T and I (cTnT and cTnI) are the main markers of acute myocardial cell damage and then of Acute Coronary Syndrome (ACS) if associated with compatible symptoms. Although their cardio-specificity, the cTn may be increased in various clinical conditions but only few recent studies have reported their trends with age. This is a single-center retrospective observational study on two groups of adults consecutive patients, with age ≥65 years, admitted to the Emergency Department of the Sant'Orsola-Malpighi Hospital of Bologna, Italy, with chest pain as chief complaint. In the first group was dosed cTnT (N=617), in the second group cTnI (N=569). The patients with final ACS’s diagnosis (N=255) or an incomplete report of blood tests (N=17) were excluded. The definitive database included 471 patients in the first group and 443 in the second one. The observed differences between clinical parameters, patients with cTnT≤14ng/L and those with cTnT&gt;14ng/L (N=207, 44%) are: older age, greater prevalence of diabetes, lower values of Hb e ALT, higher values of white blood cells, INR, glycemia, urea, creatinine, BNP e PCR. In multiple logistics regression (N=333) only 4 variables resulted independently associated to cTnT increase: age (P&lt;0.0001), PCR (P=0.01), creatinine (P=0.02) and urea (P=0.04), R2=0.30. The differences between patients with cTnI≤40ng/L and those with cTnI&gt;40ng/L (N=46, 10%) are: older age, Hb values equal and higher values of white blood cells, INR, glycemia, urea, creatinine, total bilirubin, AST, BNP e PCR. In multiple logistics regression (N=259) the only 4 variables independently associated to increase of cTnI are age (P&lt;0.0001), glycemia (P=0.004), PCR (P=0.01) and white blood cells (P=0.02), R2=0.17. Furthermore, the number of patients with high level of cTn significantly increase by age (cTnT: 65-74 years 22.2%, 75-84 years 48.5%, ≥85 years 79.5%; cTnI: 65-74 years 4.3%, 75-84 years 8.1%, ≥85 years 22.5%, P&lt;0.0001). In our study, cTnI showed fewer false positives than cTnT and seems to be less influenced by kidney failure. Furthermore, the acute phase of inflammation was associated with the rise of troponins. High cTn values were found in elderly subjects, without acute coronary syndromes, particularly cTnT. Then the age seems to be the most important factor related to this highelevated troponin levels.

HrQoL in hair loss-affected patients with alopecia areata, androgenetic alopecia and telogen effluvium: the role of personality traits and psychosocial anxiety.

Illness impact on HrQoL has been widely studied in hair loss-affected patients, yet no study has addressed whether individual differences modulate HrQoL in patients with alopecia areata (AA), androgenetic alopecia (AGA) and telogen effluvium (TE). To identify the personality dimensions most predictive of the impact of disease on HrQoL. A single-site cross-sectional study was carried out in the Dermatology Unit of Sant'Orsola-Malpighi Hospital, Bologna between September 2016 and September 2017. The study included 143 patients (105 females, ages 18-60years) diagnosed with AA (n=27), AGA (n=80) and TE (n=36). Illness severity, alopecia type, age, gender, education and civil status were documented. Health-related quality of life (HrQoL), personality traits, trait anxiety, emotional intelligence, social anxiety and social phobia were also measured. AA, AGA and TE groups differed significantly for illness severity with most severe patients falling in AA type. For HrQoL, Gender×Group interaction resulted significant with AGA females reporting a higher impact of hair loss on quality of life than males, while TE males were more impacted by hair loss than AA and AGA males. Lower scores were obtained by AGA females than males on emotional intelligence while no significant differences were evidenced on other groups. A significant Gender × Group interaction was also found for trait anxiety, social phobia and social anxiety: consistently, AGA females reported higher scores than AGA males in all three measures. Finally, discriminant analysis evidenced that anxiety-related traits can contribute to reliably predict hair loss impact on HrQoL, regardless of illness severity and alopecia type. We recommend that gender and individual differences in anxiety-related dimensions be considered as key factors in gaining a deeper understanding of hair loss impact on quality of life as well as in reducing the burden of illness in alopecia-affected patients.

Hepatobiliary scintigraphy combined with SPECT/CT in predicting liver failure before major hepatectomy: preliminary results of the HIBA-index at a single center

Introduction: Hepatobiliary scintigraphy (HBS) is able to estimate future liver remnant function (FLR-F) and may be useful to predict post-hepatectomy liver failure (PHLF) before major hepatectomy. Existing cut-off values for PHLF (FLR-F < 2.69%/min/m2) were previously set using only planar acquisitions but not combined with single photon emission computed tomography (SPECT/CT). A new index, the so-called Hospital Italiano De Buenos Aires index (HIBA-i), has been recently used to measure sectorial liver function in two-stage hepatectomy setting. Method: All consecutive patients submitted to major hepatectomy between November 2016 and November 2017 at Sant'Orsola-Malpighi Hospital (Bologna, Italy), were analyzed. Patients were resected according to their preoperative volumetry. Data regarding preoperative HBS were retrospectively reviewed. FLR-F and HIBA-i were calculated as previously described. PHLF was defined according to the International Study Group of Liver Surgery criteria. Results: Twenty-seven patients were submitted to major hepatectomy (13 right hepatectomies, 8 left hepatectomies, 5 right trisectionectomies, 1 left trisectionectomy). PHLF (grade A/B/C) was observed in 9 out of 27 patients (33.3%). The HIBA-i differed significantly (p=0.002) between patients with (14.37%, IQR 8.64-16.14) and without PHLF (24.31%, IQR 15.74-39.53). Eight of 16 patients with a preoperative FLR-F < 2.69 %/min/m2 did not experienced PHLF. FLR volumes between the two groups did not show any statistical significance. Conclusions: The HIBA-i seems a promising tool able to estimate residual liver function. Prospective clinical trial are warranted to define more precise cut-offs of FLR-F when SPECT/CT is associated.

Sialendoscopy for salivary stones: principles, technical skills and therapeutic experience.

SUMMARYObstructive sialadenitis is the most common non-neoplastic disease of the salivary glands, and sialendoscopy is increasingly used in both diagnosis and treatment, associated in selected cases with endoscopic laser lithotripsy. Sialendoscopy is also used for combined minimally invasive external and endoscopic approaches in patients with larger and proximal stones that would require excessively long laser procedures. The present paper reports on the technical experience from the Ear, Nose and Throat Unit of the Sant'Orsola-Malpighi Hospital of Bologna, and from the Department of Otorhinolaryngology of the University Hospital of Cagliari, Italy, including the retrospective analysis of the endoscopic and endoscopic assisted procedures performed on 48 patients (26 females and 22 males; median age 45.3; range 8-83 years) treated for chronic obstructive sialadenitis at the University Hospital of Cagliari from November 2010 to April 2016. The results from the Sant'Orsola-Malpighi Hospital of Bologna have been previously published. The technical aspects of sialendoscopy are carefully described. The retrospective analysis of the University Hospital of Cagliari shows that the disease was unilateral in 40 patients and bilateral in 8; a total of 56 major salivary glands were treated (22 submandibular glands and 34 parotids). Five patients underwent bilateral sialendoscopy for juvenile recurrent parotitis. 10 patients were treated for non-lithiasic obstructive disease. In 33 patients (68.75%) the obstruction was caused by salivary stones (bilateral parotid lithiasis in 1 case). Only 8 patients needed a sialectomy (5 submandibular glands and 3 parotids). The conservative approach to obstructive sialadenitis is feasible and can be performed either purely endoscopically or in a combined modality, with a high percentage of success. The procedure must be performed with dedicated instrumentation by a skilled surgeon after proper training since minor to major complications can be encountered. Sialectomy should be the "extrema ratio" after failure of a conservative approach.

Abstract OT3-05-01: Three-monthly dynamic evaluation of CEA and CA15-3 (followed by 18-FDG PET) vs usual practice in the follow-up of early breast cancer (BC) patients (pts): A prospective randomized trial (KRONOS-patient-oriented new surveillance study, Italy)

Abstract Background: Current guidelines for BC surveillance in asymptomatic pts recommend annual mammography and periodical physical examination. These recommendations arise from two trials conducted in the 1980's: since then no other randomized controlled trials (RCTs) have been conducted on BC follow-up. However our knowledge on BC biology, diagnosis of metastases and treatment has improved. The aim of this prospective RCT is to verify if the serial measurement of CEA and CA15.3 (followed by 18-FDG PET) can anticipate the diagnosis of breast cancer recurrence compared to control arm. If this intermediate end-point will be met a subsequent extension trial will investigate the impact of the earlier diagnosis of distant metastases on survival. Methods: Pts diagnosed with stage I-III BC, who underwent adequate surgery are eligible. Special histologies and low-risk cases according to St. Gallen criteria are excluded. We will include pts at the beginning of the follow-up after the conclusion of primary treatment (cohort 1), and pts that have concluded without relapse the first 5 years of follow-up (cohort 2). Eligible pts will be randomized in a 1:1 ratio to follow-up according to local practice (control arm) or to three-monthly serial dosing of CEA and CA15.3 and subsequent imaging studies (18-FDG PET) only in case of an increase of CEA and/or CA 15.3 greater than a critical difference (CEA +100% and/or CA15.3 +75%) compared to baseline (experimental arm). The following stratification factors will be used: node negative vs positive, HER2 negative vs positive, ER positive vs negative. Eight-hundred pts will be enrolled over 3 years. For such a calculation, we made the assumption of a 20% 5-year incidence of relapse. The target reduction of 3 months in restricted mean survival time (RMST) between the two arms implies a median time of diagnostic anticipation, conditional on having breast cancer recurrence, of 10 months. The follow-up will continue until 10 years from surgery. The first patient was enrolled on 23rd October 2014, up to now 434 pts have been enrolled. The present trial was approved by the Ethical Commitee of S. Orsola-Malpighi Hospital and is registered on clinicaltrials.gov (NCT02261389). Citation Format: Zamagni C, Gion M, Mariani L, Stieber P, Quercia S, Rubino D, Bernardi A, Cacciari N, Fini A, Lenzi M, Minichillo S, Pizzirani C, Pagliaro M, Tomasini S, Barbieri E. Three-monthly dynamic evaluation of CEA and CA15-3 (followed by 18-FDG PET) vs usual practice in the follow-up of early breast cancer (BC) patients (pts): A prospective randomized trial (KRONOS-patient-oriented new surveillance study, Italy) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-05-01.

Pleuroparenchymal fibroelastosis: the prevalence of secondary forms in hematopoietic stem cell and lung transplantation recipients.

Pleuroparenchymal fibroelastosis (PPFE) is a rare form of interstitial pneumonia, characterized by elastotic fibrosis involving the pleura and subpleural parenchyma, predominantly in the upper lobes. PPFE can be either idiopathic or secondary and mostly occurs as a late complication of lung or hematopoietic stem cell transplantation (HSCT). The aim of this study was to evaluate the prevalence of secondary forms in transplant recipients. An expert thoracic radiologist retrospectively reviewed high-resolution computed tomography exams of 700 HSCT recipients and 53 lung transplant recipients from the database of the Radiology Department of S. Orsola-Malpighi Hospital dating back from 2007. For each case that radiologically fulfilled PPFE criteria, the following details were retrieved: clinical characteristics, laboratory and functional data, pathologic findings (obtained from one patient) and metabolic data (obtained from three patients). Six cases clinically and radiologically consistent with PPFE were identified: two HSCT recipients (0.28%) and four lung transplant recipients (7.54%). In this study, PPFE was strongly associated with lung transplants as a late complication, with a prevalence of 7.54%.

D43 - Capecitabine and Regorafenib-related increased mean corpuscular volume of red blood cell may be a predictive marker of treatment response and survival in patients with metastatic colorectal cancer

Background: Erythrocyte mean corpuscular volume (MCV) increase has been described in patients treated with capecitabine. Moreover, tyrosine kinase inhibitors have been shown to induce macrocytosis in patients with renal cancer cell and gastrointestinal stromal tumors, presumably via the inhibition of erythroid progenitor cells of the bone marrow. Therefore, the aim of our study was to evaluate the potential association of the erythrocyte MCV increase with tumor response and survival in patients with metastatic colorectal cancer (mCRC) treated with capecitabine and regorafenib. Patients and methods: A retrospective review of 30 patients with mCRC who were treated with capecitabine or regorafenib for at least 3 months at the Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy. Complete blood count (CBC) including red blood cell indices were recorded at baseline and after 4, 8 and 12 weeks from capecitabine or regorafenib treatment. Results: Baseline MCV levels and MCV levels after 4, 8 and 12 weeks were registered for each patient treated with capecitabine or regorafenib. Median ΔMCV [(post-treatment MCV values after 12 weeks) - (baseline MCV values)] was calculated. Patients were grouped according to ΔMCV into two groups in order to carry out survival analysis and correlation with tumor response. Moreover, univariate and multivariate analysis was performed to investigate if MCV increase was independently associated with favorable survival outcomes. Conclusions: Erythrocyte MCV increase may be used as a predictive marker for treatment response, PFS and OS in patients with mCRC treated with capecitabine or regorafenib. In the future, response to TAS-102 (trifluridine-tipiracil) and MCV increase will be also evaluated.

D44 - The overall survival of patients affected by metastatic colorectal cancer before and after “monoclonal antibodies era”: a monocentric retrospective study

Background: For decades, fluorouracil was the sole active agent for metastatic colorectal cancer (mCRC). This has changed in Italy mostly since the year 2004, with approval monoclonal antibodies that target vascular endothelial growth factor and later in 2009 with the approval of monoclonal antibodies that target the epidermal growth factor receptor. The aim of our study was to investigate the overall survival in “pre-monoclonal antibodies” and modern era. Patients and methods: A retrospective review of 395 patients with mCRC who were treated with or without any monoclonal antibody for at least 3 months at the Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy, were enrolled in our study. Overall survival of the two groups of patients (treated vs. not-treated with monoclonal antibodies) was investigated. Results: Overall survival of the two groups of patients (treated vs. not-treated with monoclonal antibodies) was investigated. Moreover, univariate and multivariate analysis was performed to investigate if the treatment regim containing monoclonal antibody increased survival outcomes of our patients. Conclusions: In concordance with literature, in the modern era, the average median survival duration has significantly increased. This increase has been mainly driven by the availability of new active drugs.

Ocular-surface temperature modification by cataract surgery

To analyze ocular-surface temperature changes after microincision cataract surgery and to correlate them with surgical, clinical, and laboratory parameters. Ophthalmology Unit, Saint Orsola-Malpighi Hospital, Bologna, Italy. Prospective case series. Patients affected by monolateral senile cataract were examined preoperatively and 7days and 28days postoperatively. Infrared thermography was used to measure the temperature soon after eye opening, the temperature after 10seconds of sustained eye opening, and the difference between these 2 values in the central cornea, nasal limbus, and temporal limbus. The Ocular Surface Disease Index (OSDI), Schirmer test, vital staining, tear breakup time (TBUT), conjunctival scraping cytology, exudated tear-serum albumin, and laser flare-cell meter examinations were performed. The study comprised 26 patients (10 men, 16 women). The temperature changed significantly after surgery. The temperature soon after eye opening showed cooling in the central cornea and nasal limbus and heating in the temporal limbus. The temperature after 10seconds of sustained eye opening minus the temperature soon after eye opening increased in all regions. The temperature after 10seconds of sustained eye opening minus the temperature soon after eye opening in the central cornea was inversely related to the OSDI and directly related to TBUT. The temperature soon after eye opening increased in the temporal limbus and was directly related to inflammatory indices. The ocular-surface temperature changed after cataract surgery depending on the region analyzed. The cooling in the central cornea could be related to the increased tear-film instability. The heating in the temporal limbus could be related to postoperative inflammation. None of the authors has a financial or proprietary interest in any material or method mentioned.