Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I.

Outcomes and Risk Factors for Complications of Laser Ablation for Thyroid Nodules: A Multicenter Study on 1531 Patients.

BACKGROUND: Image-guided laser ablation therapy (LAT) of benign thyroid nodules demonstrated favorable results in randomized trials with fixed modalities of treatment. The aim of this retrospective multicenter study was to assess the effectiveness, tolerability, and complications of LAT in a large consecutive series of patients from centers using this technique in their routine clinical activity. PATIENTS: Clinical records of 1534 consecutive laser-treated nodules in 1531 patients from eight Italian thyroid referral centers were assessed. Inclusion criteria were as follows: solid or mixed nodules with fluid component up to 40%; benign cytological findings; and normal thyroid function. METHODS: LAT was performed with a fixed-power protocol, whereas the number of applicators and illumination times were different according to target size. From one to three illuminations with pullback technique and with a total energy delivery based on the nodule volume were performed during the same session. Patients were evaluated during LAT, within 30 days, and 12 months after the procedure. RESULTS: Total number of treatments was 1837; 1280 (83%) of nodules had a single LAT session. Mean nodule volume decreased from 27 ± 24 mL at baseline to 8 ± 8 mL 12 months after treatment (P < .001). Mean nodule volume reduction was 72% ± 11% (range 48%-96%). This figure was significantly greater in mixed nodules (79% ± 7%; range 70%-92%) because they were drained immediately before laser illumination. Symptoms improved from 49% to 10% of cases (P < .001) and evidence of cosmetic signs from 86% to 8% of cases (P < .001). Seventeen complications (0.9%) were registered. Eight patients (0.5%) experienced transitory voice changes that completely resolved at the ear-nose-throat examination within 2-84 days. Nine minor complications (0.5%) were reported. No changes in thyroid function or autoimmunity were observed. CONCLUSIONS: Real practice confirmed LAT as a clinically effective, reproducible, and rapid outpatient procedure. Treatments were well tolerated and risk of major complications was very low.

TROP-2 expression in papillary thyroid cancer: a preliminary cyto-histological study.

OBJECTIVE: TROP-2 (human trophoblast cell surface marker) is a gene-related protein expressed in trophoblastic cells, which is also present in a variety of epithelial cancers and whose overexpression has been found to correlate with a poor prognosis. We analysed the possibility of using the expression of TROP-2 to detect papillary thyroid carcinoma (PTC) on cytological and histological samples, and compared it with Hector Battifora mesothelial antigen-1 (HBME-1). METHODS: From 127 patients, 127 fine needle aspirates (FNAs), in which HBME-1 was detected by immunocytochemistry (ICC), were re-classified according to the Bethesda system for reporting thyroid cytopathology (TBSRTC): 20% were benign, 56% were atypical cells/follicular lesion of undetermined significance (AUS/FLUS), 4% were follicular neoplasm/suspicious for a follicular neoplasm, 5% were suspicious for malignancy and 16% were malignant. Sufficient material to test for TROP-2 was available in 64 FNAs, 22 of which had a histological control. Including six additional cases in which the FNAs were not available, immunohistochemistry (IHC) was carried out with both markers on 94 cases. RESULTS: Among 88 FNAs with histological control, the sensitivity of HBME-1 to predict PTC was 87.5% (28/32) and the specificity was 86% (48/56), whereas, in 22 FNAs, TROP-2 sensitivity was 100% (13/13) and specificity was 89% (8/9). In 94 histological specimens in which IHC was carried out with both markers, the sensitivity and specificity were 82% and 86%, respectively, for HBME-1 and 87% and 89%, respectively, for TROP-2. The difference between the markers was not significant. Concordance between IHC and ICC was 76% for HBME-1 and 91% for TROP-2. CONCLUSION: TROP-2 can be used as well as HBME-1 in thyroid cytology to detect PTC. Positivity for either or both markers could help to stratify the risk of malignancy in indeterminate FNAs. Larger studies are need to analyse its role in the behaviour of PTC and its variants.

Clinical aggressiveness of incidental and non-incidental thyroid cancer.

BACKGROUND: With the increasing use of thyroid ultrasound, the recognition of thyroid nodules in a large proportion of apparently healthy subjects has become common. Because also the papillary thyroid microcarcinomas (PTMC) are being increasingly discovered, it is important to ascertain whether PTMC may exhibit heterogenous clinical features, associated with different aggressiveness. AIM: We retrospectively examined 122 subjects [98 female (80.3%), and 24 male (19.7%)] with thyroid cancer to find potential clinical and pathological findings that could be predictive of clinically aggressive behavior. RESULTS: Twenty of the 31 patients with true incidental cancer (64.5%) in comparison to 20 of the 91 patients with non-incidental cancer (21.9%) had a diameter <10 mm, and this difference was statistically significant (p<0.0001). There was a statistically significant association between size and invasiveness because 19.3% of invasive cancers were <10 mm whereas 44.6% of non-invasive cancers were <10 mm (p=0.005). The relationship between incidental discovery and invasiveness was also evaluated, but the proportion of incidental invasive cancer (19.3%) was not significantly different from that of incidental non-invasive cancer (30.8%). In the multivariate analysis, only size <10 mm (odds ratio=0.35, p=0.013) and papillary vs other histotypes (odds ratio=0.35, p=0.04) were statistically significant protective factors against invasiveness. CONCLUSIONS: a) Incidentally discovered thyroid cancers are more frequently microcarcinomas; b) there appears to be no difference in terms of invasive behavior between incidental and non-incidental thyroid cancer; c) smaller tumor size emerges as a protective factor.

[Vascular thrombosis and pulmonary thrombo-embolism due to harness suspension]. / Attività fisica con utilizzo di imbracatura in sospensione su funi e trombosi vasale.

BACKGROUND: In many sports (such as rock-climbing and caving) and working activities (e.g., construction and maintenance of buildings, pruning of lung-trunked trees, abseiling in wells) people run the risk of falling from a height. To prevent the effects of any potential fall, personalprotection devices consisting of at least a body holding device (i.e. a harness of some type), a lanyard and a reliable anchor are used. OBJECTIVES: Reporting on the occurrence of vascular thrombosis in subjects undergoing prolonged hanging in a harness, either for work or recreation. METHODS: We investigated patients treated for vascular thrombosis in our hospital in the last 5 years to identify subjects with frequent use of a harness. RESULTS: We identified a 36-year-old rock-climber who developed pulmonary thrombo-embolism and infarction 5 days after he had been wearing a harness for 12 hours consecutively, and a 32 year-old worker who often used a harness to fix wire-nettings to prevent rocks falling from steep places and suffered thrombosis of the left superficial femoral artery. A feature of both cases was the considerable length of time spent hanging in the harness and the absence of alternative risk factors for thrombosis. CONCLUSIONS: Prolonged hanging in a harness can be dangerous in itself because it can produce vascular thrombosis. Reduction of intravascular blood flow (stasis) and compression of the femoral veins by harness groin straps were the likely pathogenetic mechanisms of the described diseases. The importance is stressed of prevention, which must be based on planned regular breaks in the hanging position, checking on the fit and comfort level of the harness before it is first used, as well as medical surveillance of the subjects who spend prolonged periods in a harness for work or recreation.

[Biological-clinical significance of angiogenesis and mast cell infiltration in squamous cell carcinoma of the oral cavity]. / Significato biologico-clinico dell'angiogenesi ed infiltrato mastocitario nel carcinoma squamoso del cavo orale.

There are little data on the biological and prognostic role of neoangiogenesis in squamous cell carcinoma of the oral cavity (SCCOC). In particular, the role mast cells--reservoirs of angiogenetic peptides--play in neovascularization is not clear. In this work 50 cases of SCCOC T1-3 N0-1 M0 were studied, examining the microvasal density (MVD), mast cell density (MCD), relationship between these two parameters and their relationship with the pathological clinical features. Microvessels were identified with an immunohistochemical method using pan-endothelial anti-CD34 antibody while a histochemical method was used to label the mast cells with toluidine blue on adjacent sections for each tumor sample. MVD and MCD were characterized using an image analyzer. The mean MVD was 30 +/- 17 s.d. per sample while the average MCD was 8 +/- 6 s.d. per sample. Statistical analysis comparing MVD and MCD using the Pearson method showed a direct, significant correlation between the two variables (correlation coefficient = 0.496; p = 0.000). When the carcinomas were divided into subgroups with high and low MVD and MCD--using the median counts (27 and 7 respectively) as cutoff point--no association was found with the main clinical pathological features (age, sex, tumor diameter, lymph node status, cytopathological grading). As regards the correlation with prognosis, after an median 020 months of follow-up, the subgroup of patients with tumors with high MVD presented a better overall survival at 18 months from diagnosis than did the subgroup with tumors with a lower degree of vascularization (70% vs. 45%; p = 0.049 log rank test). The data obtained suggest that mast cells play an active role in angiogenetic processes in SCCOC and indicate that MVD is a favorable prognostic factor for SCCOC patients.

Primary tumours neoangiogenesis and P53 expression in oral carcinoma patients.

Paraffin embebbed tumour tissues from 47 T1-2 N0-1 M0 primary oral squamous carcinoma have been utilized for immunohistochemical analysis of p53 expression (moab DO-7) and microvessel density (MVD) analysis (moab CD34). Fifty percent of cases showed p53 immunostaining with an average of 21% of p53 positive cells. A strong trend for a longer survival in patients with tumor p53- versus p53+ was evidenced (median survival: 12 months versus not reached, respectively; p=0.08 by log-rank test). A mean value of 27 MVD was found. The probability of overall survival did not result significantly different in the subgroups of tumours with high and low MVD (median survival: 6 months versus 6 months, respectively; p=0.24). Cox multivariate analysis confirmed that the only prognostic factor significantly related to the overall survival was clinical nodal status (O.R.=2.7; 95% C.I. 1.09-6.9), while p53 status only approached the statistical significance (O.R.=2.5; 95% C.I. 0.96-6.5; p=0.06).

[Mandibular metastases from rectal adenocarcinoma: clinical case report and review of the literature]. / Metastasi mandibolare da adenocarcinoma del colon: descrizione di un caso clinico e revisione della letteratura.

A case is described of a 57-year-old woman with jaw metastasis from rectal adenocarcinoma who underwent colectomy and ovariectomy for moderately differentiated adenocarcinoma of the large intestine and peritoneal carcinosis. This patient subsequently underwent several cycles of chemoantiblastic therapy although, approximately six months after the initial surgery, a tumefaction of the gingival mucosa was found in the lower right premolar area. Radiography showed this neoformation to be an area of mandibular osteolysis. A biopsy, performed at the E.N.T Clinic of the IRCCS Oncological Hospital in Bari, Italy, revealed a metastatic lesion from rectal adenocarcinoma. This led to radiation therapy vs. the external fascia of the mandibular lesion. Then, given that further cerebral and hepatic metastases were found, palliative treatment was administered until the patient's death in June 2000. A review of the international literature shows how unusual it is to find secondary metastases from rectal adenocarcinoma in the mandibular region (only 23 cases have been published in the last forty years). For nearly all the authors examined, the treatment of choice for such lesions was radiation therapy associated with chemoantiblastic therapy. Despite such treatment, the literature bears significant agreement as to the poor, short-term prognosis.

Early, late symptoms and histological type of nasopharyngeal carcinoma.

After a wide literature review, we retrospectively analyzed the accurately recorded early onset and late symptoms at first diagnosis of nasopharyngeal carcinoma (NPC) in a series of 85 patients. Thirty-seven (44%) and 48 (56%) of cases had a squamous (SCC) and undifferentiated (UCNT) histological NPC subtype, respectively. Thirteen (15%), 21 (25%) and 51 (60%) of cases were T2, T3 and T4, respectively. The involvement of locoregional lymph nodes resulted significantly more frequent in UCNT with respect to SCC (35% versus 18% respectively; p<0.05). Overall, the early onset symptoms were represented by locoregional lymph node enlargement in 35% of cases; nasal symptoms in 32%, otological symptoms in 36%, while neurological symptoms were reported in only 2% of cases. On the contrary, symptoms at first diagnosis were more frequently represented by lymph node enlargement (53%) and nasal symptoms (68%) which were the symptoms effectively conducting the patients to the specialist. A protocol for management of ORL symptomatic patients according to the incidence of described early onset and at first diagnosis symptoms is suggested.

A fatal case of trichlorofluoromethane (Freon 11) poisoning. Tissue distribution study by gas chromatography-mass spectrometry.

A case of lethal poisoning due to trichlorofluoromethane (FC11) inhalation is described. The fluorocarbon was determined in biological tissues by headspace gas chromatography-mass spectrometry. FC11 was detected in all the examined tissues, with decreasing levels in heart, lung, brain, liver, blood, kidney, and spleen. The highest concentration measured in heart could be related to the mode of toxic action of fluorocarbons postulated by many authors, characterized by the sensitization of the myocardium to the catecholamines producing arrhythmia and cardiac arrest. Nevertheless the aspecific picture of the anatomo-pathological and histological findings does not exclude that the described accidental fatality may have been caused by the combination of direct from toxicity with hypoxemic asphyxiation, due to the saturation of the atmosphere by FC11 in the closed environment in which the intoxication occurred.

[Cisplatin ototoxicity: the experience of the Institute of Oncology in Bari]. / Ototossicità da cisplatino: l'esperienza dell'Istituto Oncologico di Bari.

The Authors report their experience, developed in the E.N.T. Unit of the Oncologic Institute of Bari, concerning the ototoxic effect of Diamminedichloroplatinum (CDDP). The Study was carried out on 74 patients with advanced cancer of the head and neck, treated according to the polychemotherapeutic scheme called "MBD" in 34 cases and in 40 cases according to the scheme called "Al Sarraf". The otologic evaluation was composed, in all the cases, of a complete series of audio-vestibular investigation, carried out prior to and immediately after every administration chemotherapy and periodically, during a 4 months period after interruption of therapy. Three patients (4%) showed significative acoustical damage, none showed vestibular deficit. Symptoms did not appear beyond the second administration of CDDP, which always followed subjective acouphenic symptomatology. The ototoxic effect of CDDP, resulting in the experience of the Oncologic Institute of Bari, is percentually very low: and seems to be influenced by the single dose, rather than by the total doses and in any case is not preventable by any profilatic measure.