Sudden Unexpected Deaths and Vaccinations during the First Two Years of Life in Italy: A Case Series Study

Background The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany in 2003. A study to establish whether the immunisation with hexavalent vaccines increased the short term risk of SUD in infants was conducted in Italy. Methodology/Principal Findings The reference population comprises around 3 million infants vaccinated in Italy in the study period 1999–2004 (1.5 million received hexavalent vaccines). Events of SUD in infants aged 1–23 months were identified through the death certificates. Vaccination history was retrieved from immunisation registries. Association between immunisation and death was assessed adopting a case series design focusing on the risk periods 0–1, 0–7, and 0–14 days after immunisation. Among the 604 infants who died of SUD, 244 (40%) had received at least one vaccination. Four deaths occurred within two days from vaccination with the hexavalent vaccines (RR = 1.5; 95% CI 0.6 to 4.2). The RRs for the risk periods 0–7 and 0–14 were 2.0 (95% CI 1.2 to 3.5) and 1.5 (95% CI 0.9 to 2.4). The increased risk was limited to the first dose (RR = 2.2; 95% CI 1.1 to 4.4), whereas no increase was observed for the second and third doses combined. Conclusions The RRs of SUD for any vaccines and any risk periods, even when greater than 1, were almost an order of magnitude lower than the estimates in Germany. The limited increase in RRs found in Italy appears confined to the first dose and may be partly explained by a residual uncontrolled confounding effect of age

Observation of a Charmed Baryon Decaying to D0p at a Mass Near 2.94 GeV/c2

A search for charmed baryons decaying to D 0 p reveals two states: the Λ c ( 2880 ) + baryon and a previously unobserved state at a mass of [ 2939.8 ± 1.3 ( stat ) ± 1.0 ( syst ) ]     MeV / c 2 and with an intrinsic width of [ 17.5 ± 5.2 ( stat ) ± 5.9 ( syst ) ]     MeV . Consistent and significant signals are observed for the K − π + and K − π + π − π + decay modes of the D 0 in 287     fb − 1 annihilation data recorded by the BABAR detector at a center-of-mass energy of 10.58 GeV. There is no evidence in the D + p spectrum of doubly charged partners. The mass and intrinsic width of the Λ c ( 2880 ) + baryon and relative yield of the two baryons are also measured

Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up

In 1986, we initiated a multicenter, randomized trial to compare induction chemotherapy with cisplatin and 5-fluorouracil followed by locoregional treatment (surgery and radiotherapy or radiotherapy alone) with locoregional treatment alone in patients with head and neck squamous cell carcinoma. Here we report the long-term results of the trial. A total of 237 patients with nonmetastatic stage III or IV head and neck carcinoma were randomly assigned to receive four cycles of neoadjuvant chemotherapy followed by locoregional treatment (group A) or locoregional treatment alone (group B). Among all patients, overall survival at 5 and 10 years was 23% (95% confidence interval [CI] = 15.3% to 30.9%) and 19% (95% CI = 11.6% to 26.4%), respectively, for those in group A and 16% (95% CI = 9.6% to 23.4%) and 9% (95% CI = 3.5% to 14.7%), respectively, for those in group B (P = .13). Among operable patients, we observed no difference between group A and group B in overall survival at 5 and 10 years (group A, 31% [95% CI = 14.9% to 47.3%] and 22.7% [95% CI = 7.1% to 38.3%], respectively; group B, 43.3% [95% CI = 25.6% to 61.0%] and 14.2% [95% CI = 0.1% to 28.3%], respectively; P = .73). Among inoperable patients, overall survival at 5 and 10 years was 21% (95% CI = 12.3% to 30.1%) and 16% (95% CI = 7.7% to 23.9%), respectively, for group A and 8% (95% CI = 1.5% to 12.3%) and 6% (95% CI = 0.1% to 9.1%), respectively, for group B (log-rank P = .04). Four cycles of neoadjuvant chemotherapy is a promising approach for treating patients with inoperable advanced head and neck cancer but not for treating patients with operable disease

Appropriateness of antiplatelet therapy for primary and secondary cardio- and cerebrovascular prevention in acutely hospitalized older people

Aims: Antiplatelet therapy is recommended for the secondary prevention of cardio- and cerebrovascular disease, but for primary prevention it is advised only in patients at very high risk. With this background, this study aims to assess the appropriateness of antiplatelet therapy in acutely hospitalized older people according to their risk profile. Methods: Data were obtained from the REPOSI register held in Italian and Spanish internal medicine and geriatric wards in 2012 and 2014. Hospitalized patients aged ≥65 assessable at discharge were selected. Appropriateness of the antiplatelet therapy was evaluated according to their primary or secondary cardiovascular prevention profiles. Results: Of 2535 enrolled patients, 2199 were assessable at discharge. Overall 959 (43.6%, 95% CI 41.5–45.7) were prescribed an antiplatelet drug, aspirin being the most frequently chosen. Among patients prescribed for primary prevention, just over half were inappropriately prescribed (52.1%), being mainly overprescribed (155/209 patients, 74.2%). On the other hand, there was also a high rate of inappropriate underprescription in the context of secondary prevention (222/726 patients, 30.6%, 95% CI 27.3–34.0%). Conclusions: This study carried out in acutely hospitalized older people shows a high degree of inappropriate prescription among patients prescribed with antiplatelets for primary prevention, mainly due to overprescription. Further, a large proportion of patients who had had overt cardio- or cerebrovascular disease were underprescribed, in spite of the established benefits of antiplatelet drugs in the context of secondary prevention

Validation of a Novel Three-Dimensional (3D Fusion) Gross Sampling Protocol for Clear Cell Renal Cell Carcinoma to Overcome Intratumoral Heterogeneity: The Meet-Uro 18 Study

76siWe aimed to overcome intratumoral heterogeneity in clear cell renal cell carcinoma (clearRCC). One hundred cases of clearRCC were sampled. First, usual standard sampling was applied (1 block/cm of tumor); second, the whole tumor was sampled, and 0.6 mm cores were taken from each block to construct a tissue microarray; third, the residual tissue, mapped by taking pieces 0.5 × 0.5 cm, reconstructed the entire tumor mass. Precisely, six randomly derived pieces of tissues were placed in each cassette, with the number of cassettes being based on the diameter of the tumor (called multisite 3D fusion). Angiogenic and immune markers were tested. Routine 5231 tissue blocks were obtained. Multisite 3D fusion sections showed pattern A, homogeneous high vascular density (10%), pattern B, homogeneous low vascular density (8%) and pattern C, heterogeneous angiogenic signatures (82%). PD-L1 expression was seen as diffuse (7%), low (33%) and absent (60%). Tumor-infiltrating CD8 scored high in 25% (pattern hot), low in 65% (pattern weak) and zero in 10% of cases (pattern desert). Grading was upgraded in 26% of cases (G3-G4), necrosis and sarcomatoid/rhabdoid characters were observed in, respectively, 11 and 7% of cases after 3D fusion (p = 0.03). CD8 and PD-L1 immune expressions were higher in the undifferentiated G4/rhabdoid/sarcomatoid clearRCC subtypes (p = 0.03). Again, 22% of cases were set to intermediate to high risk of clinical recurrence due to new morphological findings of all aggressive G4, sarcomatoid/rhabdoid features by using 3D fusion compared to standard methods (p = 0.04). In conclusion, we propose an easy-to-apply multisite 3D fusion sampling that negates bias due to tumor heterogeneity.noneBrunelli, Matteo; Martignoni, Guido; Malpeli, Giorgio; Volpe, Alessandro; Cima, Luca; Raspollini, Maria Rosaria; Barbareschi, Mattia; Tafuri, Alessandro; Masi, Giulia; Barzon, Luisa; Ammendola, Serena; Villanova, Manuela; Cerruto, Maria Angela; Milella, Michele; Buti, Sebastiano; Bersanelli, Melissa; Fornarini, Giuseppe; Rebuzzi, Sara Elena; Vellone, Valerio Gaetano; Gaggero, Gabriele; Procopio, Giuseppe; Verzoni, Elena; Bracarda, Sergio; Fanelli, Martina; Sabbatini, Roberto; Passalacqua, Rodolfo; Perrucci, Bruno; Giganti, Maria Olga; Donini, Maddalena; Panni, Stefano; Tucci, Marcello; Prati, Veronica; Ortega, Cinzia; Caliò, Anna; Eccher, Albino; Alongi, Filippo; Pappagallo, Giovanni; Iacovelli, Roberto; Mosca, Alessandra; Umari, Paolo; Montagnani, Ilaria; Gobbo, Stefano; Atzori, Francesco; Munari, Enrico; Maruzzo, Marco; Basso, Umberto; Pierconti, Francesco; Patriarca, Carlo; Colombo, Piergiuseppe; Lapini, Alberto; Conti, Giario; Salvioni, Roberto; Bollito, Enrico; Cossarizza, Andrea; Massari, Francesco; Rizzo, Mimma; Franco, Renato; Zito-Marino, Federica; Aberasturi Plata, Yoseba; Galuppini, Francesca; Sbaraglia, Marta; Fassan, Matteo; Dei Tos, Angelo Paolo; Colecchia, Maurizio; Moch, Holger; Scaltriti, Maurizio; Porta, Camillo; Delahunt, Brett; Giannarini, Gianluca; Bortolus, Roberto; Rescigno, Pasquale; Banna, Giuseppe Luigi; Signori, Alessio; Obispo, Miguel Angel Llaja; Perris, Roberto; Antonelli, AlessandroBrunelli, Matteo; Martignoni, Guido; Malpeli, Giorgio; Volpe, Alessandro; Cima, Luca; Raspollini, Maria Rosaria; Barbareschi, Mattia; Tafuri, Alessandro; Masi, Giulia; Barzon, Luisa; Ammendola, Serena; Villanova, Manuela; Cerruto, Maria Angela; Milella, Michele; Buti, Sebastiano; Bersanelli, Melissa; Fornarini, Giuseppe; Rebuzzi, Sara Elena; Vellone, Valerio Gaetano; Gaggero, Gabriele; Procopio, Giuseppe; Verzoni, Elena; Bracarda, Sergio; Fanelli, Martina; Sabbatini, Roberto; Passalacqua, Rodolfo; Perrucci, Bruno; Giganti, Maria Olga; Donini, Maddalena; Panni, Stefano; Tucci, Marcello; Prati, Veronica; Ortega, Cinzia; Caliò, Anna; Eccher, Albino; Alongi, Filippo; Pappagallo, Giovanni; Iacovelli, Roberto; Mosca, Alessandra; Umari, Paolo; Montagnani, Ilaria; Gobbo, Stefano; Atzori, Francesco; Munari, Enrico; Maruzzo, Marco; Basso, Umberto; Pierconti, Francesco; Patriarca, Carlo; Colombo, Piergiuseppe; Lapini, Alberto; Conti, Giario; Salvioni, Roberto; Bollito, Enrico; Cossarizza, Andrea; Massari, Francesco; Rizzo, Mimma; Franco, Renato; Zito-Marino, Federica; Aberasturi Plata, Yoseba; Galuppini, Francesca; Sbaraglia, Marta; Fassan, Matteo; Dei Tos, Angelo Paolo; Colecchia, Maurizio; Moch, Holger; Scaltriti, Maurizio; Porta, Camillo; Delahunt, Brett; Giannarini, Gianluca; Bortolus, Roberto; Rescigno, Pasquale; Banna, Giuseppe Luigi; Signori, Alessio; Obispo, Miguel Angel Llaja; Perris, Roberto; Antonelli, Alessandr

Validation of a Novel Three-Dimensional (3D Fusion) Gross Sampling Protocol for Clear Cell Renal Cell Carcinoma to Overcome Intratumoral Heterogeneity: The Meet-Uro 18 Study

We aimed to overcome intratumoral heterogeneity in clear cell renal cell carcinoma (clearRCC). One hundred cases of clearRCC were sampled. First, usual standard sampling was applied (1 block/cm of tumor); second, the whole tumor was sampled, and 0.6 mm cores were taken from each block to construct a tissue microarray; third, the residual tissue, mapped by taking pieces 0.5 × 0.5 cm, reconstructed the entire tumor mass. Precisely, six randomly derived pieces of tissues were placed in each cassette, with the number of cassettes being based on the diameter of the tumor (called multisite 3D fusion). Angiogenic and immune markers were tested. Routine 5231 tissue blocks were obtained. Multisite 3D fusion sections showed pattern A, homogeneous high vascular density (10%), pattern B, homogeneous low vascular density (8%) and pattern C, heterogeneous angiogenic signatures (82%). PD-L1 expression was seen as diffuse (7%), low (33%) and absent (60%). Tumor-infiltrating CD8 scored high in 25% (pattern hot), low in 65% (pattern weak) and zero in 10% of cases (pattern desert). Grading was upgraded in 26% of cases (G3-G4), necrosis and sarcomatoid/rhabdoid characters were observed in, respectively, 11 and 7% of cases after 3D fusion (p = 0.03). CD8 and PD-L1 immune expressions were higher in the undifferentiated G4/rhabdoid/sarcomatoid clearRCC subtypes (p = 0.03). Again, 22% of cases were set to intermediate to high risk of clinical recurrence due to new morphological findings of all aggressive G4, sarcomatoid/rhabdoid features by using 3D fusion compared to standard methods (p = 0.04). In conclusion, we propose an easy-to-apply multisite 3D fusion sampling that negates bias due to tumor heterogeneity

Living alone as an independent predictor of prolonged length of hospital stay and non-home discharge in older patients.

Not availabl

Prognostic value of degree and types of anaemia on clinical outcomes for hospitalised older patients

Study objective This study investigated in a large sample of in-patients the impact of mild-moderate-severe anaemia on clinical outcomes such as in-hospital mortality, re-admission, and death within three months after discharge. Methods A prospective multicentre observational study, involving older people admitted to 87 internal medicine and geriatric wards, was done in Italy between 2010 and 2012. The main clinical/laboratory data were obtained on admission and discharge. Based on haemoglobin (Hb), subjects were classified in three groups: group 1 with normal Hb, (reference group), group 2 with mildly reduced Hb (10.0–11.9 g/dL in women; 10.0–12.9 g/dL in men) and group 3 with moderately-severely reduced Hb (<10 g/dL in women and men). Results Patients (2678; mean age 79.2 ± 7.4 y) with anaemia (54.7%) were older, with greater functional impairment and more comorbidity. Multivariable analysis showed that mild but not moderate-severe anaemia was associated with a higher risk of hospital re-admission within three months (group 2: OR = 1.62; 95%CI 1.21–2.17). Anaemia failed to predict in-hospital mortality, while a higher risk of dying within three months was associated with the degree of Hb reduction on admission (group 2: OR = 1.82;95%CI 1.25–2.67; group 3: OR = 2.78;95%CI 1.82–4.26) and discharge (group 2: OR = 2.37;95%CI 1.48–3.93; group 3: OR = 3.70;95%CI 2.14–6.52). Normocytic and macrocytic, but not microcytic anaemia, were associated with adverse clinical outcomes. Conclusions Mild anaemia predicted hospital re-admission of older in-patients, while three-month mortality risk increased proportionally with anaemia severity. Type and severity of anaemia affected hospital re-admission and mortality, the worst prognosis being associated with normocytic and macrocytic anaemia