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306 results on '"Vitiello, F."'

1. Patients undergoing double J substitution with a pigtail suture stent report a significant decrease of stent-related symptoms. Results from a prospective multicenter longitudinal trial

Author

Bosio, A., primary, Ferretti, S., additional, Alessandria, E., additional, Vitiello, F., additional, Vercelli, E., additional, Campobasso, D., additional, Micai, L., additional, Gozzo, C., additional, Bertello, G., additional, Guarino, G.G., additional, Alice, C., additional, Bisconti, A., additional, Fop, F., additional, and Gontero, P., additional

Published
2024
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2. Trans-perineal laser ablation of the prostate for the treatment of benign prostatic obstruction in high surgical risk patients. One-year results from a prospective cohort of extreme patients

Author

Sibona, M., primary, Vitiello, F., additional, Montefusco, G., additional, Vercelli, E., additional, Micai, L., additional, Bracco, F.M., additional, Mangione, C., additional, Colucci, F., additional, Destefanis, P., additional, and Gontero, P., additional

Published
2024
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3. Patients undergoing double J substitution with a pigtail suture stent report a significant decrease of stent-related symptoms: Results from a prospective multicenter longitudinal trial

Author

Alessandria, E., primary, Bosio, A., additional, Ferretti, S., additional, Vitiello, F., additional, Vercelli, E., additional, Campobasso, D., additional, Micai, L., additional, Gozzo, C., additional, Bertello, G., additional, Guarino, G.G., additional, Alice, C., additional, Bisconti, A., additional, Fop, F., additional, and Gontero, P., additional

Published
2024
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5. Are ureteral stent-related symptoms detectable in transplanted patients? milder, but they are. Results from a prospective observational cohort study

Author

Bosio, A., primary, Alessandria, E., additional, Pizzuto, G., additional, Lauretta, I., additional, Agosti, S.C., additional, Vitiello, F., additional, Vercelli, E., additional, Lillaz, B., additional, Pasquale, G., additional, Sedigh, O., additional, Mella, A., additional, Biancone, L., additional, and Gontero, P., additional

Published
2022
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13. Be-TeaM: An Italian real-world observational study on second-line therapy for EGFR-mutated NSCLC patients

Author

Reale, M, Chiari, R, Tiseo, M, Vitiello, F, Barbieri, F, Cortinovis, D, Ceresoli, G, Finocchiaro, G, Romano, G, Piovano, P, Del Conte, A, Borra, G, Verderame, F, Scotti, V, Nonnis, D, Galetta, D, Sergi, C, Migliorino, M, Tonini, G, Cecere, F, Berardi, R, Pino, M, Martelli, O, Gelibter, A, Carta, A, Vattemi, E, Pagano, M, Zullo, A, Ferrari, S, Rossi, A, Novello, S, Reale ML, Chiari R, Tiseo M, Vitiello F, Barbieri F, Cortinovis D, Ceresoli GL, Finocchiaro G, Romano GD, Piovano PL, Del Conte A, Borra G, Verderame F, Scotti V, Nonnis D, Galetta D, Sergi C, Migliorino MR, Tonini G, Cecere F, Berardi R, Pino MS, Martelli O, Gelibter A, Carta A, Vattemi E, Pagano M, Zullo A, Ferrari S, Rossi A, Novello S., Reale, M, Chiari, R, Tiseo, M, Vitiello, F, Barbieri, F, Cortinovis, D, Ceresoli, G, Finocchiaro, G, Romano, G, Piovano, P, Del Conte, A, Borra, G, Verderame, F, Scotti, V, Nonnis, D, Galetta, D, Sergi, C, Migliorino, M, Tonini, G, Cecere, F, Berardi, R, Pino, M, Martelli, O, Gelibter, A, Carta, A, Vattemi, E, Pagano, M, Zullo, A, Ferrari, S, Rossi, A, Novello, S, Reale ML, Chiari R, Tiseo M, Vitiello F, Barbieri F, Cortinovis D, Ceresoli GL, Finocchiaro G, Romano GD, Piovano PL, Del Conte A, Borra G, Verderame F, Scotti V, Nonnis D, Galetta D, Sergi C, Migliorino MR, Tonini G, Cecere F, Berardi R, Pino MS, Martelli O, Gelibter A, Carta A, Vattemi E, Pagano M, Zullo A, Ferrari S, Rossi A, and Novello S.

Abstract

Objectives: Molecular diagnostics and care of non-small cell lung cancer (NSCLC) are continuously evolving. Few data document the current strategies to manage advanced NSCLC patients beyond progression in clinical practice. Patients and methods: Be-TeaM is an Italian multi-center observational study conducted on consecutive EGFR-mutated stage IV NSCLC patients, progressed during/after a first-line EGFR-TKI. It consists of a retrospective phase, from first-line EGFR-TKI therapy start until study entry (i.e. beginning of the diagnostic process), and a prospective phase, until treatment choice or for 3 months if no therapy was prescribed. Primary objective was to describe the diagnostic and therapeutic approaches adopted after progression in a real-world setting. Results: Of 308 patients enrolled in 63 centers from July 2017 to June 2018, 289 were included in the analysis. In first line, 53.3 % received gefitinib, 32.5 % afatinib and 14.2 % erlotinib. The testing rate (i.e. rate of all patients undergone any biopsy -liquid and/or tissue- for the T790 M detection) was 90.7 %, with liquid biopsy being the most frequently executed. Of 262 biopsied patients, 64.5 % underwent only 1 liquid biopsy, 10.7 % only 1 tissue biopsy and 18.3 % >1 biopsy, both liquid and solid in 85.4 %. The T790M positivity rate was 45.3 %; of 166 patients undergone only a liquid biopsy and tested for the mutation, 39.8 % were T790M+ and 60.2 % T790M-/undetermined. By the observation end, 87.9 % patients had a post-progression treatment chosen, osimertinib being the most frequent among the T790M+. Conclusion: Be-TeaM provides the first snapshot of current practices for the management of NSCLC patients beyond progression in Italy; in clinical practice, assessing the T790M status is not always feasible.

Published
2020

16. 210P Atezolizumab plus bevacizumab versus lenvatinib for BCLC-B stage of patients with hepatocellular carcinoma: A large real-life worldwide population.

Author

Vitiello, F., Tada, T., Shimose, S., Kudo, M., Cheon, J., Finkelmeier, F., Lim, H.Y., Presa, J., Masi, G., Lonardi, S., Tovoli, F., Scartozzi, M., Tamburini, E., Foschi, F.G., Persano, M., Rossari, F., Foti, S., Camera, S., Gardini, A. Casadei, and Rimini, M.

Subjects
*HEPATOCELLULAR carcinoma, *ATEZOLIZUMAB, *BEVACIZUMAB
Published
2024
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26. Pembrolizumab monotherapy in advanced NSCLC patients with low PD-L1 expression: is there real evidence?

Author

Fiorelli, A., Vitiello F. b, Morgillo, F. c, Santagata, M. d, Spuntarelli, C. d, Di Domenico, M, Santini, M. a, Bianco A., Fiorelli, A., Vitiello, F. b., Morgillo, Floriana, F. c, Santagata, M. d, Spuntarelli, C., D., Domenico, Di, M, Santini, M. a, and Bianco, A.

Subjects
Oncology, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Immune checkpoint inhibitors, medicine.medical_treatment, Pembrolizumab, chemotherapy, Antibodies, Monoclonal, Humanized, B7-H1 Antigen, Disease-Free Survival, Drug Administration Schedule, Translocation, Genetic, Atezolizumab, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Medicine, cancer, Humans, Radiology, Nuclear Medicine and imaging, Anaplastic Lymphoma Kinase, Neoplasm Metastasis, protein expression, Aged, Chemotherapy, cancer immunotherapy, non small cell lung cancer, business.industry, Asia, Eastern, Immunotherapy, Genes, erbB-1, Middle Aged, Editorial Commentary, Docetaxel, Mutation, Pd l1 expression, Female, Nivolumab, business, medicine.drug
Abstract

First-line pembrolizumab monotherapy improves overall and progression-free survival in patients with untreated metastatic non-small-cell lung cancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater. We investigated overall survival after treatment with pembrolizumab monotherapy in patients with a PD-L1 TPS of 1% or greater.This randomised, open-label, phase 3 study was done in 213 medical centres in 32 countries. Eligible patients were adults (≥18 years) with previously untreated locally advanced or metastatic non-small-cell lung cancer without a sensitising EGFR mutation or ALK translocation and with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, life expectancy 3 months or longer, and a PD-L1 TPS of 1% or greater. Randomisation was computer generated, accessed via an interactive voice-response and integrated web-response system, and stratified by region of enrolment (east Asia vs rest of world), ECOG performance status score (0 vs 1), histology (squamous vs non-squamous), and PD-L1 TPS (≥50% vs 1-49%). Enrolled patients were randomly assigned 1:1 in blocks of four per stratum to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles or the investigator's choice of platinum-based chemotherapy for four to six cycles. Primary endpoints were overall survival in patients with a TPS of 50% or greater, 20% or greater, and 1% or greater (one-sided significance thresholds, p=0·0122, p=0·0120, and p=0·0124, respectively) in the intention-to-treat population, assessed sequentially if the previous findings were significant. This study is registered at ClinicalTrials.gov, number NCT02220894.From Dec 19, 2014, to March 6, 2017, 1274 patients (902 men, 372 women, median age 63 years [IQR 57-69]) with a PD-L1 TPS of 1% or greater were allocated to pembrolizumab (n=637) or chemotherapy (n=637) and included in the intention-to-treat population. 599 (47%) had a TPS of 50% or greater and 818 patients (64%) had a TPS of 20% or greater. As of Feb 26, 2018, median follow-up was 12·8 months. Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations (≥50% hazard ratio 0·69, 95% CI 0·56-0·85, p=0·0003; ≥20% 0·77, 0·64-0·92, p=0·0020, and ≥1% 0·81, 0·71-0·93, p=0·0018). The median surival values by TPS population were 20·0 months (95% CI 15·4-24·9) for pembrolizumab versus 12·2 months (10·4-14·2) for chemotherapy, 17·7 months (15·3-22·1) versus 13·0 months (11·6-15·3), and 16·7 months (13·9-19·7) versus 12·1 months (11·3-13·3), respectively. Treatment-related adverse events of grade 3 or worse occurred in 113 (18%) of 636 treated patients in the pembrolizumab group and in 252 (41%) of 615 in the chemotherapy group and led to death in 13 (2%) and 14 (2%) patients, respectively.The benefit-to-risk profile suggests that pembrolizumab monotherapy can be extended as first-line therapy to patients with locally advanced or metastatic non-small-cell lung cancer without sensitising EGFR or ALK alterations and with low PD-L1 TPS.Merck SharpDohme.

Published
2019

27. Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer: Results from a Real-World Population

Author

Crinò, L, Bidoli, P, Delmonte, A, Grossi, F, De Marinis, F, Ardizzoni, A, Vitiello, F, Lo Russo, G, Parra, H, Cortesi, E, Cappuzzo, F, Calabrò, L, Tiseo, M, Turci, D, Gamucci, T, Antonelli, P, Morabito, A, Chella, A, Giannarelli, D, Galetta, D, Crinò L, Bidoli P, Delmonte A, Grossi F, De Marinis F, Ardizzoni A, Vitiello F, Lo Russo G, Parra HS, Cortesi E, Cappuzzo F, Calabrò L, Tiseo M, Turci D, Gamucci T, Antonelli P, Morabito A, Chella A, Giannarelli D, Galetta D., Crinò, L, Bidoli, P, Delmonte, A, Grossi, F, De Marinis, F, Ardizzoni, A, Vitiello, F, Lo Russo, G, Parra, H, Cortesi, E, Cappuzzo, F, Calabrò, L, Tiseo, M, Turci, D, Gamucci, T, Antonelli, P, Morabito, A, Chella, A, Giannarelli, D, Galetta, D, Crinò L, Bidoli P, Delmonte A, Grossi F, De Marinis F, Ardizzoni A, Vitiello F, Lo Russo G, Parra HS, Cortesi E, Cappuzzo F, Calabrò L, Tiseo M, Turci D, Gamucci T, Antonelli P, Morabito A, Chella A, Giannarelli D, and Galetta D.

Abstract

Background: Nivolumab has shown a survival benefit compared with docetaxel as second-line treatment for patients with previously treated advanced squamous non-small cell lung cancer (NSCLC) in a randomized phase III trial. The experiences of patients and physicians in routine clinical practice are often different from those in a controlled clinical trial setting. We present data from the entire Italian cohort of patients with squamous NSCLC enrolled in a worldwide nivolumab NSCLC expanded access program. Patients and Methods: Patients with pretreated advanced squamous NSCLC received nivolumab 3 mg/kg every 2 weeks for up to 24 months. Safety was monitored throughout; efficacy data collected included objective tumor response, date of progression, and survival information. Results: The Italian cohort comprised 371 patients who received at least one dose of nivolumab. In the overall population, the objective response rate (ORR) was 18%, the disease control rate (DCR) was 47%, and median overall survival (OS) was 7.9 months (95% confidence interval 6.2–9.6). In subgroup analyses, ORR, DCR, and median OS were, respectively, 17%, 48%, and 9.1 months in patients previously treated with two or more lines of therapy (n = 209) and 8%, 40%, and 10.0 months in patients treated beyond disease progression (n = 65). In the overall population, the rate of any-grade and grade 3–4 adverse events was 29% and 6%, respectively. Treatment-related adverse events led to treatment discontinuation in 14 patients (5%). There were no treatment-related deaths. Conclusion: To date, this report represents the most extensive clinical experience with nivolumab in advanced squamous NSCLC in current practice outside the controlled clinical trial setting. These data suggest that the efficacy and safety profiles of nivolumab in a broad, real-world setting are consistent with those obtained in clinical trials. Implications for Practice: Nivolumab is approved in the U.S. and Europe for the treatment of a

Published
2019

36. 2001P Consolidative thoracic radiotherapy of extensive-stage small cell lung cancer in the era of chemoimmunotherapy: A retrospective analysis concerning patients from southern Italy

Author

Longo, V., Vitiello, F., Spinnato, F., Ambrosio, F., Del Giudice, T., Sergi, M.C.I., Casaluce, F., Montrone, M., Gilli, M., Reale, M.L., Di Liello, R., Russo, A., Sforza, V., Gristina, V., Servetto, A., Cristofano, A., Viscardi, G., Marchese, A., Galetta, D., and Della Corte, C.M.

Published
2023
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44. Adverse drug reactions and gender differences: What changes in drug safety?

Author

Di Mauro G., Zinzi A., Vitiello F., Restaino M., Sportiello L., Rafaniello C., Sullo M. G., Capuano A., Di Mauro, G., Zinzi, A., Vitiello, F., Restaino, M., Sportiello, L., Rafaniello, C., Sullo, M. G., and Capuano, A.

Subjects
Safety profile, Adverse drug reaction, Gender difference, Phar-macovigilance
Abstract

Gender differences are influenced by cultural, social, psychological and biological factors. A specific area of medicine has been identified to understand the mechanisms underlying gender differences affecting health status, the course of a disease and pharmacological therapy out-comes. The main gender-related variables affecting drug response are weight, body surface area, height, fat mass, plasma volume and total body water. Gender differences can also influence the drug safety profile; indeed, real-world epidemiological data show a greater incidence and severity of adverse drug reactions in women than in men. Because of several biases in conducting pre-marketing gender-spe-cific studies, post-marketing studies are needed in order to evaluate gender differences in terms of drug efficacy and safety. Therefore, the aim of this review is to provide further evidence in order to show the incidence of specific gender-related adverse drug reactions (ADRs). In this context, we analyzed ADRs reported across the 2001-2018 period in the spontaneous reporting system in the Campania Region (It-aly), in terms of number and severity. In line with literature data, our results showed a higher number of reports involv-ing women than men, especially in those aged 18-64 years. Similarly, severe ADRs were more frequently reported in women. Therefore, an implementation of gender-specific pharmacovigilance activities would allow a further better characterization of the safety profile of drugs used in clinical practice.

Published
2019

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