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1. Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Author

De Giorgi, U, Carteni, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, Cn, Procopio, G, Falcone, A, Roila, F, Cascinu, S, Tirelli, U, Giustini, L, Sobrero, A, Cappuzzo, F, Tortora, G, Tassinari, D, Passalacqua, R, Pazzola, A, Surico, G, Maio, M, Benedetti, G, Barone, C, Adamo, V, Ricevuto, E, De Censi, A, Spada, M, Tonini, G, Pinto, C, Ciuffreda, L, Ruggeri, Em, Bengala, C, Scotti, V, Fagnani, D, Bonetti, A, Mitterer, M, Castiglione, F, Bidoli, P, Ferrau, F, Crino, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Favaretto, A, Di Costanzo, F, Fasola, G, Merlano, M, Artioli, F, Di Leo, A, Romito, S, Maestri, A, Giorgio, Cg, Ionta, Mt, Verderame, F, Zampa, G, Numico, G, Minelli, M, Tagliaferri, P, Foa, P, Palmiotti, G, De Placido, S, Mattioli, R, Iuliano, F, Defraia, E, Siena, S, Clerico, M, Salvagno, L, Ceresoli, Gl, Bernardo, A, Di Lieto, M, Moroni, M, Maisano, M, Scartozzi, M, Scagliotti, G, Soraru, M, Pepe, S, Scaltriti, A, Gebbia, V, Testa, E, Lorusso, V, Bordonaro, R, De Signoribus, G, Tedde, N, Santoro, A, Francini, G, Aondio, G, De Giorgi, U., Carteni, G., Giannarelli, D., Basso, U., Galli, L., Cortesi, E., Caserta, C., Pignata, S., Sabbatini, R., Bearz, A., Buti, S., Lo Re, G., Berruti, A., Bracarda, S., Cognetti, F., Rastelli, F., Fornarini, G., Porta, C., Turci, D., Sternberg, C. N., Procopio, G., Falcone, A., Roila, F., Cascinu, S., Tirelli, U., Giustini, L., Sobrero, A., Cappuzzo, F., Tassinari, D., Passalacqua, R., Pazzola, A., Surico, G., Maio, M., Benedetti, G., Barone, C., Adamo, V., Ricevuto, E., De Censi, A., Spada, M., Tonini, G., Pinto, C., Ciuffreda, L., Ruggeri, E. M., Bengala, C., Scotti, V., Fagnani, D., Bonetti, A., Mitterer, M., Castiglione, F., Bidoli, P., Ferrau, F., Crino, L., Frassoldati, A., Marchetti, P., Mini, E., Scoppola, A., Verusio, C., Favaretto, A., Di Costanzo, F., Fasola, G., Merlano, M., Artioli, F., Di Leo, A., Romito, S., Maestri, A., Giannitto Giorgio, C., Ionta, M. T., Verderame, F., Zampa, G., Numico, G., Minelli, M., Tagliaferri, P., Foa, P., Palmiotti, G., De Placido, S., Mattioli, R., Iuliano, F., Defraia, E., Siena, S., Clerico, M., Salvagno, L., Ceresoli, G. L., Bernardo, A., Di Lieto, M., Moroni, M., Maisano, M., Scartozzi, M., Scagliotti, G., Soraru, M., Pepe, S., Scaltriti, A., Gebbia, V., Testa, E., Lorusso, V., Bordonaro, R., De Signoribus, G., Tedde, N., Santoro, A., Francini, G., Aondio, G., De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, and Bidoli, P

Subjects
0301 basic medicine, Male, expanded access programme, nivolumab, real-world experience, renal cell cancer, Antineoplastic Agent, 0302 clinical medicine, Antineoplastic Agents, Immunological, 80 and over, Sunitinib, Medicine, Urology, Aged, 80 and over, Sulfonamides, Brain Neoplasms, Kidney Neoplasm, Common Terminology Criteria for Adverse Events, Middle Aged, Kidney Neoplasms, Progression-Free Survival, Survival Rate, Everolimu, Immunological, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Retreatment, Female, Nivolumab, medicine.drug, Human, Adult, medicine.medical_specialty, Indazoles, metastatic renal cancer, Response Evaluation Criteria in Solid Tumor, Antineoplastic Agents, Bone Neoplasms, Bone Neoplasm, expanded access programme, nivolumab, real-world experience, renal cell cancer, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Agents, Immunological, Bone Neoplasms, Brain Neoplasms, Carcinoma, Renal Cell, Everolimus, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Nivolumab, Progression-Free Survival, Pyrimidines, Response Evaluation Criteria in Solid Tumors, Retreatment, Sulfonamides, Sunitinib, Survival Rate, Sulfonamide, Pazopanib, Brain Neoplasm, 03 medical and health sciences, Aged, Carcinoma, Renal Cell, Everolimus, Humans, Pyrimidines, Internal medicine, Progression-free survival, Survival rate, business.industry, Carcinoma, Renal Cell, 030104 developmental biology, Pyrimidine, Expanded access, business
Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Published
2019

2. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial

Author

Imazio, M, Belli, R, Ferrazzi, P, Finkelstein, Y, Leggieri, A, Maisch, B, Mayosi, B, Oh, JK, Ristic, AD, Seferovic, P, Adler, Y, Hoit, B, Spodick, DH, Pullara, A, Brucato, A, Cugola, D, Cumetti, D, Innocente, F, Valenti, A, Galletti, L, Comoglio, C, Dyrda, O, Trimboli, S, Lardone, E, Sorrentino, P, Biagio, I, Valesio, R, Zeoli, A, Chinaglia, A, Cecchi, E, Coda, L, Demichelis, B, Ferro, S, Forno, D, Barosi, A, Gandino, A, Martinelli, L, Flocco, R, Casabona, R, Chirillo, F, Scorsin, M, Olivari, Z, Polesel, E, Polizzi, V, Belmonte, E, Musumeci, F, Pergolini, A, Cemin, R, Graffigna, A, Ferrua, S, Varbella, F, Caforio, AL, Tarzia, V, Iliceto, S, Gerosa, G, Costanzo, P, Minelli, M., BRUCATO, ANTONIO LUCA, MAESTRONI, SILVIA, GIANNATTASIO, CRISTINA, SORMANI, PAOLA, Imazio, M, Belli, R, Brucato, A, Ferrazzi, P, Finkelstein, Y, Leggieri, A, Maisch, B, Mayosi, B, Oh, J, Ristic, A, Seferovic, P, Adler, Y, Hoit, B, Spodick, D, Pullara, A, Cugola, D, Cumetti, D, Maestroni, S, Innocente, F, Valenti, A, Galletti, L, Comoglio, C, Dyrda, O, Trimboli, S, Lardone, E, Sorrentino, P, Biagio, I, Valesio, R, Zeoli, A, Chinaglia, A, Cecchi, E, Coda, L, Demichelis, B, Ferro, S, Forno, D, Barosi, A, Gandino, A, Martinelli, L, Giannattasio, C, Sormani, P, Flocco, R, Casabona, R, Chirillo, F, Scorsin, M, Olivari, Z, Polesel, E, Polizzi, V, Belmonte, E, Musumeci, F, Pergolini, A, Cemin, R, Graffigna, A, Ferrua, S, Varbella, F, Caforio, A, Tarzia, V, Iliceto, S, Gerosa, G, Costanzo, P, and Minelli, M

Subjects
Male, medicine.medical_specialty, Pleural effusion, Gastrointestinal Diseases, postoperative AF, Placebo, Pericardial Effusion, Perioperative Care, colchicine, postpericardiotomy syndrome, Postoperative Complications, Double-Blind Method, Atrial Fibrillation, medicine, Humans, Cardiac Surgical Procedures, Adverse effect, Aged, business.industry, General Medicine, Postpericardiotomy syndrome, Number needed to harm, Perioperative, MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE, Middle Aged, COPPS-2 Investigator, medicine.disease, Tubulin Modulators, 3. Good health, Cardiac surgery, Pleural Effusion, Anesthesia, Number needed to treat, Female, business
Abstract

IMPORTANCE: Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE: To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS: Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients ≥70 kg or 0.5 mg once daily in patients

Published
2014

3. Adherence issues related to sublingual immunotherapy as perceived by allergists

Author

Scurati, S., Frati, F., Passalacqua, G., Puccinelli, P., Hilaire, C., Incorvaia, C., D Avino, G., Comi, R., Lo Schiavo, M., Pezzuto, F., Montera, C., Pio, A., Teresa Ielpo, M., Cellini, F., Vicentini, L., Pecorari, R., Aresu, T., Capra, L., Benedictis, E., Bombi, C., Zauli, D., Vanzi, A., Alberto Paltrinieri, C., Bondioli, A., Paletta, I., Ventura, D., Mei, F., Paolini, F., Colangelo, C., Cavallucci, E., Cucinelli, F., Tinari, R., Ermini, G., Beltrami, V., Novembre, E., Begliomini, C., Marchese, E., Solito, E., Ammannati, V., Molino, G., Galli, E., Baldassini, M., Di Michele, L., Calvani, M., Gidaro, M., Venuti, A., Li Bianchi, E., Benassi, F., Pocobelli, D., Zangari, P., Rocco, M. G., Lo Vecchio, A., Pingitore, G., Grimaldi, O., Schiavino, D., Perrone, N., Antonietta Frieri, M., Di Rienzo, V., Tripodi, S., Scarpa, A., Tomsic, M., Bonaguro, R., Enrico Senna, G., Sirena, A., Turatello, F., Crescioli, S., Favero, E., Billeri, L., Chieco Bianchi, F., Gemignani, C., Zanforlin, M., Angiola Crivellaro, M., Hendrick, B., Maltauro, A., Masieri, S., Elisabetta Conte, M., Fama, M., Pozzan, M., Bonadonna, P., Casanova, S., Vallerani, E., Schiappoli, M., Borghesan, F., Giro, G., Casotto, S., Berardino, L., Zanoni, G., Ariano, R., Aquilina, R., Pellegrino, R., Marsico, P., Del Giudice, A., Narzisi, G., Tomaselli, V., Fornaca, G., Favro, M., Loperfido, B., Gallo, C., Buffoni, S., Gani, F., Raviolo, P., Faggionato, S., Truffelli, T., Vivalda, L., Albano, M., Enzo Rossi, R., Lattuada, G., Bona, F., Quaglio, L., Chiesa, A., Trapani, M., Seminara, R., Cucchi, B., Oderda, S., Borio, G., Galeasso, G., Garbaccio, P., Marco, A., Marengo, F., Cadario, G., Manzoni, S., Vinay, C., Curcio, A., Silvestri, A., Peduto, A., Riario-Sforza, G. G., Maria Forgnone, A., Barocelli, P., Tartaglia, N., Feyles, G., Giacone, A., Ricca, V., Guida, G., Nebiolo, F., Bommarito, L., Heffler, E., Vietti, F., Galimberti, M., Savi, E., Pappacoda, A., Bottero, P., Porcu, S., Felice, G., Berra, D., Francesca Spina, M., Pravettoni, V., Calamari, A. M., Varin, E., Iemoli, E., Lietti, D., Ghiglioni, D., Alessandro Fiocchi, Tosi, A., Poppa, M., Caviglia, A., Restuccia, M., Russello, M., Alciato, P., Manzotti, G., Ranghino, E., Luraschi, G., Rapetti, A., Rivolta, F., Allegri, F., Terracciano, L., Agostinis, F., Paolo Piras, P., Ronchi, G., Gaspardini, G., Caria, V., Tolu, F., Fantasia, D., Carta, P., Moraschini, A., Quilleri, R., Santelli, A., Prandini, P., Del Giudice, G., Apollonio, A., Bonazza, L., Teresa Franzini, M., Branchi, S., Zanca, M., Rinaldi, S., Catelli, L., Zanoletti, T., Cosentino, C., Della Torre, F., Cremonte, L., Musazzi, D., Suli, C., Rivolta, L., Ottolenghi, A., Marino, G., Sterza, G., Sambugaro, R., Orlandini, A., Minale, P., Voltolini, S., Bignardi, D., Omodeo, P., Tiri, A., Milani, S., Ronchi, B., Licardi, G., Bruni, P., Scibilia, J., Schroeder, J., Crosti, F., Maltagliati, A., Alesina, M. R., Mosca, M., Leone, G., Napolitano, G., Di Gruttola, G., Scala, G., Mascio, S., Valente, A., Marchetiello, I., Catello, R., Gazulli, A., Del Prete, A., Varricchio, A. M., Carbone, A., Forestieri, A., Stillitano, M., Leonetti, L., Tirroni, E., Castellano, F., Abbagnara, F., Romano, F., Levanti, C., Cilia, M., Longo, R., Ferrari, A., Merenda, R., Di Ponti, A., Guercio, E., Surace, L., Ammendola, G., Tansella, F., Peccarisi, L., Stragapede, L., Minenna, M., Granato, M., Fuiano, N., Pannofino, A., Ciuffreda, S., Giannotta, A., Morero, G., D Oronzio, L., Taddeo, G., Nettis, E., Cinquepalmi, G., Lamanna, C., Mastrandrea, F., Minelli, M., Salamino, F., Muratore, L., Latorre, F., Quarta, C., Ventura, M., D Ippolito, G., Giannoccaro, F., Dambra, P., Pinto, L., Triggiani, M., Munno, G., Manfredi, G., Lonero, G., Damiano, V., Errico, G., Di Leo, E., Manzari, F., Spagna, V., Arsieni, A., Matarrese, A., Mazzarella, G., Scarcia, G., Scarano, R., Ferrannini, A., Pastore, A., Maionchi, P., Filannino, L., Tria, M., Giuliano, G., Damiani, E., Scichilone, N., Marchese, M., Lucania, A., Marino, M., Strazzeri, L., Tumminello, S., Vitale, G. I., Gulotta, S., Gragotto, G., Zambito, M., Greco, D., Valenti, G., Licitra, G., Cannata, E., Filpi, R., Contraffatto, M., Sichili, S., Randazzo, S., Scarantino, G., Lo Porto, B., Pavone, F., Di Bartolo, C., Paternò, A., Rapisarda, F., Laudani, E., Leonardi, S., Padua, V., Cabibbo, G., Marino Guzzardi, G., Deluca, F., Agozzino, C., Pettinato, R., Ghini, M., Scurati S., Frati F., Passalacqua G., Puccinelli P., Hilaire C., Incorvaia C., D'Avino G., Comi R., Lo Schiavo M., Pezzuto F., Montera C., Pio A., Teresa Ielpo M., Cellini F., Vicentini L., Pecorari R., Aresu T., Capra L., De Benedictis E., Bombi C., Zauli D., Vanzi A., Alberto Paltrinieri C., Bondioli A., Paletta I., Ventura D., Mei F., Paolini F., Colangelo C., Cavallucci E., Cucinelli F., Tinari R., Ermini G., Beltrami V., Novembre E., Begliomini C., Marchese E., Solito E., Ammannati V., Molino G., Galli E., Baldassini M., Di Michele L., Calvani M., Gidaro M., Venuti A., Li Bianchi E., Benassi F., Pocobelli D., Zangari P., De Rocco M.G., Lo Vecchio A., Pingitore G., Grimaldi O., Schiavino D., Perrone N., Antonietta Frieri M., Di Rienzo V., Tripodi S., Scarpa A., Tomsic M., Bonaguro R., Enrico Senna G., Sirena A., Turatello F., Crescioli S., Favero E., Billeri L., Chieco Bianchi F., Gemignani C., Zanforlin M., Angiola Crivellaro M., Hendrick B., Maltauro A., Masieri S., Elisabetta Conte M., Fama M., Pozzan M., Bonadonna P., Casanova S., Vallerani E., Schiappoli M., Borghesan F., Giro G., Casotto S., Berardino L., Zanoni G., Ariano R., Aquilina R., Pellegrino R., Marsico P., Del Giudice A., Narzisi G., Tomaselli V., Fornaca G., Favro M., Loperfido B., Gallo C., Buffoni S., Gani F., Raviolo P., Faggionato S., Truffelli T., Vivalda L., Albano M., Enzo Rossi R., Lattuada G., Bona F., Quaglio L., Chiesa A., Trapani M., Seminara R., Cucchi B., Oderda S., Borio G., Galeasso G., Garbaccio P., De Marco A., Marengo F., Cadario G., Manzoni S., Vinay C., Curcio A., Silvestri A., Peduto A., Riario-Sforza G.G., Maria Forgnone A., Barocelli P., Tartaglia N., Feyles G., Giacone A., Ricca V., Guida G., Nebiolo F., Bommarito L., Heffler E., Vietti F., Galimberti M., Savi E., Pappacoda A., Bottero P., Porcu S., Felice G., Berra D., Francesca Spina M., Pravettoni V., Calamari A.M., Varin E., Iemoli E., Lietti D., Ghiglioni D., Fiocchi A., Tosi A., Poppa M., Caviglia A., Restuccia M., Russello M., Alciato P., Manzotti G., Ranghino E., Luraschi G., Rapetti A., Rivolta F., Allegri F., Terracciano L., Agostinis F., Paolo Piras P., Ronchi G., Gaspardini G., Caria V., Tolu F., Fantasia D., Carta P., Moraschini A., Quilleri R., Santelli A., Prandini P., Del Giudice G., Apollonio A., Bonazza L., Teresa Franzini M., Branchi S., Zanca M., Rinaldi S., Catelli L., Zanoletti T., Cosentino C., Della Torre F., Cremonte L., Musazzi D., Suli C., Rivolta L., Ottolenghi A., Marino G., Sterza G., Sambugaro R., Orlandini A., Minale P., Voltolini S., Bignardi D., Omodeo P., Tiri A., Milani S., Ronchi B., Licardi G., Bruni P., Scibilia J., Schroeder J., Crosti F., Maltagliati A., Alesina M.R., Mosca M., Leone G., Napolitano G., Di Gruttola G., Scala G., Mascio S., Valente A., Marchetiello I., Catello R., Gazulli A., Del Prete A., Varricchio A.M., Carbone A., Forestieri A., Stillitano M., Leonetti L., Tirroni E., Castellano F., Abbagnara F., Romano F., Levanti C., Cilia M., Longo R., Ferrari A., Merenda R., Di Ponti A., Guercio E., Surace L., Ammendola G., Tansella F., Peccarisi L., Stragapede L., Minenna M., Granato M., Fuiano N., Pannofino A., Ciuffreda S., Giannotta A., Morero G., D'Oronzio L., Taddeo G., Nettis E., Cinquepalmi G., Lamanna C., Mastrandrea F., Minelli M., Salamino F., Muratore L., Latorre F., Quarta C., Ventura M., D'Ippolito G., Giannoccaro F., Dambra P., Pinto L., Triggiani M., Munno G., Manfredi G., Lonero G., Damiano V., Errico G., Di Leo E., Manzari F., Spagna V., Arsieni A., Matarrese A., Mazzarella G., Scarcia G., Scarano R., Ferrannini A., Pastore A., Maionchi P., Filannino L., Tria M., Giuliano G., Damiani E., Scichilone N., Marchese M., Lucania A., Marino M., Strazzeri L., Tumminello S., Vitale G.I., Gulotta S., Gragotto G., Zambito M., Greco D., Valenti G., Licitra G., Cannata E., Filpi R., Contraffatto M., Sichili S., Randazzo S., Scarantino G., Lo Porto B., Pavone F., Di Bartolo C., Paterno A., Rapisarda F., Laudani E., Leonardi S., Padua V., Cabibbo G., Marino Guzzardi G., Deluca F., Agozzino C., Pettinato R., Ghini M., Scurati S, Frati F, Passalacqua G, Puccinelli P, Hilaire C, Incorvaia I, D'Avino G, Comi R, Lo Schiavio M, Pezzuto F, Montera C, Pio A, Ielpo MT, Cellini F, Vicentini L, Pecorari R, Aresu T, Capra L, De Benedictis E, Bombi C, Zauli D, and et al

Subjects
medicine.medical_specialty, Pathology, genetic structures, efficacy, Alternative medicine, Medicine (miscellaneous), Adherence, Cost, Efficacy, Side effects, Sublingual immunotherapy, Settore MED/10 - Malattie Dell'Apparato Respiratorio, sublingual immunotherapy, ALLERGEN, cost, medicine, Subcutaneous immunotherapy, Sublingual immunotherapy, adherence, Clinical efficacy, Intensive care medicine, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), sublingual immunoterapy, Original Research, Asthma, AEROALLERGENS, side effects, business.industry, Health Policy, medicine.disease, Slit, eye diseases, Clinical trial, Patient Preference and Adherence, immunotherapy, sense organs, Allergists, ADHERENCE TO TREATMENT, business, Social Sciences (miscellaneous)
Abstract

Silvia Scurati1, Franco Frati1, Gianni Passalacqua2, Paola Puccinelli1, Cecile Hilaire1, Cristoforo Incorvaia3, Italian Study Group on SLIT Compliance 1Scientific and Medical Department, Stallergenes, Milan, Italy; 2Allergy and Respiratory Diseases, Department of Internal Medicine, Genoa; 3Allergy/Pulmonary Rehabilitation, ICP Hospital, Milan, ItalyObjectives: Sublingual immunotherapy (SLIT) is a viable alternative to subcutaneous immunotherapy to treat allergic rhinitis and asthma, and is widely used in clinical practice in many European countries. The clinical efficacy of SLIT has been established in a number of clinical trials and meta-analyses. However, because SLIT is self-administered by patients without medical supervision, the degree of patient adherence with treatment is still a concern. The objective of this study was to evaluate the perception by allergists of issues related to SLIT adherence.Methods: We performed a questionnaire-based survey of 296 Italian allergists, based on the adherence issues known from previous studies. The perception of importance of each item was assessed by a VAS scale ranging from 0 to 10.Results: Patient perception of clinical efficacy was considered the most important factor (ranked 1 by 54% of allergists), followed by the possibility of reimbursement (ranked 1 by 34%), and by the absence of side effects (ranked 1 by 21%). Patient education, regular follow-up, and ease of use of SLIT were ranked first by less than 20% of allergists.Conclusion: These findings indicate that clinical efficacy, cost, and side effects are perceived as the major issues influencing patient adherence to SLIT, and that further improvement of adherence is likely to be achieved by improving the patient information provided by prescribers.Keywords: adherence, sublingual immunotherapy, efficacy, cost, side effects

Published
2010

4. Practice parameters for sublingual immunotherapy

Author

Ortolani, C., Agostinis, F., Amoroso, S., Ariano, R., Barbato, A., Bassi, M., Cadario, G., Campi, P., Cardinale, F., Ciprandi, G., D Anneo, R., Di Gioacchino, M., Di Rienzo, V., Fiocchi, A., Galimberti, M., Galli, E., Giovannini, M., Incorvaia, C., La Grutta, S., Lombardi, C., Marucci, F., Marseglia, G., Minelli, M., Musarra, A., Nettis, E., Novembre, E., Pajno, G., Patriarca, G., Pezzuto, F., Piras, P., Pucci, S., Romano, A., Romano, C., Quercia, O., Scala, G., Schiavino, D., Gianenrico Senna, Sforza, F., Tosca, M., Tripodi, S., and Frati, F.

Subjects
Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, Parietaria, Rhinitis, Allergic, Perennial, Time Factors, Administration, Sublingual, lcsh:Medicine, medicine.disease_cause, Allergen, rhinitis, Meta-Analysis as Topic, medicine, conjunctivitis, Humans, Sublingual immunotherapy, Child, Contraindication, Asthma, Conjunctivitis, Allergic, Skin Tests, Clinical Trials as Topic, Evidence-Based Medicine, biology, business.industry, lcsh:R, Rhinitis, Allergic, Seasonal, Allergens, Middle Aged, biology.organism_classification, medicine.disease, Slit, Dermatology, Surgery, Clinical trial, Positive response, Desensitization, Immunologic, Child, Preschool, Safety, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract

The efficacy and safety of sublingual immunotherapy (SLIT) are currently supported by clinical trials, metaanalysis and post-marketing surveys. Practice parameters for clinical use of SLIT are proposed here by a panel of Italian specialists, with reference to evidence based criteria. Indications to SLIT include allergic rhinoconjunctivitis, asthma, and isolated conjunctivitis (strength of recommendation: grade A). As to severity of the disease, SLIT is indicated in moderate/severe intermittent rhinitis, persistent rhinitis and mild to moderate asthma (grade D). SLIT may be safely prescribed also in children aged three to five years (grade B), and its use in subjects aged more than 60 years is not prevented when the indications and contraindication are ascertained (grade D). The choice of the allergen to be employed for SLIT should be made in accordance with the combination of clinical history and results of skin prick tests (grade D). Polysensitisation, i.e. the occurrence of multiple positive response does not exclude SLIT, which may be done with the clinically most important allergens (grade D). As to practical administration, co-seasonal, pre co-seasonal, and continuous schedules are available, being the latter recommended for perennial allergens or for pollens with particularly prolonged pollination, such as Parietaria (grade D). For pollens with relatively short pollination, such as grasses and trees (cypress, birch, alder, hazelnut, olive) the pre coseasonal and perennial schedules are preferred (grade C). The build-up phases suggested by manufacturers can be safely used (grade A), but they can be modified according to the patient’s tolerance (grade C). A duration of SLIT of 3-5 years is recommended to ensure a long-lasting clinical effect after the treatment has been terminated (grade C).

Published
2006

5. PANHER study: a 20-year treatment outcome analysis from a multicentre observational study of HER2-positive advanced breast cancer patients from the real-world setting

Author

Angela Maione, Nicola Tinari, Paola Pinnarò, Enzo Maria Ruggeri, Isabella Sperduti, Olivia Bacciu, Emanuela Risi, Icro Meattini, Federica Tomao, Luca Marchetti, Nicola D’Ostilio, Patrizia Vici, Lorenza Landi, Giuseppina Sarobba, Lucia Mentuccia, Elisabetta Landucci, Emilio Bria, A.F. Scinto, Gennaro Ciliberto, Laura Pizzuti, Elena Fiorio, Andrea Michelotti, Ida Paris, Simonetta Stani, Antonio Russo, Clara Natoli, Rosa Saltarelli, Alessandra Cassano, Paolo Marchetti, Maria Agnese Fabbri, Daniele Marinelli, Ferdinando Riccardi, Mauro Minelli, Corrado Ficorella, Anna Ceribelli, Maria Rosaria Valerio, Maddalena Barba, Jennifer Foglietta, Maria Mauri, Teresa Gamucci, Luca Moscetti, Beatrice Taurelli Salimbeni, Fabio Pelle, Daniele Santini, Andrea Botticelli, Vito Lorusso, Mirco Pistelli, Giacomo Barchiesi, Francesco Giotta, Eriseld Krasniqi, Antonino Grassadonia, Simone Scagnoli, Valentina Sini, Katia Cannita, Flavia Cavicchi, Michele De Tursi, Mimma Raffaele, Marco Mazzotta, Sonia Cappelli, Paola Scavina, Francesca Sofia Di Lisa, Giuliana D’Auria, Armando Orlandi, Marcello Maugeri-Saccà, Federico Cappuzzo, Claudio Botti, Nello Salesi, Lorenzo Livi, Beatrice Fratini, Giulia Bon, Silverio Tomao, Giuseppe Sanguineti, Enzo Veltri, Domenico Corsi, Enrico Cortesi, Rossana Berardi, Laura Iezzi, Rosalinda Rossi, Giuseppe Tonini, Elisabetta Maria Capomolla, Pizzuti L., Krasniqi E., Sperduti I., Barba M., Gamucci T., Mauri M., Veltri E.M., Meattini I., Berardi R., Di Lisa F.S., Natoli C., Pistelli M., Iezzi L., Risi E., D'Ostilio N., Tomao S., Ficorella C., Cannita K., Riccardi F., Cassano A., Bria E., Fabbri M.A., Mazzotta M., Barchiesi G., Botticelli A., D'Auria G., Ceribelli A., Michelotti A., Russo A., Salimbeni B.T., Sarobba G., Giotta F., Paris I., Saltarelli R., Marinelli D., Corsi D., Capomolla E.M., Sini V., Moscetti L., Mentuccia L., Tonini G., Raffaele M., Marchetti L., Minelli M., Ruggeri E.M., Scavina P., Bacciu O., Salesi N., Livi L., Tinari N., Grassadonia A., Fedele Scinto A., Rossi R., Valerio M.R., Landucci E., Stani S., Fratini B., Maugeri-Sacca M., De Tursi M., Maione A., Santini D., Orlandi A., Lorusso V., Cortesi E., Sanguineti G., Pinnaro P., Cappuzzo F., Landi L., Botti C., Tomao F., Cappelli S., Bon G., Pelle F., Cavicchi F., Fiorio E., Foglietta J., Scagnoli S., Marchetti P., Ciliberto G., and Vici P.

Subjects
Oncology, medicine.medical_specialty, Advanced breast, T-DM1, Treatment outcome, Lapatinib, Breast cancer, pertuzumab, Internal medicine, Medicine, lapatinib, RC254-282, advanced breast cancer, business.industry, Human epidermal growth factor, HER2-positive, sequence, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Cancer, medicine.disease, Observational study, Pertuzumab, business, medicine.drug
Abstract

Background: The evolution of therapeutic landscape of human epidermal growth factor receptor-2 (HER2)-positive breast cancer (BC) has led to an unprecedented outcome improvement, even if the optimal sequence strategy is still debated. To address this issue and to provide a picture of the advancement of anti-HER2 treatments, we performed a large, multicenter, retrospective study of HER2-positive BC patients. Methods: The observational PANHER study included 1,328 HER2-positive advanced BC patients treated with HER2 blocking agents since June 2000 throughout July 2020. Endpoints of efficacy were progression-free survival (PFS) and overall survival (OS). Results: Patients who received a first-line pertuzumab-based regimen showed better PFS ( p < 0.0001) and OS ( p = 0.004) than those receiving other treatments. Median PFS and mOS from second-line starting were 8 and 28 months, without significant differences among various regimens. Pertuzumab-pretreated patients showed a mPFS and a mOS from second-line starting not significantly affected by type of second line, that is, T-DM1 or lapatinib/capecitabine ( p = 0.80 and p = 0.45, respectively). Conversely, pertuzumab-naïve patients receiving second-line T-DM1 showed a significantly higher mPFS compared with that of patients treated with lapatinib/capecitabine ( p = 0.004). Median OS from metastatic disease diagnosis was higher in patients treated with trastuzumab-based first line followed by second-line T-DM1 in comparison to pertuzumab-based first-line and second-line T-DM1 ( p = 0.003), although these data might be partially influenced by more favorable prognostic characteristics of patients in the pre-pertuzumab era. No significant differences emerged when comparing patients treated with ‘old’ or ‘new’ drugs ( p = 0.43), even though differences in the length of the follow-up between the two cohorts should be taken into account. Conclusion: Our results confirmed a relevant impact of first-line pertuzumab-based treatment and showed lower efficacy of second-line T-DM1 in trastuzumab/pertuzumab pretreated, as compared with pertuzumab-naïve patients. Our findings may help delineate a more appropriate therapeutic strategy in HER2-positive metastatic BC. Prospective randomized trials addressing this topic are awaited.

Published
2021

6. Highly Permeable Fluorinated Polymer Nanocomposites for Plasmonic Hydrogen Sensing

Author

Christoph Langhammer, Kasper Moth-Poulsen, Marianne Liebi, Manuel Guizar-Sicairos, Giacomo Foli, Barbara Berke, Amir Masoud Pourrahimi, Robson da Silva, Christian Müller, Ida Östergren, Matteo Minelli, Iwan Darmadi, Vincenzo Palermo, Sarah Lerch, Alicja Stolaś, Ostergren I., Pourrahimi A.M., Darmadi I., Da Silva R., Stolas A., Lerch S., Berke B., Guizar-Sicairos M., Liebi M., Foli G., Palermo V., Minelli M., Moth-Poulsen K., Langhammer C., and Muller C.

Subjects
Materials science, palladium nanoparticle, Hydrogen, Nanoparticle, chemistry.chemical_element, Context (language use), Nanotechnology, 02 engineering and technology, 010402 general chemistry, 01 natural sciences, fluorinated polymer, Hydrogen economy, General Materials Science, melt-processed nanocomposite, Plasmon, chemistry.chemical_classification, Nanocomposite, business.industry, Polymer, 021001 nanoscience & nanotechnology, 0104 chemical sciences, Amorphous solid, plasmonic sensing, chemistry, hydrogen permeability and diffusion, 0210 nano-technology, business, Research Article
Abstract

Hydrogen (H2) sensors that can be produced en masse with cost-effective manufacturing tools are critical for enabling safety in the emerging hydrogen economy. The use of melt-processed nanocomposites in this context would allow the combination of the advantages of plasmonic hydrogen detection with polymer technology; an approach which is held back by the slow diffusion of H2 through the polymer matrix. Here, we show that the use of an amorphous fluorinated polymer, compounded with colloidal Pd nanoparticles prepared by highly scalable continuous flow synthesis, results in nanocomposites that display a high H2 diffusion coefficient in the order of 10-5 cm2 s-1. As a result, plasmonic optical hydrogen detection with melt-pressed fluorinated polymer nanocomposites is no longer limited by the diffusion of the H2 analyte to the Pd nanoparticle transducer elements, despite a thickness of up to 100 μm, thereby enabling response times as short as 2.5 s at 100 mbar (≡10 vol. %) H2. Evidently, plasmonic sensors with a fast response time can be fabricated with thick, melt-processed nanocomposites, which paves the way for a new generation of robust H2 sensors.

Published
2021

7. Transient vs enduring distress in late pregnancy using the EPDS: a brief longitudinal exploratory study

Author

Silvia Bonapace, Stephen Matthey, Marianna Minelli, Francesca Agostini, Sara Dellabartola, Agostini F., Matthey S., Minelli M., Dellabartola S., and Bonapace S.

Subjects
Adult, medicine.medical_specialty, Weakness, Exploratory research, perinatal depression, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Intervention (counseling), medicine, transient distress, Humans, Edinburgh Postnatal Depression Scale, Longitudinal Studies, General Psychology, Psychiatric Status Rating Scales, Pregnancy, 030219 obstetrics & reproductive medicine, Depression, Obstetrics, business.industry, Obstetrics and Gynecology, enduring distre, Middle Aged, medicine.disease, Mental health, 030227 psychiatry, Pregnancy Complications, Distress, Reproductive Medicine, Pediatrics, Perinatology and Child Health, Female, pregnancy, medicine.symptom, business, Stress, Psychological, Perinatal Depression
Abstract

Background and Objective: The Edinburgh Postnatal Depression Scale (EPDS) is widely used to detect perinatal distress in women by one single administration. Recently, research has shown that during early pregnancy around half of the women scoring as 'possibly depressed' on the EPDS only have transient distress, when re-tested after few weeks. This finding may not occur if women are screened later in pregnancy, as their worries then may be more enduring; therefore an exploratory study was conducted to further investigate this issue. Methods: Pregnant women (N = 84) attending a public hospital in Italy completed the EPDS in their third trimester (x = 33 weeks) and again 8-42 days later (while still pregnant). They had not received professional mental health intervention in this time interval. Results: Approximately half of the women who initially scored high on the EPDS in late pregnancy no longer scored high just a few weeks later. Conclusions: Approximately half of women who initially score high on the EPDS when screened in pregnancy only have transient distress in both the second and third trimester. To label these women as being 'possibly depressed', and mixing them with women who show enduring distress, represents a possible weakness in research studies, and may also overburden clinical services. We would therefore recommend, as research and clinical practice, a second administration of the EPDS if a woman initially scores in the distressed range at any stage in pregnancy.

Published
2019

8. Depression and Objectively Measured Physical Activity: A Systematic Review and Meta-Analysis

Author

Stefano Cacitti, Mirko Minelli, Lorenzo Blandi, Vincenza Gianfredi, Anna Odone, Carlo Signorelli, Andrea Amerio, Gianfredi, V., Blandi, L., Cacitti, S., Minelli, M., Signorelli, C., Amerio, A., and Odone, A.

Subjects
Male, medicine.medical_specialty, SYMPTOMS, Health, Toxicology and Mutagenesis, MEDLINE, lcsh:Medicine, Poison control, Review, PsycINFO, Cochrane Library, CANCER SURVIVORS, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, QUALITY-OF-LIFE, Injury prevention, Prevalence, medicine, Humans, 030212 general & internal medicine, Exercise, Depression (differential diagnoses), ASSOCIATIONS, Depression, Physical activity, business.industry, Accelerometer, Depressive symptoms, Meta-analysis, Objectively measure, lcsh:R, SEDENTARY BEHAVIOR, Public Health, Environmental and Occupational Health, ADULTS, LIGHT, Cross-Sectional Studies, Systematic review, Physical therapy, MODERATE, Female, business, MENTAL-HEALTH, 030217 neurology & neurosurgery
Abstract

Depression is a major contributor to the overall global burden of disease, with high prevalence and relapse rate. Several factors have been considered in order to reduce the depression burden. Among them, physical activity (PA) showed a potential protective role. However, evidence is contrasting probably because of the differences in PA measurement. The aim of this systematic review with meta-analysis is to assess the association between objectively measured PA and incident and prevalent depression. The systematic review was conducted according to methods recommended by the Cochrane Collaboration and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Relevant papers published through 31 August 2019 were identified searching through the electronic databases PubMed/MEDLINE, Excerpta Medica dataBASE (Embase), PsycINFO, Scopus, Web of Science (WoS), and the Cochrane Library. All analyses were conducted using ProMeta3. Finally, 42 studies met inclusion criteria. The overall Effect size (ES) of depression for the highest vs. the lowest level of PA was −1.16 [(95% CI = −1.41; −0.91), p-value < 0.001] based on 37,408 participants. The results of the meta-analysis showed a potential protective effect of PA on prevalent and incident depression.

Published
2020
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