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1. European Position Paper on Rhinosinusitis and Nasal Polyps 2020

Author

Fokkens, Wytske, Lund, Valerie, Hopkins, Claire, Hellings, Peter, Kern, Robert, Reitsma, Sietze, Toppila- Salmi, Sanna, Bernal-Sprekelsen, Manuel, Mullol, Joaquim, Alobid, Isam, Anselmo- Lima, Wilma Terezinha, Bachert, Claus, Baroody, Fuad, von Buchwald, Christian, Cervin, Anders, Cohen, Noam, Constantinidis, Jannis, De Gabory, Ludovic, Desrosiers, Martin, Diamant, Zuzana, Douglas, Richard, Gevaert, Philippe, Hafner, Anita, Harvey, Richard, Joos, Guy, Kalogjera, Livije, Knill, Andrew, Kocks, Janwillem, Landis, Basile, Limpens, Jacqueline, Lebeer, Sarah, Lourenco, Olga, Matricardi, Paolo, Meco, Cem, O’Mahony, Liam, Philpott, Carl, Ryan, Dermot, Schlosser, Rodney, Senior, Brent, Smith, Timothy, Teeling, Thijs, Tomazic, Peter Valentin, Wang, De Yun, Wang, Dehui, Zhang, Luo, Agius, Adrian, Ahlström-Emanuelsson, Cecilia, Alabri, Rashid, Albu, Silviu, Alhabash, Saied, Aleksic, Aleksandra, Aloulah, Mohammad, Al- Qudah, Mohannad, Alsaleh, Saad, Baban, Muaid Aziz, Baudoin, Tomislav, Balvers, Tijmen, Battaglia, Paolo, Bedoya, Juan David, Beule, Achim, Bofares, Khaled, Braverman, Itzhak, Brozek-Madry, Eliza, Byaruhanga, Richard, Callejas, Claudio, Carrie, Sean, Caulley, Lisa, Chussi, Desderius, de Corso, Eugenio, Coste, Andre, El Hadi, Usama, Elfarouk, Ahmed, Eloy, Philippe, Farrokhi, Shokrollah, Felisati, Giovanni, Ferrari, Michel, Fishchuk, Roman, Grayson, Jessica, Goncalves, Paulo, Grdinic, Boris, Grgic, Velimir, Hamizan, Aneeza, Heinichen, Julio, Husain, Salina, Ing Ping, Tang, Ivaska, Justinas, Jakimovska, Frodita, Jovancevic, Ljiljana, Kakande, Emily, Kamel, Reda, Karpischenko, Sergei, Kariyawasam, Harsha, Kawauchi, Hideyuki, Kjeldsen, Anette, Klimek, Ludger, Krzeski, Antoni, Kopacheva Barsova, Gabriela, Wam Kim, Sung, Lal, Devyani, Letort, José, Lopatin, Andrey, Mahdjoubi, Abdelhak, Mesbahi, Alireza, Netkovski, Jane, Nyenbue Tshipukane, Dieudonné, Obando-Valverde, Andrés, Okano, Mitsuhiro, Onerci111, Metin, Ong, Yew Kwang, Orlandi, Richard, Otori, Nobuyoshi, Ouennoughy, Kheir, Ozkan, Muge, Peric, Aleksandar, Plzak, Jan, Prokopakis, Emmanuel, Prepageran, Nerayanan, Psaltis, Alkis, Pugin, Benoit, Raftopulos, Marco, Rombaux, Philippe, Riechelmann, Herbert, Sahtout, Semia, Sarafoleanu, Caius-Codrut, Searyoh, Kafui, Rhee, Chae-Seo, Shi, Jianbo, Shkoukani, Mahdi, Shukuryan, Arthur, Sicak, Marian, Smyth, David, Snidvongs, Kornkiat, Soklic Kosak, Tanja, Stjärne, Pär, Sutikno, Budi, Steinsvåg, Sverre, Tantilipikorn, Pongsakorn, Thanaviratananich, Sanguansak, Tran, Thuy, Urbancic, Jure, Valiulis, Arunas, Vasquez de Aparicio, Carolina, Vicheva, Dilyana, Virkkula, Paula, Vicente, Gil, Voegels, Richard, Wagenmann, Martin, Wardani, Retno, Welge-Lussen, Antje, Witterick, Ian, Wright, Erin, Zabolotniy, Dmytro, Zsolt, Bella, Zwetsloot, Casper, HUS Inflammation Center, Department of Dermatology, Allergology and Venereology, University of Helsinki, Korva-, nenä- ja kurkkutautien klinikka, HUS Head and Neck Center, uBibliorum, Faculteit Medische Wetenschappen/UMCG, Fokkens, Wytske J., UCL - (MGD) Service d'oto-rhino-laryngologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service d'oto-rhino-laryngologie, Ear, Nose and Throat, and AII - Inflammatory diseases

Subjects
Adult, medicine.medical_specialty, Evidence-based practice, Rhinosinusitis, MEDLINE, Therapeutics, PLACEBO-CONTROLLED TRIAL, 03 medical and health sciences, 0302 clinical medicine, Nasal Polyps, QUALITY-OF-LIFE, Diagnosis, paranasal sinus diseases, nasal polyps, therapeutics, diagnosis, asthma, prevention, control, Paranasal Sinus Diseases, Humans, Medicine, Nasal polyps, ENDOSCOPIC-SINUS-SURGERY, 3125 Otorhinolaryngology, ophthalmology, Sinusitis, Prevention and Control, Child, 030223 otorhinolaryngology, Intensive care medicine, UPPER RESPIRATORY-TRACT, TERM-FOLLOW-UP, Rhinitis, Science & Technology, business.industry, General Medicine, Guideline, Evidence-based medicine, RANDOMIZED CONTROLLED-TRIAL, medicine.disease, ACUTE MAXILLARY SINUSITIS, Asthma, 3. Good health, Integrated care, CHURG-STRAUSS-SYNDROME, Otorhinolaryngology, Acute Disease, Chronic Disease, Position paper, PRIMARY CILIARY DYSKINESIA, Human medicine, business, ALLERGIC FUNGAL RHINOSINUSITIS, Life Sciences & Biomedicine
Abstract

The European Position Paper on Rhinosinusitis and Nasal Polyps 2020 is the update of similar evidence based position papers published in 2005 and 2007 and 2012. The core objective of the EPOS2020 guideline is to provide revised, up-to-date and clear evidence-based recommendations and integrated care pathways in ARS and CRS. EPOS2020 provides an update on the literature published and studies undertaken in the eight years since the EPOS2012 position paper was published and addresses areas not extensively covered in EPOS2012 such as paediatric CRS and sinus surgery. EPOS2020 also involves new stakeholders, including pharmacists and patients, and addresses new target users who have become more involved in the management and treatment of rhinosinusitis since the publication of the last EPOS document, including pharmacists, nurses, specialised care givers and indeed patients themselves, who employ increasing self-management of their condition using over the counter treatments. The document provides suggestions for future research in this area and offers updated guidance for definitions and outcome measurements in research in different settings. EPOS2020 contains chapters on definitions and classification where we have defined a large number of terms and indicated preferred terms. A new classification of CRS into primary and secondary CRS and further division into localized and diffuse disease, based on anatomic distribution is proposed. There are extensive chapters on epidemiology and predisposing factors, inflammatory mechanisms, (differential) diagnosis of facial pain, allergic rhinitis, genetics, cystic fibrosis, aspirin exacerbated respiratory disease, immunodeficiencies, allergic fungal rhinosinusitis and the relationship between upper and lower airways. The chapters on paediatric acute and chronic rhinosinusitis are totally rewritten. All available evidence for the management of acute rhinosinusitis and chronic rhinosinusitis with or without nasal polyps in adults and children is systematically reviewed and integrated care pathways based on the evidence are proposed. Despite considerable increases in the amount of quality publications in recent years, a large number of practical clinical questions remain. It was agreed that the best way to address these was to conduct a Delphi exercise . The results have been integrated into the respective sections. Last but not least, advice for patients and pharmacists and a new list of research needs are included. The full document can be downloaded for free on the website of this journal: http://www.rhinologyjournal.com. ispartof: RHINOLOGY vol:58 issue:Suppl S29 pages:I-+ ispartof: location:Netherlands status: published

Published
2020

2. Afatinib vs placebo as adjuvant therapy after chemoradiotherapy in squamous cell carcinoma of the head and neck : a randomized clinical trial

Author

Burtness, Barbara, Haddad, Robert, Dinis, Jose, Trigo, Jose, Yokota, Tomoya, de Viana, Luciano Souza, Romanov, Ilya, Vermorken, Jan Baptist, Bourhis, Jean, Tahara, Makoto, Martins Segalla, Jose Getulio, Psyrri, Amanda, Vasilevskaya, Irina, Nangia, Chaitali Singh, Chaves-Conde, Manuel, Kiyota, Naomi, Homma, Akihiro, Holeckova, Petra, Del Campo, Josep Maria, Asarawala, Nirav, Nicolau, Ulisses Ribaldo, Rauch, Daniel, Even, Caroline, Wang, Bushi, Gibson, Neil, Ehrnrooth, Eva, Harrington, Kevin, Cohen, Ezra E. W., Eduardo Giglio, Raul, Raul Blajman, Cesar, Mario Freue, Jose, Graciela Pilnik, Norma, Salvador Palazzo, Felipe, McGrath, Margaret, Fureder, Thorsten, Kornek, Gabriela, Pichler, Angelika, Bauernhofer, Thomas, Tinchon, Christoph, Greil, Richard, Burian, Martin, Kienzer, Heinz, Specenier, Pol, Sautois, Brieuc, Debruyne, Philip, Graas, Marie-Pascale, Maes, Annelies, Lonchay, Christophe, Daisne, Jean-Francois, Fontaine, Christel, Castro Junior, Gilberto, de Oliveira, Frias, Pereira, Rodrigo Perez, Martins De Marchi, Pedro Rafael, Lazaretti, Nicolas Silva, Kulkarni, Swati, Alam, Yasmin, Ho, Cheryl, Shenouda, George, Soulieres, Denis, Sultanem, Khalil, Singh, Simron, Gonzalez Mella, Pablo, Solis Campos, Jose Antonio, Prausova, Jana, Obermannova, Radka, Friborg, Jeppe, Specht, Lena, Elsaid, Amr Abdelaziz, Minn, Heikki, Martin, Laurent, Rolland, Frederic, Ceruse, Philippe, Calais, Gilles, Guigay, Joe, Ferte, Charles, Peyrade, Frederic, Duffaud, Florence, Champeaux-Orange, Elise, Coutte, Alexandre, Clatot, Florian, Fournel, Pierre, Le Moal, Laurence Bozec, Dietz, Andreas, Gruenwald, Viktor, Gauler, Thomas, Guntinas-Lichius, Orlando, Hildebrandt, Guido, Kuhnt, Thomas, Schmidt, Horst-Juergen, Henke, Michael, Rueckert, Anja, Brugger, Wolfram, Rotter, Nicole, Mahlberg, Rolf, Karavasilis, Vasilios, Fountzilas, Georgios, Psyrri, Diamanto, Lang, Istvan, Boer, Andras, Kocsis, Judit, Pajkos, Gabor, Tamas, Laszlo, Anand, A. L., Sharma, Ajay, Sharma, Voona, Murali, Pandy, Ananda Selvakumar, Kumar, Kirushna, Nathan, Raj Kumar Poovna, Srinivasan, Venkatesan, Zade, Bhooshan, Jain, Minish, Srinivasa, B. J., Naik, Radheshyam, Mohanty, B. K., Charas, Tomer, Billan, Salem, Popovtzer, Aron, Licitra, Lisa, Ferrari, Daris, Fao, Paolo, Merlano, Marco, Rocca, Maria Cossu, Fujii, Hirofumi, Minami, Syujiro, Fujii, Masato, Kadowaki, Shigenori, Muro, Kei, Okami, Kenji, Yagi, Toshinari, Yoshino, Kunitoshi, Matsumoto, Koji, Takahashi, Shunji, Matsuura, Kazuto, Alvarez Avitia, Miguel Angel, Gonzalez Riestra, Hector Jorge, van Meerten, E., Buter, J., Gelderblom, A. J., Kawecki, Andrzej, Golusinski, Wojciech, Dinis, Rui, Ribeiro, Leonor, Silva, Regina, Mansinho, Helder, Selezneva, Irina, Biakhov, Mikhail, Galiulin, Rinat, Izmailov, Adel, Vladimirov, Vladimir, Vinogradov, Valery, Mufazalov, Fagim, Baste, Neus, Ma del Campo, Josep, Mesia Nin, Ricard, Lopez Pousa, Antonio, Jose Grau de Castro, Juan, Reig, Oscar, Vera, Ruth, Trigo, JoseManuel, Iglesias, Lara, Martinez Trufero, Javier, Vazquez, Sergio, Rubio, Belen, Enrique Ales, Jose, Villar, Esther, Rubio, Jordi, Escobar, Yolanda, Soria, Ainara, Chaves, Mauel, Johansson, Gun Wickart, Friesland, Signe, Tell, Roger, Nyman, Jan, Rothschild, Sacha, Zippelius, Alfred, Usluoglu, Nurguel, Gogunska, Inna, Zabolotniy, Dmytro, Vinnyk, Yuriy, Burian, Oleksandr, Sykes, Andrew, Peel, David, Lester, James, Robinson, Martin, Srinivasan, Devraj, Fragkandrea-Nixon, Ioanna, Junor, Elizabeth, Gollins, Simon, Evans, Mererid, Newbold, Kate, Hwang, David, Schipani, Stefano, Rizwanullah, Mohammed, Atiq, Omar, Arnaoutakis, Konstantinos, Bauman, Jessica, Mehra, Ranee, Kang, Hyunseok, Chung, Christine, Davis, Thomas, Jimeno, Antonio, Keresztes, Roger, Nangia, Chaitali, Ignatius, Sai-Hong, Su, Yungpo Bernard, Overton, Lindsay Carol, Garrison, Mitchell A., Jeong, Woondong, Wehbe, Ahmad, Argiris, Athanassios, Chiang, Anne, Morgensztern, Daniel, Haigentz, Missak, Jr., Martincic, Danko, Porosnicu, Mercedes, LUX-HEAD & Neck 2 Investigators, Medical Oncology, and Boehringer Ingelheim Fonds

Subjects
Oncology, Cancer Research, medicine.medical_specialty, animal structures, Afatinib, Population, Medizin, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, mental disorders, medicine, Adjuvant therapy, Clinical endpoint, 030212 general & internal medicine, education, 610 Medicine & health, Original Investigation, education.field_of_study, business.industry, food and beverages, medicine.disease, Head and neck squamous-cell carcinoma, 030220 oncology & carcinogenesis, bacteria, sense organs, Human medicine, business, Chemoradiotherapy, medicine.drug
Abstract

LUX-Head & Neck 2 investigators., [Importance] Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC., [Objective] To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC., [Design, Setting, and Participants] This multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population., [Interventions] Patients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal., [Main Outcomes and Measures] The primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life., [Results] A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group)., [Conclusions and Relevance] This study’s findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended., [Trial Registration] ClinicalTrials.gov identifier: NCT01345669., The study was funded by Boehringer Ingelheim.

Published
2019

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