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Title: | Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial | Authors: | Burtness, Barbara Haddad, Robert Dinis, Jose Trigo, Jose Yokota, Tomoya Viana, Luciano de Souza Romanov, Ilya Vermorken, Jan 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 Viana, Luciano de Souza Martins Segalla, Jose Getulio Nicolau, Ulisses Ribaldo Lazaretti, Nicolas Silva Kulkarni, Swati Alam, Yasmin Ho, Cheryl Shenouda, George Soulieres, Denis Sultanem, Khalil Singh, Simron Gonzalez Mella, Pablo Solis Campos, Jose Antonio Holeckova, Petra Prausova, Jana Obermannova, Radka Friborg, Jeppe Specht, Lena Elsaid, Amr Abdelaziz Minn, Heikki Martin, Laurent Rolland, Frederic Ceruse, Philippe Calais, Gilles Even, Caroline 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, Anshula 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. Asarawala, Nirav Charas, Tomer Billan, Salem Popovtzer, Aron Licitra, Lisa Ferrari, Daris Fao, Paolo Merlano, Marco Rocca, Maria Cossu Homma, Akihiro Fujii, Hirofumi Tahara, Makoto Minami, Syujiro Fujii, Masato Yokota, Tomoya Kadowaki, Shigenori Muro, Kei Kiyota, Naomi 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, Jose Dinis, Rui Ribeiro, Leonor Silva, Regina Mansinho, Helder Selezneva, Irina Biakhov, Mikhail Galiulin, Rinat Izmailov, Adel Romanov, Ilya Vladimirov, Vladimir Vinogradov, Valery Mufazalov, Fagim Vasilevskaya, Irina 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 Rauch, Daniel Usluoglu, Nurguel Gogunska, Inna Zabolotniy, Dmytro Vinnyk, Yuriy Burian, Oleksandr Harrington, Kevin 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 Burtness, Barbara Mehra, Ranee Kang, Hyunseok Chung, Christine Davis, Thomas Haddad, Robert 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 |
Issue Date: | 2019 | Publisher: | AMER MEDICAL ASSOC | Source: | JAMA ONCOLOGY, 5(8), p. 1170-1180 | Abstract: | ImportanceLocoregionally 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. ObjectiveTo assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC. Design, Setting, and ParticipantsThis 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. InterventionsPatients 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 MeasuresThe 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. ResultsA 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 RelevanceThis 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 RegistrationClinicalTrials.gov identifier: NCT01345669 | Notes: | [Burtness, Barbara] Yale Univ, Sch Med, Dept Med, 333 Cedar St, New Haven, CT 06520 USA. [Burtness, Barbara] Yale Univ, Sch Med, Yale Canc Ctr, 333 Cedar St, New Haven, CT 06520 USA. [Haddad, Robert] Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA. Inst Portugues Oncol Francisco Gentil, Porto, Portugal. [Trigo, Jose] Hosp Virgen de la Victoria, IBIMA, Dept Med Oncol, Malaga, Spain. [Yokota, Tomoya] Shizuoka Canc Ctr, Div Gastrointestinal Oncol, Shizuoka, Japan. [Viana, Luciano de Souza] Hosp Marcio Cunha, Dept Med Oncol, Ipatinga, Brazil. [Romanov, Ilya] Russian Oncol Res Ctr, Moscow, Russia. [Vermorken, Jan] Antwerp Univ Hosp, Dept Med Oncol, Edegem, Belgium. [Bourhis, Jean] CHU Vaudois, Dept Oncol, Lausanne, Switzerland. [Tahara, Makoto] Natl Canc Ctr Hosp East, Dept Head & Neck Med Oncol, Kashiwa, Chiba, Japan. [Martins Segalla, Jose Getulio] Hosp Amaral Carvalho, Dept Clin Oncol, Jau, Brazil. Univ Athens, Attikon Univ Hosp, Dept Internal Med, Athens, Greece. [Vasilevskaya, Irina] Oncol Ctr Moskovskiy, St Petersburg, Russia. [Nangia, Chaitali] Univ Calif Irvine, Ctr Comprehens Canc, Orange, CA 92668 USA. [Chaves-Conde, Manuel] Hosp Virgen del Rocio, Dept Oncol, Seville, Spain. [Kiyota, Naomi] Kobe Univ Hosp, Canc Ctr, Dept Med Oncol & Hematol, Kobe, Hyogo, Japan. [Homma, Akihiro] Hokkaido Univ, Fac Med, Sapporo, Hokkaido, Japan. [Homma, Akihiro] Hokkaido Univ, Grad Sch Med, Sapporo, Hokkaido, Japan. [Holeckova, Petra] Hosp Bulovce, Dept Radiotherapy & Oncol, Prague, Czech Republic. [Holeckova, Petra] Charles Univ Prague, Med Fac 1, Prague, Czech Republic. [Del Campo, Josep Maria] Vall dHebron Univ Hosp, Dept Oncol, Barcelona, Spain. [Asarawala, Nirav] Shree Krishna Hosp & Med Res Ctr, Anand, Gujarat, India. [Nicolau, Ulisses Ribaldo] AC Camargo Canc Ctr, Dept Clin Oncol, Sao Paulo, Brazil. [Rauch, Daniel] Univ Hosp Bern, Inselspital, Bern, Switzerland. [Even, Caroline] Gustave Roussy, Dept Head & Neck Canc, Villejuif, France. [Wang, Bushi] Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT USA. [Gibson, Neil] Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany. [Ehrnrooth, Eva] Boehringer Ingelheim Danmark AS, Kalundborg, Denmark. [Harrington, Kevin] Royal Marsden Hosp, Inst Canc Res, Natl Inst Hlth Res Biomed Res Ctr, Div Radiotherapy & Imaging, London, England. [Cohen, Ezra E. W.] Univ Calif San Diego, Moores Canc Ctr, Dept Translat Sci, La Jolla, CA 92093 USA. [Eduardo Giglio, Raul] Univ Buenos Aires, Inst Oncol Angel H Roffo, Buenos Aires, DF, Argentina. [Raul Blajman, Cesar] Isis Ctr Especializado Luce SA, Urquiza, Santa Fe, Argentina. [Mario Freue, Jose] Ctr Estudio & Tratamiento Efermedades Neoplas, Brandsen, Villa Dominico, Argentina. [Graciela Pilnik, Norma] Clin Colombo, Cordoba, Argentina. [Salvador Palazzo, Felipe] Ctr Oncol CAIPO, San Miguel De Tucuman, Tucuman, Argentina. 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[Rolland, Frederic] CLCC Nantes Atlantique, Ctr Rene Gauducheau, Serv Oncol Med, St Herblain, France. [Ceruse, Philippe] Ctr Hosp Lyon Sud, Pierre Benite, France. [Calais, Gilles] CHRU Tours, Hop Bretonneau, Tours, France. [Even, Caroline; Guigay, Joe] Inst Gustave Roussy, Serv Hospitalisat, Dept Cancerol Cervico Faciale, Villejuif, France. [Ferte, Charles] Inst Gustave Roussy, Villejuif, France. [Peyrade, Frederic] Ctr Antoine Lacassagne CRLCC Nice Cote dAzur, Nice, France. [Duffaud, Florence] Hop La Timone, AP HM, Marseille, France. [Champeaux-Orange, Elise] CHR Orleans Source, Cellule Essais Clin, Orleans, France. [Coutte, Alexandre] CHU Amiens Hop, Oncol RDC, Sud Batiment, Salouel, France. [Clatot, Florian] Ctr Hosp Becquerel Rouen, Rouen, France. [Fournel, Pierre] Inst Cancerol Lucien Neuwirth, St Priest En Jarez, France. [Le Moal, Laurence Bozec] Ctr Lutte Canc Rene Huguenin, St Cloud, France. [Dietz, Andreas] Univ Klinikum Leipzig, Leipzig, Germany. [Gruenwald, Viktor] Hannover Med Sch, Hannover, Germany. [Gauler, Thomas] Univ Klinikum Essen, Essen, Germany. [Guntinas-Lichius, Orlando] Univ Klinikum Jena, HNO Klin, Jena, Germany. [Hildebrandt, Guido; Kuhnt, Thomas] Univ Klinikum Rostock, Rostock, Germany. [Schmidt, Horst-Juergen] Westpfalz Klinikum, HNO Klin, Kaiserslautern, Germany. [Henke, Michael] Univ Klinikum Freiburg, Freiburg, Germany. [Rueckert, Anja] Schwarzwald Baar Klinikum, Villingen Schwenningen, Germany. [Brugger, Wolfram] Schwarzwald Baar Klinikum, Klin Hamatol Onkol Infektiol & Immunol, Villingen Schwenningen, Germany. [Rotter, Nicole] Univ Klin, Ulm, Germany. [Rotter, Nicole] Hsch Ambulanz HNO Heilkunde, Ulm, Germany. [Mahlberg, Rolf] Klinikum Mutterhaus Borromaerinnen gGmbH, Innere Med 1, Trier, Germany. [Fountzilas, Georgios] Aristoteleio Univ Thessaloniki, Gen Hosp Thessaloniki Papageorgiou, Thessaloniki, Greece. [Psyrri, Diamanto] Gen Hosp Athens Attiko B, Chaidari, Germany. [Lang, Istvan] Natl Inst Oncol B Internal Med, Budapest, Hungary. [Boer, Andras] Natl Inst Oncol, Budapest, Hungary. [Kocsis, Judit] Univ Debrecen, Debrecen, Hungary. [Pajkos, Gabor] Bacs Kiskun Cty Hosp, Kecskemet, Hungary. [Tamas, Laszlo] Semmelweis Univ, Budapest, Hungary. [Anand, A. L.] Max Superspecial Hosp, Max Canc Ctr, New Delhi, India. [Sharma, Ajay; Sharma] Sardar Patel Med Coll & Associated Grp Hosp, Acharya Tulsi Reg Canc Treatment & Res Inst, Bikaner, Rajasthan, India. [Voona, Murali] Mahatma Gandhi Canc Res Inst, Vishakapatnam, India. [Pandy, Ananda Selvakumar; Kumar, Kirushna] Meenakshi Mission Hosp & Res Ctr, Madurai, Tamil Nadu, India. [Nathan, Raj Kumar Poovna; Srinivasan, Venkatesan] Kamakshi Mem Hosp, Chennai, Tamil Nadu, India. [Zade, Bhooshan; Jain, Minish] Ruby Hall Clin, Pune, Maharashtra, India. [Srinivasa, B. J.; Naik, Radheshyam] Triesta Sci, Bangalore Inst Oncol, Bangalore, Karnataka, India. [Mohanty, B. 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[Dinis, Jose] Inst Portugues Oncol Porto Francisco Gentil, Serv Med Oncol, Porto, Portugal. [Dinis, Rui] Hosp Espirito Santo, Evora, Portugal. [Ribeiro, Leonor] Ctr Hosp Lisboa Norte, Hosp Santa Maria, Lisbon, Portugal. [Silva, Regina] Inst Portugues Oncol Coimbra Francisco Gentil, Serv Oncol Med, Coimbra, Portugal. [Mansinho, Helder] Hosp Garcia Orta, Almada, Portugal. [Selezneva, Irina; Biakhov, Mikhail] Semashko Cent Clin Hosp 2, Moscow, Russia. [Galiulin, Rinat] Clin Oncol Ctr, Omsk, Russia. [Izmailov, Adel] Bashkiria State Med Univ, Sterlitamak, Russia. [Romanov, Ilya] Russian Oncol Res Ctr, Moscow, Russia. [Vladimirov, Vladimir] GUZ Pyatigorsky Oncol Dispensary, Pyatigorsk, Russia. [Vinogradov, Valery] Russian Res Ctr Radiol & Surg Technol, St Petersburg, Russia. [Mufazalov, Fagim] Republican Clin Oncol Ctr, Ufa, Russia. [Vasilevskaya, Irina] Oncol Ctr Moskovskiy, St Petersburg, Russia. [Baste, Neus; Ma del Campo, Josep] Vall dHebron Univ Hosp, Barcelona, Spain. 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[Nyman, Jan] Sahlgrens Univ Hosp, Gothenburg, Sweden. [Rothschild, Sacha; Zippelius, Alfred] Univ Spital Basel, Basel, Switzerland. [Rauch, Daniel; Usluoglu, Nurguel] Inselspital Bern, Bern, Switzerland. [Gogunska, Inna; Zabolotniy, Dmytro] Natl Acad Med Sci Ukraine, OS Kolomiychenko Inst Otolaryngol, Kiev, Ukraine. [Vinnyk, Yuriy; Burian, Oleksandr] Kharkiv Reg Clin Oncol Ctr, Kharkov, Ukraine. [Harrington, Kevin] Royal Marsden Hosp, Inst Canc Res, Natl Inst Hlth Res Biomed Res Ctr, London, England. [Sykes, Andrew] Christie NHS Fdn Trust, Manchester, Lancs, England. [Peel, David] Univ Hosp Leicester NHS Hosp Trust, Leicester Royal Infirm, Leicester, Leics, England. [Lester, James; Robinson, Martin] Sheffield Teaching Hosp NHS Fdn Trust, Weston Pk Hosp, Sheffield, S Yorkshire, England. [Srinivasan, Devraj; Fragkandrea-Nixon, Ioanna; Junor, Elizabeth] NHS Lothian Western Gen Hosp, Edinburgh Canc Ctr, Edinburgh, Midlothian, Scotland. [Gollins, Simon] Glan Clwyd Gen Hosp, North Wales Canc Treatment Ctr, Rhyl, Wales. [Evans, Mererid] Velindre NHS Trust, Velindre Canc Ctr, Cardiff, S Glam, Wales. [Newbold, Kate] Royal Marsden NHS Fdn Trust, Sutton, Surrey, England. [Hwang, David] Royal Devon & Exeter NHS Fdn Trust, Royal Devon & Exeter Hosp, Exeter, Devon, England. [Schipani, Stefano; Rizwanullah, Mohammed] Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland. [Atiq, Omar] Univ Arkansas Med Sci, Little Rock, AR 72205 USA. [Burtness, Barbara; Bauman, Jessica; Mehra, Ranee] Fox Chase Canc Ctr, 7701 Burholme Ave, Philadelphia, PA 19111 USA. [Kang, Hyunseok; Chung, Christine] Johns Hopkins Univ, Baltimore, MD USA. [Davis, Thomas] Dartmouth Hitchcock Med Ctr, Lebanon, NH 03766 USA. [Haddad, Robert] Dana Farber Canc Inst, Boston, MA 02115 USA. [Jimeno, Antonio] Univ Colorado, Canc Ctr, Aurora, CO USA. [Keresztes, Roger] SUNY Stony Brook, Canc Ctr, Stony Brook, NY 11794 USA. [Nangia, Chaitali; Ignatius, Sai-Hong] UC Irvine Med Ctr, Chao Family Comprehens Canc Ctr, Orange, CA USA. [Su, Yungpo Bernard] Nebraska Methodist Hosp, Omaha, NE USA. [Overton, Lindsay Carol; Garrison, Mitchell A.] Wenatchee Valley Hosp & Clin, Wenatchee, WA USA. [Jeong, Woondong; Wehbe, Ahmad; Argiris, Athanassios] Univ Texas Hlth Sci Ctr San Antonio, San Antonio, TX 78229 USA. [Chiang, Anne; Morgensztern, Daniel] Yale Univ, Smilow Canc Hosp Yale New Haven, New Haven, CT USA. [Haigentz, Missak, Jr.] Montefiore Med Ctr, Albert Einstein Coll Med, Bronx, NY 10467 USA. [Martincic, Danko] Canc Care Northwest, Spokane Valley, WA USA. [Porosnicu, Mercedes] Wake Forest Baptist Hlth, Winston Salem, NC USA. | Document URI: | http://hdl.handle.net/1942/29129 | ISSN: | 2374-2437 | e-ISSN: | 2374-2445 | DOI: | 10.1001/jamaoncol.2019.1146 | ISI #: | 000480303500014 | Rights: | 2019 American Medical Association. All rights reserved | Category: | A1 | Type: | Journal Contribution |
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