Y
Yasuharu Nakahara
Publications - 10
Citations - 3684
Yasuharu Nakahara is an academic researcher. The author has contributed to research in topics: Medicine & Population. The author has an hindex of 4, co-authored 4 publications receiving 1844 citations.
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Journal ArticleDOI
Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial
Tony Mok,Yi-Long Wu,Iveta Kudaba,Dariusz M. Kowalski,Byoung Chul Cho,Hande Turna,Gilberto de Castro,Vichien Srimuninnimit,Konstantin Laktionov,Igor Bondarenko,Igor Bondarenko,Kaoru Kubota,Gregory M. Lubiniecki,Jin Zhang,Debra Kush,Gilberto Lopes,Gonzalo Gomez Aubin,Luis Enrique Fein,Diego Kaen,Ruben Dario Kowalyszyn,Guillermo Lerzo,Gaston Martinengo,Matias Molina,Eduardo Richardet,Pablo Picon,Mirta Varela,J. J. Zarba,Sergio J Azevedo,Carlos H. Barrios,Carlos Beato,Carlos Alexandre Sydow Cerny,Pedro Rafael Martins De Marchi,Gustavo Fernandes,Fabio Franke,Helano C. Freitas,Gustavo Girotto,Valeria Lopes,Lucas Vieira dos Santos,Marcos Andre Costa,Andrea Kazumi Shimada,Oren Smaletz,Joao Paulo Holanda Soares,Ana Paula Victorino,Carlos Ferreira,Marchela Koleva,Krassimir Koynov,Rumyana Micheva,Tsvetan Deliverski,Zhasmina Milanova,Boyan Doganov,Susanna Cheng,Flavia De Angelis,Giovanna Speranza,Rosalyn A. Juergens,Doran Ksienski,David Fenton,Osvaldo Rudy Aren,Christian Caglevic,Hector Galindo,Felipe Rey,Jianhua Chang,Gongyan Chen,Xi Chen,Xuenong Ouyang,Ying Cheng,Zhenyu Ding,Mei Hou,Yun Fan,Jifeng Feng,Jianxing He,Yong He,Yi Hu,Wei Li,Xiaoqing Liu,Zhe Liu,Shun Lu,Shukui Qin,Qiyou Tang,Bu-Hai Wang,Kai Wang,Li Zhang,Xin Zhang,Jun Zhao,Jie Wang,Caicun Zhou,Jianying Zhou,Qing Zhou,Andrés F. Cardona,Ricardo Duarte,Luis Gomez Wolff,Angela Zambrano,Marcela Vallejo,Libor Havel,Vitezslav Kolek,Petr Kolman,Leona Koubkova,Lubos Petruzelka,Patrice Popelkova,Jaromir Roubec,Jaroslav Vanasek,Tomas Vlasek,Jana Jaal,Gerli Kuusk,Oscar Avendano,Hugo Castro,Karla Lopez,Mario Sandoval,Chung Man James Ho,Sing Hung Lo,Ibolya Laczó,Bela Piko,Gyula Ostoros,Keisuke Aoe,Yasuhito Fujisaka,Tomonori Hirashima,Atsushi Horiike,Yukio Hosomi,Katsuyuki Hotta,Masao Ichiki,Fumio Imamura,Yasuo Iwamoto,Kazuo Kasahara,Nobuyuki Katakami,Terufumi Kato,Shuji Murakami,Tomoya Kawaguchi,Kazuma Kishi,Takayasu Kurata,Yoshitaro Torii,Yasuharu Nakahara,Takashi Nishimura,Tatsuo Ohira,Hideo Saka,Toshiyuki Sawa,Nobuhiko Seki,Shunichi Sugawara,Kazuhisa Takahashi,Nagio Takigawa,Hiroshi Tanaka,Kazuhiko Yamada,Takuma Yokoyama,Toshihide Yokoyama,Hiroshige Yoshioka,Gunta Purkalne,Zinaida Stara,Alvydas Cesas,Saulius Cicenas,Marius Zemaitis,Soon Hin How,Chong-Kin Liam,Choo Khoon Ong,Lye Mun Tho,Oscar Arrieta Rodriguez,Carlos Hernandez Hernandez,Luis Mas,Luis Vera,Jorge Salas,Hermes Tejada,Regina Edusma-Dy,Christina Galvez,Guia Ladrera,Jerry Tan Chun Bing,Jacek Jassem,Ewa Kalinka-Warzocha,Boguslawa Karaszewska,Andrzej Kazarnowicz,Krzysztof Lesniewski Kmak,Rodryg Ramlau,António Araújo,Fernando Barata,Nuno Gil,Venceslau Hespanhol,A. Alexandru,Mircea Dediu,Nelly Cherciu,Daniel Ciurescu,Doina Ganea,Lucian Miron,Daniela Sirbu,Maria Turdean,Sergey Emelyanov,Nina Karaseva,Lyudmila Kuzina,Sergey Lazarev,Igor Dmitrievich Lifirenko,Larisa Bolotina,Oleg Lipatov,Elena Ovchinnikova,Marina Matrosova,Anna Alyasova,Artem Poltoratsky,Pavel Taranov,Oleg Zarubenkov,Graham Cohen,Lydia Dreosti,Freddy Seolwane,Jacqueline Hall,Gregory Hart,Christa Jordaan,Sayeuri Buddu,Michiel Botha,Gregory Landers,Bernardo Rappaport,Paul Ruff,Lucinda Shepherd,Waldemar Szpak,Myung-Ju Ahn,Joo Hang Kim,Per Bergstrom,Ronny Ohman,Hakan Griph,Daniel Betticher,Adrian F. Ochsenbein,Alfred Zippelius,Gee Chen Chan,Chao Hua Chiu,Te Chun Hsia,Wu Chou Su,Chih-Hsin Yang,Touch Ativitavas,Pongwut Danchaivijitr,Kasan Seetalarom,Aumkhae Sookprasert,Virote Sriuranpong,Ozden Altundag,Filiz Cay Senler,Mustafa Erman,Tuncay Göksel,Erdem Göker,Ozgur Ozyilkan,Mesut Seker,Mahmut Gumus,Fulden Yumuk,Grigory Adamchuk,Oleksandr Ivashchuk,Olga Ponomarova,Andrii Rusyn,Sergii Shevnya,Yaroslav Shparyk,Ivan Sinielnikov,Orest Andrusenko,Dmytro Trukhyn,Grygoriy Ursol,Ihor Vynnychenko,Tien Quang Nguyen,Xuan Dung Pham +245 more
TL;DR: Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations, and the benefit-to-risk profile suggests that first-line pembrology monotherapy can be extended as first line therapy for locally advanced or metastatic non-small-cell lung cancer patients with sensitising EGFR or ALK translocation.
Journal ArticleDOI
Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial
Luis Paz-Ares,M. Dvorkin,Y. Chen,Niels Reinmuth,Katsuyuki Hotta,D. Trukhin,Galina Statsenko,Maximilian Hochmair,Mustafa Ozguroglu,J.H. Ji,Oleksandr Voitko,A. Poltoratskiy,Santiago Ponce,Francesco Verderame,Libor Havel,Igor Bondarenko,Andrzej Kazarnowicz,György Losonczy,Nikolay Conev,Jon Armstrong,N. Byrne,Norah J. Shire,Haiyi Jiang,Jonathan W. Goldman,Emilio Batagelj,Ignacio Casarini,Anea Viviana Pastor,Susana Noemi Sena,J. J. Zarba,Otto C. Burghuber,Sylvia Hartl,Bernd Lamprecht,Michael Studnicka,Luis Alberto Schlittler,Fabricio Augusto Martinelli de Oliveira,Aknar Calabrich,Gustavo Girotto,Peo Dos Reis,Carlos Fausto Nino Gorini,Peo Rafael Martins De Marchi,Clarissa Serodio da Rocha Baldotto,Claudia Sette,Mauro Zukin,Assen Dudov,Rumyana Ilieva,Krassimir Koynov,Rositsa Krasteva,Ivan Tonev,Spartak Valev,Violetka Venkova,Minghong Bi,Chengshui Chen,Yuan Chen,Zhendong Chen,Jian Fang,Jifeng Feng,Zhigang Han,Jie Hu,Yi Hu,Wei Li,Zongan Liang,Zhong Lin,Rui Ma,Shenglin Ma,Kejun Nan,Yongqian Shu,Kai Wang,Mengzhao Wang,Gang Wu,Nong Yang,Zhixiong Yang,Helong Zhang,Wei Zhang,Jun Zhao,Yanqiu Zhao,Caicun Zhou,Jianying Zhou,Xiangdong Zhou,Vitezslav Kolek,Leona Koubkova,Jaromir Roubec,Jana Skrickova,Milada Zemanova,Christos Chouaid,Werner Hilgers,Hervé Lena,Denis Moro-Sibilot,Gilles Robinet,Pierre-Jean Souquet,Jürgen Alt,Helge Bischoff,Christian Grohe,E. Laack,Susanne Lang,Jens Panse,Christian Schulz,Krisztina Bogos,Eszter Csánky,Anea Fülöp,Zsolt Horváth,Judit Kósa,Ibolya Laczó,Gábor Pajkos,Zsuzsanna Papai,Zsolt Pápai Székely,Veronika Sárosi,Attila Somfay,Éva Somogyiné Ezer,Anás Telekes,Jair Bar,Maya Gottfried,Norman Isaac Heching,Alona Zer Kuch,Roberta Bartolucci,Anna Cecilia Bettini,Angelo Delmonte,Marina Chiara Garassino,Mauro Minelli,F. Roila,Shinji Atagi,Koichi Azuma,Hisatsugu Goto,Koichi Goto,Yu Hara,Hidetoshi Hayashi,Toyoaki Hida,Kenya Kanazawa,Shintaro Kanda,Young Hak Kim,Shoichi Kuyama,Tadashi Maeda,Masahiro Morise,Yasuharu Nakahara,Makoto Nishio,Naoyuki Nogami,Isamu Okamoto,Haruhiro Saito,Masahiro Shinoda,Shigeki Umemura,Tatsuya Yoshida,Niels Claessens,Robin Cornelissen,Lizza Heniks,Jeroen Hiltermann,Egbert F. Smit,Agnes Staal van den Brekel,Dariusz M. Kowalski,Slawomir Mandziuk,Robert Mróz,Marek Z. Wojtukiewicz,Tudor Ciuleanu,Doina Ganea,Anei Ungureanu,Alexander Luft,Vladimir Moiseenko,Dina Sakaeva,Alexey Smolin,Alexander Vasilyev,Lyubov Vladimirova,Igor Anasina,Jozef Chovanec,Pavol Demo,Robert Godal,Peter Kasan,Marian Stresko,Michal Urda,Eun Kyung Cho,Joo Hang Kim,Sang-We Kim,Gyeong-Won Lee,Jongmin Lee,Ki Hyeong Lee,Kyung Hee Lee,Yun Gyoo Lee,Maria Amelia Insa Molla,Manuel Domine Gomez,Juan Ignacio Delgado Mingorance,Dolores Isla Casado,Marta Lopez Brea,Margarita Majem Tarruella,Teresa Morán Bueno,Alejano Navarro Mendivil,Luis Paz-Ares Rodríguez,Santiago Ponce Aix,Maria Rosario Garcia Campelo,Gee-Chen Chang,Yen-Hsun Chen,Chao-Hua Chiu,Te Chun Hsia,Kang-Yun Lee,Chien-Te Li,Chin-Chou Wang,Yu-Feng Wei,Shang-Yin Wu,Ahmet Alacacioglu,Irfan Cicin,Ahmet Demirkazik,Mustafa Erman,Tuncay Göksel,Hryhoriy Adamchuk,Oleksii Kolesnik,Anna Kryzhanivska,Yuriv Ostapenko,Serhii Shevnia,Yaroslav Shparyk,Grygorii Ursol,Nataliia Voitko,Ihor Vynnychenko,Sunil Babu,Anne Chiang,Winston Chua,Shaker R. Dakhil,Afshin Dowlati,Basir Haque,Rodney Jamil,Jeanna Knoble,Shailena Lakhanpal,Kailhong Mi,Petros Nikolinakos,Steven Francis Powell,Helen Ross,Eric Schaefer,Jeffrey Schneider,Joseph Spahr,David R. Spigel,Joseph Stilwill,Christopher Sumey,M. Williamson +227 more
TL;DR: First-line durvalumab plus platinum-etoposide significantly improved overall survival in patients with ES-SCLC versus a clinically relevant control group and safety findings were consistent with the known safety profiles of all drugs received.
Journal ArticleDOI
Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial.
Kazuhiko Nakagawa,Edward B Garon,Takashi Seto,Makoto Nishio,Santiago Ponce Aix,Luis Paz-Ares,Chao-Hua Chiu,Keunchil Park,Silvia Novello,Ernest Nadal,Fumio Imamura,Kiyotaka Yoh,Jin-Yuan Shih,Kwok Hung Au,Denis Moro-Sibilot,Sotaro Enatsu,Annamaria Zimmermann,Bente Frimodt-Moller,Carla Visseren-Grul,Martin Reck,Quincy Chu,Alexis B. Cortot,Jean-Louis Pujol,Elizabeth Fabre,Corinne Lamour,Helge Bischoff,Jens Kollmeier,M Kimmich,Walburga Engel-Riedel,Stefan Hammerschmidt,Wolfgang Schütte,Konstantinos N. Syrigos,James Chung-Man Ho,Kwok-Hung Au,Andrea Ardizzoni,Giulia Pasello,Vanessa Gregorc,Alessandro Del Conte,Domenico Galetta,Toshiaki Takahashi,Toru Kumagai,Katsuyuki Hotta,Yasushi Goto,Yukio Hosomi,Hiroshi Sakai,Yuichi Takiguchi,Young Hak Kim,Takayasu Kurata,Hiroyuki Yamaguchi,Haruko Daga,Isamu Okamoto,Miyako Satouchi,Satoshi Ikeda,Kazuo Kasahara,Shinji Atagi,Koichi Azuma,Keisuke Aoe,Yoshitsugu Horio,Nobuyuki Yamamoto,Hiroshi Tanaka,Satoshi Watanabe,Naoyuki Nogami,Tomohiro Ozaki,Ryo Koyama,Tomonori Hirashima,Hiroyasu Kaneda,Keisuke Tomii,Yuka Fujita,Masahiro Seike,Naoki Nishimura,Terufumi Kato,Masao Ichiki,Hideo Saka,Katsuya Hirano,Yasuharu Nakahara,Shunichi Sugawara,Sang-We Kim,Young Joo Min,Hyun Woo Lee,Jin-Hyoung Kang,Ho Jung An,Ki Hyeong Lee,Jin Soo Kim,Gyeong-Won Lee,Sung Yong Lee,A. Alexandru,Anghel Adrian Udrea,Óscar Juan-Vidal,Ernest Nadal-Alforja,Ignacio Gil-Bazo,Santiago Ponce-Aix,Belén Rubio-Viqueira,Miriam Alonso Garcia,Enriqueta Felip Font,Jose Fuentes Pradera,Juan Coves Sarto,Meng-Chih Lin,Wu Chou Su,Te Chun Hsia,Gee-Chen Chang,Yu-Feng Wei,Jian Su,Irfan Cicin,Tuncay Göksel,Hakan Harputluoglu,Ozgur Ozyilkan,Ivo Henning,Sanjay Popat,Olivia Hatcher,Kathryn Mileham,Jared Acoba,Edward B. Garon,Gabriel Jung,Moses Sundar Raj,William J. Martin,Shaker R. Dakhil +115 more
TL;DR: The RELAY trial as mentioned in this paper evaluated erlotinib, an EGFR tyrosine kinase inhibitor (TKI) standard of care, plus ramucirumab, a human IgG1 VEGFR2 antagonist, or placebo in patients with untreated EGFR-mutated metastatic NSCLC.
Journal ArticleDOI
Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial.
Jonathan W. Goldman,Mikhail Dvorkin,Y. Chen,Niels Reinmuth,Katsuyuki Hotta,D. Trukhin,Galina Statsenko,Maximilian J Hochmair,Mustafa Ozguroglu,J.H. Ji,Marina Chiara Garassino,Oleksandr Voitko,A. Poltoratskiy,Santiago Ponce,Francesco Verderame,Libor Havel,Igor Bondarenko,Andrzej Kazarnowicz,György Losonczy,Nikolay Conev,Jon Armstrong,N. Byrne,P. Thiyagarajah,Haiyi Jiang,Luis Paz-Ares,Nataliia Voitko,Nikolay Conev,Maximilian Hochmair,Otto C. Burghuber,Irfan Cicin,Vladimir Moiseenko,Mustafa Erman,Dariusz M. Kowalski,Marek Z. Wojtukiewicz,Hryhoriy Adamchuk,Alexander Vasilyev,Serhii Shevnia,Spartak Valev,Maria Amelia Insa Molla,Grygorii Ursol,Anne Chiang,Sylvia Hartl,Zsolt Horváth,Gábor Pajkos,Sang-We Kim,Alexey Smolin,Tuncay Göksel,Shaker R. Dakhil,Jaromir Roubec,Krisztina Bogos,Robin Cornelissen,Jongmin Lee,Maria Rosario Garcia Campelo,Marta Lopez Brea,Ahmet Alacacioglu,Ignacio Casarini,Rumyana Ilieva,Ivan Tonev,Attila Somfay,Jair Bar,Alona Zer Kuch,Mauro Minelli,Roberta Bartolucci,F. Roila,Haruhiro Saito,Koichi Azuma,Gyeong-Won Lee,Alexander Luft,Michal Urda,Juan Ignacio Delgado Mingorance,Margarita Majem Tarruella,David R. Spigel,Krassimir Koynov,Milada Zemanova,Jens Panse,Christian Schulz,Zsolt Pápai Székely,Veronika Sárosi,Angelo Delmonte,Anna Cecilia Bettini,Makoto Nishio,Isamu Okamoto,Lizza Hendriks,Slawomir Mandziuk,Yun Gyoo Lee,Lyubov Vladimirova,Dolores Isla Casado,Manuel Domine Gomez,Alejandro Navarro Mendivil,Teresa Morán Bueno,Shang-Yin Wu,Jeanna Knoble,Jana Skrickova,Violetka Venkova,Werner Hilgers,E. Laack,Helge Bischoff,Andrea Fülöp,Ibolya Laczó,Judit Kósa,Andras Telekes,Tatsuya Yoshida,Shintaro Kanda,Toyoaki Hida,Hidetoshi Hayashi,Tadashi Maeda,Tetsuji Kawamura,Yasuharu Nakahara,Niels Claessens,Ki Hyeong Lee,Chao-Hua Chiu,Sheng-Hao Lin,Chien-Te Li,Ahmet Demirkazik,Eric Schaefer,Petros Nikolinakos,Jeffrey Schneider,Sunil Babu,Bernd Lamprecht,Michael Studnicka,Carlos Fausto Nino Gorini,Juraj Kultan,Vitezslav Kolek,Pierre-Jean Souquet,Denis Moro-Sibilot,Maya Gottfried,Egbert F. Smit,Kyung Hee Lee,Peter Kasan,Jozef Chovanec,Olexandr Goloborodko,Oleksii Kolesnik,Yuriy Ostapenko,Shailendra Lakhanpal,Basir Haque,Winston Chua,Joseph Stilwill,Susana Noemi Sena,Gustavo Girotto,Pedro Rafael Martins De Marchi,Fabricio Augusto Martinelli de Oliveira,Pedro Dos Reis,Rositsa Krasteva,Yanqiu Zhao,Chengshui Chen,Leona Koubkova,Gilles Robinet,Christos Chouaid,Christian Grohe,Jürgen Alt,Eszter Csánky,Éva Somogyiné Ezer,Norman Isaac Heching,Young Hak Kim,Shinji Aatagi,Shoichi Kuyama,Daijiro Harada,Naoyuki Nogami,Hiroshi Nokihara,Hisatsugu Goto,Agnes Staal van den Brekel,Eun Kyung Cho,Joo Hang Kim,Doina Ganea,Tudor Ciuleanu,Ekaterina Popova,Dina Sakaeva,Marian Stresko,Pavol Demo,Robert Godal,Yu-Feng Wei,Yen-Hsun Chen,Te Chun Hsia,Kang-Yun Lee,Huang-Chih Chang,Chin-Chou Wang,Afshin Dowlati,Christopher Sumey,Steven Francis Powell,Jonathan H. Goldman,J. J. Zarba,Emilio Batagelj,Andrea Viviana Pastor,Mauro Zukin,Clarissa Serodio da Rocha Baldotto,Luis Alberto Schlittler,Aknar Calabrich,Claudia Sette,Asen Dudov,Caicun Zhou,Hervé Lena,Susanne Lang,Zsuzsanna Papai,Koichi Goto,Shigeki Umemura,Kenya Kanazawa,Yu Hara,Masahiro Shinoda,Masahiro Morise,Jeroen Hiltermann,Robert Mróz,Andrei Ungureanu,Igor Andrasina,Gee-Chen Chang,Ihor Vynnychenko,Yaroslav Shparyk,Anna Kryzhanivska,Helen Ross,Kailhong Mi,Rodney Jamil,M. Williamson,Joseph Spahr,Zhigang Han,Mengzhao Wang,Zhixiong Yang,Jie Hu,Wei Li,Jun Zhao,Jifeng Feng,Shenglin Ma,Xiangdong Zhou,Zongan Liang,Yi Hu,Yuan Chen,Minghong Bi,Yongqian Shu,Kejun Nan,Jianying Zhou,Wei Zhang,Rui Ma,Nong Yang,Zhong Lin,Gang Wu,Jian Fang,Helong Zhang,Kai Wang,Zhendong Chen +236 more
Abstract: Summary Background First-line durvalumab plus etoposide with either cisplatin or carboplatin (platinum–etoposide) showed a significant improvement in overall survival versus platinum–etoposide alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) in the CASPIAN study. Here we report updated results, including the primary analysis for overall survival with durvalumab plus tremelimumab plus platinum–etoposide versus platinum–etoposide alone. Methods CASPIAN is an ongoing, open-label, sponsor-blind, randomised, controlled phase 3 trial at 209 cancer treatment centres in 23 countries worldwide. Eligible patients were aged 18 years or older (20 years in Japan) and had treatment-naive, histologically or cytologically documented ES-SCLC, with a WHO performance status of 0 or 1. Patients were randomly assigned (1:1:1) in blocks of six, stratified by planned platinum, using an interactive voice-response or web-response system to receive intravenous durvalumab plus tremelimumab plus platinum–etoposide, durvalumab plus platinum–etoposide, or platinum–etoposide alone. In all groups, patients received etoposide 80–100 mg/m2 on days 1–3 of each cycle with investigator's choice of either carboplatin area under the curve 5–6 mg/mL/min or cisplatin 75–80 mg/m2 on day 1 of each cycle. Patients in the platinum–etoposide group received up to six cycles of platinum–etoposide every 3 weeks and optional prophylactic cranial irradiation (investigator's discretion). Patients in the immunotherapy groups received four cycles of platinum–etoposide plus durvalumab 1500 mg with or without tremelimumab 75 mg every 3 weeks followed by maintenance durvalumab 1500 mg every 4 weeks. The two primary endpoints were overall survival for durvalumab plus platinum–etoposide versus platinum–etoposide and for durvalumab plus tremelimumab plus platinum–etoposide versus platinum–etoposide in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This study is registered at ClinicalTrials.gov, NCT03043872. Findings Between March 27, 2017, and May 29, 2018, 972 patients were screened and 805 were randomly assigned (268 to durvalumab plus tremelimumab plus platinum–etoposide, 268 to durvalumab plus platinum–etoposide, and 269 to platinum–etoposide). As of Jan 27, 2020, the median follow-up was 25·1 months (IQR 22·3–27·9). Durvalumab plus tremelimumab plus platinum–etoposide was not associated with a significant improvement in overall survival versus platinum–etoposide (hazard ratio [HR] 0·82 [95% CI 0·68–1·00]; p=0·045); median overall survival was 10·4 months (95% CI 9·6–12·0) versus 10·5 months (9·3–11·2). Durvalumab plus platinum–etoposide showed sustained improvement in overall survival versus platinum–etoposide (HR 0·75 [95% CI 0·62–0·91]; nominal p=0·0032); median overall survival was 12·9 months (95% CI 11·3–14·7) versus 10·5 months (9·3–11·2). The most common any-cause grade 3 or worse adverse events were neutropenia (85 [32%] of 266 patients in the durvalumab plus tremelimumab plus platinum–etoposide group, 64 [24%] of 265 patients in the durvalumab plus platinum–etoposide group, and 88 [33%] of 266 patients in the platinum–etoposide group) and anaemia (34 [13%], 24 [9%], and 48 [18%]). Any-cause serious adverse events were reported in 121 (45%) patients in the durvalumab plus tremelimumab plus platinum–etoposide group, 85 (32%) in the durvalumab plus platinum–etoposide group, and 97 (36%) in the platinum–etoposide group. Treatment-related deaths occurred in 12 (5%) patients in the durvalumab plus tremelimumab plus platinum–etoposide group (death, febrile neutropenia, and pulmonary embolism [n=2 each]; enterocolitis, general physical health deterioration and multiple organ dysfunction syndrome, pneumonia, pneumonitis and hepatitis, respiratory failure, and sudden death [n=1 each]), six (2%) patients in the durvalumab plus platinum–etoposide group (cardiac arrest, dehydration, hepatotoxicity, interstitial lung disease, pancytopenia, and sepsis [n=1 each]), and two (1%) in the platinum–etoposide group (pancytopenia and thrombocytopenia [n=1 each]). Interpretation First-line durvalumab plus platinum–etoposide showed sustained overall survival improvement versus platinum–etoposide but the addition of tremelimumab to durvalumab plus platinum–etoposide did not significantly improve outcomes versus platinum–etoposide. These results support the use of durvalumab plus platinum–etoposide as a new standard of care for the first-line treatment of ES-SCLC. Funding AstraZeneca.
Journal ArticleDOI
Genetic Homology between Bacteria Isolated from Pulmonary Abscesses or Pyothorax and Bacteria from the Oral Cavity
Rinko Katsuda,Junya Inubushi,Haruko Tobata,Toru Eguchi,Kunihiko Terada,Ryogo Kagami,Tetsuji Kawamura,Yoshihiro Kajiwara,Yasuharu Nakahara +8 more
TL;DR: A new method incorporating quantitative PCR and next-generation sequencing was developed and successfully prevented contamination of pus specimens with oral bacteria by percutaneous sample collection and would be useful for enabling investigations on other miscellaneous flora.