Journal ArticleDOI
Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial
Tetsuya Mitsudomi,Satoshi Morita,Yasushi Yatabe,Shunichi Negoro,Isamu Okamoto,Junji Tsurutani,Takashi Seto,Miyako Satouchi,Hirohito Tada,Tomonori Hirashima,Kazuhiro Asami,Nobuyuki Katakami,Minoru Takada,Hiroshige Yoshioka,Kazuhiko Shibata,Shinzoh Kudoh,Eiji Shimizu,Hiroshi Saito,Shinichi Toyooka,Kazuhiko Nakagawa,Masahiro Fukuoka +20 more
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In this article, an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centers in Japan was conducted.Abstract:
Summary Background Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor ( EGFR ) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain. Methods We did an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centres in Japan. 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m 2 , intravenously) plus docetaxel (60 mg/m 2 , intravenously; n=89), administered every 21 days for three to six cycles. The primary endpoint was progression-free survival. Survival analysis was done with the modified intention-to-treat population. This study is registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539. Findings Five patients were excluded (two patients were found to have thyroid and colon cancer after randomisation, one patient had an exon 18 mutation, one patient had insufficient consent, and one patient showed acute allergic reaction to docetaxel). Thus, 172 patients (86 in each group) were included in the survival analyses. The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival time of 9·2 months (95% CI 8·0–13·9) versus 6·3 months (5·8–7·8; HR 0·489, 95% CI 0·336–0·710, log-rank p Interpretation Patients with lung cancer who are selected by EGFR mutations have longer progression-free survival if they are treated with gefitinib than if they are treated with cisplatin plus docetaxel. Funding West Japan Oncology Group (WJOG): a non-profit organisation supported by unrestricted donations from several pharmaceutical companies.read more
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Journal ArticleDOI
Gefitinib or Chemotherapy for Non–Small-Cell Lung Cancer with Mutated EGFR
Makoto Maemondo,Akira Inoue,Kunihiko Kobayashi,Shunichi Sugawara,Satoshi Oizumi,Hiroshi Isobe,Akihiko Gemma,Masao Harada,Hirohisa Yoshizawa,Ichiro Kinoshita,Yuka Fujita,Shoji Okinaga,Haruto Hirano,Kozo Yoshimori,Toshiyuki Harada,Takashi Ogura,Masahiro Ando,Hitoshi Miyazawa,Tomoaki Tanaka,Yasuo Saijo,Koichi Hagiwara,Satoshi Morita,Toshihiro Nukiwa +22 more
TL;DR: First-line gefitinib for patients with advanced non-small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival, with acceptable toxicity, as compared with standard chemotherapy.
Journal ArticleDOI
Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial.
Rafael Rosell,Enric Carcereny,Radj Gervais,A. Vergnenegre,Bartomeu Massuti,Enriqueta Felip,Ramon Palmero,Ramon Garcia-Gomez,Cinta Pallares,Jose Miguel Sanchez,Rut Porta,Manuel Cobo,Pilar Garrido,Flavia Longo,Teresa Moran,A. Insa,Filippo de Marinis,Romain Corre,Isabel Bover,Alfonso Illiano,Eric Dansin,Javier de Castro,Michele Milella,Noemi Reguart,Giuseppe Altavilla,Ulpiano Jimenez,Mariano Provencio,Miguel Angel Moreno,J. Terrasa,Jose Muñoz-Langa,Javier Valdivia,Dolores Isla,Manuel Domine,Olivier Molinier,Julien Mazieres,Nathalie Baize,Rosario García-Campelo,Gilles Robinet,Delvys Rodriguez-Abreu,Guillermo Lopez-Vivanco,Vittorio Gebbia,Lioba Ferrera-Delgado,Pierre Bombaron,R. Bernabé,Alessandra Bearz,Angel Artal,Enrico Cortesi,Christian Rolfo,Maria Sanchez-Ronco,Ana Drozdowskyj,Cristina Queralt,Itziar de Aguirre,Jose Luis Ramirez,Jose Javier Sanchez,Miguel Angel Molina,Miquel Taron,Luis Paz-Ares +56 more
TL;DR: Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations as discussed by the authors.
Journal ArticleDOI
International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society International Multidisciplinary Classification of Lung Adenocarcinoma
William D. Travis,Elisabeth Brambilla,Masayuki Noguchi,Andrew G. Nicholson,Kim R. Geisinger,Yasushi Yatabe,David G. Beer,Charles A. Powell,Gregory J. Riely,Paul Van Schil,Kavita Garg,John H. M. Austin,Hisao Asamura,Valerie W. Rusch,Fred R. Hirsch,Giorgio V. Scagliotti,Tetsuya Mitsudomi,Rudolf M. Huber,Yuichi Ishikawa,James R. Jett,Montserrat Sanchez-Cespedes,Jean-Paul Sculier,Takashi Takahashi,Masahiro Tsuboi,Johan Vansteenkiste,Ignacio I. Wistuba,Pan-Chyr Yang,Denise R. Aberle,Christian Brambilla,Douglas B. Flieder,Wilbur A. Franklin,Adi F. Gazdar,Michael K. Gould,Philip S. Hasleton,Douglas W. Henderson,Bruce E. Johnson,David A Johnson,Keith M. Kerr,Keiko Kuriyama,Jin Soo Lee,Vincent A. Miller,Iver Petersen,Victor L. Roggli,Rafael Rosell,Nagahiro Saijo,Erik Thunnissen,M. Tsao,David Yankelewitz +47 more
TL;DR: This new adenocarcinoma classification is needed to provide uniform terminology and diagnostic criteria, especially for bronchioloalveolar carcinoma (BAC), the overall approach to small nonresection cancer specimens, and for multidisciplinary strategic management of tissue for molecular and immunohistochemical studies.
Journal ArticleDOI
Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study
Caicun Zhou,Yi-Long Wu,Gongyan Chen,Jifeng Feng,Xiaoqing Liu,Changli Wang,Shucai Zhang,Jie Wang,Songwen Zhou,Shengxiang Ren,Shun Lu,Li Zhang,Chengping Hu,Chunhong Hu,Yi Luo,Lei Chen,Ming Ye,Jian'An Huang,Xiuyi Zhi,Yiping Zhang,Qingyu Xiu,Jun Ma,Changxuan You +22 more
TL;DR: It is suggested that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC, and was associated with more favourable tolerability than standard chemotherapy.
Journal ArticleDOI
Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer
Jean-Charles Soria,Yuichiro Ohe,Johan Vansteenkiste,Thanyanan Reungwetwattana,Busyamas Chewaskulyong,Ki Hyeong Lee,Arunee Dechaphunkul,Fumio Imamura,Naoyuki Nogami,Takayasu Kurata,Isamu Okamoto,Caicun Zhou,Byoung Chul Cho,Ying Cheng,Eun Kyung Cho,Pei Jye Voon,David Planchard,Wu Chou Su,Jhanelle E. Gray,Siow-Ming Lee,Rachel Hodge,Marcelo Marotti,Yuri Rukazenkov,Suresh S. Ramalingam +23 more
TL;DR: Osimertinib showed efficacy superior to that of standard EGFR‐TKIs in the first‐line treatment of EGFR mutation–positive advanced NSCLC, with a similar safety profile and lower rates of serious adverse events.
References
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Journal ArticleDOI
Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib
Thomas J. Lynch,Daphne W. Bell,Raffaella Sordella,Sarada Gurubhagavatula,Ross A. Okimoto,Brian W. Brannigan,Patricia L. Harris,Sara M. Haserlat,Jeffrey G. Supko,Frank G. Haluska,David N. Louis,David C. Christiani,Jeff Settleman,Daniel A. Haber +13 more
TL;DR: A subgroup of patients with non-small-cell lung cancer have specific mutations in the EGFR gene which correlate with clinical responsiveness to the tyrosine kinase inhibitor gefitinib, and these mutations lead to increased growth factor signaling and confer susceptibility to the inhibitor.
Journal ArticleDOI
EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy.
J. Guillermo Paez,Pasi A. Jänne,Pasi A. Jänne,Jeffrey C. Lee,Sean Tracy,Heidi Greulich,Heidi Greulich,Stacey Gabriel,Paula Herman,Frederic J. Kaye,Neal I. Lindeman,Titus J. Boggon,Katsuhiko Naoki,Hidefumini Sasaki,Yoshitaka Fujii,Michael J. Eck,William R. Sellers,William R. Sellers,William R. Sellers,Bruce E. Johnson,Bruce E. Johnson,Matthew Meyerson,Matthew Meyerson +22 more
TL;DR: Results suggest that EGFR mutations may predict sensitivity to gefitinib, and treatment with the EGFR kinase inhibitor gefitsinib causes tumor regression in some patients with NSCLC, more frequently in Japan.
Journal ArticleDOI
Cancer Statistics, 2009
TL;DR: The most recent data on cancer incidence, mortality, and survival from the American Cancer Society (ACS) is presented in this paper, where the authors compare the three major cancer sites in men (lung, prostate, and colon and rectum [colorectum]) and in two major cancers sites in women (breast and colorectal) over a 15-year period.
Journal ArticleDOI
Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
Tony Mok,Yi-Long Wu,Sumitra Thongprasert,Chih-Hsin Yang,Da Tong Chu,Nagahiro Saijo,Patrapim Sunpaweravong,Baohui Han,Benjamin Margono,Benjamin Margono,Yukito Ichinose,Yutaka Nishiwaki,Yuichiro Ohe,Jin Ji Yang,Busyamas Chewaskulyong,Haiyi Jiang,Emma Duffield,Claire Watkins,Alison Armour,Masahiro Fukuoka +19 more
TL;DR: Gefit inib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia and the presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib.
Journal ArticleDOI
Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer.
Joan H. Schiller,David P. Harrington,Chandra P. Belani,Corey J. Langer,Alan B. Sandler,James E. Krook,Junming Zhu,David H. Johnson +7 more
TL;DR: None of four chemotherapy regimens offered a significant advantage over the others in the treatment of advanced non-small-cell lung cancer.
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