Journal ArticleDOI
Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer
Masahiro Fukuoka,Seiji Yano,Giuseppe Giaccone,Tomohide Tamura,Kazuhiko Nakagawa,Jean-Yves Douillard,Yutaka Nishiwaki,Johan Vansteenkiste,Shinzoh Kudoh,Danny Rischin,Richard Eek,Takeshi Horai,Kazumasa Noda,Ichiro Takata,Egbert F. Smit,Steven D. Averbuch,Angela Macleod,A. Feyereislova,Rui Ping Dong,José Baselga +19 more
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TLDR
Gefitinib showed clinically meaningful antitumor activity and provided symptom relief as second- and third-line treatment in patients with pretreated advanced non-small-cell lung cancer.Abstract:
Purpose: To evaluate the efficacy and tolerability of two doses of gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE), a novel epidermal growth factor receptor tyrosine kinase inhibitor, in patients with pretreated advanced non–small-cell lung cancer (NSCLC). Patients and Methods: This was a randomized, double-blind, parallel-group, multicenter phase II trial. Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens (at least one containing platinum) were randomized to receive either 250-mg or 500-mg oral doses of gefitinib once daily. Results: Efficacy was similar for the 250- and 500-mg/d groups. Objective tumor response rates were 18.4% (95% confidence interval [CI], 11.5 to 27.3) and 19.0% (95% CI, 12.1 to 27.9); among evaluable patients, symptom improvement rates were 40.3% (95% CI, 28.5 to 53.0) and 37.0% (95% CI, 26.0 to 49.1); median progression-free survival times were 2.7 and 2.8 months; and median overall survival times were 7.6 and 8....read more
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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
Erlotinib in previously treated non-small-cell lung cancer.
Frances A. Shepherd,José Rodrigues Pereira,Tudor Ciuleanu,Eng Huat Tan,Vera Hirsh,Sumitra Thongprasert,Daniel Campos,Savitree Maoleekoonpiroj,Michael Smylie,Renato G. Martins,Maximiliano Van Kooten,Mircea Dediu,B. Findlay,Dongsheng Tu,Dianne Johnston,Andrea Bezjak,Gary M. Clark,Pedro Santabárbara,Lesley Seymour +18 more
TL;DR: Elotinib can prolong survival in patients with non-small-cell lung cancer after first-line or second-line chemotherapy, and five percent of patients discontinued erlot inib because of toxic effects.
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
Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer.
David Cunningham,Yves Humblet,Salvatore Siena,David Khayat,Harry Bleiberg,Armando Santoro,D. Bets,M. Mueser,Andreas Harstrick,Chris Verslype,Ian Chau,Eric Van Cutsem +11 more
TL;DR: Cetuximab has clinically significant activity when given alone or in combination with irinotecan in patients with ir inotecans-refractory colorectal cancer.
References
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Epidermal growth factor-related peptides and their receptors in human malignancies
Journal ArticleDOI
Prospective Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non–Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
Frances A. Shepherd,Janet Dancey,Rodryg Ramlau,Karin Mattson,Richard J. Gralla,Mark Allen O'Rourke,Nathan Levitan,Laurent Gressot,Mark Vincent,Ronald L. Burkes,Susan Coughlin,Yong Kim,Jocelyne Berille +12 more
TL;DR: Treatment with docetaxel is associated with significant prolongation of survival, and at a dose of 75 mg/m(2), the benefits of docetAXel therapy outweigh the risks.
Journal ArticleDOI
Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.
TL;DR: A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor.
Journal ArticleDOI
Randomized Phase III Trial of Docetaxel Versus Vinorelbine or Ifosfamide in Patients With Advanced Non–Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy Regimens
Frank V. Fossella,Russell F. DeVore,Ronald N. Kerr,Jeffrey Crawford,Ronald R. Natale,Frank Dunphy,L A Kalman,Vincent A. Miller,Jin Soo Lee,Melvin Moore,David R. Gandara,Daniel D. Karp,Everett E. Vokes,Mark G. Kris,Yong Kim,Francis Gamza,Luz Hammershaimb +16 more
TL;DR: Patients who received docetaxel had a longer time to progression and a greater progression-free survival at 26 weeks and the 1-year survival was significantly greater with D75 than with the control treat...
Journal ArticleDOI
ZD1839, a Selective Oral Epidermal Growth Factor Receptor–Tyrosine Kinase Inhibitor, Is Well Tolerated and Active in Patients With Solid, Malignant Tumors: Results of a Phase I Trial
Malcolm R Ranson,Lisa A. Hammond,David Ferry,Mark G. Kris,Andrew Tullo,Philip I. Murray,Vince Miller,Steven D. Averbuch,Judith Ochs,Charles A. Morris,A. Feyereislova,Helen Swaisland,Eric K. Rowinsky +12 more
TL;DR: ZD 1839 was well tolerated, with DLT observed at a dose well above that at which antitumor activity was seen, and Pharmacokinetic analysis confirmed that ZD1839 was suitable for administration as a once-daily oral tablet formulation.
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Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib
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
Erlotinib in previously treated non-small-cell lung cancer.
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