Originally published as JCO Early Release 10.1200/JCO.2003.10.038 on May 14 2003
Journal of Clinical Oncology, Vol 21, Issue 12
(June), 2003: 2237-2246
© 2003 American Society for Clinical Oncology
Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced NonSmall-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 Smit,
Steven Averbuch,
Angela Macleod,
Andrea Feyereislova,
Rui-Ping Dong,
José Baselga
From the Kinki University School of Medicine, Osaka City University School of Medicine, and AstraZeneca, Osaka, Tokushima University School of Medicine, Tokushima, National Cancer Center, Central Hospital, and Japanese Foundation for Cancer Research, Tokyo, National Cancer Center, East Hospital, Chiba, Kanagawa Cancer Center, Yokohama, and National Shikoku Cancer Center, Matsuyama, Japan; C.R.L.C.C. Rene Gauducheau, Saint-Herblain, France; University Hospital Gasthuisberg, Leuven, Belgium; Centre for Developmental Cancer Therapeutics, Melbourne, Australia; Mary Potter Oncology Centre, Pretoria, South Africa; Academic Hospital Free University, Amsterdam, the Netherlands; AstraZeneca, Wilmington, DE; AstraZeneca, Alderley Park, United Kingdom; and Vall dHebron University Hospital, Barcelona, Spain.
Address reprint requests to Masahiro Fukuoka, MD, Fourth Department of Internal Medicine, Kinki University School of Medicine, 377-2 Ohnohigashi Osakasayama, Osaka 589, Japan; email: mfukuoka{at}med.kindai.ac.jp.
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 nonsmall-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 8.0 months, respectively. Symptom improvements were recorded for 69.2% (250 mg/d) and 85.7% (500 mg/d) of patients with a tumor response. Adverse events (AEs) at both dose levels were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea. Drug-related toxicities were more frequent in the higher-dose group. Withdrawal due to drug-related AEs was 1.9% and 9.4% for patients receiving gefitinib 250 and 500 mg/d, respectively.
Conclusion: Gefitinib showed clinically meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients. At 250 mg/d, gefitinib had a favorable AE profile. Gefitinib 250 mg/d is an important, novel treatment option for patients with pretreated advanced NSCLC.
The authors wish to disclose the following conflicts of interest statement: José Baselga has been in receipt of a research grant from AstraZeneca and honoraria to attend advisory boards and to give talks on ZD1839; Johan Vansteenkiste has received honoraria from AstraZeneca to attend advisory boards; Jean Yves Douillard has received honoraria for participating in advisory boards or symposia; Giuseppe Giaccone has received honoraria and research grants; and Danny Rischin has been in receipt of honoraria and travel grants from AstraZeneca. Steven Averbuch, Angela Macleod, Andrea Feyereislova, and Rui-Ping Dong were employed by AstraZeneca at the time of study completion, and as such, may hold stock in the company. All other authors have nothing to declare.

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 |
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|
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|
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|
 |
|

|
 |

|
 |
 
H. Bai, L. Mao, h. S. Wang, J. Zhao, L. Yang, t. T. An, X. Wang, c. J. Duan, n. M. Wu, z. Q. Guo, et al.
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2653 - 2659.
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|
 |
|

|
 |

|
 |
 
S. KUSUMOTO, T. SUGIYAMA, K. ANDO, T. HOSAKA, H. ISHIDA, T. SHIRAI, T. YAMAOKA, K. OKUDA, T. HIROSE, T. OHNISHI, et al.
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Anticancer Res,
June 1, 2009;
29(6):
2315 - 2322.
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[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. B. Natale, D. Bodkin, R. Govindan, B. G. Sleckman, N. A. Rizvi, A. Capo, P. Germonpre, W. E.E. Eberhardt, P. K. Stockman, S. J. Kennedy, et al.
Vandetanib Versus Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer: Results From a Two-Part, Double-Blind, Randomized Phase II Study
J. Clin. Oncol.,
May 20, 2009;
27(15):
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[PDF]
|
 |
|

|
 |

|
 |
 
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May 1, 2009;
131(5):
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[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. Goss, D. Ferry, R. Wierzbicki, S. A. Laurie, J. Thompson, B. Biesma, F. R. Hirsch, M. Varella-Garcia, E. Duffield, O. U. Ataman, et al.
Randomized Phase II Study of Gefitinib Compared With Placebo in Chemotherapy-Naive Patients With Advanced Non-Small-Cell Lung Cancer and Poor Performance Status
J. Clin. Oncol.,
May 1, 2009;
27(13):
2253 - 2260.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. Takeda, S. Negoro, T. Tamura, Y. Nishiwaki, S. Kudoh, S. Yokota, K. Matsui, H. Semba, K. Nakagawa, Y. Takada, et al.
Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104)
Ann. Onc.,
May 1, 2009;
20(5):
835 - 841.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. M. Yamada and K.-W. Lee
Perspectives in mammalian IGFBP-3 biology: local vs. systemic action
Am J Physiol Cell Physiol,
May 1, 2009;
296(5):
C954 - C976.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. E. Stinchcombe and M. A. Socinski
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Proceedings of the ATS,
April 15, 2009;
6(2):
233 - 241.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. S. W. Stewart, E. E.W. Cohen, L. Licitra, C. M.L. Van Herpen, C. Khorprasert, D. Soulieres, P. Vodvarka, D. Rischin, A. M. Garin, F. R. Hirsch, et al.
Phase III Study of Gefitinib 250 Compared With Intravenous Methotrexate for Recurrent Squamous Cell Carcinoma of the Head and Neck
J. Clin. Oncol.,
April 10, 2009;
27(11):
1864 - 1871.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. Sartori, A. Cavazza, A. Sgambato, A. Marchioni, F. Barbieri, L. Longo, M. Bavieri, B. Murer, E. Meschiari, S. Tamberi, et al.
EGFR and K-ras Mutations Along the Spectrum of Pulmonary Epithelial Tumors of the Lung and Elaboration of a Combined Clinicopathologic and Molecular Scoring System to Predict Clinical Responsiveness to EGFR Inhibitors
Am J Clin Pathol,
April 1, 2009;
131(4):
478 - 489.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. L. Barros Costa
Review Article: Targeted Therapy: Comprehensive Review
American Journal of Hospice and Palliative Medicine,
April 1, 2009;
26(2):
137 - 146.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
C.-H. Gow, Y.-L. Chang, Y.-C. Hsu, M.-F. Tsai, C.-T. Wu, C.-J. Yu, C.-H. Yang, Y.-C. Lee, P.-C. Yang, and J.-Y. Shih
Comparison of epidermal growth factor receptor mutations between primary and corresponding metastatic tumors in tyrosine kinase inhibitor-naive non-small-cell lung cancer
Ann. Onc.,
April 1, 2009;
20(4):
696 - 702.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K.-K. Wong, P. M. Fracasso, R. M. Bukowski, T. J. Lynch, P. N. Munster, G. I. Shapiro, P. A. Janne, J. P. Eder, M. J. Naughton, M. J. Ellis, et al.
A Phase I Study with Neratinib (HKI-272), an Irreversible Pan ErbB Receptor Tyrosine Kinase Inhibitor, in Patients with Solid Tumors
Clin. Cancer Res.,
April 1, 2009;
15(7):
2552 - 2558.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. Inoue, K. Kobayashi, K. Usui, M. Maemondo, S. Okinaga, I. Mikami, M. Ando, K. Yamazaki, Y. Saijo, A. Gemma, et al.
First-Line Gefitinib for Patients With Advanced Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations Without Indication for Chemotherapy
J. Clin. Oncol.,
March 20, 2009;
27(9):
1394 - 1400.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. K.F. Yung, K.C. A. Chan, T. S.K. Mok, J. Tong, K.-F. To, and Y.M. D. Lo
Single-Molecule Detection of Epidermal Growth Factor Receptor Mutations in Plasma by Microfluidics Digital PCR in Non-Small Cell Lung Cancer Patients
Clin. Cancer Res.,
March 15, 2009;
15(6):
2076 - 2084.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
I. Sekine, Y. Ichinose, Y. Nishiwaki, N. Yamamoto, M. Tsuboi, K. Nakagawa, T. Shinkai, S. Negoro, F. Imamura, K. Eguchi, et al.
Quality of life and disease-related symptoms in previously treated Japanese patients with non-small-cell lung cancer: results of a randomized phase III study (V-15-32) of gefitinib versus docetaxel
Ann. Onc.,
March 12, 2009;
(2009)
mdp031v1.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
H. Jiang
Overview of Gefitinib in Non-small Cell Lung Cancer: An Asian Perspective
Jpn. J. Clin. Oncol.,
March 1, 2009;
39(3):
137 - 150.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. Scagliotti, N. Hanna, F. Fossella, K. Sugarman, J. Blatter, P. Peterson, L. Simms, and F. A. Shepherd
The Differential Efficacy of Pemetrexed According to NSCLC Histology: A Review of Two Phase III Studies
Oncologist,
March 1, 2009;
14(3):
253 - 263.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. Nakagawa, H. Minami, M. Kanezaki, A. Mukaiyama, Y. Minamide, H. Uejima, T. Kurata, T. Nogami, K. Kawada, H. Mukai, et al.
Phase I Dose-escalation and Pharmacokinetic Trial of Lapatinib (GW572016), a Selective Oral Dual Inhibitor of ErbB-1 and -2 Tyrosine Kinases, in Japanese Patients with Solid Tumors
Jpn. J. Clin. Oncol.,
February 1, 2009;
39(2):
116 - 123.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. A. Pantaleo, M. Nannini, A. Maleddu, S. Fanti, C. Nanni, S. Boschi, F. Lodi, G. Nicoletti, L. Landuzzi, P. L. Lollini, et al.
Experimental results and related clinical implications of PET detection of epidermal growth factor receptor (EGFr) in cancer
Ann. Onc.,
February 1, 2009;
20(2):
213 - 226.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. A. Memon, S. Jakobsen, F. Dagnaes-Hansen, B. S. Sorensen, S. Keiding, and E. Nexo
Positron Emission Tomography (PET) Imaging with [11C]-Labeled Erlotinib: A Micro-PET Study on Mice with Lung Tumor Xenografts
Cancer Res.,
February 1, 2009;
69(3):
873 - 878.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. H. Kesarwala, M. M. Samrakandi, and D. Piwnica-Worms
Proteasome Inhibition Blocks Ligand-Induced Dynamic Processing and Internalization of Epidermal Growth Factor Receptor via Altered Receptor Ubiquitination and Phosphorylation
Cancer Res.,
February 1, 2009;
69(3):
976 - 983.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. Okabe, I. Okamoto, S. Tsukioka, J. Uchida, E. Hatashita, Y. Yamada, T. Yoshida, K. Nishio, M. Fukuoka, P. A. Janne, et al.
Addition of S-1 to the Epidermal Growth Factor Receptor Inhibitor Gefitinib Overcomes Gefitinib Resistance in Non-small cell Lung Cancer Cell Lines with MET Amplification
Clin. Cancer Res.,
February 1, 2009;
15(3):
907 - 913.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. J. Riely, N. A. Rizvi, M. G. Kris, D. T. Milton, D. B. Solit, N. Rosen, E. Senturk, C. G. Azzoli, J. R. Brahmer, F. M. Sirotnak, et al.
Randomized Phase II Study of Pulse Erlotinib Before or After Carboplatin and Paclitaxel in Current or Former Smokers With Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol.,
January 10, 2009;
27(2):
264 - 270.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. L. Evans
Novel, Targeted Agents with Thoracic Radiation in the Treatment of Locally Advanced Non-small Cell Lung Cancer
ASCO Educational Book,
January 1, 2009;
2009(1):
445 - 449.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. Takano, T. Fukui, Y. Ohe, K. Tsuta, S. Yamamoto, H. Nokihara, N. Yamamoto, I. Sekine, H. Kunitoh, K. Furuta, et al.
EGFR Mutations Predict Survival Benefit From Gefitinib in Patients With Advanced Lung Adenocarcinoma: A Historical Comparison of Patients Treated Before and After Gefitinib Approval in Japan
J. Clin. Oncol.,
December 1, 2008;
26(34):
5589 - 5595.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S.-G. Wu, Y.-L. Chang, Y.-C. Hsu, J.-Y. Wu, C.-H. Yang, C.-J. Yu, M.-F. Tsai, J.-Y. Shih, and P.-C. Yang
Good Response to Gefitinib in Lung Adenocarcinoma of Complex Epidermal Growth Factor Receptor (EGFR) Mutations with the Classical Mutation Pattern
Oncologist,
December 1, 2008;
13(12):
1276 - 1284.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. V. Heymach, L. Paz-Ares, F. De Braud, M. Sebastian, D. J. Stewart, W. E.E. Eberhardt, A. A. Ranade, G. Cohen, J. M. Trigo, A. B. Sandler, et al.
Randomized Phase II Study of Vandetanib Alone or With Paclitaxel and Carboplatin as First-Line Treatment for Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol.,
November 20, 2008;
26(33):
5407 - 5415.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. Yano, W. Wang, Q. Li, K. Matsumoto, H. Sakurama, T. Nakamura, H. Ogino, S. Kakiuchi, M. Hanibuchi, Y. Nishioka, et al.
Hepatocyte Growth Factor Induces Gefitinib Resistance of Lung Adenocarcinoma with Epidermal Growth Factor Receptor-Activating Mutations
Cancer Res.,
November 15, 2008;
68(22):
9479 - 9487.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
H.-J. Sohn, Y.-J. Yang, J.-S. Ryu, S. J. Oh, K. C. Im, D. H. Moon, D. H. Lee, C. Suh, J.-S. Lee, and S.-W. Kim
[18F]Fluorothymidine Positron Emission Tomography before and 7 Days after Gefitinib Treatment Predicts Response in Patients with Advanced Adenocarcinoma of the Lung
Clin. Cancer Res.,
November 15, 2008;
14(22):
7423 - 7429.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. M. Chin, M. P. Quinlan, A. Singh, L. V. Sequist, T. J. Lynch, D. A. Haber, S. V. Sharma, and J. Settleman
Reduced Erlotinib Sensitivity of Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer following Cisplatin Exposure: A Cell Culture Model of Second-line Erlotinib Treatment
Clin. Cancer Res.,
November 1, 2008;
14(21):
6867 - 6876.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. Yonesaka, K. Zejnullahu, N. Lindeman, A. J. Homes, D. M. Jackman, F. Zhao, A. M. Rogers, B. E. Johnson, and P. A. Janne
Autocrine Production of Amphiregulin Predicts Sensitivity to Both Gefitinib and Cetuximab in EGFR Wild-type Cancers
Clin. Cancer Res.,
November 1, 2008;
14(21):
6963 - 6973.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Berhoune, E. Banu, F. Scotte, P. Prognon, S. Oudard, and B. Bonan
Therapeutic Strategy for Treatment of Metastatic Non-Small Cell Lung Cancer
Ann. Pharmacother.,
November 1, 2008;
42(11):
1640 - 1652.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. S. Herbst and A. Sandler
Bevacizumab and Erlotinib: A Promising New Approach to the Treatment of Advanced NSCLC
Oncologist,
November 1, 2008;
13(11):
1166 - 1176.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J.-Y. Wu, C.-J. Yu, C.-H. Yang, S.-G. Wu, Y.-H. Chiu, C.-H. Gow, Y.-C. Chang, Y.-C. Hsu, P.-F. Wei, J.-Y. Shih, et al.
First- or Second-line Therapy with Gefitinib Produces Equal Survival in Non-Small Cell Lung Cancer
Am. J. Respir. Crit. Care Med.,
October 15, 2008;
178(8):
847 - 853.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S-G. Wu, C-H. Gow, C-J. Yu, Y-L. Chang, C-H. Yang, Y-C. Hsu, J-Y. Shih, Y-C. Lee, and P-C. Yang
Frequent epidermal growth factor receptor gene mutations in malignant pleural effusion of lung adenocarcinoma
Eur. Respir. J.,
October 1, 2008;
32(4):
924 - 930.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. L. Arteaga, A. O'Neill, S. L. Moulder, M. Pins, J. A. Sparano, G. W. Sledge, and N. E. Davidson
A Phase I-II Study of Combined Blockade of the ErbB Receptor Network with Trastuzumab and Gefitinib in Patients with HER2 (ErbB2)-Overexpressing Metastatic Breast Cancer
Clin. Cancer Res.,
October 1, 2008;
14(19):
6277 - 6283.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. R. Hirsch, M. Varella-Garcia, R. Dziadziuszko, Y. Xiao, S. Gajapathy, M. Skokan, M. Lin, V. O'Neill, and P. A. Bunn Jr.
Fluorescence In situ Hybridization Subgroup Analysis of TRIBUTE, a Phase III Trial of Erlotinib Plus Carboplatin and Paclitaxel in Non-Small Cell Lung Cancer
Clin. Cancer Res.,
October 1, 2008;
14(19):
6317 - 6323.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Barve, J. Bender, N. Senzer, C. Cunningham, F. A. Greco, D. McCune, R. Steis, H. Khong, D. Richards, J. Stephenson, et al.
Induction of Immune Responses and Clinical Efficacy in a Phase II Trial of IDM-2101, a 10-Epitope Cytotoxic T-Lymphocyte Vaccine, in Metastatic Non-Small-Cell Lung Cancer
J. Clin. Oncol.,
September 20, 2008;
26(27):
4418 - 4425.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. L. Schilsky, G. Gordon, T. M. Gilmer, S. A. Courtneidge, L. M. Matrisian, O. Grad, W. G. Nelson, and on behalf of the Translational Research Working Gr
The Translational Research Working Group Developmental Pathway for Anticancer Agents (Drugs or Biologics)
Clin. Cancer Res.,
September 15, 2008;
14(18):
5685 - 5691.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. Maruyama, Y. Nishiwaki, T. Tamura, N. Yamamoto, M. Tsuboi, K. Nakagawa, T. Shinkai, S. Negoro, F. Imamura, K. Eguchi, et al.
Phase III Study, V-15-32, of Gefitinib Versus Docetaxel in Previously Treated Japanese Patients With Non-Small-Cell Lung Cancer
J. Clin. Oncol.,
September 10, 2008;
26(26):
4244 - 4252.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
L. Crino, F. Cappuzzo, P. Zatloukal, M. Reck, M. Pesek, J. C. Thompson, H. E.R. Ford, F. R. Hirsch, M. Varella-Garcia, S. Ghiorghiu, et al.
Gefitinib Versus Vinorelbine in Chemotherapy-Naive Elderly Patients With Advanced Non-Small-Cell Lung Cancer (INVITE): A Randomized, Phase II Study
J. Clin. Oncol.,
September 10, 2008;
26(26):
4253 - 4260.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C.-Q. Zhu, G. da Cunha Santos, K. Ding, A. Sakurada, J.-C. Cutz, N. Liu, T. Zhang, P. Marrano, M. Whitehead, J. A. Squire, et al.
Role of KRAS and EGFR As Biomarkers of Response to Erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21
J. Clin. Oncol.,
September 10, 2008;
26(26):
4268 - 4275.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. K. B. Parmar, Friederike. M.-S. Barthel, M. Sydes, R. Langley, R. Kaplan, E. Eisenhauer, M. Brady, N. James, M. A. Bookman, A.-M. Swart, et al.
Speeding up the Evaluation of New Agents in Cancer
J Natl Cancer Inst,
September 3, 2008;
100(17):
1204 - 1214.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. E. Stinchcombe and M. A. Socinski
Gefitinib in Advanced Non-Small Cell Lung Cancer: Does It Deserve a Second Chance?
Oncologist,
September 1, 2008;
13(9):
933 - 944.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J.-Y. Wu, S.-G. Wu, C.-H. Yang, C.-H. Gow, Y.-L. Chang, C.-J. Yu, J.-Y. Shih, and P.-C. Yang
Lung Cancer with Epidermal Growth Factor Receptor Exon 20 Mutations Is Associated with Poor Gefitinib Treatment Response
Clin. Cancer Res.,
August 1, 2008;
14(15):
4877 - 4882.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
L. V. Sequist, J. E. Settleman, J. B. Ackman, and A. J. Iafrate
Case 23-2008 -- A 26-Year-Old Man with Back Pain and a Mass in the Lung
N. Engl. J. Med.,
July 24, 2008;
359(4):
405 - 414.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. R. Khuri and J. Roman
From Nihilism to Individualism: The Evolution of Lung Cancer Therapy
Am. J. Respir. Crit. Care Med.,
June 15, 2008;
177(12):
1299 - 1300.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C.-H. Yang, C.-J. Yu, J.-Y. Shih, Y.-C. Chang, F.-C. Hu, M.-C. Tsai, K.-Y. Chen, Z.-Z. Lin, C.-J. Huang, C.-T. Shun, et al.
Specific EGFR Mutations Predict Treatment Outcome of Stage IIIB/IV Patients With Chemotherapy-Naive Non-Small-Cell Lung Cancer Receiving First-Line Gefitinib Monotherapy
J. Clin. Oncol.,
June 1, 2008;
26(16):
2745 - 2753.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. Kelly, K. Chansky, L. E. Gaspar, K. S. Albain, J. Jett, Y. C. Ung, D. H.M. Lau, J. J. Crowley, and D. R. Gandara
Phase III Trial of Maintenance Gefitinib or Placebo After Concurrent Chemoradiotherapy and Docetaxel Consolidation in Inoperable Stage III Non-Small-Cell Lung Cancer: SWOG S0023
J. Clin. Oncol.,
May 20, 2008;
26(15):
2450 - 2456.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
L. V. Sequist, R. G. Martins, D. Spigel, S. M. Grunberg, A. Spira, P. A. Janne, V. A. Joshi, D. McCollum, T. L. Evans, A. Muzikansky, et al.
First-Line Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer Harboring Somatic EGFR Mutations
J. Clin. Oncol.,
May 20, 2008;
26(15):
2442 - 2449.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. N. Contessa, M. S. Bhojani, H. H. Freeze, A. Rehemtulla, and T. S. Lawrence
Inhibition of N-Linked Glycosylation Disrupts Receptor Tyrosine Kinase Signaling in Tumor Cells
Cancer Res.,
May 15, 2008;
68(10):
3803 - 3809.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. A. Engelman and P. A. Janne
Mechanisms of Acquired Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancer
Clin. Cancer Res.,
May 15, 2008;
14(10):
2895 - 2899.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. S. Hodkinson, A. MacKinnon, and T. Sethi
Targeting Growth Factors in Lung Cancer
Chest,
May 1, 2008;
133(5):
1209 - 1216.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. D'Addario, D. Rauch, R. Stupp, M. Pless, R. Stahel, N. Mach, L. Jost, L. Widmer, C. Tapia, M. Bihl, et al.
Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03
Ann. Onc.,
April 1, 2008;
19(4):
739 - 745.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
I. I. Na, B. H. Byun, H. J. Kang, G. J. Cheon, J. S. Koh, C. H. Kim, D. H. Choe, B.-Y. Ryoo, J. C. Lee, S. M. Lim, et al.
18F-Fluoro-2-Deoxy-Glucose Uptake Predicts Clinical Outcome in Patients with Gefitinib-Treated Non-Small Cell Lung Cancer
Clin. Cancer Res.,
April 1, 2008;
14(7):
2036 - 2041.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. J. Fidler, A. Argiris, J. D. Patel, D. H. Johnson, A. Sandler, V. M. Villaflor, J. Coon IV, L. Buckingham, K. Kaiser, S. Basu, et al.
The Potential Predictive Value of Cyclooxygenase-2 Expression and Increased Risk of Gastrointestinal Hemorrhage in Advanced Non-Small Cell Lung Cancer Patients Treated with Erlotinib and Celecoxib
Clin. Cancer Res.,
April 1, 2008;
14(7):
2088 - 2094.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G A Silvestri and S G Spiro
Carcinoma of the bronchus 60 years later
Postgrad. Med. J.,
April 1, 2008;
84(990):
182 - 187.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. Verweij
Other Endpoints in Screening Studies for Soft Tissue Sarcomas
Oncologist,
April 1, 2008;
13(suppl_2):
27 - 31.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
V. A. Miller, G. J. Riely, M. F. Zakowski, A. R. Li, J. D. Patel, R. T. Heelan, M. G. Kris, A. B. Sandler, D. P. Carbone, A. Tsao, et al.
Molecular Characteristics of Bronchioloalveolar Carcinoma and Adenocarcinoma, Bronchioloalveolar Carcinoma Subtype, Predict Response to Erlotinib
J. Clin. Oncol.,
March 20, 2008;
26(9):
1472 - 1478.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. Ciardiello and G. Tortora
EGFR Antagonists in Cancer Treatment
N. Engl. J. Med.,
March 13, 2008;
358(11):
1160 - 1174.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. H. El-Maraghi and E. A. Eisenhauer
Review of Phase II Trial Designs Used in Studies of Molecular Targeted Agents: Outcomes and Predictors of Success in Phase III
J. Clin. Oncol.,
March 10, 2008;
26(8):
1346 - 1354.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. M. Rudin, W. Liu, A. Desai, T. Karrison, X. Jiang, L. Janisch, S. Das, J. Ramirez, B. Poonkuzhali, E. Schuetz, et al.
Pharmacogenomic and Pharmacokinetic Determinants of Erlotinib Toxicity
J. Clin. Oncol.,
March 1, 2008;
26(7):
1119 - 1127.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Y. Oh, R. S. Herbst, H. Burris, A. Cleverly, L. Musib, M. Lahn, and G. Bepler
Enzastaurin, an Oral Serine/Threonine Kinase Inhibitor, As Second- or Third-Line Therapy of Non-Small-Cell Lung Cancer
J. Clin. Oncol.,
March 1, 2008;
26(7):
1135 - 1141.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. Iwakiri, M. Sonobe, S. Nagai, T. Hirata, H. Wada, and R. Miyahara
Expression Status of Folate Receptor {alpha} Is Significantly Correlated with Prognosis in Non-Small-Cell Lung Cancers
Ann. Surg. Oncol.,
March 1, 2008;
15(3):
889 - 899.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. Okabe, I. Okamoto, S. Tsukioka, J. Uchida, T. Iwasa, T. Yoshida, E. Hatashita, Y. Yamada, T. Satoh, K. Tamura, et al.
Synergistic antitumor effect of S-1 and the epidermal growth factor receptor inhibitor gefitinib in non-small cell lung cancer cell lines: role of gefitinib-induced down-regulation of thymidylate synthase
Mol. Cancer Ther.,
March 1, 2008;
7(3):
599 - 606.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. Pinter, J. Papay, A. Almasi, Z. Sapi, E. Szabo, M. Kanya, A. Tamasi, B. Jori, E. Varkondi, J. Moldvay, et al.
Epidermal Growth Factor Receptor (EGFR) High Gene Copy Number and Activating Mutations in Lung Adenocarcinomas Are Not Consistently Accompanied by Positivity for EGFR Protein by Standard Immunohistochemistry
J. Mol. Diagn.,
March 1, 2008;
10(2):
160 - 168.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. A. Eberhard, G. Giaccone, and B. E. Johnson
Biomarkers of Response to Epidermal Growth Factor Receptor Inhibitors in Non-Small-Cell Lung Cancer Working Group: Standardization for Use in the Clinical Trial Setting
J. Clin. Oncol.,
February 20, 2008;
26(6):
983 - 994.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. A. Brandes, E. Franceschi, A. Tosoni, M. E. Hegi, and R. Stupp
Epidermal Growth Factor Receptor Inhibitors in Neuro-oncology: Hopes and Disappointments
Clin. Cancer Res.,
February 15, 2008;
14(4):
957 - 960.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. Rosell, G. Robinet, A. Szczesna, R. Ramlau, M. Constenla, B. C. Mennecier, W. Pfeifer, K. J. O'Byrne, T. Welte, R. Kolb, et al.
Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer
Ann. Onc.,
February 1, 2008;
19(2):
362 - 369.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
I. S. Sarkaria, M. F. Zakowski, D. Pham, M. Hezel, M. I. Ebright, S. Chuai, E. S. Venkatraman, M. G. Kris, V. W. Rusch, and B. Singh
Epidermal Growth Factor Receptor Signaling in Adenocarcinomas With Bronchioloalveolar Components
Ann. Thorac. Surg.,
January 1, 2008;
85(1):
216 - 223.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Y. Shintani, M. Maeda, N. Chaika, K. R. Johnson, and M. J. Wheelock
Collagen I Promotes Epithelial-to-Mesenchymal Transition in Lung Cancer Cells via Transforming Growth Factor Signaling
Am. J. Respir. Cell Mol. Biol.,
January 1, 2008;
38(1):
95 - 104.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
B. E. Johnson, C. M. Rudin, and R. Salgia
Novel and Targeted Agents for Small Cell Lung Cancer
ASCO Educational Book,
January 1, 2008;
2008(1):
363 - 367.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. de Marinis and F. Grossi
Clinical Evidence for Second- and Third-Line Treatment Options in Advanced Non-Small Cell Lung Cancer
Oncologist,
January 1, 2008;
13(suppl_1):
14 - 20.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. E. Stinchcombe and M. A. Socinski
Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer
Oncologist,
January 1, 2008;
13(suppl_1):
28 - 36.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. A. Engelman, K. Zejnullahu, C.-M. Gale, E. Lifshits, A. J. Gonzales, T. Shimamura, F. Zhao, P. W. Vincent, G. N. Naumov, J. E. Bradner, et al.
PF00299804, an Irreversible Pan-ERBB Inhibitor, Is Effective in Lung Cancer Models with EGFR and ERBB2 Mutations that Are Resistant to Gefitinib
Cancer Res.,
December 15, 2007;
67(24):
11924 - 11932.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. Thomas, P. Rochaix, A. Benlyazid, J. Sarini, M. Rives, J. L. Lefebvre, B. C. Allal, F. Courbon, E. Chatelut, and J.-P. Delord
Pilot Study of Neoadjuvant Treatment with Erlotinib in Nonmetastatic Head and Neck Squamous Cell Carcinoma
Clin. Cancer Res.,
December 1, 2007;
13(23):
7086 - 7092.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. J. Chen and C. S. Nirodi
The Epidermal Growth Factor Receptor: A Role in Repair of Radiation-Induced DNA Damage
Clin. Cancer Res.,
November 15, 2007;
13(22):
6555 - 6560.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Loprevite, M. Tiseo, M. Chiaramondia, M. Capelletti, C. Bozzetti, B. Bortesi, N. Naldi, R. Nizzoli, P. Dadati, A. Kunkl, et al.
Buccal Mucosa Cells as In vivo Model to Evaluate Gefitinib Activity in Patients with Advanced Non Small Cell Lung Cancer
Clin. Cancer Res.,
November 1, 2007;
13(21):
6518 - 6526.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. Zenda, Y. Onozawa, M. Tahara, M. Kawashima, N. Shikama, S. Sasaki, and N. Boku
Feasibility Study of Single Agent Cisplatin and Concurrent Radiotherapy in Japanese Patients with Squamous Cell Carcinoma of the Head and Neck: Preliminary Results
Jpn. J. Clin. Oncol.,
October 8, 2007;
(2007)
hym106v1.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. R. Ferry, M. Anderson, K. Beddard, S. Tomlinson, P. Atherfold, J. Obszynska, R. Harrison, and J. Jankowski
A Phase II Study of Gefitinib Monotherapy in Advanced Esophageal Adenocarcinoma: Evidence of Gene Expression, Cellular, and Clinical Response
Clin. Cancer Res.,
October 1, 2007;
13(19):
5869 - 5875.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. F. Doody, Y. Wang, S. N. Patel, C. Joynes, S. P. Lee, J. Gerlak, R. L. Rolser, Y. Li, P. Steiner, R. Bassi, et al.
Inhibitory activity of cetuximab on epidermal growth factor receptor mutations in non small cell lung cancers
Mol. Cancer Ther.,
October 1, 2007;
6(10):
2642 - 2651.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. V. Heymach, B. E. Johnson, D. Prager, E. Csada, J. Roubec, M. Pesek, I. Spasova, C. P. Belani, I. Bodrogi, S. Gadgeel, et al.
Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non Small-Cell Lung Cancer
J. Clin. Oncol.,
September 20, 2007;
25(27):
4270 - 4277.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. L. Kwak, J. W. Clark, and B. Chabner
Targeted Agents: The Rules of Combination
Clin. Cancer Res.,
September 15, 2007;
13(18):
5232 - 5237.
[Abstract]
[Full Text]
[PDF]
|
 |
|
|