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Originally published as JCO Early Release 10.1200/JCO.2003.10.038 on May 14 2003

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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 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 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 d’Hebron 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 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 8.0 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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Related Correspondence

  • Immunohistochemical Detection of HER1/HER2 Can Be Considered a Predictive Marker of Gefitinib Activity in Non-Small-Cell Lung Cancer?
    Cristina Noberasco, Tommaso De Pas, Giuseppe Curigliano, Sara Manzoni, Lucia Dodaro, Giuseppe Pelosi, Lorenzo Spaggiari, and Filippo De Braud
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Speeding up the Evaluation of New Agents in Cancer
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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.
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Lung Cancer with Epidermal Growth Factor Receptor Exon 20 Mutations Is Associated with Poor Gefitinib Treatment Response
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L. V. Sequist, J. E. Settleman, J. B. Ackman, and A. J. Iafrate
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N. Engl. J. Med., July 24, 2008; 359(4): 405 - 414.
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F. R. Khuri and J. Roman
From Nihilism to Individualism: The Evolution of Lung Cancer Therapy
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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
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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
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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
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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.
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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.
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P. S. Hodkinson, A. MacKinnon, and T. Sethi
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Chest, May 1, 2008; 133(5): 1209 - 1216.
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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
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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.
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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
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G A Silvestri and S G Spiro
Carcinoma of the bronchus 60 years later
Postgrad. Med. J., April 1, 2008; 84(990): 182 - 187.
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J. Verweij
Other Endpoints in Screening Studies for Soft Tissue Sarcomas
Oncologist, April 1, 2008; 13(suppl_2): 27 - 31.
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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.
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F. Ciardiello and G. Tortora
EGFR Antagonists in Cancer Treatment
N. Engl. J. Med., March 13, 2008; 358(11): 1160 - 1174.
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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.
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C. M. Rudin, W. Liu, A. Desai, T. Karrison, X. Jiang, L. Janisch, S. Das, J. Ramirez, B. Poonkuzhali, E. Schuetz, et al.
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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
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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.
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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.
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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
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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
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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.
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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
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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
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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
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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.
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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.
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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.
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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
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F. Thomas, P. Rochaix, A. Benlyazid, J. Sarini, M. Rives, J. L. Lefebvre, B. C. Allal, F. Courbon, E. Chatelut, and J.-P. Delord
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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.
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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.
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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.
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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
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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.
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Mol. Cancer Ther., October 1, 2007; 6(10): 2642 - 2651.
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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
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E. L. Kwak, J. W. Clark, and B. Chabner
Targeted Agents: The Rules of Combination
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