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Clinical Cancer Research Vol. 6, 2053-2063, May 2000
© 2000 American Association for Cancer Research

Experimental Therapeutics, Preclinical Pharmacology

Antitumor Effect and Potentiation of Cytotoxic Drugs Activity in Human Cancer Cells by ZD-1839 (Iressa), an Epidermal Growth Factor Receptor-selective Tyrosine Kinase Inhibitor1

Fortunato Ciardiello2, Rosa Caputo, Roberto Bianco, Vincenzo Damiano, Grazia Pomatico, Sabino De Placido, A. Raffaele Bianco and Giampaolo Tortora

Cattedra di Oncologia Medica, Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica, Università degli Studi di Napoli Federico II, 5-80131 Naples, Italy

Transforming growth factor {alpha} (TGF-{alpha}) is an autocrine growth factor for human cancer. Overexpression of TGF-{alpha} and its specific receptor, the epidermal growth factor receptor (EGFR), is associated with aggressive disease and poor prognosis. The EGFR has been proposed as a target for anticancer therapy. Compounds that block ligand-induced EGFR activation have been developed. ZD-1839 (Iressa) is a p.o.-active, quinazoline derivative that selectively inhibits the EGFR tyrosine kinase and is under clinical development in cancer patients. The antiproliferative activity of ZD-1839 alone or in combination with cytotoxic drugs differing in mechanism(s) of action, such as cisplatin, carboplatin, oxaliplatin, paclitaxel, docetaxel, doxorubicin, etoposide, topotecan, and raltitrexed, was evaluated in human ovarian (OVCAR-3), breast (ZR-75–1, MCF-10A ras), and colon cancer (GEO) cells that coexpress EGFR and TGF-{alpha}. ZD-1839 inhibited colony formation in soft agar in a dose-dependent manner in all cancer cell lines. The antiproliferative effect was mainly cytostatic. However, treatment with higher doses resulted in a 2–4-fold increase in apoptosis. A dose-dependent supra-additive increase in growth inhibition was observed when cancer cells were treated with each cytotoxic drug and ZD-1839. The combined treatment markedly enhanced apoptotic cell death induced by single-agent treatment. ZD-1839 treatment of nude mice bearing established human GEO colon cancer xenografts revealed a reversible dose-dependent inhibition of tumor growth because GEO tumors resumed the growth rate of controls at the end of the treatment. In contrast, the combined treatment with a cytotoxic agent, such as topotecan, raltitrexed, or paclitaxel, and ZD-1839 produced tumor growth arrest in all mice. Tumors grew slowly for approximately 4–8 weeks after the end of treatment, when they finally resumed a growth rate similar to controls. GEO tumors reached a size not compatible with normal life in all control mice within 4–6 weeks and in all single agent-treated mice within 6–8 weeks after GEO cell injection. In contrast, 50% of mice treated with ZD-1839 plus topotecan, raltitrexed, or paclitaxel were still alive 10, 12, and 15 weeks after cancer cell injection, respectively. These results demonstrate the antitumor effect of this EGFR-selective tyrosine kinase inhibitor and provide a rationale for its clinical evaluation in combination with cytotoxic drugs.




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Phase II Study of Gefitinib in Patients with Relapsed or Persistent Ovarian or Primary Peritoneal Carcinoma and Evaluation of Epidermal Growth Factor Receptor Mutations and Immunohistochemical Expression: A Gynecologic Oncology Group Study
Clin. Cancer Res., August 1, 2005; 11(15): 5539 - 5548.
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 Clin. Cancer Res.Home page
K. Kiguchi, L. Ruffino, T. Kawamoto, T. Ajiki, and J. DiGiovanni
Chemopreventive and Therapeutic Efficacy of Orally Active Tyrosine Kinase Inhibitors in a Transgenic Mouse Model of Gallbladder Carcinoma
Clin. Cancer Res., August 1, 2005; 11(15): 5572 - 5580.
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J. Terry, J. M. Lubieniecka, W. Kwan, S. Liu, and T. O. Nielsen
Hsp90 Inhibitor 17-Allylamino-17-Demethoxygeldanamycin Prevents Synovial Sarcoma Proliferation via Apoptosis in In vitro Models
Clin. Cancer Res., August 1, 2005; 11(15): 5631 - 5638.
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T. Friess, W. Scheuer, and M. Hasmann
Combination Treatment with Erlotinib and Pertuzumab against Human Tumor Xenografts Is Superior to Monotherapy
Clin. Cancer Res., July 15, 2005; 11(14): 5300 - 5309.
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 Cancer Res.Home page
Y. Zhou and M. G. Brattain
Synergy of Epidermal Growth Factor Receptor Kinase Inhibitor AG1478 and ErbB2 Kinase Inhibitor AG879 in Human Colon Carcinoma Cells Is Associated with Induction of Apoptosis
Cancer Res., July 1, 2005; 65(13): 5848 - 5856.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
H E Jones, J M W Gee, K M Taylor, D Barrow, H D Williams, M Rubini, and R I Nicholson
Development of strategies for the use of anti-growth factor treatments
Endocr. Relat. Cancer, July 1, 2005; 12(Supplement_1): S173 - S182.
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 Clin. Cancer Res.Home page
G. Xia, S. R. Kumar, R. Masood, M. Koss, C. Templeman, D. Quinn, S. Zhu, R. Reddy, V. Krasnoperov, and P. S. Gill
Up-Regulation of EphB4 in Mesothelioma and Its Biological Significance
Clin. Cancer Res., June 15, 2005; 11(12): 4305 - 4315.
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 Cancer Res.Home page
A. Hirata, F. Hosoi, M. Miyagawa, S.-i. Ueda, S. Naito, T. Fujii, M. Kuwano, and M. Ono
HER2 Overexpression Increases Sensitivity to Gefitinib, an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, through Inhibition of HER2/HER3 Heterodimer Formation in Lung Cancer Cells
Cancer Res., May 15, 2005; 65(10): 4253 - 4260.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
A. Yoshimoto, K. Kasahara, M. Nishio, T. Hourai, T. Sone, H. Kimura, M. Fujimura, and S. Nakao
Changes in Angiogenic Growth Factor Levels After Gefitinib Treatment in Non-small Cell Lung Cancer
Jpn. J. Clin. Oncol., May 1, 2005; 35(5): 233 - 238.
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 Cancer Res.Home page
A. Jimeno, B. Rubio-Viqueira, M. L. Amador, D. Oppenheimer, N. Bouraoud, P. Kulesza, V. Sebastiani, A. Maitra, and M. Hidalgo
Epidermal Growth Factor Receptor Dynamics Influences Response to Epidermal Growth Factor Receptor Targeted Agents
Cancer Res., April 15, 2005; 65(8): 3003 - 3010.
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 Clin. Cancer Res.Home page
J. W. Lee, Y. H. Soung, S. Y. Kim, H. K. Nam, W. S. Park, S. W. Nam, M. S. Kim, D. I. Sun, Y. S. Lee, J. J. Jang, et al.
Somatic Mutations of EGFR Gene in Squamous Cell Carcinoma of the Head and Neck
Clin. Cancer Res., April 15, 2005; 11(8): 2879 - 2882.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. Baselga and C. L. Arteaga
Critical Update and Emerging Trends in Epidermal Growth Factor Receptor Targeting in Cancer
J. Clin. Oncol., April 10, 2005; 23(11): 2445 - 2459.
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 JCOHome page
W. Pao and V. A. Miller
Epidermal Growth Factor Receptor Mutations, Small-Molecule Kinase Inhibitors, and Non-Small-Cell Lung Cancer: Current Knowledge and Future Directions
J. Clin. Oncol., April 10, 2005; 23(11): 2556 - 2568.
[Abstract] [Full Text] [PDF]

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 JCOHome page
N. C. Nagaria, J. Cogswell, J. K. Choe, and B. Kasimis
Side Effects and Good Effects from New Chemotherapeutic Agents: CASE 1. Gefitinib-Induced Interstitial Fibrosis
J. Clin. Oncol., April 1, 2005; 23(10): 2423 - 2424.
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 Ann OncolHome page
G. Giaccone
HER1/EGFR-targeted agents: predicting the future for patients with unpredictable outcomes to therapy
Ann. Onc., April 1, 2005; 16(4): 538 - 548.
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 Genes Dev.Home page
R. Meuwissen and A. Berns
Mouse models for human lung cancer
Genes & Dev., March 15, 2005; 19(6): 643 - 664.
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 Proc. Natl. Acad. Sci. USAHome page
J. A. Engelman, P. A. Janne, C. Mermel, J. Pearlberg, T. Mukohara, C. Fleet, K. Cichowski, B. E. Johnson, and L. C. Cantley
ErbB-3 mediates phosphoinositide 3-kinase activity in gefitinib-sensitive non-small cell lung cancer cell lines
PNAS, March 8, 2005; 102(10): 3788 - 3793.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
D. B. Solit, Y. She, J. Lobo, M. G. Kris, H. I. Scher, N. Rosen, and F. M. Sirotnak
Pulsatile Administration of the Epidermal Growth Factor Receptor Inhibitor Gefitinib Is Significantly More Effective than Continuous Dosing for Sensitizing Tumors to Paclitaxel
Clin. Cancer Res., March 1, 2005; 11(5): 1983 - 1989.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
L. P. Stabile, J. S. Lyker, C. T. Gubish, W. Zhang, J. R. Grandis, and J. M. Siegfried
Combined Targeting of the Estrogen Receptor and the Epidermal Growth Factor Receptor in Non-Small Cell Lung Cancer Shows Enhanced Antiproliferative Effects
Cancer Res., February 15, 2005; 65(4): 1459 - 1470.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
Y. Nakamura, M. Oka, H. Soda, K. Shiozawa, M. Yoshikawa, A. Itoh, Y. Ikegami, J. Tsurutani, K. Nakatomi, T. Kitazaki, et al.
Gefitinib ("Iressa", ZD1839), an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, Reverses Breast Cancer Resistance Protein/ABCG2-Mediated Drug Resistance
Cancer Res., February 15, 2005; 65(4): 1541 - 1546.
[Abstract] [Full Text] [PDF]

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 JCOHome page
N. Normanno
Gefitinib and Cisplatin-Based Chemotherapy in Non-Small-Cell Lung Cancer: Simply a Bad Combination?
J. Clin. Oncol., February 1, 2005; 23(4): 928 - 930.
[Full Text] [PDF]

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 Ann OncolHome page
J. P. Spano, R. Fagard, J.-C. Soria, O. Rixe, D. Khayat, and G. Milano
Epidermal growth factor receptor signaling in colorectal cancer: preclinical data and therapeutic perspectives
Ann. Onc., February 1, 2005; 16(2): 189 - 194.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
Y. H. Ibrahim and D. Yee
Insulin-Like Growth Factor-I and Breast Cancer Therapy
Clin. Cancer Res., January 15, 2005; 11(2): 944s - 950s.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
T. Arao, H. Fukumoto, M. Takeda, T. Tamura, N. Saijo, and K. Nishio
Small In-Frame Deletion in the Epidermal Growth Factor Receptor as a Target for ZD6474
Cancer Res., December 15, 2004; 64(24): 9101 - 9104.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
K. Mimori, K. Yamashita, M. Ohta, K. Yoshinaga, K. Ishikawa, H. Ishii, T. Utsunomiya, G. F. Barnard, H. Inoue, and M. Mori
Coexpression of Matrix Metalloproteinase-7 (MMP-7) and Epidermal Growth Factor (EGF) Receptor in Colorectal Cancer: An EGF Receptor Tyrosine Kinase Inhibitor Is Effective against MMP-7-Expressing Cancer Cells
Clin. Cancer Res., December 15, 2004; 10(24): 8243 - 8249.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
P M Harari
Epidermal growth factor receptor inhibition strategies in oncology
Endocr. Relat. Cancer, December 1, 2004; 11(4): 689 - 708.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
H E Jones, L Goddard, J M W Gee, S Hiscox, M Rubini, D Barrow, J M Knowlden, S Williams, A E Wakeling, and R I Nicholson
Insulin-like growth factor-I receptor signalling and acquired resistance to gefitinib (ZD1839; Iressa) in human breast and prostate cancer cells
Endocr. Relat. Cancer, December 1, 2004; 11(4): 793 - 814.
[Abstract] [Full Text] [PDF]

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 Integr Cancer TherHome page
M. F. McCarty
Targeting Multiple Signaling Pathways as a Strategy for Managing Prostate Cancer: Multifocal Signal Modulation Therapy
Integr Cancer Ther, December 1, 2004; 3(4): 349 - 380.
[Abstract] [PDF]

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 J. Pharmacol. Exp. Ther.Home page
J. H. Um, J. K. Kwon, C.-D. Kang, M. J. Kim, D. S. Ju, J. H. Bae, D. W. Kim, B. S. Chung, and S. H. Kim
Relationship between Antiapoptotic Molecules and Metastatic Potency and the Involvement of DNA-Dependent Protein Kinase in the Chemosensitization of Metastatic Human Cancer Cells by Epidermal Growth Factor Receptor Blockade
J. Pharmacol. Exp. Ther., December 1, 2004; 311(3): 1062 - 1070.
[Abstract] [Full Text] [PDF]

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 J. Pharmacol. Exp. Ther.Home page
S. L. Matheson, J. P. McNamee, T. Wang, M. A. Alaoui-Jamali, A. M. Tari, and B. J. Jean-Claude
The Combi-Targeting Concept: Dissection of the Binary Mechanism of Action of the Combi-Triazene SMA41 in Vitro and Antitumor Activity in Vivo
J. Pharmacol. Exp. Ther., December 1, 2004; 311(3): 1163 - 1170.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
S. Skvortsov, B. Sarg, J. Loeffler-Ragg, I. Skvortsova, H. Lindner, H. Werner Ott, P. Lukas, K. Illmensee, and H. Zwierzina
Different proteome pattern of epidermal growth factor receptor-positive colorectal cancer cell lines that are responsive and nonresponsive to C225 antibody treatment
Mol. Cancer Ther., December 1, 2004; 3(12): 1551 - 1558.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
L. H. Kalish, R. A. Kwong, I. E. Cole, R. M. Gallagher, R. L. Sutherland, and E. A. Musgrove
Deregulated Cyclin D1 Expression Is Associated with Decreased Efficacy of the Selective Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Gefitinib in Head and Neck Squamous Cell Carcinoma Cell Lines
Clin. Cancer Res., November 15, 2004; 10(22): 7764 - 7774.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
B. Friedmann, M. Caplin, J. A. Hartley, and D. Hochhauser
Modulation of DNA Repair In vitro after Treatment with Chemotherapeutic Agents by the Epidermal Growth Factor Receptor Inhibitor Gefitinib (ZD1839)
Clin. Cancer Res., October 1, 2004; 10(19): 6476 - 6486.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
V. Gregorc, G. L. Ceresoli, I. Floriani, A. Spreafico, K. B. Bencardino, V. Ludovini, L. Pistola, Z. Mihaylova, F. R. Tofanetti, M. Ferraldeschi, et al.
Effects of Gefitinib on Serum Epidermal Growth Factor Receptor and HER2 in Patients with Advanced Non-Small Cell Lung Cancer
Clin. Cancer Res., September 15, 2004; 10(18): 6006 - 6012.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
K. Yanase, S. Tsukahara, S. Asada, E. Ishikawa, Y. Imai, and Y. Sugimoto
Gefitinib reverses breast cancer resistance protein-mediated drug resistance
Mol. Cancer Ther., September 1, 2004; 3(9): 1119 - 1125.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
Y. Kuwahara, H. Hosoi, S. Osone, M. Kita, T. Iehara, H. Kuroda, and T. Sugimoto
Antitumor Activity of Gefitinib in Malignant Rhabdoid Tumor Cells In vitro and In vivo
Clin. Cancer Res., September 1, 2004; 10(17): 5940 - 5948.
[Abstract] [Full Text] [PDF]

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 JNCI J Natl Cancer InstHome page
F. Cappuzzo, E. Magrini, G. L. Ceresoli, S. Bartolini, E. Rossi, V. Ludovini, V. Gregorc, C. Ligorio, A. Cancellieri, S. Damiani, et al.
Akt Phosphorylation and Gefitinib Efficacy in Patients With Advanced Non-Small-Cell Lung Cancer
J Natl Cancer Inst, August 4, 2004; 96(15): 1133 - 1141.
[Abstract] [Full Text] [PDF]

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 GutHome page
R J Playford, H Wassan, and S Ghosh
Effects of growth factors and receptor blockade on gastrointestinal cancer
Gut, August 1, 2004; 53(8): 1059 - 1063.
[Abstract] [Full Text] [PDF]

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 JCOHome page
E. K. Rowinsky, G. H. Schwartz, J. A. Gollob, J. A. Thompson, N. J. Vogelzang, R. Figlin, R. Bukowski, N. Haas, P. Lockbaum, Y.-P. Li, et al.
Safety, Pharmacokinetics, and Activity of ABX-EGF, a Fully Human Anti-Epidermal Growth Factor Receptor Monoclonal Antibody in Patients With Metastatic Renal Cell Cancer
J. Clin. Oncol., August 1, 2004; 22(15): 3003 - 3015.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
D. Raben, C. Bianco, V. Damiano, R. Bianco, D. Melisi, C. Mignogna, F. P. D'Armiento, L. Cionini, A. R. Bianco, G. Tortora, et al.
Antitumor activity of ZD6126, a novel vascular-targeting agent, is enhanced when combined with ZD1839, an epidermal growth factor receptor tyrosine kinase inhibitor, and potentiates the effects of radiation in a human non-small cell lung cancer xenograft model
Mol. Cancer Ther., August 1, 2004; 3(8): 977 - 983.
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 Clin. Cancer Res.Home page
R. Bianco, R. Caputo, R. Caputo, V. Damiano, S. De Placido, C. Ficorella, S. Agrawal, A. R. Bianco, F. Ciardiello, and G. Tortora
Combined Targeting of Epidermal Growth Factor Receptor and MDM2 by Gefitinib and Antisense MDM2 Cooperatively Inhibit Hormone-Independent Prostate Cancer
Clin. Cancer Res., July 15, 2004; 10(14): 4858 - 4864.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. L. Dominguez-Escrig, J. D. Kelly, D. E. Neal, S. M. King, and B. R. Davies
Evaluation of the Therapeutic Potential of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Gefitinib in Preclinical Models of Bladder Cancer
Clin. Cancer Res., July 15, 2004; 10(14): 4874 - 4884.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
L. Castillo, M. C. Etienne-Grimaldi, J. L. Fischel, P. Formento, N. Magne, and G. Milano
Pharmacological background of EGFR targeting
Ann. Onc., July 1, 2004; 15(7): 1007 - 1012.
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