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Journal of Clinical Oncology, Vol 22, No 5 (March 1), 2004: pp. 777-784
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.08.001
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Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1

Giuseppe Giaccone, Roy S. Herbst, Christian Manegold, Giorgio Scagliotti, Rafael Rosell, Vincent Miller, Ronald B. Natale, Joan H. Schiller, Joachim von Pawel, Anna Pluzanska, Ulrich Gatzemeier, John Grous, Judith S. Ochs, Steven D. Averbuch, Michael K. Wolf, Pamela Rennie, Abderrahim Fandi, David H. Johnson

From the Free University Medical Center, Amsterdam, the Netherlands; Thoraxklinik, Heidelberg; Asklepios Fachkliniken, Munich-Gauting; Krankenhaus Grosshansdorf, Grosshansdorf, Germany; S. Luigi Gonzaga Hospital, Turin, Italy; Hospital Germans Trias i Pujol, Barcelona, Spain; Regional Center of Oncology, Lodz, Poland; AstraZeneca, Alderley Park, United Kingdom; University of Texas M.D. Anderson Cancer Center, Houston, TX; Memorial Sloan-Kettering Cancer Center, New York, NY; Cedars-Sinai Comprehensive Cancer Center, Beverly Hills, CA; the University of Wisconsin Hospital and Clinics, Madison, WI; AstraZeneca Pharmaceuticals, Wilmington, DE; and Vanderbilt-Ingram Cancer Center, Nashville, TN.

Address reprint requests to Giuseppe Giaccone, MD, Vrije Universiteit Medical Center, Department of Oncology, De Boelelaan 1117, 1081 Amsterdam, the Netherlands; e-mail: g.giaccone{at}vumc.nl

PURPOSE: The purpose of this study was to determine whether the addition of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (Iressa, ZD1839; AstraZeneca, Wilmington, DE) to standard first-line gemcitabine and cisplatin provides clinical benefit over gemcitabine and cisplatin alone in patients with advanced or metastatic non–small-cell lung cancer (NSCLC). Gefitinib has demonstrated encouraging efficacy in advanced NSCLC in phase II trials in pretreated patients, and a phase I trial of gefitinib in combination with gemcitabine and cisplatin showed favorable tolerability.

PATIENTS AND METHODS: This was a phase III randomized, double-blind, placebo-controlled, multicenter trial in chemotherapy-naive patients with unresectable stage III or IV NSCLC. All patients received up to six cycles of chemotherapy (cisplatin 80 mg/m2 on day 1 and gemcitabine 1,250 mg/m2 on days 1 and 8 of the 3-week cycle) plus either gefitinib 500 mg/d, gefitinib 250 mg/d, or placebo. Daily gefitinib or placebo was continued until disease progression. End points included overall survival (primary), time to progression, response rates, and safety evaluation.

RESULTS: A total of 1,093 patients were enrolled. There was no difference in efficacy end points between the treatment groups: for the gefitinib 500 mg/d, gefitinib 250 mg/d, and placebo groups, respectively, median survival times were 9.9, 9.9, and 10.9 months (global ordered log-rank [GOLrank] P = .4560), median times to progression were 5.5, 5.8, and 6.0 months (GOLrank; P = .7633), and response rates were 49.7%, 50.3%, and 44.8%. No significant unexpected adverse events were seen.

CONCLUSION: Gefitinib in combination with gemcitabine and cisplatin in chemotherapy-naive patients with advanced NSCLC did not have improved efficacy over gemcitabine and cisplatin alone. The reasons for this remain obscure and require further preclinical testing.

Supported by a grant from AstraZeneca, Wilmington, DE.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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Related Editorial

  • Combining the Anti-EGFR Agent Gefitinib With Chemotherapy in Non–Small-Cell Lung Cancer: How Do We Go From INTACT to Impact?
    Jose Baselga
    JCO 2004 22: 759-761 [Full Text]

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  • Gefitinib and Cisplatin-Based Chemotherapy in Non-Small-Cell Lung Cancer: Simply a Bad Combination?
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    JCO 2005 23: 928-930 [Full Text]


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M. A. Socinski, R. Crowell, T. E. Hensing, C. J. Langer, R. Lilenbaum, A. B. Sandler, and D. Morris
Treatment of Non-small Cell Lung Cancer, Stage IV: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition)
Chest, September 1, 2007; 132(3_suppl): 277S - 289S.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
P. D. Bonomi, L. Buckingham, and J. Coon
Selecting Patients for Treatment with Epidermal Growth Factor Tyrosine Kinase Inhibitors
Clin. Cancer Res., August 1, 2007; 13(15): 4606s - 4612s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
E. O. Hanrahan and J. V. Heymach
Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitors Vandetanib (ZD6474) and AZD2171 in Lung Cancer
Clin. Cancer Res., August 1, 2007; 13(15): 4617s - 4622s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. J. Riely and V. A. Miller
Vascular Endothelial Growth Factor Trap in Non Small Cell Lung Cancer
Clin. Cancer Res., August 1, 2007; 13(15): 4623s - 4627s.
[Abstract] [Full Text] [PDF]

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 JAMAHome page
M. V. Karamouzis, J. R. Grandis, and A. Argiris
Therapies Directed Against Epidermal Growth Factor Receptor in Aerodigestive Carcinomas
JAMA, July 4, 2007; 298(1): 70 - 82.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
B. Wacker, T. Nagrani, J. Weinberg, K. Witt, G. Clark, and P. J. Cagnoni
Correlation between Development of Rash and Efficacy in Patients Treated with the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Erlotinib in Two Large Phase III Studies
Clin. Cancer Res., July 1, 2007; 13(13): 3913 - 3921.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
C. Gridelli, M. A. Bareschino, C. Schettino, A. Rossi, P. Maione, and F. Ciardiello
Erlotinib in Non-Small Cell Lung Cancer Treatment: Current Status and Future Development
Oncologist, July 1, 2007; 12(7): 840 - 849.
[Abstract] [Full Text] [PDF]

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 JCOHome page
P. A. Bunn Jr
Can Acquired Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Be Overcome by Different Small-Molecule Tyrosine Kinase Inhibitors?
J. Clin. Oncol., June 20, 2007; 25(18): 2504 - 2505.
[Full Text] [PDF]

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 Clin. Cancer Res.Home page
T. Li, Y.-H. Ling, I. D. Goldman, and R. Perez-Soler
Schedule-Dependent Cytotoxic Synergism of Pemetrexed and Erlotinib in Human Non-Small Cell Lung Cancer Cells
Clin. Cancer Res., June 1, 2007; 13(11): 3413 - 3422.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. A. Adjei, J. R. Molina, S. J. Mandrekar, R. Marks, J. R. Reid, G. Croghan, L. J. Hanson, J. R. Jett, C. Xia, C. Lathia, et al.
Phase I Trial of Sorafenib in Combination with Gefitinib in Patients with Refractory or Recurrent Non Small Cell Lung Cancer
Clin. Cancer Res., May 1, 2007; 13(9): 2684 - 2691.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
F. Morgillo, W.-Y. Kim, E. S. Kim, F. Ciardiello, W. K. Hong, and H.-Y. Lee
Implication of the Insulin-like Growth Factor-IR Pathway in the Resistance of Non small Cell Lung Cancer Cells to Treatment with Gefitinib
Clin. Cancer Res., May 1, 2007; 13(9): 2795 - 2803.
[Abstract] [Full Text] [PDF]

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 JCOHome page
U. Gatzemeier, A. Pluzanska, A. Szczesna, E. Kaukel, J. Roubec, F. De Rosa, J. Milanowski, H. Karnicka-Mlodkowski, M. Pesek, P. Serwatowski, et al.
Phase III Study of Erlotinib in Combination With Cisplatin and Gemcitabine in Advanced Non-Small-Cell Lung Cancer: The Tarceva Lung Cancer Investigation Trial
J. Clin. Oncol., April 20, 2007; 25(12): 1545 - 1552.
[Abstract] [Full Text] [PDF]

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 Clin TrialsHome page
R. L. Schilsky
Target practice: oncology drug development in the era of genomic medicine
Clinical Trials, April 1, 2007; 4(2): 163 - 166.
[PDF]

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 Molecular Cancer TherapeuticsHome page
W. M. Stadler
The randomized discontinuation trial: a phase II design to assess growth-inhibitory agents
Mol. Cancer Ther., April 1, 2007; 6(4): 1180 - 1185.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. Giaccone
The Potential of Antiangiogenic Therapy in Non-Small Cell Lung Cancer
Clin. Cancer Res., April 1, 2007; 13(7): 1961 - 1970.
[Abstract] [Full Text] [PDF]

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 Mol Cancer ResHome page
J. Tabernero
The Role of VEGF and EGFR Inhibition: Implications for Combining Anti-VEGF and Anti-EGFR Agents
Mol. Cancer Res., March 1, 2007; 5(3): 203 - 220.
[Abstract] [Full Text] [PDF]

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J. Kurai, H. Chikumi, K. Hashimoto, K. Yamaguchi, A. Yamasaki, T. Sako, H. Touge, H. Makino, M. Takata, M. Miyata, et al.
Antibody-Dependent Cellular Cytotoxicity Mediated by Cetuximab against Lung Cancer Cell Lines
Clin. Cancer Res., March 1, 2007; 13(5): 1552 - 1561.
[Abstract] [Full Text] [PDF]

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 JCOHome page
L. V. Sequist, D. W. Bell, T. J. Lynch, and D. A. Haber
Molecular Predictors of Response to Epidermal Growth Factor Receptor Antagonists in Non-Small-Cell Lung Cancer
J. Clin. Oncol., February 10, 2007; 25(5): 587 - 595.
[Abstract] [Full Text] [PDF]

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 Ann. Surg. Oncol.Home page
N. Steeghs, J. W. R. Nortier, and H. Gelderblom
Small Molecule Tyrosine Kinase Inhibitors in the Treatment of Solid Tumors: An Update of Recent Developments
Ann. Surg. Oncol., February 1, 2007; 14(2): 942 - 953.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
L. Toschi and F. Cappuzzo
Understanding the New Genetics of Responsiveness to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors
Oncologist, February 1, 2007; 12(2): 211 - 220.
[Abstract] [Full Text] [PDF]

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 Eur Respir JHome page
R. van Puijenbroek, L. Bosquee, A-P. Meert, D. Schallier, J-C. Goeminne, G. Tits, P. Collard, K. Nackaerts, J-L. Canon, F. Duplaquet, et al.
Gefitinib monotherapy in advanced nonsmall cell lung cancer: a large Western community implementation study
Eur. Respir. J., January 1, 2007; 29(1): 128 - 133.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
R. Rosell, M. Taron, N. Reguart, D. Isla, and T. Moran
Epidermal Growth Factor Receptor Activation: How Exon 19 and 21 Mutations Changed Our Understanding of the Pathway
Clin. Cancer Res., December 15, 2006; 12(24): 7222 - 7231.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. Patnaik, D. Wood, A. W. Tolcher, M. Hamilton, J. I. Kreisberg, L. A. Hammond, G. Schwartz, M. Beeram, M. Hidalgo, M. M. Mita, et al.
Phase I, Pharmacokinetic, and Biological Study of Erlotinib in Combination with Paclitaxel and Carboplatin in Patients with Advanced Solid Tumors
Clin. Cancer Res., December 15, 2006; 12(24): 7406 - 7413.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
P Ceppi, M Volante, S Novello, I Rapa, K. Danenberg, P. Danenberg, A Cambieri, G Selvaggi, S Saviozzi, R Calogero, et al.
ERCC1 and RRM1 gene expressions but not EGFR are predictive of shorter survival in advanced non-small-cell lung cancer treated with cisplatin and gemcitabine
Ann. Onc., December 1, 2006; 17(12): 1818 - 1825.
[Abstract] [Full Text] [PDF]

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 JCOHome page
F. R. Hirsch, M. Varella-Garcia, P. A. Bunn Jr, W. A. Franklin, R. Dziadziuszko, N. Thatcher, A. Chang, P. Parikh, J. R. Pereira, T. Ciuleanu, et al.
Molecular Predictors of Outcome With Gefitinib in a Phase III Placebo-Controlled Study in Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., November 1, 2006; 24(31): 5034 - 5042.
[Abstract] [Full Text] [PDF]

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R. Govindan, J. Crowley, L. Schwartzberg, P. Kennedy, C. Williams, B. Ekstrand, A. Sandler, D. Jaunakais, V. Bolejack, and R. Ghalie
Phase II Trial of Bexarotene Capsules in Patients With Advanced Non-Small-Cell Lung Cancer After Failure of Two or More Previous Therapies
J. Clin. Oncol., October 20, 2006; 24(30): 4848 - 4854.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
F. Morgillo, J. K. Woo, E. S. Kim, W. K. Hong, and H.-Y. Lee
Heterodimerization of Insulin-like Growth Factor Receptor/Epidermal Growth Factor Receptor and Induction of Survivin Expression Counteract the Antitumor Action of Erlotinib.
Cancer Res., October 15, 2006; 66(20): 10100 - 10111.
[Abstract] [Full Text] [PDF]

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G. Giaccone, M. Gallegos Ruiz, T. Le Chevalier, N. Thatcher, E. Smit, J. A. Rodriguez, P. Janne, D. Oulid-Aissa, and J.-C. Soria
Erlotinib for Frontline Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study.
Clin. Cancer Res., October 15, 2006; 12(20): 6049 - 6055.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
W.-C. Chou, S.-F. Huang, K.-Y. Yeh, H.-M. Wang, M.-Y. Liu, J.-J. Hsieh, Y.-C. Cheung, and J. W.-C. Chang
Different Responses to Gefitinib in Lung Adenocarcinoma Coexpressing Mutant- and Wild-Type Epidermal Growth Factor Receptor Genes
Jpn. J. Clin. Oncol., August 1, 2006; 36(8): 523 - 526.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. Inoue, T. Suzuki, T. Fukuhara, M. Maemondo, Y. Kimura, N. Morikawa, H. Watanabe, Y. Saijo, and T. Nukiwa
Prospective Phase II Study of Gefitinib for Chemotherapy-Naive Patients With Advanced Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor Gene Mutations
J. Clin. Oncol., July 20, 2006; 24(21): 3340 - 3346.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
L. V. Sequist, V. A. Joshi, P. A. Janne, D. W. Bell, P. Fidias, N. I. Lindeman, D. N. Louis, J. C. Lee, E. J. Mark, J. Longtine, et al.
Epidermal growth factor receptor mutation testing in the care of lung cancer patients.
Clin. Cancer Res., July 15, 2006; 12(14): 4403s - 4408s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. Dimitroulakos, I. A. Lorimer, and G. Goss
Strategies to enhance epidermal growth factor inhibition: targeting the mevalonate pathway.
Clin. Cancer Res., July 15, 2006; 12(14): 4426s - 4431s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
R. C. Lilenbaum
The evolving role of cetuximab in non-small cell lung cancer.
Clin. Cancer Res., July 15, 2006; 12(14): 4432s - 4435s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
D. H. Johnson
Targeted therapies in combination with chemotherapy in non-small cell lung cancer.
Clin. Cancer Res., July 15, 2006; 12(14): 4451s - 4457s.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
T. Troiani, O. Lockerbie, M. Morrow, F. Ciardiello, and S. G. Eckhardt
Sequence-dependent inhibition of human colon cancer cell growth and of prosurvival pathways by oxaliplatin in combination with ZD6474 (Zactima), an inhibitor of VEGFR and EGFR tyrosine kinases.
Mol. Cancer Ther., July 1, 2006; 5(7): 1883 - 1894.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
K.-H. Lee, S.-W. Han, P. G. Hwang, D.-Y. Oh, D.-W. Kim, D. H. Chung, S.-A. Im, T.-Y. Kim, D. S. Heo, and Y.-J. Bang
Epidermal Growth Factor Receptor Mutations and Response to Chemotherapy in Patients with Non-Small-Cell Lung Cancer.
Jpn. J. Clin. Oncol., June 1, 2006; 36(6): 344 - 350.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. Ando, I. Okamoto, N. Yamamoto, K. Takeda, K. Tamura, T. Seto, Y. Ariyoshi, and M. Fukuoka
Predictive Factors for Interstitial Lung Disease, Antitumor Response, and Survival in Non-Small-Cell Lung Cancer Patients Treated With Gefitinib
J. Clin. Oncol., June 1, 2006; 24(16): 2549 - 2556.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
D. Arnold, S. Peinert, W. Voigt, and H.-J. Schmoll
Epidermal growth factor receptor tyrosine kinase inhibitors: present and future role in gastrointestinal cancer treatment: a review.
Oncologist, June 1, 2006; 11(6): 602 - 611.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
S. Ramalingam and A. B. Sandler
Salvage therapy for advanced non-small cell lung cancer: factors influencing treatment selection.
Oncologist, June 1, 2006; 11(6): 655 - 665.
[Abstract] [Full Text] [PDF]


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