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Journal of Clinical Oncology, Vol 22, No 5 (March 1), 2004: pp. 785-794
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.07.215
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Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 2

Roy S. Herbst, Giuseppe Giaccone, Joan H. Schiller, Ronald B. Natale, Vincent Miller, Christian Manegold, Giorgio Scagliotti, Rafael Rosell, Ira Oliff, James A. Reeves, Michael K. Wolf, Annetta D. Krebs, Steven D. Averbuch, Judith S. Ochs, John Grous, Abderrahim Fandi, David H. Johnson

From The University of Texas M.D. Anderson Cancer Center, Houston, TX; the University of Wisconsin Hospital and Clinics, Madison, WI; Cedars-Sinai Comprehensive Cancer Center, Beverly Hills, CA; Memorial Sloan-Kettering Cancer Center, New York, NY; Midwest Cancer Research Group, Skokie, IL; Florida Cancer Specialists, Fort Myers, FL; AstraZeneca Pharmaceuticals, Wilmington, DE; Vanderbilt-Ingram Cancer Center, Nashville, TN; Free University Medical Center, Amsterdam, the Netherlands; Thoraxklinik, Heidelberg, Germany; S. Luigi Gonzaga Hospital, Turin, Italy; Hospital Germans Trias i Pujol, Barcelona, Spain; and AstraZeneca Pharmaceuticals, Alderley Park, United Kingdom.

Address reprint requests to R.S. Herbst, MD, PhD, Department of Thoracic/Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 432, Houston, TX 77030; e-mail: rherbst{at}mail.mdanderson.org

PURPOSE: Preclinical studies indicate that gefitinib (Iressa, ZD1839; AstraZeneca, Wilmington, DE), an orally active epidermal growth factor receptor tyrosine kinase inhibitor, may enhance antitumor efficacy of cytotoxics, and combination with paclitaxel and carboplatin had acceptable tolerability in a phase I trial. Gefitinib monotherapy demonstrated unparalleled antitumor activity for a biologic agent, with less toxicity than docetaxel, in phase II trials in refractory, advanced non–small-cell lung cancer (NSCLC). This phase III, randomized, placebo-controlled, double-blind trial evaluated gefitinib plus paclitaxel and carboplatin in chemotherapy-naive patients with advanced NSCLC.

PATIENTS AND METHODS: Patients received paclitaxel 225 mg/m2 and carboplatin area under concentration/time curve of 6 mg/min/mL (day 1 every 3 weeks) plus gefitinib 500 mg/d, gefitinib 250 mg/d, or placebo. After a maximum of six cycles, daily gefitinib or placebo continued until disease progression. End points included overall survival, time to progression (TTP), response rate (RR), and safety evaluation.

RESULTS: A total of 1,037 patients were recruited. Baseline demographic characteristics were well balanced. There was no difference in overall survival (median, 8.7, 9.8, and 9.9 months for gefitinib 500 mg/d, 250 mg/d, and placebo, respectively; P = .64), TTP, or RR between arms. Expected dose-related diarrhea and skin toxicity were observed in gefitinib-treated patients, with no new significant/unexpected safety findings from combination with chemotherapy. Subset analysis of patients with adenocarcinoma who received >= 90 days' chemotherapy demonstrated statistically significant prolonged survival, suggesting a gefitinib maintenance effect.

CONCLUSION: Gefitinib showed no added benefit in survival, TTP, or RR compared with standard chemotherapy alone. This large, placebo-controlled trial confirmed the favorable gefitinib safety profile observed in phase I and II monotherapy trials.

Supported by a grant from AstraZeneca, Wilmington, DE.

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


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?
    Nicola Normanno
    JCO 2005 23: 928-930 [Full Text]


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