Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 2
Author(s) -
Roy S. Herbst,
Giuseppe Giaccone,
Joan H. Schiller,
Ronald B. Natale,
Vincent A. Miller,
Christian Manegold,
Giorgio V. Scagliotti,
Rafael Rosell,
Ira A. Oliff,
James A. Reeves,
Michael Wolf,
Annetta Krebs,
Steven D. Averbuch,
Judith Ochs,
John Grous,
Abderrahim Fandi,
David H. Johnson
Publication year - 2004
Publication title -
journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 10.482
H-Index - 548
eISSN - 1527-7755
pISSN - 0732-183X
DOI - 10.1200/jco.2004.07.215
Subject(s) - gefitinib , medicine , tolerability , carboplatin , lung cancer , placebo , oncology , chemotherapy , paclitaxel , docetaxel , phases of clinical research , pharmacology , epidermal growth factor receptor , cancer , adverse effect , pathology , cisplatin , alternative medicine
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.
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