Originally published as JCO Early Release 10.1200/JCO.2008.20.8355 on July 13 2009

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Efficacy and Safety of Axitinib in Patients With Advanced Non–Small-Cell Lung Cancer: Results From a Phase II Study

From the University of Texas Southwestern Medical Center, Simmons Comprehensive Cancer Center, Dallas, TX; Hubert H. Humphrey Cancer Center-North Memorial Health Care, Robbinsdale, MN; University of California Irvine, Orange; Pfizer Global Research and Development, San Diego, CA; Carolinas Hematology Oncology Associates, Charlotte, NC; Vanderbilt University Medical Center, Nashville, TN; University of Chicago, Chicago, IL; Pfizer Global Research and Development, New London, CT; and Asklepios-Fachkliniken Munich-Gauting, Gauting, Germany.

Corresponding author: Joan H. Schiller, MD, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-8852; e-mail: joan.schiller{at}utsouthwestern.edu.

Purpose This phase II study evaluated efficacy and safety of single-agent axitinib, an oral, potent, selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, in patients with advanced non–small-cell lung cancer (NSCLC).

Patients and Methods This was an open-label, single-arm, multicenter, phase II study with a Simon two-stage minimax design. Patients received a starting dose of axitinib 5 mg orally BID. The primary end point was Response Evaluation Criteria in Solid Tumors (RECIST) –defined objective response rate. Secondary end points included safety and tolerability, overall survival (OS), and progression-free survival (PFS).

Results Thirty-two patients were enrolled, with a median age of 66.5 years. The majority of patients (75%) had adenocarcinoma. Nine patients (28%) had received no prior chemotherapy for metastatic disease, and 23 (72%) had received one regimen. Three patients (9%) had a RECIST investigator-assessed, confirmed partial response (PR); disease control rate (PR + stable disease) was 41%. Median PFS was 4.9 months overall (95% CI, 3.6 to 7.0 months). Median OS was 14.8 months (95% CI, 10.7 months to not estimable) overall and 14.8 months (95% CI, 12.5 months to not estimable) in patients receiving first-line axitinib. One-year survival rates for patients with or without prior therapy for metastatic disease were 57% and 78%, respectively. Grade 3 treatment-related adverse events in 5% of patients comprised fatigue (22%), hypertension (9%), and hyponatremia (9%).

Conclusion Axitinib demonstrated single-agent activity in patients with advanced NSCLC. Therapy was well tolerated with manageable toxicities. Further investigation of this VEGFR inhibitor in NSCLC is of interest.

Supported by Pfizer, La Jolla Laboratories, Clinical Development Department, San Diego, CA.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

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

Clinical trial information can be found for the following: NCT00094094 [ClinicalTrials.gov] .

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