Advertisement
Journal of Clinical Oncology  
Search for:
Limit by:
  Browse by Subject or Issue
Home Search or Browse JCO Subscriptions PDA Services My JCO Customer Service

Journal of Clinical Oncology, Vol 25, No 30 (October 20), 2007: pp. 4793-4799
© 2007 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2007.12.8637

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Publisher's Note
Right arrow Erratum (v26,p514)
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a colleague
Right arrow Similar articles in this journal
Right arrow Alert me to new issues of the journal
Right arrow Save to my personal folders
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Saltz, L. B.
Right arrow Articles by Lenz, H. J.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Saltz, L. B.
Right arrow Articles by Lenz, H. J.

Phase II Trial of Sunitinib in Patients With Metastatic Colorectal Cancer After Failure of Standard Therapy

Leonard B. Saltz, Lee S. Rosen, John L. Marshall, Robert J. Belt, Herbert I. Hurwitz, S. Gail Eckhardt, Emily K. Bergsland, Daniel G. Haller, A. Craig Lockhart, Caio M. Rocha Lima, Xin Huang, Samuel E. DePrimo, Edna Chow-Maneval, Richard C. Chao, Heinz J. Lenz

From the Memorial Sloan-Kettering Cancer Center, New York, NY; Premiere Oncology, Santa Monica; University of California, San Francisco; Pfizer Global Research and Development, La Jolla; University of Southern California, Los Angeles, CA; Lombardi Cancer Center, Washington, DC; Oncology Hematology of Kansas City, Kansas City, MO; Duke University Medical Center, Durham, NC; University of Colorado Cancer Center, Aurora, CO; University of Pennsylvania, Philadelphia, PA; Vanderbilt University Medical Center, Nashville, TN; and University of Miami, Miami, FL

Address reprint requests to Leonard B. Saltz, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: saltzl{at}mskcc.org

Purpose: Sunitinib is an oral, multitargeted receptor tyrosine kinase inhibitor of the vascular endothelial growth factor receptor and multiple other growth factor receptors. We assessed the safety and efficacy of sunitinib in patients with metastatic colorectal cancer after failure of standard therapy.

Patients and Methods: Eighty-four patients were enrolled onto this two-stage phase II trial and were stratified by whether they had received prior bevacizumab (n = 43) or not (n = 41). Treatment comprised sunitinib 50 mg orally daily for 4 weeks, followed by 2 weeks off treatment, in repeated 6-week cycles.

Results: By Response Evaluation Criteria in Solid Tumors criteria, one patient, who was in the prior bevacizumab cohort, achieved a partial response, and 13 patients (two in the prior bevacizumab cohort and 11 in the no prior bevacizumab cohort) achieved stable disease lasting ≥ 22 weeks. Median time to progression in the prior bevacizumab and bevacizumab-naïve cohorts was 2.2 months (95% CI, 1.9 to 2.3 months) and 2.5 months (95% CI, 2.3 to 3.1 months), respectively, whereas median overall survival time was 7.1 months (95% CI, 4.9 to 10.6 months) and 10.2 months (95% CI, 8.2 to 15.3 months), respectively. The most common adverse events were fatigue, diarrhea, nausea, vomiting, and anorexia. Twenty-six patients (32%) required dose reduction to 37.5 mg/d, and one patient required dose reduction to 25 mg/d.

Conclusion: Sunitinib did not demonstrate a meaningful single-agent objective response rate in colorectal cancer refractory to standard chemotherapy. However, the mechanisms of action and acceptable safety profile of sunitinib warrant further study in combination with standard regimens for metastatic colorectal cancer.

Supported by Pfizer Inc.

Presented in part at 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA.

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




This article has been cited by other articles:


Home page
JCOHome page
A. J. Bilchik and J. R. Hecht
Perioperative Risks of Bevacizumab and Other Biologic Agents for Hepatectomy: Theoretical or Evidence Based?
J. Clin. Oncol., April 10, 2008; 26(11): 1786 - 1788.
[Full Text] [PDF]



About
JCO
 Editorial
Roster
 Advertising
Information
 Librarians &
Institutions
 Rights &
Permissions
 Site Map

Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
Terms and Conditions of Use
  HighWire Press HighWire Press™ assists in the publication of JCO Online