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Clinical Trial
. 2008 Feb 1;26(4):650-6.
doi: 10.1200/JCO.2007.13.9303.

Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer

Mark A Socinski  1 , Silvia Novello, Julie R Brahmer, Rafael Rosell, Jose M Sanchez, Chandra P Belani, Ramaswamy Govindan, James N Atkins, Heidi H Gillenwater, Cinta Pallares, Lesley Tye, Paulina Selaru, Richard C Chao, Giorgio V Scagliotti
Affiliations
Clinical Trial

Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer

Mark A Socinski et al. J Clin Oncol. .

Abstract

Purpose: Aberrant vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) signaling have been shown to play a role in non-small-cell lung cancer (NSCLC) pathogenesis and are associated with decreased survival. We evaluated the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multitargeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced NSCLC.

Patients and methods: Patients with stage IIIB or IV NSCLC for whom platinum-based chemotherapy had failed received 50 mg/d of sunitinib for 4 weeks followed by 2 weeks of no treatment in 6-week treatment cycles. The primary end point was objective response rate (ORR); secondary end points included progression-free survival, overall survival, and safety.

Results: Of the 63 patients treated with sunitinib, seven patients had confirmed partial responses, yielding an ORR of 11.1% (95% CI, 4.6% to 21.6%). An additional 18 patients (28.6%) experienced stable disease of at least 8 weeks in duration. Median progression-free survival was 12.0 weeks (95% CI, 10.0 to 16.1 weeks), and median overall survival was 23.4 weeks (95% CI, 17.0 to 28.3 weeks). Therapy was generally well tolerated.

Conclusion: Sunitinib has promising single-agent activity in patients with recurrent NSCLC, with an ORR similar to that of currently approved agents and an acceptable safety profile. Further evaluation in combination with other targeted agents and chemotherapy in patients with NSCLC is warranted.

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Conflict of interest statement

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a “U” are those for which no compensation was received; those relationships marked with a “C” were compensated. For a detailed description of the disclosure categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: Lesley Tye, Pfizer (C); Paulina Selaru, Pfizer (C); Richard C. Chao, Pfizer (C) Consultant or Advisory Role: Julie R. Brahmer, Eli Lilly (C), Cephalon (C), Genentech (C); Chandra P. Belani, Pfizer (C); Giorgio V Scagliotti, Eli Lilly (C) Stock Ownership: Lesley Tye, Pfizer; Paulina Selaru, Pfizer; Richard C. Chao, Pfizer Honoraria: Mark A Socinski, Genentech, Eli Lilly, Sanofi-Aventis; Heidi H. Gillenwater, Genentech; Giorgio V. Scagliotti, Eli Lilly, Sanofi-Aventis, Roche Research Funding: Mark A. Socinski, Genentech, Eli Lilly, Pfizer, Sanofi-Aventis; Julie R. Brahmer, Wyeth, AstraZeneca, Pfizer, Medarex; Ramaswamy Govindan, Pfizer; Heidi H. Gillenwater, Pfizer; Giorgio V. Scagliotti, Eli Lilly Expert Testimony: None Other Remuneration: None

Figures

Fig 1
Fig 1
Best response for target lesions by patient, based on maximal percentage of tumor reduction. Patients experiencing a partial response according Response Evaluation Criteria in Solid Tumors (RECIST) are shown in yellow bars, while those with stable disease or progressive disease are shown in blue bars. (Some patients withdrew from the study before their first postscreening scan.)
Fig 2
Fig 2
Kaplan-Meier plots of (A) progression-free survival (PFS) and (B) overall survival (OS).
See this image and copyright information in PMC

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