Researchers involved in an international multicenter trial have reported that Sutent® (sunitinib) has significant single-agent activity in previously-treated, advanced non–small cell lung cancer (NSCLC). The details of this Phase II study were published in the February 1, 2008 issue of the Journal of Clinical Oncology.

Sutent is an oral kinase inhibitor of fms-like tyrosine kinase 3 (Flt3), Kit, vascular endothelial growth factor (VEGF), and platelet-derived growth factor (PDGF) receptors. It produces anticancer effects through these targeted mechanisms that include anti-angiogenesis, as well as direct killing of the cancer cell. Sutent is approved for the treatment of advanced renal cell cancer, as well as for the treatment of gastrointestinal stromal tumors after disease progression on, or intolerance to, Gleevec® (imatinib).

To explore the effect of Sutent among patients with advanced NSCLC that has progressed after standard therapy, researchers conducted a Phase II clinical trial among 63 patients who had failed platinum-based therapy. Patients received 50 mg of Sutent daily for four weeks followed by two weeks off.

• Seven patients (11.1%) had a partial response.
• 18 patients (28.6%) had stable disease for at least eight weeks.
• Median progression-free survival was 12 weeks, and median overall survival was 23.4 weeks.
• Mild to moderate side effects included fatigue, nausea, shortness of breath, vomiting, anorexia, and diarrhea.
• Serious side effects were less common and included severe fatigue (19%), shortness of breath (13%), asthenia (9.5%), and nausea/vomiting (7%).
• Two patients died of pulmonary hemorrhage, and one patient died of cerebral hemorrhage.

The researchers concluded that Sutent was well tolerated and was probably as effective as currently approved agents for the treatment of patients with NSCLC who have failed first-line chemotherapy.

Comments: This is the first trial to evaluate Sutent alone in advanced NSCLC who have failed other therapies.

Related News:

Sutent® Shows Promise in Advanced Non-Small Cell Lung Cancer (06/13/2006)

Sutent® Linked with Heart Problems (01/11/2008)

Sutent® Improves Progression-Free Survival Over Interferon in Kidney Cancer (01/18/2007)

Sutent® Effective for Gleevec®-Resistant Gastrointestinal Stromal Tumor (10/16/2006)

Multicenter Trial Confirms Effectiveness of Sutent® for Treatment of Metastatic Renal Cell Carcinoma (06/23/2006)

Sutent® Approved by FDA for Treatment of Renal Cell Carcinoma and Gastrointestinal Stromal Tumor (04/04/2006)

Reference: Socinski MA, Novello S, Brahmer JR, et al. Multicenter, Phase II trial of sunitinib in previously treated, advanced non-small cell lung cancer. Journal of Clinical Oncology. 2008;26:650-656.