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Sunitinib (Sutent) Effective in Renal, Gastrointestinal, and Neuroendocrine Cancers: Presented at ICACT

By Jill Stein

PARIS, FRANCE -- February 1, 2006 -- Sunitinib malate (Sutent) provided clinically meaningful disease control and responses in most patients with metastatic gastrointestinal stromal tumors (GIST) tumors, metastatic renal cell carcinoma, and advanced unresectable neuroendocrine tumors in three phase 2 trials.

The data, presented here on February 1^st at the 17^th International Congress on Anti-Cancer Treatment (ICACT), also showed that patients receiving sunitinib did not experience a significant or meaningful change in fatigue levels.

Sunitinib is an oral highly selective, multi-targeted tyrosine kinase inhibitor with antiangiogenic and antitumor activities that selectively inhibits vascular endothelial growth factor receptors, platelet-derived growth factor receptors, stem cell factor receptors, glial cell line- derived neurotrophic factor and FMS-like tyrosine kinase-3 receptor.

Presenter Jennifer L. Beaumont, MS, Research Statistician, Evanston Northwestern Healthcare, Evanston, Illinois, United States, described data on efficacy and patient-reported fatigue from three phase 2 trials. Fatigue was further assessed after it had been identified in phase 1 trials as a dose-limiting toxicity.

All patients had histologically confirmed disease and an Eastern Cooperative Oncology Group performance status of 0 or 1.

Sunitinib was given orally 50 mg/day in repeated cycles of four weeks on treatment followed by 2 weeks off treatment.

Most patients in all three studies achieved a best response of partial response or stable disease.

Partial response and stable disease, determined by Response Evaluation Criteria in Solid Tumors, in the 55 GIST patients were 9% and 75%, respectively. In the 63 renal cell carcinoma patients, partial response and stable disease were observed in 40% and 28% of patients, respectively.

Median time to tumor progression in the 63 patients was 8.7 months, and the median survival was 16.4 months, Ms. Beaumont said.

In 106 patients with neuroendocrine tumors, the best objective tumor responses were a partial response in 10% of patients and stable disease in 80%. Median progression-free survival was 40 weeks, and the 1-year survival rate was 82.8%.

Baseline mean scores on the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale for the 55 GIST, the 63 renal cell carcinoma, and the 106 neuroendocrine tumor patients were 37.6, 40.4, a and 39.9 points, respectively, all lower than the general US population average of 43.6.

During the first four cycles of therapy, the mean FACIT-Fatigue score changes from baseline in each trial were 2.2 in GIST patients, -2.2 in renal cell carcinoma patients, and -2.0 in patients with neuroendocrine tumors. Mean changes from baseline were all less than the established minimally important difference of three points for the FACIT-Fatigue scale. Changes from baseline scores did not differ with response to therapy in the three trials.

Within treatment cycles, mean scores decreased slightly (reflecting more fatigue) during the 4 weeks on treatment and increased (reflecting less fatigue) during the 2 weeks off treatment. This pattern was generally consistent in all four cycles and for all three trials, Ms. Beaumont said.

The sunitinib trials were sponsored by Pfizer.


[Presentation title: Efficacy and Patient-Reported Outcomes of Sunitinib Malate (SU11248) in Three Phase II Trials in advanced Renal Cell Carcinoma, Gastrointestinal Stromal Tumor, and Neuroendocrine Tumor.]

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