Long-Term Safety, Efficacy of Sunitinib for Gastrointestinal Tumors Confirmed

the Cancer Therapy Advisor take:

The long-term safety and efficacy of sunitinib in patients with advanced gastrointestinal stromal tumor (GIST) was confirmed in a large international population, according to a study published online in the journal Cancer.

In this study, the imatinib-resistant/intolerant patients were given an initial dosage of sunitinib 50 mg daily in 6-week cycles—4 weeks on treatment and 2 weeks off treatment. Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors version 1.0.

Overall, the study included 1,124 patients in the intent-to-treat population, 15% of which had a baseline Eastern Cooperative Oncology Group performance status greater than or equal to 2. 

Median values for treatment duration and tumor progression were analyzed [7.0 months and 8.3 months (95% CI: 8.0, 9.4 months), respectively].  The median overall survival was found to be 16.6 months (95% CI: 14.9, 18.0 months), with 36% of patients alive at the time of analysis.

Patients that had a modified initial dosing schedule had a longer median overall survival of 23.5 months compared with patients who were strictly treated using the initial dosing schedule (OS 11.1 months).

Treatment-related grade 3 and 4 adverse events included hand-foot syndrome (11%), fatigue (9%), neutropenia (8%), hypertension (7%), thrombocytopenia (6%), and those associated with cardiac function (e.g., congestive heart failure) (≤1%).