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Maintenance sunitinib extends OS in metastatic pancreatic adenocarcinoma
Sunitinib maintenance therapy extended OS and PFS in patients with metastatic pancreatic adenocarcinoma, according to the results of a multicenter phase 2 study.
The open-label study included 55 patients with a performance status >50%. No patients experienced disease progression 6 months after first-line chemotherapy.
Researchers randomly assigned 27 patients to maintenance with sunitinib (Sutent, Pfizer) and 28 patients to observation. Those in the treatment group received sunitinib 37.5 mg daily for 6 months or until disease progression. The median duration of treatment was 91 days (range, 7-186).
Probability of PFS at 6 months served as the primary outcome.
Researchers reported 6-month PFS rates of 22.2% (95% CI, 6.2%-38.2%) in the treatment group compared with 3.6% (95% CI, 0%-10.6%) in the observation group. The 2-year OS rate (22.9% vs. 7.1%; P=.11) and the stable disease rate (51.9% vs. 21.4%; P=.02) were higher in the treatment arm.
The most common grade 3/4 toxic adverse events were thrombocytopenia, neutropenia and hand-foot syndrome (12% each), and diarrhea (8%).
“This is the first randomized trial on maintenance therapy in metastatic pancreatic adenocarcinoma,” the researchers wrote. “The primary endpoint was fulfilled and [2-year OS] was remarkably high, suggesting that maintenance sunitinib is promising and should be further explored in this patient population.”