Continuous daily sunitinib enhances response rates in advanced pancreatic tumors

Continuous daily sunitinib significantly improves overall survival and progression-free survival (PFS) in patients with advanced pancreatic neuroendocrine tumors, according to data from a phase 3 study.

The study examined the effect of daily oral treatment with sunitinib, 37.5 mg, in comparison with placebo in 171 patients with progressive, well-differentiated, malignant pancreatic neuroendocrine tumors.

All patients had progression of their disease during the prior 12 months despite treatment with curative intent (about 90% had surgery prior to randomization and about two-thirds in each arm had prior systemic treatments, including octreotide, octreotide acetate, lanreotide).

Almost all patients had Eastern Cooperative Oncology Group performance status of either 0 or 1 at baseline. Approximately half of the patients had nonfunctioning tumors at enrollment, and more than 90% had distant metastases, including up to 40% with extrahepatic metastases in each arm.

Median PFS, the primary end point, was 11.4 months in patients randomized to sunitinib and 5.5 months in patients randomly assigned to placebo, representing a reduction in the hazard ratio of 58% favoring sunitinib, said lead investigator Patricia Niccoli, professor in the departments of endocrinology and surgery, University of the Medeiterranea Medical School, Marseille, France, at the annual meeting of the American Society of Clinical Oncology in Chicago.

Six-month event free survival was 71.3% in patients randomized to sunitinib compared with 43.2% in those randomly assigned to placebo.

Nine deaths occurred in sunitinib-treated patients and 21 in placebo recipients (the median follow-up was 10.2 months in the sunitinib group and 11.1 months in the placebo group). Six-month overall survival was 92.6% in the sunitinib group and 85.2% in the placebo group, representing a 60% improvement in the hazard ratio in sunitinib-treated patients.

Continuous daily dosing with sunitinib was well-tolerated. Adverse events that occurred more frequently in the sunitinib group were diarrhea, neutropenia, hypertension, and hand-foot syndrome.