Source: DGNews  |  Posted 2 years ago

By Ed Susman

ORLANDO, Fla -- January 25, 2010 -- Treating neuroendocrine tumours of the
pancreas with sunitinib more than doubles progression-free survival compared
with placebo, according to a phase 3 study presented here at the 2010
Gastrointestinal Cancers Symposium (ASCO-GI).

“We found a significant improvement in progression-free survival -- 11.4 months
with sunitinib versus 5.5 months with placebo [P < .0001],” said
Eric Raymond, MD, Medical Oncology Department, Hôpital Beaujon, Clichy, France,
during a poster presentation on January 23.

“We also observed a significant survival benefit, with about a 60% reduction in
the risk of death [ P = .0204] if a person was taking sunitinib for
these cancers.”

While the percentage of patients who achieved an objective response was just
9.3%, it was still significant compared with placebo patients, none of whom
achieved a partial response to therapy.

“What we also observed is that even though these neuroendocrine tumours of the
pancreas are considered slow-growing cancers, we saw that if you don’t treat
these tumours, they are no longer indolent,” said Dr. Raymond.

Dr. Raymond presented final results from a randomised, international,
double-blind trial in patients with advanced neuroendocrine tumours that was
halted almost a year ago with only about half of the planned patients (340)
enrolled at the recommendation of the Independent Safety Data Monitoring
Committee due to differences in efficacy.

In the trial, 86 patients with progressive, well-differentiated, malignant
pancreatic neuroendocrine tumours were randomly assigned to receive sunitinib
37.5 mg/day plus best supportive care while another 85 patients were assigned
to receive placebo plus best supportive care.

“The magnitude of sunitinib’s benefit in the pancreatic neuroendocrine tumour
patient population was an encouraging finding,” said Dr. Raymond. “These
findings offer hope to a patient population for whom there are limited
treatment options.”

Adverse events were similar to those observed in other sunitinib studies. The
most commonly reported grade 3/4 adverse events in the sunitinib arm were
neutropenia (12%), hypertension (9.6%), hand-foot syndrome (6%), and leucopenia
(6%).

Funding for this study was provided by Pfizer.

The 2010 Gastrointestinal Cancers Symposium is sponsored by the American
Gastroenterological Association Institute, the American Society of Clinical
Oncology, the American Society for Therapeutic Radiation Oncology, and the
Society of Surgical Oncology.

[Presentation title: Updated Results of the Phase III Trial of Sunitinib
(SU) Versus Placebo (PBO) for Treatment of Advanced Pancreatic Neuroendocrine
Tumors (NET). Abstract 127]