Medical DevicesSutent Significantly Improved Progression-Free Survival For Patients With Advanced Pancreatic Islet Cell Tumours
Pfizer announced preliminary results
from a randomized Phase 3 trial of Sutent (sunitinib malate) in
patients with advanced pancreatic islet cell tumours, also known as
pancreatic neuroendocrine tumours, which is a different type of cancer
than the more common pancreatic adenocarcinoma. Study findings
demonstrated that median progression-free survival (PFS) was 11.1
months in patients treated with Sutent compared to 5.5 months in
patients treated with placebo. Researchers today presented these data
at the 11th World Congress on Gastrointestinal Cancer in Barcelona,
Spain. The independent Data Monitoring Committee (DMC) recommended
halting the trial earlier this year because Sutent showed significant
benefit and the study had met its primary endpoint. Full analysis of
the data is ongoing.
"In this study, Sutent demonstrated an impressive improvement in
progression-free survival for patients with pancreatic islet cell
tumours," said Dr. Eric Raymond, MD, PhD, Professor of Medical
Oncology and Head of University Department of Medical Oncology
(Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy,
France, and lead investigator on this sunitinib Phase 3 study. "This
is encouraging news for patients, especially given that there are
limited treatment options for this type of advanced cancer."
Phase 3 Trial Results
This international, Phase 3 trial compared sunitinib to placebo in
patients with progressive, well-differentiated, malignant pancreatic
islet cell tumours who had progressed in the last 12 months. Patients were randomized to either the sunitinib (n=75) (37.5 mg/day,
continuous daily dosing) plus best supportive care arm or the placebo
plus best supportive care arm (n=79).
Results showed that median PFS was 11.1 months in patients treated
with sunitinib compared to 5.5 months in patients treated in the
placebo arm (Hazard ratio 0.397, pAbout Pancreatic Islet Cell Tumours
In contrast to exocrine pancreatic adenocarcinoma, pancreatic islet
cell tumours are rare, indolent tumours of the endocrine pancreas with
an incidence of two to four people per million annually worldwide.
Pancreatic islet cell tumours include insulinomas, glucagonomas and
gastrinomas. Current treatment options are limited.
About Sutent(®) (sunitinib malate)
Sutent, an oral multi-kinase inhibitor, is currently approved for both
advanced renal cell carcinoma (RCC) and second-line gastrointestinal
stromal tumour (GIST), based on efficacy and safety data from large,
randomized Phase 3 clinical trials.
Sutent works by blocking multiple molecular targets implicated in the
growth, proliferation and spread of cancer. Two important Sutent
targets, vascular endothelial growth factor receptor (VEGFR) and
platelet-derived growth factor receptor (PDGFR), are expressed by many
types of solid tumours and are thought to play a crucial role in
angiogenesis, the process by which tumours acquire blood vessels,
oxygen and nutrients needed for growth. Sutent also inhibits other
targets important to tumour growth, including KIT, FLT3 and RET.
Important Sutent(®) (sunitinib malate) Safety Information
Women of child bearing age who are (or become) pregnant during therapy
should be informed of the potential for foetal harm while on Sutent.
Decreases in left ventricular ejection fraction (LVEF) to below the
lower limit of normal (LLN) have been observed. Patients with
concomitant cardiac conditions should be carefully monitored for
clinical signs and symptoms of congestive heart failure.
Patients should be monitored for hypertension and treated as needed
with standard antihypertensive therapy. Complete blood counts (CBCs)
with platelet count and serum chemistries should be performed at the
beginning of each treatment cycle for patients receiving treatment
with Sutent.
The most common adverse reactions in advanced RCC and GIST clinical
trials were fatigue, asthenia, diarrhea, nausea, mucositis/stomatitis,
ONC09/010
vomiting, dyspepsia, abdominal pain, constipation, hypertension, rash,
hand-foot syndrome, skin discoloration, altered taste, anorexia and
bleeding.
Pfizer Oncology