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Sunitinib Prolongs Progression-Free Survival in Patients With Well-Differentiated Pancreatic Islet Cell Tumours: Presented at ECCO-ESMO

By Chris Berrie

BERLIN -- September 25, 2009 -- Oral sunitinib shows significant efficacy and manageable safety, compared with placebo, for patients with advanced/metastatic pancreatic islet cell tumours, researchers stated here at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO).

"When surgery is impossible, treatment options (for pancreatic islet cell tumours) remain limited," said principal investigator Eric Raymond, MD, Department of Medical Oncology, Bichat-Beaujon Hospital, Clichy, France, on September 23.

"The eligibility criteria clearly stated that patients had to have well-differentiated, malignant pancreatic islet cell tumour and clearly stated also that all patients had to have progression in the past 12 months prior to study entry." A requirement was also that the tumours were not amenable to treatment with curative intent.

The multicentre, double-blind, phase 3 study included 340 patients who were randomised to best supportive care plus either placebo or oral sunitinib 37.5 mg/day, with continuous daily dosing, following stratification by geographic region

The primary endpoint of progression-free survival (PFS) was met with acceptable toxicity at interim review by the Data Safety Board Monitoring Committee. Therefore, the study was stopped and sunitinib was offered to patients in both arms.

In presenting this preliminary analysis of the results, Dr. Raymond noted that at study cessation there were 79 patients in the placebo arm and 75 patients receiving sunitinib.

The estimated median time to PFS was significantly in favour of sunitinib (11.1 months) over placebo (5.5 months; P < .001).

As a secondary endpoint, the overall survival indicated more deaths in the placebo arm (19% vs 7% for sunitinib), with further analysis awaited.

The most frequently reported (in >30% patients) all-causality, all-grade adverse events were similar with those seen previously for sunitinib treatment. These included neutropenia (12.3%), hypertension (8.8%), palmar-plantar erythrodysesthesia (7.0%), leucopenia (5.3%), and thrombocytopenia (5.3%).

"It is interesting to notice that several patients in the placebo arm had more abdominal pain [10.4% vs 7.0%] ... and more fatigue [9.0% vs 5.3%], compared with the sunitinib arm," Dr. Raymond added. There were 3 treatment-emergent deaths in each treatment group.

Thus, preliminary data support the clinical safety and efficacy of sunitinib in patients with unresectable, advanced/metastatic pancreatic islet cell tumours. "The final data analysis is ongoing and should be mature pretty soon," said Dr. Raymond.

Funding for this study was provided by Pfizer Inc.

[Presentation title: Sunitinib vs Placebo for Treatment of Progressive, Well-Differentiated Pancreatic Islet Cell Tumours: Results of a Phase III, Randomised, Double-Blind Trial. Abstract 6501]

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