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CABINET (pancreatic neuroendocrine tumors)

Trial question
What is the role of cabozantinib in patients with previously treated progressive advanced pancreatic neuroendocrine tumors?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 95
95 patients (40 female, 55 male).
Inclusion criteria: patients with previously treated progressive advanced pancreatic neuroendocrine tumors.
Key exclusion criteria: poorly differentiated neuroendocrine carcinoma or high-grade neuroendocrine carcinoma without specification of differentiation status; class III or IV congestive HF in the past 6 months; thromboembolic events in the past 6 months; uncontrolled hypertension in the past 14 days.
Interventions
N=64 cabozantinib (at an oral dose of 60 mg once daily).
N=31 placebo (matching placebo once daily).
Primary outcome
Median progression-free survival
13.8 months
4.4 months
13.8 months
10.4 months
6.9 months
3.5 months
0.0 months
Cabozantinib
Placebo
Significant increase ▲
Significant increase in median progression-free survival (13.8 months vs. 4.4 months; HR 4.3, 95% CI 2.4 to 8.3).
Secondary outcomes
No significant difference in median overall survival (40 months vs. 31.1 months; HR 1.1, 95% CI 0.5 to 2.2).
Safety outcomes
Significant difference in grade 3-4 treatment-related adverse events (65% vs. 23%).
Conclusion
In patients with previously treated progressive advanced pancreatic neuroendocrine tumors, cabozantinib was superior to placebo with respect to median progression-free survival.
Reference
Jennifer A Chan, Susan Geyer, Tyler Zemla et al. Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors. N Engl J Med. 2025 Feb 13;392(7):653-665.
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