CABINET (extrapancreatic neuroendocrine tumors)
Trial question
What is the role of cabozantinib in patients with previously treated progressive advanced extrapancreatic NETs?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 203
203 patients (105 female, 98 male).
Inclusion criteria: patients with previously treated progressive advanced extrapancreatic NETs.
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=134 cabozantinib (at an oral dose of 60 mg once daily).
N=69 placebo (matching placebo once daily).
Primary outcome
Median progression-free survival
8.4 months
3.9 months
8.4 months
6.3 months
4.2 months
2.1 months
0.0 months
Cabozantinib
Placebo
Significant
increase ▲
Significant increase in median progression-free survival (8.4 months vs. 3.9 months; HR 2.6, 95% CI 1.7 to 4).
Secondary outcomes
No significant difference in median overall survival (21.9 months vs. 19.7 months; HR 1.2, 95% CI 0.8 to 1.8).
Safety outcomes
Significant difference in ≥ 3 grade treatment-related adverse events (62% vs. 27%).
Conclusion
In patients with previously treated progressive advanced extrapancreatic NETs, 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. 2024 Sep 16. Online ahead of print.
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