Eastern Virginia Medical School, Norfolk, VA
Aaron Vinik , Edward M. Wolin , Helene Audry , Edda Gomez-Panzani , George A. Fisher
Background: ELECT, a large phase 3 study of the long-acting somatostatin analog (SSA) LAN for symptomatic control of CS in NET patients showed significant improvement over PBO in % days with short-acting octreotide use as rescue medication. Here, we investigate reduction in use of rescue medication for LAN vs PBO in subgroups defined by baseline characteristics. Methods: Patients with histologically confirmed NETs and history of CS received double-blind LAN 120 mg (n=59) or PBO (n=56) every 4 wks for 16 wks, with access to short-acting octreotide for breakthrough symptoms (NCT00774930). Least-squares mean differences in % of days rescue octreotide use for LAN vs PBO were calculated by ANCOVA within subgroups. Results: The significant reduction for LAN vs PBO in rescue medication use in the overall population (Table; approximately one-third lower for LAN group relative to PBO group) was generally consistent with reductions favoring LAN over PBO across subgroups, except small subgroups in which CIs were wide (e.g. BMI ≥30). Conclusions: Beneficial effects of LAN for CS symptom control in NET patients are consistent regardless of baseline characteristics. Clinical trial information: NCT00774930
Subgroup | Short-acting octreotide use, % days* | Treatment difference (LAN – PBO) [95% CI]* | ||
---|---|---|---|---|
LAN | PBO | |||
Overall population (n=115) | 33.7 | 48.5 | -14.8 [-26.8, -2.8] | |
Age | <65 y (n=78) | 35.8 | 53.2 | -17.4 [-34.1, -0.6] |
≥65 y (n=37) | 25.8 | 45.5 | -19.7 [-35.5, -3.9] | |
Gender | Male (n=48) | 36.7 | 60.8 | -24.1 [-45.7, -2.5] |
Female (n=67) | 33.7 | 39.1 | -5.4 [-21.5, 10.7] | |
BMI | <25 (n=41) | 29.9 | 48.5 | -18.6 [-39.6, 2.3] |
>25 to <30 (n=50) | 30.9 | 52.7 | -21.8 [-39.6, -4.1] | |
≥30 (n=21) | 37.4 | 31.6 | 5.8 [-32.4, 44.0] | |
Race/ethnicity | Caucasian (n=96) | 34.2 | 48.7 | -14.5 [-27.6, -1.4] |
Other (n=19) | 21.9 | 46.6 | -24.8 [-70.4, 21.0] | |
Region | US (n=40) | 19.6 | 30.2 | -10.7 [-32.5, 11.2] |
Ex-US (n=75) | 39.5 | 55.8 | -16.3 [-31.6, -1.0] | |
Prior SSA | No (n=51) | 25.3 | 44.3 | -18.9 [-37.0, -0.9] |
Yes (n=64) | 33.9 | 44.2 | -10.3 [-26.5, 5.9] | |
Time since diagnosis | <1 y (n=41) | 39.1 | 53.3 | -14.2 [-36.3, 7.9] |
≥1 y (n=74) | 28.8 | 38.3 | -9.5 [-24.4, 5.4] |
*LS mean, from subgroup ANCOVAs containing treatment, stratification factor(s) and baseline parameters (octreotide, diarrhea and flushing events), intent-to-treat population.
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Abstract Disclosures
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