Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study

Introduction: Subcutaneous injection of octreotide acetate is indicated to treat adults with acromegaly and diarrhea associated with carcinoid tumors or vasoactive intestinal peptide tumors. In this formative human factors study, we evaluated the readability and comprehension of the instructions for use (IFU) and ease of use of the octreotide pen injector. Methods: The study enrolled patients and healthcare practitioners who would be using the pen injector. The IFU contained a stepwise process with illustrations to detail injection administration and safe storage of the octreotide pen injector. Participants read the IFU and familiarized themselves with the device. Participants administered 2 unaided injections into skin-like pads. Injection success was defined as an attempt that delivered the correct dose into the pad. Each injection was evaluated by objective performance and subjective measures. Objective performance measures included assessment of steps necessary to deliver the correct medication dose and ensure user safety. Subjective measures included soliciting participant feedback on perceived success and difficulties administering a dose with the octreotide pen injector, as well as suggestions for improvements. Additional goals included evaluation of the IFU and octreotide pen injector usability aspects. Results: A total of 8 patients and 3 healthcare practitioners enrolled in the study. All (n = 11) participants successfully administered both injections, leading to an overall injection success rate of 100% across twenty-two injections. Subtask errors included participants priming the pen injector with the incorrect dose (n = 1) and not holding the injection button for 10 seconds after the injection (n = 2), but neither error resulted in dosing failure. Participant suggestions for improving the IFU included changes to the illustration of the plunger, reordering statements to clarify the priming process, and detailing how long to let the pen injector come to room temperature. Conclusion: Overall, participants felt the octreotide pen injector was easy to use and the instructions were clearly written and illustrated. Participant feedback and observations by moderators of the study led to recommendations for improvements to the clarity of the IFU.

PPAR-Alpha Agonist Fenofibrate Combined with Octreotide Acetate in the Treatment of Acute Hyperlipidemia Pancreatitis

At present, there are more and more patients with acute hypertriglyceridemia pancreatitis in clinical practice. Common treatment measures include fasting and water withdrawal, fluid resuscitation, and somatostatin. In recent years, studies have pointed out that the PPARa agonist fenofibrate may help improve the condition of such patients. Therefore, through clinical research and analysis, we reported for the first time that fenofibrate combined with octreotide acetate has a more excellent effect in the treatment of patients with acute hypertriglyceridemia pancreatitis, and from the perspective of signal pathways, we revealed that the combination of the two drugs has an effect on NF-κB P65. The synergistic inhibitory effect proves that the combined treatment is beneficial to control inflammation, protect liver function, and improve the prognosis of patients. It is worthy of clinical promotion.

A phase II/III randomized double-blind study of octreotide acetate LAR with axitinib versus octreotide acetate LAR with placebo in patients with advanced G1-G2 NETs of non-pancreatic origin (AXINET trial-GETNE-1107).

360 Background: Angiogenesis plays an important role in NET development and progression. Axitinib is a potent and selective VEGFR-1,2,3 inhibitor, with proven activity against several vascular-dependent solid tumors. The aim of this randomized, double-blind phase II/III study was to assess the efficacy of axitinib in patients with advanced G1-2 extra-pancreatic NETs. Methods: Eligible pts were randomized (1:1) to receive octreotide LAR (30 mg IM q4w) with axitinib (5 mg BID) or placebo BID until disease progression or unacceptable toxicity. Pteswere stratified by time from diagnosis to study entry ( > or < 12m), primary tumor site (GI tract vs non-GI) and Ki-67 index (< 5% vs > 5%). Prior therapy with SSA, IFN and up to 2 lines of systemic treatment was allowed, but not prior VEGF- or VEGFR-targeted drugs. Clinical and/or radiological disease progression within 12 months prior to study entry was required. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), time to progression, overall response rate (ORR), duration of response, biochemical response and safety. Results: 256 pts were randomized (106 in the Phase II part, and 150 additional pts in the Phase III part), 126 to axitinib and 130 to placebo. The main characteristics of the study population were: median age 61 years (range: 21-85), 52% male, PS 0-1 (64-35%), G1-2 (29%-71%), primary tumor site GI (40%)-Lung (17%)-Other (32%). Prior therapies included: SSA (46%), everolimus (13%), chemotherapy (13%), TACE (5%) and PRRT (2%). ORR was significantly higher in axitinib- vs placebo-treated patients (17.5% vs 3.8%, p = 0.0004). PFS per investigator assessment also favored axitinib vs placebo-treated patients, although the difference did not reach statistical significance (median PFS 17.2 vs 12.3 months, respectively, HR 0.816, p = 0.169). Grade 3-4 treatment-related AEs occurred more frequently in the axitinib vs placebo arm (52% vs 13.8%), and included hypertension (21% vs 6 %), cardiac disorders (3.2% vs 0.7%), diarrhoea (13% vs 1.5 %), asthenia (9% vs 3%) and nausea&vomiting (2% vs 0.7%). There were 3 treatment-related deaths, 1 in the axitinib arm (cardiac failure) and 2 in the placebo arm (myocardial infarction and hepatorenal syndrome). Conclusions: Although the study failed to demonstrate a significant PFS benefit per investigator assessment, axitinib in combination with octreotide LAR demonstrated activity and had a tolerable safety profile in patients with advanced G1-2 extra-pancreatic NETs. Data base cleaning and central blinded radiological PFS assessment are currently ongoing. Clinical trial information: NCT01744249.