RESUMO
INTRODUCTION: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can result in symptoms such as diarrhea, flushing, abdominal pain, and fatigue and are often associated with a significant disease burden and poor prognosis. This non-interventional, prospective, observational study evaluated the real-world safety and effectiveness of lanreotide depot, a somatostatin analog (SSA) used to treat GEP-NETs, in a community setting. METHODS: In this prospective, non-interventional study (NCT02730104), adult patients with locally advanced (inoperable), metastatic GEP-NETs treated with lanreotide depot were evaluated by their physician every 6 months from enrollment for 24 months. Clinically defined time to disease progression (TTDP) and overall survival (OS) were estimated for the total population and by primary tumor type (gastrointestinal [GI], pancreatic, unknown origin), and an exploratory analysis determined the rate of progression-free survival (PFS) at 12 and 24 months. Patient satisfaction was evaluated via the Treatment Satisfaction Questionnaire for Medication (TSQM-9), and safety information was recorded. RESULTS: Of 99 patients, the 24-month PFS rate was 73.7% (95% confidence interval [CI] 63.1-81.7) and 24-month OS rate was 84.2% (95% CI 74.0-90.7). Median TTDP was not reached because few patients experienced disease progression during the study period. The majority of responding patients expressed satisfaction with treatment on each domain of the TSQM-9. Treatment-related adverse events (AEs) occurred in 19.2% of patients, while no serious AEs (SAEs) were related to the study drug. CONCLUSIONS: Lanreotide depot is an effective and well-tolerated treatment for GEP-NETs in the real-world community setting. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02730104.
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare tumors that develop in the gut or pancreas. GEP-NETs may lead to a reduced lifespan, and people with GEP-NETs may have symptoms such as fatigue, muscle weakness, diarrhea, stomach pain/cramping, and skin reactions. One approved treatment for patients whose tumor cannot be removed with surgery is lanreotide depot. Clinical trials have found lanreotide depot to be effective at prolonging survival and managing symptoms in people with GEP-NETs. However, clinical trials take place under very strict conditions and often do not represent all people with a certain disease in the 'real world'. It is important to determine whether treatments are still effective when used outside of clinical trials. This study was conducted in the real world and followed 99 people with GEP-NETs whose physicians were treating them with lanreotide depot. Each person was monitored for 24 months and assessed during check-ups by their physician every 6 months. After 24 months, 73.7% of people did not have progression (worsening) of disease. The percentage of people who had not died by the end of the study was 84.2%. Most patients (91.6%) said they were satisfied with their treatment. Only 19.2% of patients experienced side effects, none of which were serious.
RESUMO
AIM: To understand the efficiency of SureSmile treatment vs conventional treatment. METHODS: First, 12,335 completed patient histories representing different treatment philosophies and geographically diverse practices were collected. Included were 9,390 SureSmile patients and 2,945 conventional patients. Variables in these patient records included: (1) treatment time, months from bonding to debonding; (2) malocclusion class, Angle Class I, II, or III; (3) patient age, adolescents (< 18 years) or adults (≥ 18 years); and (4) patient visits, total number of treatment visits. Nonparametric regression tests were used to analyze the data. RESULTS: The median treatment time for the SureSmile patient pool (15 months) was 8 months shorter than that of the conventional patient pool (23 months). The median care cycle length of Class II SureSmile patients (13 months) was 2 months shorter than that of Class I SureSmile patients (15 months) and 3 months shorter than that of Class III SureSmile patients (16 months). SureSmile patients (14 visits) had four fewer median treatment visits than conventional patients (18 visits). All results were significant at P = .001. No significant differences were noted between the median care cycle lengths of adolescents and adults. CONCLUSION: This study found that SureSmile treatment facilitates more timely care than conventional treatment. Further prospective studies are required to elucidate the effectiveness of SureSmile treatment.