PMID- 36136274
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221125
IS  - 2366-1089 (Electronic)
IS  - 2366-1070 (Print)
IS  - 2366-1089 (Linking)
VI  - 10
IP  - 2
DP  - 2022 Dec
TI  - Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US 
      Community Oncology Setting: A Prospective, Observational Study.
PG  - 463-479
LID - 10.1007/s40487-022-00208-1 [doi]
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Paulson, Scott
AU  - Paulson S
AD  - Texas Oncology-Baylor Charles A. Sammons Cancer Center, 3410 Worth St., Suite 
      400, Dallas, TX, 75246, USA. scott.paulson@usoncology.com.
AD  - US Oncology Research, Houston, TX, USA. scott.paulson@usoncology.com.
FAU - Ray, David
AU  - Ray D
AD  - Ipsen Biopharmaceuticals, Inc., Cambridge, MA, USA.
FAU - Aranha, Sharan
AU  - Aranha S
AD  - McKesson Specialty Health, The Woodlands, TX, USA.
FAU - Scales, Amy
AU  - Scales A
AD  - McKesson Specialty Health, The Woodlands, TX, USA.
FAU - Wang, Yunfei
AU  - Wang Y
AD  - McKesson Specialty Health, The Woodlands, TX, USA.
FAU - Liu, Eric
AU  - Liu E
AD  - The Neuroendocrine Institute, Rocky Mountain Cancer Centers, Presbyterian-St. 
      Luke's Hospital, Denver, CO, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02730104
PT  - Journal Article
DEP - 20220922
PL  - New Zealand
TA  - Oncol Ther
JT  - Oncology and therapy
JID - 101677510
PMC - PMC9681944
OAB - 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.
OABL- eng
OTO - NOTNLM
OT  - GEP-NETs
OT  - Lanreotide depot
OT  - Neuroendocrine tumors
OT  - Oncology
OT  - Patient satisfaction
OT  - Progression-free survival
OT  - Prospective study
OT  - Real-world evidence
EDAT- 2022/09/23 06:00
MHDA- 2022/09/23 06:01
PMCR- 2022/09/22
CRDT- 2022/09/22 11:20
PHST- 2022/07/05 00:00 [received]
PHST- 2022/08/30 00:00 [accepted]
PHST- 2022/09/23 06:00 [pubmed]
PHST- 2022/09/23 06:01 [medline]
PHST- 2022/09/22 11:20 [entrez]
PHST- 2022/09/22 00:00 [pmc-release]
AID - 10.1007/s40487-022-00208-1 [pii]
AID - 208 [pii]
AID - 10.1007/s40487-022-00208-1 [doi]
PST - ppublish
SO  - Oncol Ther. 2022 Dec;10(2):463-479. doi: 10.1007/s40487-022-00208-1. Epub 2022 
      Sep 22.