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RESEARCH PRODUCT
Nonconventional Doses of Somatostatin Analogs in Patients With Progressing Well-Differentiated Neuroendocrine Tumor
Nicole BrighiFerdinando RiccardiManuela AlbertelliDiego FeroneAntongiulio FaggianoFabio GelsominoAnnamaria ColaoAnna La SalviaSara PuscedduSalvatore TafutoRoberta ModicaFrancesco PanzutoChiara De DivitiisMaria Pia BrizziMartina TorchioGiovanni ButturiniGiuseppe LambertiAlberto BongiovanniGiuseppe BadalamentiDavide CampanaToni IbrahimSara Massironisubject
MaleEndocrinology Diabetes and MetabolismClinical BiochemistryOctreotideNeuroendocrine tumorsLanreotideBiochemistryGastroenterologychemistry.chemical_compoundEndocrinologyhigh dose80 and overMedicineProspective StudiesProspective cohort studyhigh dose; lanreotide; NET; nonconventional doses; octreotide; somatostatin analogs; Adult; Aged; Aged 80 and over; Female; Follow-Up Studies; Hormones; Humans; Liver Neoplasms; Male; Middle Aged; Neuroendocrine Tumors; Prognosis; Prospective Studies; Retrospective Studies; Somatostatin; Cell DifferentiationAged 80 and overLiver NeoplasmsCell DifferentiationMiddle Agednonconventional dosePrognosissomatostatin analogsNeuroendocrine TumorsResponse Evaluation Criteria in Solid TumorsFemalelanreotideSomatostatinmedicine.drugAdultmedicine.medical_specialtyhigh dose; lanreotide; NET; nonconventional doses; octreotide; somatostatin analogsInternal medicinenonconventional dosesHumansAdverse effectAgedRetrospective Studiesbusiness.industryBiochemistry (medical)medicine.diseaseHormonesClinical trialNETEndocrinologychemistrybusinessProgressive diseaseoctreotideFollow-Up Studiesdescription
Abstract Purpose To evaluate the antiproliferative activity and safety of nonconventional high doses of somatostatin analogs (HD-SSA) in patients with well-differentiated gastroenteropancreatic (GEP) neuroendocrine tumors (NET) with radiological disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on a previous treatment. Methods A retrospective analysis of prospectively maintained databases from 13 Italian NET-dedicated centers was performed. Main inclusion criteria were: well-differentiated G1 or G2 GEP-NET, progressive disease on a previous treatment, and subsequent treatment with HD-SSA (either by increased administered dose [dose intensity] or shortened interval between administrations [dose density]). Main endpoints were progression-free survival (PFS) and safety. Results Of 198 patients, 140 matched inclusion criteria and were included in the analysis. Overall, median PFS was 31 months. Use of HD-SSA as second-line treatment was associated with reduced risk for progression or death compared with third- or further-line treatment (HR: 2.12; P = 0.004). There was no difference in PFS between HD-SSA by increased dose density (N = 133; 95%) or intensity (N = 7; 5%). Partial response according to RECIST criteria was observed in 12 patients (8.6%), and stable disease was achieved in 106 (75.7%) patients. Adverse events occurred in 21 patients (15.0%), 2 of whom had grade 3 biliary stone disease. No patients discontinued HD-SSA treatment due to adverse events. Conclusions HD-SSA is an active and safe treatment option in patients with progressive well-differentiated GEP-NET. The high rate of objective responses observed deserves prospective validation in ad hoc clinical trials.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2020-01-01 |