BACKGROUND Gastroenteropancreatic neuroendocrine tumours(GEP-NETs)are slow-growing cancers that arise from diffuse endocrine cells in the gastrointestinal tract(GINETs)or the pancreas(P-NETs).They are relatively uncom...BACKGROUND Gastroenteropancreatic neuroendocrine tumours(GEP-NETs)are slow-growing cancers that arise from diffuse endocrine cells in the gastrointestinal tract(GINETs)or the pancreas(P-NETs).They are relatively uncommon,accounting for 2%of all gastrointestinal malignancies.The usual treatment options in advanced GEP-NET patients with metastatic disease include chemotherapy,biological therapies,and peptide receptor radionuclide therapy.Understanding the impact of treatment on GEP-NET patients is paramount given the nature of the disease.Health-related quality of life(HRQoL)is increasingly important as a concept reflecting the patients’perspective in conjunction with the disease presentation,severity and treatment.AIM To conduct a systematic literature review to identify literature reporting HRQoL data in patients with GEP-NETs between January 1985 and November 2019.METHODS The PRISMA guiding principles were applied.MEDLINE,Embase and the Cochrane library were searched.Data extracted from the publications included type of study,patient population data(mid-gut/hind-gut/GI-NET/P-NET),sample size,intervention/comparators,HRQoL instruments,average and data spread of overall and sub-scores,and follow-up time for data collection.RESULTS Forty-three publications met the inclusion criteria.The heterogeneous nature of the different study populations was evident;the percentage of female participants ranged between 30%-60%,whilst average age ranged from 53.8 to 67.0 years.Eight studies investigated GI-NET patients only,six studies focused exclusively on P-NET patients and the remaining studies involved both patient populations or did not report the location of the primary tumour.The most commonly used instrument was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30(n=28)with consistent results across studies;the GI-NET-specific module Quality of Life Questionnaire-GINET21 was used in six of these studies.A number of randomised trials demonstrated no HRQoL changes between active treatment and placebo arms.The Phase III NETTER-1 study provides the best data available for advanced GEP-NET patients;it shows that peptide receptor radionuclide therapy can significantly improve GEP-NET patients’HRQoL.CONCLUSION HRQoL instruments offer a means to monitor patients’general disease condition,disease progression and their physical and mental well-being.Instruments including the commonly used European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and GINET21 lack,however,validation and a defined minimal clinical important difference specifically for GINET and P-NET patients.展开更多
BACKGROUND Gastroenteropancreatic neuroendocrine tumors(GEP-NETs)represent a relatively rare and heterogenous group of tumors.Currently available treatment options for patients with progressive GEP-NETs include luteti...BACKGROUND Gastroenteropancreatic neuroendocrine tumors(GEP-NETs)represent a relatively rare and heterogenous group of tumors.Currently available treatment options for patients with progressive GEP-NETs include lutetium(177 Lu)oxodotreotide(177 LuDotatate)and everolimus[as well as sunitinib for patients with pancreatic NETs(P-NETs)].AIM To perform a health economic analysis to determine the cost-effectiveness of 177 LuDotatate compared with everolimus in patients with unresectable or metastatic midgut-NETs or P-NETs in both Sweden and Norway.METHODS Simulations were performed using a three-state partitioned survival model and analyses were performed separately for patients with midgut-NETs and P-NETs.Clinical input data were sourced from an indirect comparison that utilized survival data from clinical trials of 177 Lu-Dotatate and everolimus.The analyses were performed from the healthcare payer perspective over a time horizon of 20 years.For Sweden,future costs and clinical outcomes were discounted at 3%per annum.For Norway,a discount rate of 4%per annum was applied.RESULTS For Sweden,improved survival outcomes and higher lifetime costs with 177 LuDotatate resulted in an incremental cost-effectiveness ratio(ICER)of SEK 391194 per quality-adjusted life year(QALY)gained for midgut NETs and SEK 16764 per QALY gained for P-NETs for 177 Lu-Dotatate compared with everolimus.For Norway,the corresponding ICERs were NOK 244444 per QALY gained and NOK 106451 per QALY gained,respectively.One-way sensitivity analyses revealed that the results were most sensitive to changes in drug acquisition costs and health state utility values.CONCLUSION In both Sweden and Norway,from a healthcare provider perspective,177 LuDotatate is likely to be considered cost-effective relative to everolimus for the treatment of patients with unresectable or metastatic,progressive midgut-NETs or P-NETs.展开更多
文摘BACKGROUND Gastroenteropancreatic neuroendocrine tumours(GEP-NETs)are slow-growing cancers that arise from diffuse endocrine cells in the gastrointestinal tract(GINETs)or the pancreas(P-NETs).They are relatively uncommon,accounting for 2%of all gastrointestinal malignancies.The usual treatment options in advanced GEP-NET patients with metastatic disease include chemotherapy,biological therapies,and peptide receptor radionuclide therapy.Understanding the impact of treatment on GEP-NET patients is paramount given the nature of the disease.Health-related quality of life(HRQoL)is increasingly important as a concept reflecting the patients’perspective in conjunction with the disease presentation,severity and treatment.AIM To conduct a systematic literature review to identify literature reporting HRQoL data in patients with GEP-NETs between January 1985 and November 2019.METHODS The PRISMA guiding principles were applied.MEDLINE,Embase and the Cochrane library were searched.Data extracted from the publications included type of study,patient population data(mid-gut/hind-gut/GI-NET/P-NET),sample size,intervention/comparators,HRQoL instruments,average and data spread of overall and sub-scores,and follow-up time for data collection.RESULTS Forty-three publications met the inclusion criteria.The heterogeneous nature of the different study populations was evident;the percentage of female participants ranged between 30%-60%,whilst average age ranged from 53.8 to 67.0 years.Eight studies investigated GI-NET patients only,six studies focused exclusively on P-NET patients and the remaining studies involved both patient populations or did not report the location of the primary tumour.The most commonly used instrument was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30(n=28)with consistent results across studies;the GI-NET-specific module Quality of Life Questionnaire-GINET21 was used in six of these studies.A number of randomised trials demonstrated no HRQoL changes between active treatment and placebo arms.The Phase III NETTER-1 study provides the best data available for advanced GEP-NET patients;it shows that peptide receptor radionuclide therapy can significantly improve GEP-NET patients’HRQoL.CONCLUSION HRQoL instruments offer a means to monitor patients’general disease condition,disease progression and their physical and mental well-being.Instruments including the commonly used European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and GINET21 lack,however,validation and a defined minimal clinical important difference specifically for GINET and P-NET patients.
文摘BACKGROUND Gastroenteropancreatic neuroendocrine tumors(GEP-NETs)represent a relatively rare and heterogenous group of tumors.Currently available treatment options for patients with progressive GEP-NETs include lutetium(177 Lu)oxodotreotide(177 LuDotatate)and everolimus[as well as sunitinib for patients with pancreatic NETs(P-NETs)].AIM To perform a health economic analysis to determine the cost-effectiveness of 177 LuDotatate compared with everolimus in patients with unresectable or metastatic midgut-NETs or P-NETs in both Sweden and Norway.METHODS Simulations were performed using a three-state partitioned survival model and analyses were performed separately for patients with midgut-NETs and P-NETs.Clinical input data were sourced from an indirect comparison that utilized survival data from clinical trials of 177 Lu-Dotatate and everolimus.The analyses were performed from the healthcare payer perspective over a time horizon of 20 years.For Sweden,future costs and clinical outcomes were discounted at 3%per annum.For Norway,a discount rate of 4%per annum was applied.RESULTS For Sweden,improved survival outcomes and higher lifetime costs with 177 LuDotatate resulted in an incremental cost-effectiveness ratio(ICER)of SEK 391194 per quality-adjusted life year(QALY)gained for midgut NETs and SEK 16764 per QALY gained for P-NETs for 177 Lu-Dotatate compared with everolimus.For Norway,the corresponding ICERs were NOK 244444 per QALY gained and NOK 106451 per QALY gained,respectively.One-way sensitivity analyses revealed that the results were most sensitive to changes in drug acquisition costs and health state utility values.CONCLUSION In both Sweden and Norway,from a healthcare provider perspective,177 LuDotatate is likely to be considered cost-effective relative to everolimus for the treatment of patients with unresectable or metastatic,progressive midgut-NETs or P-NETs.
