A. Kolasińska-Ćwikła, Klaudia Gutowska, K. Osowiecka, T. Bednarczuk, Anna Słoniewska, K. Roszkowska-Purska, J. Pałucki, J. Cwikła
{"title":"评估散发性、晚期、不可切除的高分化胰腺神经内分泌肿瘤患者的生存结果,这些患者最初接受奥曲肽LAR治疗,随后接受复发治疗。真实世界的数据集","authors":"A. Kolasińska-Ćwikła, Klaudia Gutowska, K. Osowiecka, T. Bednarczuk, Anna Słoniewska, K. Roszkowska-Purska, J. Pałucki, J. Cwikła","doi":"10.5603/ocp.2022.0045","DOIUrl":null,"url":null,"abstract":"Introduction. Somatostatin analogs (SSA) are widely used in the treatment of patients with well-differentiated neuroendocrine tumors (NET). There are limited reports about the role of octreotide LAR in first-line therapy of advanced pancreatic NET (pan-NET). This study aimed to evaluate the antiproliferative effect of octreotide LAR in patients with sporadic, advanced, unresectable pan-NET, based on progression-free survival (PFS). Material and methods. This was a retrospective analysis of 374 patients with pan-NET; 41 treated subjects were included. The primary endpoint was PFS defined as the time to disease progression (Response Evaluation Criteria in Solid Tumors: RECIST). Univariate and multivariate analyses were used to identify predictors of PFS. Secondary endpoints included overall survival (OS) and second-line therapies after progression. Results. There were 13 (32%) patients with G1 pan-NET and 28 (68%) with pan-NET G2, 21 female and 20 male, with mean age 55.4 (range 29–87). Median PFS was 9.0 months (95% CI 4.7–24.0). Subgroup analysis revealed that G1 and no-bulky liver disease (< 25% liver volume) were associated with significantly longer PFS. Univariate analysis confirmed a correlation between G1 [0.34 hazard rate (HR) of progression or death (95% CI 0.16–0.72)] and no-bulky liver disease HR = 0.31 (95% CI 0.13–0.71). Multivariable analysis demonstrated that only functional (secretory) pan-NET was associated as an independent factor with shorter PFS HR = 2.97 (95% CI 1.0–8.74). Median OS was 105.4 months (95% CI 40.0–172.0). After relapse following initial systemic therapy, the second line was used in 34 subjects, 3rd line in 18th, and 4th line in 9 subjects. Conclusions. Octreotide LAR shows moderate antiproliferative activity in pan-NET. Prolonged PFS may be associated with G1 and low-volume metastatic liver disease. In patients with progressive disease, various treatment options were used, which resulted in median OS of 105.4 months.","PeriodicalId":42942,"journal":{"name":"Oncology in Clinical Practice","volume":"176 1","pages":""},"PeriodicalIF":0.3000,"publicationDate":"2022-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluation of survival outcomes in patients with sporadic, advanced, unresectable well-differentiated pancreatic neuroendocrine tumors treated initially with octreotide LAR and subsequent therapeutical approaches on relapse. A real-world data set\",\"authors\":\"A. Kolasińska-Ćwikła, Klaudia Gutowska, K. Osowiecka, T. Bednarczuk, Anna Słoniewska, K. Roszkowska-Purska, J. Pałucki, J. Cwikła\",\"doi\":\"10.5603/ocp.2022.0045\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction. Somatostatin analogs (SSA) are widely used in the treatment of patients with well-differentiated neuroendocrine tumors (NET). There are limited reports about the role of octreotide LAR in first-line therapy of advanced pancreatic NET (pan-NET). This study aimed to evaluate the antiproliferative effect of octreotide LAR in patients with sporadic, advanced, unresectable pan-NET, based on progression-free survival (PFS). Material and methods. This was a retrospective analysis of 374 patients with pan-NET; 41 treated subjects were included. The primary endpoint was PFS defined as the time to disease progression (Response Evaluation Criteria in Solid Tumors: RECIST). Univariate and multivariate analyses were used to identify predictors of PFS. Secondary endpoints included overall survival (OS) and second-line therapies after progression. Results. There were 13 (32%) patients with G1 pan-NET and 28 (68%) with pan-NET G2, 21 female and 20 male, with mean age 55.4 (range 29–87). Median PFS was 9.0 months (95% CI 4.7–24.0). Subgroup analysis revealed that G1 and no-bulky liver disease (< 25% liver volume) were associated with significantly longer PFS. Univariate analysis confirmed a correlation between G1 [0.34 hazard rate (HR) of progression or death (95% CI 0.16–0.72)] and no-bulky liver disease HR = 0.31 (95% CI 0.13–0.71). Multivariable analysis demonstrated that only functional (secretory) pan-NET was associated as an independent factor with shorter PFS HR = 2.97 (95% CI 1.0–8.74). Median OS was 105.4 months (95% CI 40.0–172.0). After relapse following initial systemic therapy, the second line was used in 34 subjects, 3rd line in 18th, and 4th line in 9 subjects. Conclusions. Octreotide LAR shows moderate antiproliferative activity in pan-NET. Prolonged PFS may be associated with G1 and low-volume metastatic liver disease. In patients with progressive disease, various treatment options were used, which resulted in median OS of 105.4 months.\",\"PeriodicalId\":42942,\"journal\":{\"name\":\"Oncology in Clinical Practice\",\"volume\":\"176 1\",\"pages\":\"\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2022-10-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Oncology in Clinical Practice\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5603/ocp.2022.0045\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Oncology in Clinical Practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5603/ocp.2022.0045","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
介绍。生长抑素类似物(SSA)广泛应用于高分化神经内分泌肿瘤(NET)患者的治疗。关于奥曲肽LAR在晚期胰腺NET (pan-NET)一线治疗中的作用的报道有限。本研究旨在基于无进展生存期(PFS)评估奥曲肽LAR对散发、晚期、不可切除的pan-NET患者的抗增殖作用。材料和方法。这是一项对374例pan-NET患者的回顾性分析;纳入41名治疗对象。主要终点是PFS,定义为疾病进展的时间(实体肿瘤反应评价标准:RECIST)。采用单因素和多因素分析来确定PFS的预测因素。次要终点包括总生存期(OS)和进展后的二线治疗。结果。G1期pan-NET 13例(32%),G2期pan-NET 28例(68%),女性21例,男性20例,平均年龄55.4岁(29-87岁)。中位PFS为9.0个月(95% CI 4.7-24.0)。亚组分析显示,G1和无大体积肝病(肝体积< 25%)与PFS显著延长相关。单因素分析证实G1[进展或死亡的0.34危险率(HR) (95% CI 0.16-0.72)]与非大体积肝病的HR = 0.31 (95% CI 0.13-0.71)之间存在相关性。多变量分析表明,只有功能性(分泌)pan-NET与较短的PFS HR相关(95% CI 1.0-8.74)。中位OS为105.4个月(95% CI 40.0-172.0)。初次全身治疗后复发的34例患者采用二线治疗,18例采用三线治疗,9例采用四线治疗。结论。奥曲肽LAR在pan-NET中表现出中等的抗增殖活性。PFS延长可能与G1和小体积转移性肝病有关。对于病情进展的患者,采用了多种治疗方案,中位OS为105.4个月。
Evaluation of survival outcomes in patients with sporadic, advanced, unresectable well-differentiated pancreatic neuroendocrine tumors treated initially with octreotide LAR and subsequent therapeutical approaches on relapse. A real-world data set
Introduction. Somatostatin analogs (SSA) are widely used in the treatment of patients with well-differentiated neuroendocrine tumors (NET). There are limited reports about the role of octreotide LAR in first-line therapy of advanced pancreatic NET (pan-NET). This study aimed to evaluate the antiproliferative effect of octreotide LAR in patients with sporadic, advanced, unresectable pan-NET, based on progression-free survival (PFS). Material and methods. This was a retrospective analysis of 374 patients with pan-NET; 41 treated subjects were included. The primary endpoint was PFS defined as the time to disease progression (Response Evaluation Criteria in Solid Tumors: RECIST). Univariate and multivariate analyses were used to identify predictors of PFS. Secondary endpoints included overall survival (OS) and second-line therapies after progression. Results. There were 13 (32%) patients with G1 pan-NET and 28 (68%) with pan-NET G2, 21 female and 20 male, with mean age 55.4 (range 29–87). Median PFS was 9.0 months (95% CI 4.7–24.0). Subgroup analysis revealed that G1 and no-bulky liver disease (< 25% liver volume) were associated with significantly longer PFS. Univariate analysis confirmed a correlation between G1 [0.34 hazard rate (HR) of progression or death (95% CI 0.16–0.72)] and no-bulky liver disease HR = 0.31 (95% CI 0.13–0.71). Multivariable analysis demonstrated that only functional (secretory) pan-NET was associated as an independent factor with shorter PFS HR = 2.97 (95% CI 1.0–8.74). Median OS was 105.4 months (95% CI 40.0–172.0). After relapse following initial systemic therapy, the second line was used in 34 subjects, 3rd line in 18th, and 4th line in 9 subjects. Conclusions. Octreotide LAR shows moderate antiproliferative activity in pan-NET. Prolonged PFS may be associated with G1 and low-volume metastatic liver disease. In patients with progressive disease, various treatment options were used, which resulted in median OS of 105.4 months.