Paulson Scott, Ray David, Aranha Sharan, Scales Amy, Wang Yunfei, Liu Eric
Texas Oncology-Baylor Charles A. Sammons Cancer Center, 3410 Worth St., Suite 400, Dallas, TX, 75246, USA.
US Oncology Research, Houston, TX, USA.
Oncol Ther. 2022 Dec;10(2):463-479. doi: 10.1007/s40487-022-00208-1. Epub 2022 Sep 22.
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.
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.
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.
Lanreotide depot is an effective and well-tolerated treatment for GEP-NETs in the real-world community setting.
ClinicalTrials.gov identifier, NCT02730104.
胃肠胰神经内分泌肿瘤(GEP-NETs)可导致腹泻、潮红、腹痛和疲劳等症状,并且常伴有严重的疾病负担和不良预后。本项非干预性、前瞻性观察性研究评估了用于治疗GEP-NETs的生长抑素类似物(SSA)——长效兰瑞肽在社区环境中的真实世界安全性和有效性。
在这项前瞻性非干预性研究(NCT02730104)中,接受长效兰瑞肽治疗的局部晚期(无法手术切除)、转移性GEP-NETs成年患者从入组开始每6个月由医生评估一次,为期24个月。对总体人群以及按原发肿瘤类型(胃肠道[GI]、胰腺、来源不明)估计临床定义的疾病进展时间(TTDP)和总生存期(OS),并进行探索性分析以确定12个月和24个月时的无进展生存期(PFS)率。通过药物治疗满意度问卷(TSQM-9)评估患者满意度,并记录安全信息。
99例患者中,24个月PFS率为73.7%(95%置信区间[CI]63.1-81.7),24个月OS率为84.2%(95%CI74.0-90.7)。由于在研究期间很少有患者出现疾病进展,因此未达到中位TTDP。大多数有反应的患者在TSQM-9的每个领域都对治疗表示满意。19.2%的患者发生了与治疗相关的不良事件(AE),而没有严重不良事件(SAE)与研究药物相关。
在真实世界的社区环境中,长效兰瑞肽是一种治疗GEP-NETs的有效且耐受性良好的疗法。
ClinicalTrials.gov标识符,NCT02730104。