Martín-Richard Marta, Massutí Bartomeu, Pineda Eva, Alonso Vicente, Marmol Maribel, Castellano Daniel, Fonseca Emilio, Galán Antonio, Llanos Marta, Sala Maria Angeles, Pericay Carlos, Rivera Fernando, Sastre Javier, Segura Angel, Quindós Maria, Maisonobe Pascal
Medical Oncology Department, Hospital de la Santa Creu y Sant Pau, Av, Sant Antoni Mª Claret, 167, Barcelona 08025, Spain.
BMC Cancer. 2013 Sep 20;13:427. doi: 10.1186/1471-2407-13-427.
Somatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs.
This was a multicentre, open-label, phase II trial conducted in 17 Spanish specialist centres. Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, tumour biomarkers, symptom control, quality of life (QoL), and safety. Radiographic imaging was assessed by a blinded central radiologist.
Of 30 patients included in the efficacy and safety analyses, 40% had midgut tumours and 27% pancreatic tumours; 63% of tumours were functioning. Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%). No deterioration in QoL was observed. Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe.
Lanreotide Autogel provided effective tumour stabilisation and PFS >12 months in patients with progressive NETs ineligible for surgery or chemotherapy, with a safety profile consistent with the pharmacology of the class.
ClinicalTrials.gov Identifier NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18.
生长抑素类似物（SSAs）可用于缓解类癌综合征，但似乎对神经内分泌肿瘤（NETs）具有抗增殖作用。这是第一项前瞻性研究，旨在探究长效SSA兰瑞肽缓释凝胶对进展期NETs患者的肿瘤稳定作用。
这是一项在17个西班牙专科中心进行的多中心、开放标签的II期试验。在过去6个月内患有高分化NETs且经放射学证实病情进展的患者接受兰瑞肽缓释凝胶治疗，每28天注射120mg，持续≤92周。主要终点是无进展生存期（PFS）。次要终点包括缓解率、肿瘤生物标志物、症状控制、生活质量（QoL）和安全性。由一名盲态的中心放射科医生对影像学检查进行评估。
在纳入疗效和安全性分析的30例患者中，40%患有中肠肿瘤，27%患有胰腺肿瘤；63%的肿瘤具有功能性。PFS的中位时间为12.9（95%CI：7.9，16.5）个月，大多数患者实现了疾病稳定（89%）或部分缓解（4%）。未观察到生活质量恶化。19例患者（63%）出现与治疗相关的不良事件，最常见的是腹泻和乏力；只有1例与治疗相关的不良事件（吞气症）较为严重。
兰瑞肽缓释凝胶为无法进行手术或化疗的进展期NETs患者提供了有效的肿瘤稳定作用，PFS超过12个月，其安全性与该类药物的药理学特性一致。
ClinicalTrials.gov标识符NCT00326469；欧盟临床试验注册EudraCT编号2004-002871-18。
