Sector of Endocrinology, Department of Internal Medicine Department of Nuclear Medicine, Erasmus Medical Center, 's-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands Centro de Oncologia, Hospital Sírio Libanês, São Paulo, Brazil Department of Pathophysiology, National University of Athens, Athens, Greece.
Endocr Relat Cancer. 2013 Oct 14;20(6):825-31. doi: 10.1530/ERC-13-0254. Print 2013 Dec.
Although (177)Lu-octreotate is an effective treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), some patients will fail or develop disease progression necessitating further treatment. We examined whether the safety and efficacy of everolimus after prior treatment with (177)Lu-octreotate is different from the published safety profile of everolimus in GEP-NETs. In this multicenter study, 24 GEP-NET patients were included. Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Tumor response was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. Major clinical adverse events (grade 3 or 4) during treatment with everolimus were hyperglycemia (20.8%), fatigue (8.3%), thrombocytopenia (8.3%), and elevated alanine transaminase levels (8.3%). By radiological review, there were four partial responses (16.7%), five patients (62.5%) with stable disease, and three patients (12.5%) with progressive disease. For two patients (8.3%), no data on tumor response were available. Median progression-free survival (PFS) was 13.1 months (95% CI, 11.5-21.2). Median PFS of the current study was longer when compared with the RADIANT-3 trial (13.1 vs 11.4 months) and shorter when compared with the RADIANT-1 trial (13.1 vs 16.7 months). In conclusion, the safety profile of everolimus is not influenced by previous treatment with peptide receptor radiotherapy.
虽然 (177)Lu-奥曲肽治疗胃肠胰神经内分泌肿瘤 (GEP-NETs) 患者有效，但部分患者会出现治疗失败或疾病进展，需要进一步治疗。我们研究了 (177)Lu-奥曲肽治疗后使用依维莫司的安全性和疗效是否与 GEP-NETs 中依维莫司的已公布安全性概况不同。在这项多中心研究中，纳入了 24 名 GEP-NET 患者。根据美国国立癌症研究所不良事件通用术语标准（CTCAE），版本 3.0 评估不良事件。根据实体瘤反应评价标准（RECIST），版本 1.0 测量肿瘤反应。依维莫司治疗期间的主要临床不良事件（3 或 4 级）为高血糖（20.8%）、疲劳（8.3%）、血小板减少症（8.3%）和丙氨酸氨基转移酶水平升高（8.3%）。通过放射学评估，有 4 例部分缓解（16.7%），5 例（62.5%）患者疾病稳定，3 例（12.5%）患者疾病进展。有 2 例（8.3%）患者肿瘤反应数据不可用。中位无进展生存期（PFS）为 13.1 个月（95%CI，11.5-21.2）。与 RADIANT-3 试验相比，本研究的中位 PFS 更长（13.1 与 11.4 个月），与 RADIANT-1 试验相比更短（13.1 与 16.7 个月）。结论，肽受体放疗后使用依维莫司不会影响其安全性概况。
