卡培他滨和链脲佐菌素±顺铂治疗晚期胃肠胰神经内分泌肿瘤。
Capecitabine and streptozocin ± cisplatin in advanced gastroenteropancreatic neuroendocrine tumours.
机构信息
Neuroendocrine Tumour Unit, The Royal Free Hospital, Pond Street, London, UK; UCL Cancer Institute, London, UK.
Cambridge Cancer Trials Centre, Cambridge Clinical Trials Unit - Cancer Theme, Addenbrooke's Hospital, Cambridge, UK; Medical Research Council Biostatistics Unit Hub for Trials Methodology, Cambridge, UK.
出版信息
Eur J Cancer. 2014 Mar;50(5):902-11. doi: 10.1016/j.ejca.2013.12.011. Epub 2014 Jan 17.
BACKGROUND
Cytotoxic chemotherapy is widely used for advanced, unresectable pancreatic and other gastrointestinal foregut neuroendocrine tumours (NETs) and the most commonly used regimen combines 5-fluorouracil with streptozocin. The NET01 trial was designed to investigate whether capecitabine combined with streptozocin was an acceptable regimen with or without adding cisplatin.
METHODS
Patients with advanced, unresectable NETs of pancreatic, gastrointestinal foregut or unknown primary site were randomised to receive three-weekly capecitabine (Cap) 625 mg/m(2) twice daily orally, streptozocin (Strep) 1.0 g/m(2) intravenously on day 1, with or without cisplatin (Cis) 70 mg/m(2) intravenously on day 1. The primary outcome measure was objective response. Secondary outcome measures included progression-free and overall survival, quality of life, toxicity and biochemical response.
RESULTS
86 (44 CapStrep, 42 CapStrepCis) patients were randomised. Best objective response rate was 12% (95% confidence interval (CI)=2-22%) with CapStrep and 16% (95% CI=4-27.4%) with CapStrepCis. Disease-control rate was 80% with CapStrep and 74% with CapStrepCis. The estimated median progression-free and overall survival were 10.2 and 26.7 months for CapStrep and 9.7 and 27.5 months for CapStrepCis. 44% of CapStrep and 68% of CapStrepCis patients experienced grade ≥3 adverse events.
INTERPRETATION
The efficacies of the novel CapStrep±Cis regimens were very similar. CapStrep was better tolerated than CapStrepCis. The trial was registered as EudraCT: 2004-005202-71 and ISRCTN: 35124268.
背景
细胞毒性化疗广泛用于晚期、不可切除的胰腺和其他胃肠道前肠神经内分泌肿瘤（NETs），最常用的方案是将 5-氟尿嘧啶与链脲佐菌素联合使用。NET01 试验旨在研究卡培他滨联合链脲佐菌素是否可以作为一种可接受的方案，无论是否添加顺铂。
方法
患有晚期、不可切除的胰腺、胃肠道前肠或未知原发病灶的 NETs 患者被随机分配接受每周 3 次卡培他滨（Cap）625 mg/m2 口服，每天 2 次，链脲佐菌素（Strep）1.0 g/m2 静脉注射，第 1 天，或不添加顺铂（Cis）70 mg/m2 静脉注射，第 1 天。主要终点是客观缓解。次要终点包括无进展生存期和总生存期、生活质量、毒性和生化缓解。
结果
86 例（44 例 CapStrep，42 例 CapStrepCis）患者被随机分配。CapStrep 的最佳客观缓解率为 12%（95%置信区间（CI）=2-22%），CapStrepCis 为 16%（95% CI=4-27.4%）。CapStrep 的疾病控制率为 80%，CapStrepCis 为 74%。CapStrep 的中位无进展生存期和总生存期估计分别为 10.2 个月和 26.7 个月，CapStrepCis 分别为 9.7 个月和 27.5 个月。CapStrep 组有 44%的患者和 CapStrepCis 组有 68%的患者发生≥3 级不良事件。
结论
新型 CapStrep±Cis 方案的疗效非常相似。CapStrep 的耐受性优于 CapStrepCis。该试验在 EudraCT 注册：2004-005202-71 和 ISRCTN：35124268。
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