Octreotide versus octreotide plus interferon-alpha in endocrine gastroenteropancreatic tumors:: A randomized trial
Octreotide versus octreotide plus interferon-alpha in endocrine gastroenteropancreatic tumors:: A randomized trial
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DOI：
10.1016/s1542-3565(05)00481-7
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发表时间：
2005-08-01
影响因子：
12.6
通讯作者：
Arnold, CN
中科院分区：
文献类型：
--
作者：
Arnold, R;Rinke, A;Arnold, CN
背景与目的：研究了奥曲肽联合干扰素- α与奥曲肽单药治疗对进展性转移性神经内分泌前肠（主要是胰腺）和中肠肿瘤患者治疗失败的主要研究终点（进展、死亡、停止研究治疗）和长期生存的影响。方法：从1995年1月开始随机选取125例患者中的109例，于2000年3月对105例患者（单药治疗51例，联合治疗54例）进行分析。每隔3个月通过计算机断层扫描或磁共振成像评估肿瘤生长情况。到2004年4月，所有被分析的患者和9名因病情稳定而非随机分配的患者的长期生存率进行了研究。结果：在3个月、6个月和12个月时，肿瘤部分消退的发生率分别为2.9%、1.9%和5.7%，肿瘤生长稳定的发生率分别为44.8%、27.6%和15.2%，两个治疗组之间无显著差异。2000年3月，9.15%的患者在接受治疗。两组患者的治疗失败时间和长期生存期无显著差异，奥曲肽组和联合用药组的中位生存期分别为32个月和54个月。由于病情稳定而未被随机分配的患者（中位，68个月）和核Ki-67低的患者的生存时间更长。随机化前，自发性肿瘤生长缓慢的患者有延长生存期的趋势。对治疗有反应的患者比无反应的患者寿命更长。结论：在无进展和长期生存方面，联合治疗并不优于单药治疗。对治疗有反应的患者和自发肿瘤生长缓慢的患者具有生存优势。
Background & Aims: The effect of octreotide plus interferon-alpha versus octreotide monotherapy on the primary study end points of time to treatment failure (progression, death, stop of study treatment) and long-term survival was investigated in patients with progressive metastatic neuroendocrine foregut (mainly pancreatic) and midgut tumors. Methods: One hundred nine of 125 registered patients were randomized starting in January 1995, and 105 patients (51 monotherapy, 54 combination treatment) were finally analyzed in March 2000. Tumor growth was assessed at 3-month intervals by computed tomography or magnetic resonance imaging. Long-term survival was studied up to April 2004 in all analyzed patients and in 9 patients not randomized because of stable disease. Results: Partial tumor regression occurred in 2.9%, 1.9%, and 5.7% and stabilization of tumor growth in 44.8%, 27.6%, and :15.2% at 3, 6, and 12 months, respectively, with no significant differences between both treatment arms. In March 2000, 9.15% of patients were in treatment. Time to treatment failure and long-term survival did not differ significantly between the 2 groups, with a median survival of 32 and 54 months for the octreotide and the combination groups, respectively. Survival was longer in patients not randomized because of stable disease (median, 68 months) and in those with low nuclear Ki-67. A trend toward longer survival was shown for patients with slow spontaneous tumor growth before randomization. Patients responding to treatment lived longer than unresponsive patients. Conclusions: Combination treatment was not superior to monotherapy concerning progression-free and long-term survival. Patients responding to treatment and those with slow spontaneous tumor growth had a survival advantage.