Rationale and design of PROSPECT-CONKO 004: a prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy)
Rationale and design of PROSPECT-CONKO 004: a prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy)
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DOI：
10.1186/1471-2407-8-361
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发表时间：
2008-12-05
期刊：
影响因子：
3.8
通讯作者：
Oettle, Helmut
中科院分区：
文献类型：
--
作者：
Riess, Hanno;Pelzer, Uwe;Oettle, Helmut
背景资料：晚期胰腺癌除了其高死亡率之外，其特征在于与其他类型的癌症相比，静脉血栓栓塞事件（VTE）的发生率最高。依诺肝素是一种低分子量肝素（LMWH），已被证明可有效预防和治疗外科和普通内科患者的VTE。一些小型研究的结果表明，这种益处可能扩展到癌症患者，然而，依诺肝素目前不适用于这种用途。这IIb期研究的目的是分析依诺肝素在局部晚期或转移性胰腺癌患者接受全身chemotherapy.Methods的疗效：这一前瞻性多中心试验的目的是比较伴随治疗依诺肝素没有抗凝治疗540例。主要终点是前3个月内临床相关VTE（腿部和/或骨盆和/或肺栓塞（PE）的症状性深静脉血栓形成（DVT））的发生率。次要终点包括6、9和12个月后症状性和无症状性VTE的发生率以及3、6、9和12个月时的缓解、总生存期和出血。试验注册：isrctn.org标识符CCT-NAPN-16752，controlled-trials.com标识符：ISRCTN 02140505.结果：对152例患者进行的安全性中期分析显示出血风险未增加（5例患者vs. 6例患者，Chi（2）：0.763）。结论：前景是阐明低分子肝素在晚期胰腺癌中作用的关键研究。其结果将导致肝素在预防静脉血栓栓塞中的作用及其对生存率、缓解率和化疗方案毒性的影响的新认识。
Background: Advanced pancreatic cancer, in addition to its high mortality, is characterized by one of the highest rates of venous thromboembolic events (VTE) as compared to other types of cancer. Enoxaparin, a low molecular weight heparin (LMWH), has proven to be effective for the prevention and treatment of VTE in surgical and general medical patients. Results of some small studies suggest that this benefit might extend to patients with cancer, however, enoxaparin is not currently indicated for this use. This phase IIb study was designed to analyze the efficacy of enoxaparin in patients with locally advanced or metastatic pancreatic cancer undergoing systemic chemotherapy.Methods: The aim of this prospective multicenter trial is to compare concomitant treatment with enoxaparin to no anticoagulation in 540 patients. Primary endpoint is the incidence of clinically relevant VTE (symptomatic deep venous thrombosis (DVT) of the leg and/or pelvic and/or pulmonary embolism (PE)) within the first 3 months. Secondary endpoints include the incidence of symptomatic and asymptomatic VTE after 6, 9 and 12 months as well as remission at 3, 6, 9 and 12 months, overall survival and bleeding. Trial registration: isrctn.org identifier CCT-NAPN-16752, controlled-trials.com identifier: ISRCTN02140505.Results: An interim analysis for safety performed after inclusion of 152 patients revealed no increased risk of bleeding (5 pts vs. 6 pts, Chi(2): 0.763).Conclusion: PROSPECT is a pivotal study in elucidating the role of low molecular weight heparins in advanced pancreatic cancer. Its results will lead to a new understanding of the role of heparins in the prevention of venous thromboembolism and of their effect on survival, remission rates and toxicity of chemotherapeutic regimens.