Phase III trial to evaluate the efficacy of maintaining hemoglobin levels above 12.0 g/dL with erythropoietin vs above 10.0 g/dL without erythropoietin in anemic patients receiving concurrent radiation and cisplatin for cervical cancer
Phase III trial to evaluate the efficacy of maintaining hemoglobin levels above 12.0 g/dL with erythropoietin vs above 10.0 g/dL without erythropoietin in anemic patients receiving concurrent radiation and cisplatin for cervical cancer
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DOI：
10.1016/j.ygyno.2007.10.011
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发表时间：
2008-02-01
影响因子：
4.7
通讯作者：
Begg, Adrian C.
中科院分区：
文献类型：
--
作者：
Thomas, Gillian;Ali, Shamshad;Begg, Adrian C.
目的.为了确定与“标准”治疗（HGB >= 10.0 g/dL的输血）相比，使用重组人促红细胞生成素（R-HUEPO）维持HGB水平>= 12.0 g/dL是否改善了接受每周顺铂和放疗（CT/RT）的宫颈癌妇女的无进展生存期（PFS）、总生存期（OS）和局部控制（LC）。此外，为了确定铂-DNA加合物是否与临床特征或结果相关。将患有IIB-IVA期宫颈癌和HGB < 14.0 g/dL的患者随机分配至CT/RT R-HUEPO（40，000单位s.c.每周）。如果HGB > 14.0 g/dL，则停止R-HUEPO。终点为PFS、OS和LC。用免疫细胞化学法检测口腔黏膜细胞中铂-DNA加合物的含量。2001年8月至2003年9月，114例患者中有109例合格。52例接受CT/RT，57例接受CT/RT+R-HUEPO。由于对R-HUEPO血栓栓塞事件（TE）的潜在担忧，研究提前关闭，不到计划增加的25%。中位随访时间为37个月（范围9.8-50.4个月）。CT/RT组3年PFS和OS分别为65%和75%，CT/RT+R-HUEPO组分别为58%和61%。CT/RT组中4/52例发生TE，CT/RT+R-HUEPO组中11/57例发生TE，认为并非所有TE均与治疗相关。TE未导致死亡。高铂加合物与较差的PFS和LC相关。TE在接受CT/RT的宫颈癌患者中很常见。两种治疗之间的TE率差异无统计学意义。维持HGB水平> 12.0 g/dL对PFS、OS和LC的影响尚未确定。(C)2007年爱思唯尔公司All rights reserved.
Purpose. To determine whether maintaining HGB levels >= 12.0 g/dL with recombinant human erythropoietin (R-HUEPO) compared to "standard" treatment (transfusion for HGB >= 10.0 g/dL) improves progression-free survival (PFS), overall survival (OS) and local control (LC) in women receiving concurrent weekly cisplatin and radiation (CT/RT) for carcinoma of the cervix. In addition, to determine whether platinum-DNA adducts were associated with clinical characteristics or outcome.Methods. Patients with stage IIB-IVA cervical cancer and HGB < 14.0 g/dL were randomly assigned to CT/RT R-HUEPO (40,000 units s.c. weekly). R-HUEPO was stopped if HGB > 14.0 g/dL. Endpoints were PFS, OS and LC. Platinum-DNA adducts were quantified using immunocytochemistry assay in buccal cells.Results. Between 08/01 and 09/03, 109 of 114 patients accrued were eligible. Fifty-two received CT/RT and 57 CT/RT+R-HUEPO. The study closed prematurely, with less than 25% of the planned accrual, due to potential concerns for thromboembolic event (TE) with R-HUEPO. Median follow-up was 37 months (range 9.8-50.4 months). PFS and OS at 3 years should be 65% and 75% for CT/RT and 58% and 61% for CT/RT+R-HUEPO, respectively. TE occurred in 4/52 receiving CT/RT and 11/57 with CT/RT+R-HUEPO, not all considered treatment related. No deaths occurred from TE. High-platinum adducts were associated with inferior PFS and LC.Conclusion. TE is common in cervical cancer patients receiving CT/RT. Difference in TE rate between the two treatments was not statistically significant. The impact of maintaining HGB level > 12.0 g/dL on PFS, OS and LC remains undetermined. (C) 2007 Elsevier Inc. All rights reserved.