Servicio de Oncología Radioterápica, Hospital Clínico Universitario Santiago de Compostela, Travesía Choupana, s/n, ES-15706 Santiago de Compostela, La Coruña, Spain.
Clin Transl Oncol. 2010 Dec;12(12):843-8. doi: 10.1007/s12094-010-0607-4.
The aim of the project was to assess the effectiveness and safety of weekly epoetin-beta (EB) in patients with gastrointestinal cancer (GIC) subjected to concomitant chemoradiotherapy (CCTRT).
In this clinical prospective and multicentre cohort study EB was administered at a dose of 30,000 IU/ week, during CCTRT and in the four weeks thereafter, and suspended if haemoglobin (Hb) increased >2 g/dl or Hb >12-13 g/dl. Effectiveness was defi ned as Hb increase ≥1 g/dl vs. baseline. Time to response, treatment toxicity and transfusion requirements were also assessed.
EB was effective in 75.8% of the evaluable population within a median of four weeks from EB initiation, without blood transfusions. Over 80% of all patients remained below the threshold (Hb ≤13 g/dl) and no study drug-related adverse reactions were recorded.
Weekly EB proved to be effective and well tolerated by patients with GIC subjected to CCTRT.
本项目旨在评估胃肠道癌(GIC)患者同步放化疗(CCTRT)期间每周接受促红细胞生成素-β(EB)治疗的有效性和安全性。
在这项前瞻性、多中心队列研究中,在 CCTRT 期间和之后的四周内,给予 EB 剂量为 30000IU/周,如果血红蛋白(Hb)升高超过 2g/dl 或 Hb 升高超过 12-13g/dl,则暂停给药。有效性定义为 Hb 增加≥1g/dl 与基线相比。还评估了反应时间、治疗毒性和输血需求。
在 EB 开始后中位数为四周内,可评估人群中 75.8%的患者有效,且无需输血。超过 80%的患者 Hb 仍低于阈值(Hb≤13g/dl),且未记录到任何与研究药物相关的不良反应。
每周 EB 对接受 CCTRT 的 GIC 患者有效且耐受良好。