Ariganello Ottavio, Mancuso Andrea, Di Molfetta Michele, Diana Francesco, Beccaglia Patrizia, Cortesi Enrico, De Marinis Filippo
Department of Lung Diseases, 5th Pulmonary-Oncological Unit, S. Camillo-Forlanini Hospitals, Via Portuense 332, 00149 Rome, Italy.
Lung Cancer. 2004 Oct;46(1):119-24. doi: 10.1016/j.lungcan.2004.03.017.
Non-small cell lung cancer (NSCLC) treatment with new drugs in combination with platinum salts induce anemia G1/2 and G3/4 WHO in about 35 and 10-20% of patients, respectively, with a chemotherapy (CT) dose intensity decrease in 20% of cases. Epoetin alfa, administered at standard dosages has been shown to significantly increase hemoglobin (Hb) levels, decrease transfusion requirements, and improve quality-of-life parameters in patients undergoing chemotherapy.
This open-label, non-randomized study was conducted to evaluate the efficacy and safety of an induction dose of epoetin alfa 40.000 IU in lung cancer patients with moderate or severe anemia who were receiving CT.
Twenty-four patients (8 SCLC and 16 NSCLC) were enrolled in the study to receive single subcutaneous (s.c.) injections of epoetin alfa 40.000 IU on days 1, 4, 7, 10, and 13, followed by standard treatment (10.000 IU t.i.w.) for the further 2 weeks. Nine patients had been previously treated with epoetin alfa 10.000 IU t.i.w. Twenty-two patients were receiving first-line CT and two patients were receiving docetaxel as second-line CT.
After 15 days of treatment, in 21 evaluable patients, Hb was 10.5 +/- 1.3 g/dL (mean +/- S.D.), with a mean increase from baseline of 2.0 g/dL (95%CI: 1.3-2.7). Hb increase was > or =2g/dL in 11 patients, 1-1.9 g/dL in 5 patients, and <1g/dL in 5 patients. After 30 days of treatment, Hb was 11.5 +/- 0.8 g/dL (mean +/- S.D.), with a mean increase from baseline of 2.9 g/dL (95%CI: 2.4-3.4) in 20 evaluable patients. No adverse events possibly related to epoetin alfa treatment were observed.
An induction therapy with epoetin alfa 40.000 IU for 2 weeks followed by standard treatment allows an Hb increase of 2.9 g/dL even in advanced lung cancer patients with a moderate/severe anemia, without RBC transfusion requirements. A randomized study of the proposed induction dose of epoetin alfa 40.000 IU is actually ongoing.
非小细胞肺癌（NSCLC）采用新药联合铂盐治疗时，分别约有35%和10 - 20%的患者会出现WHO 1/2级和3/4级贫血，20%的病例化疗（CT）剂量强度会降低。已证明，按标准剂量使用促红细胞生成素α可显著提高血红蛋白（Hb）水平，减少输血需求，并改善接受化疗患者的生活质量参数。
本开放标签、非随机研究旨在评估诱导剂量的促红细胞生成素α 40000 IU对接受CT治疗的中重度贫血肺癌患者的疗效和安全性。
24例患者（8例小细胞肺癌和16例非小细胞肺癌）入组本研究，于第1、4、7、10和13天接受单次皮下注射促红细胞生成素α 40000 IU，随后进行2周的标准治疗（每周3次，每次10000 IU）。9例患者此前接受过每周3次、每次10000 IU促红细胞生成素α的治疗。22例患者接受一线CT治疗，2例患者接受多西他赛作为二线CT治疗。
治疗15天后，21例可评估患者的Hb为10.5±1.3 g/dL（均值±标准差），较基线平均升高2.0 g/dL（95%CI：1.3 - 2.7）。11例患者Hb升高≥2 g/dL，5例患者升高1 - 1.9 g/dL，5例患者升高<1 g/dL。治疗30天后，20例可评估患者的Hb为11.5±0.8 g/dL（均值±标准差），较基线平均升高2.9 g/dL（95%CI：2.4 - 3.4）。未观察到可能与促红细胞生成素α治疗相关的不良事件。
采用促红细胞生成素α 40000 IU进行2周诱导治疗，随后进行标准治疗，即使是中重度贫血的晚期肺癌患者，Hb也可升高2.9 g/dL，且无需输注红细胞。关于促红细胞生成素α 40000 IU诱导剂量的随机研究正在进行中。
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