Oncology Unit, ICOT Hospital, Policlinico Umberto I Hospital, University of Rome, Italy.
Ther Clin Risk Manag. 2013;9:457-62. doi: 10.2147/TCRM.S48387. Epub 2013 Nov 11.
Neutropenia is a common toxicity in patients receiving myelosuppressive chemotherapy. In this prospective pilot study, we compared the efficacy and safety profiles of pegfilgrastim administered subcutaneously once per cycle and lenograstim administered subcutaneously daily six times per cycle, for primary neutropenia prophylaxis in women with breast cancer receiving adjuvant anthracycline-based chemotherapy.
Twenty women were enrolled. All patients received epirubicin 100 mg/m(2) with 5-fluorouracil 500 mg/m(2) and cyclophosphamide 500 mg/m(2) on day 1 and every 21 days thereafter, according to the FEC 100 chemotherapy regimen. Eight patients received a single dose of pegfilgrastim on day 2, while 12 patients were treated with daily administration of lenograstim from days five to ten. Absolute neutrophil count and duration of grade 3-4 neutropenia were monitored using seriated blood samples. The incidence of bone pain was evaluated using the visual analog scale (VAS).
The incidence of grade 3-4 neutropenia was 75% in patients who received pegfilgrastim, and 25% in patients who received lenograstim. One case of febrile neutropenia was shown in pegfilgrastim patients. The mean duration of grade 3-4 neutropenia was 2 days in pegfilgrastim group versus 1.4 days in the lenograstim group. Bone pain was present in 37.5% of pegfilgrastim patients versus 58.3% of lenograstim patients. The mean duration of bone pain in the pegfilgrastim group was 4 days versus 6 days in the lenograstim group.
In our experience, a single injection of pegfilgrastim was less effective for controlling neutropenia than six daily injections of lenograstim. The safety profiles of pegfilgrastim and lenograstim were similar with a lower incidence of bone pain in patients treated with pegfilgrastim.
中性粒细胞减少是接受骨髓抑制化疗的患者常见的毒性。在这项前瞻性的初步研究中，我们比较了培非格司亭皮下注射每周期一次和格拉司琼皮下注射每日六次用于接受蒽环类药物辅助化疗的乳腺癌患者初级中性粒细胞减少预防的疗效和安全性。
共纳入 20 名女性患者。所有患者均接受表柔比星 100mg/m²联合氟尿嘧啶 500mg/m²和环磷酰胺 500mg/m²，第 1 天和此后每 21 天 1 次，根据 FEC100 化疗方案。8 例患者在第 2 天给予单次培非格司亭剂量，而 12 例患者则从第 5 天至第 10 天给予每日格拉司琼治疗。使用系列血样监测绝对中性粒细胞计数和 3-4 级中性粒细胞减少的持续时间。使用视觉模拟量表（VAS）评估骨痛的发生率。
接受培非格司亭的患者中 3-4 级中性粒细胞减少的发生率为 75%，接受格拉司琼的患者中发生率为 25%。培非格司亭组有 1 例发热性中性粒细胞减少症。培非格司亭组 3-4 级中性粒细胞减少的平均持续时间为 2 天，格拉司琼组为 1.4 天。培非格司亭组 37.5%的患者出现骨痛，格拉司琼组 58.3%的患者出现骨痛。培非格司亭组骨痛的平均持续时间为 4 天，格拉司琼组为 6 天。
根据我们的经验，培非格司亭单次注射控制中性粒细胞减少的效果不如格拉司琼每日 6 次注射。培非格司亭和格拉司琼的安全性相似，培非格司亭治疗的患者骨痛发生率较低。
