Chevallier B, Chollet P, Merrouche Y, Roche H, Fumoleau P, Kerbrat P, Genot J Y, Fargeot P, Olivier J P, Fizames C
Centre Régional de Lutte contre le Cancer (CRLCC), Rouen, France.
J Clin Oncol. 1995 Jul;13(7):1564-71. doi: 10.1200/JCO.1995.13.7.1564.
To compare the efficacy and safety of recombinant human granulocyte colony-stimulating factor (rHuG-CSF) versus its inert vehicle in patients with unilateral nonmetastatic inflammatory breast cancer treated with fluorouracil, epirubicin, and cyclophosphamide high-dose (FEC-HD) neoadjuvant chemotherapy.
One hundred twenty patients have been enrolled by nine French centers in this double-blind, parallel-group, vehicle-controlled study to compare at each cycle subcutaneous lenograstim (5 micrograms/kg/d) with placebo given from day 6 to day 15 after the induction chemotherapy (day 1 to day 4, fluorouracil 750 mg/m2 continuous intravenous [IV] infusion; day 2 to day 4, epirubicin 35 mg/m2 and cyclophosphamide 400 mg/m2 both IV push). Four cycles were planned every 3 weeks before locoregional treatment. Patients with febrile neutropenia remained blinded for the subsequent cycles.
Lenograstim significantly reduced the duration of neutropenia at less than 0.5 x 10(9)/L and less than 1 x 10(9)/L to a median duration of 2 and 3 days, respectively, as compared with 5 and 7 days in the placebo group. This translated into a statistically significant reduced incidence of microbiologically documented infections, and a decreased need for rehospitalizations for infectious events and antibiotic use. Clinical objective tumor response rate observed after four cycles was 89.6% and 93%, respectively, in the placebo and treated groups. Mild transient bone and injection-site pain, myelemia, and hyperleukocytosis were the most frequently reported adverse events associated with lenograstim.
Lenograstim is safe and effective to reduce morbidity associated with FEC-HD neoadjuvant chemotherapy in inflammatory breast cancer. Response rate is not affected.
比较重组人粒细胞集落刺激因子（rHuG-CSF）与其惰性赋形剂在接受氟尿嘧啶、表柔比星和环磷酰胺大剂量（FEC-HD）新辅助化疗的单侧非转移性炎性乳腺癌患者中的疗效和安全性。
九个法国中心招募了120例患者参与这项双盲、平行组、赋形剂对照研究，在诱导化疗（第1天至第4天，氟尿嘧啶750mg/m²持续静脉输注；第2天至第4天，表柔比星35mg/m²和环磷酰胺400mg/m²均静脉推注）后的第6天至第15天，比较每个周期皮下注射来格司亭（5μg/kg/天）与安慰剂的效果。计划每3周进行四个周期的治疗，然后进行局部区域治疗。发热性中性粒细胞减少的患者在后续周期中保持盲态。
与安慰剂组的5天和7天相比，来格司亭显著缩短了中性粒细胞计数低于0.5×10⁹/L和低于1×10⁹/L的持续时间，中位数分别为2天和3天。这转化为微生物学记录的感染发生率在统计学上显著降低，以及因感染事件再次住院和使用抗生素的需求减少。安慰剂组和治疗组在四个周期后观察到的临床客观肿瘤缓解率分别为89.6%和93%。轻度短暂的骨骼和注射部位疼痛、骨髓血症和白细胞增多是与来格司亭相关的最常报告的不良事件。
来格司亭在降低炎性乳腺癌FEC-HD新辅助化疗相关发病率方面是安全有效的。缓解率不受影响。
