Miles D W, Fogarty O, Ash C M, Rudd R M, Trask C W, Spiro S G, Gregory W M, Ledermann J A, Souhami R L, Harper P G
Guy's Hospital, Medical Oncology Clinic, London, England.
J Clin Oncol. 1994 Jan;12(1):77-82. doi: 10.1200/JCO.1994.12.1.77.
A prospective randomized trial to determine if granulocyte colony-stimulating factor (G-CSF) could increase the received dose-intensity (RDI) of weekly chemotherapy in patients with small-cell lung cancer (SCLC).
Forty patients with SCLC with good prognostic features (all patients with limited disease [LD], and extensive-disease [ED] patients with Eastern Cooperative Oncology Group [ECOG] 0 or 1 and plasma alkaline phosphatase levels < 1.5 times the upper limit of normal) were randomized to receive weekly chemotherapy with or without G-CSF. G-CSF (5 micrograms/kg) was self-administered subcutaneously on days when chemotherapy was not given. Chemotherapy consisted of cisplatin 50 mg/m2 intravenously (IV) on day 1 and etoposide 75 mg/m2 IV on days 1 and 2 alternating weekly with ifosfamide 2 g/m2 IV (with mesna) and doxorubicin 25 mg/m2 on day 1, for a total of 12 courses. Dose modifications (dose reductions and treatment delays) were made according to defined hematologic criteria.
Dose reductions were made at some point during treatment in 12 of 17 patients in the control arm and in 11 of 23 patients in the G-CSF arm (P = .20). The proportion of patients experiencing dose reductions due to leukopenia was significantly higher in the control arm (nine of 17) compared with the G-CSF arm (four of 23, P < .04). Cycle delays due to leukopenia were similar in both arms of the study. The RDI was 82% of projected in the control arm (95% confidence interval [CI], 79% to 84%) and 84% in patients receiving G-CSF (95% CI, 82% to 87%) (P value not significant).
In this randomized trial, G-CSF significantly decreased dose reductions due to neutropenia. However, administration of G-CSF did not decrease dose reductions or treatment delays to a level that would allow an increase in received dose-intensity. Nonhematologic toxicities such as increased creatinine concentration also prevented an increase in the RDI in the G-CSF arm.
进行一项前瞻性随机试验，以确定粒细胞集落刺激因子（G-CSF）是否能提高小细胞肺癌（SCLC）患者每周化疗的接受剂量强度（RDI）。
40例具有良好预后特征的SCLC患者（所有局限性疾病[LD]患者，以及东部肿瘤协作组[ECOG]评分为0或1且血浆碱性磷酸酶水平<正常上限1.5倍的广泛期疾病[ED]患者）被随机分为接受或不接受G-CSF的每周化疗组。在未进行化疗的日子里，患者自行皮下注射G-CSF（5微克/千克）。化疗方案为第1天静脉注射顺铂50毫克/平方米，第1天和第2天静脉注射依托泊苷75毫克/平方米，每周交替使用异环磷酰胺2克/平方米（加美司钠）和第1天静脉注射多柔比星25毫克/平方米，共12个疗程。根据既定的血液学标准进行剂量调整（剂量减少和治疗延迟）。
对照组17例患者中有12例在治疗的某个阶段进行了剂量减少，G-CSF组23例患者中有11例（P = 0.20）。与G-CSF组（23例中的4例）相比，对照组中因白细胞减少而进行剂量减少的患者比例显著更高（17例中的9例，P < 0.04）。研究的两组中因白细胞减少导致的周期延迟相似。对照组的RDI为预计值的82%（95%置信区间[CI]，79%至84%），接受G-CSF的患者为84%（95%CI，82%至87%）（P值无统计学意义）。
在这项随机试验中，G-CSF显著减少了因中性粒细胞减少导致的剂量减少。然而，G-CSF的使用并未将剂量减少或治疗延迟降低到足以提高接受剂量强度的水平。肌酐浓度升高等非血液学毒性也阻碍了G-CSF组RDI的提高。
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