Woll P J, Hodgetts J, Lomax L, Bildet F, Cour-Chabernaud V, Thatcher N
Cancer Research Campaign Department of Medical Oncology, Christie Hospital, Manchester, United Kingdom.
J Clin Oncol. 1995 Mar;13(3):652-9. doi: 10.1200/JCO.1995.13.3.652.
The use of granulocyte colony-stimulating factor (G-CSF) to increase cytotoxic dose-intensity was assessed in a randomized trial in better-prognosis small-cell lung cancer (SCLC). Both control and G-CSF arms were subject to the same dose-intensification strategy.
Patients with newly diagnosed SCLC and either no or one adverse prognostic factor were randomized to receive vincristine, ifosfamide, carboplatin, and etoposide (VICE) alone or with recombinant human (rHu)G-CSF (lenograstim) 5 micrograms/kg/d between cycles. Six chemotherapy cycles were given, with prophylactic cranial irradiation after cycle 1 and thoracic irradiation after cycle 3. There was no fixed dose interval. In both arms, patients were eligible for re-treatment when the WBC count was > or = 3 x 10(9)/L and platelet count was > or = 100 x 10(9)/L. No dose reductions were permitted. Dose-intensity was expressed relative to standard every-4-weeks VICE.
Sixty-five consecutive patients in one institution were randomized to control (n = 31) or G-CSF (n = 34). WBC and neutrophil counts were consistently higher in G-CSF patients than in the control group, but there were no significant differences in the incidence of febrile neutropenia, antibiotic or transfusion requirements, or days in hospital. In both treatment arms, the median dose-intensity was greater than one for each cycle (control group, P = .0009; G-CSF group, P = .0001). The G-CSF group received a significantly higher dose-intensity than the control group, with the greatest difference in the first three cycles (1.34 v 1.17, P = .001). There were more chemotherapy-related deaths in the G-CSF group than in the control group (six v one), but this group had a better 2-year survival rate (32% with G-CSF, 95% confidence interval [CI], 16 to 48; 15% with controls, 95% CI, 2 to 27).
The dose-intensity of VICE chemotherapy was increased in both groups. Patients randomized to receive G-CSF achieved a significantly higher dose-intensity than controls. Despite early toxicity, they had a better 2-year survival rate.
在一项针对预后较好的小细胞肺癌（SCLC）的随机试验中，评估使用粒细胞集落刺激因子（G-CSF）来提高细胞毒性剂量强度的效果。对照组和G-CSF组均采用相同的剂量强化策略。
新诊断为SCLC且无不良预后因素或仅有一个不良预后因素的患者被随机分组，分别接受长春新碱、异环磷酰胺、卡铂和依托泊苷（VICE）单药治疗，或在两个周期之间接受重组人（rHu）G-CSF（来格司亭）5微克/千克/天治疗。共给予六个化疗周期，在第1周期后进行预防性颅脑照射，在第3周期后进行胸部照射。没有固定的剂量间隔。在两组中，当白细胞计数≥3×10⁹/L且血小板计数≥100×10⁹/L时，患者有资格接受再次治疗。不允许降低剂量。剂量强度相对于标准的每4周一次的VICE方案来表示。
一家机构的65例连续患者被随机分为对照组（n = 31）或G-CSF组（n = 34）。G-CSF组患者的白细胞和中性粒细胞计数始终高于对照组，但在发热性中性粒细胞减少症的发生率、抗生素或输血需求或住院天数方面没有显著差异。在两个治疗组中，每个周期的中位剂量强度均大于1（对照组，P = 0.0009；G-CSF组，P = 0.0001）。G-CSF组的剂量强度显著高于对照组，在前三个周期差异最大（1.34对1.17，P = 0.001）。G-CSF组的化疗相关死亡人数多于对照组（6例对1例），但该组的2年生存率更高（G-CSF组为32%，95%置信区间[CI]，16%至48%；对照组为15%，95%CI，2%至27%）。
两组的VICE化疗剂量强度均有所提高。随机接受G-CSF治疗的患者的剂量强度显著高于对照组。尽管有早期毒性，但他们的2年生存率更高。
