METHODS: Chemotherapy consisted of intravenous administration of docetaxel (70 mg/m2 per day) and cisplatin (70 mg/m2 per day) on day 1 and continuous infusion of 5-fluorouracil (750 mg/m2 per day) on days 1-5. Pegfilgrastim was given as a single subcutaneous injection at a dose of 3.6 mg on day 3 during each treatment course. This regimen was repeated every 3 weeks for up to a maximum of three courses. Prophylactic antibiotics were not needed but were allowed to be given at the discretion of the physician. The primary endpoint was the incidence of FN.
RESULTS: Twenty-six patients were administered DCF in combination with pegfilgrastim on day 3. After the first course of DCF, 10 out of 26 patients (38.5%) experienced grade 4 neutropenia, and two patients (7.7%) experienced FN. Of the 14 patients who did not receive prophylactic antibiotics, four had grade 4 neutropenia, including two who developed FN. On the contrary, of the 12 patients who received prophylactic levofloxacin, six had grade 4 neutropenia, but no cases of FN were observed.
CONCLUSIONS: Administration of pegfilgrastim on day 3 was not sufficient to prevent FN due to DCF treatment, and prophylactic administration of both pegfilgrastim and antibiotics could be a solution.
方法:化疗包括在第1天静脉内施用多西他赛(每天70mg/m2)和顺铂(每天70mg/m2),以及在第1-5天连续输注5-氟尿嘧啶(每天750mg/m2)。在每个治疗过程中的第3天以3.6mg的剂量给予Pegfilgrastim单次皮下注射。该方案每3周重复一次,最多三个疗程。不需要预防性抗生素,但允许医生酌情给予。主要终点是FN的发生率。
结果:26名患者在第3天联合给予DCF和pegfilgrastim。在DCF的第一个疗程之后,26例患者中有10例(38.5%)经历了4级中性粒细胞减少症,和两名患者(7.7%)经历了FN。在14名没有接受预防性抗生素治疗的患者中,四个人患有4级中性粒细胞减少症,包括两名开发FN的人。相反,在接受预防性左氧氟沙星的12名患者中,六人有4级中性粒细胞减少症,但未观察到FN病例。
结论:在第3天服用pegfilgrastim不足以预防由于DCF治疗引起的FN,预防性使用pegfilgrastim和抗生素可能是一种解决方案。