Dunlop D J, Eatock M M, Paul J, Anderson S, Reed N S, Soukop M, Lucie N, Fitzsimmons E J, Tansey P, Steward W P
Glasgow Royal Infirmary University NHS Trust, UK.
Clin Oncol (R Coll Radiol). 1998;10(2):107-14. doi: 10.1016/s0936-6555(05)80490-x.
This study was intended to ascertain whether the adjunctive administration of filgrastim (r metHuG-CSF, Amgen) would influence the dose intensity of chemotherapy or the morbidity of myelosuppression in patients receiving MOPP or MOPP/EVAP hybrid chemotherapy for Hodgkin's disease. In a prospective randomized trial, two regimens for the treatment of Hodgkin's disease were compared. The substudy described here randomized patients receiving either regimen to receive filgrastim on the days when chemotherapy was not administered. During chemotherapy, parameters of myelosuppression were documented, including dose delays, the severity and duration of neutrophil and platelet nadirs, infective episodes, and resulting hospital admissions. In the MOPP arm, 13/25 eligible patients, and, in the MOPP/EVAP arm, 12/22 eligible patients, received filgrastim. The use of filgrastim made no statistically significant difference to the administered dose intensity for either MOPP (P = 0.57, 95% confidence interval (CI) 15-point increase to 8-point reduction) or MOPP/EVAP (P = 0.53; 95% CI 7-point increase to 11-point reduction). In patients receiving MOPP, filgrastim reduced the median duration of leucopenia (P = 0.007) and the severity of the white blood cell nadir (P = 0.036); however, no statistically significant effect (at the 5% level) was seen in platelet or haemoglobin nadirs, the number of days of in-patient hospitalization, the number of admissions for infective complications, the incidence, grade or duration of infections, or the incidence of febrile neutropenia. In patients receiving MOPP/EVAP, filgrastim had no significant effect on the duration or depth of leucopenia but was associated with a reduction in the median haemoglobin (P = 0.002) and platelet nadirs (P = 0.015). No effect on the above listed sequelae of myelosuppression was influenced by the administration of filgrastim. This study, although small, suggests that the routine use of filgrastim, aimed at influencing the administered dose intensity of conventional dose chemotherapy in Hodgkin's disease, is not warranted.
本研究旨在确定对于接受MOPP或MOPP/EVAP混合化疗治疗霍奇金淋巴瘤的患者，辅助使用非格司亭（重组人粒细胞集落刺激因子，安进公司）是否会影响化疗的剂量强度或骨髓抑制的发病率。在一项前瞻性随机试验中，比较了两种治疗霍奇金淋巴瘤的方案。此处描述的子研究将接受任一方案治疗的患者随机分为在未进行化疗的日子接受非格司亭治疗组。化疗期间，记录骨髓抑制参数，包括剂量延迟、中性粒细胞和血小板最低点的严重程度及持续时间、感染发作情况以及由此导致的住院情况。在MOPP组，13/25例符合条件的患者，以及在MOPP/EVAP组，12/22例符合条件的患者接受了非格司亭治疗。对于MOPP（P = 0.57，95%置信区间（CI）：增加15个点至减少8个点）或MOPP/EVAP（P = 0.53；95% CI：增加7个点至减少11个点），使用非格司亭对给药剂量强度均无统计学上的显著差异。在接受MOPP治疗的患者中，非格司亭缩短了白细胞减少的中位持续时间（P = 0.007），并降低了白细胞最低点的严重程度（P = 0.036）；然而，在血小板或血红蛋白最低点、住院天数、感染并发症入院次数、感染的发生率、分级或持续时间，或发热性中性粒细胞减少的发生率方面，未观察到统计学上的显著影响（在5%水平）。在接受MOPP/EVAP治疗的患者中，非格司亭对白细胞减少的持续时间或深度无显著影响，但与血红蛋白中位数降低（P = 0.002）和血小板最低点降低（P = 0.015）相关。非格司亭的使用对上述列出的骨髓抑制后遗症均无影响。本研究虽然规模较小，但表明旨在影响霍奇金淋巴瘤常规剂量化疗给药剂量强度而常规使用非格司亭是没有必要的。
