Carlson J W, Fowler J M, Saltzman A K, Carter J R, Chen M D, Mitchell S K, Dunn D, Carson L F, Adcock L L, Twiggs L B
Women's Cancer Center, University of Minnesota Hospital and Clinics, Minneapolis.
Gynecol Oncol. 1994 Dec;55(3 Pt 1):415-20. doi: 10.1006/gyno.1994.1315.
The purpose of this study was to review the clinical outcomes and cost of administration of a prophylactic antibiotic compared to G-CSF for the prevention of neutropenic morbidity associated with taxol. The study group was composed of 62 patients with ovarian cancer who received a 24-h infusion of a taxol-based regimen at doses less than or equal to 175 mg/m2 between June 1992 and April 1994. The records were retrospectively reviewed and the patients were grouped and analyzed according to the management of their myelosuppression. Group I patients (n = 29) were observed until their absolute neutrophil count (ANC) was less than 500/microliters and then were placed on ciprofloxacin 500 mg orally twice a day until their ANC was 1,000/microliters. Group II patients (n = 15) received G-CSF from Day 2 until the ANC was greater than 10,000/microliters beginning with their first cycle. Group III patients (n = 18) received their taxol regimen without either ciprofloxacin or G-CSF. Two hundred eighty-two taxol-based chemotherapy cycles were administered to these 62 patients. There was no statistically significant difference between the groups concerning disease status as measured by age, stage, performance status, dose intensity, or number of previous regimens. There were two episodes of febrile neutropenia in Group I and three episodes in Group II. Group III had 15 episodes of febrile neutropenia. The estimated cost of the different prophylactic regimens was $5,215.00 for Group I versus $104,000.00 for G-CSF in Group II. Within the three groups, there were 27 patients with an episode of febrile neutropenia (n = 20) or prolonged myelosuppression (n = 7) that were followed for an additional 104 taxol cycles. Twenty-four of these patients received G-CSF prophylaxis with intermittent ciprofloxacin and three received only ciprofloxacin. There were eight more episodes of febrile neutropenia in the patients receiving G-CSF. There were no additional febrile episodes on cycles prophylaxed with ciprofloxacin. There was no septic mortality. For patients receiving a 24 h infusion of taxol at doses less than 175 mg/m2, ciprofloxacin given through the ANC nadir may be effective in preventing febrile morbidity. A prospective randomized trial is underway to evaluate this approach.
本研究的目的是比较预防性使用抗生素与粒细胞集落刺激因子（G-CSF）预防紫杉醇相关中性粒细胞减少症的临床疗效和给药成本。研究组由62例卵巢癌患者组成，这些患者在1992年6月至1994年4月期间接受了基于紫杉醇的方案24小时输注，剂量小于或等于175mg/m²。对记录进行回顾性审查，并根据骨髓抑制的处理方法对患者进行分组和分析。第一组患者（n = 29）在绝对中性粒细胞计数（ANC）低于500/微升时进行观察，然后口服环丙沙星500mg，每日两次，直至ANC达到1000/微升。第二组患者（n = 15）从第2天开始接受G-CSF治疗，直至第一个周期开始时ANC大于10000/微升。第三组患者（n = 18）接受基于紫杉醇的方案治疗，未使用环丙沙星或G-CSF。这62例患者共接受了282个基于紫杉醇的化疗周期。在年龄、分期、体能状态、剂量强度或既往治疗方案数量所衡量的疾病状态方面，各组之间无统计学显著差异。第一组有2例发热性中性粒细胞减少症发作，第二组有3例。第三组有15例发热性中性粒细胞减少症发作。不同预防方案的估计成本为：第一组5215.00美元，第二组G-CSF为104000.00美元。在这三组中，有27例患者出现发热性中性粒细胞减少症发作（n = 20）或骨髓抑制延长（n = 7），随后又进行了104个紫杉醇周期的治疗。其中24例患者接受了G-CSF预防并间断使用环丙沙星，3例仅接受环丙沙星治疗。接受G-CSF治疗的患者发热性中性粒细胞减少症发作又增加了8例。接受环丙沙星预防的周期中没有额外的发热发作。没有感染性死亡病例。对于接受剂量小于175mg/m²的紫杉醇24小时输注的患者，在ANC最低点时给予环丙沙星可能有效预防发热性疾病。一项前瞻性随机试验正在进行中，以评估这种方法。
