Mehdi S A, Perry M C, Herndon J E, Crawford J, Young R, Graziano S L
Department of Medicine, SUNY-Health Science Center and VAMC, Syracuse, NY 13210, USA.
J Interferon Cytokine Res. 1998 Aug;18(8):623-7. doi: 10.1089/jir.1998.18.623.
A previous phase II study (CALGB 9132) of etoposide/cisplatin + rG-CSF in patients with advanced non-small cell lung cancer (NSCLC) showed a marked difference in the absolute neutrophil count (ANC) nadirs between courses 1 and 2. Median ANC nadirs for courses 1 and 2 were 200 and 2500, respectively, suggesting a priming effect for rG-CSF. The present study was designed to determine whether rG-CSF given prior to the first cycle of chemotherapy would decrease the severity and duration of neutropenia. Twelve patients with stage IIIB or IV NSCLC and performance status 0-1 received rG-CSF 5 microg/kg for 5 consecutive days starting 7 days before treatment with etoposide 200 mg/m2 on days 1-3 and cisplatin 35 mg/m2 on days 1-3, repeated every 3 weeks. Patients also received rG-CSF 5 microg/kg s.c. day 4 to postnadir ANC > 10,000. The median WBC nadir, ANC nadir, and platelet nadir after the first cycle of chemotherapy in the historical group (CALGB 9132) were 1300 cells/microl, 200 cells/microl, and 80,000 cells/microl, respectively. In the present study, the median WBC nadir, ANC nadir, and platelet nadir were 1300 cells/microl, 144 cells/microl, and 56,000 cells/microl, respectively. The median time for ANC to reach 10,000 cells/microl was 15 days in both the historical and the present study. For course 2, the WBC, ANC, platelet nadirs, and duration of grade 4 neutropenia were 2600, 1450, 70,000, and 0 days, respectively. This study failed to show a priming effect for rG-CSF when given in this dose and schedule.
先前一项关于依托泊苷/顺铂联合重组人粒细胞集落刺激因子（rG-CSF）治疗晚期非小细胞肺癌（NSCLC）患者的II期研究（CALGB 9132）显示，第1疗程和第2疗程之间的中性粒细胞绝对计数（ANC）最低点存在显著差异。第1疗程和第2疗程的ANC最低点中位数分别为200和2500，提示rG-CSF具有启动效应。本研究旨在确定在化疗的第1周期之前给予rG-CSF是否会降低中性粒细胞减少的严重程度和持续时间。12例III B期或IV期NSCLC且体能状态为0 - 1的患者，在第1 - 3天接受200 mg/m²依托泊苷、第1 - 3天接受35 mg/m²顺铂治疗前7天开始，连续5天接受5 μg/kg的rG-CSF，每3周重复一次。患者还在第4天接受5 μg/kg的rG-CSF皮下注射，直至最低点后ANC > 10,000。历史组（CALGB 9132）化疗第1周期后的白细胞最低点中位数、ANC最低点中位数和血小板最低点中位数分别为1300个/μl、200个/μl和80,000个/μl。在本研究中，白细胞最低点中位数、ANC最低点中位数和血小板最低点中位数分别为1300个/μl、144个/μl和56,000个/μl。在历史组和本研究中，ANC达到10,000个/μl的中位时间均为15天。对于第2疗程，白细胞、ANC、血小板最低点以及4级中性粒细胞减少的持续时间分别为2600、1450、70,000和0天。本研究未能显示以该剂量和给药方案给予rG-CSF时具有启动效应。
