Yokoyama Masahiro, Kusano Yoshiharu, Takahashi Anna, Inoue Norihito, Ueda Kyoko, Nishimura Noriko, Mishima Yuko, Terui Yasuhito, Nukada Tomoyuki, Nomura Takanobu, Hatake Kiyohiko
Division of Hematology Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Medical Affairs, Kyowa Hakko Kirin Co. Ltd., Tokyo, Japan.
Support Care Cancer. 2017 Nov;25(11):3313-3320. doi: 10.1007/s00520-017-3747-z. Epub 2017 May 27.
The incidence of and risk factors for febrile neutropenia (FN) in Japanese non-Hodgkin B-cell lymphoma (B-NHL) patients receiving rituximab, cyclophosphamide, doxorubicin, vincristine, and predonisolone (R-CHOP) chemotherapy are unknown. We conducted this study to address this issue.
In this single-center, retrospective, observational study, 466 patients with B-NHL who completed an R-CHOP regimen within a 7-year period and who planned to undergo at least three cycles of this regimen were analyzed. The following FN-related factors were assessed: fever, infection, disease state, neutrophil count, and prophylactic interventions such as use of antibiotics and/or granulocyte colony-stimulating factor (G-CSF). We simulated the FN incidence and 95% confidence interval (CI) of patients without prophylaxis with G-CSF (cycle 1) using bootstrap sampling.
The incidence of FN was 9.1% (42 of 462) in cycle 1 and 12.3% (57 of 462 patients) throughout all cycles, with 73.7% (42/57) developing FN during cycle 1. Risk factors for FN among patients with B-NHL treated with R-CHOP were albumin <35 g/L (p = 0.0047), relative dose intensity <85% (p = 0.0007), and lack of prophylaxis with G-CSF (p = 0.0006) in cycle 1. In the simulation analysis, the estimated FN incidence in cycle 1 was 16.2% (95% CI [10.9-22.2]).
At 9.1% in cycle 1 and 12.3% throughout all cycles, the incidence of FN was lower than previously reported, possibly reflecting the appropriate use of G-CSF in this clinical setting. For patients with risk factors, the prophylaxis with G-CSF may decrease the occurrence of FN.
接受利妥昔单抗、环磷酰胺、多柔比星、长春新碱和泼尼松龙(R-CHOP)化疗的日本非霍奇金B细胞淋巴瘤(B-NHL)患者中发热性中性粒细胞减少症(FN)的发生率及危险因素尚不清楚。我们开展本研究以解决这一问题。
在这项单中心、回顾性观察研究中,分析了466例在7年期间完成R-CHOP方案且计划接受至少三个周期该方案治疗的B-NHL患者。评估了以下与FN相关的因素:发热、感染、疾病状态、中性粒细胞计数以及预防性干预措施,如使用抗生素和/或粒细胞集落刺激因子(G-CSF)。我们使用自助抽样模拟了未接受G-CSF预防的患者(第1周期)的FN发生率及95%置信区间(CI)。
第1周期FN的发生率为9.1%(462例中的42例),所有周期的发生率为12.3%(462例患者中的57例),其中73.7%(42/57)在第1周期发生FN。接受R-CHOP治疗的B-NHL患者中,FN的危险因素包括白蛋白<35 g/L(p = 0.0047)、相对剂量强度<85%(p = 0.0007)以及第1周期未接受G-CSF预防(p = 0.0006)。在模拟分析中,第1周期FN的估计发生率为16.2%(95% CI [10.9 - 22.2])。
第1周期FN发生率为9.1%,所有周期为12.3%,该发生率低于先前报道,这可能反映了在本临床环境中G-CSF的合理使用。对于有危险因素的患者,使用G-CSF进行预防可能会降低FN的发生。