Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore, Singapore.
Support Care Cancer. 2011 Apr;19(4):497-504. doi: 10.1007/s00520-010-0843-8. Epub 2010 Mar 17.
Data from US Oncology Adjuvant Trial 9735 has shown that four cycles of docetaxel plus cyclophosphamide (TC) improved disease-free and overall survival when compared against doxorubicin and cyclophosphamide (AC) in early-stage breast cancer. The febrile neutropenia (FN) rate was 4% in this study without primary granulocyte colony-stimulating factors (G-CSF) prophylaxis. However, the incidence of docetaxel-induced myelosuppression is recognized to be higher among Asian population. Hence, this study was designed to evaluate the impact of G-CSF to reduce FN-related events in Asian cancer patients treated with TC.
This retrospective cohort study was conducted on Asian breast cancer patients who have received intravenous docetaxel 75 mg/m(2) and cyclophosphamide 600 mg/m(2) between 2006 to 2008. Patients did not receive oral antibiotic prophylaxis, and prophylactic G-CSF after chemotherapy was prescribed under the discretion of the primary oncologist.
During cycle 1 of chemotherapy, 6.3% patients received G-CSF manifested FN, while 25% patients who did not receive G-CSF manifested FN (RR = 0.252, 95% CI 0.102 to 0.622). Introduction of G-CSF as primary prophylaxis provided an absolute risk reduction of FN events by 18.7%. Chemotherapy doses were maintained throughout all cycles. Patients with pretreatment white blood cell counts (WBC) below 6.0 × 10(3)/mm(3) and absolute neutrophil counts (ANC) below 3.1 × 10(3)/mm(3) were associated with higher rates of FN during Cycle 1 (p = 0.009, p = 0.007).
Our findings indicate that TC was associated with higher rates of FN than reported in the clinical trial. The 25% incidence fulfills the requirement of primary prophylaxis with G-CSF. Routine administration of G-CSF is highly recommended to reduce the rates of FN in breast cancer patients receiving TC.
来自美国肿瘤学辅助试验 9735 的数据显示,与阿霉素和环磷酰胺(AC)相比,早期乳腺癌患者接受多西他赛加环磷酰胺(TC)治疗可改善无病生存和总生存。本研究中未进行预防性应用粒细胞集落刺激因子(G-CSF),发热性中性粒细胞减少症(FN)的发生率为 4%。然而,亚洲人群中多西他赛引起的骨髓抑制发生率更高。因此,本研究旨在评估 G-CSF 对降低接受 TC 治疗的亚洲癌症患者 FN 相关事件的影响。
本回顾性队列研究纳入了 2006 年至 2008 年间接受静脉多西他赛 75mg/m2 和环磷酰胺 600mg/m2 治疗的亚洲乳腺癌患者。患者未接受口服抗生素预防,化疗后预防性应用 G-CSF 由主治肿瘤医生决定。
化疗第 1 周期时,6.3%接受 G-CSF 治疗的患者发生 FN,而未接受 G-CSF 治疗的 25%患者发生 FN(RR=0.252,95%CI 0.102-0.622)。采用 G-CSF 作为一级预防可使 FN 事件的绝对风险降低 18.7%。所有周期的化疗剂量均得以维持。化疗前白细胞计数(WBC)<6.0×103/mm3 和绝对中性粒细胞计数(ANC)<3.1×103/mm3 的患者在第 1 周期发生 FN 的比例较高(p=0.009,p=0.007)。
本研究结果表明,TC 引起 FN 的发生率高于临床试验报道的发生率。25%的发生率符合应用 G-CSF 进行一级预防的要求。建议常规应用 G-CSF 以降低接受 TC 治疗的乳腺癌患者 FN 的发生率。