J Natl Compr Canc Netw. 2017 Sep;15(9):1122-1130. doi: 10.6004/jnccn.2017.7010.
NCCN has classified commonly used chemotherapy regimens into high (>20%), intermediate (10%-20%), or low (<10%) febrile neutropenia (FN) risk categories based primarily on clinical trial evidence. Many chemotherapy regimens, however, remain unclassified by NCCN or lack FN incidence data in real-world clinical practice. We evaluated incidence proportions of FN and grade 4 and 3/4 neutropenia during the first chemotherapy course among patients from Kaiser Permanente Southern California who received selected chemotherapy regimens without well-established FN risk. Patients given granulocyte colony-stimulating factor (G-CSF) prophylaxis were excluded. Sensitivity analyses were performed to account for FN misclassification and censoring. From 2008 to 2013, 1,312 patients with breast cancer who received docetaxel and cyclophosphamide (TC; n=853) or docetaxel, carboplatin, and trastuzumab (TCH; n=459); 1,321 patients with colorectal cancer who received capecitabine and oxaliplatin (XELOX; n=401) or leucovorin, 5-fluorouracil, and oxaliplatin (FOLFOX6; n=920); 307 patients with non-Hodgkin's lymphoma who received bendamustine with or without rituximab; and 181 patients with multiple myeloma who received lenalidomide with or without dexamethasone were included. Crude FN risk was >20% for both breast cancer regimens (TC and TCH). Crude FN risks for XELOX, FOLFOX6, bendamustine, and lenalidomide were <10%; however, when potential FN misclassification and censoring were considered, FN risks were >10%. Our results support published literature highlighting the real-world, "high" FN risk of the TC and TCH regimens for breast cancer. There is strong suggestive evidence that FN risks for XELOX, FOLFOX6, bendamustine, and lenalidomide are >10%. Calculation of chemotherapy course-level FN incidence without controlling for differential censoring for patients who discontinued regimens early, or possible FN misclassification, might have resulted in bias toward an underestimation of the true FN risk. These findings help define FN risk of the selected regimens in the real-world setting and inform prophylactic G-CSF use.
NCCN 主要根据临床试验证据，将常用的化疗方案分为高（>20%）、中（10%-20%）或低（<10%）发热性中性粒细胞减少症（FN）风险类别。然而，许多化疗方案未被 NCCN 分类，或在真实临床实践中缺乏 FN 发病率数据。我们评估了 Kaiser Permanente Southern California 接受选定化疗方案且未建立明确 FN 风险的患者在第一个化疗疗程中 FN 和 4 级和 3/4 级中性粒细胞减少症的发生率比例。排除接受粒细胞集落刺激因子（G-CSF）预防的患者。进行了敏感性分析以考虑 FN 分类错误和删失的影响。2008 年至 2013 年，共纳入 1312 例接受多西他赛和环磷酰胺（TC；n=853）或多西他赛、卡铂和曲妥珠单抗（TCH；n=459）的乳腺癌患者；1321 例接受卡培他滨和奥沙利铂（XELOX；n=401）或亚叶酸、5-氟尿嘧啶和奥沙利铂（FOLFOX6；n=920）的结直肠癌患者；307 例接受苯达莫司汀联合或不联合利妥昔单抗的非霍奇金淋巴瘤患者；181 例接受来那度胺联合或不联合地塞米松的多发性骨髓瘤患者。两种乳腺癌方案（TC 和 TCH）的 FN 风险均>20%。XELOX、FOLFOX6、苯达莫司汀和来那度胺的 FN 风险<10%；然而，当考虑到潜在的 FN 分类错误和删失时，FN 风险>10%。我们的结果支持发表的文献，强调了 TC 和 TCH 方案在乳腺癌中的真实世界“高”FN 风险。有强烈的提示性证据表明，XELOX、FOLFOX6、苯达莫司汀和来那度胺的 FN 风险>10%。如果不控制因早期停止治疗方案或可能的 FN 分类错误而导致的患者差异删失，计算化疗疗程水平的 FN 发生率可能会导致对真实 FN 风险的低估。这些发现有助于确定真实世界环境中选定方案的 FN 风险，并为预防性 G-CSF 应用提供信息。
