Department of Pharmacy, Hokkaido University Hospital, Kita 14-jo, Nishi 5-chome, Kita-ku, Sapporo, 060-8648, Japan.
Laboratory of Clinical Pharmaceutics & Therapeutics, Faculty of Pharmaceutical Sciences, Hokkaido University, Kita 12-jo, Nishi 6-chome, Kita-ku, Sapporo, 060-0812, Japan.
Support Care Cancer. 2021 Jun;29(6):3277-3285. doi: 10.1007/s00520-020-05842-x. Epub 2020 Oct 26.
The combination of gemcitabine (GEM) and nanoparticle albumin-bound paclitaxel (nab-PTX) is an effective chemotherapeutic regimen for locally advanced and metastatic pancreatic cancer. The dose-limiting toxicities (DLTs) of this treatment are sepsis and neutropenia, while the relative dose intensity (RDI) of GEM is approximately 75% and of nab-PTX is 70-80%. In this study, we evaluated the risk factor(s) regarding treatment suspension, which leads to reduction in the RDI of these agents, enabling appropriate schedule management.
Two hundred patients with pancreatic cancer who received GEM + nab-PTX were retrospectively investigated. Frequency and risk factor(s) of suspension of the treatment and grade 3/4 neutropenia in the first course were evaluated.
The frequency of treatment suspension in the first course was 61%. The frequency of grade 3/4 neutropenia was 51%, while that of thrombocytopenia was 7.5%. The RDI was 78.0% for GEM and 77.7% for nab-PTX. Univariate and multivariate analyses to identify risk or preventive factors related to treatment suspension suggested that low platelet count at baseline was a risk factor, whereas dose reduction from the treatment initiation was a preventive factor. The most common cause of abeyance was grade 3/4 neutropenia (83.6%), the risk factors of which were low platelet count and age ≥ 65 years at baseline, while dose reduction was a preventive factor.
We found that a low platelet level at baseline was a risk factor, whereas dose reduction from initiation was a preventive factor in regard to treatment suspension and severe neutropenia occurrence in GEM + nab-PTX treatment.
吉西他滨（GEM）联合白蛋白结合型紫杉醇（nab-PTX）联合治疗局部晚期和转移性胰腺癌是一种有效的化疗方案。该治疗方案的剂量限制毒性（DLTs）为败血症和中性粒细胞减少症，而 GEM 的相对剂量强度（RDI）约为 75%，nab-PTX 的 RDI 为 70-80%。本研究旨在评估导致这些药物 RDI 降低的治疗暂停的危险因素，从而实现适当的治疗方案管理。
回顾性分析 200 例接受 GEM+nab-PTX 治疗的胰腺癌患者。评估了第一个疗程中治疗暂停的频率和危险因素，以及 3/4 级中性粒细胞减少症的发生情况。
第一个疗程中治疗暂停的频率为 61%。3/4 级中性粒细胞减少症的发生率为 51%，血小板减少症的发生率为 7.5%。GEM 的 RDI 为 78.0%，nab-PTX 的 RDI 为 77.7%。单因素和多因素分析确定了与治疗暂停相关的风险或预防因素，结果表明基线时血小板计数低是一个风险因素，而从治疗开始时剂量减少是一个预防因素。暂停治疗的最常见原因是 3/4 级中性粒细胞减少症（83.6%），其危险因素为基线时血小板计数低和年龄≥65 岁，而剂量减少是一个预防因素。
我们发现，基线时血小板水平低是治疗暂停和 GEM+nab-PTX 治疗中严重中性粒细胞减少症发生的一个风险因素，而从治疗开始时剂量减少是一个预防因素。
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