Sato Shinya, Kurishima Koichi, Miyazaki Kunihiko, Kodama Takahide, Ishikawa Hiroichi, Kagohashi Katsunori, Tamura Tomohiro, Homma Shinsuke, Satoh Hiroaki, Hizawa Nobuyuki
Division of Respiratory Medicine, Ryugasaki Saiseikai General Hospital, Ryugasaki, Ibaraki 301-0854, Japan.
Division of Respiratory Medicine, Faculty of Clinical Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.
Mol Clin Oncol. 2014 Jul;2(4):604-608. doi: 10.3892/mco.2014.281. Epub 2014 Apr 16.
The objective of this study was to evaluate the efficacy of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in patients undergoing dose reduction and in those with a low body surface area (BSA). The association between dose reduction, low BSA and efficacy, including response rate (RR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS), were evaluated in patients prescribed TKIs between September, 2002 and May, 2013. A total of 282 patients received EGFR-TKIs during the study period, 53 (18.8%) of whom underwent a dose reduction (21.4 and 31.6% of the patients with a BSA of <1.5 and <1.25 m, respectively). Eleven (20.8%) of these 53 patients had a dose reduction due to adverse events (AEs) >grade 3. In either gefitinib or erlotinib treatment, the RR, DCR, PFS and OS in EGFR-mutated patients with a BSA of <1.5 m were not different from those in patients with a BSA of >1.5 m. In addition, there were no differences in these parameters between patients with and those without a dose reduction of TKIs. The dose of TKIs in patients with AEs and in those with low BSA should be determined with caution. To confirm the equal efficacy of TKIs in patients undergoing a dose reduction, prospective observational studies with less patient heterogeneity are required.
本研究的目的是评估表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)在接受剂量减少的患者以及低体表面积(BSA)患者中的疗效。在2002年9月至2013年5月期间接受TKIs治疗的患者中,评估了剂量减少、低BSA与疗效之间的关联,包括缓解率(RR)、疾病控制率(DCR)、无进展生存期(PFS)和总生存期(OS)。在研究期间,共有282例患者接受了EGFR-TKIs治疗,其中53例(18.8%)接受了剂量减少(BSA<1.5 m和<1.25 m的患者分别为21.4%和31.6%)。这53例患者中有11例(20.8%)因3级以上不良事件(AE)而进行了剂量减少。在吉非替尼或厄洛替尼治疗中,BSA<1.5 m的EGFR突变患者的RR、DCR、PFS和OS与BSA>1.5 m的患者无差异。此外,接受TKIs剂量减少的患者与未接受剂量减少的患者在这些参数上也没有差异。对于出现AE的患者和低BSA患者,TKIs的剂量应谨慎确定。为了证实TKIs在接受剂量减少的患者中具有同等疗效,需要进行患者异质性较小的前瞻性观察研究。