Department of Respiratory Medicine, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
Department of Pharmacy, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
Invest New Drugs. 2020 Aug;38(4):1192-1195. doi: 10.1007/s10637-019-00851-y. Epub 2019 Sep 5.
Osimertinib is a key drug for cancer patients with EGFR mutations. However, there is little information about its safety in cancer patients who require hemodialysis (HD) for chronic renal failure, despite notable increases in their numbers. Herein, we examined osimertinib safety in such a patient via pharmacokinetics analysis. A 66-year-old man was diagnosed with relapsed stage IV non-small cell lung cancer with an EGFR mutation in exon 21 (L858R) 2 years after stereotactic body radiotherapy. He was undergoing HD three times a week owing to worsening diabetic nephropathy. We administered osimertinib (80 mg/day) as the first-line therapy. We measured osimertinib concentrations on multiple days, either before, after, or in the absence of HD. Maximum concentrations and areas under the curve were determined. We found that HD did not affect the pharmacokinetics of osimertinib. We conclude that osimertinib can be safely administered to cancer patients undergoing HD.
奥希替尼是 EGFR 突变的癌症患者的关键药物。然而，尽管需要血液透析（HD）治疗慢性肾衰竭的癌症患者数量显著增加，但有关其安全性的信息却很少。在此，我们通过药代动力学分析检查了此类患者的奥希替尼安全性。一名 66 岁男性在立体定向体放射治疗后 2 年被诊断为复发的 IV 期非小细胞肺癌，具有外显子 21（L858R）的 EGFR 突变。由于糖尿病肾病恶化，他每周需要进行 3 次 HD。我们给予奥希替尼（80mg/天）作为一线治疗。我们在 HD 前后或没有 HD 的情况下测量了奥希替尼的浓度。确定了最大浓度和曲线下面积。我们发现 HD 不影响奥希替尼的药代动力学。我们得出结论，奥希替尼可以安全地用于接受 HD 的癌症患者。
