Sato Junya, Morikawa Naoto, Nitanai Hiroo, Nagashima Hiromi, Nihei Satoru, Yamauti Kohei, Kudo Kenzo
Department of pharmacy, Iwate Medical University Hospital, 19-1Uchimaru, Morioka, Iwate 020-8505 Japan ; Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate 028-3694 Japan.
Department of Internal Medicine, Division of Pulmonary Medicine, Allergy and Rheumatology, School of Medicine, Iwate Medical University, 19-1Uchimaru, Morioka, Iwate 020-8505 Japan.
J Pharm Health Care Sci. 2016 Mar 5;2:6. doi: 10.1186/s40780-016-0041-z. eCollection 2016.
Cisplatin (CDDP) is used as a key anticancer drug for solid cancers, including lung cancer. However, a large quantity of fluid replacement is required to prevent renal dysfunction. This requirement have made outpatient chemotherapies including CDDP administration less popular among the available therapeutic options. We designed a short-term hydration regimen combined with oral rehydration solution (ORS) that has a supplementary water ability equivalent to intravenous electrolyte maintenance infusion and investigated its safety and feasibility in the CDDP including chemotherapy.
The subjects received chemotherapy including CDDP administration (60-80 mg/m(2)) for untreated lung cancer were recruited. The intravenous hydration was infused at around 2000 mL on Day 1, and patients drank ORS at a dose of 1000 mL/day for 3 days. Any renal dysfunction, gastrointestinal symptoms or other tolerability variables pertaining to the remaining three cycles of this regimen were analyzed in the patients who were able to continue treatment after the second cycle.
The majority (29/35, 82.9 %) of patients completed intake of ORS for 3 days. The mean ± standard deviation of patient body-surface area-adjusted estimated glomerular filtration rate (eGFR), serum creatinine (sCre) and urea nitrogen from the initial therapy to 1 month after the last administration changed from 79.8 ± 11.7-67.0 ± 16.9 mL/min (p = 0.15), 0.70 ± 0.13-0.85 ± 0.27 mg/dL (p = 0.02), and 14.3 ± 3.8-17.1 ± 5.4 mg/dL (p = 0.09), respectively. The CTCAE ver 4.0 grades 1 or 2 adverse events pertaining to renal function after the last administration were 2 (5.7 %)/2 (5.7 %) patients assessed by sCre, and 14 (40.0 %)/12 (34.3 %) patients assessed by eGFR, respectively. There was no patient with ≥3 grade renal dysfunction based on either evaluation.
Based on the results of this study, supplementary use of the ORS as a method of short-term hydration may be a feasible regimen for shortening infusion times and improving safety for those undergoing chemotherapy including CDDP administration.
顺铂(CDDP)是包括肺癌在内的实体癌的关键抗癌药物。然而,需要大量补液以预防肾功能不全。这一需求使得包括顺铂给药在内的门诊化疗在现有的治疗选择中不太受欢迎。我们设计了一种短期补液方案,联合口服补液盐(ORS),其补充水分的能力等同于静脉输注维持电解质液,并研究了其在包括顺铂化疗中的安全性和可行性。
招募未接受过治疗的肺癌患者,接受包括顺铂给药(60 - 80mg/m²)的化疗。第1天静脉补液约2000mL,患者连续3天每天饮用1000mL ORS。对在第二个周期后能够继续治疗的患者,分析与该方案剩余三个周期相关的任何肾功能不全、胃肠道症状或其他耐受性变量。
大多数患者(29/35,82.9%)完成了3天的ORS摄入。从初始治疗到最后一次给药后1个月,患者体表面积校正的估计肾小球滤过率(eGFR)、血清肌酐(sCre)和尿素氮的平均值±标准差分别从79.8±11.7 - 67.0±16.9mL/min(p = 0.15)、0.70±0.13 - 0.85±0.27mg/dL(p = 0.02)和14.3±3.8 - 17.1±5.4mg/dL(p = 0.09)发生变化。最后一次给药后,根据sCre评估,与肾功能相关的美国国立癌症研究所不良事件通用术语标准(CTCAE)4.0版1级或2级不良事件分别为2例(5.7%)/2例(5.7%)患者,根据eGFR评估分别为14例(40.0%)/12例(34.3%)患者。基于任何一项评估,均无≥3级肾功能不全的患者。
基于本研究结果,补充使用ORS作为短期补液方法,对于缩短包括顺铂给药在内的化疗患者的输液时间和提高安全性可能是一种可行的方案。