Reappraisal of Short-term Low-volume Hydration in Cisplatin-based Chemotherapy: Results of a Prospective Feasibility Study in Advanced Lung Cancer in the Okayama Lung Cancer Study Group Trial 1002
Reappraisal of Short-term Low-volume Hydration in Cisplatin-based Chemotherapy: Results of a Prospective Feasibility Study in Advanced Lung Cancer in the Okayama Lung Cancer Study Group Trial 1002
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DOI：
10.1093/jjco/hyt128
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发表时间：
2013-11-01
影响因子：
2.4
通讯作者：
Kiura, Katsuyuki
中科院分区：
文献类型：
--
作者：
Hotta, Katsuyuki;Takigawa, Nagio;Kiura, Katsuyuki
目的：顺铂可引起严重的肾毒性。然而，对预防它最有效的水合作用的程度和模式几乎没有得到正式的评价。我们在此进行了一项以顺铂为基础的化疗联合短期小体积水合治疗晚期肺癌的前瞻性可行性研究。方法：适合顺铂治疗（第1天>= 60 mg/m(2)）的晚期肺癌、保留肾功能的未化疗患者纳入本研究。在4.5小时内研究了2.5升的水合作用。主要终点是在第一个周期内接受顺铂化疗且无2级或以上肾毒性的患者比例。结果：共登记了46例患者，所有患者均可评估肾毒性。基线中位肌酐评分为0.70 mg/dl，第1天的中位顺铂剂量为80 mg/m(2)。在第一个周期中，没有患者出现2级或以上的肌酐毒性，达到了主要终点。4例患者（9%）有1级毒性，最差中位肌酐评分为1.19 mg/dl，但很快消失。肌酸酐毒性受几个临床因素的影响，包括运动状态。10例患者（22%）在第一个周期需要额外的水合作用，主要是由于胃肠道毒性。然而，所有10名患者都能够接受进一步的治疗周期。37名患者中有32名（86%）被认为能够在我们研究所接受进一步治疗，他们在门诊接受了治疗。结论：本研究前瞻性地证明了短期小体积水化的可行性。
Objective: Cisplatin can induce severe renal toxicity. However, the degree and pattern of hydration that is most efficient at preventing it have scarcely been formally evaluated. We here performed a prospective feasibility study of cisplatin-based chemotherapy with short-term low-volume hydration in advanced lung cancer.Methods: Chemo-naive patients with advanced lung cancer and reserving renal function who were suitable for cisplatin use (>= 60 mg/m(2) on Day 1) were eligible for this study. Two-and-a-half-liter hydration within similar to 4.5 h was investigated. The primary end point was the proportion of patients who underwent cisplatin-based chemotherapy without any Grade 2 or more renal toxicity in the first cycle.Results: A total of 46 patients were registered, all of whom were evaluable for renal toxicity. The median baseline creatinine score was 0.70 mg/dl and the median cisplatin dose on Day 1 was 80 mg/m(2). In the first cycle, none of the patients developed Grade 2 or more creatinine toxicity, which met the primary endpoint. Four patients (9%) had Grade 1 toxicity, with a median worst creatinine score of 1.19 mg/dl, but it disappeared rapidly. Creatinine toxicity was influenced by several clinical factors, including the performance status. Ten patients (22%) needed extra hydration during the first cycle, mainly due to gastrointestinal toxicity. However, all 10 were able to undergo further cycles of treatment. Thirty-two (86%) of the 37 patients who were assumed to be able to undergo further treatment at our institute received it in an outpatient setting.Conclusions: This study demonstrated prospectively the feasibility of short-term low-volume hydration.