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顺铂为基础的化疗中短期低容量水化的再评估:在冈山肺癌研究组试验 1002 中晚期肺癌的前瞻性可行性研究结果。

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.

机构信息

*Department of Respiratory Medicine, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.

出版信息

Jpn J Clin Oncol. 2013 Nov;43(11):1115-23. doi: 10.1093/jjco/hyt128. Epub 2013 Sep 29.

Abstract

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-naïve 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 ∼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.

摘要

目的

顺铂可引起严重的肾毒性。然而,最有效的预防顺铂肾毒性的水化程度和方式尚未得到正式评估。本研究前瞻性地评估了短期小容量水化在晚期肺癌患者顺铂化疗中的可行性。

方法

本研究纳入了适合使用顺铂(第 1 天≥60mg/m²)的晚期肺癌且保留肾功能的初治患者。研究方案为 4.5 小时内给予 2.5 升水化液。主要终点是第 1 周期无任何 2 级或更高级别肾毒性的患者比例。

结果

共纳入 46 例患者,所有患者均进行了肾毒性评估。中位基线肌酐值为 0.70mg/dl,第 1 天顺铂剂量为 80mg/m²。第 1 周期无患者发生 2 级或更高级别的肌酐毒性,达到了主要终点。4 例(9%)患者出现 1 级毒性,中位最差肌酐值为 1.19mg/dl,但迅速消失。肌酐毒性受到包括体能状态在内的多种临床因素的影响。10 例(22%)患者在第 1 周期需要额外水化,主要是由于胃肠道毒性。然而,所有患者均能接受进一步的治疗周期。在我们中心假设能接受进一步治疗的 37 例患者中,有 32 例(86%)在门诊接受了治疗。

结论

本研究前瞻性地证明了短期小容量水化的可行性。

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