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

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-nai{dotless}̈ve patients with advanced lung cancer and reserving renal function who were suitable for cisplatin use (≥60mg/m2 on Day 1) were eligible for this study. Two-and-a-half-liter hydration within (4.5h 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 0.70mg/dl and the median cisplatin dose on Day 1 was 80mg/m2. 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 1.19mg/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.