Phase II Study of Short Hydration without Diuretics for Cisplatin-Based Chemotherapy.

Background: Diuretics are commonly used to reduce renal dysfunction during cisplatin-based chemotherapy; however, reports suggest that renal function is unaffected when diuretics are not administered. This phase II trial evaluated the effectiveness and safety of a short hydration method without diuretics.

Methods: Patients were included if they were aged 20-74 years, had a thoracic malignancy for which a cisplatin-based regimen (dose: ≥60 mg/m²) was indicated, and had adequate renal function. All patients received cisplatin-based chemotherapy using a short hydration method without diuretics. The primary endpoint was the proportion of patients without grade 2 or higher elevations in creatinine levels during the first cycle of cisplatin.

Results: Forty-six patients were enrolled between June 2019 and April 2022. The patients included 38 men and 8 women with a median age of 64 years (range: 45-74 years). Of these, 13 patients received adjuvant chemotherapy, 19 received chemoradiotherapy, 1 received chemotherapy for post-surgical recurrence, and 13 received chemotherapy for advanced disease. The median number of chemotherapy cycles was 3 (range: 1-4). A total of 93.5% (43/46) of the patients completed cisplatin-based chemotherapy without grade 2 or higher creatinine elevation during the first cycle, and 84.8% (39/46) of participants, including those who discontinued treatment, did not show grade 2 or higher creatinine elevation after all cycles of cisplatin-based chemotherapy.

Conclusions: Short hydration without diuretics is safe for patients receiving cisplatin-containing chemotherapy. Randomized trials with or without diuretics in this setting are warranted.