PROSPECTIVE FEASIBILITY STUDY OF CISPLATIN-BASED CHEMOTHERAPY WITH A SHORT-TERM SMALL AMOUNT OF HYDRATION METHOD IN ADVANCED LUNG CANCER

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Abstract

Introduction

Cisplatin-based chemotherapy is a mainstay for the treatment of advanced lung cancer. However, cisplatin can induce severe renal toxicity leading to an acute renal failure. Classically, three to four litter of hydration (standard hydration) on the day when cisplatin is administered has been applied to avoid the toxicity, but it shall usually reduce patient's quality of life. To improve this situation, we prospectively investigated here a feasibility study of cisplatin-based chemotherapy with a short-term small amount of hydration in advanced lung cancer.

Methods

Chemo-naïve patients with advanced lung cancer, performance status (PS) of 0-1, aged 75 or younger and appropriate for cisplatin use (60 mg/m2 or more on day (i) with reserved renal function were eligible for this study. The administration schedule on day 1 consisted of (i) 100 ml normal saline with anti-emetic agents (5 min), (ii) 500 ml 5% glucose with KCl (10 mEq) and MgSO4 (4 mEq) (1 h), 3) 500 ml normal saline with anticancer agent combined with cisplatin (5 min–1 h), (iv) 150 ml mannitol (30 min), (v) cisplatin diluted with normal saline (a total of 500 ml) (1 h), and (vi) same as (ii) (1 h). The primary end point was set as proportion of patients who could receive successfully cisplatin-based chemotherapy without any grade 2 or worse renal toxicity in the first cycle, assuming a 90% success rate would indicate potential usefulness, whereas a 75% would constitute the lower limit of interest, with α = 0.10 and β = 0.10. (UMIN registration number: 000004493.)

Results

A total of 46 patients were registered in this study. Demographics of the patients were as follows: median age: 62, male/female: 34/12, PS 0/1: 16/30, non-small-cell/small-cell: 38/8, and stage IV/others: 41/5. Median baseline Cr and Ccr scores were 0.70 mg/dl and 92.6 ml/min, ranging from 0.45 to 0.91 mg/dl and 62.6 to 144.8 ml/min, respectively. Median cisplatin dose on day 1 was 78 mg/m2 ranging from 60 to 80 mg/m2. During the first cycle in the evaluable 44 patients, no patients developed grade 2 or worse renal toxicity (grades 0/1/2 or worse: 40/4/0). The grade 1 renal toxicity was soon improved in all four patients.

Conclusions

This study met the primary end point, which would suggest a feasibility of the short-term small amount of hydration method.

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