Randomized phase II study comparing mannitol with furosemide for the prevention of cisplatin-induced renal toxicity in advanced non-small cell lung cancer: The OLCSG1406 trial.

Abstract

e23105 Background: Although cisplatin-based chemotherapy has been the mainstay in the treatment of advanced non-small cell lung cancer (NSCLC), it is still controversial as to whether furosemide (FUR) or mannitol (MAN) is better as a forced diuresis for avoiding cisplatin-induced nephrotoxicity. We conducted a randomized phase II trial to clarify this issue in candidates. Methods: Those with advanced NSCLC, suitable for receiving cisplatin-based chemotherapy with an adequate renal function were randomly assigned either to the FUR arm or the MAN arm. Either of forced diuretics was administered with an appropriate hydration in cisplatin administration. The primary endpoint of the study was a proportion of ≥ grade 1 serum Creatinine (Cr) elevation in the first cycle, defined by the CTCAE v4.0. Results: The trial was terminated early with 44 (FUR arm; 22 and MAN arm; 22) of the planned 66 patients because of slow accrual. The patient demographics are listed in Table1. In the first cycle, 2 (9%) and 4 patients (18%) developed grade 1 Cr elevation, respectively (P = 0.33), despite no ≥ grade 2 toxicity. The median time to develop the worst Cr score was 29 (range: 26-31) and 12 (range: 8-28) days, respectively. All patients recovered within 3 to 330 days, respectively. Cisplatin induced grade 3 emesis was observed in 3 patients (14%) in MAN arm, whilst none developed in FUR arm. No treatment related deaths were observed. Conclusions: In this setting, the preventive effect of the two types of forced diuretics on cisplatin-induced renal toxicity was not significantly different. Clinical trial information: UMIN000015293. [Table: see text]