175P - A prospective, randomized, double-blind study of pre-chemotherapy hydration with or without mannitol to prevent renal toxicity in non-small cell lung cancer (NSCLC) patients receiving cisplatin-gemcitabine chemotherapy
- Nattiya Thavornpattanpong (TH)
- Nattiya Thavornpattanpong (TH)
Abstract
Background
Cisplatin-induced renal toxicity is the most serious adverse event in cisplatin-gemcitabine treated NSCLC patients. Currently there is no gold standard pre-medication regimen that can prevent cisplatin-induced nephrotoxicity.
Methods
We randomized 55 patients who received cisplatin 80 mg/m2 every 3–4 weeks into two hydration arms. The patients of each arm received one liter of 0.9% sodium chloride solution pre-hydration and also received a half liter of 0.9% sodium chloride solution post hydration. Both arm receives cisplatin (80 mg/m2 IV: d1) plus gemcitabine (1000 mg/m2 IV: d1, 8). In the 0.9% sodium chloride solution added with mannitol arm, 40 g of mannitol was mixed with the cisplatin. Chemotherapy was given at 21-day intervals for 6 cycles or until the patient developed intolerable toxicity or progressive disease, whichever occurred first. Clinical parameters, renal function, clinical response and adverse events were recorded. Renal toxicity was defined as more than 20% reduction in creatinine clearance compared with baseline level.
Results
29 patients were randomized to the 0.9% sodium chloride solution arm and 26 patients were randomized to 0.9% sodium chloride solution added with 40 g of mannitol arm. There were no significant differences between randomized groups in age, gender, comorbid disease and baseline creatinine clearance. For each group, decreases in creatinine clearance of more than 20% were 82% in arm 0.9% sodium chloride solution alone and 54% in arm 0.9% sodium chloride solution added with 40 g of mannitol (p-value = 0.021). The decline rate of creatinine clearance in arm 0.9% sodium chloride was greater than in the other arm (p-value = 0.004). There were no differences in the safety profiles.
Conclusions
Hydration with 0.9% sodium chloride solution alone appears to be associated with greater cisplatin nephrotoxicity than 0.9% sodium chloride solution with added mannitol.
Legal entity responsible for the study
Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University Thailand
Funding
Has not received any funding
Disclosure
All authors have declared no conflicts of interest.
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