O1-030 - Feasibility Study of High Dose Cisplatin Administered with Short Hydration and Magnesium Supplementation in Patients with Lung Cancer

Abstract

ABSTRACT Background Cisplatin has been an important but toxic chemotherapeutic agent and administered with 3–5 l of hydration for over 10 h. We previously reported that 22% of lung cancer patients experienced grade 2/3 creatinine elevation after chemotherapies containing high-dose cisplatin (Sekine et al., Cancer Science 162–165, 2011). Methods Major eligibility criteria included patients with lung cancer, indication for 75 mg/m2 or higher cisplatin-based regimens, age between 20 and 74 years, and adequate renal function. Cisplatin was administered with pre- and post-hydration containing 10 mEq of potassium chloride in 500 ml fluid, respectively, over 60 min. Immediately before the cisplatin, mannitol (20%, 200 ml) was administered as forced urination over 30 min and magnesium sulfate (8 mEq) was added in pre-hydration. Antiemetic prophylaxis consisted of an appropriate dose of palonosetron, aprepitant and dexamethasone. The primary end point is the proportion of patients without grade 2 or more creatinine elevation and the planned sample size was 44 to reject the proportion of 70% under the expectation of 88% with a power of 90% and an alpha error of 5%. Results Forty-four patients were enrolled between April 2011 and December 2011 and three patients are still on protocol treatment at the time of abstract submission. There were 29 men and 15 women with a median (range) age of 64 (42–74) years. Of these, 13 had adjuvant chemotherapy, 5 had chemoradiotherapy, and 26 had chemotherapy for advanced diseases. Twenty patients received cisplatin and pemetrexed as the most frequent regimen and 38 patients received 3–4 cycles of chemotherapy. During the chemotherapy, 13 patients received intravenous hydration and 6 patients experienced a dose reduction of cisplatin mainly because of gastrointestinal toxic effects except one with grade 2 elevation of creatinine. Conclusions The short hydration and magnesium supplementation resulted in significantly low frequency of renal dysfunction.