1519P - Oral hydration as a post-hydration method for cisplatin (CDDP) administration in patients with lung cancer: A prospective multicenter trial

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Supportive Care
Lung and other Thoracic Tumours
Presenter Hidehito Horinouchi
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors H. Horinouchi1, K. Kubota2, A. Miyanaga2, Y. Minegishi3, S. Takeuchi4, S. Nakamichi4, A. Gemma4, F. Kurimoto5, J. Sudo5, Y. Yamane5, H. Tsuzuki5, H. Sakai5, H. Utsumi1, K.S. Sunami1, H. Mizugaki1, S. Kanda1, Y. Fujiwara1, H. Nokihara1, N. Yamamoto1, T. Tamura1
  • 1Department Of Thoracic Oncology, National Cancer Center Hospital, 1040045 - Tokyo/JP
  • 2Internal Medicine, Nippon Medical School, Tokyo/JP
  • 3Internal Medicine, Division Of Pulmonary Medicine, Infectious Diseases, And Oncology, Nippon Medical School, 113-8603 - Tokyo/JP
  • 4Department Of Internal Medicine, Nippon Medical School Main Hospital, Tokyo/JP
  • 5Thoracic Oncology, Saitama Cancer Center, 362-0806 - Saitama/JP

Abstract

Aim

The aim of this trial was to evaluate the safety and efficacy of oral hydration as a substitute for intravenous (IV) hydration after CDDP administration.

Methods

The major eligibility criteria included patients with lung cancer, indications for a CDDP-based regimen at a dose of 60 mg/m2 or higher, an age of between 20 and 74 years, and adequate renal function. Antiemetic prophylaxis consisted of an appropriate dose of palonosetron, aprepitant and dexamethasone. CDDP was administered after IV pre-hydration with MgSO4 (8 mEq) and KCL. Five hundred milliliters of commercially available oral hydration solution (OS-1®: Otsuka Pharmaceutical Factory, Inc., Japan) was used as a substitute for IV post-hydration and was administered orally within an hour after CDDP administration. OS-1® contains 50 mEq/L of NaCl, 20 mEq/L of K and 2 mEq/L of MgSO4. The primary endpoint was the proportion of patients without a grade (G) 2 or higher creatinine (Cr) elevation after the first cycle of chemotherapy. The planned sample size was 46 to reject a proportion of 70% under an expectation of 88% with a power of 90% and an alpha error of 5%.

Results

Between May and November 2013, 31 men and 15 women with a median (range) age of 64 (33-74) years were enrolled from three institutions. Of these, 5 received adjuvant chemotherapy, 17 received definitive chemoradiotherapy, and 24 received chemotherapy for advanced diseases. All the patients were able to consume OS-1® within 1 hour without requiring IV post-hydration. The median (range) number of chemotherapy cycles was 4 (3-5). Seven patients received additional IV hydration on day 2 or later, with a median duration (range) of 2 (1-19) days, mainly because of chemotherapy-related anorexia. After the first cycle of CDDP administration, none of the patients experienced a Cr elevation of G 2 or higher, thereby meeting the primary endpoint. Of the 46 patients, 45 (97.8%) completed the CDDP-based chemotherapy without G 2 or higher renal dysfunction. The only patient who experienced a G 2 elevation in Cr (maximum value, 1.97 mg/dL) experienced G 3 chemotherapy-induced diarrhea and exhibited a prompt improvement in the Cr level to 1.11 mg/dL after the resolution of the diarrhea.

Conclusions

Oral hydration can be used as a safe and convenient substitute for IV post-hydration for CDDP administration at the standard dose.

Disclosure

K. Kubota: Honoraria from TAIHO PHARMACEUTICAL CO., LTD.; All other authors have declared no conflicts of interest.