Abstract
Objective
We previously reported the feasibility of short-term low-volume hydration in patients with advanced lung cancer who received cisplatin-based chemotherapy (Jpn J Clin Oncol 2013). We sought to determine the clinical usefulness of a more convenient hydration method, evaluating the safety and efficacy of shorter-term and lower-volume hydration.
Method
Chemonaïve patients with advanced lung cancer who were ≤75 years and reserved an adequate renal function for cisplatin use (≥60 mg/m2) were eligible. An intravenously administered hydration of 1700 ml in ~3.5 h with 1500 ml of orally administered hydration was investigated. The primary endpoint was the proportion of patients without grade 2 or worse renal toxicity in the first cycle.
Results
A total of 45 patients were registered, all of whom were evaluable for renal toxicity. The median baseline creatinine score was 0.70 mg/dl, and the median cisplatin dose on day 1 was 75 mg/m2. In the first cycle, one patient (2 %) developed grade 2 creatinine toxicity, and thus, the proportion of patients with less than grade 2 was 98 % (the lower limit of 95 % confidence interval; 93 %), which met the primary endpoint. Five patients (11 %) had grade 1 or greater nephrotoxicity, three of whom successfully recovered. The objective response rate was 24 % and median progression-free survival 5.8 months.
Conclusion
This prospective study demonstrated the safety and efficacy of shorter-term lower-volume hydration.
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Acknowledgments
The authors acknowledge and thank the following investigators and all other investigators who made this study possible: Drs. Koji Uchida, Kayo Yanase-Nakamura and Go Makimoto.
Conflict of interest
KN has received honoraria from Eli Lilly Japan. KH has received honoraria from Eli Lilly Japan, Nippon Kayaku, AstraZeneca, Pfizer, Daiichi-Sankyo Pharmaceutical, Boehringer-Ingelheim, Taiho Pharmaceutical, Chugai Pharmaceutical, and Sanofi-Aventis. KK has received honoraria from Eli Lilly Japan, Nippon Kayaku, AstraZeneca, Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, and Sanofi-Aventis. All other authors declare that they have no conflicts of interest relating to this study.
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UMIN registration number: 000015533. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000018042&language=J.
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Ninomiya, K., Hotta, K., Hisamoto-Sato, A. et al. Short-term low-volume hydration in cisplatin-based chemotherapy for patients with lung cancer: the second prospective feasibility study in the Okayama Lung Cancer Study Group Trial 1201. Int J Clin Oncol 21, 81–87 (2016). https://doi.org/10.1007/s10147-015-0860-1
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DOI: https://doi.org/10.1007/s10147-015-0860-1