An integrated analysis of hyponatremia in cancer patients receiving platinum-based chemotherapy in clinical trials (JCOG1405-A)

Background

Hyponatremia is one of the most common electrolyte abnormalities in cancer patients who receive chemotherapy. However, its actual incidence and risk factors remain unknown. Among anti-cancer agents, platinum-based agent (platinum) is reported to cause chemotherapy-induced hyponatremia. Our aim is to evaluate the profile of chemotherapy-induced hyponatremia by integrated analysis from completed clinical trials.

Methods

The present study is an epidemiological study based on the integrated analysis of clinical trials performed by Japan Clinical Oncology Group (JCOG). We included clinical trials of systemic chemotherapies for solid cancers (lung, esophageal, gastric, colorectal, biliary tract, breast, ovarian, cervical, bladder, and head and neck cancers), which were approved by the JCOG Protocol Review Committee after January 2000 and of which the patient recruitment was completed by January 2014. The incidences of hyponatremia and the patient/treatment profiles in the latest analysis reports of each trial were used. The associations between hyponatremia and the following factors were investigated: platinum use (yes/no), platinum regimens (Cisplatin/Carboplatin), administration methods (bolus/split), the number and types of concomitant medications, and planned administration dose.

Results

Twenty-nine trials (4313 patients) were included. Incidence of Grade 3/4 hyponatremia in patients with platinum administration was 11.9%, which was significantly higher than those without platinum (3.8%, p 

Conclusions

Our study revealed that platinum agent administration was associated with chemotherapy induced hyponatremia regardless of administration method and planned dose. Careful monitoring of sodium level is needed when platinum is administered.

Clinical trial identification

Legal entity responsible for the study

Japan Clinical Oncology Group (JCOG)

Funding

1. Ministry of Health, Labour and Welfare, Japan 2. Japan Agency for Medical Research and Development (AMED)

Disclosure

Y. Ezoe, J. Mizusawa, K. Takizawa, H. Katayama, K. Kataoka, M. Muto: Grants from Ministry of Health, Labour and Welfare, Japan, grants from Japan Agency for Medical Research and Development (AMED). K. Tobinai: Grants from Japan AMED, during the conduct of the study; grants and personal fees from Eisai, Takeda, Mundipharma, Janssen, grants from Chugai, Kyowa Kirin, Ono, Celgene, GSK, SERVIER, Abbvie, outside the submitted work.