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External Validation and Update of the Risk Prediction Model for Denosumab-Induced Hypocalcemia Developed From a

Keisuke Ikegami¹, Shungo Imai¹, Osamu Yasumuro²

¹Keio University Faculty of Pharmacy/Graduate School of Pharmaceutical Sciences, Tokyo, Japan.

JCO Clinical Cancer Informatics

|July 15, 2024

Summary

This study validated and updated a risk model for denosumab-induced hypocalcemia. The new model, using basic lab tests, shows good performance across different hospitals, aiding bone metastasis treatment management.

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Area of Science:

Oncology
Pharmacology
Clinical Medicine

Background:

Denosumab effectively treats bone metastasis from solid tumors.
Severe hypocalcemia is a significant adverse effect of denosumab, necessitating careful clinical management.
Accurate risk prediction is crucial for mitigating denosumab-induced hypocalcemia.

Purpose of the Study:

To externally validate a previously developed risk prediction model for denosumab-induced hypocalcemia.
To develop an updated, generalizable risk prediction model with improved performance.
To assess model performance across two distinct Japanese healthcare facilities.

Main Methods:

Retrospective data from Kameda General Hospital (KGH) and Miyagi Cancer Center (MCC) (June 2013-June 2022) were analyzed.
External validation primarily evaluated receiver operating characteristic (ROC)-AUC.
An updated scoring-based model was developed using administrative database data, informed by external validation results.

Main Results:

External validation included 235 KGH patients and 224 MCC patients.
Original model ROC-AUC values were 0.879 (KGH) and 0.774 (MCC).
The updated model, incorporating calcium, albumin, and alkaline phosphatase, achieved similar ROC-AUC values: 0.837 (KGH) and 0.856 (MCC).

Conclusions:

An updated risk prediction model for denosumab-induced hypocalcemia was developed with minimal interfacility variation.
External validation using data from diverse facilities is essential for generalizable prediction models.
The findings support improved clinical management of bone metastasis treatment with denosumab.