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2014 ; 99
(9
): 3144-52
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Denosumab for treatment of hypercalcemia of malignancy
#MMPMID24915117
Hu MI
; Glezerman IG
; Leboulleux S
; Insogna K
; Gucalp R
; Misiorowski W
; Yu B
; Zorsky P
; Tosi D
; Bessudo A
; Jaccard A
; Tonini G
; Ying W
; Braun A
; Jain RK
J Clin Endocrinol Metab
2014[Sep]; 99
(9
): 3144-52
PMID24915117
show ga
CONTEXT: Hypercalcemia of malignancy (HCM) in patients with advanced cancer is
often caused by excessive osteoclast-mediated bone resorption. Patients may not
respond to or may relapse after iv bisphosphonate therapy. OBJECTIVE: We
investigated whether denosumab, a potent inhibitor of osteoclast-mediated bone
resorption, reduces serum calcium in patients with bisphosphonate-refractory HCM.
DESIGN, SETTING, AND PARTICIPANTS: In this single-arm international study,
participants had serum calcium levels corrected for albumin (CSC) >12.5 mg/dL
(3.1 mmol/L) despite bisphosphonates given >7 and ?30 days before screening.
INTERVENTION: Patients received 120 mg sc denosumab on days 1, 8, 15, and 29 and
then every 4 weeks. MAIN OUTCOME MEASURES: The primary endpoint was the
proportion of patients with CSC ?11.5 mg/dL (2.9 mmol/L) (response) by day 10.
Secondary endpoints included response by visit, duration of response, and the
proportion of patients with a complete response (CSC ?10.8 mg/dL [2.7 mmol/L]) by
day 10 and during the study. RESULTS: Patients (N = 33) had solid tumors or
hematologic malignancies. By day 10, 21 patients (64%) reached CSC ?11.5 mg/dL,
and 12 patients (33%) reached CSC ?10.8 mg/dL. During the study, 23 patients
(70%) reached CSC ?11.5 mg/dL, and 21 patients (64%) reached CSC ?10.8 mg/dL.
Estimated median response duration was 104 days. The most common serious adverse
events were hypercalcemia worsening (5 patients, 15%) and dyspnea (3 patients,
9%). CONCLUSIONS: In patients with HCM despite recent iv bisphosphonate
treatment, denosumab lowered serum calcium in 64% of patients within 10 days,
inducing durable responses. Denosumab may offer a new treatment option for HCM.
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