2014
Denosumab for Treatment of Hypercalcemia of Malignancy
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. Denosumab for Treatment of Hypercalcemia of Malignancy. The Journal Of Clinical Endocrinology & Metabolism 2014, 99: 3144-3152. PMID: 24915117, PMCID: PMC4154084, DOI: 10.1210/jc.2014-1001.Peer-Reviewed Original ResearchConceptsHypercalcemia of malignancyProportion of patientsDay 10Serum calciumBone resorptionCommon serious adverse eventsMedian response durationSerious adverse eventsSerum calcium levelsTreatment of hypercalcemiaDuration of responseNew treatment optionsBisphosphonate therapyPrimary endpointSecondary endpointsAdverse eventsBisphosphonate treatmentDurable responsesComplete responseAdvanced cancerTreatment optionsHematologic malignanciesResponse durationDenosumabCalcium levels
2013
Denosumab for Patients With Persistent or Relapsed Hypercalcemia of Malignancy Despite Recent Bisphosphonate Treatment
Hu MI, Glezerman I, Leboulleux S, Insogna K, Gucalp R, Misiorowski W, Yu B, Ying W, Jain RK. Denosumab for Patients With Persistent or Relapsed Hypercalcemia of Malignancy Despite Recent Bisphosphonate Treatment. Journal Of The National Cancer Institute 2013, 105: 1417-1420. PMID: 23990665, PMCID: PMC3776443, DOI: 10.1093/jnci/djt225.Peer-Reviewed Original ResearchConceptsHypercalcemia of malignancyBisphosphonate treatmentResponse durationDay 10Albumin-corrected serum calciumTumor-induced bone resorptionIntravenous bisphosphonate treatmentPrespecified interim analysisMedian response durationProportion of patientsKaplan-Meier methodNew treatment optionsDenosumab initiationIntravenous bisphosphonatesSubcutaneous denosumabPrimary endpointRenal failureComplete responseSerum calciumTreatment optionsHCM patientsBone resorptionDenosumabInterim analysisPatientsDenosumab for the treatment of bisphosphonate-refractory hypercalcemia of malignancy (HCM).
Hu M, Glezerman I, Leboulleux S, Insogna K, Gucalp R, Misiorowski W, Yu B, Zorsky P, Tosi D, Bessudo A, Jaccard A, Tonini G, Wang H, Braun A, Jain R. Denosumab for the treatment of bisphosphonate-refractory hypercalcemia of malignancy (HCM). Journal Of Clinical Oncology 2013, 31: e20512-e20512. DOI: 10.1200/jco.2013.31.15_suppl.e20512.Peer-Reviewed Original ResearchBone resorptionDay 10RANK ligandTumor-induced bone resorptionUnexpected safety findingsSerious adverse eventsNew treatment optionsDenosumab initiationSubcutaneous denosumabPrimary endpointDurable responsesFirst doseMedian durationSafety findingsAdverse eventsComplete responseMedian timeSerum calciumTreatment optionsDenosumabDay 1CSC levelsDlMedianTreatment
2011
A single-arm multicenter proof-of-concept study of denosumab to treat hypercalcemia of malignancy in patients who are refractory to IV bisphosphonates.
Hu M, Gucalp R, Insogna K, Glezerman I, Bone H, Jaccard A, Misiorowski W, Yu B, Yeh H. A single-arm multicenter proof-of-concept study of denosumab to treat hypercalcemia of malignancy in patients who are refractory to IV bisphosphonates. Journal Of Clinical Oncology 2011, 29: tps245-tps245. DOI: 10.1200/jco.2011.29.15_suppl.tps245.Peer-Reviewed Original Research