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 The Treatment Of Hypercalcemia Of Malignancy Refractory To IV Bisphosphonates In Patients With Hematologic Malignancies
Gucalp R, Insogna K, Hu M, Glezerman I, Leboulleux S, Misiorowski W, Yu B, Zorsky P, Tosi D, Bessudo A, Jaccard A, Tonini G, Ying W, Braun A, Jain R. Denosumab For The Treatment Of Hypercalcemia Of Malignancy Refractory To IV Bisphosphonates In Patients With Hematologic Malignancies. Blood 2013, 122: 2536. DOI: 10.1182/blood.v122.21.2536.2536.Peer-Reviewed Original ResearchHypercalcemia of malignancyProportion of patientsSerious adverse eventsTreatment of hypercalcemiaHematologic malignanciesTreatment responseComplete responseDay 10Bisphosphonate treatmentStudy visitRANK ligandAmgen Inc.Unexpected safety findingsKey secondary endpointOpen-label studyHematologic malignancy patientsOverall study populationUse of denosumabKey baseline characteristicsStudy of patientsOff-label useHuman monoclonal antibodyBisphosphonate therapyDenosumab initiationSubcutaneous denosumab
2011
Denosumab for Treatment of Hypercalcemia of Malignancy in Patients with Solid Tumors or Hematological Malignancies Refractory to IV Bisphosphonates: A Single-Arm Multicenter Study
Hu M, Gucalp R, Insogna K, Glezerman I, Leboulleux S, Misiorowski W, Yu B, Ying W, Yeh H. Denosumab for Treatment of Hypercalcemia of Malignancy in Patients with Solid Tumors or Hematological Malignancies Refractory to IV Bisphosphonates: A Single-Arm Multicenter Study. Blood 2011, 118: 2483. DOI: 10.1182/blood.v118.21.2483.2483.Peer-Reviewed Original ResearchHypercalcemia of malignancyDose of denosumabTreatment of hypercalcemiaAdverse eventsBP treatmentInterim analysisDay 10RANK ligandComplete responseAdvanced cancerCSC levelsBone resorptionHematological malignanciesTreatment of HCMSolid tumorsSingle-arm multicenter studyAmgen Inc.Denosumab-treated patientsDoses of denosumabStudy day 10Serious adverse eventsSerum calcium levelsSingle-arm studyStudy days 1Population of patients