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 denosumabDenosumab 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
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