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 denosumabDenosumab 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
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