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 analysisPatients