Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

Bortezomib Added to Melphalan-Prednisone Significantly Improves Overall Survival in Previously Untreated Patients With Multiple Myeloma: Presented at EHA By Emma Hitt, PhD COPENHAGEN, Denmark -- June 16, 2008 -- Bortezomib plus melphalan-prednisone (VMP) significantly improved overall survival (OS) and response rates compared with melphalan-prednisone (MP) alone in patients with previously untreated multiple myeloma ineligible for high-dose therapy (HDT) autologous stem cell transplant (ASCT), according to the latest data from the Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment With Melphalan and Prednisone (VISTA) trial. Jesus San-Miguel, MD, Hospital Universitario de Salamanca, Salamanca, Spain presented the latest results of the randomised, phase 3 VISTA trial at the Presidential Symposium: 5 Best Abstracts session on June 15 at the 13th Congress of the European Hematology Association (EHA). According to Dr. San-Miguel, MP has been the standard of care for patients with multiple myeloma who are ineligible for HDT-ASCT. Previously, bortezomib demonstrated significant activity as monotherapy in relapsed/refractory multiple myeloma, and a previous phase 1/2 Programme for the Treatment of Hematological Malignancies -- Spanish Group of Myeloma (PETHEMA/GEM) study indicated that VMP achieved a response rate in 89% of patients. In the VISTA trial, patients received nine 6-week cycles of melphalan 9 mg/m2 and prednisone 60 mg/m2 on days 1 to 4, alone (MP group) or with bortezomib (1.3 mg/m2 given twice weekly on days 1, 4, 8, 11, 22, 25, 29, and 32 during cycles 1 to 4, and once weekly on days 1, 8, 22, and 29 during cycles 5 to 9 [VMP group]). A total of 682 patients were randomised from December 2004 to September 2006 to receive VMP or MP. The Independent Data Monitoring Committee recommended that the study be stopped in September 2007 due to an interim analysis showing that VMP was significantly superior to MP for all efficacy endpoints including time to progression (hazard ratio [HR] = 0.540, P = .000002); progression-free survival (HR = 0.609, P = .00001); OS (HR = 0.607, P = .00782); time to next therapy (HR = 0.522, P = .000009); and complete response (HR = 0.540, P = .000002). In patients receiving VMP (n = 337), complete remission (CR) was observed in 30% of patients and partial remission (PR) was observed in 40%, for an overall response rate (ORR) of 70%. Stable disease was observed in an additional 18% of patients. By comparison, in patients receiving MP alone (n = 331), the ORR was 35% (4% CR, 31% PR); P < .00001 for both ORR and CR between treatment arms. In addition, bortezomib improved time to response and duration of response. Time to first response was 1.4 months in the VMP arm versus 4.2 months in the MP arm (P < 10-10), and time to CR was 4.2 months versus 5.3 months (P < 10-10). Among patients achieving a CR, the duration of remission was 24 months with VMP compared with 12.8 months with MP. The risk of progression was reduced by 52% among patients receiving VMP versus MP (HR = 0.483, P < .000001). Likewise, the risk of death was reduced by 36%. However, at a median follow-up of 25.9 months, the median OS was not reached for VMP or MP (HR = 0.644, P = .0032). According to Dr. San-Miguel, VMP was consistently superior across all prognostic subgroups including patients with poor prognostic characteristics. The rate of serious adverse events was 46% with VMP versus 36% with MP. The overall rate of peripheral sensory neuropathy, a known side effect of bortezomib, was 44% in patients receiving VMP and appeared to be mostly transient. Gastrointestinal side effects were higher with VMP relative to MP (grade 3/4, 20% vs ~5%), and 3% developed herpes zoster. Incidence of grade 3/4 haematologic adverse events was comparable between treatment arms. "VMP was well tolerated, with patients remaining on therapy for a median of 46 weeks (8 cycles) compared with 39 weeks (7 cycles) with MP," noted Dr. San-Miguel during his presentation. "Given the high response and survival benefit, VMP should be the standard of care in patients with untreated multiple myeloma ineligible for HDT-ASCT," he added. "This is really a step forward for the treatment of multiple myeloma." [Presentation title: Superior Efficacy With Bortezomib Plus Melphalan-Prednisone (VMP) Versus Melphalan-Prednisone (MP) Alone in Previously Untreated Multiple Myeloma (MM): Results of the Phase III MMY-3002 VISTA Study. From "Presidential Symposium: 5 Best Abstracts."] E-mail this page to a friend or colleague! To print, use this version