First-line therapy for non-transplant eligible patients with multiple myeloma: direct and adjusted indirect comparison of treatment regimens on the existing market in Germany.
Objectives: The purpose of this study was to compare approved first-line therapies for patients with multiple myeloma. Methods: A systematic literature search for phase III randomized controlled trials (RCTs) comparing first-line chemotherapies approved in Germany and recommended by guidelines at th...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 72; no. 3; pp. 257 - 266 |
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| Autores principales: | , , , , |
| Formato: | research systematic review tables/charts Journal Article |
| Publicado: |
Springer Nature
Mar2016
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=112926729&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 112926729 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Mar2016 vid: 72 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 112926729 112926729 112926729 10.1007/s00228-015-1998-5 112926729 ppf: 257 ppct: 9 formats: fmt: @attributes: type: P tig: atl: First-line therapy for non-transplant eligible patients with multiple myeloma: direct and adjusted indirect comparison of treatment regimens on the existing market in Germany. aug: au: Kuhr, Kathrin Wirth, Daniel Srivastava, Kunal Lehmacher, Walter Hellmich, Martin affil: Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, 50924 Koeln Germany sug: subj: Multiple Myeloma Drug Therapy Chemotherapy, Cancer Evaluation Systematic Review Human Germany Confidence Intervals Melphalan Therapeutic Use Prednisone Therapeutic Use Bortezomib Therapeutic Use Thalidomide Therapeutic Use Survival Treatment Outcomes Meta Analysis Descriptive Statistics Data Analysis Software ab: Objectives: The purpose of this study was to compare approved first-line therapies for patients with multiple myeloma. Methods: A systematic literature search for phase III randomized controlled trials (RCTs) comparing first-line chemotherapies approved in Germany and recommended by guidelines at the time of study design was conducted. Random-effects meta-analysis (MA) was used for direct and the Bucher method for adjusted indirect treatment comparison. Results: One RCT comparing melphalan and prednisone plus bortezomib (VMP) vs. melphalan and prednisone (MP) and six RCTs comparing MP plus thalidomide (MPT) vs. MP were analysed. For MPT vs. MP, an individual patient data (IPD) MA was used for sensitivity analyses. VMP and MPT were superior to MP regarding efficacy endpoints (VMP vs. MP, overall survival (OS): hazard ratio (HR) 0.70, 95 % confidence interval (CI) 0.57-0.86; progression-free survival (PFS): HR 0.56, 0.39-0.79; complete response (CR), risk-ratio (RR) for non-response: 0.70, 0.65-0.75; MPT vs. MP, OS: HR 0.83, 0.66-1.03; PFS: HR 0.67, 0.56-0.81; CR, RR for non-response 0.92, 0.88-0.95); but had a higher risk of developing any grade 3-4 adverse events (AEs) (VMP vs. MP: RR 1.13, 1.06-1.20; MPT vs. MP: RR 2.06, 1.43-2.98). The indirect comparison of VMP vs. MPT via MP showed a statistically not significant advantage for VMP regarding survival outcomes (OS: HR 0.85, 0.63-1.14; PFS: HR 0.83, 0.56-1.23) and a significant advantage regarding CR (RR for non-response 0.76, 0.70-0.83) and AEs (RR 0.55, 0.38-0.80). Treatment comparisons using results of IPD MA yielded similar effect sizes. Conclusions: VMP and MPT seem more effective than MP, VMP was superior to MPT regarding response criteria and AEs. Our results may best be confirmed by a head-to-head trial of VMP vs. MPT. pubtype: Academic Journal doctype: meta analysis research systematic review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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