PS1-12 META-ANALYSIS AND INDIRECT TREATMENT COMPARISON OF SAFETY PROFILES OF BORTEZOMIB- AND THALIDOMIDE-BASED REGIMENS FOR THE FIRST LINE TREATMENT OF ELDERLY TRANSPLANT-INELIGIBLE PATIENTS WITH MULTIPLE MYELOMA

Sunday, June 12, 2016
Exhibition Space (30 Euston Square)
Poster Board # PS1-12

Milica Jevdjevic, DMD1, Durda Vukicevic, MD2, Monika Buchberger, MSc2, Marjan Arvandi, MS1, Werner Hackl, DI Dr.3, Wolfgang Willenbacher, MD4, Guenther Gastl, MD5, Uwe Siebert, MD, MPH, MSc, ScD6 and Ursula Rochau, MD, MSc7, (1)Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i. T., Austria, (2)UMIT - University for Health Sciences, Medical Informatics and Technology, Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, Hall i.T., Austria, (3)Institute of Biomedical Informatics, Department of Biomedical Informatics and Mechatronics, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria, Hall i.T., Austria, (4)Area 4 Health Technology Assessment and Bioinformatics, ONCOTYROL - Center for Personalized Cancer Medicine; Internal Medicine V, Hematology and Oncology, Medical University, Innsbruck, Austria, (5)Internal Medicine V, Hematology and Oncology, Medical University, Innsbruck, Austria, (6)Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria, (7)UMIT - University for Health Sciences, Medical Informatics and Technology, Institute of Public Health, Medical Decision Making and HTA, Department of Public Health and HTA/ ONCOTYROL - Center for Personalized Cancer Medicine, Area 4 HTA and Bioinformatics, Hall in Tyrol/ Innsbruck, Austria
Purpose: We performed a systematic review and meta-analysis comparing the safety of different first-line treatment strategies for newly diagnosed, transplant-ineligible patients with multiple myeloma (MM). Treatment alternatives for these patients include multidrug regimens combining melphalan and prednisone (MP) with bortezomib (MPV) or thalidomide (MPT) and combinations of cyclophosphamide, thalidomide and dexamethasone (CTd). 

Method(s): A systematic literature review was conducted and eligible studies (randomized clinical trials (RCT) comparing first-line therapies for MM) were identified from several databases including Medline, Embase, Cochrane Library and CRD. We extracted data on grade 3-4 adverse events and calculated pooled odds ratios (OR) with 95% confidence intervals (CI). A random-effects meta-analysis and indirect treatment comparison were performed to compare treatment-related adverse events (AEs) in the included clinical trials.

Result(s): Our meta-analysis included six studies comparing MP and MPT with a total of 1399 patients. Withdrawals due to AEs were significantly lower in MP treatment when compared with MPT 0.18 (0.12-0.28) (OR (95% CI)). The MP regimen was associated with a significantly lower risk of DVT 0.37 (0.15-0.86), as well as a decreased risk of constipation 0.45 (0.27-0.77), infection 0.46 (0.30- 0.71) and peripheral neuropathy 0.25 (0.09-0.67). Other AEs including neutropenia, cardiac disorder, rash and nausea were less frequent for MP but the differences were not statistically significant. The indirect treatment comparison assessed the safety of MPV compared with MPT and CTd with MPT using MP as common comparator. Results of indirect comparisons did not show statistically significant difference except in the case of peripheral neuropathy 0.04 (0.00-0.90) and nausea 0.11 (0.03-0.48), which were less frequent in MPV regimen.

Conclusion(s): Based on the results of our comparative safety analysis, the MP regimen appears to have a favorable safety profile. The addition of novel and more potent therapeutic agents is in general followed by an increase of grade 3 and 4 adverse events.  Therefore, the benefits and harms of the treatment alternatives should be carefully balanced, particularly in elderly patients, although higher and deeper responses, a better  progression-free survival (PFS) as well as  overall survival (OS) has been reported for triplet therapies comprising novel agents in multiple clinical trials.

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