PMID- 30027641 OWN - NLM STAT- MEDLINE DCOM- 20181224 LR - 20220331 IS - 1600-0609 (Electronic) IS - 0902-4441 (Linking) VI - 101 IP - 4 DP - 2018 Oct TI - Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice. PG - 556-565 LID - 10.1111/ejh.13147 [doi] AB - OBJECTIVE: The efficacy and safety of bortezomib-based therapy for relapsed/refractory multiple myeloma (RRMM) in clinical trials may differ from the oncology practice experience. The electronic VELCADE((R)) OBservational Study was designed to prospectively evaluate bortezomib for multiple myeloma (MM) in real-world medical practice. METHOD: Patients scheduled to receive intravenous bortezomib for MM were eligible. The primary objective was to evaluate clinical outcomes, including response, time to response, time to next therapy, treatment-free interval, progression-free survival (PFS), and overall survival (OS). Secondary objectives included safety and healthcare resource utilization. RESULTS: In total, 873 patients with a median of two therapy lines prior to initiating bortezomib were included. The overall response rate (>/=partial response) was 69%, including 37% complete response/near-complete response. Median time to response was 1.8 months, median time to next therapy was 9.7 months, and median treatment-free interval was 7.9 months. After 22.6 months' median follow-up, median PFS was 12.0 months and median OS was 36.1 months. The most common adverse events (AEs) were neuropathy not otherwise specified (19%), diarrhea NOS, and thrombocytopenia (each 17%); 230 (26%) patients discontinued bortezomib due to AEs. Of 689 (79%) patients without baseline peripheral neuropathy (PN), the rate of new-onset any-grade PN increased to 51% (12% grade 3/4) by cycle 8. Overall, 244 (28%) patients were hospitalized, 372 (43%) attended an outpatient visit, and 341 (39%) underwent a diagnostic/therapeutic procedure during bortezomib treatment. CONCLUSION: These prospective real-world data demonstrate the effectiveness and safety of bortezomib-based therapy for RRMM and confirm high response rates and long OS for this population. CI - (c) 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Terpos, Evangelos AU - Terpos E AUID- ORCID: 0000-0001-5133-1422 AD - Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece. FAU - Katodritou, Eirini AU - Katodritou E AD - Department of Hematology, Theagenion Cancer Centre, Thessaloniki, Greece. FAU - de la Rubia, Javier AU - de la Rubia J AD - Department of Hematology, Hospital Dr Peset, Universidad Catolica de Valencia, Valencia, Spain. FAU - Hungria, Vania AU - Hungria V AD - Department of Hematology, Theagenion Cancer Centre, Thessaloniki, Greece. FAU - Hulin, Cyrille AU - Hulin C AD - Service d'hematologie Hopital Haut leveque CHU Bordeaux, Bordeaux, France. FAU - Roussou, Maria AU - Roussou M AD - Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece. FAU - Delforge, Michel AU - Delforge M AD - Department of Hematology, University Hospital Leuven, Leuven, Belgium. FAU - Bries, Greet AU - Bries G AD - Department of Hematology, AZ Turnhout, Turnhout, Belgium. FAU - Stoppa, Anne-Marie AU - Stoppa AM AD - Departement D'Onco-Hematologie, Institut Paoli-Calmettes, Marseilles, France. FAU - Aagesen, Jesper AU - Aagesen J AD - Department of Medicine, Ryhov County Hospital, Jonkoping, Sweden. FAU - Sargin, Deniz AU - Sargin D AD - Division of Hematology, Department of Internal Medicine, Istanbul University, Istanbul, Turkey. FAU - Belch, Andrew AU - Belch A AD - Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada. FAU - Ahlberg, Lucia AU - Ahlberg L AD - Hematologliniken Universitetssjukhuset, Linkoping, Sweden. FAU - Diels, Joris AU - Diels J AD - Division of Janssen Pharmaceutica NV, Janssen Research & Development, Beerse, Belgium. FAU - Olie, Robert A AU - Olie RA AD - Janssen-Cilag AG, Baar, Switzerland. FAU - Robinson, Don Jr AU - Robinson D Jr AD - Janssen Global Services, Raritan, New Jersey. FAU - Spencer, Mike AU - Spencer M AD - Janssen-Cilag UK, High Wycombe, UK. FAU - Potamianou, Anna AU - Potamianou A AD - Janssen-Cilag Pharmaceutical SACI, Athens, Greece. FAU - van de Velde, Helgi AU - van de Velde H AD - Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts. FAU - Dimopoulos, Meletios A AU - Dimopoulos MA AD - Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece. LA - eng GR - Janssen Global Services/ GR - Millennium Pharmaceuticals, Inc./ PT - Clinical Trial PT - Journal Article PT - Multicenter Study DEP - 20180905 PL - England TA - Eur J Haematol JT - European journal of haematology JID - 8703985 RN - 69G8BD63PP (Bortezomib) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/*therapeutic use MH - Bortezomib/administration & dosage MH - Combined Modality Therapy MH - Comorbidity MH - Drug Resistance, Neoplasm MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Multiple Myeloma/*drug therapy/mortality/*pathology MH - Recurrence MH - Retreatment MH - Treatment Outcome OTO - NOTNLM OT - bortezomib OT - multiple myeloma OT - non-interventional OT - observational OT - real-world OT - relapsed EDAT- 2018/07/22 06:00 MHDA- 2018/12/26 06:00 CRDT- 2018/07/21 06:00 PHST- 2018/05/01 00:00 [received] PHST- 2018/07/12 00:00 [accepted] PHST- 2018/07/22 06:00 [pubmed] PHST- 2018/12/26 06:00 [medline] PHST- 2018/07/21 06:00 [entrez] AID - 10.1111/ejh.13147 [doi] PST - ppublish SO - Eur J Haematol. 2018 Oct;101(4):556-565. doi: 10.1111/ejh.13147. Epub 2018 Sep 5.