PMID- 30697597
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231005
IS  - 2398-8835 (Electronic)
IS  - 2398-8835 (Linking)
VI  - 2
IP  - 1
DP  - 2019 Jan
TI  - Bortezomib retreatment for relapsed and refractory multiple myeloma in real-world 
      clinical practice.
PG  - e104
LID - 10.1002/hsr2.104 [doi]
LID - e104
AB  - AIMS: Studies have shown that bortezomib retreatment is effective in 
      relapsed/refractory multiple myeloma (MM). The observational, prospective 
      electronic VELCADE((R)) OBservational Study (eVOBS) study assessed bortezomib-based 
      therapies for patients with MM in everyday practice. Here, we report on those 
      patients receiving retreatment with bortezomib. METHODS: Consenting adults 
      scheduled to receive bortezomib for MM were enrolled at 162 sites across Europe, 
      Canada, Brazil, Russia, and Turkey between 2006 and 2010. Retrospective data on 
      prior therapies and prospective observational data after bortezomib initiation 
      were captured electronically at baseline, after every bortezomib cycle, and every 
      12 weeks after discontinuation or progression. Investigator-assessed responses 
      and adverse events (AEs) were evaluated. RESULTS: Ninety-six of 873 patients 
      enrolled to eVOBS received bortezomib as first retreatment for progressive 
      disease during the prospective observation period. Median age was 62 years, 53% 
      were male, and median number of prior therapies at retreatment was 4. Overall, 
      41% of patients initiated bortezomib retreatment in combination with 
      dexamethasone, 16% in combination with lenalidomide, and 21% received 
      monotherapy. Rate of partial response or better (>/=PR) was 75% at initial 
      bortezomib therapy, including 44% complete response (CR)/near CR (nCR); at 
      retreatment, >/=PR rate was 46%, including 15% CR/nCR. Median progression-free 
      survival was 11.4 months (95% confidence interval [CI]: 9.1-12.7) from start of 
      initial bortezomib treatment and 6.4 months (95% CI: 4.4-7.2) from start of 
      retreatment. Median overall survival from start of retreatment was 17.6 months 
      (95% CI: 14.4-23.5). Of the 96 patients retreated with bortezomib, 77% reported 
      an AE. Peripheral neuropathy during bortezomib retreatment occurred in 49% of 
      patients, including 10% grade 3/4. CONCLUSION: These data suggest that 
      retreatment with bortezomib is a feasible option for patients with 
      relapsed/refractory MM.
FAU - Hulin, Cyrille
AU  - Hulin C
AUID- ORCID: 0000-0002-3749-5161
AD  - Service d'Hematologie Hopital Haut-Leveque CHU Bordeaux France.
FAU - de la Rubia, Javier
AU  - de la Rubia J
AD  - Department of Hematology, Hospital Dr Peset Universidad Catolica de Valencia 
      Valencia Spain.
FAU - Dimopoulos, Meletios A
AU  - Dimopoulos MA
AD  - Department of Clinical Therapeutics National and Kapodistrian University of 
      Athens School of Medicine Athens Greece.
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 - Hungria, Vania
AU  - Hungria V
AUID- ORCID: 0000-0002-4327-1957
AD  - Santa Casa de Sao Paulo Medical School Sao Paulo Brazil.
FAU - De Samblanx, Hadewijch
AU  - De Samblanx H
AD  - Hematology, St Dimpna Hospital Geel 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 - Sioni, Anastasia
AU  - Sioni A
AD  - Department of Clinical Therapeutics National and Kapodistrian University of 
      Athens School of Medicine Athens Greece.
FAU - Belch, Andrew
AU  - Belch A
AD  - Department of Oncology Cross Cancer Institute Edmonton AB Canada.
FAU - Diels, Joris
AU  - Diels J
AD  - Janssen Research and Development, Division of Janssen Pharmaceutica NV Beerse 
      Belgium.
FAU - Olie, Robert A
AU  - Olie RA
AD  - Janssen-Cilag AG Zug Switzerland.
FAU - Robinson, Don Jr
AU  - Robinson D Jr
AD  - Janssen Global Services Raritan NJ USA.
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, MA, USA a wholly owned subsidiary of 
      Takeda Pharmaceutical Company Limited.
FAU - Delforge, Michel
AU  - Delforge M
AD  - Department of Hematology University Hospital Leuven Leuven Belgium.
LA  - eng
PT  - Journal Article
DEP - 20181207
PL  - United States
TA  - Health Sci Rep
JT  - Health science reports
JID - 101728855
PMC - PMC6346989
OTO - NOTNLM
OT  - multiple myeloma
OT  - real world
OT  - refractory
OT  - relapsed
OT  - retreatment
EDAT- 2019/01/31 06:00
MHDA- 2019/01/31 06:01
PMCR- 2018/12/07
CRDT- 2019/01/31 06:00
PHST- 2017/10/25 00:00 [received]
PHST- 2018/10/24 00:00 [revised]
PHST- 2018/10/25 00:00 [accepted]
PHST- 2019/01/31 06:00 [entrez]
PHST- 2019/01/31 06:00 [pubmed]
PHST- 2019/01/31 06:01 [medline]
PHST- 2018/12/07 00:00 [pmc-release]
AID - HSR2104 [pii]
AID - 10.1002/hsr2.104 [doi]
PST - epublish
SO  - Health Sci Rep. 2018 Dec 7;2(1):e104. doi: 10.1002/hsr2.104. eCollection 2019 
      Jan.