PMID- 21913826
OWN - NLM
STAT- MEDLINE
DCOM- 20111229
LR  - 20151119
IS  - 1750-7448 (Electronic)
IS  - 1750-743X (Linking)
VI  - 3
IP  - 9
DP  - 2011 Sep
TI  - An overview of the VISTA trial: newly diagnosed, untreated patients with multiple 
      myeloma ineligible for stem cell transplantation.
PG  - 1033-40
LID - 10.2217/imt.11.104 [doi]
AB  - Multiple myeloma, a plasma cell neoplasm, is the second most common hematologic 
      malignancy after non-Hodgkins lymphoma and is responsible for 2% of cancer 
      deaths. Melphalan and prednisone (MP) has been the standard treatment in elderly 
      patients for many decades. The VISTA study evaluated the effect of this 
      combination with or without the first-in-class proteasome inhibitor bortezomib in 
      newly diagnosed myeloma patients who were not candidates for autologous stem cell 
      transplantation. Altogether 682 patients were enrolled and prospectively 
      randomized in this trial. All patients received nine 6-week cycles of oral 
      melphalan (9 mg/m(2)) and prednisone (60 mg/m(2)) on days 1-4, either alone or 
      with bortezomib administered intravenously (1.3 mg/m(2) on days 1, 4, 8, 11, 22, 
      25, 29 and 32 during the first four cycles and on days 1, 8, 22, 29 during 
      remaining course of therapy). Median time to progression (the primary end point 
      of the trial) was 24 months in the bortezomib-containing group compared with 16.6 
      months in the control group (p < 0.001). Response was evaluated in 337 patients 
      receiving bortezomib compared with 331 patients in the control group who received 
      MP alone; the percentages of partial response or better was 71 vs 35% (p < 
      0.001), with complete response seen in 30 vs 4%, respectively (p < 0.001). Median 
      response duration in both groups was 19.9 versus 13.1 months, respectively. 
      Median overall survival has not been reached in VMP group compared with 43 months 
      in the MP group (p < 0.001), and this benefit is maintained after long term 
      follow-up and subsequent antimyeloma therapies. Hematological adverse events 
      (AEs) were similar in both groups, although patients in the bortezomib group 
      experienced more frequent peripheral sensory neuropathy (including 13% grade 3, 
      with less than 1% grade 4). Overall, the occurrence of grade 3 AEs was higher in 
      patients receiving bortezomib (53 vs 44%, p = 0.02), but the risk of grade 4 AEs 
      was identical (28 vs 27%). These results confirm the superiority of MP plus 
      bortezomib combination over MP therapy in treatment-naive patients with newly 
      diagnosed multiple myeloma who are ineligible for autologous stem cell 
      transplantation.
FAU - Spicka, Ivan
AU  - Spicka I
AD  - Hospital Universitario de Salamanca, Salamanca, Spain. spicka@cesnet.cz
FAU - Mateos, M V
AU  - Mateos MV
FAU - Redman, K
AU  - Redman K
FAU - Dimopoulos, M A
AU  - Dimopoulos MA
FAU - Richardson, P G
AU  - Richardson PG
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Immunotherapy
JT  - Immunotherapy
JID - 101485158
RN  - 0 (Boronic Acids)
RN  - 0 (Pyrazines)
RN  - 69G8BD63PP (Bortezomib)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Boronic Acids/administration & dosage
MH  - Bortezomib
MH  - Female
MH  - Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy/mortality
MH  - Pyrazines/administration & dosage
EDAT- 2011/09/15 06:00
MHDA- 2011/12/30 06:00
CRDT- 2011/09/15 06:00
PHST- 2011/09/15 06:00 [entrez]
PHST- 2011/09/15 06:00 [pubmed]
PHST- 2011/12/30 06:00 [medline]
AID - 10.2217/imt.11.104 [doi]
PST - ppublish
SO  - Immunotherapy. 2011 Sep;3(9):1033-40. doi: 10.2217/imt.11.104.