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学科主题: 临床医学
题名:
Bortezomib Plus Melphalan and Prednisone Compared With Melphalan and Prednisone in Previously Untreated Multiple Myeloma: Updated Follow-Up and Impact of Subsequent Therapy in the Phase III VISTA Trial
作者: Mateos, Maria-Victoria; Richardson, Paul G.; Schlag, Rudolf; Khuageva, Nuriet K.; Dimopoulos, Meletios A.; Shpilberg, Ofer; Kropff, Martin; Spicka, Ivan; Petrucci, Maria T.; Palumbo, Antonio; Samoilova, Olga S.; Dmoszynska, Anna; Abdulkadyrov, Kudrat M.; Schots, Rik; Jiang, Bin; Esseltine, Dixie L.; Liu, Kevin; Cakana, Andrew; van de Velde, Helgi; San Miguel, Jesus F.1
刊名: JOURNAL OF CLINICAL ONCOLOGY
发表日期: 2010-05-01
DOI: 10.1200/JCO.2009.26.0638
卷: 28, 期:13, 页:2259-2266
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology
研究领域[WOS]: Oncology
关键词[WOS]: INTERNATIONAL STAGING SYSTEM ; STEM-CELL TRANSPLANTATION ; NEWLY-DIAGNOSED MYELOMA ; ELDERLY-PATIENTS ; PERIPHERAL NEUROPATHY ; IMPROVED SURVIVAL ; PROGRESSION-FREE ; YOUNGER PATIENTS ; THALIDOMIDE ; EFFICACY
英文摘要:

Purpose

The purpose of this study was to confirm overall survival (OS) and other clinical benefits with bortezomib, melphalan, and prednisone (VMP) versus melphalan and prednisone (MP) in the phase III VISTA (Velcade as Initial Standard Therapy in Multiple Myeloma) trial after prolonged follow-up, and evaluate the impact of subsequent therapies.

Patients and Methods

Previously untreated symptomatic patients with myeloma ineligible for high-dose therapy received up to nine 6-week cycles of VMP (n = 344) or MP (n = 338).

Results

With a median follow-up of 36.7 months, there was a 35% reduced risk of death with VMP versus MP (hazard ratio, 0.653; P < .001); median OS was not reached with VMP versus 43 months with MP; 3-year OS rates were 68.5% versus 54.0%. Response rates to subsequent thalidomide( 41% v 53%) and lenalidomide-based therapies (59% v 52%) appeared similar after VMP or MP; response rates to subsequent bortezomib-based therapy were 47% versus 59%. Among patients treated with VMP (n = 178) and MP (n = 233), median survival from start of subsequent therapy was 30.2 and 21.9 months, respectively, and there was no difference in survival from salvage among patients who received subsequent bortezomib, thalidomide, or lenalidomide. Rates of adverse events were higher with VMP versus MP during cycles 1 to 4, but similar during cycles 5 to 9. With VMP, 79% of peripheral neuropathy events improved within a median of 1.9 months; 60% completely resolved within a median of 5.7 months.

Conclusion

VMP significantly prolongs OS versus MP after lengthy follow-up and extensive subsequent antimyeloma therapy. First-line bortezomib use does not induce more resistant relapse. VMP used upfront appears more beneficial than first treating with conventional agents and saving bortezomib- and other novel agent-based treatment until relapse.

语种: 英语
项目资助者: Johnson &amp ; Johnson Pharmaceutical Research Development ; Millennium Pharmaceuticals
WOS记录号: WOS:000277180300022
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/66383
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Praxisklin Dr Schlag, Wurzburg, Germany
2.Univ Munster, Munster, Germany
3.St Petersburg Botkin Moscow City Clin Hosp, Moscow, Russia
4.Nizhnii Novgorod Reg Clin Hosp, Nizhnii Novgorod, Russia
5.St Petersburg Clin Res Inst Hematol & Transfusiol, St Petersburg, Russia
6.Univ Athens, Sch Med, GR-11527 Athens, Greece
7.Rabin Med Ctr, Petah Tiqwa, Israel
8.Johnson & Johnson Pharmaceut Res & Dev, Beerse, Belgium
9.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
10.Univ Salamanca, Hosp Univ Salamanca, Ctr Invest Canc,CSIC, Inst Biol Mol & Celular Canc, Salamanca 37007, Spain
11.Dana Farber Canc Inst, Boston, MA 02115 USA
12.Univ Hosp, Prague, Czech Republic
13.Univ Roma La Sapienza, Rome, Italy
14.Univ Turin, Turin, Italy
15.Med Univ Lublin, Lublin, Poland
16.Belgian Hematol Soc, Myeloma Study Grp, Brussels, Belgium
17.Millennium Pharmaceut Inc, Cambridge, MA USA
18.Johnson & Johnson Pharmaceut Res & Dev, Raritan, NJ USA
19.Johnson & Johnson Pharmaceut Res & Dev, High Wycombe, Bucks, England

Recommended Citation:
Mateos, Maria-Victoria,Richardson, Paul G.,Schlag, Rudolf,et al. Bortezomib Plus Melphalan and Prednisone Compared With Melphalan and Prednisone in Previously Untreated Multiple Myeloma: Updated Follow-Up and Impact of Subsequent Therapy in the Phase III VISTA Trial[J]. JOURNAL OF CLINICAL ONCOLOGY,2010,28(13):2259-2266.
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