Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance With Bortezomib-Thalidomide Compared With Bortezomib-Melphalan-Prednisone for Initial Treatment of Multiple Myeloma: Updated Follow-Up and Improved Survival

被引：180

作者：

Palumbo, Antonio ^{[1
]}

Bringhen, Sara ^{[1
]}

Larocca, Alessandra ^{[1
]}

Rossi, Davide ^{[3
]}

Di Raimondo, Francesco ^{[4
]}

Magarotto, Valeria ^{[1
]}

Patriarca, Francesca ^{[5
]}

Levi, Anna ^{[6
]}

Benevolo, Giulia ^{[1
]}

Vincelli, Iolanda Donatella ^{[8
]}

Grasso, Mariella ^{[9
]}

Franceschini, Luca ^{[7
]}

Gottardi, Daniela

Zambello, Renato ^{[10
]}

Montefusco, Vittorio ^{[11
]}

Falcone, Antonietta Pia ^{[12
,13
]}

Omede, Paola ^{[1
]}

Marasca, Roberto ^{[14
]}

Morabito, Fortunato ^{[15
]}

Mina, Roberto ^{[1
]}

Guglielmelli, Tommasina ^{[16
]}

Nozzoli, Chiara ^{[17
]}

Passera, Roberto ^{[2
]}

Gaidano, Gianluca ^{[3
]}

Offidani, Massimo ^{[18
]}

Ria, Roberto ^{[19
]}

Petrucci, Maria Teresa ^{[6
]}

Musto, Pellegrino ^{[20
]}

Boccadoro, Mario ^{[1
]}

Cavo, Michele ^{[21
]}

机构：

[1] Azienda Osped AO Citta Salute & Sci Torino, Turin, Italy

[2] Univ Turin, San Giovanni Battista Hosp, Turin, Italy

[3] Amedeo Avogadro Univ Eastern Piedmont, Novara, Italy

[4] Univ Catania, Ferrarotto Hosp, Catania, Italy

[5] AO Univ, Udine, Italy

[6] Univ Roma La Sapienza, Rome, Italy

[7] Tor Vergata Univ Hosp, Rome, Italy

[8] AO Bianchi Melacrino Morelli, Reggio Di Calabria, Italy

[9] S Croce & Carle Hosp, Cuneo, Italy

[10] Univ Padua, Padua, Italy

[11] Univ Milan, Ist Nazl Tumori Milano, IRCCS, Milan, Italy

[12] IRCCS Casa Sollievo Sofferenza, San Giovanni Rotondo, Italy

[13] Unita Ematol, San Giovanni Rotondo, Italy

[14] Univ Modena, I-41100 Modena, Italy

[15] AO Cosenza, Cosenza, Italy

[16] S Luigi Gonzaga Hosp, Orbassano, Italy

[17] AO Univ Careggi, Florence, Italy

[18] Osped Riuniti, Ancona, Italy

[19] Univ Bari Aldo Moro, Sch Med, Bari, Italy

[20] IRCCS Ctr Reg Oncol Basilicata, Rionero In Vulture, Italy

[21] Univ Bologna, Policlin S Orsola Malpighi, Bologna, Italy

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2014年 / 32卷 / 07期

关键词：

STEM-CELL TRANSPLANTATION; RANDOMIZED CONTROLLED-TRIAL; ELDERLY-PATIENTS; PLUS THALIDOMIDE; PHASE-III; ORAL MELPHALAN; LENALIDOMIDE; THERAPY; DEXAMETHASONE; METAANALYSIS;

D O I：

10.1200/JCO.2013.52.0023

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose Bortezomib-melphalan-prednisone (VMP) has improved overall survival in multiple myeloma. This randomized trial compared VMP plus thalidomide (VMPT) induction followed by bortezomib-thalidomide maintenance (VMPT-VT) with VMP in patients with newly diagnosed multiple myeloma. Patients and Methods We randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT (nine 5-week cycles of VMPT followed by 2 years of VT maintenance) or VMP (nine 5-week cycles without maintenance). Results In the initial analysis with a median follow-up of 23 months, VMPT-VT improved complete response rate from 24% to 38% and 3-year progression-free-survival (PFS) from 41% to 56% compared with VMP. In this analysis, median follow-up was 54 months. The median PFS was significantly longer with VMPT-VT (35.3 months) than with VMP (24.8 months; hazard ratio [HR], 0.58; P < .001). The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group (HR, 0.52; P < .001). The 5-year overall survival (OS) was greater with VMPT-VT (61%) than with VMP (51%; HR, 0.70; P = .01). Survival from relapse was identical in both groups (HR, 0.92; P = .63). In the VMPT-VT group, the most frequent grade 3 to 4 adverse events included neutropenia (38%), thrombocytopenia (22%), peripheral neuropathy (11%), and cardiologic events (11%). All of these, except for thrombocytopenia, were significantly more frequent in the VMPT-VT patients. Conclusion Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation.

引用

页码：634 / +

页数：10

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