硼替佐米-马法兰-泼尼松-沙利度胺序贯治疗随后硼替佐米-沙利度胺维持治疗与硼替佐米-马法兰-泼尼松方案比较用于初治多发性骨髓瘤：更新随访结果和改善生存。
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.
机构信息
Antonio Palumbo, Sara Bringhen, Alessandra Larocca, Valeria Magarotto, Paola Omedé, Roberto Mina, Mario Boccadoro, and Giulia Benevolo, Azienda Ospedaliera (A.O.) Città della Salute e della Scienza di Torino; Daniela Gottardi, A.O. Ordine Mauriziano; Roberto Passera, San Giovanni Battista Hospital, University of Torino, Torino; Davide Rossi and Gianluca Gaidano, Amedeo Avogadro University of Eastern Piedmont, Novara; Francesco Di Raimondo, Ferrarotto Hospital, University of Catania, Catania; Francesca Patriarca, A.O. Universitaria, Udine; Anna Levi and Maria Teresa Petrucci, Sapienza University of Rome; Luca Franceschini, Tor Vergata University Hospital, Rome; Iolanda Donatella Vincelli, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria; Mariella Grasso, S. Croce e Carle Hospital, Cuneo; Renato Zambello, Università degli Studi di Padova, Padova; Vittorio Montefusco, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori Milano, University of Milano, Milan; Antonietta Pia Falcone, IRCCS Casa Sollievo della Sofferenza and Unità di Ematologia, San Giovanni Rotondo; Roberto Marasca, University of Modena, Modena; Fortunato Morabito, A.O. di Cosenza, Cosenza; Tommasina Guglielmelli, "S. Luigi Gonzaga" Hospital, Orbassano; Chiara Nozzoli, A.O. Universitaria Careggi, Firenze; Massimo Offidani, Ospedali Riuniti, Ancona; Roberto Ria, University of Bari "Aldo Moro" Medical School, Bari; Pellegrino Musto, IRCCS-Centro Regionale Oncologico Basilicata, Rionero in Vulture; and Michele Cavo, Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
出版信息
J Clin Oncol. 2014 Mar 1;32(7):634-40. doi: 10.1200/JCO.2013.52.0023. Epub 2014 Jan 21.
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.
目的
硼替佐米-美法仑-泼尼松（VMP）改善了多发性骨髓瘤患者的总生存。这项随机试验比较了新诊断多发性骨髓瘤患者接受硼替佐米-沙利度胺（VMPT）诱导后接受硼替佐米-沙利度胺维持（VMPT-VT）与 VMP 治疗。
患者和方法
我们随机分配了 511 名不符合移植条件的患者，接受 VMPT-VT（9 个 5 周周期的 VMPT 后进行 2 年的 VT 维持）或 VMP（9 个 5 周周期无维持）。
结果
在中位随访 23 个月的初始分析中，VMPT-VT 将完全缓解率从 24%提高到 38%，3 年无进展生存（PFS）从 41%提高到 56%，与 VMP 相比。在这项分析中，中位随访时间为 54 个月。VMPT-VT 的中位 PFS 明显长于 VMP（35.3 个月对 24.8 个月；风险比[HR]，0.58；P <.001）。VMPT-VT 组的下一次治疗时间为 46.6 个月，VMP 组为 27.8 个月（HR，0.52；P <.001）。VMPT-VT 组的 5 年总生存率（OS）为 61%，高于 VMP 组的 51%（HR，0.70；P =.01）。两组的复发后生存情况相同（HR，0.92；P =.63）。在 VMPT-VT 组中，最常见的 3 级至 4 级不良事件包括中性粒细胞减少症（38%）、血小板减少症（22%）、周围神经病（11%）和心血管事件（11%）。除了血小板减少症，这些不良事件在 VMPT-VT 患者中都更为常见。
结论
硼替佐米和沙利度胺显著改善了不适合移植的多发性骨髓瘤患者的 OS。
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