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Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplant for Patients with Multiple Myeloma: Long-Term Follow-Up Results from the Blood and Marrow Transplant Clinical Trials Network 0102 Trial.
Biology of Blood and Marrow Transplantation ( IF 5.609 ) Pub Date : 2019-11-19 , DOI: 10.1016/j.bbmt.2019.11.018
Sergio Giralt 1 , Luciano J Costa 2 , David Maloney 3 , Amrita Krishnan 4 , Mingwei Fei 5 , Joseph H Antin 6 , Claudio Brunstein 7 , Nancy Geller 8 , Stacey Goodman 9 , Parameswaran Hari 5 , Brent Logan 10 , Robert Lowsky 11 , Muzaffar H Qazilbash 12 , Firoozeh Sahebi 4 , George Somlo 4 , Scott Rowley 13 , Dan T Vogl 14 , David H Vesole 15 , Marcelo Pasquini 5 , Edward Stadtmauer 14
Affiliation  

Allogeneic hematopoietic cell transplant (HCT) may improve long-term multiple myeloma (MM) control through the graft-versus-myeloma effect. The Blood and Marrow Transplant Clinical Trials Network 0102 trial was a biologic assignment trial comparing tandem autologous transplant (auto-auto) versus autologous followed by reduced-intensity allogeneic (auto-allo) transplant in patients with newly diagnosed MM with standard-risk (n = 625) or high-risk (n = 85; β2-microglobulin at diagnosis ≥ 4 mg/dL or deletion of chromosome 13 by conventional karyotyping) disease. Although the initial 3-year analysis showed no difference in progression-free survival (PFS) between arms in either risk group, we hypothesized that long-term follow-up may better capture the impact of the graft-versus-myeloma effect. Median follow-up of survivors was over 10 years. Among standard-risk patients there was no difference in PFS (hazard ratio [HR], 1.11; 95% confidence interval [CI], .93 to 1.35; P = .25) or OS (HR, 1.03; 95% CI, .82 to 1.28; P = .82). The 6-year PFS was 25% in the auto-auto arm versus 22% in the auto-allo arm (P = .32), and 6-year overall survival (OS) was 60% and 59%, respectively (P = .85). In the high-risk group, although there was no statistically significant difference in PFS (HR, .66; 95% CI, .41 to 1.07; P = .07) and OS (HR, 1.01; 95% CI, .60 to 1.71; P = .96), a reduction in 6-year risk of relapse of 77% versus 47% (P = .005) was reflected in better PFS of 13% versus 31% (P = .05) but similar OS, at 47% versus 51% (P = .69). Allogeneic HCT can lead to long-term disease control in patients with high-risk MM and needs to be explored in the context of modern therapy.

中文翻译:

多发性骨髓瘤患者的串联自体-自体与异体造血干细胞移植:血液和骨髓移植临床试验网络0102试验的长期随访结果。

同种异体造血细胞移植(HCT)可能通过移植物抗骨髓瘤的作用改善长期多发性骨髓瘤(MM)的控制。血液和骨髓移植临床试验网络0102试验是一项生物学研究,比较了新诊断为标准风险(MM)的MM患者的串联自体移植(auto-auto)与自体移植随后进行强度降低的同种异体(auto-allo)移植。 = 625)或高危(n = 85;诊断为≥4 mg / dL或通过常规核型分析缺失13号染色体的β2-微球蛋白)疾病。尽管最初的3年分析显示,在任一风险组中,两组之间的无进展生存期(PFS)均无差异,但我们假设,长期随访可能更好地捕捉了移植物抗骨髓瘤效应的影响。幸存者的中位随访时间超过10年。在标准风险患者中,PFS(危险比[HR]为1.11; 95%置信区间[CI]为0.93至1.35; P = .25)或OS(HR为1.03; 95%CI为0.23)没有差异。 82至1.28; P = 0.82)。自动臂的6年PFS为25%,而自动臂的6年PFS为22%(P = .32),6年总生存率(OS)分别为60%和59%(P = .85)。在高风险组中,尽管PFS(HR,.66; 95%CI,.41至1.07; P = .07)和OS(HR,1.01; 95%CI,.60至0.96)差异无统计学意义。 1.71; P = 0.96),六年复发风险降低77%比47%(P = .005)反映为PFS更好,分别为13%和31%(P = .05),但OS相似,分别为47%和51%(P = 0.69)。异基因HCT可以导致高危MM患者的长期疾病控制,需要在现代治疗的背景下进行研究。
更新日期:2019-11-19
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