Superiority of tandem autologous transplantation over standard therapy for previously untreated multiple myeloma

Superiority of tandem autologous transplantation over standard therapy for previously untreated multiple myeloma
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DOI:
10.1182/blood.v89.3.789
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发表时间:
1997-02-01
期刊:
影响因子:
20.3
通讯作者:
Tricot, G
Tricot, G
中科院分区:
医学1区
文献类型:
--
作者:
Barlogie, B;Jagannath, S;Tricot, G

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在涉及标准治疗(ST)的多发性骨髓瘤(MM)临床试验的20多年中,几乎没有取得任何进展。最近的研究表明,需要造血干细胞支持的剂量强化导致更高的完全缓解(CR)率和延长的疾病控制。对123例未经治疗的症状性MM患者进行了“全面治疗”(TT),包括非交叉耐药诱导方案,随后进行双重自体移植(AT)程序。血液学恢复后,给予干扰素(IFN)维持治疗(每周三次皮下注射,每次300万单位[MU]/m2),直至疾病复发/进展。根据西南肿瘤组(SWOG)试验,将结果与接受ST治疗的未治疗患者的结局进行比较。从TT和1,123名患者中选择了116对配偶,以匹配主要预后特征。在所有123例患者中,TT诱导了40%的CR(意向治疗)。到12个月时,7%的人死亡,其中4%死于治疗相关并发症。中位随访时间为31个月,无事件生存期(EFS)和总生存期(OS)的中位持续时间分别为49和62+个月。染色体11 q和13的缺失与较差的预后相关,而诱导后6个月内的CR是EFS和OS的有利预后特征。与ST相比,TT诱导的PR率较高(85% v52%,P < .0001)(SWOG试验中CR率不可用)和延长的EFS(49 v22个月,P = .0001)和OS(62+ v48个月,P = .01)。与ST相比,双AT剂量强化可显着增强肿瘤细胞减少,不仅提高CR率,还显着延长既往未经治疗的MM患者的EFS和OS。(C)1997,美国血液学会。
Virtually no progress has been made during more than 2 decades of clinical trials for multiple myeloma (MM) involving standard therapy (ST). Recent studies suggest that dose intensification requiring hematopoietic stem cell support results in higher complete response (CR) rates and extended disease control. ''Total Therapy'' (TT) consisting of non-cross-resistant induction regimens, followed by a double autotransplant (AT) procedure, was administered to 123 untreated patients with symptomatic MM. Upon hematologic recovery, interferon (IFN) maintenance (3 million units [MU]/m(2) subcutaneously thrice weekly) was given until disease recurrence/progression. Results were compared with the outcome of untreated patients receiving ST according to Southwest Oncology Group (SWOG) trials. One hundred sixteen pair mates were selected from both TT and among 1,123 patients to match for the major prognostic features. TT induced CR in 40% of all 123 patients (intent-to-treat). By 12 months, 7% had died, including 4% from treatment-related complications. With a median follow-up of 31 months, median durations of event-free survival (EFS) and overall survival (OS) are 49 and 62+ months, respectively. Abnormalities of chromosomes 11q and 13 were associated with inferior outcome, whereas CR within 6 months after induction was a favorable prognostic feature for both EFS and OS. In comparison to ST, TT induced higher PR rates (85% v 52%, P < .0001) (CR rates not available on SWOG trials) and extended EFS (49 v 22 months, P = .0001) and OS (62+ v 48 months, P = .01). Compared to ST, dose intensification with double AT markedly augments tumor cytoreduction, effecting not only higher CR rates but also significantly extending EFS and OS in previously untreated patients with MM. (C) 1997 by The American Society of Hematology.