Long Term Follow-up Analysis of HD9601 Trial Comparing ABVD Vs Stanford V Vs MOPPABVCAD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma. A Study from the Intergruppo Italiano Linfomi (IIL)
Long Term Follow-up Analysis of HD9601 Trial Comparing ABVD Vs Stanford V Vs MOPPABVCAD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma. A Study from the Intergruppo Italiano Linfomi (IIL)
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HD9601 试验在新诊断的晚期霍奇金淋巴瘤患者中比较 ABVD、Stanford V 和 MOPPABVCAD 的长期随访分析。
DOI：
10.1182/blood.v112.11.2602.2602
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发表时间：
2008
期刊：
影响因子：
20.3
通讯作者：
M. Federico
中科院分区：
文献类型：
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作者：
T. Chisesi;M. Bellei;S. Luminari;L. Marcheselli;A. Levis;U. Vitolo;C. Stelitano;V. Pavone;F. Merli;M. Liberati;L. Baldini;R. Bordonaro;Emanuela A Pesce;P. Gobbi;M. Federico
目的：提供HD9601试验的长期随访结果，比较ABVD、MOPP-EBV-CAD(MEC)和Stanford V(STV)方案对晚期霍奇金淋巴瘤(HL)患者的初始治疗效果。方法：IIB-III或IV期患者可以在ABVD、MEC和STV的6个周期中随机进行治疗；治疗必须在肿大或慢反应部位进行可选的累及野放疗。就长期而言，后续分析研究数据库用最新的后续数据和关于长期毒性的信息进行了更新。结果：1996至2000年间，355名患者登记进入试验，并被随机分配到三组中的一组(ABVD122例，MEC106例，STV107例)。放疗有效率分别为62%、47%和66%。如前所述，治疗方案结束时，3个支队的有效率分别为%、94%和76%。初步结果于2005年公布，中位数为61个月。目前分析的中位随访期为86个月。与之前的数据相比，我们观察到2例额外的复发，均为STV ARM。此外，我们观察到，在最初治疗后获得完全缓解的患者中，又有7人死亡。总体而言，20名患者在获得CR后死亡，与我们之前的报告相比，增加了7起事件(Gobbi等人。JCO 2007)。通过研究ARM总体分析数据，我们观察到随机分为ABVD、MEC和STV的CR患者中分别有4例(+3)、11例(+3)和5例(+1)死亡。对先前报告的CR中的其他死亡进行了进一步分析，这些死亡是由肺栓塞(3例：2例ABVD，1例MEC)、败血症(2例：1例MEC，1例STV)、LMA(1例MEC)和第二癌NOS(1例ABVD)引起的。没有记录到其他重大的长期毒性事件。长期分析结果显示，ABVD、MEC和STV的8年生存率分别为88%、84%和77%，不同研究组之间差异无统计学意义(P=0.337)。结论：对HD9601试验的长期分析证实了初步分析的结果。几乎没有观察到的额外事件主要表现为CR患者的死亡，但这些事件并没有实质性地改变三组患者的存活率。
PURPOSE: To provide long term follow-up results of HD9601 trial that compared ABVD vs MOPP-EBV-CAD (MEC) vs Stanford V (StV) regimens for the initial treatment of patients with advanced stage Hodgkin Lymphoma (HL) PATIENTS AND Methods: Patients with stage IIB–III or IV were eligible for randomization among 6 cycles of ABVD, 6 cycles of MEC and 12 weeks of StV; treatment had to be consolidated with optional Involved Field radiotherapy on Bulky or slow responding sites. For the long term, follow-up analysis study database was updated with most recent follow-up data and with information on long-term toxicity. Results: Between 1996 and 2000, 355 patients were registered into the trial and were randomly assigned to one of the three arms (ABVD 122 pts, MEC 106 pts, and StV 107 pts). Radiotherapy was administered to 62%, 47%, and 66% of cases in the 3 arms respectively. As previously described response rates at the end of treatment program were 89%, 94%, and 76% in the 3 arms, respectively. Initial results were published in 2005 with a median f-up of 61 months. Median follow-up of current analysis is 86 months. Compared with previous data we observed 2 additional relapses, both in StV arm. Moreover, we observed 7 additional deaths in patients who had achieved a CR after initial treatment. Overall, 20 patients died after achievement of CR with 7 additional events compared with our previous report (Gobbi et al. JCO 2007). Overall analyzing data by study arm we observed 4 (+3), 11 (+3), and 5 (+1) deaths in CR patients randomized toABVD, MEC, and StV, respectively. Additional deaths in CR from previous report were further analyzed and were caused by pulmonary embolism (3 cases: 2 ABVD, 1 MEC), sepsis (2 cases: 1 MEC, 1 StV), LMA (1 MEC), and second cancer NOS (1 ABVD). No additional significant longterm toxic event was recorded. Long-term analysis resulted in 8-yr OS of 88%, 84%, and 77% for ABVD, MEC, and StV, respectively without differences among study arms (P=0.337). Conclusions: The long-term analysis of HD9601 trial confirmed the results of the initial analysis. Few additional events observed were mostly represented by deaths in CR patients but these events did not substantially modify survival rates of the three arms.