With currently available combination chemotherapy regimens, the outcome of the patients newly diagnosed with aggressive non-Hodgkin's lymphoma (NHL) identified as 'high' and 'high-intermediate' risk groups according to the international prognostic index (IPI) is still unsatisfactory and a more innovative therapy is urgently required to improve the survival of the patients. The purpose of this study was to compare the efficacy of rituximab given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) and ESHAP (etoposide, methylprednisolone, high-dose Ara-C, cisplatin) vs CHOP-ESHAP and upfront high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) vs standard CHOP in patients aged < or = 65 years old newly diagnosed with 'high' and 'high-intermediate' risk aggressive lymphoma enrolled onto two consecutive treatment trials at the institute. Between May 1995 - July 2002, 84 patients, aged 15 - 65 years old, with newly diagnosed aggressive NHL and an age-adjusted IPI of 2 or 3 were enrolled. The median age of the patients was 38 years (range 15 - 65). The baseline demographic features, in particular the major prognostic variables, were similar between the treatment groups. Patients treated with rituximab-CHOP-ESHAP received eight cycles of rituximab (375 mg m(-2) on day 1 of cycles 1 - 6 and days 21 and 28 of cycle 7) plus CHOP (day 3 of cycles 1, 3 and 5) and ESHAP (day 3 of cycles 2, 4 and 6 and day 1 of cycle 7) at 21-day intervals. Patients enrolled onto the CHOP-ESHAP-HDT arm (n = 23) were treated with three courses of CHOP and then switched to two or four cycles of ESHAP followed by HDT. Patients treated with CHOP alone (n = 25) were treated with the standard eight cycles of CHOP. The rate of complete remission was significantly improved with rituximab-CHOP-ESHAP compared with either CHOP-ESHAP-HDT or CHOP alone (67% compared with 44% and 36%, respectively; p = 0.043). With a median follow-up time of 53 months, the 5-year overall survival (OS) was improved by the addition of rituximab-61% with rituximab-CHOP-ESHAP, compared with 43% for CHOP-ESHAP-HDT and 24% for CHOP alone (p = 0.088). Significant increases in failure-free survival (FFS) and disease-free survival (DFS) (61% and 96%), compared with CHOP-ESHAP-HDT (34% and 90%) and CHOP (16% and 44%; p = 0.002 and p < 0.001, respectively) were observed. Compared to CHOP, rituximab-CHOP-ESHAP yielded significantly superior OS (p = 0.014), FFS (p < 0.001) and DFS (p < 0.001). The survivals, however, were not significantly different from patients treated with CHOP-ESHAP-HDT. It is concluded that rituximab-ESHAP-CHOP is superior over standard CHOP and fares comparably to upfront HDT/ASCT in previously untreated patients with aggressive lymphoma. A prospective randomized controlled trial is warranted to confirm these results.

译文

:在目前可用的联合化疗方案下,根据国际预后指标(IPI)刚被诊断为侵袭性非霍奇金淋巴瘤(NHL)的患者的预后仍然不尽人意,并且迫切需要一种更具创新性的疗法来提高患者的生存率。这项研究的目的是比较利妥昔单抗与CHOP(环磷酰胺,阿霉素,长春新碱,泼尼松)和ESHAP(依托泊苷,甲基强的松龙,大剂量Ara-C,顺铂)联合使用时与CHOP-ESHAP和先期高在该研究所进行的两项连续治疗试验中,对新诊断为“高”和“高中度”风险性侵袭性淋巴瘤的年龄≤65岁的患者进行剂量治疗(HDT)和自体干细胞移植(ASCT)与标准CHOP对照。在1995年5月至2002年7月之间,纳入了84例年龄在15至65岁之间,新诊断为侵袭性NHL且年龄校正后的IPI为2或3的患者。患者的中位年龄为38岁(范围15-65)。治疗组之间的基线人口统计学特征,尤其是主要的预后变量相似。接受利妥昔单抗-CHOP-ESHAP治疗的患者接受了八个周期的利妥昔单抗(第1-6周期的第1天以及第7周期的第21和28天)(375 mg m(-2))加CHOP(第1、3和5周期的第3天) )和ESHAP(周期2、4和6的第3天和周期7的第1天),间隔为21天。入组CHOP-ESHAP-HDT组(n = 23)的患者接受了三个疗程的CHOP治疗,然后切换到ESSHAP的两个或四个周期,然后进行HDT。单独接受CHOP治疗的患者(n = 25)接受了标准的八个CHOP周期治疗。与单独使用CHOP-ESHAP-HDT或CHOP相比,利妥昔单抗-CHOP-ESHAP的完全缓解率显着提高(分别为67%,44%和36%; p = 0.043)。中位随访时间为53个月,利妥昔单抗-CHOP-ESHAP加利妥昔单抗-61%改善了5年总生存(OS),相比之下,CHOP-ESHAP-HDT和43%改善了5年总生存率仅适用于CHOP(p = 0.088)。与CHOP-ESHAP-HDT(34%和90%)和CHOP(16%和44%)相比,无失败生存率(FFS)和无病生存率(DFS)显着增加(61%和96%);分别观察到= 0.002和p​​ <0.001)。与CHOP相比,利妥昔单抗-CHOP-ESHAP产生显着优越的OS(p = 0.014),FFS(p <0.001)和DFS(p <0.001)。但是,其存活率与用CHOP-ESHAP-HDT治疗的患者无明显差异。结论是,对于以前未经治疗的侵袭性淋巴瘤患者,利妥昔单抗-ESHAP-CHOP优于标准CHOP,且其费用可与前期HDT / ASCT相提并论。必须进行前瞻性随机对照试验来证实这些结果。

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