Salvage Regimens With Autologous Transplantation for Relapsed Large B-Cell Lymphoma in the Rituximab Era
Salvage Regimens With Autologous Transplantation for Relapsed Large B-Cell Lymphoma in the Rituximab Era
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DOI：
10.1200/jco.2010.28.1618
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发表时间：
2010-09-20
影响因子：
45.3
通讯作者：
Schmitz, Norbert
中科院分区：
文献类型：
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作者：
Gisselbrecht, Christian;Glass, Bertram;Schmitz, Norbert
目的 挽救性化疗后进行高剂量治疗和自体干细胞移植 (ASCT) 是复发性弥漫性大 B 细胞淋巴瘤 (DLBCL) 的标准治疗方法。挽救方案从未被比较过；患者和方法首次复发的 CD20(+) DLBCL 患者或一线治疗后难治的患者被随机分配至利妥昔单抗、异环磷酰胺、依托泊苷和卡铂 (R-ICE) 组或利妥昔单抗、地塞米松、大剂量阿糖胞苷和顺铂 (R-DHAP) 组。有反应的患者接受了高剂量化疗和 ASCT。 结果 纳入的 396 名患者（R-ICE，n = 202；R-DHAP，n = 194）的中位年龄为 55 岁。三个周期的 R-ICE（63.5%；95% CI，56% 至 70%）和 R-DHAP（62.8%；95 CI，55% 至 69%）后观察到类似的反应率。影响缓解率的因素 (P < .001) 为诊断后 12 个月内难治性疾病/复发与超过 12 个月（分别为 46% vs 88%）、国际预后指数 (IPI) 大于 1 vs 0 至 1（分别为 52% vs 71%）、既往接受过利妥昔单抗治疗与未接受过利妥昔单抗治疗（分别为 51% vs 83%）。 R-ICE 和 R-DHAP 之间的 3 年无事件生存期 (EFS) 或总生存期没有显着差异。三年 EFS 受到既往利妥昔单抗治疗与未接受利妥昔单抗治疗的影响（分别为 21% 和 47%）、诊断后 12 个月以内和超过 12 个月的复发（分别为 20% 和 45%）以及 IPI 为 2 至 3 与 0 至 1（分别为 18% 和 40%）。在 Cox 模型中，这些参数显着 (P < .001)。 结论 对于诊断后 12 个月以上复发的患者，先前的利妥昔单抗治疗不会影响 EFS。含利妥昔单抗一线治疗后早期复发的患者预后较差，R-ICE 和 R-DHAP 的效果无差异。
Purpose Salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation (ASCT) is the standard treatment for relapsed diffuse large B-cell lymphoma (DLBCL). Salvage regimens have never been compared; their efficacy in the rituximab era is unknown.Patients and Methods Patients with CD20(+) DLBCL in first relapse or who were refractory after first-line therapy were randomly assigned to either rituximab, ifosfamide, etoposide, and carboplatin (R-ICE) or rituximab, dexamethasone, high-dose cytarabine, and cisplatin (R-DHAP). Responding patients received high-dose chemotherapy and ASCT.Results The median age of the 396 patients enrolled (R-ICE, n = 202; R-DHAP, n = 194) was 55 years. Similar response rates were observed after three cycles of R-ICE (63.5%; 95% CI, 56% to 70%) and R-DHAP (62.8%; 95 CI, 55% to 69%). Factors affecting response rates (P < .001) were refractory disease/relapse less than versus more than 12 months after diagnosis (46% v 88%, respectively), International Prognostic Index (IPI) of more than 1 versus 0 to 1 (52% v 71%, respectively), and prior rituximab treatment versus no prior rituximab (51% v 83%, respectively). There was no significant difference between R-ICE and R-DHAP for 3-year event-free survival (EFS) or overall survival. Three-year EFS was affected by prior rituximab treatment versus no rituximab (21% v 47%, respectively), relapse less than versus more than 12 months after diagnosis (20% v 45%, respectively), and IPI of 2 to 3 versus 0 to 1 (18% v 40%, respectively). In the Cox model, these parameters were significant (P < .001).Conclusion In patients who experience relapse more than 12 months after diagnosis, prior rituximab treatment does not affect EFS. Patients with early relapses after rituximab-containing first-line therapy have a poor prognosis, with no difference between the effects of R-ICE and R-DHAP.