R-CHOP with iodine-131 tositumomab consolidation for advanced stage diffuse large B-cell lymphoma (DLBCL): SWOG S0433.
R-CHOP with iodine-131 tositumomab consolidation for advanced stage diffuse large B-cell lymphoma (DLBCL): SWOG S0433.
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DOI：
10.1111/bjh.12906
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发表时间：
2014-08
影响因子：
6.5
通讯作者：
Fisher RI
中科院分区：
文献类型：
--
作者：
Friedberg JW;Unger JM;Burack WR;Gopal AK;Raju RN;Nademanee AP;Kaminski MS;Li H;Press OW;Miller TP;Fisher RI
放射标记的anti -20抗体在复发的弥漫性大b细胞淋巴瘤（DLBCL）中显示出单药活性。S0433临床试验招募了新诊断、晚期或大体积II期、组织学证实的DLBCL患者。患者接受6个周期的R-CHOP（利妥昔单抗、环磷酰胺、阿霉素、长春新碱、强的松），2个周期的CHOP，然后在化疗完成后30-60天进行碘-131托西单抗放射免疫巩固治疗。主要终点为两年无进展生存期（PFS）。84名符合条件的患者入组，56名患者完成了整个方案治疗过程。在84例可评估治疗反应的患者中，72例（86%，95%置信区间[CI]: 76%-92%）对治疗达到部分缓解（n=21）或确诊（n=41）或未确诊（n=10）完全缓解。中位随访时间为3.9年，2年PFS估计为69%，2年总生存率估计为77%。放射免疫治疗时的利妥昔单抗水平与毒性或结果无关。20%的患者免疫组化表现为双重打击特征（MYC+; BCL2+），预后较差。这些目前的结果表明，在治疗早期联合使用新药物可能最终对DLBCL产生更大的影响，因为CHOP化疗期间的早期进展、死亡和表现状态下降限制了最终从放射免疫治疗巩固中受益的患者数量。
Radiolabelled antiCD-20 antibodies have demonstrated single agent activity in relapsed diffuse large B-cell lymphoma (DLBCL). The S0433 clinical trial enrolled patients with newly diagnosed, advanced stage or bulky stage II, histologically confirmed DLBCL. Patients received six cycles of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), two cycles of CHOP, then iodine-131 tositumomab radioimmunotherapy consolidation 30–60 days after completion of chemotherapy. The primary endpoint was two-year progression-free survival (PFS). Eighty-four eligible patients were enrolled, and 56 patients completed the entire course of protocol treatment. Of the 84 patients evaluable for treatment response, 72 (86%, 95% confidence interval [CI]: 76%–92%) achieved a partial response (n=21) or a confirmed (n=41) or unconfirmed (n=10) complete response to therapy. With a median follow-up of 3.9 years, the 2-year PFS estimate is 69% and the 2-year overall survival estimate is 77%. Rituximab levels at time of radioimmunotherapy did not correlate with toxicity or outcome. Twenty percent of patients had double hit features (MYC+; BCL2+) by immunohistochemistry, and had inferior outcome. These current results suggest that the incorporation of novel agents earlier in therapy may ultimately have greater impact in DLBCL, as early progressions, deaths and declining performance status during CHOP chemotherapy limited the number of patients who ultimately could benefit from radioimmunotherapy consolidation.
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