含聚乙二醇脂质体多柔比星的CHOP样方案治疗初治老年晚期弥漫大B 细胞淋巴瘤的Ⅱ期临床研究*

目的：评价含聚乙二醇脂质体多柔比星（PLD ）的CHOP 样方案治疗初治老年晚期弥漫大B 淋巴瘤（DLBCL）的疗效和安全性。方法：2011年11月至2014年3 月共入组30例患者，中位年龄70（63～80）岁，24例（80.0%）国际预后指数≥3 分；21例联合应用利妥昔单抗。进行前瞻性II 期临床研究，以含PLD 的CHOP 样方案治疗初治老年晚期DLBCL。PLD 剂量为30mg/m2，环磷酰胺、长春新碱和强的松采用标准CHOP 方案中的剂量。CD20阳性的患者可联合利妥昔单抗，计划完成6 个周期。结果：客观缓解率为86.7% ，其中完全缓解率为66.7% 。中位随访20.1（0.7～38.5）个月，18个月总生存率及无进展生存率分别为 82.4% 及70.1% 。主要不良反应为中性粒细胞减少。24例（80.0%）发生3～4 级中性粒细胞减少。研究中患者左室射血分数及血清肌钙蛋白T 无显著变化。4 例（13.3%）在PLD 输注后新发无症状性心电图异常。结论：含PLD 的CHOP 样方案是治疗初治老年晚期DLB-CL患者毒性可接受的备选方案，缓解率较高，心脏安全性较好。

Pegylated liposomal doxorubicin in CHOP regimen for untreated elderly patients with advanced diffuse large B-cell lymphoma: results from a prospective phase II study

Objective:To evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in CHOP regimen for un -treated elderly patients with advanced diffuse large B-cell lymphoma (DLBCL). Methods:In a prospective phase II study, we analyzed the feasibility of PLD-modified CHOP regimen in elderly patients with advanced stages of DLBCL. PLD was administered at 30mg/m2 in combination with cyclophosphamide, vincristine, and prednisone at standard doses every 21d for six cycles. CD20positive patients were given option for rituximab treatment. Results: From November 2011 to March 2014, 30patients with a median age of70years range: 63to 80) were enrolled in this study. Up to 24cases ( 80.0%) obtained an International Prognostic Index of ≥3. The overall re-sponse rate was 86.7%, and the complete remission rate was 66.7%. With a median follow-up of20.1 months, the 18-month overall and progression-free survival rates were 82.4% and70.1%, respectively. The main toxicity was neutropenia, reaching grades3 to 4 in the 24 cases ( 80.0%). No significant changes existed in patients' left ventricular ejection fraction and serum troponin-T during the study. Four patients ( 13.3%) showed asymptomatic abnormal changes in electrocardiogram after PLD infusion. Conclusion: CHOP regimen with PLD is an effective alternative for the treatment of DLBCL in elderly patients, exhibiting an acceptable toxicity.