[Effectiveness and safety of polyethylene glycol liposome doxorubicin in the treatment of osteosarcoma].

Objective: To evaluate the efficacy and safety of polyethylene glycol liposome doxorubicin (PLD) in the treatment of osteosarcoma. Methods: This study was a single-center retrospective clinical study. Two hundreds and seventy-six classical osteosarcoma treated in Beijing Jishuitan Hospital from 2015 to 2016 were enrolled. There were 213 patients who received combined chemotherapy of high dose methotrexate, ifosfamide, cisplatin and doxorubicin (ADM) were classified in ADM group. Other 63 patients received the same types, doses and cycles of chemotherapy drugs except ADM replaced by PLD were identified as PLD group. Clinical and imaging evaluation and surgical treatment were performed after neoadjuvant chemotherapy. Tumor necrosis rate was examined according to Huvos method. The efficacy of neoadjuvant chemotherapy was evaluated based on 90% necrosis rate. The recurrence, metastasis and survival were followed up regularly after operation. The adverse reactions of hematology, hepatorenal toxicity, gastrointestinal reaction and cardiotoxicity were evaluated. Results: There were no significant differences between PLD group and ADM group in age, sex, location, stage and surgical margin (all P>0.05). There were no significant differences in clinical symptoms and imaging evaluation between PLD group and ADM group after preoperative chemotherapy (all P>0.05). The tumor necrosis rate was detected in 134 cases. Among 27 cases of PLD group, tumor necrosis rates more than 90% were 11 cases, while among 107 cases of ADM group, tumor necrosis rates more than 90% were 45 cases. No significant difference of tumor necrosis rate between this two group was observed (P=0.901). The recurrence rates of PLD group and ADM group were 7.8% (4/51) and 7.3% (12/164), the metastasis rates were 19.6% (10/51) and 16.5% (27/164), the median progression free survival (PFS) were 42 and 37 months, respectively, without significant differences (all P>0.05). The incidence of granulocytopenia and decrease degree of granulocytes in PLD group were significantly lower than those in ADM group (P<0.001). There were no significant differences in the incidences of thrombocytopenia, anemia, gastrointestinal reaction, liver function damage and stomatitis between two groups (all P>0.05). Conclusions: PLD and ADM have similar chemotherapeutic effects in osteosarcoma. The incidences of adverse reactions of PLD are lower, especially the hematological toxicity represented by granulocytopenia is significantly reduced. PLD has a better application prospect.目的： 评价聚乙二醇化脂质体多柔比星(PLD)在骨肉瘤化疗中的有效性和安全性。 方法： 采用单中心回顾性研究方法。选取2015—2016年在北京积水潭医院接受治疗的经典型骨肉瘤患者276例，其中使用大剂量甲氨蝶呤、异环磷酰胺、顺铂和多柔比星(ADM)联合化疗的213例患者为ADM组，其他63例患者的化疗方案中除PLD替代ADM外，化疗药物、剂量强度和化疗周期均相同，为PLD组。新辅助化疗后进行临床和影像学评价，并行手术治疗。采用Huvos评级系统评估肿瘤坏死率，以坏死率90%为标准评估新辅助化疗疗效。术后定期随访患者的肿瘤复发、转移和生存情况。评价患者化疗后的血液学、肝肾毒性、胃肠道反应、心脏毒性等不良反应。 结果： PLD组和ADM组的患者年龄、性别、肿瘤部位、肿瘤分期和外科边界等差异无统计学意义(均P>0.05)。术前新辅助化疗后PLD组和ADM组的临床症状和影像学评价结果差异无统计学意义(均P>0.05)。134例行肿瘤坏死率检测。PLD组27例中，肿瘤坏死率>90% 11例；ADM组107例中，肿瘤坏死率>90% 45例，两组差异无统计学意义(P＝0.901)。PLD组和ADM组复发率分别为7.8%(4/51)和7.3%(12/164)，转移率分别为19.6%(10/51)和16.5%(27/164)，中位无进展生存时间分别为42和37个月，差异均无统计学意义(均P>0.05)。PLD组患者粒细胞减少发生率和粒细胞降低程度均低于ADM组(均P<0.001)，两组血小板减少、贫血、胃肠道反应、肝功能损害和口腔炎等发生率差异无统计学意义(均P>0.05)。 结论： PLD与ADM在骨肉瘤中的化疗效果相似，PLD的化疗不良反应发生率相对较低，尤其是以粒细胞减少为代表的血液学毒性明显减轻，具有良好的应用前景。.