聚乙二醇化脂质体多柔比星、顺铂与异环磷酰胺的联合化疗对Ⅱ期肢体骨肉瘤的疗效和安全性分析

Efficacy and safety of pegylated liposomal doxorubicin,cisplatin and ifosfamide in the combined chemotherapy treatment of stageⅡextremity osteosarcoma

目的探讨聚乙二醇化脂质体多柔比星(pegylated liposomal doxorubicin,PLD)、顺铂与异环磷酰胺的联合化疗对Ⅱ期肢体骨肉瘤的疗效和安全性。方法选择2016年1月至2018年12月于中国人民解放军空军军医大学第二附属医院行新辅助化疗联合手术、辅助化疗的92例Ⅱ期肢体骨肉瘤患者为研究对象,采用随机数字表法将入选患者分为观察组(PLD+顺铂+异环磷酰胺,46例)和对照组(多柔比星+顺铂+异环磷酰胺,46例)。比较两组患者的近期疗效、远期疗效和安全性。结果观察组患者新辅助化疗后的客观缓解率、疾病控制率、肿瘤组织反应良好率均显著高于对照组(均P<0.05)。两组患者的不良反应以胃肠道反应和骨髓抑制最为常见,予对症处理后均有所好转或痊愈,观察组患者的胃肠道反应、白细胞减少的发生率均显著低于对照组(均P<0.05),两组患者血红蛋白减少、血小板减少、肝功能损害、口腔黏膜炎、心脏毒性、脱发的发生率比较差异均无统计学意义(均P>0.05)。全部患者均进行定期随访,中位随访时间为48.3个月(5~69个月),随访期间共有10例患者死亡。两组患者的复发率、转移率、总生存率、中位无进展生存时间和总生存时间比较差异均无统计学意义(均P>0.05)。结论PLD+顺铂+异环磷酰胺对Ⅱ期肢体骨肉瘤患者的新辅助化疗的疗效与安全性优于多柔比星+顺铂+异环磷酰胺,而二者的远期疗效接近。

Objective To investigate the efficacy and safety of pegylated liposomal doxorubicin(PLD),cisplatin and ifosfamide in the combined chemotherapy treatment of stageⅡextremity osteosarcoma.Method Ninety-two patients with stageⅡextremity osteosarcoma who underwent neoadjuvant combined chemotherapy in the Second Affiliated Hospital of Air Force Military Medical University of the People's Liberation Army from January 2016 to December 2018 were randomly divided into observation group(PLD+cisplatin+ifosfamide,46 cases)and control group(doxorubicin+cisplatin+ifosfamide,46 cases).The short-term and long-term therapeutic effects and safety between the two groups were compared.Result The objective response rate,disease control rate and good response rate of tumor tissue in observation group were significantly higher than those in control group(all P<0.05).In terms of safety,gastrointestinal reaction and bone marrow suppression were the most common adverse reactions in the two groups,which were improved or cured after symptomatic treatment.The incidences of gastrointestinal reaction and leukaemia in observation group were significantly lower than those in control group(all P<0.05).There were no significant differences the incidences of hemoglobin reduction,thrombocytopenia,liver function damage,oral mucositis,cardiotoxicity and hair loss between the two groups(all P>0.05).All patients were followed up regularly,and the median follow-up time was 48.3 months(5~69 months).A total of 10 patients died during the follow-up period.There were no significant differences in recurrence rate,metastasis rate,overall survival rate,median progression free survival and overall survival between the two groups(P>0.05).Conclusion The efficacy and safety of PLD+cisplatin+ifosfamide in neoadjuvant chemotherapy for patients with stageⅡextremity osteosarcoma were better than doxorubicin+cisplatin+ifosfamide,but their long-term efficacy is close.