脂质体多柔比星单药治疗老年软组织肉瘤的安全性和有效性研究

Safety and efficacy of liposome doxorubicin in the treatment of soft tissue sarcoma in the elderly

目的探讨老年软组织肉瘤脂质体多柔比星单药化疗的安全性和有效性。方法回顾性分析解放军第九六〇医院2017年1月至2021年1月间所有接受术后辅助化疗的老年软组织肉瘤患者临床资料,按性别、年龄、肿瘤类型、发病部位、保肢情况、辅助化疗方案、化疗不良反应、无疾病生存时间、总生存时间分别进行统计,将所有患者分成脂质体多柔比星化疗组和多柔比星-异环磷酰胺联合化疗组,统计分析两组间患者化疗的安全性和临床有效性。结果23例患者中有20例(87.0%)老年软组织肉瘤患者纳入本研究,其中男13例(65.0%),女7例(35.0%),发病年龄为60~72岁,平均年龄66.0岁,所有患者病理类型均为高度恶性,未分化多形性肉瘤是最常见的病理类型。脂质体多柔比星单药化疗组7例患者,多柔比星--异环磷酰胺联合化疗组13例患者,对恶心、呕吐、白细胞降低等10项最常见的化疗不良反应进行了统计,参考美国国立癌症研究所不良事件通用术语标准(NCI CTCAE)4.0.3版标准,单药化疗组1~2级不良反应16人次,无3~5级不良反应发生,联合化疗组1~2级不良反应60人次,3级7人次,4级4人次,无5级不良反应发生。组间统计分析显示联合化疗组比单药化疗组需治疗的化疗并发症多,差异存在统计学意义(c2=8.811,P=0.003),化疗后白细胞最小值联合化疗组更低,差异存在统计学意义(F=6.605,P=0.019)。中位无疾病生存时间单药化疗组为12个月,联合化疗组为17个月,单药化疗组随访时间内未出现中位总生存时间,联合化疗组中位总生存时间为35个月,组间差异均无统计学意义。结论老年软组织肉瘤脂质体多柔比星单药化疗具有更好的安全性,与联合化疗具有相似的临床疗效。

Objective To investigate the safety and efficacy of liposomal doxorubicin monotherapy in elderly soft tissue sarcoma.Methods From January 2017 to January 2021,the clinical data of all elderly patients with soft tissue sarcoma who received surgical treatment and adjuvant chemotherapy in PLA 960th Hospital were retrospectively analyzed.The patients'gender,age,tumor type,site of disease,limb salvage,adjuvant chemotherapy regimen,adverse reaction of chemotherapy,disease-free survival time,and overall survival time were analyzed.All patients were divided into liposome doxorubicin chemotherapy group and doxorubicin and ifosfamide combined chemotherapy group.The safety and clinical effectiveness of chemotherapy between the two groups were statistically analyzed.Results Among the 23 patients,20(87.0%)elderly patients with soft tissue sarcoma were included in this study,including 13 males(65.0%)and 7 females(35.0%).The age of onset was 60-72 years old,with an average age of 66.0 years.The pathological types of all patients were highly malignant,and undifferentiated pleomorphic sarcoma was the most common pathological type.There were 7 patients in liposomal doxorubicin single drug chemotherapy group and 13 patients in doxorubicin ifosfamide combined chemotherapy group.The 10 most common adverse reactions of chemotherapy such as nausea,vomiting and leucopenia were counted.Referring to the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)version 4.0.3 standard,there were 16 times of grade 1-2 adverse reactions and no grade 3-5 adverse reactions in single drug chemotherapy group.There were 60 times of grade 1-2 adverse reactions,7 times of grade 3 adverse reactions and 4 times of grade 4 adverse reactions,and no grade 5 adverse reactions in combined chemotherapy group.Statistical analysis between groups showed that the combined chemotherapy group had more chemotherapy complications than the single drug chemotherapy group,and the difference was statistically significant(c2=8.811,P=0.003),the minimum value of leukocyte after chemotherapy was lower in the combined chemotherapy group,and the difference was statistically significant(F=6.605,P=0.019).The median PFS in the monotherapy group was 12 months.The median PFS in the combined chemotherapy group was 17 months,the median OS in the single drug chemotherapy group did not appear during the follow-up time,and the median OS in the combined chemotherapy group was 35 months.There was no difference between the groups.Conclusion Liposomal doxorubicin monotherapy has better safety and similar clinical efficacy to combined chemotherapy in elderly soft tissue sarcoma.