Efficacy analysis of pegylated liposomal doxorubicin and dacarbazine for the treatment of leiomyosarcoma

ZHANG Lu; FAN Zheng-fu; BAI Chu-jie; XUE Rui-feng; LI Shu; GAO Tian; WANG Xin-yu; TAN Zhi-chao; TAN Xue-yi; LIU Jia-yong

doi:10.3969/j.issn.2095-252X.2025.11.003

Abstract：Objective To explore the efficacy and safety of pegylated liposome doxorubicin and dacarbazine for the treatment of leiomyosarcoma.Methods A retrospective analysis was conducted on patients with leiomyosarcoma who underwent pegylated liposomal doxorubicin and dacarbazine chemotherapy in the Department of Orthopedic Oncology at Peking University Cancer Hospital from August 2019 to July 2024.The clinical data of the patients were collected,and the overall survival(OS),progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),prognostic factors,and adverse reactions were analyzed.Results A total of 116 patients were enrolled.The mean follow-up period was 13 months.Disease progression occurred in 43 patients(37.1%),and 15 patients(12.9%)died.There were 20 males and 96 females,with a male-to-female ratio of 5:24.The average age was 53.There were 42 cases in the adjuvant chemotherapy group and 74 cases in the local advanced/distant metastatic chemotherapy group.The median OS for all patients was 48 months(range:44-52 months),and the median OS was not reached in the postoperative adjuvant chemotherapy and local advanced/distant metastatic chemotherapy groups.The median PFS for all patients was 18 months(range:10-26 months),not reached in the adjuvant chemotherapy group and 13 months(range:9-17 months)in the locally advanced/distant metastatic chemotherapy group.Data on tumor changes were available for 55 patients in the locally advanced/distant metastatic chemotherapy group,including 11 patients with partial response(PR)(20.0%),34 patients with stable disease(SD)(61.8%),10 patients with progressive disease(PD)(18.2%),an ORR of 20.0%,and a DCR of 81.8%.Univariate analysis revealed that the number of chemotherapy cycles was a risk factor for OS in the local advanced/distant metastasis group,and the median OS in the group with chemotherapy cycles>4(not reached)was longer than that in the group with chemotherapy cycles≤4(39 months)(P<0.05).Other factors showed no significant differences in OS and PFS among all groups(P≥0.05).No cardiac injury was observed in all patients.Other adverse reactions included liver injury in 7 cases(6.0%),nausea and vomiting in 6 cases(5.2%),neutropenia in 3 cases(2.6%),and anemia in 2 cases(1.7%).Conclusions The combination of pegylated liposome doxorubicin and dacarbazine in the treatment of leiomyosarcoma exhibits comparable efficacy,enhanced safety,and a lower incidence of myocardial damage compared to traditional regimens.Future studies with larger sample sizes and multi-center clinical trials are required to formulate more optimized treatment strategies for patients with leiomyosarcoma.