Phase I study of pegylated liposomal doxorubicin and cisplatin in patients with advanced osteosarcoma

医学 中性粒细胞减少症 阿霉素 白细胞减少症 口炎 胃肠病学 内科学 不利影响 白细胞减少症 毒性 顺铂 养生 化疗 药理学 外科
作者
Xin Wen,Qiuzhong Pan,Bu-Shu Xu,Wei Xiao,Desheng Weng,Jingjing Zhao,Huiling Xu,Zhen Huang,Xiaohui Niu,Xing Zhang
出处
期刊:Cancer Chemotherapy and Pharmacology [Springer Nature]
卷期号:89 (2): 209-215 被引量:9
标识
DOI:10.1007/s00280-021-04371-6
摘要

The repeated use of doxorubicin is limited due to dose-limiting cardiac toxicity. Pegylated liposomal doxorubicin (PEG-LD, Duomeisu) has a reduced cardiac toxicity. This phase I study aimed to investigate the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of the PEG-LD and cisplatin combination in patients with metastatic and recurrent osteosarcoma.Patients were given PEG-LD at a dose of 40, 50, or 60 mg/m2 on day 1 of each 21-day cycle, according to a 3 + 3 approach for dose escalation. Cisplatin was administered as a fixed dose of 100 mg/m2 for every cycle. Toxicities and tumor response were observed.A total of 15 patients were enrolled in this trial, and nine of the patients had received prior doxorubicin. The MTD of PEG-LD was reached at 50 mg/m2 in this regimen, with neutropenic fever and stomatitis as DTLs. The main adverse event (AE) was myelosuppression. The most common non-hematological AEs were vomiting, hypoproteinemia, stomatitis and transient sinus arrhythmia. Grade 3-4 toxicity was neutropenia, leukopenia, thrombocytopenia, anemia and stomatitis in the whole cohort. All the AEs were relieved after symptomatic and supportive treatment. Totally, the overall response rate was 13.3% and disease control rate was 66.7%. For the six patients who have not received prior doxorubicin, one partial response and five stable diseases were observed.We provide the data showing that PEG-LD 50 mg/m2 combined with cisplatin 100 mg/m2 demonstrated an acceptable safety profile and promising clinical activity in advanced osteosarcoma, which merits further evaluation in phase II studies.ChiCTR1900021550.
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