Smith Judith A, Costales Anthony B, Jaffari Mona, Urbauer Diana L, Frumovitz Michael, Kutac Christine K, Tran Huyentran, Coleman Robert L
Department of Obstetrics, Gynecology & Reproductive Sciences, UTHealth Medical School, Houston, TX, USA
Department of Obstetrics, Gynecology & Reproductive Sciences, UTHealth Medical School, Houston, TX, USA.
J Oncol Pharm Pract. 2016 Aug;22(4):599-604. doi: 10.1177/1078155215594415. Epub 2015 Jul 15.
In response to the critical shortage of liposomal doxorubicin (Doxil®) in the United States, the Food and Drug Administration (FDA) approved temporary importation of doxorubicin hydrochloride liposome (Lipodox®). The objective was to compare toxicity and clinical activity of Lipodox® with Doxil®.
Recurrent ovarian cancer patients who received Lipodox® were compared 3:1 to matched control Doxil® patients who had received Doxil®. Patients were matched based on age, stage, dose, platinum sensitivity, and prior treatments from an existing de-identified database. Patients receiving combination regimens were excluded.
The data from 40 Lipodox® patients was compared to 120 matched control Doxil® patients. In this study, 17 (42.5%) of the Lipodox® patients were switched to Doxil®. The overall response rate Lipodox® was 4.3% (1/23) compared to 18% (20/111) in matched control Doxil® patients. In the platinum-sensitive patients, 100% progressed in the Lipodox® group compared to 78.4% in matched control Doxil® patients. The mean time to progression was 4.1 ± 2.8 months for Lipodox® and 6.2 ± 7.2 months in control Doxil®s (p = 0·25). Toxicity was similar in the Lipodox® group and control Doxil® group.
Lipodox® for treatment of recurrent ovarian cancer did not appear to have equivalent efficacy compared to Doxil®. A prospective clinical study is warranted before Lipodox® can be deemed equivalent substitution for Doxil®.
为应对美国脂质体阿霉素（多柔比星脂质体，商品名Doxil®）的严重短缺，美国食品药品监督管理局（FDA）批准临时进口盐酸阿霉素脂质体（商品名Lipodox®）。目的是比较Lipodox®与Doxil®的毒性和临床活性。
将接受Lipodox®治疗的复发性卵巢癌患者与接受Doxil®治疗的匹配对照患者按3:1进行比较。根据年龄、分期、剂量、铂敏感性和既往治疗情况，从现有的匿名数据库中匹配患者。接受联合治疗方案的患者被排除。
将40例接受Lipodox®治疗的患者数据与120例匹配的接受Doxil®治疗的对照患者数据进行比较。在本研究中，17例（42.5%）接受Lipodox®治疗的患者改用了Doxil®。Lipodox®的总体缓解率为4.3%（1/23），而匹配的接受Doxil®治疗的对照患者为18%（20/111）。在铂敏感患者中，Lipodox®组100%病情进展，而匹配的接受Doxil®治疗的对照患者为78.4%。Lipodox®组的平均进展时间为4.1±2.8个月，对照Doxil®组为6.2±7.2个月（p = 0.25）。Lipodox®组和对照Doxil®组的毒性相似。
与Doxil®相比，Lipodox®用于治疗复发性卵巢癌似乎没有同等疗效。在Lipodox®可被视为Doxil®的等效替代品之前，有必要进行一项前瞻性临床研究。
