aRabin Medical Center, Petach Tikva bMeir Medical Center, Kfar Saba cTel Aviv Souraski Medical Center, Tel Aviv, affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv dSoroka Medical Center, Beer Sheva, affiliated with Ben-Gurion University of the Negev, Beer Sheva eNaharia Medical Center, Naharia fRambam Medical Center, Haifa gLin Medical Center, Haifa, affiliated with the Faculty of Medicine, the Technion Israel Institute of Technology, Haifa hZiv Medical Center, Safed iShaare Zedek Medical Center, Jerusalem, affiliated with the Faculty of Medicine, the Hebrew University of Jerusalem, Jerusalem, Israel jNew York University Cancer Institute, NYU School of Medicine, New York, New York, USA.
Anticancer Drugs. 2014 Jan;25(1):101-5. doi: 10.1097/CAD.0000000000000023.
The aim of this study was to assess the clinical activity and toxicity of liposome-encapsulated doxorubicin citrate (Myocet) in a retrospective multicenter cohort of epithelial ovarian, primary peritoneal, and tubal cancer patients. Records of patients with recurrent epithelial ovarian, primary peritoneal, and tubal cancer treated with liposome-encapsulated doxorubicin citrate (60 mg/m on day 1 of a 21-day cycle) after failure of more than one previous regimen were reviewed. Fifty-three patients were evaluated for efficacy and toxicity. The median age of the patients was 59 (range 39-73). The median follow-up was 6 months (range 1-17). One patient (1.9%) showed a complete response and 13 patients (24.5%) showed a partial response, yielding an overall response rate of 26.4% (14/53 patients). Clinical benefit was achieved in 36 patients (67.9%). The median progression-free survival (PFS) for the entire study population was 4.0 months (range 1.0-14.8). The median PFS for platinum-sensitive and platinum-resistant patients was 4.0 months (ranges 1.0-14.8 and 1.0-9.4, respectively; P=0.652). The median overall survival from the start of liposome-encapsulated doxorubicin citrate was 10.0 months. Multivariate survival analysis showed no association between the liposome-encapsulated doxorubicin citrate line of treatment or platinum sensitivity to PFS in age and BRCA status-adjusted models. Only 11.3% of patients experienced grade 3-4 hematologic toxicities, 80% grade-2 alopecia, and 50% grade-1-2 fatigue. No other grade-4 toxicities, no significant cardiac events, or hand and foot syndromes were reported. Liposome-encapsulated doxorubicin citrate was well tolerated, with a good response and high clinical benefit rate. Further evaluation in a larger prospective cohort is warranted.
本研究旨在评估脂质体阿霉素枸橼酸盐（Myocet）在复发性上皮性卵巢癌、原发性腹膜癌和输卵管癌患者回顾性多中心队列中的临床活性和毒性。对接受脂质体阿霉素枸橼酸盐（60mg/m，第 1 天，21 天周期）治疗的复发性上皮性卵巢癌、原发性腹膜癌和输卵管癌患者的记录进行了回顾，这些患者在之前的治疗方案失败后均超过一次。对 53 例患者进行了疗效和毒性评估。患者的中位年龄为 59 岁（范围 39-73 岁）。中位随访时间为 6 个月（范围 1-17 个月）。1 例患者（1.9%）完全缓解，13 例患者（24.5%）部分缓解，总缓解率为 26.4%（53 例患者中的 14 例）。36 例患者（67.9%）获得临床获益。整个研究人群的中位无进展生存期（PFS）为 4.0 个月（范围 1.0-14.8 个月）。铂敏感和铂耐药患者的中位 PFS 分别为 4.0 个月（范围 1.0-14.8 个月和 1.0-9.4 个月；P=0.652）。从脂质体阿霉素枸橼酸盐开始的中位总生存期为 10.0 个月。多变量生存分析显示，在年龄和 BRCA 状态调整后的模型中，脂质体阿霉素枸橼酸盐治疗线或铂敏感性与 PFS 之间无关联。仅 11.3%的患者发生 3-4 级血液学毒性，80%发生 2 级脱发，50%发生 1-2 级疲劳。未报告其他 4 级毒性、无明显心脏事件或手足综合征。脂质体阿霉素枸橼酸盐耐受性良好，反应良好，临床获益率高。需要在更大的前瞻性队列中进一步评估。
