Safra T, Groshen S, Jeffers S, Tsao-Wei D D, Zhou L, Muderspach L, Roman L, Morrow C P, Burnett A, Muggia F M
Department of Medical Oncology, Kenneth Norris Jr. Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA.
Cancer. 2001 Jan 1;91(1):90-100.
Pegylated liposomal doxorubicin is a new formulation with activity against epithelial ovarian carcinoma (EOC). The authors sought to determine patient characteristics that may predict for response to this treatment and favorable time to failure as well as survival.
Eight patients in a Phase I study and 44 patients in two consecutive Phase II studies who were treated with pegylated liposomal doxorubicin (40-60 mg/m2 every 3 weeks for the first two cycles and 40 mg/m2 every 4 weeks thereafter) after failing initial platinum-based chemotherapies for ovarian carcinoma were analyzed. Associations were sought for response, time to failure (TTF), and survival after the treatment and various pretreatment characteristics.
Treatment with pegylated liposomal doxorubicin yielded 23% objective responses in measurable disease and 31% overall responses, including serum CA 125-defined responses. The median TTF was 5.2 months (95% confidence interval, 4.1-6.9 months) in all patients, and the median response duration in all responders was 13.2 months (95% confidence interval, 11.9-18.5 months). The overall median survival was 15 months (95% confidence interval, 11-40 months). The main predictive factors were tumor size and baseline hemoglobin level for TTF, and these plus Karnofsky performance status were the main predictive factors for survival.
Pegylated liposomal doxorubicin is an effective drug when it is given as secondary therapy to patients with EOC. Lack of bulky disease is the major predictor for a favorable response, TTF, and survival. The role of this treatment in combination with other effective drugs should be explored in both previously treated and untreated patients with ovarian carcinoma.
聚乙二醇化脂质体阿霉素是一种对上皮性卵巢癌（EOC）有活性的新制剂。作者试图确定可能预测该治疗反应、有利的失败时间以及生存情况的患者特征。
分析了1项I期研究中的8例患者以及2项连续II期研究中的44例患者，这些患者在基于铂类的卵巢癌初始化疗失败后接受了聚乙二醇化脂质体阿霉素治疗（前两个周期每3周40 - 60 mg/m²，之后每4周40 mg/m²）。研究了治疗反应、失败时间（TTF）、治疗后的生存情况与各种治疗前特征之间的关联。
聚乙二醇化脂质体阿霉素治疗在可测量疾病中产生了23%的客观反应，总体反应率为31%，包括血清CA 125定义的反应。所有患者的中位TTF为5.2个月（95%置信区间，4.1 - 6.9个月），所有反应者的中位反应持续时间为13.2个月（95%置信区间，11.9 - 18.5个月）。总体中位生存期为15个月（95%置信区间，11 - 40个月）。TTF的主要预测因素是肿瘤大小和基线血红蛋白水平，这些因素加上卡诺夫斯基功能状态是生存的主要预测因素。
聚乙二醇化脂质体阿霉素作为EOC患者的二线治疗药物是有效的。无大块疾病是良好反应、TTF和生存的主要预测因素。应在既往治疗和未治疗的卵巢癌患者中探索该治疗与其他有效药物联合使用的作用。
