A phase II evaluation of nanoparticle, albumin-bound (nab) paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer: a Gynecologic Oncology Group study.
A phase II evaluation of nanoparticle, albumin-bound (nab) paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer: a Gynecologic Oncology Group study.
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DOI：
10.1016/j.ygyno.2011.03.036
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发表时间：
2011-07
影响因子：
4.7
通讯作者：
Shahin MS
中科院分区：
文献类型：
--
作者：
Coleman RL;Brady WE;McMeekin DS;Rose PG;Soper JT;Lentz SS;Hoffman JS;Shahin MS
白蛋白结合型紫杉醇是白蛋白稳定的紫杉醇的新型不含Cremophor®的纳米颗粒，其相对于其他溶剂基紫杉烷（例如紫杉醇和多西他赛）具有有利的功效和毒性特征。符合条件的患者患有铂类和紫杉烷耐药卵巢癌，定义为原发性化疗后持续或进展性疾病（n=5）或治疗完成后6个月内复发（n=42）。所有患者均有可测量的疾病，既往未接受过复发性疾病治疗，妇科肿瘤组体能状态≤ 2。治疗为白蛋白结合型紫杉醇，100 mg/m2，第1、8、15天，28天。主要终点为实体瘤缓解评价标准v1.0缓解率，采用2阶段设计进行评价（RR为25%时把握度为0.90，RR为10%时α为0.05）。入组了51例患者，其中47例可评价;从一线治疗完成至登记的中位时间为21天。患者人口统计学资料包括中位年龄：59（34-78）岁，浆液性组织学：72%，高级别：81%。疗效：确认了1例完全缓解和10例部分缓解（23%）; 17例患者（36%）病情稳定。中位无进展生存期为4.5个月（95%CI：2.2-6.7）;总生存期为17.4个月（95%CI：13.2-20.8）。17例患者（36%）的PFS> 6个月。毒性：没有4级事件; 3级事件为中性粒细胞减少症（6）、贫血（3）、GI（2）、代谢（2）、疼痛（2）和白细胞减少症（1）;观察到的感觉神经毒性为2：5级、3：1级。白蛋白结合型紫杉醇具有值得注意的单药活性，并且在既往接受过紫杉醇治疗的难治性卵巢癌患者队列中是耐受的。
Nab-paclitaxel is a novel Cremophor®-free nanoparticle of albumin-stabilized paclitaxel, which has favorable efficacy and toxicity characteristics relative to other solvent-based taxanes, such as paclitaxel and docetaxel. Eligible patients had platinum- and taxane-resistant ovarian cancer, defined by persistent or progressive disease following primary chemotherapy (n=5) or recurrence within six months of treatment completion (n=42). All patients had measurable disease, no prior therapy for recurrent disease and Gynecologic Oncology Group performance status of ≤ 2. Treatment was nab-paclitaxel, 100 mg/m2 days 1,8,15 on a 28-day schedule. The primary endpoint was Response Evaluation Criteria in Solid Tumors v1.0 response rate, evaluated in a 2-stage design (with power of 0.90 for a RR of 25% and with alpha of 0.05 for RR of 10%). Fifty-one patients were enrolled of which 47 were evaluable; median time from frontline therapy completion to registration was 21 days. Patient demographics include median age: 59 (34–78) years, serous histology: 72%, and high-grade: 81%. Efficacy: One complete and 10 partial responses were confirmed (23%); 17 patients (36%) had stable disease. The median progression-free survival was 4.5 months (95%CI: 2.2–6.7); overall survival was 17.4 months (95%CI: 13.2–20.8). Seventeen patients (36%) had PFS>six months. Toxicity: there were no grade 4 events; grade 3 events were neutropenia (6), anemia (3), GI (2), metabolic (2), pain (2), and leukopenia (1); neurosensory toxicity was observed as grade 2:5, grade 3:1. Nab-paclitaxel has noteworthy single-agent activity and is tolerable in this cohort of refractory ovarian cancer patients previously treated with paclitaxel.
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影响因子：
11.5
作者：
Desai, N;Trieu, V;Soon-Shiong, P
通讯作者：
Soon-Shiong, P
影响因子：
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