Efficacy and safety of paclitaxel poliglumex as first-line chemotherapy in patients at high risk with advanced-stage non-small-cell lung cancer: Results of a phase II study
Efficacy and safety of paclitaxel poliglumex as first-line chemotherapy in patients at high risk with advanced-stage non-small-cell lung cancer: Results of a phase II study
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DOI：
10.3816/clc.2005.n.039
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发表时间：
2005-11-01
影响因子：
3.6
通讯作者：
Oldham, Fred
中科院分区：
文献类型：
--
作者：
Richards, Donald A.;Richards, Paul;Oldham, Fred
背景：这项开放标记、多中心、II期试验的目的是评估晚期非小细胞肺癌（NSCLC）高危患者（东部肿瘤合作组表现状态[PS]为2岁或年龄>= 70岁）接受单药紫杉醇聚光美作为一线单药治疗的反应、生存和耐受性。患者和方法：在每3周周期的第1天输注紫杉醇10-20分钟。30例患者入组：28例接受紫杉醇聚氨醇175 mg/m(2)治疗，2例接受235 mg/m(2)治疗。显示部分缓解（PR；根据实体瘤反应评价标准）或疾病稳定（SD）的患者持续不间断地使用紫杉醇聚光酮治疗70年为7.8个月。无4级非血液学毒性报道。3例患者出现3级神经病变。每周血液学评估显示2例患者为3级贫血，3例患者为3级中性粒细胞减少症（与中性粒细胞减少症发热无关），2例患者为4级中性粒细胞减少症。没有患者需要生长因子支持。结论：本研究结果表明，紫杉醇多聚维莫司作为一线单药治疗晚期NSCLC高危患者的耐受性良好，且剂量水平为175 mg/m(2)时具有活性。
BACKGROUND: The objectives of this open-labeled, multicenter, phase II trial were to evaluate response, survival, and tolerability in patients at high risk (Eastern Cooperative Oncology Group performance status [PS] of 2 or age >= 70 years) with advanced-stage non-small-cell lung cancer (NSCLC) receiving single-agent paclitaxel poliglumex as first-line monotherapy. PATIENTS AND METHODS: Paclitaxel poliglumex was administered as a 10-20-minute infusion on day 1 of each 3-week cycle. Thirty patients were enrolled: 28 received paclitaxel poliglumex 175 mg/m(2), and 2 received 235 mg/m(2). Patients exhibiting a partial response (PR; by Response Evaluation Criteria in Solid Tumors) or stable disease (SD) continued uninterrupted treatment with paclitaxel poliglumex for = 70 years was 7.8 months. No grade 4 nonhematologic toxicities were reported. Three patients experienced grade 3 neuropathy. Weekly hematologic assessments showed grade 3 anemia in 2 patients, grade 3 neutropenia (not associated with neutropenic fever) in 3 patients, and grade 4 neutropenia in 2 patients. No patient required growth factor support. CONCLUSION: The results of this study indicate that paclitaxel poligiumex is generally well tolerated and has activity at a dose level of 175 mg/m(2) as first-line monotherapy in patients at high risk with advanced NSCLC.