Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab-paclitaxel) (Abraxane®) in combination with gemcitabine in patients with metastatic breast cancer (N0531)
Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab-paclitaxel) (Abraxane®) in combination with gemcitabine in patients with metastatic breast cancer (N0531)
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DOI：
10.1093/annonc/mdn661
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发表时间：
2009-03-01
影响因子：
50.5
通讯作者：
Palmieri, F. M.
中科院分区：
文献类型：
--
作者：
Roy, V.;LaPlant, B. R.;Palmieri, F. M.
纳米粒白蛋白结合（nab）紫杉醇具有更好的疗效，实际上消除了与溶剂型紫杉醇相关的超敏反应风险。我们研究了每周nab-紫杉醇和吉西他滨组合在一个开放标签的一期，II期临床试验，在以前未经治疗的转移性乳腺癌（MBC）患者。在21天周期的第1天和第8天给予白蛋白结合型紫杉醇（125 mg/m2）和吉西他滨（1000 mg/m2），直至疾病进展。入组了50例患者。40例（80%）有内脏器官受累，30例（60%）有≥ 3个转移部位。根据实体瘤疗效评价标准（RECIST），4例（8%）和21例（42%）患者达到完全缓解和部分缓解。中位缓解持续时间为6.9个月[95%置信区间（CI）5.7，未达到]，中位无进展生存期（PFS）为7.9个月（95% CI 5.4-10个月），未达到中位总生存期（OS）。6个月时的PFS和OS分别为60%（95% CI 48%至76%）和92%（95% CI 85%至100%）。治疗耐受性良好。中性粒细胞减少症是最常见的毒性（42%和12%的3级和4级中性粒细胞减少症）。仅1例患者发生发热性中性粒细胞减少症。显著的活性和有利的毒性特征为考虑在III期试验中进一步评价该方案或与生物制剂联合使用提供了基础。
Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and practically eliminates the risk of hypersensitivity reactions associated with solvent-based paclitaxel. We studied weekly nab-paclitaxel and gemcitabine combination in an open-label one-stage, phase II trial in patients with previously untreated metastatic breast cancer (MBC). Nab-paclitaxel (125 mg/m(2)) and gemcitabine (1000 mg/m(2)) were administered on days 1 and 8 of a 21-day cycle until disease progression. Fifty patients were enrolled. Forty (80%) had visceral organ involvement and 30 (60%) had >= 3 sites of metastases. Four (8%) and 21 (42%) patients had complete and partial responses by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Median duration of response was 6.9 months [95% confidence interval (CI) 5.7, not reached], median progression-free survival (PFS) 7.9 months (95% CI 5.4-10 months), and median overall survival (OS) was not reached. PFS and OS at 6 months were 60% (95% CI 48% to 76%) and 92% (95% CI 85% to 100%), respectively. Therapy was well tolerated. Neutropenia was commonest toxicity (42% and 12% grades 3 and 4 neutropenia). Only one patient developed febrile neutropenia. Significant activity and favorable toxicity profile provides a basis for considering this regimen for further evaluation in phase III trials or in combination with biologic agents.