Roy V, LaPlant B R, Gross G G, Bane C L, Palmieri F M
Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 32224, USA.
Ann Oncol. 2009 Mar;20(3):449-53. doi: 10.1093/annonc/mdn661. Epub 2008 Dec 15.
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 >or= 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.
纳米白蛋白结合型（nab）紫杉醇具有更好的疗效，且几乎消除了与溶剂型紫杉醇相关的过敏反应风险。我们在一项开放标签的单阶段II期试验中，对先前未经治疗的转移性乳腺癌（MBC）患者研究了每周一次的nab紫杉醇与吉西他滨联合用药方案。在21天周期的第1天和第8天给予nab紫杉醇（125mg/m²）和吉西他滨（1000mg/m²），直至疾病进展。共入组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%）患者完全缓解，21例（42%）患者部分缓解。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），中位总生存期（OS）未达到。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。中性粒细胞减少是最常见的毒性反应（3/4级中性粒细胞减少分别为42%和12%）。仅1例患者发生发热性中性粒细胞减少。显著的活性和良好的毒性特征为在III期试验中进一步评估该方案或与生物制剂联合使用提供了依据。
