O'shaughnessy Joyce
Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Texas Oncology PA, US Oncology, Dallas, USA.
Semin Oncol. 2003 Apr;30(2 Suppl 3):22-6. doi: 10.1053/sonc.2003.37272.
The background, rationale, and preliminary results of a phase II trial of gemcitabine plus trastuzumab in heavily pretreated metastatic breast cancer patients are presented. Gemcitabine and trastuzumab both exhibit single-agent activity in previously treated metastatic breast cancer. Preclinical studies of gemcitabine and trastuzumab in combination showed additive or synergistic antitumor effects in human breast cancer cell lines that overexpress HER2. A multicenter phase II trial was thus conducted to define the safety and efficacy of gemcitabine/trastuzumab in patients previously treated for metastatic breast cancer. Women with measurable metastatic breast cancer whose primary or secondary tumor overexpressed HER2 were eligible for inclusion. Gemcitabine 1,200 mg/m(2) was administered on days 1 and 8 of a 21-day cycle. Trastuzumab was administered at a loading dose of 4 mg/kg initially, then at 2 mg/kg weekly thereafter. Preliminary analysis of 38 evaluable patients showed that gemcitabine/trastuzumab was well tolerated and had significant antitumor activity in this patient population. The study is now concluded, and final analysis of the data is nearing completion. Publication of the results is anticipated in 2003.
本文介绍了吉西他滨联合曲妥珠单抗用于多线治疗的转移性乳腺癌患者的II期试验的背景、理论依据和初步结果。吉西他滨和曲妥珠单抗在既往治疗过的转移性乳腺癌中均显示出单药活性。吉西他滨与曲妥珠单抗联合应用的临床前研究表明，在过表达HER2的人乳腺癌细胞系中具有相加或协同的抗肿瘤作用。因此开展了一项多中心II期试验，以确定吉西他滨/曲妥珠单抗对既往接受过转移性乳腺癌治疗的患者的安全性和疗效。可测量的转移性乳腺癌且原发或继发肿瘤过表达HER2的女性患者符合入选条件。在21天周期的第1天和第8天给予吉西他滨1200mg/m²。曲妥珠单抗初始负荷剂量为4mg/kg，之后每周2mg/kg。对38例可评估患者的初步分析表明，吉西他滨/曲妥珠单抗耐受性良好，在该患者群体中具有显著的抗肿瘤活性。该研究现已结束，数据的最终分析即将完成。预计2003年发表研究结果。
