Chitapanarux Imjai, Kamnerdsupaphon Pimkhuan, Tharavichitkul Ekasit, Lorvidhaya Vicharn, Trakultivakorn Hongsin, Srisukho Songpol, Somwangprasert Areewan, Watcharachan Kirati, Sukthomya Vimol
Division of Therapeutic Radiology and Oncology, Department of Radiology, Chiang Mai University, Thailand.
Asia Pac J Clin Oncol. 2012 Mar;8(1):76-82. doi: 10.1111/j.1743-7563.2011.01467.x. Epub 2012 Jan 12.
The combination of a taxane and capecitabine offers synergistic antitumor activity. This study aimed to determine the efficacy and tolerability of a paclitaxel and capecitabine combination in Thai patients with metastatic breast cancer (MBC) not previously treated for metastatic disease.
This open-label, single-center, non-comparative phase II study was conducted between December 2006 and March 2009. In all 40 MBC patients were treated with oral capecitabine 1000 mg/m(2) twice daily on days 1 to 14, and weekly paclitaxel 80 mg/m(2) in a 3-week cycle for a total of six cycles.
After a median follow up of 13.4 months, an overall objective response rate of 80%, with a partial response of 74% and a complete response of 5% were achieved. While 8% of patients achieved stable disease, 13% had progressive disease. Median time to progress was 8 months and median overall survival was 24.4 months. One patient discontinued because of hypersensitivity to paclitaxel. There was no grade 4 toxicity. Skin and nail toxicity was found in 75% of patients (with 25% in grade 2 or 3), followed by neutropenia (45% in all with 15% in grades 2 or 3), neuropathy (25% in total with 5% in grade 2) and stomatitis and diarrhea (in both of which 5% experienced grade 1 severity).
A first-line regimen of weekly paclitaxel plus capecitabine is effective and tolerable in Thai MBC patients.
紫杉烷类与卡培他滨联合使用具有协同抗肿瘤活性。本研究旨在确定紫杉醇与卡培他滨联合方案对既往未接受过转移性疾病治疗的泰国转移性乳腺癌（MBC）患者的疗效和耐受性。
这项开放标签、单中心、非对照的II期研究于2006年12月至2009年3月进行。40例MBC患者均接受口服卡培他滨治疗，剂量为1000mg/m²，每日两次，第1至14天用药，紫杉醇80mg/m²，每周一次，每3周为一个周期，共六个周期。
中位随访13.4个月后，总客观缓解率为80%，其中部分缓解率为74%，完全缓解率为5%。8%的患者病情稳定，13%的患者病情进展。中位疾病进展时间为8个月，中位总生存期为24.4个月。1例患者因对紫杉醇过敏而停药。无4级毒性反应。75%的患者出现皮肤和指甲毒性（25%为2级或3级），其次是中性粒细胞减少（总体发生率为45%，2级或3级为15%）、神经病变（总体发生率为25%，2级为5%）以及口腔炎和腹泻（两者1级严重程度的发生率均为5%）。
紫杉醇联合卡培他滨一线方案对泰国MBC患者有效且耐受性良好。
