Department of Medical Oncology, Tata Memorial Hospital, Parel, Mumbai, India.
Clin Oncol (R Coll Radiol). 2012 Nov;24(9):604-9. doi: 10.1016/j.clon.2011.09.012. Epub 2011 Oct 19.
To study the toxicity profile and response rates of weekly paclitaxel given as neoadjuvant chemotherapy (NACT) in patients with locally advanced breast cancer.
The study was planned as a single arm, prospective phase II study. Twenty-six patients with locally advanced breast cancer were enrolled in the study from December 2006 to October 2007. These patients underwent NACT with weekly paclitaxel at 100 mg/m(2) for 8 consecutive weeks followed by surgery. This was followed by anthracycline-based chemotherapy for three to four cycles followed by radiation. The patients received standard adjuvant hormonal therapy. The patients were carefully monitored for side-effects using common toxicity criteria. The clinical and pathological response rates were documented. The response rates were descriptively stated.
The median age of the patients was 52 years (30-67 years) and the median tumour size was 7 cm (2.5-15 cm). Of the 208 planned weekly cycles, 207 could be given. The rates of grade 3-4 neutropenia, thrombocytopenia and neuropathy were 4, 12 and 4%, respectively. A complete clinical response was observed in 10 patients (38.5%) and a completed pathological response, defined as the absence of invasive cancer from the breast and axillary nodes, was seen in 11.5% of patients. Breast-conserving surgery was possible in 23% of patients.
The regimen of weekly single agent paclitaxel is feasible in patients with locally advanced breast cancer with acceptable toxicity. It resulted in a pathological response rate that was comparable with other regimens in this group of advanced stage patients. Considering the efficacy and low toxicity of this regimen, it is worth exploring in larger studies.
研究每周紫杉醇新辅助化疗（NACT）治疗局部晚期乳腺癌的毒性谱和反应率。
该研究设计为单臂、前瞻性 II 期研究。2006 年 12 月至 2007 年 10 月期间，共纳入 26 例局部晚期乳腺癌患者。这些患者接受每周紫杉醇 100mg/m2，连续 8 周的 NACT，然后手术。随后接受蒽环类药物为基础的化疗 3-4 个周期，然后进行放疗。患者接受标准辅助激素治疗。使用常见毒性标准仔细监测患者的不良反应。记录临床和病理反应率。反应率以描述性方式陈述。
患者的中位年龄为 52 岁（30-67 岁），中位肿瘤大小为 7cm（2.5-15cm）。在计划的 208 个每周周期中，207 个周期得以完成。3-4 级中性粒细胞减少症、血小板减少症和神经病变的发生率分别为 4%、12%和 4%。10 例患者（38.5%）观察到完全临床缓解，11.5%的患者观察到完全病理缓解，定义为乳房和腋窝淋巴结无浸润性癌。23%的患者可行保乳手术。
每周单药紫杉醇方案在局部晚期乳腺癌患者中是可行的，毒性可接受。它导致病理缓解率与该组晚期患者的其他方案相当。考虑到该方案的疗效和低毒性，值得在更大规模的研究中进一步探索。
