Shimada Hiroko, Ueda Shigeto, Saeki Toshiaki, Shigekawa Takashi, Takeuchi Hideki, Hirokawa Eiko, Sugitani Ikuko, Sugiyama Michiko, Takahashi Takao, Matsuura Kazuo, Yamane Tomohiko, Kuji Ichiei, Hasebe Takahiro, Osaki Akihiko
Department of Breast Oncology, International Medical Center, Saitama Medical University, Hidaka, Saitama.
Department of Breast Oncology, International Medical Center, Saitama Medical University, Hidaka, Saitama
Jpn J Clin Oncol. 2015 Jul;45(7):642-9. doi: 10.1093/jjco/hyv055. Epub 2015 May 19.
Nanoparticle albumin-bound paclitaxel (nab-PTX) is a solvent-free paclitaxel coupled to human albumin without an associated increase in toxicity. The neoadjuvant study of primary breast cancer was planned to evaluate tumor response and safety of triweekly nanoparticle albumin-bound paclitaxel.
Patients with Stage II/III HER2-negative primary breast cancer received four courses of nanoparticle albumin-bound paclitaxel 260 mg/m(2) every 3 weeks (q3w), followed by four courses of epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) q3w. Tumor response after nanoparticle albumin-bound paclitaxel was histologically evaluated. In addition, the clinical response, breast-conserving rate and safety of this treatment were monitored.
Among 53 patients who received nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide neoadjuvant chemotherapy, pathological complete response and near-pathological complete response were confirmed in 3 (5.7%) and 7 (13.2%) patients who had surgery, respectively. The overall objective response rate was 71.7% after completion of chemotherapy. Based on Positron Emission Tomography Response Criteria in Solid Tumors using (18)F-fluorodeoxyglucose, complete metabolic response and partial metabolic response after 2-3 courses of nanoparticle albumin-bound paclitaxel were 15.1 and 52.8%, respectively. The most common significant toxicities of q3w nanoparticle albumin-bound paclitaxel were Grade 3 muscle pain, neuropathy and febrile neutropenia, each in 1 (1.9%) patient. There were no incidences of anaphylaxis or Grade 4/5 adverse events.
Neoadjuvant chemotherapy using q3w nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide was feasible in breast cancer patients with acceptable clinical response and drug tolerance, but conferred a low rate of pathological complete response. Monotherapy with q3w nanoparticle albumin-bound paclitaxel could be an appropriate substitute for solvent-based taxane in terms of therapeutic and safety management.
纳米白蛋白结合型紫杉醇（nab-PTX）是一种无溶剂的紫杉醇，与人白蛋白偶联，且毒性未相应增加。本项原发性乳腺癌新辅助治疗研究旨在评估每三周一次纳米白蛋白结合型紫杉醇的肿瘤反应及安全性。
II/III期HER2阴性原发性乳腺癌患者每3周接受4个疗程的纳米白蛋白结合型紫杉醇260mg/m²治疗，随后每3周接受4个疗程的表柔比星90mg/m²加环磷酰胺600mg/m²治疗。对纳米白蛋白结合型紫杉醇治疗后的肿瘤反应进行组织学评估。此外，监测该治疗的临床反应、保乳率及安全性。
在53例接受纳米白蛋白结合型紫杉醇序贯表柔比星及环磷酰胺新辅助化疗的患者中，接受手术的患者分别有3例（5.7%）和7例（13.2%）达到病理完全缓解和接近病理完全缓解。化疗结束后总体客观缓解率为71.7%。根据实体瘤正电子发射断层显像反应标准，使用（18）F-氟脱氧葡萄糖，在2-3个疗程的纳米白蛋白结合型紫杉醇治疗后，完全代谢缓解率和部分代谢缓解率分别为15.1%和52.8%。每3周一次纳米白蛋白结合型紫杉醇最常见的显著毒性为3级肌肉疼痛、神经病变和发热性中性粒细胞减少，各有1例（1.9%）患者出现。无过敏反应或4/5级不良事件发生。
对于乳腺癌患者，每3周一次纳米白蛋白结合型紫杉醇序贯表柔比星及环磷酰胺的新辅助化疗具有可接受的临床反应和药物耐受性，是可行的，但病理完全缓解率较低。就治疗和安全性管理而言，每3周一次纳米白蛋白结合型紫杉醇单药治疗可作为基于溶剂的紫杉烷的合适替代方案。
