Moon Yong Wha, Lee Soohyeon, Park Byeong-Woo, Kim Eun-Kyung, Kim Seung Il, Koo Ja Seung, Park Seho, Kim Min Jung, Chung Hyun Cheol, Kim Joo-Hang, Sohn Joohyuk
Yonsei Cancer Center, Divison of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.
BMC Cancer. 2013 Dec 6;13:583. doi: 10.1186/1471-2407-13-583.
This study evaluated the efficacy and safety of S-1 combined with docetaxel (SD) following doxorubicin plus cyclophosphamide (AC) as neoadjuvant therapy in patients with HER2-negative, stage II-III breast cancer.
Patients received AC every 3 weeks for four cycles followed by S-1 (30 mg/m2 orally b.i.d. on days 1-14) and docetaxel (75 mg/m2 i.v. on day 1) every 3 weeks for four cycles. The primary endpoint was the pathological complete response (pCR) rate in breast and axillary lymph nodes.
The study included 49 patients with a median age of 43 years. The median breast tumor size was 4.0 cm by palpation. All patients were positive for involvement of axillary lymph node and five patients also had supraclavicular lymph node metastasis, which was confirmed by histological examination. In total, 85.4% of patients (41/49) completed eight cycles of therapy and 95.9% of patients (47/49) received curative surgery. The pCR rate was 22.5% (n = 11). The clinical response rate was 67.4%. During SD chemotherapy, the most frequent grade 3-4 toxicity was neutropenia (8.5% by cycle). There was a single treatment-related mortality from severe neutropenia. Grade 3 S-1 specific toxicities such as epigastric pain (12.2% by person), stomatitis (4.1% by person), and diarrhea (2.0% by person) were also observed. In particular, gastrointestinal discomfort led to dose reduction of S-1 in 45.8% of patients.
Given all axillary lymph node positive diseases, neoadjuvant S-1 combined with docetaxel following AC showed a favorable anti-tumor activity but gastrointestinal discomfort should be carefully considered for future studies.
NCT00994968.
本研究评估了在HER2阴性的II - III期乳腺癌患者中，多柔比星加环磷酰胺（AC）之后序贯S-1联合多西他赛（SD）作为新辅助治疗的疗效和安全性。
患者每3周接受AC治疗，共4个周期，随后每3周接受S-1（第1 - 14天口服，30 mg/m²，每日2次）和多西他赛（第1天静脉注射，75 mg/m²）治疗，共4个周期。主要终点是乳腺和腋窝淋巴结的病理完全缓解（pCR）率。
该研究纳入了49例患者，中位年龄43岁。触诊时乳腺肿瘤中位大小为4.0 cm。所有患者腋窝淋巴结受累均为阳性，5例患者还伴有锁骨上淋巴结转移，经组织学检查证实。总体而言，85.4%的患者（41/49）完成了8个周期的治疗，95.9%的患者（47/49）接受了根治性手术。pCR率为22.5%（n = 11）。临床缓解率为67.4%。在SD化疗期间，最常见的3 - 4级毒性是中性粒细胞减少（每个周期为8.5%）。有1例因严重中性粒细胞减少导致的治疗相关死亡。还观察到3级S-1特异性毒性，如上腹部疼痛（按人计算为12.2%）、口腔炎（按人计算为4.1%）和腹泻（按人计算为2.0%）。特别是，胃肠道不适导致45.8%的患者减少了S-1的剂量。
对于所有腋窝淋巴结阳性疾病，AC之后序贯新辅助S-1联合多西他赛显示出良好的抗肿瘤活性，但在未来研究中应仔细考虑胃肠道不适问题。
NCT00994968。
