Open Access Research article

S-1 combined with docetaxel following doxorubicin plus cyclophosphamide as neoadjuvant therapy in breast cancer: phase II trial

Yong Wha Moon15, Soohyeon Lee1, Byeong-Woo Park2, Eun-Kyung Kim3, Seung Il Kim2, Ja Seung Koo4, Seho Park2, Min Jung Kim3, Hyun Cheol Chung1, Joo-Hang Kim1 and Joohyuk Sohn1*

Author Affiliations

1 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

2 Department of General Surgery, Yonsei University College of Medicine, Seoul, Korea

3 Department of Radiology, Yonsei University College of Medicine, Seoul, Korea

4 Department of Pathology, Yonsei University College of Medicine, Seoul, Korea

5 Current address: The University of Texas MD Anderson Cancer Center, Houston, TX, USA

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BMC Cancer 2013, 13:583  doi:10.1186/1471-2407-13-583

Published: 6 December 2013

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.

Trial registration

NCT00994968

Keywords:
Breast cancer; Neoadjuvant chemotherapy; S-1; Docetaxel; Pathological complete response