title: S-1 combined with docetaxel following doxorubicin plus cyclophosphamide as neoadjuvant therapy in breast cancer: phase II trial.
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.
  
  
  BACKGROUND
  NCT00994968.
authors: Yong Wha
authors: YW
authors: Moon
authors: Soohyeon
authors: S
authors: Lee
authors: Byeong-Woo
authors: BW
authors: Park
authors: Eun-Kyung
authors: EK
authors: Kim
authors: Seung Il
authors: SI
authors: Kim
authors: Ja Seung
authors: JS
authors: Koo
authors: Seho
authors: S
authors: Park
authors: Min Jung
authors: MJ
authors: Kim
authors: Hyun Cheol
authors: HC
authors: Chung
authors: Joo-Hang
authors: JH
authors: Kim
authors: 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. oncosohn@yuhs.ac.
authors: Joohyuk
authors: J
authors: Sohn
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D004338:Drug Combinations; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D012307:Risk Factors; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D004317:Doxorubicin; D003520:Cyclophosphamide