PMID- 25932284 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20150501 LR - 20201001 IS - 1940-5901 (Print) IS - 1940-5901 (Electronic) IS - 1940-5901 (Linking) VI - 8 IP - 2 DP - 2015 TI - Phase II multi-center clinical study on using S-1 to treat advanced breast cancer after resistance to anthracycline and taxane drugs in Chinese patients. PG - 3072-9 AB - BACKGROUND: Treatment for metastatic breast cancer (MBC) in patients who have relapsed from anthracycline and taxane is difficult. S-1, an oral 5-FU derivative, has demonstrated a potential antitumor effect in patients with MBC. Thus, we evaluated the efficacy and safety of S-1 as second-line chemotherapy MBC patients in a phase II trial. METHODS: The study was conducted at seven centers in China and enrolled MBC patients who had previously relapsed from one chemotherapy regimen. The median progression-free survival (PFS) was the primary end point. The treatment schedule involved the administration of S-1 at a standard dose based on the body surface area (BSA) in 28-day cycles with consecutive administration followed by a 14-day rest, as follows: 40 mg twice daily if BSA < 1.25 m(2); 50 mg twice daily if 1.25 m(2) /= 1.5 m(2); and 60 mg twice daily if BSA > 1.5 m(2). RESULTS: Thirty-three patients were included in the analysis. S-1 demonstrated moderate efficacy with a PFS of 3.3 months, a response rate of 33.3%, and a disease control rate of 72.7%. The treatment was well-tolerated with mild-to-moderate toxicity. Grade 3 adverse events (AEs) occurred in 4 patients (2 with hyperbilirubinemia, 1 with anorexia, and 1 with vomiting). Grade 4 AEs were not observed. CONCLUSION: S-1 demonstrated encouraging efficacy and safety in a prospective trial as second-line treatment in MBC patients. All AEs were manageable; however, bilirubin monitoring is recommended during treatment. FAU - Yuan, Peng AU - Yuan P AD - Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College China. FAU - Di, Li-Jun AU - Di LJ AD - Department of Breast Cancer, Beijing Cancer Hospital China. FAU - Liu, Wei AU - Liu W AD - Department of Medical Oncology, The Fourth Hospital of Hebei Medical University China. FAU - Wan, Dong-Gui AU - Wan DG AD - Department of TCM Oncology China-Japan Friendship Hospital China. FAU - Dai, Hong AU - Dai H AD - Department of Oncology, Beijing Chaoyang Hospital Attached To The Capital Medical University China. FAU - Tong, Zhong-Sheng AU - Tong ZS AD - Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital China. FAU - Du, Feng AU - Du F AD - Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College China. FAU - Xu, Bing-He AU - Xu BH AD - Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College China. LA - eng PT - Journal Article DEP - 20150215 PL - United States TA - Int J Clin Exp Med JT - International journal of clinical and experimental medicine JID - 101471010 PMC - PMC4402931 OTO - NOTNLM OT - Metastatic breast cancer OT - S-1 OT - chemotherapy EDAT- 2015/05/02 06:00 MHDA- 2015/05/02 06:01 PMCR- 2015/02/15 CRDT- 2015/05/02 06:00 PHST- 2014/12/01 00:00 [received] PHST- 2015/01/29 00:00 [accepted] PHST- 2015/05/02 06:00 [entrez] PHST- 2015/05/02 06:00 [pubmed] PHST- 2015/05/02 06:01 [medline] PHST- 2015/02/15 00:00 [pmc-release] PST - epublish SO - Int J Clin Exp Med. 2015 Feb 15;8(2):3072-9. eCollection 2015.