Peng Yuan1, Li-Jun Di2, Wei Liu3, Dong-Gui Wan4, Hong Dai5, Zhong-Sheng Tong6, Feng Du1, Bing-He Xu1. 1. Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College China. 2. Department of Breast Cancer, Beijing Cancer Hospital China. 3. Department of Medical Oncology, The Fourth Hospital of Hebei Medical University China. 4. Department of TCM Oncology China-Japan Friendship Hospital China. 5. Department of Oncology, Beijing Chaoyang Hospital Attached To The Capital Medical University China. 6. Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital China.
Abstract
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) ≤ BSA ≥ 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.
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 MBCpatients in a phase II trial. METHODS: The study was conducted at seven centers in China and enrolled MBCpatients 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) ≤ BSA ≥ 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 MBCpatients. All AEs were manageable; however, bilirubin monitoring is recommended during treatment.
Entities:
Keywords:
Metastatic breast cancer; S-1; chemotherapy
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