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A Phase II Trial of S-1 and Oxaliplatin in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane (KCSG-BR07-03)

 Dae-Won Lee  ;  Bhumsuk Keam  ;  Keun Seok Lee  ;  Jin-Hee Ahn  ;  Joohyuk Sohn  ;  Jin Seok Ahn  ;  Moon Hee Lee  ;  Jee Hyun Kim  ;  Kyung Eun Lee  ;  Hyo Jung Kim  ;  Si-Young Kim  ;  Yeon Hee Park  ;  Chan-Young Ock  ;  Kyung-Hun Lee  ;  Sae-Won Han  ;  Sung-Bae Kim  ;  Young Hyuck Im  ;  Hyun Cheol Chung  ;  Do-Youn Oh  ;  Seock-Ah Im 
 CANCER RESEARCH AND TREATMENT, Vol.55(2) : 523-530, 2023-04 
Journal Title
Issue Date
Anthracyclines / therapeutic use ; Antineoplastic Combined Chemotherapy Protocols / adverse effects ; Breast Neoplasms* / pathology ; Female ; Humans ; Neoplasm Metastasis ; Neutropenia* / chemically induced ; Oxaliplatin / therapeutic use ; Taxoids / adverse effects
Breast neoplasms ; Drug therapy ; Oxaliplatin ; Phase II trial ; S-1
Purpose This single-arm phase II trial investigate the efficacy and safety of S-1 plus oxaliplatin (SOX) in patients with metastatic breast cancer.
Materials and Methods Patients with metastatic breast cancer previously treated with anthracyclines and taxanes were enrolled. Patients received S-1 (40-60 mg depending on patient’s body surface area, twice a day, day 1-14) and oxaliplatin (130 mg/m2, day 1) in 3 weeks cycle until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumor 1.1. Secondary endpoints included time-to-progression (TTP), duration-of-response (DoR), overall survival (OS), and adverse events.
Results A total of 87 patients were enrolled from 11 institutions in Korea. Hormone receptor was positive in 54 (62.1%) patients and six (6.9%) had human epidermal growth factor receptor 2–positive disease. Forty-eight patients (85.1%) had visceral metastasis and 74 (55.2%) had more than three sites of metastases. The ORR of SOX regimen was 38.5% (95% confidence interval [CI], 26.9 to 50.0) with a median TTP of 6.0 months (95% CI, 5.1 to 6.9). Median DoR and OS were 10.3 months (95% CI, 5.5 to 15.1) and 19.4 (95% CI, not estimated) months, respectively. Grade 3 or 4 neutropenia was reported in 28 patients (32.1%) and thrombocytopenia was observed in 23 patients (26.6%).
Conclusion This phase II study showed that SOX regimen is a reasonable option in metastatic breast cancer previously treated with anthracyclines and taxanes.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
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