Cancer Res Treat. 2023;55(2):523-530.

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

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제1저자 이대원, 김범석 · 교신저자 임석아

PMID 36397238 PMC10101794 DOI 10.4143/crt.2022.1360 IF 4.2 혈액종양내과

소속 (13)

Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Department of Translational Medicine, Seoul National University College of Medicine, Seoul, Korea.
Cancer Research Institute, Seoul National University, Seoul, Korea.
Center for Breast Cancer, National Cancer Center, Goyang, Korea.
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Division of Medical Oncology and Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Division of Hematology-Oncology, Samsung Medical Center, Seoul, Korea.
Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Department of Hematology and Oncology, Ewha Womans University Medical Center, Seoul, Korea.
Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
Department of Medical Oncology and Hematology, Kyung Hee University Hospital, Seoul, Korea.

Abstract

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.

Keywords

Breast neoplasmsDrug therapyOxaliplatinPhase II trialS-1

Figures

**Fig. 2** Kaplan-Meier survival curve for time to progression (A) and overall survival (B).

그림 출처: PubMed Central 공개 논문 (PMC10101794)

Conflict of interest statement

Conflicts of Interest . SA Im received research fund from AstraZeneca, Daewoong Pharm, Eisai, Pfizer, and Roche outside of the current work and have been work as advisory board for AstraZeneca, Amgen, Eisai, GSK, Hanmi Corp., Lilly, MSD, Novartis, Pfizer, and Roche. DY Oh received research fund from AstraZeneca, Novartis, Array, Eli Lilly, Servier, BeiGene, MSD, and Handok outside of the current work and have been work as advisory board for AstraZeneca, Novartis, Genentech/Roche, Merck Serono, Bayer, Taiho, ASLAN, Halozyme, Zymeworks, BMS/Celgene, BeiGene, Basilea, Turning Point, and Yuhan. SB Kim received research fund from Novartis, Sanofi-Aventis, and DongKook Pharm Co. outside of the current work, have been work as advisory board for Novartis, AstraZeneca, Lilly, Dae Hwa Pharmaceutical Co. Ltd, ISU Abxis, and Daiichi-Sankyo, and has stock in Genopeaks, and NeogeneTC. JH Kim received research fund from Ono Korea Ltd outside of the current work and attended advisory board for BIXINK, Daichii Sankyo, Eisai, Lilly, Novartis, Pfizer, and Roche. KS Lee reports grants from Dong-A Socio outside of the current work and have been work as advisory board for Eli Lilly, Novartis, Pfizer, Roche, and Bixink. TS-1 was supported by Taiho Pharmaceutical and Jeil Pharmaceutical. Oxaliplatin was supported by Sanofi-Aventis.

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