Cancer Res Treat.  2023 Apr;55(2):523-530. 10.4143/crt.2022.1360.

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

• Lee DW
• Keam B
• Lee KS
• Ahn JH
• Sohn J
• Ahn JS
• Lee MH
• Kim JH
• Lee KE
• Kim HJ
• Kim SY
• Park YH
• Ock CY
• Lee KH
• Han SW
• Kim SB
• Im YH
• Chung HC
• Oh DY
• Im SA

• KMID: 2541239
• DOI: http://doi.org/10.4143/crt.2022.1360

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.

Keyword

Breast neoplasms; Drug therapy; S-1; Oxaliplatin; Phase II trial

Figure

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  Fig. 1 CONSORT diagram.

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

Reference

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