一项在既往接受过蒽环类和紫杉类药物治疗的转移性乳腺癌患者中进行的 S-1 和奥沙利铂的 II 期临床试验（KCSG-BR07-03）。
A Phase II Trial of S-1 and Oxaliplatin in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane (KCSG-BR07-03).
机构信息
Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
出版信息
Cancer Res Treat. 2023 Apr;55(2):523-530. doi: 10.4143/crt.2022.1360. Epub 2022 Nov 8.
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.
目的
本单臂 II 期临床试验旨在研究替吉奥（S-1）联合奥沙利铂（SOX）在转移性乳腺癌患者中的疗效和安全性。
材料与方法
本研究纳入了先前接受过蒽环类和紫杉类药物治疗的转移性乳腺癌患者。患者接受 S-1（根据患者体表面积，40-60mg，每日两次，第 1-14 天）和奥沙利铂（130mg/m2，第 1 天）治疗，每 3 周为一个周期，直至疾病进展或出现不可接受的毒性。主要终点为根据实体瘤反应评价标准 1.1 评估的客观缓解率（ORR）。次要终点包括无进展生存期（TTP）、缓解持续时间（DoR）、总生存期（OS）和不良事件。
结果
本研究共纳入了来自韩国 11 家机构的 87 例患者。其中，54 例（62.1%）患者的激素受体阳性，6 例（6.9%）患者的人表皮生长因子受体 2 阳性。48 例（85.1%）患者有内脏转移，74 例（55.2%）患者有超过 3 个转移部位。SOX 方案的 ORR 为 38.5%（95%置信区间，26.9%至 50.0%），中位 TTP 为 6.0 个月（95%置信区间，5.1 至 6.9）。中位 DoR 和 OS 分别为 10.3 个月（95%置信区间，5.5 至 15.1）和 19.4 个月（95%置信区间，未估计）。32.1%（28 例）的患者出现 3 级或 4 级中性粒细胞减少症，26.6%（23 例）的患者出现血小板减少症。
结论
本 II 期研究表明，SOX 方案是先前接受蒽环类和紫杉类药物治疗的转移性乳腺癌的一种合理选择。
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