贝伐珠单抗联合 S-1 和雷替曲塞治疗标准治疗耐药的转移性结直肠癌患者：一项 II 期研究。
Bevacizumab Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: A Phase II Study.
机构信息
Department of Abdominal Cancer, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.
Department of Biotherapy, Cancer Center, West China Hospital, West China Medical School, Sichuan University, Chengdu, People's Republic of China.
出版信息
Oncologist. 2021 Aug;26(8):e1320-e1326. doi: 10.1002/onco.13778. Epub 2021 Apr 30.
LESSONS LEARNED
Bevacizumab combined with S-1 and raltitrexed demonstrated positive antitumor efficacy and acceptable toxicity. This combination might represent a treatment option for refractory metastatic colorectal cancer.
BACKGROUND
In patients with metastatic colorectal cancer (mCRC) refractory to standard therapies, S-1 plus raltitrexed showed a good objective response rate (ORR) and significant survival benefit in our previous study. In the present study, we assessed the activity and safety of bevacizumab combined with S-1 and raltitrexed.
METHODS
This investigator-initiated, open-label, single-arm, phase II trial was performed at West China Hospital in China. Patients with mCRC who had disease progression after fluoropyrimidine, irinotecan, and oxaliplatin and had at least one measurable lesion were eligible for this trial. Anti-epidermal growth factor receptor (EGFR) (for tumors with wild-type RAS) and anti-vascular endothelial growth factor (VEGF) therapy in the first or second line was allowed, but patients who had been treated with bevacizumab across two consecutive chemotherapy regimens were excluded. Patients received bevacizumab (7.5 mg/kg on day 1), oral S-1 (80-120 mg per day for 14 days), and raltitrexed (3 mg/m on day 1) every 3 weeks. The primary endpoint was ORR. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity.
RESULTS
From September 2015 to November 2019, 44 patients were enrolled. Tumor response evaluation was available in 44 patients at the time of the analysis. There were no complete responses; the ORR was 15.9%, and the disease control rate was 54.5%. Median PFS and OS were 110 days (95% confidence interval [CI], 65.0-155.0) and 367 days (95% CI, 310.4-423.6), respectively. The combination was well tolerated.
CONCLUSION
Bevacizumab combined with S-1 and raltitrexed showed promising antitumor activity and safety in refractory mCRC.
经验教训
贝伐珠单抗联合 S-1 和雷替曲塞显示出积极的抗肿瘤疗效和可接受的毒性。这种联合治疗可能成为难治性转移性结直肠癌的一种治疗选择。
背景
在我们之前的研究中，对于标准治疗耐药的转移性结直肠癌（mCRC）患者，S-1 加雷替曲塞显示出良好的客观缓解率（ORR）和显著的生存获益。在本研究中，我们评估了贝伐珠单抗联合 S-1 和雷替曲塞的活性和安全性。
方法
这是一项在中国华西医院进行的、由研究者发起的、开放标签、单臂、II 期临床试验。该试验纳入了在氟嘧啶、伊立替康和奥沙利铂治疗后疾病进展且至少有一个可测量病灶的 mCRC 患者。允许在一线或二线使用抗表皮生长因子受体（EGFR）（针对 RAS 野生型肿瘤）和抗血管内皮生长因子（VEGF）治疗，但排除了在两个连续化疗方案中接受贝伐珠单抗治疗的患者。患者接受贝伐珠单抗（第 1 天 7.5mg/kg）、口服 S-1（第 1-14 天 80-120mg/天）和雷替曲塞（第 1 天 3mg/m），每 3 周一次。主要终点是 ORR。次要终点包括无进展生存期（PFS）、总生存期（OS）和毒性。
结果
从 2015 年 9 月至 2019 年 11 月，共纳入 44 例患者。在分析时，44 例患者的肿瘤反应评估可评估。无完全缓解；ORR 为 15.9%，疾病控制率为 54.5%。中位 PFS 和 OS 分别为 110 天（95%置信区间 [CI]，65.0-155.0）和 367 天（95% CI，310.4-423.6）。该联合方案耐受性良好。
结论
贝伐珠单抗联合 S-1 和雷替曲塞在难治性 mCRC 中显示出有希望的抗肿瘤活性和安全性。
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