Zou Jiayun, Wang Yuanyuan, Xu Jiayu, Li Jinna, Wang Tianzhuo, Zhang Ying, Bai Yibo
Department of Oncology, Shengjing Hospital of China Medical University, Shenyang 110004, China.
Department of Nephrology, Shengjing Hospital of China Medical University, Shenyang 110004, China.
J Clin Med. 2023 Dec 21;13(1):57. doi: 10.3390/jcm13010057.
Trifluridine/tipiracil (TAS-102) and fruquintinib are novel antitumor agents for patients with refractory metastatic colorectal cancer (mCRC). We conducted a retrospective study to explore the clinical efficacy and drug toxicities of combination therapy with TAS-102 and fruquintinib in real-life clinical practice.
Between March 2021 and February 2023, patients at two different centers with mCRC who failed two or more lines of prior therapy and received TAS-102 in combination with fruquintinib were recruited.
In total, 32 mCRC patients were included in the analysis. The objective response rate (ORR) and the disease control rate (DCR) were 9.4% and 75%. The median progression-free survival (PFS) and overall survival (OS) were 6.3 (95% CI: 5.3-7.3) and 13.5 (95% CI: 9.5-17.5) months, respectively. Patients without liver metastasis or peritoneal metastasis obtained better median PFS (7.1 m vs. 5.6 m, = 0.03 and 6.3 m vs. 3.4 m, = 0.04), and OS (15.2 m vs. 10.4 m, = 0.01 and 13.6 m vs. 7.1 m, = 0.03), respectively. Other clinicopathological features, including age, tumor site, KRAS status, dosage of fruquintinib, and treatment line, did not affect the clinical efficacy of TAS-102 combined with fruquintinib. The most common grade three-four toxicities were neutropenia (46.9%), anemia (21.9%), diarrhea (15.6%), nausea (12.5%), and hand-foot syndrome rash (12.5%).
Our results suggest that TAS-102 combined with fruquintinib has promising clinical efficacy and manageable safety for refractory mCRC patients in a real-world clinical setting. Further prospective trials are warranted to confirm our results.
曲氟尿苷/替匹嘧啶（TAS-102）和呋喹替尼是用于难治性转移性结直肠癌（mCRC）患者的新型抗肿瘤药物。我们进行了一项回顾性研究，以探讨在实际临床实践中TAS-102与呋喹替尼联合治疗的临床疗效和药物毒性。
在2021年3月至2023年2月期间，招募了来自两个不同中心的mCRC患者，这些患者之前接受过两线或更多线治疗失败，并接受了TAS-102与呋喹替尼联合治疗。
总共32例mCRC患者纳入分析。客观缓解率（ORR）和疾病控制率（DCR）分别为9.4%和75%。中位无进展生存期（PFS）和总生存期（OS）分别为6.3（95%CI：5.3-7.3）个月和13.5（95%CI：9.5-17.5）个月。无肝转移或腹膜转移的患者获得了更好的中位PFS（7.1个月对5.6个月，P=0.03；6.3个月对3.4个月，P=0.04）和OS（15.2个月对10.4个月，P=0.01；13.6个月对7.1个月，P=0.03）。其他临床病理特征，包括年龄、肿瘤部位、KRAS状态、呋喹替尼剂量和治疗线数，均不影响TAS-102联合呋喹替尼的临床疗效。最常见的三/四级毒性为中性粒细胞减少（46.9%）、贫血（21.9%）、腹泻（15.6%）、恶心（12.5%）和手足综合征皮疹（12.5%）。
我们的结果表明，在真实世界临床环境中，TAS-102联合呋喹替尼对难治性mCRC患者具有有前景的临床疗效和可控的安全性。需要进一步的前瞻性试验来证实我们的结果。
