| 王 奕,李坚炯,唐莺莺,等.立体定向放射治疗序贯呋喹替尼联合信迪利单抗三线及后线治疗转移性结直肠癌：前瞻性Ⅱ期临床研究的初步结果[J].肿瘤学杂志,2024,30(11):917-923. |
| 立体定向放射治疗序贯呋喹替尼联合信迪利单抗三线及后线治疗转移性结直肠癌：前瞻性Ⅱ期临床研究的初步结果 |
| Stereotactic Body Radiation Therapy Followed by Fruquintinib in Combination with Immunotherapy as Third- and Later-Line Treatment for Metastatic Colorectal Cancer: Preliminary Results from A Prospective Phase Ⅱ Clinical Study |
| 投稿时间：2024-06-18 |
| DOI：10.11735/j.issn.1671-170X.2024.11.B005 |
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| 中文关键词: 立体定向放射治疗 呋喹替尼 信迪利单抗 结直肠癌 疗效 安全性 |
| 英文关键词:stereotactic body radiation therapy fruquintinib sintilimab colorectal cancer efficacy safety |
| 基金项目:吴阶平医学基金（320.6750.2022-09-06） |
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| 中文摘要: |
| 摘 要： ［目的］ 分析立体定向放射治疗（stereotactic body radiation therapy，SBRT）序贯呋喹替尼联合免疫治疗作为转移性结直肠癌（metastatic colorectal cancer，mCRC）三线和后线治疗的初步结果。 ［方法］ 样本量估算招募30例mCRC患者，患者均接受了二线或更多线治疗，根据实体瘤反应性评价标准（response evaluation criteria in solid tumors，RECIST）1.1 至少有1个可测量的病灶。SBRT由研究者判断开展。放疗后1周序贯使用呋喹替尼（3~5 mg口服，第1~14 d，每21 d为1 个周期）联合信迪利单抗（200 mg静脉注射，第1 d，每21 d为1周期），直至出现疾病进展或无法耐受的不良反应导致出组。有效性评估参照RECIST1.1评估，安全性评估参照美国国家癌症研究所临床试验通用标准不良事件 5.0。主要研究终点为无进展生存期。 ［结果］ 已入组22例患者，其中14例男性，中位年龄为59岁，中位随访8.5个月。可评估疗效14例，其中2例(14.29%)达到部分缓解，12例(85.71%)为病情稳定。客观缓解率为14.29%，疾病控制率为100.00%，中位无进展生存期和总生存期仍未达到。最常见的治疗不良事件包括乏力（n=9），22.7%患者发生3~4级不良事件。［结论］ SBRT序贯呋喹替尼联合免疫治疗的初步分析看到了初期疗效，并且作为mCRC的三线及后线治疗其安全性良好，需更多的病例数进一步证实。 |
| 英文摘要: |
| Abstract： ［Objective］ To investigate the preliminary results of stereotactic body radiation therapy(SBRT) followed by fruquintinib in combination with immunotherapy as third- and later-line treatment in metastatic colorectal cancer (mCRC). ［Methods］ A sample size of 30 patients with mCRC was planned. The patients had received second- or later-line treatment for mCRC and had at least 1 measurable lesion per response evaluation criteria in solid tumors(RECIST) version 1.1. One week after SBRT， fruquintinib was orally administered with a daily dose of 3~5 mg on d1~14 in combination with sinti-limab 200 mg intravenously once for d1 with a 21d-cycle. The treatment would continue until progressive disease or intolerable toxicity. The effectiveness evaluation refers to RECIST1.1 evaluation， and the safety evaluation refers to National Cancer Institute common terminology criteria for adverse events(NCI-CTCAE) version 5.0. The primary endpoint was progression-free survival(PFS). ［Results］ Twenty- two patients were enrolled so far with a median follow-up of 8.5 months， of whom 14 patients were males and the median age was 59 years old. Among 14 patients in whom efficacy could be evaluated， 2(14.29%) achieved partial response， 12(85.71%) kept stable disease. The objective response rate was 14.29% and the disease control rate was 100.00%. The median PFS and overall survival were still not reached. The most common treatment related adverse events were fatigue(n=9)， grade 3~4 adverse events occurred in 22.7% of patients. ［Conclusion］ SBRT followed by fruquintinib in combination with immunotherapy yields a promising efficacy and acceptable safety as third- and later-line treatment for mCRC patients， which warrants further large-scale studies. |
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