Objective: Therapeutic regimens are relatively scarce among patients with treatment-refractory metastatic colorectal cancer (CRC). This study aimed to determine the feasibility and tolerability of anlotinib plus PD-1 blockades in patients with treatment-refractory metastatic CRC retrospectively.
Methods: A total of 68 patients with previously treated metastatic CRC who received anlotinib plus PD-1 blockades in clinical practice were included in this study retrospectively. Demographic and clinical characteristics of the patients, therapeutic outcomes and safety profile during administration were collected and briefly analyzed. All subjects were followed up regularly. Therapeutic outcomes, including drug response and prognosis, were presented, and a safety profile was depicted to illustrate the adverse reactions.
Results: A total of 68 patients with treatment-refractory metastatic CRC who received anlotinib plus PD-1 blockades in clinical practice were included in the final analysis. Best therapeutic response during treatment indicated that partial response was observed in 11 patients, stable disease was noted in 41 patients, and progressive disease was found in 16 patients, producing an objective response rate of 16.2% (95% CI: 8.4%– 27.1%) and a disease control rate of 76.5% (95% CI: 64.6%– 85.9%). Prognostic analysis suggested that the median progression-free survival (PFS) of the 68 patients was 5.3 months (95% CI: 3.01– 7.59), and the median overall survival (OS) was 12.5 months (95% CI: 9.40– 15.60). Of the 11 patients who responded, the median duration of response was 6.7 months (95% CI: 2.89– 10.53). Safety profile during treatment showed that patients experienced adverse reactions regardless of grade, and grade ≥ 3 adverse reactions were found in 61 patients (89.7%) and 41 patients (60.3%), respectively. Common adverse reactions were hypertension, myelosuppression (including leukopenia, neutropenia, thrombocytopenia, and anemia), fatigue, and hand-foot syndrome.
Conclusion: Anlotinib plus PD-1 blockades demonstrated encouraging efficacy and acceptable safety profile in patients with treatment-refractory metastatic CRC preliminarily in clinical practice. This conclusion should be confirmed in prospective clinical trials.

Keywords: colorectal cancer, anlotinib, PD-1 blockades, efficacy, safety


中文翻译：

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安罗替尼联合 PD-1 阻断治疗难治性转移性结直肠癌患者的可行性和耐受性：一项回顾性探索性研究

目的：难治性转移性结直肠癌（CRC）患者的治疗方案相对匮乏。本研究旨在回顾性确定安罗替尼加 PD-1 阻断治疗难治性转移性 CRC 患者的可行性和耐受性。
方法：本研究回顾性纳入 68 例既往接受过治疗、在临床实践中接受安罗替尼加 PD-1 阻断的转移性 CRC 患者。收集并简要分析患者的人口统计学和临床​​特征、治疗结果和给药期间的安全性概况。所有受试者均定期随访。提出了治疗结果，包括药物反应和预后，并描述了安全性概况以说明不良反应。
结果：最终分析共纳入68例在临床实践中接受安罗替尼加PD-1阻断治疗的难治性转移性CRC患者。治疗期间的最佳治疗反应表明，11 名患者出现部分缓解，41 名患者病情稳定，16 名患者出现疾病进展，客观缓解率为 16.2%（95% CI：8.4%–27.1%） ），疾病控制率为 76.5%（95% CI：64.6%–85.9%）。预后分析表明，68 名患者的中位无进展生存期 (PFS) 为 5.3 个月 (95% CI: 3.01–7.59)，中位总生存期 (OS) 为 12.5 个月 (95% CI: 9.40–15.60) 。在 11 名有缓解的患者中，中位缓解持续时间为 6.7 个月（95% CI：2.89-10.53）。治疗期间的安全性状况显示，无论级别如何，患者都会出现不良反应，其中≥3级不良反应分别为61例（89.7%）和41例（60.3%）。常见不良反应为高血压、骨髓抑制（包括白细胞减少、中性粒细胞减少、血小板减少和贫血）、疲劳和手足综合征。
结论：安罗替尼联合 PD-1 阻断剂在临床实践中初步显示出对难治性转移性 CRC 患者的令人鼓舞的疗效和可接受的安全性。这一结论应在前瞻性临床试验中得到证实。

关键词:结直肠癌, 安罗替尼, PD-1 阻断, 疗效, 安全性