Department of Medical Oncology, Beijing Chaoyang District Sanhuan Cancer Hospital, Beijing, 100122, China.
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Br J Cancer. 2024 Dec;131(11):1775-1780. doi: 10.1038/s41416-024-02885-3. Epub 2024 Oct 24.
To explore the efficacy and safety of the combination of irinotecan, trifluridine/tipiracil (TAS-102), and bevacizumab in a later-line setting for metastatic colorectal cancer (mCRC) patients.
This was a single-center, phase II trial. The mCRC patients who are refractory to standard first-line and second-line treatment are eligible. Patients who previously received irinotecan while progressing during maintenance therapy are also eligible. The primary endpoint was the objective response rate (ORR).
Between August 1, 2022, and September 30, 2023, 35 patients were enrolled, and 31 of them were evaluable for efficacy. The ORR was 25.8% (8/31), and the disease control rate (DCR) was 93.5% (29/31). As of April 30, 2024, the median progression-free survival (PFS) was 9.2 months (95% CI 6.285-12.115), whereas the median overall survival (OS) was not reached with the 1-year OS rate of 73.5%. The most common grade 3/4 treatment-related adverse events were neutropenia (34.3%), anemia (17.1%), and thrombocytopenia (8.6%).
Irinotecan, TAS-102 plus bevacizumab regimen preliminarily demonstrated promising efficacy with tolerable toxicity for mCRC patients as later-line treatment. This regimen warrants further exploration in refractory mCRC patients.
探索伊立替康、三氟尿苷/替匹嘧啶（TAS-102）联合贝伐珠单抗在转移性结直肠癌（mCRC）患者二线治疗中的疗效和安全性。
这是一项单中心、二期临床试验。符合标准的一线和二线治疗难治性 mCRC 患者有资格入组。在维持治疗中进展时曾接受过伊立替康治疗的患者也符合条件。主要终点是客观缓解率（ORR）。
2022 年 8 月 1 日至 2023 年 9 月 30 日期间，共入组 35 例患者，其中 31 例可评估疗效。ORR 为 25.8%（8/31），疾病控制率（DCR）为 93.5%（29/31）。截至 2024 年 4 月 30 日，中位无进展生存期（PFS）为 9.2 个月（95%CI 6.285-12.115），中位总生存期（OS）尚未达到，1 年 OS 率为 73.5%。最常见的 3/4 级治疗相关不良事件是中性粒细胞减少（34.3%）、贫血（17.1%）和血小板减少（8.6%）。
伊立替康、TAS-102 联合贝伐珠单抗方案作为二线治疗mCRC 患者，初步显示出有前景的疗效和可耐受的毒性。该方案值得在难治性 mCRC 患者中进一步探索。
