Department of Radiation Oncology, The First Affiliated Hospital of Anhui Medical University, No. 120, Wanshui Road, Hefei, 230000, Anhui, People's Republic of China.
Sci Rep. 2023 Aug 16;13(1):13285. doi: 10.1038/s41598-023-40030-x.
Although the effectiveness of camrelizumab plus apatinib has been confirmed in a phase II clinical study, the efficacy of camrelizumab plus apatinib versus sorafenib for primary liver cancer (PLC) remains unverified. We retrospectively collected the data of 143 patients with PLC who received camrelizumab plus apatinib or sorafenib as the first-line treatment at The First Affiliated Hospital of Anhui Medical University from April 2018 to November 2021. Of these, 71 patients received an intravenous injection of camrelizumab 200 mg (body weight ≥ 50 kg) or 3 mg/kg (body weight < 50 kg) followed by an oral dosage of apatinib 250 mg/day every 3 weeks and 72 patients received sorafenib 400 mg orally, twice a day in 28-day cycles. The primary outcomes were overall survival and progression-free survival. The secondary outcomes were objective response rate, disease control rate, and safety. The median median progression-free survival and median overall survival with camrelizumab plus apatinib and sorafenib were 6.0 (95% confidence interval (CI) 4.2-7.8) and 3.0 months (95% CI 2.3-3.7) and 19.0 (95% CI 16.4-21.6) and 12.0 months (95% CI 8.9-15.1), respectively (death hazard ratio: 0.61, P = 0.023). Grade 3/4 treatment-related adverse events were noted in 50 (70.4%) patients in the camrelizumab plus apatinib group and 19 (26.4%) patients in the sorafenib group. Two treatment-related deaths were recorded. Clinically significant improvements were observed in overall survival and progression-free survival with camrelizumab plus apatinib versus sorafenib. Although the side effects of camrelizumab plus apatinib are relatively high, they can be controlled.
虽然卡瑞利珠单抗联合阿帕替尼在 II 期临床研究中已被证实有效，但卡瑞利珠单抗联合阿帕替尼对比索拉非尼治疗原发性肝癌（PLC）的疗效仍未经证实。我们回顾性收集了 2018 年 4 月至 2021 年 11 月安徽医科大学第一附属医院收治的 143 例 PLC 患者接受卡瑞利珠单抗联合阿帕替尼或索拉非尼一线治疗的数据。其中 71 例患者接受静脉注射卡瑞利珠单抗 200mg（体重≥50kg）或 3mg/kg（体重<50kg），随后口服阿帕替尼 250mg/天，每 3 周一次；72 例患者接受索拉非尼 400mg，每日 2 次，28 天为 1 个周期。主要结局为总生存期和无进展生存期。次要结局为客观缓解率、疾病控制率和安全性。卡瑞利珠单抗联合阿帕替尼和索拉非尼的中位无进展生存期和中位总生存期分别为 6.0（95%置信区间 4.2-7.8）和 3.0 个月（95%置信区间 2.3-3.7）和 19.0（95%置信区间 16.4-21.6）和 12.0 个月（95%置信区间 8.9-15.1）（死亡风险比：0.61，P=0.023）。卡瑞利珠单抗联合阿帕替尼组有 50 例（70.4%）患者和索拉非尼组有 19 例（26.4%）患者发生 3/4 级治疗相关不良事件。记录到 2 例治疗相关死亡。与索拉非尼相比，卡瑞利珠单抗联合阿帕替尼可显著改善总生存期和无进展生存期。虽然卡瑞利珠单抗联合阿帕替尼的副作用相对较高，但可控制。
