Departments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Department of Radiation, Peking University Third Hospital, Haidian District, Beijing, China.
J Clin Oncol. 2022 Jun 1;40(16):1795-1805. doi: 10.1200/JCO.21.02091. Epub 2022 Feb 22.
No combined immunotherapy and antiangiogenic therapy have been investigated in exclusively programmed death-ligand 1 (PD-L1)-positive advanced cervical cancer (CA). We investigated the efficacy and safety of sintilimab plus anlotinib as second-line or later therapy for PD-L1-positive recurrent or metastatic (R/M) CA.
Patients with PD-L1-positive (Combined Positive Score ≥ 1) R/M CA who progressed after at least one prior systemic chemotherapeutic regimen or could not tolerate chemotherapy were eligible for the phase II trial. The patients received 200 mg sintilimab once on day 1 and 10 mg anlotinib once daily on days 1-14 every 3 weeks. The primary end point was investigator-confirmed objective response rate (ORR) per RECIST v1.1. Secondary end points included progression-free survival (PFS), overall survival, and disease control rate. Biomarkers were explored.
Forty-two patients were enrolled. The ORR was 54.8% (95% CI, 38.7 to 70.2). In 39 efficacy-evaluable patients, the ORR was 59.0% (95% CI, 42.1 to 74.4); the disease control rate was 94.9% (95% CI, 82.7 to 99.4). The median PFS was 9.4 months (95% CI, 8.0 to 14.6). The median overall survival was not reached. Furthermore, 85.8% of the patients experienced treatment-related adverse events. The most frequent treatment-related adverse events were hypothyroidism (33.3%), elevated aspartate aminotransferase levels (21.4%), and hypertension (19.0%). Patients with altered , PI3K-AKT signaling, or had a higher ORR, whereas those with altered and/or had a significantly shorter PFS.
Sintilimab plus anlotinib as second-line or later therapy is efficacious and safe for patients with advanced CA who have failed prior chemotherapy.
尚未研究联合免疫治疗和抗血管生成治疗在单纯程序性死亡配体 1（PD-L1）阳性的晚期宫颈癌（CA）中的疗效。我们研究了信迪利单抗联合安罗替尼作为二线或后线治疗 PD-L1 阳性复发性或转移性（R/M）CA 的疗效和安全性。
本 II 期临床试验纳入了至少接受过一种先前全身化疗方案治疗后进展或不能耐受化疗的 PD-L1 阳性（综合阳性评分≥1）R/M CA 患者。患者接受信迪利单抗 200 mg 静脉输注，第 1 天，安罗替尼 10 mg 口服，第 1-14 天，每 3 周 1 次。主要终点为研究者确认的客观缓解率（ORR）根据 RECIST v1.1 评估。次要终点包括无进展生存期（PFS）、总生存期和疾病控制率。对生物标志物进行了探索。
共纳入 42 例患者。ORR 为 54.8%（95%CI，38.7 至 70.2）。在 39 例可评估疗效的患者中，ORR 为 59.0%（95%CI，42.1 至 74.4）；疾病控制率为 94.9%（95%CI，82.7 至 99.4）。中位 PFS 为 9.4 个月（95%CI，8.0 至 14.6）。中位总生存期未达到。此外，85.8%的患者发生治疗相关不良事件。最常见的治疗相关不良事件为甲状腺功能减退症（33.3%）、天门冬氨酸氨基转移酶升高（21.4%）和高血压（19.0%）。改变的 、PI3K-AKT 信号或 患者的 ORR 更高，而改变的 和/或 患者的 PFS 明显更短。
信迪利单抗联合安罗替尼作为二线或后线治疗，对先前化疗失败的晚期 CA 患者有效且安全。
