ENT institute and Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, 200031, China.
Department of Radiation Oncology, Eye & ENT Hospital, Fudan University, Shanghai, 200031, China.
Nat Commun. 2024 Jun 19;15(1):5251. doi: 10.1038/s41467-024-49121-3.
This phase II trial aimed to determine the efficacy and safety of induction chemoimmunotherapy of camrelizumab plus modified TPF in locally advanced hypopharyngeal squamous cell carcinoma (LA HSCC) (NCT04156698). The primary endpoint was objective response rate (ORR), and secondary endpoints were 3-year overall survival (OS), progression-free survival (PFS), larynx preservation rate (LPR), and metastasis-free survival (MFS). Patients (cT3-4aN0-2M0), regardless of sex, received induction chemoimmunotherapy for three cycles: camrelizumab 200 mg d1, docetaxel 75 mg/m d1, cisplatin 25 mg/m d1-3, and capecitabine 800 mg/m bid d1-14, q21d. Patients were assigned to radioimmunotherapy if they had a complete or partial response, those with stable or progressive disease underwent surgery and adjuvant (chemo)radiotherapy. Camrelizumab was maintained post-radioimmunotherapy. Fifty-one patients were enrolled with a median follow-up duration of 23.7 months. After induction therapy, the ORR was 82.4% (42/51), meeting the prespecified endpoint. Grade 3/4 adverse events occurred in 26 patients, and no treatment-related death occurred. As three-year outcomes were immature, two-year OS, PFS and LPR were reported. As no distant metastatic event had occurred, MFS was not reported here. The two-year OS, PFS, and LPR rates were 83.0%, 77.1%, and 70.0%, respectively. The induction chemoimmunotherapy of camrelizumab plus TPF showed a high ORR rate with an acceptable safety profile in LA HSCC.
这项 II 期临床试验旨在确定卡瑞利珠单抗联合改良 TPF 诱导化疗治疗局部晚期下咽鳞状细胞癌（LA HSCC）的疗效和安全性（NCT04156698）。主要终点是客观缓解率（ORR），次要终点是 3 年总生存率（OS）、无进展生存率（PFS）、喉保留率（LPR）和无转移生存率（MFS）。患者（cT3-4aN0-2M0），无论性别，均接受三周期诱导化疗免疫治疗：卡瑞利珠单抗 200mg d1，多西他赛 75mg/m d1，顺铂 25mg/m d1-3，卡培他滨 800mg/m bid d1-14，q21d。完全或部分缓解的患者接受放化疗，稳定或进展的患者行手术和辅助（化疗）放疗。放化疗后继续使用卡瑞利珠单抗。51 例患者入组，中位随访时间为 23.7 个月。诱导治疗后，ORR 为 82.4%（42/51），达到预设终点。26 例患者发生 3/4 级不良事件，无治疗相关死亡。由于 3 年结果不成熟，报告了 2 年 OS、PFS 和 LPR。由于没有远处转移事件发生，因此未在此报告 MFS。2 年 OS、PFS 和 LPR 率分别为 83.0%、77.1%和 70.0%。卡瑞利珠单抗联合 TPF 的诱导化疗在 LA HSCC 中显示出高 ORR 率和可接受的安全性。
