Neoadjuvant chemotherapy plus camrelizumab for locally advanced cervical cancer (NACI study): a multicentre, single-arm, phase 2 trial

Kezhen Li & Chaoyang Sun et al. · 2023-12-01

Locally advanced cervical cancer constitutes around 37% of cervical cancer cases globally and has a poor prognosis due to limited therapeutic options. Immune checkpoint inhibitors in the neoadjuvant setting could address these challenges. We aimed to investigate the efficacy and safety of neoadjuvant chemo-immunotherapy for locally advanced cervical cancer. In this single-arm, phase 2 trial, which was done across eight tertiary hospitals in China, we enrolled patients aged 18-70 years with untreated cervical cancer (IB3, IIA2, or IIB/IIIC1r with a tumour diameter ≥4 cm [International Federation of Gynecology and Obstetrics, 2018]) and an Eastern Cooperative Oncology Group performance status of 0 or 1. Eligible patients underwent one cycle of priming doublet chemotherapy (75-80 mg/m Between Dec 1, 2020, and Feb 10, 2023, 85 patients were enrolled and all received at least one dose of camrelizumab. Median age was 51 years (IQR 46-57) and no data on race or ethnicity were collected. At data cutoff (April 30, 2023), median follow-up was 11·0 months (IQR 6·0-14·5). An objective response was noted in 83 (98% [95% CI 92-100]) patients, including 16 (19%) patients who had a complete response and 67 (79%) who had a partial response. The most common grade 3-4 treatment-related adverse events during neoadjuvant chemo-immunotherapy were lymphopenia (21 [25%] of 85), neutropenia (ten [12%]), and leukopenia (seven [8%]). No serious adverse events or treatment-related deaths occurred. Neoadjuvant chemo-immunotherapy showed promising antitumour activity and a manageable adverse event profile in patients with locally advanced cervical cancer. The combination of neoadjuvant chemo-immunotherapy with radical surgery holds potential as a novel therapeutic approach for locally advanced cervical cancer. National Key Technology Research and Development Program of China and the National Clinical Research Center of Obstetrics and Gynecology.
Authors
Kezhen Li, Jing Chen, Yingjie Hu, Yan-Zhou Wang, Yuanming Shen, Gang Chen, Wenju Peng, Zixuan Fang, Bairong Xia, Xiaojun Chen, Kun Song, Yingmei Wang, Dongling Zou, Yan-Chun Wang, Yingyan Han, Xue Feng, Jing Yuan, Shuaiqingying Guo, Xiaolin Meng, Chenzhao Feng, Yin Chen, Jie Yang, Junpeng Fan, Jianliu Wang, Jihui Ai, Ding Ma, Chaoyang Sun
Funding

New York University

Jiangsu Hengrui Medicine

National Key Research and Development Program of China

2022YFC2702504

National Key Research and Development Program of China

2022YFC2704400

National Key Research and Development Program of China

2022YFC2704403