In the Chinese phase II NACI trial reported in The Lancet Oncology, Li et al found that neoadjuvant chemotherapy plus camrelizumab produced antitumor activity and had a manageable adverse event profile in patients with locally advanced cervical cancer.
Study Details
A total of 85 patients were enrolled in the multicenter trial between December 2020 and February 2023. Patients received one cycle of priming doublet chemotherapy (cisplatin at 75–80 mg/m² plus nab-paclitaxel at 260 mg/m², followed by two cycles of cisplatin/nab-paclitaxel) on day 1 with camrelizumab at 200 mg on day 2, with a 3-week interval between treatment cycles. Patients with stable disease or progressive disease received concurrent chemoradiotherapy; patients with complete or partial response proceeded to radical surgery. The primary endpoint was objective response rate on independent central review.
Key Findings
At data cutoff at the end of April 2023, median follow-up was 11.0 months (interquartile range = 6.0–14.5 months). Objective response was observed in 83 patients (98%, 95% confidence interval [CI] = 92%–100%), including 16 (19%) with complete response. Pathologic complete response was observed in 38% (95% CI = 27%–49%).
The most common grade 3 or 4 treatment-related adverse events during neoadjuvant chemoimmunotherapy were lymphopenia (25%) neutropenia (12%), and leukopenia (8%). No serious adverse events or treatment-related deaths were reported.
The investigators concluded: “Neoadjuvant chemoimmunotherapy showed promising antitumor activity and a manageable adverse event profile in patients with locally advanced cervical cancer. The combination of neoadjuvant chemoimmunotherapy with radical surgery holds potential as a novel therapeutic approach for locally advanced cervical cancer.”
Chaoyang Sun, PhD, of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, is the corresponding author of The Lancet Oncology article.
Disclosure: The study supported by the National Key Technology Research and Development Program of China and others. For full disclosures of the study authors, visit thelancet.com.
