Abstract 562P
Background
Camrelizumab, a humanized antibody against programmed death protein 1, has shown promising efficacy in patients with recurrent, metastatic cervical cancer. We assessed the anti-tumor activity and safety of camrelizumab plus concurrent chemoradiotherapy in patients with locally advanced cervical cancer.
Methods
This is a single-arm, open-label, phase II study. Patients aged 18 to 75 years with previously untreated locally advanced cervical cancer (FIGO stage IB2 to IIB with positive nodes, or IIIA to IIIC) were enrolled. All patients were treated with six cycles of concurrent chemoradiotherapy including cisplatin (40 mg/m2, Q1W) combined with three-dimensional intensity modulated external radiation and three-dimensional afterloading radiotherapy. Camrelizumab was administered intravenously at 200 mg every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was objective response rate (ORR) assessed by investigators per RECIST version 1.1. Key secondary endpoints were disease control rate (DCR) and safety.
Results
From January 2021 to March 2022, a total of 32 patients was enrolled and 25 patients were evaluable for tumor response. Median age was 50.2 years (range, 30-65 years). The ORR was 96.0% (24/25) and DCR was 100.0% (25/25), with seven patients achieving complete response, 17 partial responses, and one having stable disease. Treatment-related grade 3 or 4 adverse events occurred in 16.0% (4/25) of patients, primarily conjunctivitis (4.0%), lateral rectus paralysis (4.0%), leucopenia (4.0%), and thrombocytopenia (4.0%). The most common potentially immune-related adverse events were reactive cutaneous capillary endothelial proliferation (92.0%) and all were grade 1-2, followed by radiation enteritis (80.0%) and anemia (56.0%). No treatment-related deaths occurred.
Conclusions
Camrelizumab plus concurrent chemoradiotherapy show promising antitumor activity and manageable toxicities in patients with locally advanced cervical cancer. Long-term outcomes are still pending to further evaluate their therapeutic effects (ChiCTR2100046760).
Clinical trial identification
ChiCTR2100046760.
Editorial acknowledgement
Legal entity responsible for the study
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.