Article Text
Abstract
Introduction The survival benefits and choice of neoadjuvant regimens remain controversial in locally advanced cervical cancer (LACC). The efficacy of immunotherapy plus anti-angiogenic therapy has been demonstrated in advanced/recurrent cervical cancer. Adebrelimab is a monoclonal antibody against PD-L1. Here, we assessed the activity and safety of adbrelimab plus bevacizumab in patients with LACC.
Methods This single-center, single-arm exploratory study prospectively enrolled patients with LACC with T1b3, T2a2 and T2b, regardless of lymph node status, and with no signs of metastasis (AJCC 9th TNM staging). Patients received adbrelimab 20mg/kg every 3 weeks for 3 cycles and bevacizumab 15mg/kg every 3 weeks for the prior 2 cycles. The primary endpoint was ORR. Key secondary endpoints were pCR rate, PFS, OS and safety.
Results As of 20 April 2024, Seven patients were enrolled and received treatment. One patient discontinued treatment and two were still on treatment. Four patients were eligible for evaluation. The confirmed ORR was 75% (3 of 4), with 3 partial responses and no complete response. These three patients received radical surgery and none of them were omitted from adjuvant therapy. None pCR were observed. The most common all-grade TEAEs were hypertension (33.3%), fatigue (16.7%), hypothyroidism (16.7%). Fistula occurred in one patient during postoperative chemotherapy/adbrelimab/bev and resulted in surgical emergency of total abdominal colectomy.
Conclusion/Implications Neoadjuvant immuno-anti-angiogenic therapy showed promising antitumor activity in LACC but did not lower the percentage of adjuvant treatment. The risk of fistula should be noted and the rationale of the combination in neoadjuvant settings should be considered.