Article Text
Abstract
Background Recurrent or metastatic cervical and endometrial carcinoma is largely an incurable disease due to lack of effective therapies. New treatment strategies are needed to provide long-term anti-tumor responses. Blocking the interaction between PD-1 and its ligands is a promising treatment strategy, and has previously shown encouraging antitumor activity in cervical and endometrial carcinoma. Camrelizumab is a humanised anti-programmed death-1 (anti PD-1) antibody. Therefore, this study aimed to assess the efficacy and safety of camrelizumab combination therapy in patients with recurrent or metastatic cervical and endometrial carcinoma.
Methods Patients (pts) with recurrent or metastatic cervical and endometrial carcinoma were enrolled. Eligible patients were aged 30–70 years with an Eastern Cooperative Oncology Group performance status of 0-2. Pts received camrelizumab (200mg iv d1 q2w) with concurrent chemoradiotherapy (CRT)/radiation/chemotherapy. Paclitaxel and carboplatin are delivered with 175mg/m2 and AUC=5, respectively, d1, q3w for 6-8 cycles. Pts received radiation with external-beam radiotherapy 45~50.4Gy/25~28f, lymph node 60Gy/25~30f 5 times/week, brachytherapy 28~30Gy/4-5f. The primary endpoint was objective response (ORR). The secondary endpoints included disease control rate (DCR), median progression-free survival (mPFS) and safety.
Results 37 pts were enrolled from Sept. 2019 to Apr. 2022. 36 patients were evaluated for efficacy, the ORR and DCR was 53% (19/36) and 83% (30/36), respectively. In addition, 18 pts received camrelizumab combination CRT with the ORR of 76% (13/17) and DCR of 100% (17/17), and 8 pts received camrelizumab combination radiotherapy with the ORR of 12.5% (1/18) and DCR of 50% (4/8), and 11 pts received camrelizumab combination chemotherapy with the ORR of 45% (5/11) and DCR of 82% (9/11). 7 of 37 pts were still receiving the treatment, the mPFS was 12.5 months. Treatment-related adverse events occurred in 57% (21/37) of patients, and the most common adverse events were RCCEP (35%), Thyroid injury (14%) and diarrhea (14%). Treatment-related grade 3 adverse events occurred in 3% (1/37) of pts.
Conclusions Our Results indicates that Camrelizumab with chemoradiotherapy exhibites efficacy rather than combination with radiation/chemotherapy for recurrent or metastatic cervical and endometrial carcinoma. Further studies are planned to explore this new treatment option in a larger study population.